Department of Laboratory Medicine, Peking University Third Hospital, Beijing, P.R. China.
Clin Chem Lab Med. 2022 May 16;60(8):1299-1307. doi: 10.1515/cclm-2021-1136. Print 2022 Jul 26.
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.
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.
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.
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.
验证新型高敏心肌肌钙蛋白 I（hs-cTnI）测定法在自动化光激化学发光测定（LiCA）平台上对非 ST 段抬高型心肌梗死（NSTEMI）的分析性能和诊断准确性。
进行了全面的分析验证，并确定了来自健康个体的第 99 百分位上参考限（URL）。我们评估了该测定法对 NSTEMI 的诊断性能。
定量下限（LoQ）分别为 1.9ng/L（20%CV）和 5.1ng/L（10%CV）。血清中男性（年龄 20-79 岁）的性别特异性 99 百分位 URL 为 17.6ng/L（4.2%CV），女性（年龄 19-89 岁）为 14.2ng/L（4.9%CV）；男性（年龄 19-88 岁）的血浆中为 14.4ng/L（4.9%CV），女性（年龄 19-87 岁）为 12.9ng/L（5.2%CV）。在健康个体中，检测率为 98.7%至 99.1%。LiCA 与 Architect 之间的相关系数和中位数偏倚在血清标本的整个分析范围内分别为 0.985 和 0.1%（-2.0-2.9%）。在较低的范围内（<100ng/L），LiCA 的总阳性偏倚为 6.7%（-1.6-13.3%），R=0.949。在特定的医学决策水平（15.2、26.2 和 64.0ng/L）下，测定法差异估计为<10%。LiCA 与 Architect 用于诊断 NSTEMI 的 AUC、敏感性、特异性、阴性预测值和阳性预测值无显著差异。
LiCA hs-cTnI 是一种精确、高度敏感和特异的测定法，符合第三代（4 级）高敏方法的要求。LiCA 测定法对 NSTEMI 的诊断准确性与已建立的 Architect hs-cTnI 测定法相当。
