Detection Limit, Cut-off and Specificity of an Improved Rapid Assay for Cardiac Troponin T
Baum, H.; Bertsch, T.; Bohner, J.; Klaus-Werner von Pape; Hoff, T.; Wilke, B.; Katz, N.; Luthe, H.; Luz, H.; Nagel, D.; Niederhauser, C.; Ron H. N. van Schaik; Aschenneller, C.; Schulz, I.; Zerback, R.
Clinical Laboratory 47(11-12): 549-554
2001
ISSN/ISBN: 1433-6510 PMID: 11759956 Document Number: 6515
The performance of an improved version of the troponin T rapid test TROPT Sensitive was investigated in a multicentre evaluation at twelve centres. The detection limit and the cut-off were determined in a method comparison with Elecsys Troponin T using a total of 365 samples from patients with suspected acute coronary syndromes and 91 samples from healthy blood donors or non-cardiological patients. The analytical specificity was determined by measuring 1271 blood samples from blood donors without any myocardial injury. The test cut-off (90% of results positive) is 0.08 µg/L, and, the detection limit is about 0.05 µg/L. The analytical specifïcity of the test is between 99.7 and 99.9%. With its small area of undefined significance between positive and negative results and its high sensitivity and specificity, TROPT Sensitive is very well suited to the reliable detection of troponin T positive patients with acute coronary syndromes.
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