医学
百分位
变异系数
内科学
心肌梗塞
心脏病学
相关系数
曲线下面积
罗氏诊断公司
肌钙蛋白
数学
统计
作者
Zhongxin Li,Shuo Yang,Junfeng Qiao,Yuan Tan,Qi Liu,Boxin Yang,Feng Wang,Liyan Cui
标识
DOI:10.1515/cclm-2023-0789
摘要
Abstract Objectives To evaluate the analytical characteristics of a novel high-sensitivity cardiac troponin T (hs-cTnT) test on the automatic light-initiated chemiluminescent assay (LiCA ® ) system, and validated its diagnostic performance for non-ST-segment elevation myocardial infarction (NSTEMI). Methods Studies included an extensive analytical evaluation and established the 99th percentile upper reference limit (URL) from apparently healthy individuals, followed by a diagnostic performance validation for NSTEMI. Results Sex-specific 99th percentile URLs were 16.0 ng/L (1.7 % CV: coefficient of variation) for men (21–92 years) and 13.4 ng/L (2.0 % CV) for women (23–87 years) in serum, and 30.6 ng/L (0.9 % CV) for men (18–87 years) and 20.2 ng/L (1.4 % CV) for women (18–88 years) in heparin plasma. Detection rates in healthy individuals ranged from 98.9 to 100 %. An excellent agreement was identified between LiCA ® and Elecsys ® assays with a correlation coefficient of 0.993 and mean bias of −0.7 % (−1.8–0.4 %) across the full measuring range, while the correlation coefficient and overall bias were 0.967 and −1.1 % (−2.5–0.3 %) for the lower levels of cTnT (10–100 ng/L), respectively. At the specific medical decision levels (14.0 and 52.0 ng/L), assay difference was estimated to be <5.0 %. No significant difference was found between these two assays in terms of area under curve (AUC), sensitivity and specificity, negative predictive value (NPV) and positive predictive value (PPV) for the diagnosis of NSTEMI. Conclusions LiCA ® hs-cTnT is a reliable 3rd-generation (level 4) high-sensitivity assay for detecting cardiac troponin T. The assay is acceptable for practical use in the diagnosis of NSTEMI.
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