high sensitive cTnI Testing kits by POCT device in hospitical lab clinic cardiac troponin i

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

Test Principle

The Cardiac Troponin I Test Kit is a single use time resolved fluorescence immunoassay device designed to quantify the cTnI level in human serum and heparin anticoagulated whole blood or plasma specimens. The test kit contains two monoclonal antibodies against cTnI. One of the antibodies is covalently bound to the surface of the fluorescent microspheres. 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 is suitable for use in vitro with Time-Resolved Fluorescence Immunoanalyzer reader to rapidly quantify the concentration of cTnI in human serum and heparin anticoagulated whole blood or plasma specimens at a point of care site. The test is intended to be used as an aid in diagnosis of acute myocardial infarction (AMI), risk stratification of acute coronary syndrome (ACS), 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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