Patented TRFIA Platform CTnI Testing Kits IVD Used In Lab Clinic Cardiac Troponin I

Patented TRFIA Platform CTnI Testing Kits IVD Used Only In Hospitical Lab Clinic Cardiac Troponin I

High sensitivity cFDA approved Cardiac Troponin I Quantitative Detection Kit (TRFIA)

The Cardiac Troponin I (cTnI) Test Kit is used in vitro with a Time-Resolved Fluorescence Immunoanalyzer reader to quickly measure the amount of cTnI in human serum and heparin-anticoagulated whole blood or plasma specimens at a point of care location. The test is meant to be used to help with acute myocardial infarction (AMI) diagnosis, acute coronary syndrome (ACS) risk assessment, and monitoring of myocardial damage.

The Cardiac Troponin I Test Kit is a time-resolved fluorescence immunoassay instrument intended for single use and is used to measure the concentration of cardiac troponin I (cTnI) in human serum and whole blood or plasma specimens that have been anticoagulated with heparin. Two monoclonal antibodies against cTnI are present in the test kit. The surface of the fluorescent microspheres has a covalent bond with one of the antibodies. On the conjugation pad, antibody-labeled microspheres are sprayed, and the other antibody is fixed on the detection pad's test line. cTnI in the material combines with the fluorescent microsphere and cTnI mouse antihuman monoclonal antibody to generate a fluorescent antigen-antibody complex, which then flows to the test line and is grabbed by the other antibody to form a fluorescent antibody sandwich complex. As a result, the more fluorescent antibody sandwich complex collects in the test line the more cTnI is present in the material. To assess the quantity of cTnI in the material, the fluorescence from the test kit is collected and quantified using a time-resolved fluorescence immune analyzer.

• The validity of the test kit sealed in an aluminum foil pouch is 18 months under conditions of 2-8°C.
• The sealed test kit is stable for up to 30 days at room temperature (2-30°C) within the validity period.
• Temperature change (< 37°C) during shipment has no effect on the quality of the test kit.
• The unsealed kit is stable within 1 hour under ambient conditions.