from Lot 115304 (PDF: 77KB)

from Lot 115304 (PDF: 77KB)
Use after reading this “Instructions for Use”
Plasma/Serum test for calcium
FUJI DRI-CHEM SLIDE Ca-PIII
Date of issue: 1/Jul/2014
9903050
[Intended use]
[Procedure]
Quantitative measurement of calcium concentration in plasma or serum.
For in vitro diagnostic use only.
1. Read in the new QC-card when you switch to a new box of slides.
2. Set slides on FUJI DRI-CHEM ANALYZER.
3. Set a sample tube in the specified sample rack.
4. Input a sequence No. and a sample ID if appropriate.
5. Press the “START” key to initiate testing.
CAUTION: Use immediately after opening the individual package.
For further details of operation procedure, consult “INSTRUCTION MANUAL”
for FUJI DRI-CHEM ANALYZER.
[Principle of the measurement]
10 μL of plasma or serum is deposited on a FUJI DRI-CHEM SLIDE Ca-PIII.
The deposited sample spreads uniformly in the spreading layer, where bound
type calcium is converted to free type calcium by the dissociation agent contained
in the layer. The free calcium penetrates into the reagent layer and reacts with
chlorophosphonazo III to form a dye.
The slide is incubated at 37 °C for a fixed time in the FUJI DRI-CHEM ANALYZER
and the optical reflection density is measured at 625 nm. The optical reflection
density is then converted into the calcium concentration using a calibration curve
preinstalled in the analyzer.
Ca2+ + Bound type Ca
Dissociation agent
Ca2+
2+
Ca + Chlorophosphonazo III
Ca-Chlorophosphonazo III
[Composition of the slide]
1. Multi-layered structure
Sample
Spreading layer
Reagent layer
Transparent support
Barcode side
2. Ingredients per slide
• Chlorophosphonazo III
The accuracy and precision of this product can be evaluated with FUJI DRICHEM CONTROL QP-L and/or QP-H.
1. Select control level in accordance with your purpose.
2. Measure FUJI DRI-CHEM CONTROL QP-L and/or QP-H in the same way as
patient samples.
3. When the results obtained are outside the expected range shown in the sheet
attached to FUJI DRI-CHEM CONTROL QP-L or QP-H, investigate the cause.
For additional information, consult “Instructions for Use” for FUJI DRI-CHEM
CONTROL QP-L or QP-H.
[Reference intervals]
8.4–10.2 mg/dL (2.10–2.55 mmol/L)
As the reference intervals depend on the population of the test, it is required
that each laboratory set its own reference intervals.
[Limitation of the examination procedure]
0.058 mg (0.072 μmol)
[Additional special equipment]
Analyzer:
Other implements:
:
:
[Internal quality control]
FUJI DRI-CHEM ANALYZER
FUJI DRI-CHEM QC CARD (attached)
FUJI DRI-CHEM CLEAN TIPS or FUJI DRI-CHEM AUTO TIPS
FUJI HEPARIN/PLAIN TUBE or Blood collection tube
specified in the “INSTRUCTION MANUAL” for FUJI DRICHEM ANALYZER
[Storage and shelf life]
1. Storage: This product must be stored between 2–8 °C (35.6–46.4 °F) before
use.
2. Expiry date is printed on the carton.
CAUTION: Do not use expired slides.
The clinical diagnosis must be made by the doctor in charge based on the measured results in the light of clinical symptoms and other test results.
Known interfering substances
No significant effect was observed to the following concentration for each substance.
Ascorbic acid 10 mg/dL (0.57 mmol/L)
Bilirubin
20 mg/dL (340 μmol/L)
Magnesium
3 mg/dL (1.25 mmol/L)
Hemoglobin
3000 mg/L
Total protein 40–95 g/L
These results are representative;
• Test condition may have some influence on your results.
• Interferences from other substances are not predictable.
[Performance characteristics]
1. Dynamic range
2. Accuracy
4.0–16.0 mg/dL (1.00–4.00 mmol/L)
[Warnings and precautions]
1. Only the required number of slides should be taken out of the refrigerator and
warmed up to room temperature before opening the individual packages.
2. Do not touch the membrane in the center of the slide.
3. A new slide must be used for each measurement. Do not reuse.
4. Do not use EDTA salt as an anticoagulant.
5. When measured value is displayed as Ca–P&>16 mg/dL (4.00 mmol/L), it is
because the sample is not deposited or is abnormally high concentration. Confirm the trace of spot and if not spotted, repeat operation of spot.
6. Handle all patient samples, control serum and used tips carefully as biohazardous samples. Wear proper gloves, glasses and other protective gear for your
safety.
7. Used slides are categorized as infectious waste. Make sure to dispose them
in accordance with the Waste Disposal Law and other related regulations,
which prescribe the proper method of disposal, such as incineration, melting,
sterilization or disinfection.
8. Keep QC card away from magnetic material.
9. Do not use the slide if the individual package is damaged.
3. Precision
Concentration range
Accuracy
4.0–7.0 mg/dL
(1.00–1.75 mmol/L)
Within ± 1.0 mg/dL
(Within ± 0.25 mmol/L)
7.0–16.0 mg/dL
(1.75–4.00 mmol/L)
Within ± 15 %
Concentration range
Precision
4.0–7.0 mg/dL
(1.00–1.75 mmol/L)
SD 0.35 mg/dL
(SD 0.09 mmol/L)
7.0–16.0 mg/dL
(1.75–4.00 mmol/L)
CV
5%
4. Correlation
Correlation was evaluated between o-cresolphthalein complexone (CPC)
method and FUJI DRI-CHEM system. The CPC method was run on a HITACHI
automated analyzer. This examination was carried out at the laboratory of
FUJIFILM Corporation.
Serum
n
Slope
Intercept
Correlation
coefficient
68
1.021
-0.31
0.99
[Sample requirements]
[Traceability of calibrators and control materials]
1. After collecting blood sample immediate measurement is recommended.
2. For plasma, heparin is recommended to use as an anticoagulant. The amount
of heparin should be used less than 50 units per 1 mL of blood. EDTA salt
should not be used because of serious interference for calcium determination
(calcium concentration 1.00 mmol/L). Do not use sodium fluoride, citric acid,
oxalic acid and monoiodoacetic acid.
3. Avoid using plasma or serum with precipitate such as fibrin.
4. When the measured value exceeds the upper limit of the dynamic range, dilute
the sample with distilled water or saline. Since the data obtained by dilution
may deviate more widely than usual, the data should be treated as estimation.
Calcium…ReCCS (CA-6)
Note: This reference material is applied to the reference method of FUJIFILM
Corporation and is not directly applicable to FUJI DRI-CHEM SLIDE.
ReCCS : Reference Material Institute for Clinical Chemistry Standards
1/2
[Contents]
Slide
QC card
:
:
24
1
http://www.fujifilm.com/products/medical/
FUJIFILM Europe GmbH
Heesenstrasse 31,40549 Düsseldorf, GERMANY
26-30, Nishiazabu 2-Chome, Minato-ku, Tokyo 106-8620, JAPAN
[Symbols]
Do not touch the center part of the slide.
Warmed up to room temperature before opening the individual packages.
SLIDE CODE
Do not reuse
Lot number
Use by
Contains sufficient for <n> tests
Temperature limitation
Consult instructions for use
In vitro diagnostic medical devices
Manufacturer
Authorized representative in the European Community
2/2
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertising