HemoCue Hb 201+: Appendix C – Microcuvettes Microcuvettes

HemoCue Hb 201+: Appendix C – Microcuvettes Microcuvettes
PHSA Laboratories CW Site - Point of Care
Title: CWPC_HGB_0140 HemoCue Hb 201 Appendix C - Microcuvettes
HemoCue Hb 201+: Appendix C – Microcuvettes
Microcuvettes Hemocue Hb 201+
Microcuvettes Hb 201+:
 Sealed Vial -50 each
 Box of individually packaged –
50 each
 Package insert.
Note: Microcuvettes are designed to
be used with the Hemocue Hb 201+ or
Box of individually View of open
Hemocue Hb 201 DM Analyzer
microcuvette
Sealed Vial – 50 ea packaged – 50 ea
exclusively.
Note: Preferred packaging is the Box of individually wrapped microcuvettes.
Stock Storage


Stock supply is at room temperature (15-30oC) Laboratory – POCT Room 2J8.
Document Microcuvette Utilization on Form – located with the stock supply.
Ward Storage:
 Microcuvettes stored at room temperature with the Hemocue Hb 201+ analyzer.
Note: Sealed Vial – 50 each – Replace cap immediately.
Open container stability is 3 months.
Individually packaged – use within 5 minutes of opening package seal.
Sample

10 uL whole blood. Use fresh capillary blood. (venous or arterial may be used)
Principle of the Test




Microcuvette is made of plastic and comprises a body having a cavity with a volume of about 10
uL
The Microcuvette contains dry reagents deposited uniformly within the cavity.
Whole blood sample is drawn into the cavity by capillary action and is mixed spontaneously with
the reagents. No manual mixing is required.
Microcuvette is placed into the HemoCue Hb 201+ analyzer and the chemical reaction (Modified
azidemethemoglobin reaction), is measured photometrically at endpoint – two wavelengths 570
and 880 nm for turbidity compensation.
Microcuvette Reagent Composition

40 % w/w Sodium Deoxycholate; 18 % w/w Sodium Azide; 20 % w/w Sodium Nitrite; 22 % w/w
Nonreactive Ingredients.
Measuring Range, reproducibility and accuracy.




Linear to 235 g/L. Confirm results > 235 g/L with laboratory method.
Results > 256 g/L are reported as “HHH” on the meter display.
Reproducibility: Level 1 (77 g/L) CV = 0.74 %; Level 2 (154 g/L) CV=0.51%
Precision: 7 sets data; Range 41 – 210 g/L; Regression Y= 0.981X-1.045; Correlation Coefficient
r=0.994-0.999.
Medical Approval: Dr Benjamin Jung
Medical Approval Date: 28 Dec 2016
Version: 1.1
Implementation Date: 1/3/2017 11:44:55 AM
Folder Name: CW\Point of Care\Hemoglobin
This is a controlled document for CW use only. Any printed copies are uncontrolled unless specified. Please refer to Lab QMS
Page 1 of 2
PHSA Laboratories CW Site - Point of Care
Title: CWPC_HGB_0140 HemoCue Hb 201 Appendix C - Microcuvettes
Test Limitations:




Measurement is immediately after the blood is drawn into the microcuvette.
Measurement after 10 minutes of filling the microcuvette will lead to false results.
Air bubbles present in the center of the microcuvette cavity should be discarded. Air bubbles
around the edge do not affect the result.
Do not hold the microcuvette by the filling end. Wipe excess specimen from the outer surface of
the optical eye.
Interfering Substances
Highest concentration tested is referred to in brackets. Following has not been found to interfere:
 Acetaminophen (1324 umol/L); ascorbic acid (170 umol/L); conjugated bilirubin (1365 umol/L);
unconjugated bilirubin (324 umol/L); ibuprofen (1939 umol/L); creatinine (2652 umol/L); salicylic
acid (3620 umol/L); tetracycline (20 mg/dl); urea (179 mmil/L); uric acid (1190 umol/L); lipaemia
(Intralipid 4.6 mmol/L, approx. Triglycerides 13.7 mmol/L).
REFERENCES
HemoCue Hb 201+ Operating Manual. HemoCue AB, Box 1204 SE-262 23 Angelholm, Sweden.
info@hemocue.se www.hemocue.com
HemoCue Hb 201 Microcuvettes, Package Insert. HemoCue AB, Box 1204 SE-262 23 Angelholm,
Sweden. info@hemocue.se www.hemocue.com
Eurotrol HemoTrol, Assayed Controls for In Vitro Diagnostic Use, Package Insert. Eurotrol B.V.
Postbus 722 6710 BS Ede, The Netherlands office@eurotrol.com www.eurotrol.com
REVISION & APPROVAL LOG
Version
Revision
Type
1.0
1.1
Description of Change
Jun 2012
New document
Minor
Revision
Date
Document title and number change.
Upload to QMS document control
28 Dec 2016
Technical
Approval
Medical
Approval
Elvira Kozak
Dr. Cathy
Halstead
Dr.
Benjamin
Jung
Attention: This document is published on the BCCW SharePoint website
Revisions made to this document require an update to the corresponding document
published on BCCW SharePoint website
Medical Approval: Dr Benjamin Jung
Medical Approval Date: 28 Dec 2016
Version: 1.1
Implementation Date: 1/3/2017 11:44:55 AM
Folder Name: CW\Point of Care\Hemoglobin
This is a controlled document for CW use only. Any printed copies are uncontrolled unless specified. Please refer to Lab QMS
Page 2 of 2
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