AN IMPROVED RAPID TROPONIN-T TEST WITH A DECREASED DETECTION LIMIT - A MULTICENTER STUDY OF THE ANALYTICAL AND CLINICAL-PERFORMANCE IN SUSPECTED MYOCARDIAL DAMAGE

In a multicentre study, we evaluated the analytical and diagnostic per formance of the second version of the TROPT(R) rapid test (TROPT 2, CA RDIACT in the US). We tested TROPT 2 on 796 brood samples from 487 pat ients admitted on suspicion of myocardial infarction between 1 and 72 h after onset of symptoms and determined cTnT ELISA and CK MB mass in the corresponding serum samples. Frequency distributions of the result s with TROPT 2 showed a detection limit of 0.18 mu g/l (for 50% positi ve results) as determined by the quantitative cTnT ELISA method. In a total of 796 samples the sensitivities in the detection of myocardial infarction (WHO criteria) 8-12 h after onset of symptoms were highest for cTnT ELISA (98%), followed by the rapid assay and CK MB mass (92%) . A subgroup of 87 patients was primarily classified by the WHO criter ia for definite infarction. Based on the maximum values within each pa tient timeseries, diagnostic sensitivities for infarction were 100% fo r TROPT 2, cTnT ELISA and CK MB mass. The corresponding specificities were 90%, 82% and 100%, respectively. After reclassification summarizi ng all cases of myocardial damage (acute and subacute myocardial infar ctions and minor myocardial damage) the sensitivities were 87% (TROPT2 ), 100% (cTnT ELISA) and 71% (CK MB mass). The specificities of all th ree markers were 100%. Over 50% of all cases of minor myocardial damag e were detected by TROPT 2. The clinical evaluation showed that the di agnostic performance of TROPT 2 is only slightly lower than that of cT nT ELISA.