title: Detection limit, cut-off and specificity of an improved rapid assay for cardiac troponin T.
abstract: 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 microg/L, and the detection limit is about 0.05 microg/L. The analytical specificity 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.
authors.affiliation: Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der TU München, Germany,
authors.forename: H
authors.initials: H
authors.lastname: Baum
authors.forename: T
authors.initials: T
authors.lastname: Bertsch
authors.forename: J
authors.initials: J
authors.lastname: Bohner
authors.forename: K W
authors.initials: KW
authors.lastname: von Pap
authors.forename: T
authors.initials: T
authors.lastname: Hoff
authors.forename: B
authors.initials: B
authors.lastname: Wilke
authors.forename: N
authors.initials: N
authors.lastname: Katz
authors.forename: H
authors.initials: H
authors.lastname: Luthe
authors.forename: H
authors.initials: H
authors.lastname: Luz
authors.forename: D
authors.initials: D
authors.lastname: Nagel
authors.forename: C
authors.initials: C
authors.lastname: Niederhauser
authors.forename: R H
authors.initials: RH
authors.lastname: van Schaik
authors.forename: C
authors.initials: C
authors.lastname: Aschenneller
authors.forename: I
authors.initials: I
authors.lastname: Schul
authors.forename: R
authors.initials: R
authors.lastname: Zerback
mesh_terms: D015415:Biomarkers / Q000097:blood; D003327:Coronary Disease / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D009206:Myocardium / Q000737:chemistry; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012044:Regression Analysis; D012680:Sensitivity and Specificity; D013997:Time Factors; D020107:Troponin T / Q000097:blood*
chemical_list: D015415:Biomarkers; D011933:Reagent Kits, Diagnostic; D020107:Troponin T