Diagnostic Kit for Cardiac Troponin T (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521000518

Basic UDI-DI Code

B-06974521000518

Reference

SUPF026025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is suitable for in vitro quantitative detection of the concentration of Troponin T (cTnT) in human serum, plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of myocardial infarction. Troponin is composed of three subunits of troponin I, T and C, which, together with tropomyosin, regulate the interaction between actin and myosin by regulating the activity of Ca2+ on rhabdomyactin ATPase. When myocardial injury, the cardiac troponin complex is released into the blood, and the increase can be detected in the blood after 4~6 hours. About 50% of patients with acute myocardial infarction (AMI) have increased cTnT 3~4 hours after chest pain. Within 10 hours to 5 days after the onset of chest pain, the clinical sensitivity of cTnT in the diagnosis of AMI is 100%. The increase of cTnT after myocardial injury is more than 100 times of the upper limit of reference range, which is more obvious than CK-MB and myoglobin. Therefore, cTnT is the most reliable marker for the diagnosis of unstable angina pectoris, cardiac trauma and small-area myocardial infarction following cardiac surgery.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).