Detection limit, cut-off and specificity of an improved rapid assay for cardiac troponin T.
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.
Baum
H
H
Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der TU München, Germany,
Bertsch
T
T
Bohner
J
J
von Pap
K W
KW
Hoff
T
T
Wilke
B
B
Katz
N
N
Luthe
H
H
Luz
H
H
Nagel
D
D
Niederhauser
C
C
van Schaik
R H
RH
Aschenneller
C
C
Schul
I
I
Zerback
R
R
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*
D015415:Biomarkers; D011933:Reagent Kits, Diagnostic; D020107:Troponin T