Immunofluorescence-Based test strip was prepared with K68t3-K69v5 matched antibody pairs (30 Beckman calibrators, Concentration: 2-80 ng/ml, R² > 97%)

The quality control samples with concentration of 8 ng/ml-10 ng/ml and 25 ng/ml-30 ng/ml respectively were required to repeat test three times. B= (M-T) / T×100% (B: Relative Standard Deviation, M: Average, T: Concentration)

The quality control samples with concentration of 8 ng/ml-10 ng/ml and 25 ng/ml-30 ng/ml respectively were required to repeat test over 10 times. CV= (S /) ×100% (CV < 15% as indicated in the following table)

Human Creatine Phosphokinase (CPK or CK) enzyme consists of two subunits with greatest activity in muscle (CK-MM), heart (CK-MB), and brain (CK-BB). It is released within 12 hours after symptom onset of acute myocardial infarction (AMI), peaks in serum at 24–36 hours, and returns to normal in 48–72 hours.

Patients with skeletal muscle disease, acute muscle exertion, chronic renal failure, and cocaine use can have elevations in levels of CK-MB in the absence of infarction. In order to distinguish true positive elevations (secondary to myocardial injury) from the false positive elevations (due to skeletal muscle injury), the measurement of CK-MB as a percentage of total CK has been used to calculate relative index. A CK-MB to CK ratio of > 6% is reported to be specific for myocardial injury, whereas a ratio of < 6% is consistent with skeletal muscle damage or non-cardiac causes.