Cleartest light Troponin I

The CLEARTEST® light Troponin I rapid test is a rapid chromatographic immunoassay for the immunoassay for the qualitative detection of human cardiac troponin I in whole blood, serum or plasma to aid in the diagnosis of myocardial infarction (MI). The detection limit is 0.5ng/mL. The test is for professional in vitro diagnostic use only.

Cardiac Troponin I (cTnI) is a protein found in the heart muscle with a molecular weight of 22.5 kDa. Troponin I is part of a complex with three subunits, consisting of troponin T and troponin C. Along with tropomyosin, this structural complex forms the main component regulating the calcium-sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle. After the onset of cardiac injury, troponin I is released into the blood 4 to 6 hours after the onset of pain. The release pattern of cTnI is similar to that of CK-MB. While CK-MB levels return to normal after 72 hours, troponin I remains elevated for 6 to 10 days, providing a wider window of opportunity to detect cardiac injury. The high specificity of cTnI measurements for identifying myocardial damage has been demonstrated in conditions such as the perioperative period after marathon running and blunt chest trauma. The release of cTnI has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure and ischaemic damage due to coronary artery bypass grafting.

The CLEARTEST® light Troponin I rapid test simple test using a combination of particles coated with anti-cTnI antibodies and capture reagent to detect cTnI.

Performance characteristics

Sensitivity, specificity and accuracy

Troponin I rapid test

• Sensitivity: 97.6 % (95 %CI*: 91.8 %~99.7 %)
• Specificity: 99.4 % (95 %CI*: 98.0 %~99.9 %)
• Accuracy: 99.1 % (95 %CI*: 97.7 %~99.8 %)

3 step procedure (sample collection, preparation, testing)

Test evaluation after 10 minutes

Can be performed with whole blood, serum or plasma

Store sealed bag at room temperature or refrigerated (2-30°C). Do not freeze.