Description
INTENDED USE
ELITech Clinical Systems CK-MB SL /CK-MB is an in vitro diagnostic reagent intended for the quantitative
determination of creatine kinase MB (CK-MB) in human serum and plasma samples on analyzers or semi- automatic analyzers.
This in vitro diagnostic device is for professional use only.
CLINICAL SIGNIFICANCE
Creatine kinase (CK) exists in 3 cytoplasmic forms:
CK-MB (mostly in cardiac muscle), CK-MM (dominant isoenzyme in striated and cardiac muscles) and CK-BB
(only isoenzyme in brain).
Enzymatic activity of CK-MB is increased mainly during myocardial infarction, but elevated levels can also be
observed during muscle damage such as Duchenne dystrophy, rhabdomyolysis and trauma. In myocardial
infarction, the rates of CK-MB increase quickly until reaching a peak about 24h after the onset of the infarction. The levels return to normal within 2 to 3 days.
Determination of CK-MB in blood is used to reinforce the diagnostic presumption of myocardial infarction.
LIMITATION OF USE
CK-MB SL /CK-MB is not intended for monitoring cardiac muscle injury. The quantitative assay of CK-MB
alone cannot be used to diagnose a disease or a specific pathology.
The results must be interpreted in conjunction with other diagnostic test results, clinical findings and the
patient’s medical history.
COMPOSITION
Reagent 1: R1
Imidazole buffer, pH 6.1 (20°C)
D-Glucose 25 mmol/L
NADP 2.5 mmol/L
Hexokinase ≥ 6 800 U/L
Sodium azide < 0.1 % (w/w)
The concentration of anti-CK-M antibody contained in reagent R1 is sufficient to inhibit 2000 U/L of CK-M
at 37 °C.
Reagent 2: R2
Imidazole buffer, pH 8.9 (20°C)
Creatine Phosphate 250 mmol/L
ADP 15.2 mmol/L
G-6-PDH ≥ 8 800 U/L
Sodium azide < 0.1 % (w/w)
Also contains magnesium salts, N-acetyl cysteine, EDTA, diadenosine pentaphosphate and AMP for optimal performance.
MATERIALS REQUIRED BUT NOT PROVIDED
– CKMB-0900 CK-MB CONTROL
– Normal saline solution (NaCl 9 g/L).
– Analyzers or semi-automatic analyzers.
– General Laboratory equipment (e.g. pipette).
– Do not use materials that are not required as indicated above.
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