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The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial cTnI Chemiluminescence immune assay using clinical specimens. The results show that the sensitivity of the Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/ Plasma) is 97.6% and the specificity is 99.4% relative to the Chemiluminescence immune assay.
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| Purpose of Use | A rapid test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin I(cTnI) qualitatively in whole blood, serum or plasma. |