LDH LR liquid reagent

REF 4000420 4x20 ml

For in vitro medical device

Use - The kit, according to this method, must be The test sensitivity in terms of detection limit is
Kit for measurement of lactate dehydrogenase used in manual procedures. About 19.0 U/l.
in serum or plasma. Kinetic optimized method automatic use follow specific applications.
SCE. - Avoid direct light, contamination and “Intra-Assay” precision (within-Run)
evaporation. Determined on 20 samples for each control (N-
Summary - The volumes in the procedure can be H) (Normal-High). Results:
LDH measurements are used in the diagnosis changed proportionally. MEAN (U/l) N = 308.40 H = 522.20
and treatment of liver disease such as acute - In case of complaint or quality control S.D. N = 2.29 H = 5.32
viral hepatitis, cirrhosisand metastatic request, refer to the lot number on the C.V.% N = 0.74 H = 1.02
carcinoma, cardiac diseases such as package or the lot number on the single
myocardial infarction, and tumors of the lungs vials. “Inter-Assay” precision (between-run)
or kidneys. Determined on 20 samples for each control
Procedures (N-H). Results:
Principle Wavelength λ: 340 (330 - 360) nm MEAN (U/l) N = 308.13 H = 521.22
Lactate dehydrogenase (LDH) catalyzes the Working temperature 37°C S.D. N = 2.46 H = 5.83
reaction between pyruvic acid and NADH. The Optical path 1 cm C.V.% N = 0.80 H = 1.12
NADH oxidization into NAD+ allows to Reaction kinetic (decreasing)
determine the LDH in the tested sample. Bring the reagents at 15-25°C before use Correlation
them. A study based comparing this method with a
Reagents similar method on 20 samples has given a
Monoreagent Procedure “sample starter” correlating factor r = 0.92
R1 Goods buffer pH 7.3 100.0 mmol/l
EDTA Na2 5.0 mmol/l BLANK SAMPLE y = 0.9945 x – 24.655
pyruvic acid 1.6 mmol/l Working Reagent 1000 µl 1000 µl
R2 Goods buffer pH 7.3 100.0 mmol/l Distilled Water 20 µl -- Interferences
NADH 1.25 mmol/l Sample -- 20 µl No interferences was observed by the
Mix, then incubate for 1’ a 37°C. Measure the presence of:
Reagents Preparation absorbance of sample (EC) against distilled water. Bilirubin ≤ 25 mg/dl
Reagents are liquid and ready to use. About Make at least two readings at a distance of 60’’. Triglycerides ≤ 800 mg/dl
use as monoreagent (“sample-starter” Calculate the absorbance variation ∆E/min from Ascorbate acid ≤ 20 mg/dl
procedure) add the entire content of one bottle performed readings. Haemolysed specimens should not be used for
of LDH R2 in the LDH R1 bottle and mix analysis. For a comprehensive review of
gently. For minor use add for every 4 ml of R1 Bireagent Procedure “substrate starter” interfering substances, refer to the publication
reagent, 1 ml of R2 reagent. Keep out the BLANK SAMPLE by Young.
reagents from refrigerator only for the use and Reagent R1 800 µl 800 µl
recap them immediately. Distilled Water 20 µl -- Quality controls
Sample -- 20 µl It’s necessary, each time the kit is used, to
Storage And Stability Mix, then incubate for 1’ a 37°C. Then add: perform quality controls and to check that
- Store the kit at 2-8°C. Reagent R2 200 µl 200 µl values obtained are within the acceptance
- After opening, the vials R1 and R2 are Mix , then incubate for 1’ a 37°C. Measure the range provided in the insert. Each laboratory
stable 90 days if recapped immediately and absorbance of sample (EC) against distilled water . should establish its own mean and standard
protected from contamination, evaporation, Make at least two readings at a distance of 60’’. deviation and adopt a quality control program
direct light, and stored at the correct Calculate the absorbance variation ∆E/min from to monitor laboratory testing.
temperature. readings executed.
- Working solution stability (R1+ R2): 20 days Bibliography
at 2-8°C. Calculation Kreutzer, H. H. et al., Clin. Chim. Acta, 9, 64,
LDH [U/l] = ∆E/min x 8095 (1964).
Precaution in Use The factor and the reagent performances are Young, D.S. et al., Clin. Chem., 21 ID 432D,
The product is not classified as dangerous related to 37 °C, 1 cm and 340 nm. (1975).
(DLg. N. 285 art. 28 l. n. 128/1998). Fischbach, F., Zawta, B., Klin. Lab., 38:555-61,
However the reagent should be handled with (1992).
Reference Values at 37°C Kaplan, L.A., Pesce, A..J.: “Clinical Chemistry”,
care, according to good laboratory practice. Adults [U/l] < 480 U/l
Caution: the reagents contain Sodium Azide Mosby Ed. (1996 )
The LDH level in children (up to 12 years old) Young D.S., Effects of Drugs on Clinical
(0.095%) as preservative. Avoid swallowing
is 10-15% higher than in the adults. Reference Laboratory Tests, AACC Press, Washington,
and contact with skin, eyes and mucous
values are considered indicative since each DC 5th ed. 2000.
membranes.
laboratory should establish reference ranges Symbols
for its own patient population. The analytical
Waste Management
results should be evaluated with other CE Mark (98/79 CE regulation)
Please refer to the local legal requirements. information coming from patient’s clinical
history. in vitro medical device
Specimen Collection and Preparation
- Serum-heparinized plasma or EDTA Batch Code
ANALYTICAL PERFORMANCES
plasma. Use by
- Do not use samples with haemolysis. Linearity
- The serum must be separated, as soon as Storage temperature limits
Reaction is linear up to a concentration of 800
possible, from corpuscular part. U/l. Samples with values exceeding this range Read instruction for use
- The LDH activity decreases in 8% within 3 must be diluted with saline solution. Then
days at 2-8°C multiply the result for diluting factor. Gesan Production srl
Note Analytical Sensitivity

LDH LR
Mod. 7.3.5 Rev. 0 of 2006-01

Gesan Production s.r.l.

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