REF:

C5103 (Cassette)

INTENDED PURPOSE:

NOVAtest® Creatine Kinase MB Isoenzyme Test is an immunochromatographic assay that use double-antibody sandwich method for qualitative detection of creatine kinase MB (CK-MB) from human serum and plasma specimens. It’s used as an aid in the diagnosis of acute myocardial infarction. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Acute myocardial infarction (AMI) is an event of myocardial necrosis caused by an unstable ischemic syndrome. Cardiovascular diseases cause about 1/3 of all death in 2013. Cardiac-specific serum markers are generally used for aid to diagnosis of AMI. Cardiac troponin I, myoglobin and creatine kinase MB are major serum marker released into the bloodstream after cardiac injury.

Cardiac Troponin I is naturally present in cardiac muscle, which may release within 4-6 hours after onset of pain and remains elevated for 6-10 days. cTnI could extended detection window of cardiac injury. Myoglobin is a haemoprotein normally found in skeletal and cardiac muscle, appears highly useful as an early marker of AMI. Myoglobin is released into the blood rapidly within 2-4 hours post-infarct, peaking at 6-9 hours. CK-MB is an enzyme also present in the cardiac muscle. CK-MB is the isoenzyme of creatine kinase most involved in the metabolism of cardiac muscle tissue which is released within 3-8 hours after the onset of symptoms.

Creatine Kinase MB Isoenzyme Test provided a convenient and rapid way to aid to diagnosis AMI, especially in near-patient test (NPT) scenario. The cut-off value for CK-MB is 5ng/mL.