2019/11/07

Clinical Chemistry A93A01303DEN

A11A01640

90 mL
ABX Pentra Triglycerides CP

■ Pentra C400

Diagnostic reagent for quantitative in vitro determination of Triglycerides in

serum or plasma by colorimetry.

Application Release Glycerokinase

Glycerol + ATP ————————▶ Glycerol-3-phosphate + ADP

Glycerol-3-phosphate Oxidase
Serum, plasma: Trigly Glycerol-3-Phosphate + O2 ——————————————▶ H2O2 + DHAP

1.xx Peroxidase
2H2O2 + 4-AAP + p-Chlorophenol ——————▶ Quinoneimine + 4H2O

Intended Use (DHAP = Dihydroxyacetone phosphate, 4-AAP = 4-

aminoantipyrine)
ABX Pentra Triglycerides CP reagent is intended for the
quantitative in vitro diagnostic determination of
triglycerides in human serum and plasma based on an Reagents
enzymatic colorimetric assay. Measurements obtained by
this device are used in the diagnosis and treatment of ABX Pentra Triglycerides CP is ready-to-use.
patients with diabetes mellitus, nephrosis, liver
obstruction, other diseases involving lipid metabolism, or Reagent:
various endocrine disorders. PIPES free acid 50 mmol/L
Sodium hydroxide 3.36 g/L
Clinical Interest (1, 2) Triton X-100 1 mL/L
Magnesium salt 14.8 mmol/L
Triglycerides constitute 95% of fat stocked in tissues and
their main role is to provide energy to cells. They are p-chlorophenol 2.7 mmol/L
synthetised on one hand in the intestine from fat brought ATP 3.15 mmol/L
by food and on the other hand in liver from ingested Sodium azide 7.99 mmol/L
saccharides, and are then transported in the blood by
Potassium ferrocyanide 10 µmol/L
chylomycrons and very low density lipoproteins (VLDL).
High levels of triglycerides are associated with important 4-aminoantipyrine 0.31 mmol/L
risks of atherosclerosis. They may be caused by diseases Lipoprotein lipase ≥ 2000 U/L
such as different lipid metabolism troubles Glycerokinase ≥ 500 U/L
(hyperlipoproteinemia, deficit in lipase activity, deficit in
Glycerol phosphate Oxidase ≥ 4000 U/L
apolipoprotein CII), but also by diabetes, renal or
endocrinal troubles. Peroxidase ≥ 500 U/L

ABX Pentra Triglycerides CP should be used according

Method (3) to this notice. The manufacturer cannot guarantee its
QUAL-QA-WORI-5541 Rev.1

performance if used otherwise.

Enzymatic determination of triglycerides according to the
following reactions:
Lipoprotein lipase
Triglycerides + H2O ————————▶ Glycerol + fatty acids

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 Clinical Chemistry

ABX Pentra Triglycerides CP

Handling Specimen (4)

1. Remove the cap of the cassette. ■ Serum.

■ Plasma in lithium heparin.
2. If present, remove foam by using a plastic pipette.
3. Place the cassette into the refrigerated reagent Anticoagulants other than those listed have not been
compartment. tested by HORIBA Medical and are therefore not
recommended for use with this assay.

Calibrator These specimens should be drawn from the patient after

12 - 14 h fast.
For calibration, use:
Stability (4):
ABX Pentra Multical (A11A01652) (not included)
No significant change of triglycerides concentration after
10 x 3 mL (lyophilisate)
storage for 4 days at 4°C.

Control a Reference Range (2)

For internal quality control, use: Each laboratory should establish its own reference
■ ABX Pentra N Control / ABX Pentra N MultiControl ranges. The values given here are used as guidelines only.
(A11A01653 / 1300054414) (not included) In a study conducted within the NCEP (National
10 x 5 mL (lyophilisate) Cholesterol Education Program, launched by the US
■ ABX Pentra P Control / ABX Pentra P MultiControl
Ministry of Health), the triglycerides values in serum have
(A11A01654 / 1300054415) (not included) been classified according to the risk of developing
10 x 5 mL (lyophilisate) cardiovascular diseases:

Each control should be assayed daily and/or after a Normal: < 150 mg/dL
calibration. Low risk: 150 - 200 mg/dL
The frequency of controls and the confidence intervals High: 200 - 500 mg/dL
should correspond to laboratory guidelines and country- Extremely high: > 500 mg/dL
specific directives. You should follow federal, state and
local guidelines for testing quality control materials. The
results must be within the range of the defined confidence Storage and Stability
limits. Each laboratory should establish a procedure to
follow if the results exceed these confidence limits.
Stability before opening:
Stable up to the expiry date on the label if stored at
Materials Required but not Provided a 2-8°C.

■ Automated clinical chemistry analyzer: Pentra C400 Stability after opening:

■ Calibrator: ABX Pentra Multical (A11A01652) Refer to the paragraph "Performance on Pentra C400".
■ Controls:
ABX Pentra N Control / ABX Pentra N MultiControl Note: the reagents' colour may change to brown in the
(A11A01653 / 1300054414) course of time, but this does not affect the reagent
ABX Pentra P Control / ABX Pentra P MultiControl performance.
(A11A01654 / 1300054415)
■ Cleaning solutions:
ABX Pentra Clean-Chem CP (A11A01755), 30 mL or
ABX Pentra Clean-Chem 99 CP (A11A01789),
4 x 99 mL
■ Standard laboratory equipment.

aModification: new control.

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 Clinical Chemistry

ABX Pentra Triglycerides CP

Waste Management Sample volume: 3 µL/test

■ Please refer to local legal requirements. Detection Limit

■ This reagent contains less than 0.1% of sodium azide The detection limit is determined according to the Valtec
as a preservative. Sodium azide may react with lead protocol (6) and equals 0.08 mmol/L (7 mg/dL).
and copper to form explosive metal azides.
Accuracy and Precision
General Precautions b
Repeatability (within-run precision)
■ This reagent is for professional in vitro diagnostic use Repeatability according to the recommendations found in
only. the Valtec protocol (6) with samples tested 20 times:
■ For prescription use only.
■ This reagent is classified as non-hazardous in ■ 2 controls
compliance with regulation (EC) N°.1272/2008. ■ 3 specimens (low / medium / high levels)
■ Warning: This reagent is obtained from substances of
animal origin. Consequently, it should be treated as Mean value Mean value
CV %
potentially infectious and handled with the appropriate mmol/L mg/dL
cautions in accordance with good laboratory practices Control
1.44 126 2.52
(5). specimen 1
■ Do not pipette by mouth. Control
■ Do not replenish the reagents. 2.44 214 0.82
specimen 2
■ Do not swallow. Avoid contact with skin and mucous
Specimen 1 0.68 60 2.83
membranes.
■ Observe the standard laboratory precautions for use. Specimen 2 1.24 108 1.84
■ The reagent cassettes are disposable and should be Specimen 3 2.65 232 1.00
disposed of in accordance with the local legal
requirements. Reproducibility (total precision)
■ Please refer to the SDS associated with the reagent.
■ Do not use the product if there is visible evidence of A variance analysis (ANOVAR) is carried out for 6 days out
biological, chemical or physical deterioration. of 2 specimens (medium and high levels) and 2 controls
■ It is the user's responsibility to verify that this (n=36).
document is applicable to the reagent used.
Mean value Mean value
CV %
mmol/L mg/dL
Performance on Pentra C400 Control
1.47 128 1.91
specimen 1
Serum, plasma
Control
2.47 216 1.70
The performance data listed below are representative of specimen 2
performance on HORIBA Medical Systems. Specimen 1 1.51 132 1.57
Number of tests: 295 tests Specimen 2 2.78 243 1.37
If the number of tests requested is low and the
Pentra C400 user intends to utilise the cassette to the
Measuring Range
maximum on board stability, it is the recommendation of
HORIBA Medical, to utilise the consumable part XEC083 The assay confirmed a measuring range from
(Kit membrane) to achieve the number of tests stated in 0.08 mmol/L (7 mg/dL) to 16.39 mmol/L (1434.1 mg/dL).
this notice. The measuring range is extended up to 67.20 mmol/L
(5880 mg/dL) with the automatic post-dilution.
On Board Reagent Stability The reagent linearity has been assessed up to
Once opened, the reagent cassette placed in the 16.8 mmol/L (1470.0 mg/dL) according to the
refrigerated Pentra C400 compartment is stable for 48 recommendations found in the CLSI (NCCLS), EP6-A
days. protocol (7).

bModification: general precautions modification.

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 Clinical Chemistry

ABX Pentra Triglycerides CP

Correlation Reference
Patient samples: Serum 1. Naito HK, Coronary Artery Disease and Disorders of
Number of patient samples: 135 Lipid Metabolism. Clinical Chemistry: Theory,
Specimens are correlated with a commercial reagent Analysis, Correlation, 4ème Ed., Kaplan LA, Pesce AJ,
taken as reference according to the recommendations Kazmierczak SC. (Mosby, Inc. eds. St Louis USA),
found in the CLSI (NCCLS), EP9-A2 protocol (8). (2003): 603.
Values ranged from 0.04 mmol/L (3.1 mg/dL) to 2. Expert Panel on Detection, Evaluation and Treatment
16.39 mmol/L (1434.1 mg/dL). of High Blood Cholesterol in Adults (Adult Treatment
The equation for the allometric line obtained using Panel III), Executive Summary of the Third Report of
Passing-Bablok regression procedure (9) is: the National Cholesterol Education Program (NCEP).
Y = 0.99 X + 0.00 (mmol/L) JAMA, (2001) 285: 2486.
Y = 0.99 X + 0.20 (mg/dL) 3. Fossati P, Prencipe L, Serum triglycerides
with a correlation coefficient r2 = 0.9994. determined colorimetrically with an enzyme that
produces hydrogen peroxide. Clin. Chem. (1982) 28:
Interferences c 2077.
4. Thomas L. Clinical Laboratory Diagnostics. 1st Ed.
Haemoglobin: No significant influence is
Frankfurt: TH-Books Verlagsgesellschaft, (1998):
observed up to 290 µmol/L
169-170.
(500 mg/dL).
5. Council Directive (2000/54/EC). Official Journal of the
Total Bilirubin: No significant influence is
European Communities. No. L262 from October 17,
observed up to 385 µmol/L
2000: 21-45.
(22.5 mg/dL).
6. Vassault A, Grafmeyer D, Naudin C et al. Protocole
Direct Bilirubin: No significant influence is
de validation de techniques (document B). Ann. Biol.
observed up to 385 µmol/L
Clin. (1986) 44: 686-745.
(22.5 mg/dL).
N-Acetylcysteine Patients treated with 7. Evaluation of the Linearity of Quantitative Analytical
(NAC): N-Acetylcysteine (NAC) for Methods. Approved Guideline, CLSI (NCCLS)
Paracetamol overdose may document EP6-A (2003) 23 (16).
generate a false low result. 8. Method Comparison and Bias Estimation Using
The presence of N-Acetylbenzoquinoneimine (NAPQI) in Patient Samples. Approved Guideline, 2nd ed., CLSI
serum/plasma can cause false results. (NCCLS) document EP9-A2 (2002) 22 (19).
Other limitations are given by Young as a list of drugs and 9. Passing H, Bablok W. A new biometrical procedure
preanalytical variables known to affect this methodology for testing the equality of measurements from two
(10, 11). different analytical methods. J. Clin. Chem. Clin.
Biochem. (1983) 21: 709-20.
Calibration Stability 10. Young DS. Effects of Drugs on Clinical Laboratory
Tests. 4th Edition, Washington, DC, AACC Press
The reagent is calibrated on Day 0. The calibration (1997) 3: 143-163.
stability is checked by testing 2 control specimens. 11. Young DS. Effects of Preanalytical Variables on
The calibration stability is 14 days. Clinical Laboratory Tests. 2nd Edition, Washington,
Note: A recalibration is recommended when reagent lots DC, AACC Press (1997) 3: 120-132.
change, and when quality control results fall outside the
range established.

Conversion Factor
mmol/L x 0.875 = g/L
mmol/L x 87.5 = mg/dL

cModification: modification of interferences.

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