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Abstract

Detection Limit, Cut-off and Specificity of an Improved Rapid Assay for Cardiac Troponin T by Hannsjoerg Baum, Thomas Bertsch, Juergen Bohner, Klaus-Werner von Pape, Torsten Hoff, Baerbel Wilke, Norbert Katz, Hilmar Luthe, Hartwig Luz, Dietmar Nagel, Christoph Niederhauser, Ron H. N. van Schaik, Christine Aschenneller, Ilse Schulz, Rainer Zerback

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.

DOI: Clin. Lab. 2001;47:549-554