Analytical performance of high-sensitivity cardiac troponin I detection by VITROS ECIQ with enhanced chemiluminescence method / 中华检验医学杂志

ABSTRACT

Objective To evaluate the performances of high-sensitivity cardiac troponin I ( cTnI ) on VITRO ECIQ with enhanced chemiluminescence method .Methods This verification study validated the limited of detection,function sensitivity,imprecision,linearity of the high-sensitivity cardic troponin used VITROS ECIQ according to the document EP-17A, EP-6A,EP-15A published by Clinical and Laboratory Standards Institute (CLSI) and determined 99th percentiles.All 652 patients with chest pain on immediate admission in TEDA International Cardiovascular Hospital during January to November 2013 were enrolled in this study.Including 323 cases of acute ST segment elevation myocardial infarction and non ST segment elevation myocardial infarction patients as the case group , exclude 329 cases of other diagnosis ,303 cases of apparent normal people as control group .The receiver operating characteristic curve was used to evaluated the sensitivity and the specificity of cTnI . Non-normal distribution of quantitative data were used nonparametric test Mann-Whitney U, With P was 1.73 % -2.33 %, reproducibility CV was 4.93% -9.96%.The imprecision were lower than that declared by assay producer.The linearity was 0.015 5-78.4 ng/ml(R2 =0.999 9); the 99th percentile reference value was 0.017 ng/ml.The area under the curve ( AUC) of cTnI was 0.986,95%CI 0.973 -0.994,with the cut-off value as 0.017 ng/ml, the diagnostic sensitivity and specificity in CIN were 90.09%and 99.34%.Compared between STEMI and NSTEMI groups after admission , the levels of cTnI had no significantly difference , Z were -0.485, P >0.05;compared between STEMI and control groups after admission, the levels of cTnI had significantly difference , Z were -19.567,P<0.001;compared between NSTEMI and control groups after admission , the levels of cTnI had significantly difference , Z were-14.598,P<0.001.Conclusions High-sensitivity cardiac troponin I detection by VITROS ECIQ with enhanced chemiluminescence method has good performances of sensitivity , linearity, specificity, which meet the clinical needs.