cTnI Rapid Test Cassette, 25t/kit

A rapid test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin I(cTnI) qualitatively in whole blood, serum, or plasma. For professional in vitro diagnostic use only.

【INTENDED USE】

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

【SUMMARY】

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa. 1 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. 2 After a 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. 3 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. 4 Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction. 5 The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) 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 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of cardiac Troponin I(cTnI) in whole blood, serum, or plasma. In this test procedure, the capture reagent is immobilized in the test line region of the test. After a specimen is added to the specimen area 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 a proper volume of specimen has been added and membrane wicking has occurred.

【REAGENTS】

The test contains anti-cTnI antibody-coated colloid gold particles and captures reagent coated on the membrane.

【PRECAUTIONS】

• For professional in vitro diagnostic use only. Do not use it after the expiration date.

• Do not eat, drink or smoke in the area where the specimens or kits are handled.

• Do not use test if pouch is damaged.

• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

• Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are assayed.

• The used test should be discarded according to local regulations.

• Humidity and temperature can adversely affect results.