Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

Primary DI

D-GDTRO-402aDM

Basic UDI-DI Code

B-GDTRO-402aDM

Reference

GDTRO-402a

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Cardiac Troponin I (cTnl) is a protein found in cardiac muscle with a molecular weight of22.5 kDa. Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle. After cardiac injury occurs, Troponin l is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnl is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of cTnl measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma. cTnl release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery. Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction.

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