Finecare Troponin-I [cTn-I] Rapid Quantitative Test Kit

Intended Use

The Finecare cTn I Rapid Quantitative Test along with Finecare™ FIA Meter is intended for vitro quantitative determination of cardiac troponin I (cTnI) in human whole blood, serum or plasma.

- Fluorescence immunoassay

- Diagnosis of myocardial infarction

For in vitro diagnostic use only. For professional use only

Summary

Cardiac Troponin I (cTnI) is a cardiac muscle protein with a molecular weight of 22.5 kilodaltons. Together with Troponin T (TnT) and Troponin C (TnC), Tnl forms a Troponin complex in heart to play a fundamental role in the transmission of intracellular calcium signal actin-myosin interaction. cTnI is released rapidly into blood after the onset of acute myocardial infarction (AMI). It releases 4-6 hours after AMI and remains elevated for up to 6-10 days. The level of cTnI is very low in normal healthy people, and not detected in patients with skeletal muscle injury. Therefore, cTnI is a specific marker for diagnosis of AMI.

Principle

The Finecare cTn I Rapid Quantitative Test is based on fluorescence immunoassay technology. The Finecare™ cTn I Rapid Quantitative Test uses a sandwich immunodetection method, when sample is added to the sample well of the test cartridge, the fluorescence-labeled detector cTnI antibody binds to cTnI antigen in blood specimen. As the sample mixture migrates on the nitrocellulose matrix of test strip by capillary action, the complexes of detector antibody and cTnI are captured to cTnI antibody that has been immobilized on test strip. Thus the more cTnI antigen is in blood specimen, the more complexes are accumulated on test strip. Signal intensity of fluorescence of detector antibody reflects amount of cTnI captured and Finecare™ FIA Meter shows cTnI concentrations in blood specimen. The default results unit of Finecare™ cTn I Rapid Quantitative Test is displayed as XXX ng/ml from Finecare™ FIA Meter. The working range and the detection limit of the cTnI Test system are 0.1~50 ng/ml and 0.1 ng/ml.