One Step High Sensitivity Serum Cardiac Troponin I (cTnI) POC Test Kit cardiac troponin i Immunoassay

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

Test Principle

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. Antibody labeled microspheres are sprayed on conjugate pad, the other antibody is immobilized on the test line of detection pad. After the addition of diluted whole blood/plasma specimen, cTnI in the specimen reacts with the fluorescent microsphere coupled with cTnI mouse antihuman monoclonal antibody to form fluorescent antigen-antibody complex, this complex flows to the test line and captured by the other antibody to form fluorescent antibody sandwich complex. So the more cTnI in the specimen, the more fluorescent antibody sandwich complex accumulate in the test line. The fluorescence from the test kit is collected and calculated by Time-resolved Fluorescence Immunoanalyzer to quantify the concentration of cTnI in the specimen.

Intended Use

The Cardiac Troponin I (cTnI) Test Kit can be 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 (1-3).

Specification

Storage conditions and expiry date?

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

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