cTnI Colloidal Gold Assay

Sample type : whole blood, serum or plasma specimens
cut-off of 1.0 ng/mL
Relative sensitivity: 98.8% (95%CI*: 95.6%~99.8%)
Relative specificity: 98.9% (95%CI*: 97.7%~99.5%)
Accuracy: 98.8% (95%CI*: 97.8%~99.5%) *Confidence Intervals

The BIOSYNEX® Troponin Test is an immunochromatographic rapid test for the qualitative
presumptive detection of cardiac Troponin I in human whole blood, serum or plasma
specimens. This kit is intended for use as an aid in the diagnosis of a myocardial infarction
(MI). The test is designed for professional in vitro diagnostic use.
A positive result indicates a high risk for myocardial infarction (MI). A negative result,
however, does not exclude a MI and further follow-up testing is required including quantitative
cardiac troponin testing.

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5
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 I is released into the blood 4-6 hours after the onset of pain.
The release pattern of cTnI 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 cTnI measurements for the identification of
myocardial damage has been demonstrated in conditions such as the perioperative period,
after marathon runs, and blunt chest trauma. cTnI 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