Pi e LDH 21 Ifcc 3

LDH 21 FS*
Order Information Assay Procedure

Cat. No. Kit size Basic settings for BioMajesty® JCA-BM6010/C
1 4251 99 10 021 R1 5 x 20 mL + R2 1 x 25 mL
1 4251 99 10 704 R1 8 x 50 mL + R2 8 x 12.5 mL Wavelength 340/410 nm (bichromatic)
1 4251 99 10 930 R1 4 x 20 mL + R2 2 x 10 mL Temperature 37°C
Measurement Linear kinetics
Intended Use Sample/calibrator 1.5 µL
Diagnostic reagent for quantitative in vitro determination of lactate Reagent 1 80 µL
dehydrogenase (LDH) in human serum or heparin plasma on Reagent 2 20 µL
automated photometric systems. Addition reagent 2 Cycle 19 (286 s)
Absorbance 1 Cycle 25 (367 s)
Summary Absorbance 2 Cycle 40 (527 s)
Lactate dehydrogenase (LDH) is an enzyme, consisting of five Calibration Linear
different isoenzymes, which catalyze the interconversion of
L-lactate and pyruvate. LDH is present in the cytoplasm of all human Calculation
tissues with higher concentrations in liver, heart and skeletal muscle
and lower values in erythrocytes, pancreas, kidney and stomach. With calibrator
Increased LDH activities are found in a variety of pathological ΔA Sample
conditions such as myocardial infarction, cancer, diseases of liver, LDH [U/L] = x Conc. Cal [U/L]
blood or muscle. However, because of the lack of organ specificity, ΔA Cal
determination of its isoenzymes or other enzymes such as alkaline Calibrators and Controls
phosphatase or ALAT/ASAT is necessary for differential diagnosis.
[1,2] DiaSys TruCal U is recommended for calibration. TruCal U
calibrator values have been standardized against the original IFCC
Method formulation. Use DiaSys TruLab N and P for internal quality control.
Each laboratory should establish corrective action in case of
Optimized UV-test according to IFCC (International Federation of deviations in control recovery.
Clinical Chemistry and Laboratory Medicine) [modified].
Cat. No. Kit size
LDH TruCal U 5 9100 99 10 063 20 x 3 mL
L-Lactate + NAD ◄─────► Pyruvate + NADH + H+
+
5 9100 99 10 064 6 x 3 mL
Reagents TruLab N 5 9000 99 10 062 20 x 5 mL
5 9000 99 10 061 6 x 5 mL
Components and Concentrations
TruLab P 5 9050 99 10 062 20 x 5 mL
R1: N-Methyl-D-Glucamine pH 8.4 420 mmol/L
5 9050 99 10 061 6 x 5 mL
L-Lactate 65 mmol/L
R2: NAD+ 50 mmol/L
Performance Characteristics
Storage and Stability Data evaluated on BioMajesty® JCA-BM6010/C
Reagents are stable up to the date of expiry indicated on the kit, if Exemplary data mentioned below may slightly differ in case of
stored at 2 – 8°C and contamination is avoided. Do not freeze deviating measurement conditions.
reagents and protect them from light.
Measuring range from 43 U/L up to 1500 U/L.
Warnings and Precautions When values exceed this range, samples should be diluted
1. Reagent 1 contains sodium azide (0.95 g/L) as preservative. 1 + 10 with NaCl solution (9 g/L) and the result multiplied by 11.
Do not swallow! Avoid contact with skin and mucous Limit of detection** 15 U/L
membranes.
2. In very rare cases, samples of patients with gammopathy might Interfering substance Interferences
give falsified results [3]. ≤ 10% up to
3. Please refer to the safety data sheets and take the necessary Ascorbic acid 60 mg/dL
precautions for the use of laboratory reagents. For diagnostic
purposes, the results should always be assessed with the Bilirubin (conjugated) 60 mg/dL
patient’s medical history, clinical examinations and other Bilirubin (unconjugated) 60 mg/dL
findings.
Lipemia (triglycerides) 2000 mg/dL
4. For professional use only.
Sulfapyridine 30 mg/dL
Waste Management
Sulfasalazine 30 mg/dL
Refer to local legal requirements.
Hemoglobin interferes at low concentrations.
Reagent Preparation For further information on interfering substances refer to Young DS [5,6].
The reagents are ready to use.
Materials Required
General laboratory equipment
Specimen
Human serum or heparin plasma
Stability [4]:
7 days at 20 – 25°C
4 days at 4 – 8°C
6 weeks at –20°C
Only freeze once. Discard contaminated specimens.
LDH 21 FS – Page 1 844 4251 10 02 00 February 2022/3

Precision
Within run (n=20) Sample 1 Sample 2 Sample 3
Mean [U/L] 106 265 990
CV [%] 1.85 0.824 1.89
Total Precision CLSI Sample 1 Sample 2 Sample 3
(n=80)
Mean [U/L] 104 254 978
CV [%] 2.16 1.70 1.87
Method comparison (n=216)
Test x DiaSys LDH 21 FS
Test y Competitor LDH
Slope 0.998
Intercept –0.628 U/L
Coefficient of correlation 0.999
** according to CLSI document EP17-A2, Vol. 32, No. 8
Conversion Factor
LDH [U/L] x 0.0167 = LDH [µkat/L]
Reference Range
Female Male
[U/L] [µkat/L] [U/L] [µkat/L]
Adults [7] < 247 < 4.12 < 248 < 4.14
Children [8]
1 – 30 day(s) 145 – 765 2.42 – 12.8 125 – 735 2.09 – 12.3
31 – 365 days 190 – 420 3.17 – 7.01 170 – 450 2.84 – 7.52
1 – 3 year(s) 165 – 395 2.76 – 6.60 155 – 345 2.59 – 5.76
4 – 6 years 135 – 345 2.25 – 5.76 155 – 345 2.59 – 5.76
7 – 9 years 140 – 280 2.34 – 4.68 145 – 300 2.42 – 5.01
10 – 12 years 120 – 260 2.00 – 4.34 120 – 325 2.00 – 5.43
13 – 15 years 100 – 275 1.67 – 4.59 120 – 290 2.00 – 4.84
16 – 18 years 105 – 230 1.75 – 3.84 105 – 235 1.75 – 3.92
Each laboratory should check if the reference ranges are
transferable to its own patient population and determine own
reference ranges if necessary.
Literature
1. Thomas L. Clinical laboratory diagnostics. 1st ed. Frankfurt:
TH-Books Verlagsgesellschaft; 1998. p. 89-94.
2. Moss DW, Henderson AR. Clinical enzymology In: Burtis CA,
Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd
ed. Philadelphia: W.B Saunders Company;1999. 617-721.
3. Bakker AJ, Mücke M. Gammopathy interference in clinical
chemistry assays: Mechanisms, detection and prevention. Clin
Chem Lab med 2007; 45(9): 1240-1243.
4. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality
of Diagnostic Samples. 3rd ed. Darmstadt: GIT Verlag; 2010.
p. 52-3.
5. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
ed. Volume 1 and 2. Washington, DC: The American
Association for Clinical Chemistry Press 2000.
6. Young DS. Effects on Clinical Laboratory Tests - Drugs
Disease, Herbs & Natural Products, https://clinfx.wiley.com/
aaccweb/aacc/, accessed in March 2021. Published by AACC
Press and John Wiley and Sons, Inc.
7. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC
primary reference procedure for the measurement of catalytic
activity concentrations of enzymes at 37°C. Part 3: Reference
procedure for the measurement of catalytic concentration of
lactate dehydrogenase. Clin Chem Lab Med 2002;40:643-48.
8. Soldin SJ, Brugnara C, Wong EC. Pediatric reference ranges.
6th Edition. Washington: AACC Press:2007:140.
DiaSys Diagnostic Systems GmbH
Alte Strasse 9 65558 Holzheim Germany
www.diasys-diagnostics.com
* Fluid Stable
LDH 21 FS – Page 2 844 4251 10 02 00 February 2022/3

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LDH 21 FS*

Order Information Assay Procedure

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