INTENDED USE

The Troponin T Rapid Test is a rapid chromatographic immu noassay for the qualitative detection of human cardiac Troponin T in whole blood, serum or plasma as an aid in the diagnosis of heart attack.

SUMMARY

Troponin T is a part of the troponin complex, which are proteins integral to the contraction of skeletal and heart muscles. They are expressed in skeletal and cardiac myocytes. Troponin T binds to tropomyosin and helps position it on actin, and together with the rest of the troponin complex, modulates contraction of striated muscle. The cardiac subtype of troponin T is especially useful in the laboratory diagnosis of heart attack because it is released into the blood-stream when damage to heart muscle occurs.
The Troponin T Rapid Test is a simple test that utilizes a combination of anti-cTnT antibody coated particles and capture reagent to selectively detect cTnT in whole blood, serum or plasma. The minimum detection level is 0.01 ng/mL.

PRINCIPLE

The Troponin T Rapid Test is a qualitative, membrane based immunoassay for the detection of cTnT in whole blood, serum or plasma. The membrane is pre-coated with Strepavidin-IgG on the test line region of the test and cTnT-biotin on the sample pad. During testing, the whole blood, serum or plasma specimen reacts with the cTnT-biotin on the sample pad frist, then migrates and react with the particle coated with anti-cTnT antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with capture reagent on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.