Randox Level 3 (HUM ASY CONTROL 3) Human Assayed Multi-sera Instruction manual
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0120 HUMAN ASSAYED MULTI-SERA - LEVEL 3 (HUM ASY CONTROL 3) CAT. NO. HE1532 / HS2611 SIZE: 20 x 5ml / 5 x 5ml LOT NO. 751UE EXP: 2019-01 INTENDED USE This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy. DEVICE DESCRIPTION The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels. SAFETY PRECAUTIONS AND WARNINGS For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents. Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NONREACTIVE. FDA approved methods have been used to conduct these tests. However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly. Health and Safety Data Sheets are available on request. STORAGE AND STABILITY OPENED: Store refrigerated (+2°C to +8°C). Reconstituted serum is stable for 8 hours at +15°C to +25°C or 7 days at +2°C to +8°C, and 28 days when frozen once at –18°C to –24°C. (See Limitations) UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials. LIMITATIONS For Total & Prostatic Acid Phosphatase, the material should be stabilised by adding 1 drop (25 - 30µl) of 0.7M Acetic acid solution to 1ml of the serum exactly 30 minutes after reconstitution. After stabilisation Total and Prostatic Acid Phosphatase is stable for 2 hours at +15°C to +25°C, 2 days at +2°C to +8°C, and 28 days when frozen once at –18°C to –24°C. Alkaline Phosphatase levels in the reconstituted serum will rise over the stability period. It is recommended that the reconstituted serum is allowed to stand for 1 hour at +15°C to +25°C before measurement. Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark. Stored in the dark, it is stable for 4 days at +2°C to +8°C. Do not store at +15°C to +25°C. Do not freeze. NEFA is stable for 1 day at +2°C to +8°C. Total PSA is stable for 4 days at +2°C to +8°C, or 28 days in aliquots frozen at –18°C to –24°C. Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. Different lot numbers of this control should not be interchanged, as the values assigned to the controls vary from lot to lot. The control should not be used as a calibration material. PREPARATION FOR USE The Human Assayed Multi-sera is supplied lyophilised. 1. Carefully reconstitute each vial of lyophilised serum with exactly 5ml of distilled water at +15°C to +25°C. Close the bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of foam. Do not shake. 2. Refer to the Control section of the individual analyser application. 3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly. MATERIALS PROVIDED Human Assayed Multi-sera - Level 3 20 x 5ml / 5 x 5ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www.randox.com PAGE 1 OF 2 HE1532 - Lot No. 751UE 0120 MATERIALS REQUIRED BUT NOT PROVIDED Volumetric pipette ASSIGNED VALUES Each batch of assayed human serum is submitted to reference laboratories for assignment against international Reference Standards. Where international Reference Standards are unavailable, Reference Methods are used. Values are also collected from approx. 3000 laboratories worldwide and using a unique statistical analysis, a value is assigned. With each batch, a control range is provided for individual parameters and each parameter method. The control range is equivalent to the assigned mean ±2S.D. This results in an assayed serum with extremely accurate values, which may be confidently used by laboratories to ensure the accuracy of their methods. If an instrument specific value is not available, refer to the Mean of all Instruments section. If necessary, contact Randox Laboratories Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email [email protected] NOTES ® All trademarks recognised (1) (2) (3) (4) (5) Applies only in Germany. Ranges established according to the Guidelines of the Federal Chamber of Physicians in Germany. Values established by reference laboratories officially recognised by the Federal Chamber of Physicians in Germany. DGKC: German Society for Clinical Chemistry. IFCC: International Federation of Clinical Chemistry. SCE: Scandinavian Committee on Enzymes. 05 May ’15 ne Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www.randox.com PAGE 2 OF 2 A ABBOTT AEROSET® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 28.2 24.0 32.4 2.10 4.20 Bromocresol Green g/dl 2.82 2.40 3.24 0.21 0.42 Alkaline Phosphatase U/l 351 299 403 26.00 52.00 AMP optimised to IFCC 37°C ALT (GPT) U/l 133 106 160 13.50 27.00 Tris buffer without P5P 37°C AST (GOT) U/l 136 109 163 13.50 27.00 Tris buffer without P5P 37°C Bilirubin Direct µmol/l 28.5 22.5 34.5 3.00 6.00 Diazo with Dichloroaniline (DCA) mg/dl 1.67 1.32 2.02 0.18 0.35 Bilirubin Total µmol/l 85.3 67.4 103 8.95 17.90 mg/dl 4.99 3.94 6.04 0.53 1.05 Calcium mmol/l 3.16 2.85 3.47 0.16 0.31 mg/dl 12.7 11.4 14.0 0.65 1.30 mmol/l 6.82 5.93 7.71 0.45 0.89 mg/dl 263 229 297 17.00 34.00 Chloride mmol/l 113 104 122 4.50 9.00 ISE direct CK Total U/l 561 460 662 50.50 101.00 CK-NAC (IFCC) 37°C Creatinine µmol/l 360 288 432 36.00 72.00 Alkaline picrate no deproteinization mg/dl 4.07 3.25 4.89 0.41 0.82 mmol/l 16.0 13.6 18.4 1.20 2.40 mg/dl 288 245 331 21.50 43.00 mmol/l 2.51 2.13 2.89 0.19 0.38 mg/dl 96.9 82.2 112 7.35 14.70 Cholesterol Glucose HDL - Cholesterol Diazo with Dichloroaniline (DCA) Arsenazo III Cholesterol Oxidase Hexokinase HDL - Ultra Page 1 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A ABBOTT AEROSET® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Iron Range unit Target low high 1SD 2SD methods Colorimetric without ppt. µmol/l 36.8 30.2 43.4 3.30 6.60 µg/dl 206 169 243 18.50 37.00 Phosphate Inorganic mmol/l 2.29 1.95 2.63 0.17 0.34 mg/dl 7.10 6.05 8.15 0.53 1.05 Potassium mmol/l 6.00 5.52 6.48 0.24 0.48 ISE method - direct Protein Total g/l 45.5 36.4 54.6 4.55 9.10 Biuret reaction end point g/dl 4.55 3.64 5.46 0.46 0.91 Sodium mmol/l 158 150 166 4.00 8.00 ISE method - direct Triglycerides mmol/l 2.97 2.50 3.44 0.24 0.47 Lipase/GPO-PAP no correction mg/dl 263 221 305 21.00 42.00 mmol/l 0.56 0.49 0.63 0.04 0.07 mg/dl 9.39 8.16 10.6 0.62 1.23 mmol/l 0.57 0.50 0.65 0.04 0.07 1.24 Uric Acid (Urate) Urea mg/dl 9.61 8.37 10.9 0.62 mmol/l 19.7 16.7 22.7 1.50 3.00 mg/dl 118 100 136 9.00 18.00 mmol/l 18.9 16.1 21.7 1.40 2.80 mg/dl 114 96.8 131 8.60 17.20 mmol/l 19.7 16.7 22.7 1.50 3.00 mg/dl 55.3 47.0 63.6 4.15 8.30 Phosphomolybdate UV Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic Urease hypochlorite BUN Page 2 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Abbott Architect c/ci Systems® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 29.1 24.8 33.4 2.15 4.30 Bromocresol Green g/dl 2.91 2.48 3.34 0.22 0.43 g/l 27.6 23.4 31.8 2.10 4.20 Bromocresol Purple g/dl 2.76 2.34 3.18 0.21 0.42 Alkaline Phosphatase U/l 330 281 379 24.50 49.00 U/l 332 283 381 24.50 49.00 AMP non-optimised 37°C ALT (GPT) U/l 133 107 159 13.00 26.00 Tris buffer without P5P 37°C Amylase Pancreatic U/I 279 237 321 21.00 42.00 Immunoinhibition EPS substrate 37°C AMP optimised to IFCC 37°C Amylase Total U/I 326 277 375 24.50 49.00 Randox liquid stable pNPG7 37°C AST (GOT) U/l 136 109 163 13.50 27.00 Tris buffer without P5P 37°C Bile Acids µmol/l 50.8 40.6 61.0 5.10 10.20 Enzymatic Colorimetric Bicarbonate mmol/l 15.5 12.3 18.7 1.60 3.20 Enzymatic Bilirubin Direct µmol/l 27.1 21.4 32.8 2.85 5.70 Diazo with Sulphanilic Acid mg/dl 1.59 1.25 1.93 0.17 0.34 µmol/l 26.6 21.0 32.2 2.80 5.60 mg/dl 1.56 1.23 1.89 0.17 0.33 µmol/l 84.5 66.7 102 8.90 17.80 mg/dl 4.94 3.90 5.98 0.52 1.04 µmol/l 87.5 69.1 106 9.20 18.40 mg/dl 5.12 4.04 6.20 0.54 1.08 µmol/l 87.6 69.2 106 9.20 18.40 mg/dl 5.12 4.05 6.19 0.54 1.07 Bilirubin Total Diazo with Dichloroaniline (DCA) Diazo with Dichloroaniline (DCA) Diazo with Sulphanilic Acid Dichlorophenyl Diazonium (DPD) Page 1 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Abbott Architect c/ci Systems® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Bilirubin Total µmol/l 85.1 67.2 103 mg/dl 4.98 3.93 6.03 Calcium mmol/l 3.21 2.89 3.53 0.16 0.32 mg/dl 12.9 11.6 14.2 0.65 1.30 Cholesterol mmol/l 6.54 5.69 7.39 0.43 0.85 mg/dl 252 220 284 16.00 32.00 Chloride mmol/l 114 105 123 4.50 9.00 ISE indirect CK Total U/l 540 443 637 48.50 97.00 CK-NAC (IFCC) 37°C Creatinine µmol/l 383 306 460 38.50 77.00 Alkaline picrate no deproteinization mg/dl 4.33 3.46 5.20 0.44 0.87 µmol/l 394 315 473 39.50 79.00 mg/dl 4.45 3.56 5.34 0.45 0.89 µmol/l 384 307 461 38.50 77.00 mg/dl 4.34 3.47 5.21 0.44 0.87 µmol/l 379 303 455 38.00 76.00 mg/dl 4.28 3.42 5.14 0.43 0.86 pmol/l 55.8 41.8 69.8 7.00 14.00 ng/dl 4.35 3.26 5.44 0.55 1.09 pg/ml 43.5 32.6 54.4 5.45 10.90 Free T4 gamma-GT Glucose high 1SD 2SD methods 8.95 17.90 Diazonium ion 0.53 1.05 Arsenazo III Cholesterol Oxidase Randox Enzymatic UV method Jaffe rate blanked IDMS traceable Abbott Architect Abbott Architect U/I 157 133 181 12.00 24.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 160 136 184 12.00 24.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 160 136 184 12.00 24.00 DCL gamma glutamyl-3-carboxy-4-nitroanilide 37°C mmol/l 15.7 13.4 18.0 1.15 2.30 Hexokinase mg/dl 283 241 325 21.00 42.00 Page 2 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Abbott Architect c/ci Systems® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods HDL - Cholesterol mmol/l 2.77 2.35 3.19 0.21 0.42 Direct HDL PPD mg/dl 107 90.7 123 8.15 16.30 mmol/l 2.77 2.35 3.19 0.21 0.42 mg/dl 107 90.7 123 8.15 16.30 mmol/l 2.72 2.31 3.13 0.21 0.41 Direct Clearance Method HDL - Ultra mg/dl 105 89.2 121 7.90 15.80 µmol/l 37.9 31.1 44.7 3.40 6.80 µg/dl 212 174 250 19.00 38.00 µmol/l 38.1 31.3 44.9 3.40 6.80 µg/dl 213 175 251 19.00 38.00 Lactate mmol/l 5.57 4.57 6.57 0.50 1.00 mg/dl 50.2 41.2 59.2 4.50 9.00 LD (LDH) U/l 384 327 441 28.50 57.00 U/l 386 328 444 29.00 58.00 L->P IFCC 37°C Lipase U/I 66 53 79 6.50 13.00 Other Colorimetric 37°C Lithium mmol/l 2.11 1.86 2.36 0.13 0.25 Spectrophotometric mg/dl 1.47 1.29 1.65 0.09 0.18 Magnesium mmol/l 1.83 1.61 2.05 0.11 0.22 mg/dl 4.45 3.91 4.99 0.27 0.54 Iron mmol/l 1.82 1.60 2.04 0.11 0.22 mg/dl 4.42 3.89 4.95 0.27 0.53 Colorimetric with ppt. Colorimetric without ppt. Colorimetric Lactate Oxidase L->P 37°C Arsenazo III Enzymatic Osmolality mOsm/kg 358 287 429 35.50 71.00 Calculated Phosphate Inorganic mmol/l 2.30 1.96 2.64 0.17 0.34 Phosphomolybdate enzymatic mg/dl 7.13 6.08 8.18 0.53 1.05 mmol/l 2.30 1.96 2.64 0.17 0.34 mg/dl 7.13 6.08 8.18 0.53 1.05 Phosphomolybdate UV Page 3 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Abbott Architect c/ci Systems® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Range unit Target low high 1SD 2SD methods Potassium mmol/l 6.19 5.70 6.68 0.25 0.49 ISE method - indirect Protein Total g/l 45.7 36.6 54.8 4.55 9.10 Biuret reaction end point g/dl 4.57 3.66 5.48 0.46 0.91 g/l 45.5 36.4 54.6 4.55 9.10 g/dl 4.55 3.64 5.46 0.46 0.91 PSA Total ng/ml = 27.0 20.2 33.8 3.40 6.80 Abbott Architect Sodium mmol/l 162 154 170 4.00 8.00 ISE method - indirect Thyroid Stimulating Hormone µU/ml = 1.01 0.81 1.21 0.10 0.20 Abbott Architect TIBC µmol/l 50.5 39.9 61.1 5.30 10.60 FE+UIBC(saturation with iron) µg/dl 282 223 341 29.50 59.00 mmol/l 3.05 2.56 3.54 0.25 0.49 Triglycerides Uric Acid (Urate) mg/dl 270 227 313 21.50 43.00 mmol/l 3.08 2.59 3.57 0.25 0.49 44.00 mg/dl 273 229 317 22.00 mmol/l 3.04 2.55 3.53 0.25 0.49 mg/dl 269 226 312 21.50 43.00 mmol/l 3.05 2.56 3.54 0.25 0.49 mg/dl 270 227 313 21.50 43.00 mmol/l 0.57 0.50 0.65 0.04 0.08 mg/dl 9.59 8.33 10.9 0.63 1.26 mmol/l 0.57 0.50 0.64 0.04 0.07 mg/dl 9.56 8.32 10.8 0.62 1.24 mmol/l 0.56 0.49 0.63 0.04 0.07 mg/dl 9.42 8.20 10.6 0.61 1.22 Biuret reaction kinetic Lipase/GPO-PAP no correction Lipase/GPO-PAP 0.11mmol/l correction L/G Kinase EP. no correction Agappe - GPO - TOPS Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Page 4 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Abbott Architect c/ci Systems® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Urea mmol/l 19.8 16.8 22.8 mg/dl 119 101 137 1.50 3.00 Urease kinetic 9.00 18.00 mmol/l 19.8 16.8 22.8 1.50 3.00 mg/dl 55.6 47.3 63.9 4.15 8.30 BUN Page 5 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Alfa Wassermann Alfa 600/Analyticon Biolyzer 600 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.0 25.5 34.5 2.25 4.50 Bromocresol Green g/dl 3.00 2.55 3.45 0.23 0.45 U/l 147 118 176 14.50 29.00 Tris buffer without P5P 37°C ALT (GPT) AST (GOT) Cholesterol Creatinine U/I 109 87 131 11.00 22.00 Tris buffer without P5P 30°C U/I 83 66 100 8.50 17.00 Tris buffer without P5P 25°C U/l 148 119 177 14.50 29.00 Tris buffer without P5P 37°C U/I 100 80 120 10.00 20.00 Tris buffer without P5P 30°C U/I 70 57 83 6.50 13.00 Tris buffer without P5P 25°C mmol/l 6.82 5.93 7.71 0.45 0.89 Cholesterol Oxidase mg/dl 263 229 297 17.00 34.00 µmol/l 363 290 436 36.50 73.00 mg/dl 4.10 3.28 4.92 0.41 0.82 Glucose mmol/l 16.6 14.1 19.1 1.25 2.50 mg/dl 299 254 344 22.50 45.00 Protein Total g/l 47.7 38.1 57.3 4.80 9.60 g/dl 4.77 3.81 5.73 0.48 0.96 mmol/l 3.03 2.54 3.52 0.25 0.49 mg/dl 268 225 311 21.50 43.00 Uric Acid (Urate) mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.24 8.05 10.4 0.60 1.19 Urea mmol/l 19.1 16.2 22.0 1.45 2.90 mg/dl 115 97.4 133 8.80 17.60 Triglycerides Alkaline picrate no deproteinization Hexokinase Biuret reaction end point Lipase/GPO-PAP no correction Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic Page 1 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Alfa Wassermann Alfa 600/Analyticon Biolyzer 600 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high Urea mmol/l 19.1 16.2 22.0 mg/dl 53.6 45.6 61.6 1SD 2SD methods 1.45 2.90 BUN 4.00 8.00 Page 2 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman Coulter AU Series® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 28.1 23.9 32.3 2.10 4.20 Bromocresol Green g/dl 2.81 2.39 3.23 0.21 0.42 U/l 436 371 501 32.50 65.00 U/l 561 477 645 42.00 84.00 Diethanolamine buffer DEA 37°C U/l 273 232 314 20.50 41.00 Roche Integra AMP buffer 37°C Alkaline Phosphatase p-Nitrophenylphosphate AMP 37°C U/l 422 359 485 31.50 63.00 AMP optimised to IFCC 37°C ALT (GPT) U/l 139 111 167 14.00 28.00 Tris buffer without P5P 37°C Amylase Total U/I 302 256 348 23.00 46.00 pNP Maltotrioside substrates 37°C U/I 304 258 350 23.00 46.00 Biotrol - blocked pNPG7 37°C U/I 297 252 342 22.50 45.00 Beckman maltotetraose 37°C U/I 286 243 329 21.50 43.00 Roche liquid stable pNPG7 37°C AST (GOT) U/I 303 258 348 22.50 45.00 Beckman Coulter - blocked pNPG7 37°C U/l 145 116 174 14.50 29.00 Tris buffer without P5P 37°C Bicarbonate mmol/l 16.9 13.4 20.4 1.75 3.50 Enzymatic Bilirubin Direct µmol/l 23.1 18.3 27.9 2.40 4.80 Dichlorophenyl Diazonium (DPD) mg/dl 1.35 1.07 1.63 0.14 0.28 µmol/l 85.0 67.2 103 8.90 17.80 mg/dl 4.97 3.93 6.01 0.52 1.04 µmol/l 85.7 67.7 104 9.00 18.00 mg/dl 5.01 3.96 6.06 0.53 1.05 µmol/l 83.2 65.7 101 8.75 17.50 mg/dl 4.87 3.84 5.90 0.52 1.03 Bilirubin Total Diazo with Sulphanilic Acid Dichlorophenyl Diazonium (DPD) Oxidation to Biliverdin Page 1 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman Coulter AU Series® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Calcium mmol/l 3.19 2.87 3.51 mg/dl 12.8 11.5 14.1 0.16 0.32 Cresolphthalein complexone 0.65 1.30 mmol/l 3.22 2.90 3.54 0.16 0.32 Arsenazo III mg/dl 12.9 11.6 14.2 0.65 1.30 Cholesterol mmol/l 6.60 5.75 7.45 0.43 0.85 mg/dl 255 222 288 16.50 33.00 Chloride mmol/l 113 104 122 4.50 9.00 Cholinesterase U/l 5026 4021 6031 502.50 1005.00 Colorimetric Butyrylthiocholine 37°C CK Total U/l 567 465 669 51.00 102.00 U/l 560 459 661 50.50 101.00 CK-NAC (IFCC) 37°C Copper µmol/l 26.4 21.1 31.7 2.65 5.30 Colorimetric µg/dl 168 134 202 17.00 34.00 Creatinine µmol/l 361 289 433 36.00 72.00 mg/dl 4.08 3.27 4.89 0.41 0.81 µmol/l 376 301 451 37.50 75.00 mg/dl 4.25 3.40 5.10 0.43 0.85 µmol/l 383 306 460 38.50 77.00 mg/dl 4.33 3.46 5.20 0.44 0.87 µmol/l 377 302 452 37.50 75.00 mg/dl 4.26 3.41 5.11 0.43 0.85 µmol/l 368 295 441 36.50 73.00 mg/dl 4.16 3.33 4.99 0.42 0.83 µmol/l 363 290 436 36.50 73.00 mg/dl 4.10 3.28 4.92 0.41 0.82 Cholesterol Oxidase ISE indirect CK-NAC substrate start (DGKC) 37°C Alkaline picrate no deproteinization Randox Enzymatic UV method Creatinine PAP method Roche Creatinine Plus Jaffe rate blanked Jaffe rate blanked comp. (-26 µmol/l) Page 2 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman Coulter AU Series® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Creatinine µmol/l 368 294 442 37.00 74.00 Jaffe rate blanked compensated (-18 µmol/l) mg/dl 4.16 3.32 5.00 0.42 0.84 µmol/l 371 297 445 37.00 74.00 D-3-Hydroxybutyrate gamma-GT mg/dl 4.19 3.36 5.02 0.42 0.83 mmol/l 1.18 1.00 1.36 0.09 0.18 IDMS traceable Tris buffer 100mmol pH 8.5 U/I 168 143 193 12.50 25.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 166 141 191 12.50 25.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C GLDH U/I 29 23 35 3.00 6.00 Triethanolamine buffer 50 mmol 37°C Glucose mmol/l 15.7 13.4 18.0 1.15 2.30 Hexokinase mg/dl 283 241 325 21.00 42.00 mmol/l 16.1 13.7 18.5 1.20 2.40 HDL - Cholesterol Iron Lactate LD (LDH) mg/dl 290 247 333 21.50 43.00 mmol/l 2.63 2.24 3.02 0.20 0.39 mg/dl 102 86.5 118 7.75 15.50 mmol/l 2.79 2.37 3.21 0.21 0.42 mg/dl 108 91.5 125 8.25 16.50 mmol/l 2.98 2.53 3.43 0.23 0.45 mg/dl 115 97.7 132 8.65 17.30 µmol/l 37.4 30.7 44.1 3.35 6.70 µg/dl 209 172 246 18.50 37.00 µmol/l 37.5 30.7 44.3 3.40 6.80 µg/dl 210 172 248 19.00 38.00 mmol/l 5.57 4.57 6.57 0.50 1.00 mg/dl 50.2 41.2 59.2 4.50 9.00 U/l 378 321 435 28.50 57.00 Glucose oxidase Direct HDL Immunoseparation Direct Clearance Method Direct HDL Roche 3rd generation Colorimetric with ppt. Colorimetric without ppt. Colorimetric Lactate Oxidase L->P 37°C Page 3 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman Coulter AU Series® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods LD (LDH) U/l 874 743 1005 65.50 131.00 P->L Scandinavian & Dutch 37°C U/l 758 644 872 57.00 114.00 P->L German methods 37°C U/l 384 326 442 29.00 58.00 L->P IFCC 37°C U/I 67 54 80 6.50 13.00 Other Colorimetric 37°C U/I 61 49 73 6.00 12.00 Roche Colorimetric 37°C Lipase U/I 82 66 98 8.00 16.00 Randox Colorimetric 37°C mmol/l 2.10 1.85 2.35 0.13 0.25 Spectrophotometric mg/dl 1.46 1.28 1.64 0.09 0.18 mmol/l 1.81 1.60 2.02 0.11 0.21 mg/dl 4.40 3.89 4.91 0.26 0.51 Osmolality mOsm/kg 355 284 426 35.50 71.00 Calculated Phosphate Inorganic mmol/l 2.31 1.96 2.66 0.18 0.35 Phosphomolybdate enzymatic mg/dl 7.16 6.08 8.24 0.54 1.08 Lithium Magnesium Xylidyl Blue mmol/l 2.31 1.97 2.65 0.17 0.34 mg/dl 7.16 6.11 8.21 0.53 1.05 Potassium mmol/l 6.16 5.67 6.65 0.25 0.49 ISE method - indirect Protein Total g/l 44.6 35.7 53.5 4.45 8.90 Biuret reaction end point g/dl 4.46 3.57 5.35 0.45 0.89 Sodium mmol/l 160 152 168 4.00 8.00 ISE method - indirect TIBC µmol/l 51.6 40.8 62.4 5.40 10.80 FE+UIBC(saturation with iron) µg/dl 288 228 348 30.00 60.00 mmol/l 3.08 2.59 3.57 0.25 0.49 mg/dl 273 229 317 22.00 44.00 mmol/l 3.12 2.62 3.62 0.25 0.50 mg/dl 276 232 320 22.00 44.00 Triglycerides Phosphomolybdate UV Lipase/GPO-PAP no correction L/G Kinase EP. no correction Page 4 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman Coulter AU Series® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Uric Acid (Urate) mmol/l 0.57 0.50 0.65 0.04 0.07 Uricase peroxidase with ascorbate oxidase mg/dl 9.59 8.35 10.8 0.62 1.24 mmol/l 0.58 0.50 0.65 0.04 0.08 mg/dl 9.68 8.42 10.9 0.63 1.26 mmol/l 0.56 0.48 0.63 0.04 0.07 Urea mg/dl 9.32 8.10 10.5 0.61 1.22 mmol/l 19.4 16.5 22.3 1.45 2.90 mg/dl 117 99.2 135 8.90 17.80 mmol/l 19.4 16.5 22.3 1.45 2.90 mg/dl 54.4 46.2 62.6 4.10 8.20 Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic BUN Page 5 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman CX4/5/7/9/LX20®/DxC600/800® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 29.0 24.6 33.4 2.20 4.40 Bromocresol Purple g/dl 2.90 2.46 3.34 0.22 0.44 Alkaline Phosphatase U/l 388 330 446 29.00 58.00 U/l 391 332 450 29.50 59.00 AMP optimised to IFCC 37°C ALT (GPT) U/l 130 104 156 13.00 26.00 Tris buffer without P5P 37°C U/l 124 99 149 12.50 25.00 Tris buffer SCE 37°C Amylase Total U/I 310 264 356 23.00 46.00 Beckman maltotetraose 37°C U/I 313 266 360 23.50 47.00 Beckman Synchron AMY7 37°C U/l 134 108 160 13.00 26.00 Tris buffer without P5P 37°C U/l 132 105 159 13.50 27.00 Tris buffer SCE 37°C Bicarbonate mmol/l 16.6 13.2 20.0 1.70 3.40 Differential rate pH change mmol/l 16.6 13.1 20.1 1.75 3.50 Ion selective electrode Bilirubin Direct µmol/l 16.2 12.8 19.6 1.70 3.40 Diazo with Sulphanilic Acid mg/dl 0.948 0.749 1.15 0.10 0.20 Bilirubin Total µmol/l 83.1 65.7 101 8.70 17.40 mg/dl 4.86 3.84 5.88 0.51 1.02 mmol/l 3.11 2.80 3.42 0.16 0.31 mg/dl 12.5 11.2 13.8 0.65 1.30 mmol/l 3.18 2.87 3.49 0.16 0.31 AST (GOT) Calcium Cholesterol mg/dl 12.7 11.5 13.9 0.60 1.20 mmol/l 6.55 5.70 7.40 0.43 0.85 mg/dl 253 220 286 16.50 33.00 p-Nitrophenylphosphate AMP 37°C Diazo with Sulphanilic Acid Ion selective electrode Arsenazo III Cholesterol Oxidase Page 1 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman CX4/5/7/9/LX20®/DxC600/800® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD Chloride mmol/l 114 105 123 4.50 9.00 ISE indirect CK Total U/l 554 454 654 50.00 100.00 CK-NAC (IFCC) 37°C U/l 553 454 652 49.50 99.00 Monothioglycerol 37°C µmol/l 376 301 451 37.50 75.00 Alkaline picrate no deproteinization mg/dl 4.25 3.40 5.10 0.43 0.85 µmol/l 375 300 450 37.50 75.00 mg/dl 4.24 3.39 5.09 0.43 0.85 µmol/l 377 302 452 37.50 75.00 mg/dl 4.26 3.41 5.11 0.43 0.85 µmol/l 379 303 455 38.00 76.00 mg/dl 4.28 3.42 5.14 0.43 0.86 Creatinine gamma-GT Glucose HDL - Cholesterol Iron Lactate LD (LDH) methods Randox Enzymatic UV method Jaffe rate blanked IDMS traceable U/I 139 118 160 10.50 21.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 133 113 153 10.00 20.00 Gamma glutamyl-4-nitroanilide 37°C mmol/l 15.3 13.0 17.6 1.15 2.30 Hexokinase mg/dl 276 234 318 21.00 42.00 mmol/l 15.3 13.0 17.6 1.15 2.30 mg/dl 276 234 318 21.00 42.00 mmol/l 3.41 2.90 3.92 0.26 0.51 mg/dl 132 112 152 10.00 20.00 µmol/l 37.0 30.4 43.6 3.30 6.60 µg/dl 207 170 244 18.50 37.00 mmol/l 5.35 4.39 6.31 0.48 0.96 mg/dl 48.2 39.6 56.8 4.30 8.60 U/l 322 274 370 24.00 48.00 Glucose oxidase Direct HDL PPD Colorimetric without ppt. Colorimetric Lactate Oxidase L->P 37°C Page 2 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Beckman CX4/5/7/9/LX20®/DxC600/800® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods LD (LDH) U/l 997 847 1147 75.00 150.00 Pyruvate 1.4 mM - Beckman LD-P 37°C U/l 366 311 421 27.50 55.00 L->P IFCC 37°C Lipase U/I 60 48 72 6.00 12.00 Other Colorimetric 37°C Magnesium mmol/l 1.77 1.56 1.98 0.11 0.21 Calmagite mg/dl 4.30 3.79 4.81 0.26 0.51 mmol/l 2.35 2.00 2.70 0.18 0.35 mg/dl 7.29 6.20 8.38 0.55 1.09 Potassium mmol/l 6.18 5.69 6.67 0.25 0.49 ISE method - indirect Protein Total g/l 45.3 36.2 54.4 4.55 9.10 Biuret reaction CX4/5/7 g/dl 4.53 3.62 5.44 0.46 0.91 g/l 45.4 36.3 54.5 4.55 9.10 g/dl 4.54 3.63 5.45 0.46 0.91 g/l 44.1 35.2 53.0 4.45 8.90 Phosphate Inorganic Phosphomolybdate UV Biuret reaction end point Biuret reaction kinetic g/dl 4.41 3.52 5.30 0.45 0.89 Sodium mmol/l 160 152 168 4.00 8.00 ISE method - indirect Triglycerides mmol/l 3.10 2.61 3.59 0.25 0.49 Lipase/GPO-PAP no correction 43.00 Uric Acid (Urate) Urea mg/dl 274 231 317 21.50 mmol/l 3.21 2.69 3.73 0.26 0.52 mg/dl 284 238 330 23.00 46.00 mmol/l 0.54 0.47 0.61 0.04 0.07 mg/dl 9.02 7.85 10.2 0.59 1.17 mmol/l 19.6 16.7 22.5 1.45 2.90 mg/dl 118 100 136 9.00 18.00 mmol/l 19.6 16.7 22.5 1.45 2.90 mg/dl 55.0 46.8 63.2 4.10 8.20 L/G Kinase EP. no correction Uricase peroxidase no ascorbate oxidase Urease kinetic BUN Page 3 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A BIOSYSTEMS A25 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 28.5 24.2 32.8 2.15 4.30 Bromocresol Green g/dl 2.85 2.42 3.28 0.22 0.43 U/l 341 290 392 25.50 51.00 AMP optimised to IFCC 37°C Alkaline Phosphatase U/I 266 226 306 20.00 40.00 AMP optimised to IFCC 30°C U/I 218 185 251 16.50 33.00 AMP optimised to IFCC 25°C U/l 142 114 170 14.00 28.00 Tris buffer without P5P 37°C U/I 105 84 126 10.50 21.00 Tris buffer without P5P 30°C U/I 80 64 96 8.00 16.00 Tris buffer without P5P 25°C U/l 160 128 192 16.00 32.00 Tris buffer without P5P 37°C U/I 108 87 129 10.50 21.00 Tris buffer without P5P 30°C U/I 76 61 91 7.50 15.00 Tris buffer without P5P 25°C µmol/l 32.7 25.8 39.6 3.45 6.90 Diazo with Sulphanilic Acid mg/dl 1.91 1.51 2.31 0.20 0.40 µmol/l 87.1 68.8 105 9.15 18.30 mg/dl 5.10 4.02 6.18 0.54 1.08 Calcium mmol/l 3.14 2.83 3.45 0.16 0.31 mg/dl 12.6 11.3 13.9 0.65 1.30 Cholesterol mmol/l 6.80 5.92 7.68 0.44 0.88 mg/dl 262 229 295 16.50 33.00 U/l 569 467 671 51.00 102.00 CK-NAC (IFCC) 37°C U/I 356 292 420 32.00 64.00 CK-NAC (IFCC) 30°C U/I 242 198 286 22.00 44.00 CK-NAC (IFCC) 25°C ALT (GPT) AST (GOT) Bilirubin Direct Bilirubin Total CK Total Diazo with Sulphanilic Acid Arsenazo III Cholesterol Oxidase Page 1 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A BIOSYSTEMS A25 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Range Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte unit Creatinine µmol/l 321 mg/dl 3.63 Glucose mmol/l 15.7 13.3 mg/dl 283 Protein Total g/l 45.6 g/dl 4.56 3.65 5.47 0.46 0.91 Triglycerides mmol/l 2.83 2.38 3.28 0.23 0.45 mg/dl 250 211 289 19.50 39.00 mmol/l 0.57 0.49 0.64 0.04 0.07 mg/dl 9.49 8.27 10.7 0.61 1.22 mmol/l 0.56 0.48 0.63 0.04 0.07 Uric Acid (Urate) Urea Target low high 1SD 2SD methods 257 385 2.90 4.36 32.00 64.00 Alkaline picrate no deproteinization 0.37 0.73 18.1 1.20 2.40 240 326 21.50 43.00 36.5 54.7 4.55 9.10 mg/dl 9.34 8.13 10.6 0.61 1.21 mmol/l 18.0 15.3 20.7 1.35 2.70 mg/dl 108 92.0 124 8.00 16.00 mmol/l 18.0 15.3 20.7 1.35 2.70 mg/dl 50.5 42.9 58.1 3.80 7.60 Glucose oxidase Biuret reaction end point Lipase/GPO-PAP no correction Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Urease kinetic BUN Page 2 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A COBAS INTEGRA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.5 25.9 35.1 2.30 4.60 Bromocresol Green g/dl 3.05 2.59 3.51 0.23 0.46 g/l 27.7 23.6 31.8 2.05 4.10 g/dl 2.77 2.36 3.18 0.21 0.41 g/l 27.0 22.9 31.1 2.05 4.10 Alkaline Phosphatase ALT (GPT) Bromocresol Purple Turbidimetric Assays g/dl 2.70 2.29 3.11 0.21 0.41 U/l 258 220 296 19.00 38.00 Roche Integra AMP buffer 37°C U/I 201 171 231 15.00 30.00 Roche Integra AMP buffer 30°C U/I 165 141 189 12.00 24.00 Roche Integra AMP buffer 25°C U/l 128 103 153 12.50 25.00 Tris buffer without P5P 37°C U/I 95 76 114 9.50 19.00 Tris buffer without P5P 30°C U/I 72 58 86 7.00 14.00 Tris buffer without P5P 25°C Amylase Pancreatic U/I 271 230 312 20.50 41.00 Randox EPS Liquid and BM/Roche EPS Liquid 37°C Amylase Total U/I 297 252 342 22.50 45.00 BM/Roche Colorimetric pNPG7 37°C U/I 295 251 339 22.00 44.00 Roche Integra 2-chloro-pNPG7 37°C U/I 295 251 339 22.00 44.00 Roche liquid stable pNPG7 37°C U/l 135 108 162 13.50 27.00 Tris buffer without P5P 37°C U/I 91 73 109 9.00 18.00 Tris buffer without P5P 30°C U/I 64 51 77 6.50 13.00 Tris buffer without P5P 25°C AST (GOT) Bicarbonate mmol/l 16.0 12.7 19.3 1.65 3.30 Enzymatic Bilirubin Direct µmol/l 29.6 23.4 35.8 3.10 6.20 Dichlorophenyl Diazonium (DPD) mg/dl 1.73 1.37 2.09 0.18 0.36 Page 1 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A COBAS INTEGRA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Bilirubin Total µmol/l 78.7 62.2 95.2 mg/dl 4.60 3.64 5.56 8.25 16.50 Diazo with Sulphanilic Acid 0.48 0.96 µmol/l 78.6 62.1 95.1 8.25 16.50 mg/dl 4.60 3.63 5.57 0.49 0.97 µmol/l 78.8 62.2 95.4 8.30 16.60 0.97 mg/dl 4.61 3.64 5.58 0.49 mmol/l 3.21 2.89 3.53 0.16 0.32 mg/dl 12.9 11.6 14.2 0.65 1.30 mmol/l 3.21 2.88 3.54 0.17 0.33 mg/dl 12.9 11.5 14.3 0.70 1.40 Cholesterol mmol/l 6.71 5.84 7.58 0.44 0.87 mg/dl 259 225 293 17.00 34.00 Chloride mmol/l 115 106 124 4.50 9.00 Calcium Dichlorophenyl Diazonium (DPD) Diazonium ion Cresolphthalein complexone NM-BAPTA Cholesterol Oxidase ISE indirect Cholinesterase U/l 5263 4210 6316 526.50 1053.00 Colorimetric Butyrylthiocholine 37°C CK Total U/l 561 460 662 50.50 101.00 CK-NAC substrate start (DGKC) 37°C U/I 351 288 414 31.50 63.00 CK-NAC substrate start (DGKC) 30°C U/I 238 196 280 21.00 42.00 CK-NAC substrate start (DGKC) 25°C U/l 575 471 679 52.00 104.00 CK-NAC (IFCC) 37°C U/I 360 295 425 32.50 65.00 CK-NAC (IFCC) 30°C Creatinine U/I 244 200 288 22.00 44.00 CK-NAC (IFCC) 25°C µmol/l 358 286 430 36.00 72.00 Alkaline picrate with deproteinization mg/dl 4.05 3.23 4.87 0.41 0.82 µmol/l 351 281 421 35.00 70.00 mg/dl 3.97 3.18 4.76 0.40 0.79 Alkaline picrate no deproteinization Page 2 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A COBAS INTEGRA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Creatinine µmol/l 377 302 452 37.50 75.00 Randox Enzymatic UV method mg/dl 4.26 3.41 5.11 0.43 0.85 µmol/l 366 293 439 36.50 73.00 mg/dl 4.14 3.31 4.97 0.42 0.83 µmol/l 343 274 412 34.50 69.00 mg/dl 3.88 3.10 4.66 0.39 0.78 µmol/l 350 280 420 35.00 70.00 mg/dl 3.96 3.16 4.76 0.40 0.80 µmol/l 358 287 429 35.50 71.00 mg/dl 4.05 3.24 4.86 0.41 0.81 U/I 148 125 171 11.50 23.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 117 99 135 9.00 18.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 91 77 105 7.00 14.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C U/I 170 144 196 13.00 26.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 134 113 155 10.50 21.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 105 89 121 8.00 16.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C mmol/l 15.7 13.4 18.0 1.15 2.30 Hexokinase mg/dl 283 241 325 21.00 42.00 mmol/l 15.5 13.1 17.9 1.20 2.40 gamma-GT Glucose HDL - Cholesterol Iron mg/dl 279 236 322 21.50 43.00 mmol/l 3.11 2.64 3.58 0.24 0.47 mg/dl 120 102 138 9.00 18.00 mmol/l 3.12 2.65 3.59 0.24 0.47 mg/dl 120 102 138 9.00 18.00 µmol/l 37.8 31.0 44.6 3.40 6.80 µg/dl 211 173 249 19.00 38.00 Roche Creatinine Plus Jaffe rate blanked Jaffe rate blanked comp. (-26 µmol/l) Jaffe rate blanked compensated (-18 µmol/l) Glucose oxidase Direct HDL PEGME Direct HDL Roche 3rd generation Colorimetric with ppt. Page 3 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A COBAS INTEGRA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Iron Range unit Target low high 1SD 2SD methods Colorimetric without ppt. µmol/l 37.6 30.9 44.3 3.35 6.70 µg/dl 210 173 247 18.50 37.00 Lactate mmol/l 5.85 4.80 6.90 0.53 1.05 mg/dl 52.7 43.2 62.2 4.75 9.50 LD (LDH) U/l 727 618 836 54.50 109.00 P->L German methods 37°C U/I 525 446 604 39.50 79.00 P->L German methods 30°C U/I 369 313 425 28.00 56.00 P->L German methods 25°C U/l 401 341 461 30.00 60.00 L->P IFCC 37°C U/I 290 246 334 22.00 44.00 L->P IFCC 30°C U/I 203 173 233 15.00 30.00 L->P IFCC 25°C Lipase U/I 68 55 81 6.50 13.00 Roche Colorimetric 37°C Lithium mmol/l 2.16 1.90 2.42 0.13 0.26 Ion selective electrode mg/dl 1.50 1.32 1.68 0.09 0.18 mmol/l 1.78 1.57 1.99 0.11 0.21 mg/dl 4.33 3.82 4.84 0.26 0.51 mmol/l 1.77 1.55 1.99 0.11 0.22 0.53 Magnesium Phosphate Inorganic mg/dl 4.30 3.77 4.83 0.27 mmol/l 2.34 1.99 2.69 0.18 0.35 mg/dl 7.25 6.17 8.33 0.54 1.08 Colorimetric Lactate Oxidase Methylthymol blue Chlorphosphonazo III Phosphomolybdate enzymatic mmol/l 2.36 2.00 2.72 0.18 0.36 mg/dl 7.32 6.20 8.44 0.56 1.12 Phosphomolybdate UV Potassium mmol/l 6.21 5.72 6.70 0.25 0.49 ISE method - indirect Protein Total g/l 43.6 34.9 52.3 4.35 8.70 Biuret reaction end point g/dl 4.36 3.49 5.23 0.44 0.87 Page 4 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A COBAS INTEGRA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Protein Total g/l 43.7 34.9 52.5 4.40 8.80 Biuret reaction kinetic g/dl 4.37 3.49 5.25 0.44 0.88 Sodium mmol/l 160 152 168 4.00 8.00 ISE method - indirect TIBC µmol/l 52.9 41.8 64.0 5.55 11.10 FE+UIBC(saturation with iron) µg/dl 296 234 358 31.00 62.00 mmol/l 2.97 2.50 3.44 0.24 0.47 mg/dl 263 221 305 21.00 42.00 mmol/l 3.01 2.53 3.49 0.24 0.48 42.00 Triglycerides Uric Acid (Urate) Urea mg/dl 266 224 308 21.00 mmol/l 2.85 2.40 3.30 0.23 0.45 mg/dl 252 212 292 20.00 40.00 mmol/l 2.93 2.46 3.40 0.24 0.47 mg/dl 259 218 300 20.50 41.00 mmol/l 0.56 0.49 0.63 0.04 0.07 mg/dl 9.42 8.20 10.6 0.61 1.22 mmol/l 0.56 0.49 0.63 0.04 0.07 mg/dl 9.37 8.15 10.6 0.61 1.22 mmol/l 0.56 0.49 0.63 0.04 0.07 mg/dl 9.41 8.20 10.6 0.61 1.21 mmol/l 18.7 15.9 21.5 1.40 2.80 mg/dl 112 95.6 128 8.20 16.40 mmol/l 18.7 15.9 21.5 1.40 2.80 mg/dl 52.5 44.6 60.4 3.95 7.90 Lipase/GPO-PAP no correction Lipase/GPO-PAP 0.11mmol/l correction L/G Kinase EP. no correction Lipase/Glycerol Dehydrogenase Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic BUN Page 5 of 5 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A ELITech/Vitalab Selectra Pro/E/XL Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 29.9 25.5 34.3 2.20 4.40 Bromocresol Green g/dl 2.99 2.55 3.43 0.22 0.44 Alkaline Phosphatase U/l 534 454 614 40.00 80.00 Diethanolamine buffer DEA 37°C ALT (GPT) U/l 140 112 168 14.00 28.00 Tris buffer without P5P 37°C AST (GOT) U/l 142 114 170 14.00 28.00 Tris buffer without P5P 37°C Calcium mmol/l 3.09 2.78 3.40 0.16 0.31 Cresolphthalein complexone mg/dl 12.4 11.1 13.7 0.65 1.30 mmol/l 2.71 2.43 2.99 0.14 0.28 Methylthymol blue mg/dl 10.9 9.74 12.1 0.58 1.16 mmol/l 3.25 2.93 3.57 0.16 0.32 mg/dl 13.0 11.7 14.3 0.65 1.30 mmol/l 6.77 5.89 7.65 0.44 0.88 mg/dl 261 227 295 17.00 34.00 CK Total U/l 543 445 641 49.00 98.00 CK-NAC (IFCC) 37°C Creatinine µmol/l 353 282 424 35.50 71.00 Alkaline picrate no deproteinization mg/dl 3.99 3.19 4.79 0.40 0.80 µmol/l 357 286 428 35.50 71.00 mg/dl 4.03 3.23 4.83 0.40 0.80 gamma-GT U/I 155 132 178 11.50 23.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C Glucose mmol/l 15.8 13.5 18.1 1.15 2.30 Glucose oxidase mg/dl 285 243 327 21.00 42.00 Cholesterol Arsenazo III Cholesterol Oxidase Jaffe rate blanked Page 1 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A ELITech/Vitalab Selectra Pro/E/XL Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Range unit Target low high 1SD 2SD methods LD (LDH) U/l 359 305 413 27.00 54.00 L->P IFCC 37°C Phosphate Inorganic mmol/l 2.28 1.94 2.62 0.17 0.34 Phosphomolybdate UV mg/dl 7.07 6.01 8.13 0.53 1.06 g/l 51.6 41.3 61.9 5.15 10.30 g/dl 5.16 4.13 6.19 0.52 1.03 mmol/l 2.89 2.43 3.35 0.23 0.46 mg/dl 256 215 297 20.50 41.00 Uric Acid (Urate) mmol/l 0.56 0.48 0.63 0.04 0.07 mg/dl 9.34 8.11 10.6 0.62 1.23 Urea mmol/l 18.5 15.8 21.2 1.35 2.70 mg/dl 111 95.0 127 8.00 16.00 Protein Total Triglycerides mmol/l 18.5 15.7 21.3 1.40 2.80 mg/dl 51.9 44.1 59.7 3.90 7.80 Biuret reaction end point Lipase/GPO-PAP no correction Uricase peroxidase no ascorbate oxidase Urease kinetic BUN Page 2 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A HITACHI SERIES® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.3 25.8 34.8 2.25 4.50 Bromocresol Green g/dl 3.03 2.58 3.48 0.23 0.45 g/l 27.3 23.2 31.4 2.05 4.10 Alkaline Phosphatase ALT (GPT) Amylase Pancreatic g/dl 2.73 2.32 3.14 0.21 0.41 U/l 241 205 277 18.00 36.00 Bromocresol Purple Roche Integra AMP buffer 37°C U/I 188 160 216 14.00 28.00 Roche Integra AMP buffer 30°C U/I 154 131 177 11.50 23.00 Roche Integra AMP buffer 25°C U/l 374 318 430 28.00 56.00 Randox AMP 37°C U/I 291 248 334 21.50 43.00 Randox AMP 30°C U/I 239 203 275 18.00 36.00 Randox AMP 25°C U/l 132 106 158 13.00 26.00 Tris buffer without P5P 37°C U/I 98 78 118 10.00 20.00 Tris buffer without P5P 30°C U/I 74 60 88 7.00 14.00 Tris buffer without P5P 25°C U/I 267 227 307 20.00 40.00 Roche liquid stable pNPG7 37°C U/I 300 255 345 22.50 45.00 Randox liquid stable pNPG7 37°C Amylase Total U/I 287 244 330 21.50 43.00 Roche liquid stable pNPG7 37°C U/I 333 283 383 25.00 50.00 Randox liquid stable pNPG7 37°C Acid Phosphatase (non-prostatic) U/I 10.5 7.04 14.0 1.73 3.46 1-Naphthyl Phosphate, Kinetic with Pentane diol Activation 37°C U/I 14.9 9.98 19.8 2.46 4.92 1-Naphthyl Phosphate substrate Kinetic 37°C U/I 41.0 27.5 54.5 6.75 13.50 1-Naphthyl Phosphate, Kinetic with Pentane diol Activation 37°C U/I 23.5 15.7 31.3 3.90 7.80 1-Naphthyl Phosphate substrate Kinetic 37°C Acid Phosphatase (Prostatic) Page 1 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A HITACHI SERIES® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Acid Phosphatase (Total) U/I 51.5 34.5 68.5 8.50 17.00 1-Naphthyl Phosphate, Kinetic with Pentane diol Activation 37°C U/I 38.4 25.7 51.1 6.35 12.70 1-Naphthyl Phosphate substrate Kinetic 37°C U/l 136 109 163 13.50 27.00 Tris buffer without P5P 37°C AST (GOT) U/I 92 74 110 9.00 18.00 Tris buffer without P5P 30°C U/I 65 52 78 6.50 13.00 Tris buffer without P5P 25°C Bile Acids µmol/l 51.7 41.4 62.0 5.15 10.30 5th Generation Colorimetric Bicarbonate mmol/l 16.8 13.3 20.3 1.75 3.50 Colorimetric mmol/l 16.3 12.9 19.7 1.70 3.40 Enzymatic µmol/l 26.8 21.2 32.4 2.80 5.60 Dichlorophenyl Diazonium (DPD) mg/dl 1.57 1.24 1.90 0.17 0.33 µmol/l 27.7 21.9 33.5 2.90 5.80 Bilirubin Direct Bilirubin Total Calcium mg/dl 1.62 1.28 1.96 0.17 0.34 µmol/l 83.8 66.2 101 8.80 17.60 mg/dl 4.90 3.87 5.93 0.52 1.03 µmol/l 79.0 62.4 95.6 8.30 16.60 mg/dl 4.62 3.65 5.59 0.49 0.97 µmol/l 77.1 60.9 93.3 8.10 16.20 mg/dl 4.51 3.56 5.46 0.48 0.95 µmol/l 76.7 60.6 92.8 8.05 16.10 mg/dl 4.49 3.55 5.43 0.47 0.94 mmol/l 3.18 2.86 3.50 0.16 0.32 mg/dl 12.7 11.5 13.9 0.60 1.20 mmol/l 3.24 2.92 3.56 0.16 0.32 mg/dl 13.0 11.7 14.3 0.65 1.30 mmol/l 3.17 2.85 3.49 0.16 0.32 mg/dl 12.7 11.4 14.0 0.65 1.30 Diazo with Sulphanilic Acid Diazo with Dichloroaniline (DCA) Diazo with Sulphanilic Acid Dichlorophenyl Diazonium (DPD) Diazonium ion Cresolphthalein complexone Arsenazo III NM-BAPTA Page 2 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A HITACHI SERIES® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high Cholesterol mmol/l 6.58 5.73 7.43 mg/dl 254 221 287 Chloride mmol/l 112 103 121 4.50 9.00 ISE indirect CK Total U/l 524 429 619 47.50 95.00 CK-NAC substrate start (DGKC) 37°C U/I 328 269 387 29.50 59.00 CK-NAC substrate start (DGKC) 30°C Creatinine D-3-Hydroxybutyrate gamma-GT 1SD 2SD methods 0.43 0.85 Cholesterol Oxidase 16.50 33.00 U/I 223 182 264 20.50 41.00 CK-NAC substrate start (DGKC) 25°C U/l 535 439 631 48.00 96.00 CK-NAC (IFCC) 37°C U/I 335 275 395 30.00 60.00 CK-NAC (IFCC) 30°C U/I 227 187 267 20.00 40.00 CK-NAC (IFCC) 25°C µmol/l 363 290 436 36.50 73.00 Alkaline picrate no deproteinization mg/dl 4.10 3.28 4.92 0.41 0.82 µmol/l 383 306 460 38.50 77.00 mg/dl 4.33 3.46 5.20 0.44 0.87 µmol/l 376 301 451 37.50 75.00 mg/dl 4.25 3.40 5.10 0.43 0.85 mmol/l 1.13 0.96 1.30 0.09 0.17 Roche Creatinine Plus Jaffe rate blanked comp. (-26 µmol/l) Tris buffer 100mmol pH 8.5 U/I 145 123 167 11.00 22.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 114 97 131 8.50 17.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 89 76 102 6.50 13.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C U/I 159 135 183 12.00 24.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 125 106 144 9.50 19.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 98 83 113 7.50 15.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C U/I 170 145 195 12.50 25.00 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 134 114 154 10.00 20.00 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 105 89 121 8.00 16.00 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C Page 3 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A HITACHI SERIES® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte GLDH Glucose alpha-HBDH HDL - Cholesterol Iron Lactate LD (LDH) Range unit Target low high 1SD 2SD methods U/I 34 27 41 3.50 7.00 Triethanolamine buffer 50 mmol 37°C U/I 26 21 31 2.50 5.00 Triethanolamine buffer 50 mmol 30°C U/I 21 17 25 2.00 4.00 Triethanolamine buffer 50 mmol 25°C mmol/l 15.6 13.3 17.9 1.15 2.30 Hexokinase mg/dl 281 240 322 20.50 41.00 mmol/l 15.7 13.3 18.1 1.20 2.40 mg/dl 283 240 326 21.50 43.00 U/I 466 368 564 49.00 98.00 Oxobutyrate < 10 mmol/l 37°C Oxobutyrate < 10 mmol/l 30°C Glucose oxidase U/I 352 278 426 37.00 74.00 U/I 264 208 320 28.00 56.00 Oxobutyrate < 10 mmol/l 25°C mmol/l 3.04 2.58 3.50 0.23 0.46 Direct HDL PEGME mg/dl 117 99.6 134 8.70 17.40 mmol/l 2.99 2.54 3.44 0.23 0.45 Direct HDL Roche 3rd generation mg/dl 115 98.0 132 8.50 17.00 µmol/l 36.5 29.9 43.1 3.30 6.60 µg/dl 204 167 241 18.50 37.00 mmol/l 5.61 4.60 6.62 0.51 1.01 mg/dl 50.5 41.4 59.6 4.55 9.10 U/l 736 626 846 55.00 110.00 P->L German methods 37°C U/I 531 452 610 39.50 79.00 P->L German methods 30°C U/I 373 317 429 28.00 56.00 P->L German methods 25°C U/l 378 322 434 28.00 56.00 L->P IFCC 37°C U/I 273 232 314 20.50 41.00 L->P IFCC 30°C U/I 192 163 221 14.50 29.00 L->P IFCC 25°C Colorimetric without ppt. Colorimetric Lactate Oxidase Page 4 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A HITACHI SERIES® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Range unit Target low high 1SD 2SD methods Lipase U/I 60 48 72 6.00 12.00 Roche Colorimetric 37°C Lithium mmol/l 2.12 1.86 2.38 0.13 0.26 Spectrophotometric mg/dl 1.47 1.29 1.65 0.09 0.18 mmol/l 1.78 1.57 1.99 0.11 0.21 mg/dl 4.33 3.82 4.84 0.26 0.51 Magnesium Xylidyl Blue mmol/l 1.81 1.59 2.03 0.11 0.22 mg/dl 4.40 3.86 4.94 0.27 0.54 Phosphate Inorganic mmol/l 2.30 1.95 2.65 0.18 0.35 mg/dl 7.13 6.05 8.21 0.54 1.08 Potassium mmol/l 6.27 5.77 6.77 0.25 0.50 ISE method - indirect Protein Total g/l 44.8 35.8 53.8 4.50 9.00 Biuret reaction end point g/dl 4.48 3.58 5.38 0.45 0.90 Sodium mmol/l 163 155 171 4.00 8.00 ISE method - indirect TIBC µmol/l 48.9 38.6 59.2 5.15 10.30 FE+UIBC(saturation with iron) µg/dl 273 216 330 28.50 57.00 mmol/l 2.91 2.45 3.37 0.23 0.46 41.00 Triglycerides Uric Acid (Urate) mg/dl 258 217 299 20.50 mmol/l 2.85 2.39 3.31 0.23 0.46 mg/dl 252 212 292 20.00 40.00 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.24 8.03 10.5 0.61 1.21 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.22 8.03 10.4 0.60 1.19 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.26 8.05 10.5 0.61 1.21 Enzymatic Phosphomolybdate UV Lipase/GPO-PAP no correction L/G Kinase EP. no correction Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Page 5 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A HITACHI SERIES® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Urea mmol/l 19.4 16.5 22.3 1.45 2.90 Urease kinetic mg/dl 117 99.2 135 8.90 17.80 mmol/l 19.4 16.5 22.3 1.45 2.90 mg/dl 54.4 46.2 62.6 4.10 8.20 BUN Page 6 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A ILab 600®/650®/Aries® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.0 25.5 34.5 2.25 4.50 Bromocresol Green g/dl 3.00 2.55 3.45 0.23 0.45 U/l 382 324 440 29.00 58.00 AMP optimised to IFCC 37°C Alkaline Phosphatase U/I 298 252 344 23.00 46.00 AMP optimised to IFCC 30°C U/I 244 207 281 18.50 37.00 AMP optimised to IFCC 25°C U/l 129 103 155 13.00 26.00 Tris buffer without P5P 37°C U/I 95 76 114 9.50 19.00 Tris buffer without P5P 30°C U/I 73 58 88 7.50 15.00 Tris buffer without P5P 25°C U/l 133 106 160 13.50 27.00 Tris buffer without P5P 37°C U/I 90 72 108 9.00 18.00 Tris buffer without P5P 30°C U/I 63 50 76 6.50 13.00 Tris buffer without P5P 25°C Bile Acids µmol/l 49.9 39.9 59.9 5.00 10.00 Enzymatic Colorimetric Bilirubin Total µmol/l 88.2 69.7 107 9.25 18.50 Diazo with Sulphanilic Acid mg/dl 5.16 4.08 6.24 0.54 1.08 Calcium mmol/l 3.32 2.99 3.65 0.17 0.33 mg/dl 13.3 12.0 14.6 0.65 1.30 mmol/l 6.58 5.72 7.44 0.43 0.86 mg/dl 254 221 287 16.50 33.00 Chloride mmol/l 114 104 124 5.00 10.00 ISE indirect CK Total U/l 496 407 585 44.50 89.00 CK-NAC (IFCC) 37°C U/I 310 255 365 27.50 55.00 CK-NAC (IFCC) 30°C U/I 211 173 249 19.00 38.00 CK-NAC (IFCC) 25°C ALT (GPT) AST (GOT) Cholesterol Cresolphthalein complexone Cholesterol Oxidase Page 1 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A ILab 600®/650®/Aries® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Creatinine µmol/l 339 mg/dl 3.83 mmol/l 1.20 1.02 D-3-Hydroxybutyrate gamma-GT Glucose Target low high 1SD 2SD methods 271 407 3.06 4.60 34.00 68.00 Alkaline picrate no deproteinization 0.39 0.77 1.38 0.09 0.18 Tris buffer 100mmol pH 8.5 U/I 152 129 175 11.50 23.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 120 102 138 9.00 18.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 94 80 108 7.00 14.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C U/I 151 129 173 11.00 22.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 119 102 136 8.50 17.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 93 80 106 6.50 13.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C mmol/l 15.8 13.4 18.2 1.20 2.40 Hexokinase mg/dl 285 241 329 22.00 44.00 mmol/l 15.3 13.0 17.6 1.15 2.30 mg/dl 276 234 318 21.00 42.00 Glucose oxidase Lipase U/I 86 69 103 8.50 17.00 Randox Colorimetric 37°C Magnesium mmol/l 1.98 1.74 2.22 0.12 0.24 Enzymatic mg/dl 4.81 4.23 5.39 0.29 0.58 mmol/l 2.33 1.98 2.68 0.18 0.35 mg/dl 7.22 6.14 8.30 0.54 1.08 Potassium mmol/l 6.32 5.81 6.83 0.26 0.51 ISE method - indirect Protein Total g/l 46.2 37.0 55.4 4.60 9.20 Biuret reaction end point g/dl 4.62 3.70 5.54 0.46 0.92 Phosphate Inorganic Phosphomolybdate UV Sodium mmol/l 162 154 170 4.00 8.00 ISE method - indirect Triglycerides mmol/l 3.05 2.56 3.54 0.25 0.49 Lipase/GPO-PAP no correction mg/dl 270 227 313 21.50 43.00 Page 2 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A ILab 600®/650®/Aries® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Triglycerides mmol/l 3.16 2.65 3.67 0.26 0.51 L/G Kinase EP. no correction mg/dl 280 235 325 22.50 45.00 Uric Acid (Urate) mmol/l 0.59 0.51 0.66 0.04 0.08 mg/dl 9.86 8.58 11.1 0.64 1.28 Urea mmol/l 19.9 16.9 22.9 1.50 3.00 18.00 mg/dl 120 102 138 9.00 mmol/l 19.9 16.9 22.9 1.50 3.00 mg/dl 55.9 47.5 64.3 4.20 8.40 Uricase peroxidase no ascorbate oxidase Urease end point BUN Page 3 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A JOHNSON AND JOHNSON VITROS® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 27.5 23.4 31.6 2.05 4.10 Ortho Vitros Microslide Systems g/dl 2.75 2.34 3.16 0.21 0.41 Alkaline Phosphatase U/l 213 181 245 16.00 32.00 Ortho Vitros Microslide Systems 37°C ALT (GPT) U/l 143 115 171 14.00 28.00 Ortho Vitros Microslide Systems 37°C U/l 142 113 171 14.50 29.00 Vitros DT60/DT60 II/DTSC II 37°C Amylase Total U/I 180 153 207 13.50 27.00 Ortho Vitros Microslide Systems 37°C AST (GOT) U/l 171 137 205 17.00 34.00 Ortho Vitros Microslide visible slide 37°C Bicarbonate mmol/l 19.4 15.4 23.4 2.00 4.00 Ortho Vitros Microslide Systems Bilirubin Total µmol/l 74.3 58.7 89.9 7.80 15.60 Vitros 250/500/700/950 Total Bilirubin mg/dl 4.35 3.43 5.27 0.46 0.92 µmol/l 73.6 58.1 89.1 7.75 15.50 Calcium Cholesterol Chloride mg/dl 4.31 3.40 5.22 0.46 0.91 mmol/l 3.14 2.83 3.45 0.16 0.31 mg/dl 12.6 11.3 13.9 0.65 1.30 mmol/l 3.25 2.92 3.58 0.17 0.33 mg/dl 13.0 11.7 14.3 0.65 1.30 mmol/l 5.91 5.14 6.68 0.39 0.77 mg/dl 228 198 258 15.00 30.00 mmol/l 6.05 5.26 6.84 0.40 0.79 mg/dl 234 203 265 15.50 31.00 mmol/l 114 105 123 4.50 9.00 Vitros 250/500/700/950 Total BUBC Ortho Vitros Microslide Systems Vitros DT60/DT60 II/DTSC II Ortho Vitros Microslide Systems Vitros DT60/DT60 II Ortho Vitros Microslide Systems Page 1 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A JOHNSON AND JOHNSON VITROS® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Chloride mmol/l 114 105 123 4.50 9.00 Vitros DT60/DT60 II/DTE II Cholinesterase U/l 5127 4102 6152 512.50 1025.00 Ortho Vitros Microslide Systems 37°C CK Total U/l 438 359 517 39.50 79.00 Ortho Vitros Microslide Systems 37°C Creatinine µmol/l 371 297 445 37.00 74.00 Vitros DT60/DT60 II/DTSC II mg/dl 4.19 3.36 5.02 0.42 0.83 µmol/l 381 304 458 38.50 77.00 mg/dl 4.31 3.44 5.18 0.44 0.87 gamma-GT U/I 197 168 226 14.50 29.00 Ortho Vitros Microslide Systems 37°C U/I 199 169 229 15.00 30.00 Vitros DT60/DT60 II/DTSC II 37°C Glucose mmol/l 14.4 12.3 16.5 1.05 2.10 Ortho Vitros Microslide Systems mg/dl 259 222 296 18.50 37.00 mmol/l 14.6 12.4 16.8 1.10 2.20 mg/dl 263 223 303 20.00 40.00 mmol/l 2.40 2.04 2.76 0.18 0.36 mg/dl 92.6 78.7 107 6.95 13.90 mmol/l 2.43 2.07 2.79 0.18 0.36 HDL - Cholesterol Iron Lactate mg/dl 93.8 79.9 108 6.95 13.90 µmol/l 38.6 31.7 45.5 3.45 6.90 µg/dl 216 177 255 19.50 39.00 mmol/l 5.15 4.22 6.08 0.47 0.93 mg/dl 46.4 38.0 54.8 4.20 8.40 Vitros IDMS Traceable Vitros DT60/DT60 II Vitros Magnetic HDL Vitros dHDL PTA/MgCl2 direct precipitation Ortho Vitros Microslide Systems Ortho Vitros Microslide Systems LD (LDH) U/l 1135 965 1305 85.00 170.00 Ortho Vitros Microslide Systems 37°C Lipase U/I 751 602 900 74.50 149.00 Ortho Vitros Microslide Systems 37°C Lithium mmol/l 2.48 2.18 2.78 0.15 0.30 Ortho Vitros Microslide Systems mg/dl 1.72 1.51 1.93 0.11 0.21 Page 2 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A JOHNSON AND JOHNSON VITROS® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD Magnesium mmol/l 1.82 1.61 2.03 mg/dl 4.42 3.91 4.93 Phosphate Inorganic mmol/l 2.29 1.95 mg/dl 7.10 Potassium mmol/l 6.12 mmol/l 6.11 5.62 6.60 0.25 0.49 Vitros DT60/DT60 II/DTE II Protein Total g/l 45.5 36.4 54.6 4.55 9.10 Ortho Vitros Microslide Systems g/dl 4.55 3.64 5.46 0.46 0.91 mmol/l 158 150 166 4.00 8.00 Ortho Vitros Microslide Systems mmol/l 156 148 164 4.00 8.00 Vitros DT60/DT60 II/DTE II Thyroid Stimulating Hormone µU/ml = 1.25 1.00 1.50 0.13 0.25 Vitros ECi TIBC µmol/l 62.4 49.3 75.5 6.55 13.10 Ortho Vitros Microslide Systems µg/dl 349 276 422 36.50 73.00 mmol/l 3.57 3.00 4.14 0.29 0.57 mg/dl 316 266 366 25.00 50.00 mmol/l 3.45 2.90 4.00 0.28 0.55 48.00 Sodium Triglycerides Uric Acid (Urate) Urea 2SD methods 0.11 0.21 Ortho Vitros Microslide Systems 0.26 0.51 2.63 0.17 0.34 6.05 8.15 0.53 1.05 5.63 6.61 0.25 0.49 mg/dl 305 257 353 24.00 mmol/l 0.52 0.46 0.59 0.03 0.07 mg/dl 8.79 7.64 9.94 0.58 1.15 mmol/l 0.54 0.47 0.61 0.04 0.07 mg/dl 9.00 7.83 10.2 0.59 1.17 mmol/l 18.1 15.4 20.8 1.35 2.70 mg/dl 109 92.6 125 8.20 16.40 mmol/l 18.6 15.8 21.4 1.40 2.80 mg/dl 112 95.0 129 8.50 17.00 Ortho Vitros Microslide Systems Ortho Vitros Microslide Systems Ortho Vitros Microslide Systems Vitros DT60/DT60 II Ortho Vitros Microslide Systems Vitros DT60/DT60 II Ortho Vitros Microslide Systems Vitros DT60/DT60 II Page 3 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A JOHNSON AND JOHNSON VITROS® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high Urea mmol/l 18.1 15.4 20.8 mg/dl 50.8 43.2 58.4 1SD 2SD methods 1.35 2.70 BUN 3.80 7.60 Page 4 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Konelab 20/30/60®/Thermo Scientific Indiko Plus Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 28.9 24.6 33.2 2.15 4.30 Bromocresol Green g/dl 2.89 2.46 3.32 0.22 0.43 U/l 540 459 621 40.50 81.00 Diethanolamine buffer DEA 37°C U/I 421 358 484 31.50 63.00 Diethanolamine buffer DEA 30°C U/I 345 293 397 26.00 52.00 Diethanolamine buffer DEA 25°C U/l 344 292 396 26.00 52.00 AMP optimised to IFCC 37°C U/I 268 227 309 20.50 41.00 AMP optimised to IFCC 30°C U/I 220 187 253 16.50 33.00 AMP optimised to IFCC 25°C U/l 144 115 173 14.50 29.00 Tris buffer without P5P 37°C U/I 107 85 129 11.00 22.00 Tris buffer without P5P 30°C U/I 81 65 97 8.00 16.00 Tris buffer without P5P 25°C Amylase Total U/I 286 243 329 21.50 43.00 bioMerieux 2-chloro-pNPG3 37°C AST (GOT) U/l 153 122 184 15.50 31.00 Tris buffer without P5P 37°C U/I 103 82 124 10.50 21.00 Tris buffer without P5P 30°C U/I 73 58 88 7.50 15.00 Tris buffer without P5P 25°C Bile Acids µmol/l 49.5 39.6 59.4 4.95 9.90 Enzymatic Colorimetric Bilirubin Total µmol/l 81.5 64.4 98.6 8.55 17.10 Diazo with Sulphanilic Acid mg/dl 4.77 3.77 5.77 0.50 1.00 µmol/l 80.3 63.4 97.2 8.45 16.90 Alkaline Phosphatase ALT (GPT) Calcium mg/dl 4.70 3.71 5.69 0.50 0.99 mmol/l 3.35 3.01 3.69 0.17 0.34 mg/dl 13.4 12.1 14.7 0.65 1.30 Nitrobenzenediazonium salt Arsenazo III Page 1 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Konelab 20/30/60®/Thermo Scientific Indiko Plus Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high Cholesterol mmol/l 6.50 5.65 7.35 mg/dl 251 218 284 Chloride mmol/l 116 107 125 4.50 9.00 ISE direct CK Total U/l 549 450 648 49.50 99.00 CK-NAC (IFCC) 37°C U/I 344 282 406 31.00 62.00 CK-NAC (IFCC) 30°C Creatinine gamma-GT Glucose HDL - Cholesterol Iron Magnesium 1SD 2SD methods 0.43 0.85 Cholesterol Oxidase 16.50 33.00 U/I 233 191 275 21.00 42.00 CK-NAC (IFCC) 25°C µmol/l 365 292 438 36.50 73.00 Alkaline picrate no deproteinization mg/dl 4.12 3.30 4.94 0.41 0.82 µmol/l 385 308 462 38.50 77.00 mg/dl 4.35 3.48 5.22 0.44 0.87 µmol/l 376 301 451 37.50 75.00 mg/dl 4.25 3.40 5.10 0.43 0.85 U/I 160 136 184 12.00 24.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 126 107 145 9.50 19.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 99 84 114 7.50 15.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C mmol/l 15.8 13.4 18.2 1.20 2.40 Hexokinase mg/dl 285 241 329 22.00 44.00 mmol/l 15.9 13.5 18.3 1.20 2.40 mg/dl 287 243 331 22.00 44.00 mmol/l 3.01 2.56 3.46 0.23 0.45 mg/dl 116 98.8 133 8.60 17.20 µmol/l 38.1 31.2 45.0 3.45 6.90 µg/dl 213 174 252 19.50 39.00 mmol/l 1.81 1.59 2.03 0.11 0.22 mg/dl 4.40 3.86 4.94 0.27 0.54 Randox Enzymatic UV method Creatinine PAP method Glucose oxidase Direct HDL PEGME Colorimetric without ppt. Calmagite Page 2 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Konelab 20/30/60®/Thermo Scientific Indiko Plus Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Magnesium mmol/l 1.63 1.43 1.83 mg/dl 3.96 3.47 4.45 Phosphate Inorganic mmol/l 2.36 2.00 2.72 0.18 0.36 mg/dl 7.32 6.20 8.44 0.56 1.12 Potassium mmol/l 6.03 5.55 6.51 0.24 0.48 ISE method - direct Protein Total g/l 46.5 37.2 55.8 4.65 9.30 Biuret reaction end point g/dl 4.65 3.72 5.58 0.47 0.93 Sodium mmol/l 156 148 164 4.00 8.00 ISE method - direct Triglycerides mmol/l 3.05 2.57 3.53 0.24 0.48 Lipase/GPO-PAP no correction mg/dl 270 227 313 21.50 43.00 mmol/l 0.58 0.50 0.65 0.04 0.08 mg/dl 9.73 8.47 11.0 0.63 1.26 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.24 8.03 10.5 0.61 1.21 mmol/l 0.59 0.51 0.67 0.04 0.08 mg/dl 9.88 8.58 11.2 0.65 1.30 mmol/l 18.5 15.7 21.3 1.40 2.80 mg/dl 111 94.4 128 8.30 16.60 mmol/l 18.5 15.7 21.3 1.40 2.80 mg/dl 51.9 44.1 59.7 3.90 7.80 Uric Acid (Urate) Urea high 1SD 2SD methods 0.10 0.20 Xylidyl Blue 0.25 0.49 Phosphomolybdate UV Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic BUN Page 3 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 29.7 25.3 34.1 2.20 4.40 Bromocresol Green g/dl 2.97 2.53 3.41 0.22 0.44 g/l 28.2 24.0 32.4 2.10 4.20 g/dl 2.82 2.40 3.24 0.21 0.42 g/l 27.5 23.4 31.6 2.05 4.10 g/dl 2.75 2.34 3.16 0.21 0.41 g/l 26.9 22.8 31.0 2.05 4.10 g/dl 2.69 2.28 3.10 0.21 0.41 U/l 389 330 448 29.50 59.00 p-Nitrophenylphosphate AMP 37°C U/I 303 257 349 23.00 46.00 p-Nitrophenylphosphate AMP 30°C U/I 249 211 287 19.00 38.00 p-Nitrophenylphosphate AMP 25°C U/l 213 181 245 16.00 32.00 Ortho Vitros Microslide Systems 37°C U/l 550 467 633 41.50 83.00 Diethanolamine buffer DEA 37°C U/I 428 364 492 32.00 64.00 Diethanolamine buffer DEA 30°C U/I 351 298 404 26.50 53.00 Diethanolamine buffer DEA 25°C U/l 375 319 431 28.00 56.00 AMP optimised to IFCC 37°C AMP optimised to IFCC 30°C Alkaline Phosphatase ALT (GPT) Bromocresol Purple Ortho Vitros Microslide Systems Turbidimetric Assays U/I 292 249 335 21.50 43.00 U/I 240 204 276 18.00 36.00 AMP optimised to IFCC 25°C U/l 143 115 171 14.00 28.00 Ortho Vitros Microslide Systems 37°C U/l 160 128 192 16.00 32.00 Tris buffer with P5P 37°C U/I 118 95 141 11.50 23.00 Tris buffer with P5P 30°C U/I 90 72 108 9.00 18.00 Tris buffer with P5P 25°C Page 1 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods ALT (GPT) U/l 132 105 159 13.50 27.00 Tris buffer without P5P 37°C U/I 98 78 118 10.00 20.00 Tris buffer without P5P 30°C U/I 74 59 89 7.50 15.00 Tris buffer without P5P 25°C U/l 124 100 148 12.00 24.00 Tris buffer SCE 37°C U/I 92 74 110 9.00 18.00 Tris buffer SCE 30°C U/I 70 56 84 7.00 14.00 Tris buffer SCE 25°C U/I 276 235 317 20.50 41.00 Immunoinhibition EPS substrate 37°C U/I 267 227 307 20.00 40.00 Roche liquid stable pNPG7 37°C Amylase Pancreatic Amylase Total U/I 300 255 345 22.50 45.00 Randox liquid stable pNPG7 37°C U/I 302 257 347 22.50 45.00 pNP Maltotrioside substrates 37°C U/I 301 256 346 22.50 45.00 Siemens - blocked pNPG7 37°C U/I 304 258 350 23.00 46.00 Biotrol - blocked pNPG7 37°C U/I 317 270 364 23.50 47.00 I.L. - blocked pNPG7 37°C U/I 251 213 289 19.00 38.00 Randox - Ethylidene pNPG7 37°C U/I 329 279 379 25.00 50.00 Randox liquid stable pNPG7 37°C U/I 288 244 332 22.00 44.00 BM/Roche Colorimetric pNPG7 37°C U/I 308 261 355 23.50 47.00 Beckman maltotetraose 37°C U/I 347 295 399 26.00 52.00 Siemens - maltopenta/hexaoside 37°C U/I 365 311 419 27.00 54.00 Siemens 2-chloro-pNP linked substrate 37°C U/I 292 248 336 22.00 44.00 Roche Integra 2-chloro-pNPG7 37°C U/I 180 153 207 13.50 27.00 Ortho Vitros Microslide Systems 37°C U/I 289 246 332 21.50 43.00 Roche liquid stable pNPG7 37°C U/I 361 307 415 27.00 54.00 Siemens 2-chloro-pNPG3 37°C U/I 281 239 323 21.00 42.00 bioMerieux 2-chloro-pNPG3 37°C Page 2 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Amylase Total U/I 303 257 349 23.00 46.00 Beckman Coulter - blocked pNPG7 37°C U/I 313 266 360 23.50 47.00 Beckman Synchron AMY7 37°C Apolipoprotein A-1 g/l 0.90 0.74 1.07 0.08 0.16 Immunoturbidimetric mg/dl 90.4 74.1 107 8.15 16.30 Apolipoprotein B g/l 0.56 0.46 0.66 0.05 0.10 mg/dl 55.6 45.6 65.6 5.00 10.00 Acid Phosphatase (non-prostatic) U/I 14.9 9.98 19.8 2.46 4.92 1-Naphthyl Phosphate substrate Kinetic 37°C U/I 10.5 7.04 14.0 1.73 3.46 1-Naphthyl Phosphate, Kinetic with Pentane diol Activation 37°C U/I 23.5 15.7 31.3 3.90 7.80 1-Naphthyl Phosphate substrate Kinetic 37°C U/I 41.0 27.5 54.5 6.75 13.50 1-Naphthyl Phosphate, Kinetic with Pentane diol Activation 37°C U/I 38.4 25.7 51.1 6.35 12.70 1-Naphthyl Phosphate substrate Kinetic 37°C U/I 51.5 34.5 68.5 8.50 17.00 1-Naphthyl Phosphate, Kinetic with Pentane diol Activation 37°C U/l 171 137 205 17.00 34.00 Ortho Vitros Microslide visible slide 37°C Acid Phosphatase (Prostatic) Acid Phosphatase (Total) AST (GOT) Bile Acids Bicarbonate Immunoturbidimetric U/l 182 146 218 18.00 36.00 Tris buffer with P5P 37°C U/I 123 99 147 12.00 24.00 Tris buffer with P5P 30°C U/I 87 69 105 9.00 18.00 Tris buffer with P5P 25°C U/l 138 110 166 14.00 28.00 Tris buffer without P5P 37°C U/I 93 74 112 9.50 19.00 Tris buffer without P5P 30°C U/I 66 52 80 7.00 14.00 Tris buffer without P5P 25°C U/l 133 106 160 13.50 27.00 Tris buffer SCE 37°C U/I 90 72 108 9.00 18.00 Tris buffer SCE 30°C Tris buffer SCE 25°C U/I 63 50 76 6.50 13.00 µmol/l 50.1 40.1 60.1 5.00 10.00 4th Generation Colorimetric µmol/l 51.7 41.4 62.0 5.15 10.30 5th Generation Colorimetric mmol/l 16.5 13.1 19.9 1.70 3.40 Colorimetric Page 3 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Bicarbonate mmol/l 19.4 15.4 23.4 2.00 4.00 Ortho Vitros Microslide Systems mmol/l 16.6 13.2 20.0 1.70 3.40 Differential rate pH change mmol/l 16.5 13.1 19.9 1.70 3.40 Enzymatic Bilirubin Direct Bilirubin Total mmol/l 16.9 13.4 20.4 1.75 3.50 Ion selective electrode µmol/l 28.0 22.1 33.9 2.95 5.90 Dichlorophenyl Diazonium (DPD) mg/dl 1.64 1.29 1.99 0.18 0.35 µmol/l 29.4 23.2 35.6 3.10 6.20 mg/dl 1.72 1.36 2.08 0.18 0.36 µmol/l 26.9 21.2 32.6 2.85 5.70 mg/dl 1.57 1.24 1.90 0.17 0.33 µmol/l 30.5 24.1 36.9 3.20 6.40 mg/dl 1.78 1.41 2.15 0.19 0.37 µmol/l 32.0 25.3 38.7 3.35 6.70 0.39 mg/dl 1.87 1.48 2.26 0.20 µmol/l 74.3 58.7 89.9 7.80 15.60 mg/dl 4.35 3.43 5.27 0.46 0.92 µmol/l 73.6 58.1 89.1 7.75 15.50 mg/dl 4.31 3.40 5.22 0.46 0.91 µmol/l 93.8 74.1 114 9.85 19.70 mg/dl 5.49 4.33 6.65 0.58 1.16 µmol/l 82.9 65.5 100 8.70 17.40 mg/dl 4.85 3.83 5.87 0.51 1.02 µmol/l 92.5 73.1 112 9.70 19.40 mg/dl 5.41 4.28 6.54 0.57 1.13 µmol/l 81.9 64.7 99.1 8.60 17.20 mg/dl 4.79 3.78 5.80 0.51 1.01 Diazo with Sulphanilic Acid Diazo with Dichloroaniline (DCA) Oxidation to Biliverdin Modified Jendrassik Vitros 250/500/700/950 Total Bilirubin Vitros 250/500/700/950 Total BUBC Diazo with Dichloroaniline (DCA) Diazo with Sulphanilic Acid Dichlorophenyl Diazonium (DPD) Nitrobenzenediazonium salt Page 4 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Bilirubin Total µmol/l 78.1 61.7 94.5 mg/dl 4.57 3.61 5.53 µmol/l 87.7 69.3 106 9.20 18.40 mg/dl 5.13 4.05 6.21 0.54 1.08 µmol/l 96.1 75.9 116 10.10 20.20 1.18 Calcium Cholesterol Chloride high 1SD 2SD methods 8.20 16.40 Diazonium ion 0.48 0.96 mg/dl 5.62 4.44 6.80 0.59 mmol/l 3.17 2.85 3.49 0.16 0.32 mg/dl 12.7 11.4 14.0 0.65 1.30 mmol/l 3.14 2.83 3.45 0.16 0.31 mg/dl 12.6 11.3 13.9 0.65 1.30 mmol/l 3.12 2.81 3.43 0.16 0.31 mg/dl 12.5 11.3 13.7 0.60 1.20 mmol/l 2.75 2.48 3.02 0.14 0.27 mg/dl 11.0 9.94 12.1 0.53 1.06 mmol/l 3.21 2.89 3.53 0.16 0.32 mg/dl 12.9 11.6 14.2 0.65 1.30 mmol/l 3.22 2.89 3.55 0.17 0.33 mg/dl 12.9 11.6 14.2 0.65 1.30 mmol/l 5.91 5.14 6.68 0.39 0.77 mg/dl 228 198 258 15.00 30.00 mmol/l 6.65 5.78 7.52 0.44 0.87 Oxidation to Biliverdin Modified Jendrassik Cresolphthalein complexone Ortho Vitros Microslide Systems Ion selective electrode Methylthymol blue Arsenazo III NM-BAPTA Ortho Vitros Microslide Systems Cholesterol Oxidase mg/dl 257 223 291 17.00 34.00 mmol/l 113 104 122 4.50 9.00 Colorimetric mmol/l 114 105 123 4.50 9.00 Ortho Vitros Microslide Systems Page 5 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Chloride mmol/l 113 104 122 4.50 9.00 ISE indirect mmol/l 114 105 123 4.50 9.00 ISE direct Cholinesterase U/l 5385 4308 6462 538.50 1077.00 Colorimetric Butyrylthiocholine 37°C CK Total U/l 438 359 517 39.50 79.00 Ortho Vitros Microslide Systems 37°C U/l 545 447 643 49.00 98.00 CK-NAC serum start (DGKC) 37°C U/I 341 280 402 30.50 61.00 CK-NAC serum start (DGKC) 30°C U/I 232 190 274 21.00 42.00 CK-NAC serum start (DGKC) 25°C U/l 559 458 660 50.50 101.00 CK-NAC substrate start (DGKC) 37°C U/I 350 287 413 31.50 63.00 CK-NAC substrate start (DGKC) 30°C U/I 238 195 281 21.50 43.00 CK-NAC substrate start (DGKC) 25°C U/l 558 457 659 50.50 101.00 CK-NAC (IFCC) 37°C U/I 349 286 412 31.50 63.00 CK-NAC (IFCC) 30°C U/I 237 194 280 21.50 43.00 CK-NAC (IFCC) 25°C U/l 553 454 652 49.50 99.00 Monothioglycerol 37°C U/I 346 284 408 31.00 62.00 Monothioglycerol 30°C U/I 235 193 277 21.00 42.00 Monothioglycerol 25°C U/l 511 419 603 46.00 92.00 Dithioerythritol 37°C U/I 320 262 378 29.00 58.00 Dithioerythritol 30°C U/I 217 178 256 19.50 39.00 Dithioerythritol 25°C U/l 510 418 602 46.00 92.00 Dithioerythritol (DTE) IFCC correlated 37°C U/I 319 262 376 28.50 57.00 Dithioerythritol (DTE) IFCC correlated 30°C Copper U/I 217 178 256 19.50 39.00 Dithioerythritol (DTE) IFCC correlated 25°C µmol/l 26.4 21.1 31.7 2.65 5.30 Atomic absorption µg/dl 168 134 202 17.00 34.00 µmol/l 25.8 20.6 31.0 2.60 5.20 µg/dl 164 131 197 16.50 33.00 Colorimetric Page 6 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Cortisol Creatinine Range unit Target low high 1SD 2SD methods Roche Cobas E411 nmol/l 1095 821 1369 137.00 274.00 µg/dl 39.4 29.6 49.2 4.90 9.80 µmol/l 342 274 410 34.00 68.00 mg/dl 3.86 3.10 4.62 0.38 0.76 µmol/l 357 285 429 36.00 72.00 mg/dl 4.03 3.22 4.84 0.41 0.81 µmol/l 379 304 454 37.50 75.00 mg/dl 4.28 3.44 5.12 0.42 0.84 µmol/l 378 303 453 37.50 75.00 mg/dl 4.27 3.42 5.12 0.43 0.85 µmol/l 378 303 453 37.50 75.00 mg/dl 4.27 3.42 5.12 0.43 0.85 µmol/l 372 298 446 37.00 74.00 mg/dl 4.20 3.37 5.03 0.42 0.83 µmol/l 376 301 451 37.50 75.00 mg/dl 4.25 3.40 5.10 0.43 0.85 µmol/l 362 289 435 36.50 73.00 mg/dl 4.09 3.27 4.91 0.41 0.82 µmol/l 381 304 458 38.50 77.00 mg/dl 4.31 3.44 5.18 0.44 0.87 µmol/l 375 300 450 37.50 75.00 0.85 Alkaline picrate with deproteinization Alkaline picrate no deproteinization Randox Enzymatic UV method Creatinine PAP method Roche Creatinine Plus Jaffe rate blanked Jaffe rate blanked comp. (-26 µmol/l) Jaffe rate blanked compensated (-18 µmol/l) Vitros IDMS Traceable IDMS traceable mg/dl 4.24 3.39 5.09 0.43 D-3-Hydroxybutyrate mmol/l 1.17 1.00 1.34 0.09 0.17 Tris buffer 100mmol pH 8.5 Digoxin nmol/l 3.67 2.94 4.40 0.37 0.73 Immunoturbidimetric ng/ml 2.87 2.30 3.44 0.29 0.57 Page 7 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Folate Free T4 Range unit Target low high 1SD 2SD methods Roche Cobas E411 nmol/l 26.1 19.8 32.4 3.15 6.30 ng/ml 11.5 8.73 14.3 1.39 2.77 pmol/l 55.4 41.5 69.3 6.95 13.90 Abbott Architect ng/dl 4.32 3.24 5.40 0.54 1.08 pg/ml 43.2 32.4 54.0 5.40 10.80 Abbott Architect pmol/l 70.3 52.7 87.9 8.80 17.60 Siemens Centaur XP/Classic ng/dl 5.48 4.11 6.85 0.69 1.37 pg/ml 54.8 41.1 68.5 6.85 13.70 Siemens Centaur XP/Classic Diasorin Liaison pmol/l 87.2 65.4 109 10.90 21.80 ng/dl 6.80 5.10 8.50 0.85 1.70 pg/ml 68.0 51.0 85.0 8.50 17.00 Diasorin Liaison pmol/l 66.0 49.5 82.5 8.25 16.50 Siemens Immulite 1000 ng/dl 5.15 3.86 6.44 0.65 1.29 pg/ml 51.5 38.6 64.4 6.45 12.90 Siemens Immulite 1000 pmol/l 67.8 50.9 84.7 8.45 16.90 Siemens Immulite 2000/2500 ng/dl 5.29 3.97 6.61 0.66 1.32 pg/ml 52.9 39.7 66.1 6.60 13.20 Siemens Immulite 2000/2500 pmol/l 89.1 66.8 111 11.15 22.30 Roche Elecsys ng/dl 6.95 5.21 8.69 0.87 1.74 pg/ml 69.5 52.1 86.9 8.70 17.40 Roche Elecsys pmol/l 85.1 63.8 106 10.65 21.30 Roche Modular E170 ng/dl 6.64 4.98 8.30 0.83 1.66 pg/ml 66.4 49.8 83.0 8.30 16.60 Roche Modular E170 pmol/l 80.9 60.7 101 10.10 20.20 Roche Cobas E411 ng/dl 6.31 4.73 7.89 0.79 1.58 pg/ml 63.1 47.3 78.9 7.90 15.80 Roche Cobas E411 Page 8 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target Free T4 pmol/l 82.3 61.7 ng/dl 6.42 4.81 pg/ml 64.2 48.1 µmol/l 18.4 µg/ml 8.80 Gentamicin gamma-GT GLDH Glucose low high 1SD 2SD methods 103 10.30 20.60 Roche Cobas 6000/8000 8.03 0.81 1.61 80.3 8.05 16.10 Roche Cobas 6000/8000 14.7 22.1 1.85 3.70 Immunoturbidimetric 7.03 10.6 0.89 1.77 U/I 153 130 176 11.50 23.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 121 102 140 9.50 19.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 94 80 108 7.00 14.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C U/I 197 168 226 14.50 29.00 Ortho Vitros Microslide Systems 37°C U/I 133 113 153 10.00 20.00 Gamma glutamyl-4-nitroanilide 37°C U/I 105 89 121 8.00 16.00 Gamma glutamyl-4-nitroanilide 30°C U/I 82 70 94 6.00 12.00 Gamma glutamyl-4-nitroanilide 25°C U/I 167 142 192 12.50 25.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 132 112 152 10.00 20.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 103 88 118 7.50 15.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C U/I 170 145 195 12.50 25.00 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 134 114 154 10.00 20.00 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 105 89 121 8.00 16.00 Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C U/I 27 21 33 3.00 6.00 Triethanolamine buffer 50 mmol 37°C U/I 21 16 26 2.50 5.00 Triethanolamine buffer 50 mmol 30°C U/I 17 13 21 2.00 4.00 Triethanolamine buffer 50 mmol 25°C mmol/l 14.4 12.3 16.5 1.05 2.10 Ortho Vitros Microslide Systems mg/dl 259 222 296 18.50 37.00 Page 9 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Glucose alpha-HBDH HDL - Cholesterol Range unit Target low high 1SD 2SD methods Glucose dehydrogenase mmol/l 16.0 13.6 18.4 1.20 2.40 mg/dl 288 245 331 21.50 43.00 mmol/l 15.6 13.3 17.9 1.15 2.30 mg/dl 281 240 322 20.50 41.00 mmol/l 15.4 13.1 17.7 1.15 2.30 Hexokinase Glucose oxidase mg/dl 278 236 320 21.00 42.00 U/I 466 368 564 49.00 98.00 Oxobutyrate < 10 mmol/l 37°C U/I 352 278 426 37.00 74.00 Oxobutyrate < 10 mmol/l 30°C U/I 264 208 320 28.00 56.00 Oxobutyrate < 10 mmol/l 25°C mmol/l 3.03 2.57 3.49 0.23 0.46 Direct HDL PPD mg/dl 117 99.2 135 8.90 17.80 mmol/l 2.61 2.21 3.01 0.20 0.40 mg/dl 101 85.3 117 7.85 15.70 mmol/l 2.40 2.04 2.76 0.18 0.36 mg/dl 92.6 78.7 107 6.95 13.90 mmol/l 3.01 2.56 3.46 0.23 0.45 mg/dl 116 98.8 133 8.60 17.20 mmol/l 2.77 2.35 3.19 0.21 0.42 mg/dl 107 90.7 123 8.15 16.30 mmol/l 2.43 2.07 2.79 0.18 0.36 mg/dl 93.8 79.9 108 6.95 13.90 mmol/l 3.00 2.55 3.45 0.23 0.45 mg/dl 116 98.4 134 8.80 17.60 mmol/l 2.72 2.31 3.13 0.21 0.41 mg/dl 105 89.2 121 7.90 15.80 Direct HDL Immunoseparation Vitros Magnetic HDL Direct HDL PEGME Direct Clearance Method Vitros dHDL PTA/MgCl2 direct precipitation Direct HDL Roche 3rd generation HDL - Ultra Page 10 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD Immunoglobulin A g/l 1.75 1.31 2.19 mg/dl 175 131 219 Immunoglobulin G g/l 5.83 4.78 6.88 mg/dl 583 478 Immunoglobulin M g/l 0.76 0.61 Iron Lactate 2SD methods 0.22 0.44 Immunoturbidimetric 22.00 44.00 0.53 1.05 688 52.50 105.00 0.91 0.08 0.15 mg/dl 76.2 61.0 91.4 7.60 15.20 µmol/l 37.7 30.9 44.5 3.40 6.80 µg/dl 211 173 249 19.00 38.00 µmol/l 37.2 30.5 43.9 3.35 6.70 µg/dl 208 170 246 19.00 38.00 µmol/l 38.6 31.7 45.5 3.45 6.90 µg/dl 216 177 255 19.50 39.00 mmol/l 5.22 4.28 6.16 0.47 0.94 mg/dl 47.0 38.6 55.4 4.20 8.40 mmol/l 5.61 4.60 6.62 0.51 1.01 mg/dl 50.5 41.4 59.6 4.55 9.10 mmol/l 5.15 4.22 6.08 0.47 0.93 mg/dl 46.4 38.0 54.8 4.20 8.40 mmol/l 5.72 4.69 6.75 0.52 1.03 mg/dl 51.5 42.3 60.7 4.60 9.20 mmol/l 5.06 4.15 5.97 0.46 0.91 8.20 Immunoturbidimetric Immunoturbidimetric Colorimetric with ppt. Colorimetric without ppt. Ortho Vitros Microslide Systems Ion selective electrode Colorimetric Lactate Oxidase Ortho Vitros Microslide Systems Enzymatic Electrode UV LDH mg/dl 45.6 37.4 53.8 4.10 LAP U/l 14 12 16 1.00 2.00 NAGEL 37°C LD (LDH) U/l 1135 965 1305 85.00 170.00 Ortho Vitros Microslide Systems 37°C U/l 349 296 402 26.50 53.00 L->P 37°C U/I 252 214 290 19.00 38.00 L->P 30°C U/I 177 150 204 13.50 27.00 L->P 25°C Page 11 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods LD (LDH) U/l 865 735 995 65.00 130.00 P->L Scandinavian & Dutch 37°C U/I 625 531 719 47.00 94.00 P->L Scandinavian & Dutch 30°C U/I 439 373 505 33.00 66.00 P->L Scandinavian & Dutch 25°C Lipase Lithium U/l 752 639 865 56.50 113.00 P->L German methods 37°C U/I 543 461 625 41.00 82.00 P->L German methods 30°C U/I 381 324 438 28.50 57.00 P->L German methods 25°C U/l 765 650 880 57.50 115.00 P->L SFBC 37°C U/I 552 469 635 41.50 83.00 P->L SFBC 30°C U/I 388 330 446 29.00 58.00 P->L SFBC 25°C U/l 384 327 441 28.50 57.00 L->P IFCC 37°C U/I 277 236 318 20.50 41.00 L->P IFCC 30°C U/I 195 166 224 14.50 29.00 L->P IFCC 25°C U/I 68 55 81 6.50 13.00 Other Colorimetric 37°C U/I 751 602 900 74.50 149.00 Ortho Vitros Microslide Systems 37°C U/I 62 49 75 6.50 13.00 Roche Colorimetric 37°C U/I 415 333 497 41.00 82.00 Randox Turbidimetric with colipase 37°C U/I 82 66 98 8.00 16.00 Randox Colorimetric 37°C mmol/l 2.48 2.18 2.78 0.15 0.30 Ortho Vitros Microslide Systems mg/dl 1.72 1.51 1.93 0.11 0.21 mmol/l 2.16 1.90 2.42 0.13 0.26 mg/dl 1.50 1.32 1.68 0.09 0.18 mmol/l 2.11 1.85 2.37 0.13 0.26 mg/dl 1.47 1.28 1.66 0.10 0.19 Ion selective electrode Spectrophotometric Page 12 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Lithium mmol/l 2.07 1.82 2.32 mg/dl 1.44 1.26 1.62 mmol/l 1.80 1.59 2.01 0.11 0.21 Magnesium high 1SD 2SD methods 0.13 0.25 Randox Colorimetric 0.09 0.18 mg/dl 4.37 3.86 4.88 0.26 0.51 mmol/l 1.82 1.61 2.03 0.11 0.21 mg/dl 4.42 3.91 4.93 0.26 0.51 mmol/l 1.78 1.56 2.00 0.11 0.22 mg/dl 4.33 3.79 4.87 0.27 0.54 Arsenazo III Ortho Vitros Microslide Systems Calmagite mmol/l 1.80 1.59 2.01 0.11 0.21 mg/dl 4.37 3.86 4.88 0.26 0.51 mmol/l 1.79 1.58 2.00 0.11 0.21 mg/dl 4.35 3.84 4.86 0.26 0.51 mmol/l 1.78 1.56 2.00 0.11 0.22 mg/dl 4.33 3.79 4.87 0.27 0.54 mmol/l 1.82 1.60 2.04 0.11 0.22 mg/dl 4.42 3.89 4.95 0.27 0.53 NEFA mmol/l 0.48 0.41 0.55 0.04 0.07 Colorimetric Osmolality mOsm/kg 346 277 415 34.50 69.00 Calculated mOsm/kg 381 305 457 38.00 76.00 Freezing point depression mmol/l 0.60 0.48 0.72 0.06 0.12 Colorimetric mg/l 90.6 72.5 109 9.05 18.10 mmol/l 2.29 1.95 2.63 0.17 0.34 mg/dl 7.10 6.05 8.15 0.53 1.05 mmol/l 2.32 1.97 2.67 0.18 0.35 mg/dl 7.19 6.11 8.27 0.54 1.08 Paracetamol Phosphate Inorganic Xylidyl Blue Methylthymol blue Chlorphosphonazo III Enzymatic Ortho Vitros Microslide Systems Phosphomolybdate enzymatic Page 13 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Phosphate Inorganic mmol/l 2.31 1.96 2.66 mg/dl 7.16 6.08 8.24 mmol/l 6.12 5.63 6.61 0.25 0.49 Ortho Vitros Microslide Systems mmol/l 6.35 5.84 6.86 0.26 0.51 Enzymatic mmol/l 5.94 5.47 6.41 0.24 0.47 Flame photometry mmol/l 6.13 5.64 6.62 0.25 0.49 ISE method - direct mmol/l 6.21 5.71 6.71 0.25 0.50 ISE method - indirect g/l 45.5 36.4 54.6 4.55 9.10 Ortho Vitros Microslide Systems g/dl 4.55 3.64 5.46 0.46 0.91 g/l 45.2 36.1 54.3 4.55 9.10 g/dl 4.52 3.61 5.43 0.46 0.91 g/l 44.1 35.3 52.9 4.40 8.80 g/dl 4.41 3.53 5.29 0.44 0.88 Potassium Protein Total PSA Total Salicylate Sodium high 1SD 2SD methods 0.18 0.35 Phosphomolybdate UV 0.54 1.08 Biuret reaction end point Biuret reaction kinetic ng/ml = 34.4 25.8 43.0 4.30 8.60 Roche Elecsys Modular E170 ng/ml = 31.4 23.5 39.3 3.95 7.90 bioMerieux VIDAS TPSA ng/ml = 27.0 20.3 33.7 3.35 6.70 Siemens Centaur XP/Classic ng/ml = 28.3 21.2 35.4 3.55 7.10 Abbott Architect ng/ml = 35.6 26.7 44.5 4.45 8.90 Cobas E411 ng/ml = 36.0 27.0 45.0 4.50 9.00 Roche Cobas 6000/8000 mmol/l 0.83 0.67 1.00 0.08 0.17 Enzymatic mg/dl 11.5 9.19 13.8 1.16 2.31 mmol/l 158 150 166 4.00 8.00 mmol/l 158 150 166 4.00 8.00 Enzymatic mmol/l 156 148 164 4.00 8.00 Flame photometry mmol/l 159 151 167 4.00 8.00 ISE method - direct Ortho Vitros Microslide Systems Page 14 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Range unit Target low high 1SD 2SD methods Sodium mmol/l 161 153 169 4.00 8.00 ISE method - indirect Theophylline µmol/l 118 94.4 142 11.80 23.60 Immunoturbidimetric µg/ml 21.3 17.0 25.6 2.15 4.30 µU/ml = 1.02 0.82 1.22 0.10 0.20 Abbott Architect µU/ml = 1.32 1.06 1.58 0.13 0.26 bioMerieux VIDAS TSH bioMerieux VIDAS TSH3 Ultrasensitive Thyroid Stimulating Hormone TIBC Tobramycin µU/ml = 1.28 1.02 1.54 0.13 0.26 µU/ml = 1.20 0.96 1.44 0.12 0.24 Siemens Immulite 1000 µU/ml = 1.25 1.00 1.50 0.13 0.25 Vitros ECi µU/ml = 1.41 1.13 1.69 0.14 0.28 Roche Elecsys µU/ml = 1.42 1.14 1.70 0.14 0.28 Roche Modular E170 µU/ml = 1.45 1.16 1.74 0.15 0.29 Roche Cobas E411 µU/ml = 1.41 1.13 1.69 0.14 0.28 Roche Cobas 6000/8000 µU/ml = 1.14 0.91 1.37 0.12 0.23 Siemens Centaur XP/Classic TSH3-Ultra µmol/l 62.4 49.3 75.5 6.55 13.10 Ortho Vitros Microslide Systems µg/dl 349 276 422 36.50 73.00 µmol/l 47.1 37.2 57.0 4.95 9.90 55.00 µg/dl 263 208 318 27.50 µmol/l 51.5 40.7 62.3 5.40 10.80 µg/dl 288 228 348 30.00 60.00 µmol/l 47.8 37.8 57.8 5.00 10.00 µg/dl 267 211 323 28.00 56.00 µmol/l 51.9 41.0 62.8 5.45 10.90 µg/dl 290 229 351 30.50 61.00 µmol/l 15.4 12.3 18.5 1.55 3.10 µg/ml 7.21 5.76 8.66 0.73 1.45 Removal of excess free iron FE+UIBC(saturation with iron) Direct Colorimetric Randox Direct Immunoturbidimetric Page 15 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Total T3 nmol/l 3.48 2.61 4.35 0.44 0.87 Abbott Architect ng/ml 2.27 1.70 2.84 0.29 0.57 ng/dl 227 170 284 28.50 57.00 Abbott Architect nmol/l 3.99 2.99 4.99 0.50 1.00 BioMerieux Vidas ng/ml 2.60 1.95 3.25 0.33 0.65 ng/dl 260 195 325 32.50 65.00 BioMerieux Vidas nmol/l 4.65 3.49 5.81 0.58 1.16 Roche Cobas E411 ng/ml 3.03 2.27 3.79 0.38 0.76 Total T4 Transferrin Triglycerides ng/dl 303 227 379 38.00 76.00 Roche Cobas E411 nmol/l 242 181 303 30.50 61.00 Abbott Architect µg/dl 18.9 14.1 23.7 2.40 4.80 ng/ml 189 141 237 24.00 48.00 Abbott Architect nmol/l 211 158 264 26.50 53.00 BioMerieux Vidas µg/dl 16.5 12.3 20.7 2.10 4.20 ng/ml 165 123 207 21.00 42.00 BioMerieux Vidas nmol/l 220 165 275 27.50 55.00 Siemens Immulite 2000/2500 µg/dl 17.2 12.9 21.5 2.15 4.30 ng/ml 172 129 215 21.50 43.00 Siemens Immulite 2000/2500 nmol/l 195 146 244 24.50 49.00 Roche Cobas E411 µg/dl 15.2 11.4 19.0 1.90 3.80 ng/ml 152 114 190 19.00 38.00 Roche Cobas E411 g/l 1.64 1.31 1.97 0.17 0.33 Immunoturbidimetric mg/dl 164 131 197 16.50 33.00 mmol/l 2.96 2.48 3.44 0.24 0.48 mg/dl 262 219 305 21.50 43.00 Lipase/GPO-PAP no correction Page 16 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Triglycerides mmol/l 3.00 2.52 3.48 0.24 0.48 Lipase/GPO-PAP 0.11mmol/l correction mg/dl 266 223 309 21.50 43.00 mmol/l 3.06 2.57 3.55 0.25 0.49 Uric Acid (Urate) Urea mg/dl 271 227 315 22.00 44.00 mmol/l 3.00 2.52 3.48 0.24 0.48 mg/dl 266 223 309 21.50 43.00 mmol/l 2.99 2.51 3.47 0.24 0.48 mg/dl 265 222 308 21.50 43.00 mmol/l 3.57 3.00 4.14 0.29 0.57 mg/dl 316 266 366 25.00 50.00 mmol/l 0.52 0.46 0.59 0.03 0.07 mg/dl 8.79 7.64 9.94 0.58 1.15 mmol/l 0.57 0.49 0.64 0.04 0.07 mg/dl 9.54 8.30 10.8 0.62 1.24 mmol/l 0.56 0.49 0.63 0.04 0.07 mg/dl 9.39 8.18 10.6 0.61 1.21 mmol/l 0.55 0.48 0.63 0.04 0.07 mg/dl 9.29 8.08 10.5 0.61 1.21 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.21 8.01 10.4 0.60 1.20 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.27 8.08 10.5 0.60 1.19 mmol/l 18.1 15.4 20.8 1.35 2.70 mg/dl 109 92.6 125 8.20 16.40 mmol/l 17.9 15.2 20.6 1.35 2.70 mg/dl 108 91.4 125 8.30 16.60 L/G Kinase EP. no correction L/G kinase EP. 0.11 mmol/l correction Lipase/Glycerol Dehydrogenase Ortho Vitros Microslide Systems Ortho Vitros Microslide Systems Uricase catalase 340nm Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Spectrophotometric at 280-290 Uricase Peroxidase with ascorbate oxidase @ 546nm Ortho Vitros Microslide Systems Urease end point Page 17 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Urea mmol/l 19.2 16.3 22.1 1.45 2.90 Urease kinetic mg/dl 115 98.0 132 8.50 17.00 mmol/l 18.7 15.9 21.5 1.40 2.80 Vitamin B12 Zinc mg/dl 112 95.6 128 8.20 16.40 mmol/l 18.9 16.1 21.7 1.40 2.80 mg/dl 114 96.8 131 8.60 17.20 mmol/l 19.2 16.3 22.1 1.45 2.90 mg/dl 53.9 45.8 62.0 4.05 8.10 pmol/l 221 177 265 22.00 44.00 pg/ml 299 240 358 29.50 59.00 µmol/l 33.1 26.5 39.7 3.30 6.60 µg/dl 216 173 259 21.50 43.00 µmol/l 34.3 27.4 41.2 3.45 6.90 µg/dl 224 179 269 22.50 45.00 Urease hypochlorite Urease Berthelot BUN Roche Cobas E411 Atomic absorption Colorimetric with deproteinisation Page 18 of 18 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MEAN OF ALL INSTRUMENTS (Elec.) Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Range unit Target low high 1SD 2SD methods alpha-1-globulin 7.0 5.3 8.7 0.84 1.68 % of total Protein (Beckman Capillary) alpha-2-globulin 7.4 5.6 9.2 0.89 1.78 % of total Protein (Beckman Capillary) Albumin (electrophoresis) 60.7 54.7 66.7 3.00 6.00 % of total Protein (Beckman Capillary) beta-globulin 11.9 9.0 14.8 1.43 2.86 % of total Protein (Beckman Capillary) gamma-globulin 13.0 9.9 16.1 1.56 3.12 % of total Protein (Beckman Capillary) Page 1 of 1 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MINDRAY BS-200/300/400 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.5 26.0 35.0 2.25 4.50 Bromocresol Green g/dl 3.05 2.60 3.50 0.23 0.45 U/l 141 113 169 14.00 28.00 Tris buffer without P5P 37°C ALT (GPT) AST (GOT) Bilirubin Total Calcium U/I 104 84 124 10.00 20.00 Tris buffer without P5P 30°C U/I 79 64 94 7.50 15.00 Tris buffer without P5P 25°C U/l 149 119 179 15.00 30.00 Tris buffer without P5P 37°C U/I 101 80 122 10.50 21.00 Tris buffer without P5P 30°C U/I 71 57 85 7.00 14.00 Tris buffer without P5P 25°C µmol/l 95.1 75.2 115 9.95 19.90 Diazo with Sulphanilic Acid mg/dl 5.56 4.40 6.72 0.58 1.16 µmol/l 95.7 75.6 116 10.05 20.10 mg/dl 5.60 4.42 6.78 0.59 1.18 mmol/l 3.41 3.07 3.75 0.17 0.34 Dichlorophenyl Diazonium (DPD) Cresolphthalein complexone mg/dl 13.7 12.3 15.1 0.70 1.40 mmol/l 3.15 2.83 3.47 0.16 0.32 mg/dl 12.6 11.3 13.9 0.65 1.30 mmol/l 6.60 5.74 7.46 0.43 0.86 mg/dl 255 222 288 16.50 33.00 Chloride mmol/l 116 106 126 5.00 10.00 ISE direct CK Total U/l 531 435 627 48.00 96.00 CK-NAC (IFCC) 37°C U/I 332 272 392 30.00 60.00 CK-NAC (IFCC) 30°C U/I 226 185 267 20.50 41.00 CK-NAC (IFCC) 25°C Cholesterol Arsenazo III Cholesterol Oxidase Page 1 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MINDRAY BS-200/300/400 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit high 1SD Creatinine µmol/l 347 mg/dl 3.92 277 417 3.13 4.71 µmol/l 367 293 mg/dl U/I 4.15 154 U/I U/I Glucose mmol/l 15.8 mg/dl 285 241 329 22.00 44.00 HDL - Cholesterol mmol/l 2.86 2.43 3.29 0.22 0.43 mg/dl 110 93.8 126 8.10 16.20 mmol/l 2.81 2.39 3.23 0.21 0.42 mg/dl 108 92.3 124 7.85 15.70 gamma-GT Iron LD (LDH) Target low 2SD methods 35.00 70.00 Alkaline picrate no deproteinization 0.40 0.79 441 37.00 74.00 3.31 4.99 0.42 0.84 130 178 12.00 24.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C 121 102 140 9.50 19.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C 95 80 110 7.50 15.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C 13.4 18.2 1.20 2.40 Glucose oxidase Randox Enzymatic UV method Direct HDL PPD Direct Clearance Method µmol/l 36.1 29.6 42.6 3.25 6.50 µg/dl 202 165 239 18.50 37.00 Colorimetric without ppt. U/l 734 624 844 55.00 110.00 P->L German methods 37°C U/I 530 451 609 39.50 79.00 P->L German methods 30°C U/I 372 316 428 28.00 56.00 P->L German methods 25°C U/l 758 644 872 57.00 114.00 P->L SFBC 37°C U/I 547 465 629 41.00 82.00 P->L SFBC 30°C U/I 384 327 441 28.50 57.00 P->L SFBC 25°C U/l 380 323 437 28.50 57.00 L->P IFCC 37°C U/I 274 233 315 20.50 41.00 L->P IFCC 30°C U/I 193 164 222 14.50 29.00 L->P IFCC 25°C Page 2 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A MINDRAY BS-200/300/400 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Magnesium mmol/l 1.71 1.51 1.91 mg/dl 4.16 3.67 4.65 Phosphate Inorganic mmol/l 2.43 2.06 2.80 0.19 0.37 mg/dl 7.53 6.39 8.67 0.57 1.14 Potassium mmol/l 5.90 5.42 6.38 0.24 0.48 ISE method - direct Protein Total g/l 48.8 39.1 58.5 4.85 9.70 Biuret reaction end point g/dl 4.88 3.91 5.85 0.49 0.97 Sodium mmol/l 156 148 164 4.00 8.00 ISE method - direct Triglycerides mmol/l 3.07 2.58 3.56 0.25 0.49 Lipase/GPO-PAP no correction mg/dl 272 228 316 22.00 44.00 mmol/l 0.60 0.52 0.68 0.04 0.08 mg/dl 10.1 8.77 11.4 0.67 1.33 mmol/l 0.58 0.51 0.66 0.04 0.08 mg/dl 9.74 8.48 11.0 0.63 1.26 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.21 8.00 10.4 0.61 1.21 mmol/l 19.4 16.5 22.3 1.45 2.90 mg/dl 117 99.2 135 8.90 17.80 mmol/l 19.6 16.7 22.5 1.45 2.90 mg/dl 118 100 136 9.00 18.00 mmol/l 18.9 16.1 21.7 1.40 2.80 mg/dl 114 96.8 131 8.60 17.20 mmol/l 19.6 16.7 22.5 1.45 2.90 mg/dl 55.0 46.8 63.2 4.10 8.20 Uric Acid (Urate) Urea high 1SD 2SD methods 0.10 0.20 Xylidyl Blue 0.25 0.49 Phosphomolybdate UV Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease end point Urease kinetic Urease hypochlorite BUN Page 3 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A PRESTIGE 24i Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 29.4 25.0 33.8 2.20 4.40 Bromocresol Green g/dl 2.94 2.50 3.38 0.22 0.44 U/l 483 411 555 36.00 72.00 Diethanolamine buffer DEA 37°C Alkaline Phosphatase U/I 376 320 432 28.00 56.00 Diethanolamine buffer DEA 30°C U/I 309 263 355 23.00 46.00 Diethanolamine buffer DEA 25°C U/l 138 110 166 14.00 28.00 Tris buffer without P5P 37°C U/I 102 81 123 10.50 21.00 Tris buffer without P5P 30°C U/I 78 62 94 8.00 16.00 Tris buffer without P5P 25°C U/l 143 114 172 14.50 29.00 Tris buffer without P5P 37°C U/I 97 77 117 10.00 20.00 Tris buffer without P5P 30°C U/I 68 54 82 7.00 14.00 Tris buffer without P5P 25°C µmol/l 23.8 18.8 28.8 2.50 5.00 Diazo with Dichloroaniline (DCA) mg/dl 1.39 1.10 1.68 0.15 0.29 µmol/l 86.2 68.1 104 9.05 18.10 mg/dl 5.04 3.98 6.10 0.53 1.06 Calcium mmol/l 3.23 2.91 3.55 0.16 0.32 mg/dl 12.9 11.7 14.1 0.60 1.20 Cholesterol mmol/l 6.74 5.86 7.62 0.44 0.88 mg/dl 260 226 294 17.00 34.00 Chloride mmol/l 120 110 130 5.00 10.00 ISE direct CK Total U/l 531 435 627 48.00 96.00 CK-NAC (IFCC) 37°C U/I 332 272 392 30.00 60.00 CK-NAC (IFCC) 30°C U/I 226 185 267 20.50 41.00 CK-NAC (IFCC) 25°C ALT (GPT) AST (GOT) Bilirubin Direct Bilirubin Total Diazo with Dichloroaniline (DCA) Arsenazo III Cholesterol Oxidase Page 1 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A PRESTIGE 24i Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Creatinine µmol/l 384 307 461 38.50 77.00 Jaffe rate blanked comp. (-26 µmol/l) mg/dl 4.34 3.47 5.21 0.44 0.87 Glucose mmol/l 15.8 13.4 18.2 1.20 2.40 mg/dl 285 241 329 22.00 44.00 Phosphate Inorganic mmol/l 2.24 1.91 2.57 0.17 0.33 mg/dl 6.94 5.92 7.96 0.51 1.02 Protein Total g/l 43.7 35.0 52.4 4.35 8.70 g/dl 4.37 3.50 5.24 0.44 0.87 mmol/l 3.00 2.52 3.48 0.24 0.48 mg/dl 266 223 309 21.50 43.00 mmol/l 0.56 0.48 0.63 0.04 0.07 mg/dl 9.32 8.11 10.5 0.61 1.21 mmol/l 0.56 0.48 0.63 0.04 0.07 Triglycerides Uric Acid (Urate) Urea mg/dl 9.36 8.13 10.6 0.61 1.23 mmol/l 19.3 16.4 22.2 1.45 2.90 mg/dl 116 98.6 133 8.70 17.40 mmol/l 19.3 16.4 22.2 1.45 2.90 mg/dl 54.2 46.1 62.3 4.05 8.10 Glucose oxidase Phosphomolybdate UV Biuret reaction end point Lipase/GPO-PAP no correction Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Urease kinetic BUN Page 2 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas 6000 c501 e601 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.5 25.9 35.1 2.30 4.60 Bromocresol Green g/dl 3.05 2.59 3.51 0.23 0.46 g/l 27.5 23.4 31.6 2.05 4.10 g/dl 2.75 2.34 3.16 0.21 0.41 g/l 26.7 22.7 30.7 2.00 4.00 Alkaline Phosphatase ALT (GPT) Bromocresol Purple Turbidimetric Assays g/dl 2.67 2.27 3.07 0.20 0.40 U/l 269 228 310 20.50 41.00 Roche Integra AMP buffer 37°C U/I 210 178 242 16.00 32.00 Roche Integra AMP buffer 30°C U/I 172 146 198 13.00 26.00 Roche Integra AMP buffer 25°C U/l 127 102 152 12.50 25.00 Tris buffer without P5P 37°C U/I 94 75 113 9.50 19.00 Tris buffer without P5P 30°C U/I 72 57 87 7.50 15.00 Tris buffer without P5P 25°C Amylase Pancreatic U/I 266 226 306 20.00 40.00 Randox EPS Liquid and BM/Roche EPS Liquid 37°C Amylase Total U/I 286 243 329 21.50 43.00 Roche Integra 2-chloro-pNPG7 37°C U/I 288 245 331 21.50 43.00 Roche liquid stable pNPG7 37°C U/l 135 108 162 13.50 27.00 Tris buffer without P5P 37°C Tris buffer without P5P 30°C AST (GOT) U/I 91 73 109 9.00 18.00 U/I 64 51 77 6.50 13.00 Tris buffer without P5P 25°C Bile Acids µmol/l 50.3 40.2 60.4 5.05 10.10 Enzymatic Colorimetric Bicarbonate mmol/l 16.5 13.1 19.9 1.70 3.40 Colorimetric mmol/l 16.5 13.1 19.9 1.70 3.40 Enzymatic Page 1 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas 6000 c501 e601 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD Bilirubin Direct µmol/l 29.2 23.1 35.3 mg/dl 1.71 1.35 2.07 µmol/l 29.2 23.0 mg/dl 1.71 µmol/l 29.6 Bilirubin Total Calcium Cholesterol Chloride 2SD methods 3.05 6.10 Dichlorophenyl Diazonium (DPD) 0.18 0.36 35.4 3.10 6.20 1.35 2.07 0.18 0.36 23.3 35.9 3.15 6.30 0.37 mg/dl 1.73 1.36 2.10 0.19 µmol/l 77.8 61.4 94.2 8.20 16.40 mg/dl 4.55 3.59 5.51 0.48 0.96 µmol/l 77.9 61.5 94.3 8.20 16.40 mg/dl 4.56 3.60 5.52 0.48 0.96 µmol/l 77.6 61.3 93.9 8.15 16.30 mg/dl 4.54 3.59 5.49 0.48 0.95 mmol/l 3.22 2.90 3.54 0.16 0.32 mg/dl 12.9 11.6 14.2 0.65 1.30 mmol/l 3.23 2.90 3.56 0.17 0.33 mg/dl 12.9 11.6 14.2 0.65 1.30 mmol/l 6.58 5.72 7.44 0.43 0.86 mg/dl 254 221 287 16.50 33.00 mmol/l 110 101 119 4.50 9.00 Diazo with Sulphanilic Acid Diazo with Dichloroaniline (DCA) Diazo with Sulphanilic Acid Dichlorophenyl Diazonium (DPD) Diazonium ion Cresolphthalein complexone NM-BAPTA Cholesterol Oxidase ISE indirect Cholinesterase U/l 5324 4259 6389 532.50 1065.00 Colorimetric Butyrylthiocholine 37°C CK Total U/l 577 473 681 52.00 104.00 CK-NAC substrate start (DGKC) 37°C U/I 361 296 426 32.50 65.00 CK-NAC substrate start (DGKC) 30°C U/I 245 201 289 22.00 44.00 CK-NAC substrate start (DGKC) 25°C U/l 574 471 677 51.50 103.00 CK-NAC (IFCC) 37°C U/I 359 295 423 32.00 64.00 CK-NAC (IFCC) 30°C U/I 244 200 288 22.00 44.00 CK-NAC (IFCC) 25°C Page 2 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas 6000 c501 e601 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Creatinine µmol/l 375 mg/dl 4.24 300 450 3.39 5.09 37.50 75.00 Alkaline picrate no deproteinization 0.43 0.85 µmol/l 387 310 464 38.50 77.00 mg/dl 4.37 3.50 5.24 0.44 0.87 µmol/l 383 306 460 38.50 77.00 mg/dl 4.33 3.46 5.20 0.44 0.87 µmol/l 377 302 452 37.50 75.00 mg/dl 4.26 3.41 5.11 0.43 0.85 µmol/l 377 301 453 38.00 76.00 mg/dl 4.26 3.40 5.12 0.43 0.86 µmol/l 365 292 438 36.50 73.00 Randox Enzymatic UV method Roche Creatinine Plus Jaffe rate blanked Jaffe rate blanked comp. (-26 µmol/l) Jaffe rate blanked compensated (-18 µmol/l) mg/dl 4.12 3.30 4.94 0.41 0.82 D-3-Hydroxybutyrate mmol/l 1.16 0.99 1.33 0.09 0.17 Tris buffer 100mmol pH 8.5 Free T4 pmol/l 82.3 61.7 103 10.30 20.60 Roche Cobas 6000/8000 ng/dl 6.42 4.81 8.03 0.81 1.61 pg/ml 64.2 48.1 80.3 8.05 16.10 gamma-GT Glucose Roche Cobas 6000/8000 U/I 147 125 169 11.00 22.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 116 99 133 8.50 17.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 91 77 105 7.00 14.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C U/I 167 142 192 12.50 25.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 132 112 152 10.00 20.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 103 88 118 7.50 15.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C mmol/l 15.5 13.2 17.8 1.15 2.30 Hexokinase mg/dl 279 238 320 20.50 41.00 Page 3 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas 6000 c501 e601 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target Glucose mmol/l 15.7 13.3 18.1 mg/dl 283 240 326 mmol/l 2.94 2.50 3.38 0.22 0.44 mg/dl 113 96.5 130 8.25 16.50 mmol/l 2.97 2.52 3.42 0.23 0.45 HDL - Cholesterol low high 1SD 2SD methods 1.20 2.40 Glucose oxidase 21.50 43.00 Direct HDL PEGME Direct HDL Roche 3rd generation mg/dl 115 97.3 133 8.85 17.70 µmol/l 37.6 30.8 44.4 3.40 6.80 µg/dl 210 172 248 19.00 38.00 µmol/l 37.2 30.5 43.9 3.35 6.70 µg/dl 208 170 246 19.00 38.00 Lactate mmol/l 5.60 4.59 6.61 0.51 1.01 mg/dl 50.5 41.4 59.6 4.55 9.10 LD (LDH) U/l 734 624 844 55.00 110.00 P->L German methods 37°C U/I 530 451 609 39.50 79.00 P->L German methods 30°C U/I 372 316 428 28.00 56.00 P->L German methods 25°C U/l 734 624 844 55.00 110.00 P->L SFBC 37°C U/I 530 451 609 39.50 79.00 P->L SFBC 30°C U/I 372 316 428 28.00 56.00 P->L SFBC 25°C U/l 379 322 436 28.50 57.00 L->P IFCC 37°C U/I 274 232 316 21.00 42.00 L->P IFCC 30°C U/I 192 163 221 14.50 29.00 L->P IFCC 25°C Iron Colorimetric with ppt. Colorimetric without ppt. Colorimetric Lactate Oxidase Lipase U/I 60 48 72 6.00 12.00 Roche Colorimetric 37°C Lithium mmol/l 2.10 1.85 2.35 0.13 0.25 Spectrophotometric mg/dl 1.46 1.28 1.64 0.09 0.18 mmol/l 1.81 1.59 2.03 0.11 0.22 mg/dl 4.40 3.86 4.94 0.27 0.54 Magnesium Xylidyl Blue Page 4 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas 6000 c501 e601 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Magnesium mmol/l 1.80 1.58 2.02 mg/dl 4.37 3.84 4.90 0.11 0.22 Chlorphosphonazo III 0.27 0.53 Osmolality mOsm/kg 342 274 410 34.00 68.00 Calculated Phosphate Inorganic mmol/l 2.28 1.94 2.62 0.17 0.34 Phosphomolybdate enzymatic mg/dl 7.07 6.01 8.13 0.53 1.06 mmol/l 2.29 1.95 2.63 0.17 0.34 mg/dl 7.10 6.05 8.15 0.53 1.05 Potassium mmol/l 6.25 5.75 6.75 0.25 0.50 ISE method - indirect Protein Total g/l 44.3 35.4 53.2 4.45 8.90 Biuret reaction end point g/dl 4.43 3.54 5.32 0.45 0.89 g/l 44.2 35.4 53.0 4.40 8.80 PSA Total Phosphomolybdate UV Biuret reaction kinetic g/dl 4.42 3.54 5.30 0.44 0.88 ng/ml = 36.0 27.0 45.0 4.50 9.00 Roche Cobas 6000/8000 ISE method - indirect Sodium mmol/l 161 153 169 4.00 8.00 Thyroid Stimulating Hormone µU/ml = 1.41 1.13 1.69 0.14 0.28 Roche Cobas 6000/8000 TIBC µmol/l 51.2 40.5 61.9 5.35 10.70 FE+UIBC(saturation with iron) µg/dl 286 226 346 30.00 60.00 Triglycerides mmol/l 2.90 2.44 3.36 0.23 0.46 mg/dl 257 216 298 20.50 41.00 mmol/l 2.89 2.43 3.35 0.23 0.46 mg/dl 256 215 297 20.50 41.00 mmol/l 2.91 2.45 3.37 0.23 0.46 mg/dl 258 217 299 20.50 41.00 mmol/l 0.54 0.47 0.61 0.04 0.07 mg/dl 9.07 7.90 10.2 0.59 1.17 Uric Acid (Urate) Lipase/GPO-PAP no correction Lipase/GPO-PAP 0.11mmol/l correction L/G Kinase EP. no correction Uricase peroxidase with ascorbate oxidase Page 5 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas 6000 c501 e601 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target Uric Acid (Urate) mmol/l 0.55 0.48 0.62 mg/dl 9.17 7.98 10.4 mmol/l 0.55 0.48 0.62 0.04 0.07 Urea low high 1SD 2SD methods 0.04 0.07 Uricase peroxidase no ascorbate oxidase 0.60 1.19 mg/dl 9.19 8.00 10.4 0.60 1.19 mmol/l 19.1 16.2 22.0 1.45 2.90 mg/dl 115 97.4 133 8.80 17.60 mmol/l 19.1 16.2 22.0 1.45 2.90 mg/dl 53.6 45.6 61.6 4.00 8.00 Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic BUN Page 6 of 6 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C111® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.1 25.6 34.6 2.25 4.50 Bromocresol Green g/dl 3.01 2.56 3.46 0.23 0.45 U/l 250 212 288 19.00 38.00 Alkaline Phosphatase Roche Integra AMP buffer 37°C U/I 195 165 225 15.00 30.00 Roche Integra AMP buffer 30°C U/I 160 135 185 12.50 25.00 Roche Integra AMP buffer 25°C U/l 127 101 153 13.00 26.00 Tris buffer without P5P 37°C U/I 94 75 113 9.50 19.00 Tris buffer without P5P 30°C U/I 72 57 87 7.50 15.00 Tris buffer without P5P 25°C Amylase Total U/I 294 250 338 22.00 44.00 Roche liquid stable pNPG7 37°C AST (GOT) U/l 134 108 160 13.00 26.00 Tris buffer without P5P 37°C U/I 91 73 109 9.00 18.00 Tris buffer without P5P 30°C ALT (GPT) U/I 64 51 77 6.50 13.00 Tris buffer without P5P 25°C Bicarbonate mmol/l 17.0 13.5 20.5 1.75 3.50 Enzymatic Bilirubin Direct µmol/l 30.6 24.2 37.0 3.20 6.40 Dichlorophenyl Diazonium (DPD) mg/dl 1.79 1.42 2.16 0.19 0.37 µmol/l 29.7 23.5 35.9 3.10 6.20 0.37 Bilirubin Total mg/dl 1.74 1.37 2.11 0.19 µmol/l 77.4 61.1 93.7 8.15 16.30 mg/dl 4.53 3.57 5.49 0.48 0.96 µmol/l 77.0 60.9 93.1 8.05 16.10 mg/dl 4.50 3.56 5.44 0.47 0.94 Diazo with Sulphanilic Acid Diazo with Sulphanilic Acid Dichlorophenyl Diazonium (DPD) Page 1 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C111® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Bilirubin Total µmol/l 77.5 61.2 93.8 mg/dl 4.53 3.58 5.48 mmol/l 3.26 2.93 3.59 0.17 0.33 Calcium high 1SD 2SD methods 8.15 16.30 Diazonium ion 0.48 0.95 mg/dl 13.1 11.7 14.5 0.70 1.40 mmol/l 3.24 2.92 3.56 0.16 0.32 1.30 Cresolphthalein complexone NM-BAPTA mg/dl 13.0 11.7 14.3 0.65 mmol/l 6.84 5.95 7.73 0.45 0.89 mg/dl 264 230 298 17.00 34.00 Chloride mmol/l 116 106 126 5.00 10.00 ISE indirect CK Total U/l 575 471 679 52.00 104.00 CK-NAC (IFCC) 37°C U/I 360 295 425 32.50 65.00 CK-NAC (IFCC) 30°C Cholesterol Creatinine gamma-GT Glucose Cholesterol Oxidase U/I 244 200 288 22.00 44.00 CK-NAC (IFCC) 25°C µmol/l 354 283 425 35.50 71.00 Alkaline picrate no deproteinization mg/dl 4.00 3.20 4.80 0.40 0.80 µmol/l 365 292 438 36.50 73.00 mg/dl 4.12 3.30 4.94 0.41 0.82 µmol/l 341 273 409 34.00 68.00 mg/dl 3.85 3.08 4.62 0.39 0.77 U/I 163 139 187 12.00 24.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 128 110 146 9.00 18.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 101 86 116 7.50 15.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C Roche Creatinine Plus Jaffe rate blanked compensated (-18 µmol/l) U/I 160 136 184 12.00 24.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 126 107 145 9.50 19.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 99 84 114 7.50 15.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C mmol/l 15.8 13.4 18.2 1.20 2.40 Hexokinase mg/dl 285 241 329 22.00 44.00 Page 2 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C111® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target Glucose mmol/l 15.9 13.5 18.3 mg/dl 287 243 331 mmol/l 2.93 2.49 3.37 0.22 0.44 mg/dl 113 96.1 130 8.45 16.90 mmol/l 3.06 2.60 3.52 0.23 0.46 HDL - Cholesterol low high 1SD 2SD methods 1.20 2.40 Glucose oxidase 22.00 44.00 Direct HDL PEGME Direct HDL Roche 3rd generation mg/dl 118 100 136 9.00 18.00 µmol/l 34.5 28.3 40.7 3.10 6.20 µg/dl 193 158 228 17.50 35.00 U/l 396 336 456 30.00 60.00 L->P IFCC 37°C U/I 286 243 329 21.50 43.00 L->P IFCC 30°C U/I 201 170 232 15.50 31.00 L->P IFCC 25°C mmol/l 1.78 1.57 1.99 0.11 0.21 Chlorphosphonazo III mg/dl 4.33 3.82 4.84 0.26 0.51 mmol/l 2.38 2.02 2.74 0.18 0.36 mg/dl 7.38 6.26 8.50 0.56 1.12 Potassium mmol/l 6.12 5.63 6.61 0.25 0.49 ISE method - indirect Protein Total g/l 45.1 36.1 54.1 4.50 9.00 Biuret reaction end point g/dl 4.51 3.61 5.41 0.45 0.90 Sodium mmol/l 158 150 166 4.00 8.00 ISE method - indirect Triglycerides mmol/l 2.95 2.48 3.42 0.24 0.47 Lipase/GPO-PAP no correction mg/dl 261 219 303 21.00 42.00 mmol/l 2.88 2.42 3.34 0.23 0.46 mg/dl 255 214 296 20.50 41.00 mmol/l 0.56 0.49 0.63 0.04 0.07 mg/dl 9.41 8.18 10.6 0.62 1.23 Iron LD (LDH) Magnesium Phosphate Inorganic Uric Acid (Urate) Colorimetric without ppt. Phosphomolybdate UV Lipase/GPO-PAP 0.11mmol/l correction Uricase peroxidase with ascorbate oxidase Page 3 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C111® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target Uric Acid (Urate) mmol/l 0.56 0.49 0.63 mg/dl 9.42 8.20 10.6 mmol/l 0.55 0.48 0.62 0.04 0.07 Urea low high 1SD 2SD methods 0.04 0.07 Uricase peroxidase no ascorbate oxidase 0.61 1.22 mg/dl 9.21 8.01 10.4 0.60 1.20 mmol/l 18.8 16.0 21.6 1.40 2.80 mg/dl 113 96.2 130 8.40 16.80 mmol/l 18.5 15.7 21.3 1.40 2.80 mg/dl 111 94.4 128 8.30 16.60 mmol/l 18.8 16.0 21.6 1.40 2.80 mg/dl 52.8 44.9 60.7 3.95 7.90 Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic Urease hypochlorite BUN Page 4 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C311® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.1 25.6 34.6 2.25 4.50 Bromocresol Green g/dl 3.01 2.56 3.46 0.23 0.45 g/l 27.9 23.7 32.1 2.10 4.20 Alkaline Phosphatase ALT (GPT) g/dl 2.79 2.37 3.21 0.21 0.42 U/l 262 223 301 19.50 39.00 Bromocresol Purple Roche Integra AMP buffer 37°C U/I 204 174 234 15.00 30.00 Roche Integra AMP buffer 30°C U/I 167 142 192 12.50 25.00 Roche Integra AMP buffer 25°C U/l 129 103 155 13.00 26.00 Tris buffer without P5P 37°C U/I 95 76 114 9.50 19.00 Tris buffer without P5P 30°C U/I 73 58 88 7.50 15.00 Tris buffer without P5P 25°C Amylase Total U/I 290 247 333 21.50 43.00 Roche liquid stable pNPG7 37°C AST (GOT) U/l 136 109 163 13.50 27.00 Tris buffer without P5P 37°C U/I 92 74 110 9.00 18.00 Tris buffer without P5P 30°C U/I 65 52 78 6.50 13.00 Tris buffer without P5P 25°C Bicarbonate mmol/l 16.4 13.0 19.8 1.70 3.40 Enzymatic Bilirubin Direct µmol/l 28.6 22.6 34.6 3.00 6.00 Dichlorophenyl Diazonium (DPD) mg/dl 1.67 1.32 2.02 0.18 0.35 µmol/l 28.7 22.7 34.7 3.00 6.00 mg/dl 1.68 1.33 2.03 0.18 0.35 µmol/l 29.4 23.2 35.6 3.10 6.20 mg/dl 1.72 1.36 2.08 0.18 0.36 Diazo with Sulphanilic Acid Diazo with Dichloroaniline (DCA) Page 1 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C311® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Bilirubin Total µmol/l 78.9 62.3 95.5 mg/dl 4.62 3.64 5.60 8.30 16.60 Diazo with Sulphanilic Acid 0.49 0.98 µmol/l 77.6 61.3 93.9 8.15 16.30 mg/dl 4.54 3.59 5.49 0.48 0.95 µmol/l 77.9 61.6 94.2 8.15 16.30 0.96 Dichlorophenyl Diazonium (DPD) Diazonium ion mg/dl 4.56 3.60 5.52 0.48 mmol/l 3.25 2.93 3.57 0.16 0.32 mg/dl 13.0 11.7 14.3 0.65 1.30 mmol/l 3.24 2.91 3.57 0.17 0.33 mg/dl 13.0 11.7 14.3 0.65 1.30 Cholesterol mmol/l 6.59 5.73 7.45 0.43 0.86 mg/dl 254 221 287 16.50 33.00 Chloride mmol/l 110 101 119 4.50 9.00 ISE indirect CK Total U/l 576 472 680 52.00 104.00 CK-NAC (IFCC) 37°C U/I 361 295 427 33.00 66.00 CK-NAC (IFCC) 30°C U/I 245 201 289 22.00 44.00 CK-NAC (IFCC) 25°C Alkaline picrate no deproteinization Calcium Creatinine gamma-GT µmol/l 363 291 435 36.00 72.00 mg/dl 4.10 3.29 4.91 0.41 0.81 µmol/l 392 314 470 39.00 78.00 mg/dl 4.43 3.55 5.31 0.44 0.88 µmol/l 387 310 464 38.50 77.00 mg/dl 4.37 3.50 5.24 0.44 0.87 µmol/l 384 307 461 38.50 77.00 mg/dl 4.34 3.47 5.21 0.44 0.87 Cresolphthalein complexone NM-BAPTA Cholesterol Oxidase Randox Enzymatic UV method Roche Creatinine Plus Jaffe rate blanked comp. (-26 µmol/l) U/I 149 127 171 11.00 22.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 117 100 134 8.50 17.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 92 78 106 7.00 14.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C Page 2 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C311® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte gamma-GT Glucose HDL - Cholesterol Iron Lactate LD (LDH) Range unit Target low high 1SD 2SD methods U/I 169 144 194 12.50 25.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 133 113 153 10.00 20.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C U/I 104 89 119 7.50 15.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C mmol/l 15.6 13.3 17.9 1.15 2.30 Hexokinase mg/dl 281 240 322 20.50 41.00 mmol/l 15.0 12.8 17.2 1.10 2.20 mg/dl 270 231 309 19.50 39.00 mmol/l 2.95 2.51 3.39 0.22 0.44 Glucose oxidase Direct HDL Roche 3rd generation mg/dl 114 96.9 131 8.55 17.10 µmol/l 36.4 29.9 42.9 3.25 6.50 µg/dl 203 167 239 18.00 36.00 mmol/l 5.64 4.63 6.65 0.51 1.01 mg/dl 50.8 41.7 59.9 4.55 9.10 U/l 379 322 436 28.50 57.00 L->P IFCC 37°C U/I 274 232 316 21.00 42.00 L->P IFCC 30°C U/I 192 163 221 14.50 29.00 L->P IFCC 25°C Colorimetric without ppt. Colorimetric Lactate Oxidase Lipase U/I 61 49 73 6.00 12.00 Roche Colorimetric 37°C Magnesium mmol/l 1.79 1.57 2.01 0.11 0.22 Xylidyl Blue mg/dl 4.35 3.82 4.88 0.27 0.53 Phosphate Inorganic mmol/l 1.83 1.61 2.05 0.11 0.22 mg/dl 4.45 3.91 4.99 0.27 0.54 mmol/l 2.32 1.97 2.67 0.18 0.35 mg/dl 7.19 6.11 8.27 0.54 1.08 Chlorphosphonazo III Phosphomolybdate UV Page 3 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas C311® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Range unit Target low high 1SD 2SD methods Potassium mmol/l 6.27 5.77 6.77 0.25 0.50 ISE method - indirect Protein Total g/l 44.5 35.6 53.4 4.45 8.90 Biuret reaction end point g/dl 4.45 3.56 5.34 0.45 0.89 Sodium mmol/l 162 154 170 4.00 8.00 ISE method - indirect Triglycerides mmol/l 2.92 2.45 3.39 0.24 0.47 Lipase/GPO-PAP no correction 41.00 Uric Acid (Urate) Urea mg/dl 258 217 299 20.50 mmol/l 2.92 2.45 3.39 0.24 0.47 mg/dl 258 217 299 20.50 41.00 mmol/l 0.56 0.48 0.63 0.04 0.07 mg/dl 9.36 8.13 10.6 0.61 1.23 mmol/l 0.56 0.48 0.63 0.04 0.07 mg/dl 9.34 8.13 10.6 0.61 1.21 mmol/l 0.55 0.48 0.63 0.04 0.07 mg/dl 9.29 8.08 10.5 0.61 1.21 mmol/l 19.2 16.3 22.1 1.45 2.90 mg/dl 115 98.0 132 8.50 17.00 mmol/l 19.2 16.3 22.1 1.45 2.90 mg/dl 53.9 45.8 62.0 4.05 8.10 L/G Kinase EP. no correction Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic BUN Page 4 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas c701 / c702 / c711 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 30.3 25.8 34.8 2.25 4.50 Bromocresol Green g/dl 3.03 2.58 3.48 0.23 0.45 U/l 231 196 266 17.50 35.00 Alkaline Phosphatase Roche Integra AMP buffer 37°C U/I 180 153 207 13.50 27.00 Roche Integra AMP buffer 30°C U/I 148 125 171 11.50 23.00 Roche Integra AMP buffer 25°C U/l 131 105 157 13.00 26.00 Tris buffer without P5P 37°C U/I 97 78 116 9.50 19.00 Tris buffer without P5P 30°C U/I 74 59 89 7.50 15.00 Tris buffer without P5P 25°C Amylase Pancreatic U/I 271 231 311 20.00 40.00 Randox EPS Liquid and BM/Roche EPS Liquid 37°C Amylase Total U/I 289 246 332 21.50 43.00 Roche liquid stable pNPG7 37°C AST (GOT) U/l 136 109 163 13.50 27.00 Tris buffer without P5P 37°C ALT (GPT) U/I 92 74 110 9.00 18.00 Tris buffer without P5P 30°C U/I 65 52 78 6.50 13.00 Tris buffer without P5P 25°C Bicarbonate mmol/l 16.8 13.3 20.3 1.75 3.50 Enzymatic Bilirubin Direct µmol/l 29.7 23.5 35.9 3.10 6.20 Dichlorophenyl Diazonium (DPD) mg/dl 1.74 1.37 2.11 0.19 0.37 µmol/l 74.9 59.2 90.6 7.85 15.70 mg/dl 4.38 3.46 5.30 0.46 0.92 µmol/l 76.2 60.2 92.2 8.00 16.00 mg/dl 4.46 3.52 5.40 0.47 0.94 µmol/l 76.1 60.1 92.1 8.00 16.00 mg/dl 4.45 3.52 5.38 0.47 0.93 Bilirubin Total Diazo with Sulphanilic Acid Dichlorophenyl Diazonium (DPD) Diazonium ion Page 1 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas c701 / c702 / c711 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Calcium mmol/l 3.19 2.87 3.51 mg/dl 12.8 11.5 14.1 0.16 0.32 Cresolphthalein complexone 0.65 1.30 mmol/l 3.19 2.87 3.51 0.16 0.32 NM-BAPTA mg/dl 12.8 11.5 14.1 0.65 1.30 Cholesterol mmol/l 6.51 5.66 7.36 0.43 0.85 mg/dl 251 218 284 16.50 33.00 Chloride mmol/l 111 102 120 4.50 9.00 ISE indirect CK Total U/l 508 416 600 46.00 92.00 CK-NAC (IFCC) 37°C U/I 318 260 376 29.00 58.00 CK-NAC (IFCC) 30°C U/I 216 177 255 19.50 39.00 CK-NAC (IFCC) 25°C µmol/l 389 311 467 39.00 78.00 Roche Creatinine Plus mg/dl 4.40 3.51 5.29 0.45 0.89 µmol/l 375 300 450 37.50 75.00 mg/dl 4.24 3.39 5.09 0.43 0.85 U/I 145 124 166 10.50 21.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 37°C U/I 114 98 130 8.00 16.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 30°C U/I 89 77 101 6.00 12.00 Gamma glutamyl.-3-carboxy-4-nitroanilide 25°C U/I 165 140 190 12.50 25.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 130 110 150 10.00 20.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30°C Creatinine gamma-GT Cholesterol Oxidase Jaffe rate blanked comp. (-26 µmol/l) U/I 102 86 118 8.00 16.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25°C Glucose mmol/l 15.3 13.0 17.6 1.15 2.30 Hexokinase mg/dl 276 234 318 21.00 42.00 HDL - Cholesterol mmol/l 2.91 2.47 3.35 0.22 0.44 mg/dl 112 95.3 129 8.35 16.70 Direct HDL Roche 3rd generation Page 2 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas c701 / c702 / c711 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte Iron Range unit Target low high 1SD 2SD methods Colorimetric without ppt. µmol/l 35.9 29.4 42.4 3.25 6.50 µg/dl 201 164 238 18.50 37.00 Lactate mmol/l 5.63 4.61 6.65 0.51 1.02 mg/dl 50.7 41.5 59.9 4.60 9.20 LD (LDH) U/l 378 321 435 28.50 57.00 L->P IFCC 37°C U/I 273 232 314 20.50 41.00 L->P IFCC 30°C U/I 192 163 221 14.50 29.00 L->P IFCC 25°C Lipase U/I 59 48 70 5.50 11.00 Roche Colorimetric 37°C Lithium mmol/l 2.04 1.80 2.28 0.12 0.24 Spectrophotometric mg/dl 1.42 1.25 1.59 0.09 0.17 Magnesium mmol/l 1.78 1.57 1.99 0.11 0.21 mg/dl 4.33 3.82 4.84 0.26 0.51 Phosphate Inorganic mmol/l 2.26 1.92 2.60 0.17 0.34 mg/dl 7.01 5.95 8.07 0.53 1.06 Potassium mmol/l 6.31 5.81 6.81 0.25 0.50 ISE method - indirect Protein Total g/l 44.2 35.3 53.1 4.45 8.90 Biuret reaction end point g/dl 4.42 3.53 5.31 0.45 0.89 Sodium mmol/l 163 154 172 4.50 9.00 ISE method - indirect TIBC µmol/l 51.4 40.6 62.2 5.40 10.80 FE+UIBC(saturation with iron) µg/dl 287 227 347 30.00 60.00 Triglycerides mmol/l 2.88 2.42 3.34 0.23 0.46 mg/dl 255 214 296 20.50 41.00 Uric Acid (Urate) mmol/l 0.53 0.47 0.60 0.03 0.07 mg/dl 8.97 7.81 10.1 0.58 1.16 mmol/l 0.54 0.47 0.61 0.04 0.07 mg/dl 9.11 7.91 10.3 0.60 1.20 Colorimetric Lactate Oxidase Xylidyl Blue Phosphomolybdate UV Lipase/GPO-PAP no correction Uricase peroxidase with ascorbate oxidase Uricase peroxidase no ascorbate oxidase Page 3 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Roche Cobas c701 / c702 / c711 Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Uric Acid (Urate) mmol/l 0.54 0.47 0.61 0.04 0.07 Uricase Peroxidase with ascorbate oxidase @ 546nm mg/dl 9.07 7.88 10.3 0.60 1.19 mmol/l 18.8 16.0 21.6 1.40 2.80 mg/dl 113 96.2 130 8.40 16.80 mmol/l 18.8 16.0 21.6 1.40 2.80 mg/dl 52.8 44.9 60.7 3.95 7.90 Urea Urease kinetic BUN Page 4 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A RX DAYTONA®/IMOLA®/SUZUKA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 29.8 25.3 34.3 2.25 4.50 Bromocresol Green g/dl 2.98 2.53 3.43 0.23 0.45 Alkaline Phosphatase U/l 590 502 678 44.00 88.00 U/l 374 318 430 28.00 56.00 AMP optimised to IFCC 37°C ALT (GPT) U/l 144 115 173 14.50 29.00 Tris buffer without P5P 37°C Diethanolamine buffer DEA 37°C Amylase Pancreatic U/I 300 255 345 22.50 45.00 Randox liquid stable pNPG7 37°C Amylase Total U/I 333 283 383 25.00 50.00 Randox liquid stable pNPG7 37°C AST (GOT) U/l 145 116 174 14.50 29.00 Tris buffer without P5P 37°C Bile Acids µmol/l 52.2 41.8 62.6 5.20 10.40 5th Generation Colorimetric Bicarbonate mmol/l 17.7 14.0 21.4 1.85 3.70 Enzymatic Bilirubin Direct µmol/l 30.0 23.7 36.3 3.15 6.30 Diazo with Sulphanilic Acid mg/dl 1.76 1.39 2.13 0.19 0.37 µmol/l 31.6 25.0 38.2 3.30 6.60 0.39 Bilirubin Total mg/dl 1.85 1.46 2.24 0.20 µmol/l 87.0 68.7 105 9.15 18.30 mg/dl 5.09 4.02 6.16 0.54 1.07 µmol/l 90.0 71.1 109 9.45 18.90 mg/dl 5.27 4.16 6.38 0.56 1.11 Calcium mmol/l 3.14 2.83 3.45 0.16 0.31 mg/dl 12.6 11.3 13.9 0.65 1.30 Cholesterol mmol/l 6.68 5.81 7.55 0.44 0.87 mg/dl 258 224 292 17.00 34.00 Vanadate Oxidation Diazo with Sulphanilic Acid Vanadate Oxidation Arsenazo III Cholesterol Oxidase Page 1 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A RX DAYTONA®/IMOLA®/SUZUKA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD Chloride mmol/l 110 102 118 4.00 8.00 ISE direct CK Total U/l 524 430 618 47.00 94.00 CK-NAC substrate start (DGKC) 37°C U/l 583 478 688 52.50 105.00 CK-NAC (IFCC) 37°C Alkaline picrate no deproteinization Creatinine methods µmol/l 320 256 384 32.00 64.00 mg/dl 3.62 2.89 4.35 0.37 0.73 µmol/l 375 300 450 37.50 75.00 mg/dl 4.24 3.39 5.09 0.43 0.85 gamma-GT U/I 170 145 195 12.50 25.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C Glucose mmol/l 15.5 13.2 17.8 1.15 2.30 Hexokinase mg/dl 279 238 320 20.50 41.00 mmol/l 16.1 13.7 18.5 1.20 2.40 Randox Enzymatic UV method Glucose oxidase mg/dl 290 247 333 21.50 43.00 Iron µmol/l 37.9 31.1 44.7 3.40 6.80 µg/dl 212 174 250 19.00 38.00 Lactate mmol/l 5.57 4.57 6.57 0.50 1.00 mg/dl 50.2 41.2 59.2 4.50 9.00 U/l 812 690 934 61.00 122.00 P->L German methods 37°C U/l 385 327 443 29.00 58.00 L->P IFCC 37°C Lipase U/I 84 67 101 8.50 17.00 Randox Colorimetric 37°C Lithium mmol/l 2.07 1.82 2.32 0.13 0.25 Colorimetric mg/dl 1.44 1.26 1.62 0.09 0.18 mmol/l 1.77 1.56 1.98 0.11 0.21 mg/dl 4.30 3.79 4.81 0.26 0.51 mmol/l 2.34 1.99 2.69 0.18 0.35 mg/dl 7.25 6.17 8.33 0.54 1.08 LD (LDH) Magnesium Phosphate Inorganic Colorimetric without ppt. Colorimetric Lactate Oxidase Xylidyl Blue Phosphomolybdate UV Page 2 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A RX DAYTONA®/IMOLA®/SUZUKA® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Potassium mmol/l 6.35 5.84 6.86 0.26 0.51 Enzymatic mmol/l 6.01 5.53 6.49 0.24 0.48 ISE method - direct Protein Total g/l 45.5 36.4 54.6 4.55 9.10 Biuret reaction end point g/dl 4.55 3.64 5.46 0.46 0.91 Sodium mmol/l 158 150 166 4.00 8.00 Enzymatic mmol/l 159 151 167 4.00 8.00 ISE method - direct µmol/l 51.9 41.0 62.8 5.45 10.90 Direct Colorimetric µg/dl 290 229 351 30.50 61.00 mmol/l 3.00 2.52 3.48 0.24 0.48 mg/dl 266 223 309 21.50 43.00 mmol/l 0.57 0.50 0.65 0.04 0.08 mg/dl 9.59 8.33 10.9 0.63 1.26 mmol/l 0.56 0.49 0.64 0.04 0.07 TIBC Triglycerides Uric Acid (Urate) Urea mg/dl 9.44 8.22 10.7 0.61 1.22 mmol/l 19.2 16.3 22.1 1.45 2.90 mg/dl 115 98.0 132 8.50 17.00 mmol/l 19.2 16.3 22.1 1.45 2.90 mg/dl 53.9 45.8 62.0 4.05 8.10 Lipase/GPO-PAP no correction Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic BUN Page 3 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A SIEMENS ADVIA 1200/1650/2400® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 28.5 24.3 32.7 2.10 4.20 Bromocresol Green g/dl 2.85 2.43 3.27 0.21 0.42 g/l 29.0 24.7 33.3 2.15 4.30 Bromocresol Purple g/dl 2.90 2.47 3.33 0.22 0.43 Alkaline Phosphatase U/l 376 320 432 28.00 56.00 U/l 361 307 415 27.00 54.00 AMP non-optimised 37°C ALT (GPT) U/l 137 110 164 13.50 27.00 Tris buffer without P5P 37°C Amylase Total U/I 301 256 346 22.50 45.00 Siemens - blocked pNPG7 37°C AMP optimised to IFCC 37°C AST (GOT) U/l 142 114 170 14.00 28.00 Tris buffer without P5P 37°C Bicarbonate mmol/l 18.3 14.5 22.1 1.90 3.80 Enzymatic Bilirubin Direct µmol/l 30.4 24.0 36.8 3.20 6.40 Oxidation to Biliverdin mg/dl 1.78 1.40 2.16 0.19 0.38 Bilirubin Total µmol/l 89.7 70.9 109 9.40 18.80 mg/dl 5.25 4.15 6.35 0.55 1.10 Calcium mmol/l 3.23 2.91 3.55 0.16 0.32 mg/dl 12.9 11.7 14.1 0.60 1.20 mmol/l 3.15 2.83 3.47 0.16 0.32 mg/dl 12.6 11.3 13.9 0.65 1.30 Cholesterol mmol/l 6.52 5.67 7.37 0.43 0.85 mg/dl 252 219 285 16.50 33.00 Chloride mmol/l 115 106 124 4.50 9.00 Oxidation to Biliverdin Cresolphthalein complexone Arsenazo III Cholesterol Oxidase ISE indirect Page 1 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A SIEMENS ADVIA 1200/1650/2400® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods CK Total U/l 533 437 629 48.00 96.00 CK-NAC (IFCC) 37°C Creatinine µmol/l 357 285 429 36.00 72.00 Alkaline picrate no deproteinization mg/dl 4.03 3.22 4.84 0.41 0.81 µmol/l 371 297 445 37.00 74.00 mg/dl 4.19 3.36 5.02 0.42 0.83 µmol/l 354 283 425 35.50 71.00 mg/dl 4.00 3.20 4.80 0.40 0.80 µmol/l 366 293 439 36.50 73.00 Randox Enzymatic UV method Jaffe rate blanked Jaffe rate blanked comp. (-26 µmol/l) mg/dl 4.14 3.31 4.97 0.42 0.83 gamma-GT U/I 167 142 192 12.50 25.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C Glucose mmol/l 15.3 13.0 17.6 1.15 2.30 Hexokinase mg/dl 276 234 318 21.00 42.00 mmol/l 15.4 13.1 17.7 1.15 2.30 HDL - Cholesterol Iron mg/dl 278 236 320 21.00 42.00 mmol/l 2.26 1.92 2.60 0.17 0.34 mg/dl 87.2 74.1 100 6.55 13.10 µmol/l 38.1 31.2 45.0 3.45 6.90 µg/dl 213 174 252 19.50 39.00 Lactate mmol/l 5.62 4.61 6.63 0.51 1.01 mg/dl 50.6 41.5 59.7 4.55 9.10 LD (LDH) U/l 368 312 424 28.00 56.00 Glucose oxidase Direct Clearance Method Colorimetric without ppt. Colorimetric Lactate Oxidase L->P 37°C U/l 775 659 891 58.00 116.00 P->L German methods 37°C U/l 370 314 426 28.00 56.00 L->P IFCC 37°C Lipase U/I 81 65 97 8.00 16.00 Other Colorimetric 37°C Lithium mmol/l 2.07 1.82 2.32 0.13 0.25 Spectrophotometric mg/dl 1.44 1.26 1.62 0.09 0.18 Page 2 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A SIEMENS ADVIA 1200/1650/2400® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low Magnesium mmol/l 1.81 1.60 2.02 mg/dl 4.40 3.89 4.91 Phosphate Inorganic mmol/l 2.32 1.97 2.67 0.18 0.35 mg/dl 7.19 6.11 8.27 0.54 1.08 Potassium mmol/l 6.25 5.75 6.75 0.25 0.50 ISE method - indirect Protein Total g/l 45.1 36.1 54.1 4.50 9.00 Biuret reaction end point g/dl 4.51 3.61 5.41 0.45 0.90 Sodium mmol/l 162 154 170 4.00 8.00 ISE method - indirect TIBC µmol/l 49.4 39.0 59.8 5.20 10.40 FE+UIBC(saturation with iron) µg/dl 276 218 334 29.00 58.00 µmol/l 52.3 41.3 63.3 5.50 11.00 Triglycerides Uric Acid (Urate) Urea high 1SD 2SD methods 0.11 0.21 Xylidyl Blue 0.26 0.51 µg/dl 292 231 353 30.50 61.00 mmol/l 3.03 2.55 3.51 0.24 0.48 42.00 mg/dl 268 226 310 21.00 mmol/l 2.99 2.51 3.47 0.24 0.48 mg/dl 265 222 308 21.50 43.00 mmol/l 0.56 0.49 0.64 0.04 0.07 mg/dl 9.44 8.22 10.7 0.61 1.22 mmol/l 0.58 0.51 0.66 0.04 0.08 mg/dl 9.76 8.48 11.0 0.64 1.28 mmol/l 19.8 16.8 22.8 1.50 3.00 18.00 mg/dl 119 101 137 9.00 mmol/l 19.8 16.8 22.8 1.50 3.00 mg/dl 55.6 47.3 63.9 4.15 8.30 Phosphomolybdate UV Direct Colorimetric Lipase/GPO-PAP no correction L/G Kinase EP. no correction Uricase peroxidase no ascorbate oxidase Uricase Peroxidase with ascorbate oxidase @ 546nm Urease kinetic BUN Page 3 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Siemens Dimension EXL Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 28.0 23.8 32.2 2.10 4.20 Bromocresol Purple g/dl 2.80 2.38 3.22 0.21 0.42 Alkaline Phosphatase U/l 327 278 376 24.50 49.00 AMP optimised to IFCC 37°C ALT (GPT) U/l 138 111 165 13.50 27.00 Tris buffer with P5P 37°C U/l 144 115 173 14.50 29.00 Siemens Dade Standard Non IFCC Correlated 37°C U/I 365 311 419 27.00 54.00 Siemens 2-chloro-pNP linked substrate 37°C U/I 367 312 422 27.50 55.00 Siemens 2-chloro-pNPG3 37°C AST (GOT) U/l 159 127 191 16.00 32.00 Tris buffer with P5P 37°C U/l 160 128 192 16.00 32.00 Siemens Dade Standard Non IFCC Correlated 37°C Bicarbonate mmol/l 17.5 13.9 21.1 1.80 3.60 Enzymatic Bilirubin Direct µmol/l 18.3 14.5 22.1 1.90 3.80 Diazo with Sulphanilic Acid mg/dl 1.07 0.848 1.29 0.11 0.22 Bilirubin Total µmol/l 82.5 65.2 99.8 8.65 17.30 mg/dl 4.83 3.81 5.85 0.51 1.02 Calcium mmol/l 3.19 2.87 3.51 0.16 0.32 mg/dl 12.8 11.5 14.1 0.65 1.30 mmol/l 5.96 5.18 6.74 0.39 0.78 mg/dl 230 200 260 15.00 30.00 Chloride mmol/l 114 105 123 4.50 9.00 ISE indirect CK Total U/l 511 419 603 46.00 92.00 CK-NAC (IFCC) 37°C Creatinine µmol/l 382 306 458 38.00 76.00 Alkaline picrate no deproteinization mg/dl 4.32 3.46 5.18 0.43 0.86 Amylase Total Cholesterol Diazo with Sulphanilic Acid Cresolphthalein complexone Dimension-Siemens reagents Page 1 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Siemens Dimension EXL Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Analyte gamma-GT Glucose Range unit Target low high 1SD 2SD methods U/I 176 149 203 13.50 27.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 200 170 230 15.00 30.00 Siemens Dimension (non IFCC) 37°C mmol/l 15.7 13.3 18.1 1.20 2.40 Hexokinase mg/dl 283 240 326 21.50 43.00 Iron µmol/l 35.5 29.1 41.9 3.20 6.40 µg/dl 198 163 233 17.50 35.00 LD (LDH) U/l 384 326 442 29.00 58.00 L->P IFCC 37°C Lipase U/I 269 215 323 27.00 54.00 Colorimetric Siemens Dimension (LIPL Kit) 37°C Lithium mmol/l 2.42 2.13 2.71 0.15 0.29 Spectrophotometric mg/dl 1.68 1.48 1.88 0.10 0.20 Magnesium mmol/l 1.81 1.60 2.02 0.11 0.21 mg/dl 4.40 3.89 4.91 0.26 0.51 Phosphate Inorganic mmol/l 2.30 1.96 2.64 0.17 0.34 mg/dl 7.13 6.08 8.18 0.53 1.05 Potassium mmol/l 6.16 5.67 6.65 0.25 0.49 ISE method - indirect Protein Total g/l 46.2 37.0 55.4 4.60 9.20 Biuret reaction end point g/dl 4.62 3.70 5.54 0.46 0.92 Sodium mmol/l 160 152 168 4.00 8.00 ISE method - indirect Triglycerides mmol/l 2.93 2.46 3.40 0.24 0.47 Lipase/GPO-PAP no correction Uric Acid (Urate) mg/dl 259 218 300 20.50 41.00 mmol/l 3.02 2.53 3.51 0.25 0.49 43.00 mg/dl 267 224 310 21.50 mmol/l 0.57 0.49 0.64 0.04 0.07 mg/dl 9.49 8.25 10.7 0.62 1.24 Colorimetric without ppt. Methylthymol blue Phosphomolybdate UV L/G Kinase EP. no correction Uricase peroxidase no ascorbate oxidase Page 2 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Siemens Dimension EXL Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Uric Acid (Urate) mmol/l 0.55 0.48 0.62 0.04 0.07 Spectrophotometric at 280-290 mg/dl 9.27 8.06 10.5 0.61 1.21 mmol/l 19.7 16.8 22.6 1.45 2.90 Urea mg/dl 118 101 135 8.50 17.00 mmol/l 19.7 16.7 22.7 1.50 3.00 mg/dl 55.3 47.0 63.6 4.15 8.30 Urease kinetic BUN Page 3 of 3 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A SIEMENS DIMENSION RxL/Max/Xpand® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 28.3 24.0 32.6 2.15 4.30 Bromocresol Green g/dl 2.83 2.40 3.26 0.22 0.43 g/l 28.0 23.8 32.2 2.10 4.20 Alkaline Phosphatase g/dl 2.80 2.38 3.22 0.21 0.42 U/l 271 203 339 34.00 68.00 Bromocresol Purple Siemens Dimension AMP buffer 37°C U/l 324 275 373 24.50 49.00 AMP optimised to IFCC 37°C U/l 325 276 374 24.50 49.00 Randox AMP 37°C ALT (GPT) U/l 139 111 167 14.00 28.00 Tris buffer with P5P 37°C U/l 142 114 170 14.00 28.00 Siemens Dade Standard Non IFCC Correlated 37°C Amylase Total U/I 352 299 405 26.50 53.00 Siemens - maltopenta/hexaoside 37°C U/I 362 308 416 27.00 54.00 Siemens 2-chloro-pNPG3 37°C AST (GOT) U/l 161 129 193 16.00 32.00 Tris buffer with P5P 37°C U/l 161 129 193 16.00 32.00 Siemens Dade Standard Non IFCC Correlated 37°C Bicarbonate mmol/l 17.7 14.0 21.4 1.85 3.70 Enzymatic Bilirubin Direct µmol/l 17.2 13.6 20.8 1.80 3.60 Diazo with Sulphanilic Acid mg/dl 1.01 0.796 1.22 0.11 0.21 µmol/l 82.0 64.8 99.2 8.60 17.20 mg/dl 4.80 3.79 5.81 0.51 1.01 Calcium mmol/l 3.19 2.87 3.51 0.16 0.32 mg/dl 12.8 11.5 14.1 0.65 1.30 Cholesterol mmol/l 6.06 5.27 6.85 0.40 0.79 mg/dl 234 203 265 15.50 31.00 Bilirubin Total Diazo with Sulphanilic Acid Cresolphthalein complexone Dimension-Siemens reagents Page 1 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A SIEMENS DIMENSION RxL/Max/Xpand® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD Chloride mmol/l 115 106 124 4.50 9.00 ISE indirect CK Total U/l 507 415 599 46.00 92.00 CK-NAC (IFCC) 37°C U/l 508 417 599 45.50 91.00 Dithioerythritol 37°C Alkaline picrate no deproteinization Creatinine gamma-GT Glucose HDL - Cholesterol Iron µmol/l 385 308 462 38.50 77.00 mg/dl 4.35 3.48 5.22 0.44 0.87 µmol/l 370 296 444 37.00 74.00 mg/dl 4.18 3.34 5.02 0.42 0.84 µmol/l 370 296 444 37.00 74.00 mg/dl 4.18 3.34 5.02 0.42 0.84 µmol/l 394 315 473 39.50 79.00 mg/dl 4.45 3.56 5.34 0.45 0.89 methods Randox Enzymatic UV method Creatinine PAP method Jaffe rate blanked U/I 174 148 200 13.00 26.00 Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37°C U/I 198 169 227 14.50 29.00 Siemens Dimension (non IFCC) 37°C mmol/l 15.7 13.3 18.1 1.20 2.40 Hexokinase mg/dl 283 240 326 21.50 43.00 mmol/l 3.20 2.72 3.68 0.24 0.48 mg/dl 124 105 143 9.50 19.00 mmol/l 3.10 2.63 3.57 0.24 0.47 mg/dl 120 102 138 9.00 18.00 mmol/l 3.03 2.58 3.48 0.23 0.45 mg/dl 117 99.6 134 8.70 17.40 µmol/l 36.0 29.5 42.5 3.25 6.50 µg/dl 201 165 237 18.00 36.00 µmol/l 35.3 29.0 41.6 3.15 6.30 µg/dl 197 162 232 17.50 35.00 Direct HDL PPD Direct HDL PEGME Direct Clearance Method Colorimetric with ppt. Colorimetric without ppt. Page 2 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A SIEMENS DIMENSION RxL/Max/Xpand® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target Lactate mmol/l 5.20 4.26 6.14 mg/dl 46.9 38.4 55.4 LD (LDH) U/l 380 323 437 28.50 57.00 U/l 384 326 442 29.00 58.00 L->P IFCC 37°C Lipase U/I 266 213 319 26.50 53.00 Colorimetric Siemens Dimension (LIPL Kit) 37°C Magnesium mmol/l 1.80 1.58 2.02 0.11 0.22 Methylthymol blue mg/dl 4.37 3.84 4.90 0.27 0.53 Phosphate Inorganic mmol/l 2.29 1.95 2.63 0.17 0.34 mg/dl 7.10 6.05 8.15 0.53 1.05 Potassium mmol/l 6.12 5.63 6.61 0.25 0.49 ISE method - indirect Protein Total g/l 46.1 36.9 55.3 4.60 9.20 Biuret reaction end point g/dl 4.61 3.69 5.53 0.46 0.92 Sodium mmol/l 160 152 168 4.00 8.00 ISE method - indirect TIBC µmol/l 45.6 36.0 55.2 4.80 9.60 Removal of excess free iron µg/dl 255 201 309 27.00 54.00 µmol/l 46.4 36.6 56.2 4.90 9.80 Triglycerides Uric Acid (Urate) low high 1SD 2SD methods 0.47 0.94 UV LDH 4.25 8.50 µg/dl 259 205 313 27.00 54.00 mmol/l 3.02 2.54 3.50 0.24 0.48 mg/dl 267 225 309 21.00 42.00 mmol/l 3.06 2.57 3.55 0.25 0.49 mg/dl 271 227 315 22.00 44.00 mmol/l 3.09 2.59 3.59 0.25 0.50 mg/dl 273 229 317 22.00 44.00 mmol/l 0.55 0.48 0.63 0.04 0.07 mg/dl 9.29 8.08 10.5 0.61 1.21 Siemens Dimension L-P Non IFCC 37°C Phosphomolybdate UV Direct Colorimetric Lipase/GPO-PAP no correction L/G Kinase EP. no correction Lipase/Glycerol Dehydrogenase Uricase catalase 340nm Page 3 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A SIEMENS DIMENSION RxL/Max/Xpand® Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target Uric Acid (Urate) mmol/l 0.55 0.48 0.62 mg/dl 9.22 8.01 10.4 mmol/l 0.55 0.48 0.62 0.04 0.07 mg/dl 9.17 7.98 10.4 0.60 1.19 mmol/l 0.55 0.48 0.62 0.04 0.07 1.19 Urea low high 1SD 2SD methods 0.04 0.07 Uricase peroxidase no ascorbate oxidase 0.61 1.21 mg/dl 9.19 8.00 10.4 0.60 mmol/l 19.5 16.6 22.4 1.45 2.90 mg/dl 117 99.8 134 8.60 17.20 mmol/l 19.5 16.6 22.4 1.45 2.90 mg/dl 117 99.8 134 8.60 17.20 mmol/l 19.5 16.6 22.4 1.45 2.90 mg/dl 54.7 46.5 62.9 4.10 8.20 Spectrophotometric at 280-290 Uricase Peroxidase with ascorbate oxidase @ 546nm Urease end point Urease kinetic BUN Page 4 of 4 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Siemens Dimension Vista Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods Albumin g/l 29.4 25.0 33.8 2.20 4.40 Bromocresol Purple g/dl 2.94 2.50 3.38 0.22 0.44 Alkaline Phosphatase U/l 325 276 374 24.50 49.00 AMP optimised to IFCC 37°C ALT (GPT) U/l 138 111 165 13.50 27.00 Tris buffer with P5P 37°C Amylase Total U/I 340 289 391 25.50 51.00 Siemens 2-chloro-pNPG3 37°C Tris buffer with P5P 37°C AST (GOT) U/l 159 127 191 16.00 32.00 Bicarbonate mmol/l 17.7 14.1 21.3 1.80 3.60 Enzymatic Bilirubin Direct µmol/l 17.4 13.8 21.0 1.80 3.60 Diazo with Sulphanilic Acid mg/dl 1.02 0.807 1.23 0.11 0.21 Bilirubin Total µmol/l 80.2 63.3 97.1 8.45 16.90 mg/dl 4.69 3.70 5.68 0.50 0.99 mmol/l 3.16 2.84 3.48 0.16 0.32 mg/dl 12.7 11.4 14.0 0.65 1.30 mmol/l 6.09 5.30 6.88 0.40 0.79 mg/dl 235 205 265 15.00 30.00 Chloride mmol/l 116 107 125 4.50 9.00 ISE indirect Creatinine µmol/l 372 297 447 37.50 75.00 Alkaline picrate no deproteinization mg/dl 4.20 3.36 5.04 0.42 0.84 gamma-GT U/I 197 168 226 14.50 29.00 Siemens Dimension (non IFCC) 37°C Glucose mmol/l 15.0 12.8 17.2 1.10 2.20 Hexokinase mg/dl 270 231 309 19.50 39.00 Calcium Cholesterol Diazo with Sulphanilic Acid Cresolphthalein complexone Dimension-Siemens reagents Page 1 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com A Siemens Dimension Vista Lot. No. 751UE ASSAYED HUMAN SERA LEVEL 3 (HUM ASY CONTROL 3) Cat. No. HE1532 / HS2611 Size 20 x 5ml / 5 x 5ml Expiry 2019-01 Range Analyte unit Target low high 1SD 2SD methods HDL - Cholesterol mmol/l 3.06 2.60 3.52 0.23 0.46 Direct HDL PEGME mg/dl 118 100 136 9.00 18.00 U/l 377 320 434 28.50 57.00 L->P IFCC 37°C LD (LDH) Lipase U/I 319 255 383 32.00 64.00 Colorimetric Siemens Dimension (LIPL Kit) 37°C Lithium mmol/l 2.16 1.90 2.42 0.13 0.26 Spectrophotometric mg/dl 1.50 1.32 1.68 0.09 0.18 Magnesium mmol/l 1.78 1.57 1.99 0.11 0.21 mg/dl 4.33 3.82 4.84 0.26 0.51 mmol/l 2.28 1.94 2.62 0.17 0.34 mg/dl 7.07 6.01 8.13 0.53 1.06 Potassium mmol/l 6.03 5.54 6.52 0.25 0.49 ISE method - indirect Protein Total g/l 46.2 36.9 55.5 4.65 9.30 Biuret reaction end point g/dl 4.62 3.69 5.55 0.47 0.93 Phosphate Inorganic Methylthymol blue Phosphomolybdate UV Sodium mmol/l 160 152 168 4.00 8.00 ISE method - indirect Uric Acid (Urate) mmol/l 0.53 0.46 0.60 0.03 0.07 Spectrophotometric at 280-290 mg/dl 8.85 7.71 9.99 0.57 1.14 mmol/l 19.0 16.1 21.9 1.45 2.90 mg/dl 114 96.8 131 8.60 17.20 mmol/l 19.0 16.2 21.8 1.40 2.80 mg/dl 53.3 45.3 61.3 4.00 8.00 Urea Urease kinetic BUN Page 2 of 2 05/05/2015 ___________________________________________________________________________________________________ RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 Email: [email protected] Website: www.randox.com ">
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