2013/06/24

Clinical Chemistry A93A01344AEN

A11A01688

1 x 5 mL
ABX Pentra
Apo B

■ Pentra C400

Diagnostic reagent for quantitative in vitro determination of

Apolipoprotein B in serum or plasma by turbidimetry.

Application Release Reagents

■ ABX Pentra Apo B is ready-to-use.

Serum, plasma: Apo B (not for use in the USA)
It is a fraction of purified immunoglobulins from rabbit
1.xx anti-human apolipoprotein B antibody. It contains
15 mM NaN3 as stabiliser.
■ Immunogen: LDL fraction isolated from a pool of
Intended Use (not for use in the USA) human plasma.
■ ABX Pentra Apo B should be used according to this
ABX Pentra Apo B reagent is intended for the reagent notice. The manufacturer cannot guarantee its
quantitative in vitro diagnostic determination of performance if used otherwise.
Apolipoprotein B in serum and plasma by turbidimetry.
Lipoprotein measurements are used in the diagnosis and
treatment of lipid disorders (such as diabetes mellitus), Handling
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,
■ response monitoring of therapy with lipid-regulating Reagent 1
drugs.

2. If present, remove foam by using a plastic pipette.

Method (2) 3. Place the reagent rack into the refrigerated Pentra
C400 reagent compartment.
Human serum or plasma is mixed with the antibody After the tests, recap immediately the reagent vial and
solution. The resulting immune complexes are measured place it in a refrigerator.
by turbidimetry. The signal generated is in direct
4. Place the ABX Pentra Accelerator I CP,
correlation with the concentration of apolipoprotein B in
QUAL-QA-TEMP-0846 Rev.8

Ref.A11A01655 and ABX Pentra Sample Diluent CP,

the sample.
Ref.A11A01662 cassettes in the refrigerated Pentra
The concentration of apolipoprotein B in the sample is
C400 reagent compartment.
calculated by comparison of the results on a standard
curve.

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 Clinical Chemistry

ABX Pentra
Apo B

Calibrator Each laboratory should establish its own reference

ranges. The values given here are used as guidelines only.
For calibration, use:
ABX Pentra Apo Cal, Ref. A11A01773 (not included)
2 x 1 mL (lyophilisate) Storage and Stability

Reagents, in unopened or opened vials, are stable up to

Control the expiry date written on the label if stored at 2-8°C.
This stability is obtained when vials are tightly recapped
For internal quality control, use: immediately after use and if contamination is avoided.
ABX Pentra Apo Control L/H, Ref. A11A01774 (not
included)
1 x 1 mL (lyophilisate) + 1 x 1 mL (lyophilisate) Packaging spoiling
Each control should be assayed daily and/or after a
calibration.
The frequency of controls and the confidence intervals In case of protective packaging spoiling, do not use the
should correspond to laboratory guidelines and country- reagent if the damages might have an effect on the
specific directives. You should follow federal, state and product performance.
local guidelines for testing quality control materials. The
results must be within the range of the defined confidence
limits. Each laboratory should establish a procedure to Waste Management
follow if the results exceed these confidence limits.
■ Please refer to local legal requirements.
■ This reagent contains less than 0.1% of sodium azide
Materials Required but not Provided as a preservative. Sodium azide may react with lead
and copper to form explosive metal azides.
■ Automated clinical chemistry analyzer: Pentra C400
■ Calibrator: ABX Pentra Apo Cal, Ref.A11A01773
■ Control: ABX Pentra Apo Control L/H, Ref. General Precautions
A11A01774
■ ABX Pentra Sample diluent CP, Ref. A11A01662,
■ This reagent is for professional in vitro diagnostic use
99 mL only.
■ ABX Pentra Accelerator I CP, Ref. A11A01655, ■ This reagent is obtained from substances of animal
99 mL origin. There may be traces of human material.
■ Standard laboratory equipment.
Consequently, it should be treated like patient
specimens as potentially infectious and handled with
the appropriate caution.
Specimen ■ The reagent vials are disposable and should be
disposed of in accordance with the local legal
■ Serum. requirements.
■ Plasma in EDTA. ■ Please refer to the MSDS associated with the reagent.
■ Do not use the product if there is visible evidence of
Anticoagulants other than those listed have not been biological, chemical or physical deterioration.
tested by HORIBA Medical and are therefore not
recommended for use with this assay.
Performance on Pentra C400
Stability (serum):
At 2-8°C: 1 week The performance data listed below are representative of
performance on HORIBA Medical Systems.

Number of Tests: 300 tests

Reference Range (3)
Sample Volume: 13 µL/test
0.5 - 1.4 g/L (serum).

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 Clinical Chemistry

ABX Pentra
Apo B

Detection Limit: Interferences:

The detection limit is determined according to the Valtec Haemoglobin: No significant influence is observed up
protocol (4) and equals 0.11 g/L. to 290 µmol/L (500 mg/dL).
Triglycerides: No significant influence is observed up
Accuracy and Precision: to an Intralipid® concentration
(representative of lipemia) of 7 mmol/L
■ Repeatability (within-run precision)
(612.5 mg/dL).
Total Bilirubin: No significant influence is observed up
3 specimens of low, medium and high concentration and to 616 µmol/L (36.0 mg/dL).
1 control are tested 20 times according to the Direct Bilirubin: No significant influence is observed up
recommendations found in the Valtec protocol (4). to 616 µmol/L (36.0 mg/dL).

Mean value g/L CV % Other limitations are given by Young as a list of drugs and
Control specimen 1.01 2.1 preanalytical variables known to affect this methodology
(9, 10).
Specimen 1 0.64 2.4
Specimen 2 1.53 1.3
Prozone Effect:
Specimen 3 2.02 1.9
No antigen excess has been detected up to a
■ Reproducibility (total precision) concentration of 9.24 g/L.

2 specimens (low and high levels) and 1 control are tested Calibration Stability:
in duplicate for 20 days (2 series per day) according to the
recommendations found in the CLSI (NCCLS), EP5-A The reagent is calibrated on Day 0. The calibration
protocol (5). stability is checked by testing 2 control specimens.
The calibration stability is 18 days.
Note: A recalibration is recommended when reagent lots
Mean value g/L CV %
change, and when quality control results fall outside the
Control specimen 0.98 4.39 range established.
Specimen 1 0.95 4.50
Specimen 2 1.60 3.53 Application release:

1.xx
Measuring Range:
The assay confirmed a measuring range from 0.11 to
2.31 g/L. Warning
The reagent linearity has been assessed up to 2.31 g/L
according to the recommendations found in the CLSI
(NCCLS), EP6-P protocol (6). It is the user's responsibility to verify that this document is
applicable to the reagent used.
Correlation:
Reference
100 patient samples (serum) are correlated with a
commercial reagent taken as reference according to the 1. Thomas L. Clinical Laboratory Diagnostics. 1st ed.
recommendations found in the CLSI (NCCLS), EP9-A2 Frankfurt: THBooks Verlagsgesellschaft, (1998):
protocol (7). 173-174.
The equation for the allometric line obtained using 2. Bachorik PS, Kwiterowitch PO Jr. Apolipoprotein
Passing-Bablock regression procedure (8) is: Measurements in Clinical Biochemistry and Their
Y = 1.00 X + 0.03 (g/L) Utility vis-a-vis Conventional Assays. Clinica Chimica
with a correlation coefficient r2 = 0.983. Acta (1988): 1-34.
3. Bernard S. Biochimie Clinique. Eg. Maloine (1985) 19:
164-167.
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 B

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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