2019/05/27

Clinical Chemistry A93A01317CEN

A11A01824

26 mL
ABX Pentra LDH CP 6.5 mL

■ Pentra C400

Diagnostic reagent for quantitative in vitro determination of Lactate

Dehydrogenase (LDH) in serum or plasma by colorimetry.

Application Release LDH

Pyruvate + NADH + H+ ◀————▶ Lactate + NAD+

(LDH = Lactate Dehydrogenase)

Serum, plasma: LDH (not for use in the USA)
1.xx
Reagents
Intended Use (not for use in the USA) ABX Pentra LDH CP is ready-to-use.
ABX Pentra LDH CP reagent is intended for the Reagent 1:
quantitative in vitro diagnostic determination of Lactate
Dehydrogenase (LDH) in serum or plasma. Phosphate buffer, pH 7.5 64 mmol/L
Lactate dehydrogenase measurements are used in the Pyruvate 0.81 mmol/L
diagnosis and treatment of liver diseases such as acute Sodium azide < 1 g/L
viral hepatitis, cirrhosis, and metastatic carcinoma of the
liver, cardiac diseases such as myocardial infarction, and Reagent 2:
tumors of the lung or kidneys.
Good’s buffer, pH 9.6
NADH 1.05 mmol/L
Clinical Interest (1, 2) Sodium azide < 1 g/L

Lactate dehydrogenase (LDH) is an enzyme, consisting of ABX Pentra LDH CP should be used according to this
five different isoenzymes that catalyze the interconversion notice. The manufacturer cannot guarantee its
of L-lactate and pyruvate. LDH is present in the performance if used otherwise.
cytoplasm of all human tissues with higher concentrations
in liver, heart and skeletal muscle, and lower in
erythrocytes, pancreas, kidney and stomach. Increased Handling
LDH activities are found in a variety of pathological
conditions such as myocardial infarction, liver diseases,
blood diseases, cancer or muscle diseases. However, 1. Remove both caps of the cassette.
because of the lack of organ specificity , determination of 2. If present, remove foam by using a plastic pipette.
its isoenzymes or other enzymes such as alkaline
3. Place the cassette into the refrigerated reagent
phosphatase or ALAT / ASAT is necessary for differential
compartment.
diagnosis.
QUAL-QA-WORI-5541 Rev.1

Method (3)
Optimized test according to German Society of Clinical
Chemistry (DGKC).

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 Clinical Chemistry

ABX Pentra LDH CP

Calibrator Stability (1, 4):

■ At 20-25°C: 7 days
For calibration, use: ■ At 4-8°C: 4 days
ABX Pentra Multical (A11A01652) (not included) ■ At -20°C: 6 weeks
10 x 3 mL (lyophilisate)
For routine analysis, the serum should be stored at room
temperature because of the sensitivity of LD-4 and LD-5
Control a to cold conditions.

For internal quality control, use:

Reference Range (5)
■ ABX Pentra N Control / ABX Pentra N MultiControl
(A11A01653 / 1300054414) (not included) Each laboratory should establish its own reference
10 x 5 mL (lyophilisate) ranges. The values given here are used as guidelines only.
■ ABX Pentra P Control / ABX Pentra P MultiControl
(A11A01654 / 1300054415) (not included) Adults: < 480 [U/L] (37°C).
10 x 5 mL (lyophilisate)

Each control should be assayed daily and/or after a Storage and Stability
calibration.
The frequency of controls and the confidence intervals
Stability before opening:
should correspond to laboratory guidelines and country-
specific directives. You should follow federal, state and Stable up to the expiry date on the label if stored at
local guidelines for testing quality control materials. The 2-8°C. Store protected from light.
results must be within the range of the defined confidence
limits. Each laboratory should establish a procedure to Stability after opening:
follow if the results exceed these confidence limits.
Refer to the paragraph "Performance on Pentra C400".

Do not freeze.
Materials Required but not Provided a

■ Automated clinical chemistry analyzer: Pentra C400 Waste Management

■ Calibrator: ABX Pentra Multical (A11A01652)
■ Controls: ■ Please refer to local legal requirements.
ABX Pentra N Control / ABX Pentra N MultiControl ■ This reagent contains less than 0.1% of sodium azide
(A11A01653 / 1300054414) as a preservative. Sodium azide may react with lead
ABX Pentra P Control / ABX Pentra P MultiControl and copper to form explosive metal azides.
(A11A01654 / 1300054415)
■ Standard laboratory equipment.
General Precautions
Specimen ■ This reagent is for professional in vitro diagnostic use
only.
■ Serum. ■ For prescription use only.
■ Plasma in lithium heparin. ■ This reagent is classified as non-hazardous in
■ Plasma in EDTA. compliance with regulation (EC) N°.1272/2008.
■ Do not pipette by mouth.
Anticoagulants other than those listed have not been ■ Do not replenish the reagents.
tested by HORIBA Medical and are therefore not ■ Do not swallow. Avoid contact with skin and mucous
recommended for use with this assay. membranes.
■ Observe the standard laboratory precautions for use.

aModification: new control.

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 Clinical Chemistry

ABX Pentra LDH CP

■ The reagent cassettes are disposable and should be Reproducibility (total precision)
disposed of in accordance with the local legal
Reproductibility according to the recommendations found
requirements.
in the CLSI (NCCLS), EP5-A protocol (7) with samples
■ Please refer to the SDS associated with the reagent.
tested in duplicate for 20 days (2 series per day):
■ Do not use the product if there is visible evidence of
biological, chemical or physical deterioration. ■ 2 controls
■ It is the user's responsibility to verify that this ■ 2 specimens (low / high levels)
document is applicable to the reagent used.
Mean value U/L CV %
Control specimen 1 333 2.59
Performance on Pentra C400
Control specimen 2 521 2.41

Serum, plasma Specimen 1 272 4.38

Specimen 2 701 2.78
The performance data listed below are representative of
performance on HORIBA Medical Systems. Measuring Range

Number of tests: 125 tests The assay confirmed a measuring range from 10 U/L to
If the number of tests requested is low and the 1800 U/L.
Pentra C400 user intends to utilise the cassette to the The measuring range is extended up to 3600 U/L with the
maximum on board stability, it is the recommendation of automatic post-dilution.
HORIBA Medical, to utilise the consumable part XEC232 The reagent linearity has been assessed up to 1800 U/L
(Kit membrane) to achieve the number of tests stated in according to the recommendations found in the CLSI
this notice. (NCCLS), EP6-P protocol (8).

Correlation
On Board Reagent Stability
Patient samples: Serum
Once opened, the reagent cassette placed in the Number of patient samples: 100
refrigerated Pentra C400 compartment is stable for 32 Specimens are correlated with a commercial reagent
days. taken as reference according to the recommendations
found in the CLSI (NCCLS), EP9-A2 protocol (9).
Sample volume: 5.0 µL/test The equation for the allometric line obtained using
Passing-Bablock regression procedure (10) is:
Detection Limit Y = 1.05 X - 13.5 (U/L)
The detection limit is determined according to the Valtec with a correlation coefficient r2 = 0.991.
protocol (6) and equals 10 U/L.
Interferences
Accuracy and Precision Haemoglobin: Do not use hemolysed samples.
Triglycerides: No significant influence is observed up
Repeatability (within-run precision) to an Intralipid® concentration
(representative of lipemia) of
Repeatability according to the recommendations found in 7 mmol/L (612.5 mg/dL).
the Valtec protocol (6) with samples tested 20 times: Total Bilirubin: No significant influence is observed up
to 450 µmol/L (26.3 mg/dL).
■ 2 controls Direct Bilirubin: No significant influence is observed up
■ 3 specimens (low / medium / high levels) to 900 µmol/L (52.6 mg/dL).
Other limitations are given by Young as a list of drugs and
Mean value U/L CV % preanalytical variables known to affect this methodology
Control specimen 1 323 1.05 (11, 12).
Control specimen 2 512 0.51
Calibration Stability
Specimen 1 147 1.46
The reagent is calibrated on Day 0. The calibration
Specimen 2 269 1.13
stability is checked by testing 2 control specimens.
Specimen 3 681 0.56 The calibration stability is 8 days.

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 Clinical Chemistry

ABX Pentra LDH CP

Note: A recalibration is recommended when reagent lots

change, and when quality control results fall outside the
range established.

Reference
1. Thomas L. Clinical laboratory diagnostics. 1st ed.
Frankfurt: THBooks Verlagsgesellschaft (1998):
89-94.
2. Moss DW, Henderson AR. Clinical enzymology In:
Burtis CA, Ashwood ER, editors. Tietz Textbook of
Clinical Chemistry. 3rd ed. Philadelphia: WB
Saunders Company (1999): 617-721.
3. Deutsche Gesellschaft für Klinische Chemie.
Empfehlungen der deutschen Gesellschaft für
Klinische Chemie (DGCK). Standardisierung von
Methoden zur Bestimmung von Enzymaktivitäten in
biologischen Flüssigkeiten. (Recommendation of the
German Society of Clinical Chemistry.
Standardization of methods for measurement of
enzymatic activities in biological fluids.) Z. Klin.
Chem. Klin. Biochem. (1972) 10:182-192.
4. Use of anticoagulants in diagnostic laboratory
investigations. WHO publication WHO/DIL/LAB/99.1
Rev. 2 (2002): 36.
5. Fischbach F, Zawta B. Age-dependent reference
limits of several enzymes in plasma at different
measuring temperatures. Klin. Lab. (1992) 38:
555-561.
6. Vassault A, Grafmeyer D, Naudin C et al. Protocole
de validation de techniques (document B). Ann. Biol.
Clin. (1986) 44: 686-745.
7. Evaluation of Precision Performance of Clinical
Chemistry Devices. Approved Guideline, CLSI
(NCCLS) document EP5-A (1999) 19 (2).
8. Evaluation of the Linearity of Quantitative Analytical
Methods. Proposed Guideline, CLSI (NCCLS)
document EP6-P (1986) 6 (18).
9. Method Comparison and Bias Estimation Using
Patient Samples. Approved Guideline, 2nd ed., CLSI
(NCCLS) document EP9-A2 (2002) 22 (19).
10. 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.
11. Young DS. Effects of Drugs on Clinical Laboratory
Tests. 4th Edition, Washington, DC, AACC Press
(1997) 3: 143-163.
12. Young DS. Effects of Preanalytical Variables on
Clinical Laboratory Tests. 2nd Edition, Washington,
DC, AACC Press (1997) 3: 120-132.

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