一种新的高灵敏度心肌肌钙蛋白I检测方法的分析和临床性能评价

Shuo Yang, Qian Zhang, Boxin Yang, Zijing Li, Wenyuan Sun, L. Cui
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引用次数: 3

摘要

目的在自动光致化学发光分析(LiCA®)平台上验证一种新的高灵敏度心肌肌钙蛋白I (hs-cTnI)检测方法对非st段抬高型心肌梗死(NSTEMI)的分析性能和诊断准确性。方法进行综合分析验证,以表面健康人群为标准,建立第99百分位参考上限(URL)。我们评估了该检测对NSTEMI的诊断性能。结果定量限(LoQ)分别为1.9 ng/L (20% CV)和5.1 ng/L (10% CV)。男性(20 - 79岁)和女性(19 - 89岁)血清中性别特异性的第99百分位url分别为17.6 ng/L (4.2% CV)和14.2 ng/L (4.9% CV),男性(19 - 88岁)和女性(19 - 87岁)血浆中分别为14.4 ng/L (4.9% CV)和12.9 ng/L (5.2% CV)。健康人群检出率为98.7% ~ 99.1%。在全分析范围内,LiCA与Architect的相关系数和中位偏差分别为0.985和0.1%(−2.0 ~ 2.9%)。在较低范围内(<100 ng/L), LiCA的总体正偏倚为6.7% (- 1.6 ~ 13.3%),R=0.949。在特定的医疗决策水平(15.2、26.2和64.0 ng/L),测定差异估计为<10%。LiCA和Architect在诊断NSTEMI的AUC、敏感性和特异性、NPV和PPV方面均无显著差异。结论LiCA hs-cTnI是一种精确、高灵敏度、特异的检测方法,符合第三代(4级)高灵敏度检测方法的要求。LiCA检测对NSTEMI的诊断准确性与已建立的Architect hs-cTnI检测相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical and clinical performance evaluation of a new high-sensitivity cardiac troponin I assay
Abstract Objectives To validate the analytical performance and diagnostic accuracy for non-ST-segment elevation myocardial infarction (NSTEMI) with a new high-sensitivity cardiac troponin I (hs-cTnI) assay on the automated light-initiated chemiluminescent assay (LiCA®) platform. Methods Comprehensive analytical validations were performed, and the 99th percentile upper reference limit (URL) from apparently healthy individuals were established. We evaluated the diagnostic performance of the assay for NSTEMI. Results The limit of quantitation (LoQ) were 1.9 ng/L (20% CV) and 5.1 ng/L (10% CV). The sex-specific 99th percentile URLs were 17.6 ng/L (4.2% CV) for men (age 20–79y) and 14.2 ng/L (4.9% CV) for women (age 19–89y) in serum, 14.4 ng/L (4.9% CV) for men (age 19–88y) and 12.9 ng/L (5.2% CV) for women (age 19–87y) in plasma, respectively. Detection rates in healthy individuals were from 98.7 to 99.1%. The correlation coefficient and median bias between LiCA and Architect were 0.985 and 0.1% (−2.0–2.9%) in full analytical range of serum specimens. In lower range (<100 ng/L), LiCA had an overall positive bias 6.7% (−1.6–13.3%), R=0.949. At the specific medical decision levels (15.2, 26.2 and 64.0 ng/L), assay difference was estimated to be <10%. No significant differences on AUC, sensitivity and specificity, NPV and PPV were found between LiCA and Architect for the diagnosis of NSTEMI. Conclusions LiCA hs-cTnI is a precise, highly sensitive and specific assay that meets the requirement of a 3rd generation (level 4) high-sensitivity method. The diagnostic accuracy of LiCA assay for NSTEMI is comparable to the established Architect hs-cTnI assay.
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