2013/04/11
Clinical Chemistry A93A01343AEN
A11A01687
1 x 5 mL
ABX Pentra
Apo A1
■ Pentra C400
Diagnostic reagent for quantitative in vitro determination of
Apolipoprotein A1 in serum or plasma by turbidimetry.
Application Release Reagents
■ ABX Pentra Apo A1 is ready-to-use.
Serum, plasma: Apo A1 (not for use in the USA)
It is a fraction of purified immunoglobulins from rabbit
1.xx serum. It contains 15 mM NaN3 as stabiliser.
■ Immunogen: Apolipoprotein A1 isolated from human
HDL.
Intended Use (not for use in the USA) ■ ABX Pentra Apo A1 should be used according to this
reagent notice. The manufacturer cannot guarantee its
ABX Pentra Apo A1 reagent is intended for the performance if used otherwise.
quantitative in vitro diagnostic determination of
Apolipoprotein A1 in serum and plasma by turbidimetry.
Lipoprotein measurements are used in the diagnosis and Handling
treatment of lipid disorders (such as diabetes mellitus),
atherosclerosis, and various liver and renal diseases. 1. Place the reagent directly in position 1 of one available
sector using a specific adapter.
Clinical Interest (1)
The determination of apolipoproteins is indicated for:
■ early recognition of coronary risk: risk estimation in
persons with a family history of atherosclerotic
changes, Reagent 1
■ response monitoring of therapy with lipid-regulating
drugs.
2. If present, remove foam by using a plastic pipette.
3. Place the reagent rack into the refrigerated Pentra
Method (2) C400 reagent compartment.
After the tests, recap immediately the reagent vial and
Human serum or plasma is mixed with the antibody place it in a refrigerator.
solution. The resulting immune complexes are measured
4. Place the ABX Pentra Accelerator I CP,
by turbidimetry. The signal generated is in direct
Ref.A11A01655 and ABX Pentra Sample Diluent CP,
correlation with the concentration of Apolipoprotein A1 in
QUAL-QA-TEMP-0846 Rev.8
Ref.A11A01662 cassettes in the refrigerated Pentra
the sample.
C400 reagent compartment.
The concentration of Apolipoprotein A1 in the sample is
calculated by comparison of the results on a standard
curve.
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Clinical Chemistry
ABX Pentra
Apo A1
Calibrator Storage and Stability
For calibration, use:
ABX Pentra Apo Cal, Ref. A11A01773 (not included) Reagents, in unopened or opened vials, are stable up to
2 x 1 mL (lyophilisate) the expiry date written on the label if stored at 2-8°C.
This stability is obtained when vials are tightly recapped
immediately after use and if contamination is avoided.
Control
For internal quality control, use:
ABX Pentra Apo Control L/H, Ref. A11A01774 (not
Packaging spoiling
included)
1 x 1 mL (lyophilisate) + 1 x 1 mL (lyophilisate) In case of protective packaging spoiling, do not use the
Each control should be assayed daily and/or after a reagent if the damages might have an effect on the
calibration. product performance.
The frequency of controls and the confidence intervals
should correspond to laboratory guidelines and country-
specific directives. You should follow federal, state and Waste Management
local guidelines for testing quality control materials. The
results must be within the range of the defined confidence
■ Please refer to local legal requirements.
limits. Each laboratory should establish a procedure to
■ This reagent contains less than 0.1% of sodium azide
follow if the results exceed these confidence limits.
as a preservative. Sodium azide may react with lead
and copper to form explosive metal azides.
Materials Required but not Provided
■ Automated clinical chemistry analyzer: Pentra C400 General Precautions
■ Calibrator: ABX Pentra Apo Cal, Ref.A11A01773
■ Control: ABX Pentra Apo Control L/H, Ref. ■ This reagent is for professional in vitro diagnostic use
A11A01774 only.
■ ABX Pentra Sample diluent CP, Ref. A11A01662, ■ This reagent is obtained from substances of animal
99 mL origin. There may be traces of human material.
■ ABX Pentra Accelerator I CP, Ref. A11A01655, Consequently, it should be treated like patient
99 mL specimens as potentially infectious and handled with
■ Standard laboratory equipment. the appropriate caution.
■ The reagent vials are disposable and should be
disposed of in accordance with the local legal
Specimen requirements.
■ Please refer to the MSDS associated with the reagent.
■ Serum. ■ Do not use the product if there is visible evidence of
■ Plasma in EDTA. biological, chemical or physical deterioration.
Anticoagulants other than those listed have not been
tested by HORIBA Medical and are therefore not Performance on Pentra C400
recommended for use with this assay.
The performance data listed below are representative of
Stability:
performance on HORIBA Medical Systems.
■ At 2-8°C: 1 week
■ At -20°C: 1 month. Do not refreeze. Number of Tests: 215 tests
Sample Volume: 7 µL/test
Reference Range (3)
Detection Limit:
Each laboratory should establish its own reference
ranges. The values given here are used as guidelines only. The detection limit is determined according to the Valtec
1.1 - 2.1 g/L (serum). protocol (4) and equals 0.17 g/L.
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Clinical Chemistry
ABX Pentra
Apo A1
Accuracy and Precision: Interferences:
■ Repeatability (within-run precision) Haemoglobin: No significant influence is observed up
to 290 µmol/L (500 mg/dL).
3 specimens of low, medium and high concentration and Triglycerides: No significant influence is observed up
1 control are tested 20 times according to the to an Intralipid® concentration
recommendations found in the Valtec protocol (4). (representative of lipemia) of 7 mmol/L
(612.5 mg/dL).
Total Bilirubin: No significant influence is observed up
Mean value g/L CV %
to 616 µmol/L (36.0 mg/dL).
Control specimen 1.46 0.75 Direct Bilirubin: No significant influence is observed up
Specimen 1 0.62 2.20 to 616 µmol/L (36.0 mg/dL).
Specimen 2 1.36 1.77
Other limitations are given by Young as a list of drugs and
Specimen 3 2.04 1.08 preanalytical variables known to affect this methodology
(9, 10).
■ Reproducibility (total precision)
Prozone Effect:
2 specimens (low and high levels) and 1 control are tested
in duplicate for 20 days (2 series per day) according to the No antigen excess has been detected up to a
recommendations found in the CLSI (NCCLS), EP5-A concentration of 15.9 g/L.
protocol (5).
Calibration Stability:
Mean value g/L CV % The reagent is calibrated on Day 0. The calibration
Control specimen 1.45 3.24 stability is checked by testing 2 control specimens.
The calibration stability is 12 days.
Specimen 1 1.48 3.57
Note: A recalibration is recommended when reagent lots
Specimen 2 2.17 3.16 change, and when quality control results fall outside the
range established.
Measuring Range:
The reagent linearity is determined according to the Application release:
recommendations found in the CLSI (NCCLS), EP6-P 1.xx
protocol (6). It is variable according to the standard value,
approximately:
Low linearity: 0.17 g/L Warning
High linearity: 3.96 g/L
It is the user's responsibility to verify that this document is
Correlation: applicable to the reagent used.
100 patient samples (serum) are correlated with a
commercial reagent taken as reference according to the Reference
recommendations found in the CLSI (NCCLS), EP9-A2 1. Thomas L. Clinical Laboratory Diagnostics. 1st ed.
protocol (7).
Frankfurt: THBooks Verlagsgesellschaft, (1998):
The equation for the allometric line obtained using
173-174.
Passing-Bablock regression procedure (8) is:
2. Bachorik PS, Kwiterowitch PO Jr. Apolipoprotein
Y = 1.04 X + 0.01 (g/L)
Measurements in Clinical Biochemistry and Their
with a correlation coefficient r2 = 0.99. Utility vis-a-vis Conventional Assays. Clinica Chimica
Acta (1988): 1-34.
3. Dati F. IFCC program for the standardization of
assays for apolipoprotein A-1 and B. In: Progress in
Clinical Biochemistry. Ed Miyai K, Kanno T, Ishikawa
E. New York Elseiver(1992): 419-423.
4. Vassault A, Grafmeyer D, Naudin C et al. Protocole
de validation de techniques (document B). Ann. Biol.
Clin. (1986) 44: 686-745.
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Clinical Chemistry
ABX Pentra
Apo A1
5. Evaluation of Precision Performance of Clinical
Chemistry Devices. Approved Guideline, CLSI
(NCCLS) document EP5-A (1999) 19 (2).
6. Evaluation of the Linearity of Quantitative Analytical
Methods. Proposed Guideline, CLSI (NCCLS)
document EP6-P (1986) 6 (18).
7. Method Comparison and Bias Estimation Using
Patient Samples. Approved Guideline, 2nd ed., CLSI
(NCCLS) document EP9-A2 (2002) 22 (19).
8. Passing H, Bablock W. A new biometrical procedure
for testing the equality of measurements from two
different analytical methods. J. Clin. Chem. Clin.
Biochem. (1983) 21: 709-20.
9. Young DS. Effects of Drugs on Clinical Laboratory
Tests. 4th Edition, Washington, DC, AACC Press
(1997) 3: 143-163.
10. Young DS. Effects of Preanalytical Variables on
Clinical Laboratory Tests. 2nd Edition, Washington,
DC, AACC Press (1997) 3: 120-132.
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