INTENDED USE

The Cardiac Troponin I (cTnI) Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

INTRODUCTION

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.
The Cardiac Troponin I (cTnI) Rapid Test is a simple test that utilizes a combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI in whole blood, serum or plasma. The minimum detection level is 0.5ng/mL.

PRINCIPLE

The Cardiac Troponin I (cTnI) Rapid Test is a qualitative, membrane based immunoassay for the detection of cardiac Troponin I (cTnI) in whole blood, serum or plasma. In this test procedure, capture reagent is immobilized in the test line region of the test. After specimen is added to the specimen well of the cassette, it reacts with anti-cTnI antibody coated colloid gold particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized capture reagent. The test format can detect cardiac Troponin I (cTnI) in specimens. If the specimen contains cardiac Troponin I (cTnI), a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain cardiac Troponin I (cTnI), a colored line will not appear in this region, indicating 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.