Department of Laboratory Medicine, 16268 La Paz University Hospital , Madrid, Spain.
Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid, Madrid, Spain.
Clin Chem Lab Med. 2024 May 28;62(12):2519-2525. doi: 10.1515/cclm-2024-0352. Print 2024 Nov 26.
This study performed an analytical validation study of the Mindray high-sensitivity cardiac troponin I (hs-cTnI) assay addressing limit of blank (LoB), limit of detection (LoD), precision, linearity, analytical specificity and sex-specific 99th percentile upper reference limits.
LoB, LoD, precision, linearity and analytical specificity were studied according to Clinical and Laboratory Standards Institute. We used one reagent lot and one CL1200i analyzer. Skeletal troponin I and T, cardiac troponin T, troponin C, actin, tropomyosin, myosin light chain, myoglobin and creatine kinase (CK-MB) were studied for cross-reactivity. Interference with biotin was examined. Lithium heparin samples (one freeze thaw cycle) from healthy males and females were measured to determine the 99th percentiles by using the non-parametric method. Analyses were performed before and after excluding subjects with clinical conditions and/or increased surrogate biomarkers.
The Mindray hs-cTnI assay met criteria to be considered as a hs-cTn assay. LoB and LoD was <0.1 ng/L and 0.1 ng/L, respectively. Repeatability had a coefficient of variation 1.2-3.8 %, and within-laboratory imprecision 1.7-5.0 %. The measuring interval ranged from 1.1 to 28,180 ng/L. The analytical specificity was clinically acceptable for the interferents studied. After exclusions, the 99th percentile URLs obtained were 10 ng/L overall, 5 ng/L for females and 12 ng/L for males.
Analytical observations of the Mindray hs-cTnI assay demonstrated excellent LoB, LoD, precision, linearity and analytical specificity, that were in alignment with the manufacturer's claims and regulatory guidelines for hs-cTnI. The assay is suitable for clinical investigation for patient-oriented studies.
本研究对迈瑞高敏心肌肌钙蛋白 I（hs-cTnI）检测进行分析验证，评估其检测限（LoD）、重复性、线性、分析特异性和性别特异性 99 百分位参考上限。
根据临床和实验室标准协会（CLSI）的标准，研究 LoB、LoD、重复性、线性和分析特异性。我们使用了一个试剂批号和一个 CL1200i 分析仪。检测了肌钙蛋白 I 和 T、肌钙蛋白 T、肌钙蛋白 C、肌动蛋白、原肌球蛋白、肌球蛋白轻链、肌红蛋白和肌酸激酶同工酶（CK-MB）的交叉反应性。研究了生物素的干扰情况。使用非参数法，对健康男性和女性的锂肝素样本（一个冻融循环）进行测量，以确定 99 百分位。在排除具有临床情况和/或增加的替代生物标志物的个体之前和之后进行分析。
迈瑞 hs-cTnI 检测符合高敏肌钙蛋白检测的标准。LoB 和 LoD 分别<0.1ng/L 和 0.1ng/L。重复性的变异系数为 1.2-3.8%，实验室内部精密度为 1.7-5.0%。测量范围为 1.1-28180ng/L。研究的干扰物的分析特异性在临床上可接受。排除后，获得的 99 百分位 URL 总体为 10ng/L，女性为 5ng/L，男性为 12ng/L。
迈瑞 hs-cTnI 检测的分析观察结果表明，其具有出色的 LoB、LoD、重复性、线性和分析特异性，与制造商声称和高敏肌钙蛋白的监管指南一致。该检测适用于面向患者的研究的临床研究。
