Uncut Sheet for Immunofluorescence Assay CK-MB/cTnI/Myo Combo Test Kit

The CK-MB/cTnI/Myo Combo FIA reagent  (Uncut  sheet  for manufacturing use) is a fluorescence immunochromatographic assay intended for the quantitative determination of creatine kinase MB isoenzyme (CK-MB), cardiac troponin I (cTnI), and myoglobin (Myo) concentrations in human serum, plasma, or venous whole blood specimen.

This test is intended for in vitro diagnostic professional use and serves as an aid in the early differential diagnosis of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients presenting with clinical signs and symptoms suggestive of acute cardiac injury

The three cardiac biomarkers provide complementary diagnostic information with different temporal release patterns following myocardial injury

• Myoglobin (Myo) is an early marker that can be detected in the bloodstream within 1–2 hours after symptom onset, peaking at 6–9 hours, and returning to baseline within 24–36 hours. Its high negative predictive value makes it useful for early rule-out of acute myocardial infarction
• CK-MB is a cardiac-specific isoenzyme that rises within 3–8 hours after symptom onset, peaks at 9–24 hours, and returns to normal within 48–72 hours. It is useful for estimating infarct size, detecting reinfarction, and assessing reperfusion success
• Cardiac Troponin I (cTnI) is a highly sensitive and specific marker of myocardial injury. It rises within 4–6 hours after symptom onset and remains elevated for 6–10 days, providing a longer diagnostic window. cTnI is considered the preferred biomarker for diagnosing acute myocardial infarction

The device provides quantitative screening results. Negative results do not rule out myocardial infarction, particularly if the specimen is collected within the early window following symptom onset. Serial testing is recommended to monitor biomarker dynamics. Positive results should be interpreted in conjunction with clinical presentation, electrocardiographic findings, and other laboratory data.

This product is intended for use by trained healthcare professionals or laboratory personnel, and is not intended for self-testing. This product is for manufacturing use only and is intended for further processing into final device format.