[Clinical evaluation of the new creatine kinase MB reagent kit "L-System CK-MB MtO"]

The creatine kinase MB (CK-MB) activity assay, which is based on the immunoinhibition method, has long been used in the diagnosis of acute myocardial infarction (AMI) because of its good cost-performance ratio and simplicity. However, the immunoinhibition method can not differentiate between CK-MB and MtCK, and therefore, CK-MB activity determined using this method is higher than the actual value in the sample which MtCK appears; this may lead to the misdiagnosis of AMI. We, therefore, evaluated the analytical and clinical performance of a new CK-MB reagent kit "L-System CK-MB MtO," which can inhibit MtCK. The kit yielded good precision and linearity and no interference from hemolysis, bilirubin or chyle. A good correlation was observed between the values determined using this kit and those determined using the conventional kit for samples of patients with acute coronary syndromes. However, differences were observed in the CK-MB values determined for samples from patients with malignancy. CK isoenzyme analysis indicated that MtCK was present in all these samples. The new method permits the accurate estimation of CK-MB activity in samples of patients with high serum levels of MtCK activity and indicates that the conventional method has a high false-positive rate for CK-MB activity. CK-MB activity in the serum of healthy individuals measured using the new and the conventional kits was 1.9-9.5 U/l and 4.5-15.3 U/l, respectively. The new kit, enables accurate estimation of CK-MB activity and is, therefore, more useful than the conventional kit in the diagnosis of acute coronary syndromes.