McMaster University, Hamilton, ON, Canada.
Core Laboratory, Hamilton Health Sciences, Hamilton, ON, Canada.
Clin Chem Lab Med. 2020 Oct 21;59(4):749-755. doi: 10.1515/cclm-2020-1115. Print 2021 Mar 26.
To analytically evaluate Ortho Clinical Diagnostics VITROS high-sensitivity cardiac troponin I (hs-cTnI) assay in specific matrices with comparison to other hs-cTn assays.
The limit of detection (LoD), imprecision, interference and stability testing for both serum and lithium heparin (Li-Hep) plasma for the VITROS hs-cTnI assay was determined. We performed Passing-Bablok regression analyses between sample types for the VITROS hs-cTnI assay and compared them to the Abbott ARCHITECT, Beckman Access and the Siemens ADVIA Centaur hs-cTnI assays. We also performed Receiver-operating characteristic curve analyses with the area under the curve (AUC) determined in an emergency department (ED)-study population (n=131) for myocardial infarction (MI).
The VITROS hs-cTnI LoD was 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep). Stability up to five freeze-thaws was observed for the Ortho hs-cTnI assay, with the analyte stability at room temperature in serum superior to Li-Hep with gross hemolysis also affecting Li-Hep plasma hs-cTnI results. Comparison of Li-Hep to serum concentrations (n=202), yielded proportionally lower concentrations in plasma with the VITROS hs-cTnI assay (slope=0.85; 95% confidence interval [CI]:0.83-0.88). In serum, the VITROS hs-cTnI concentrations were proportionally lower compared to other hs-cTnI assays, with similar slopes observed between assays in samples frozen <-70 °C for 17 years (ED-study) or in 2020. In the ED-study, the VITROS hs-cTnI assay had an AUC of 0.974 (95%CI:0.929-0.994) for MI, similar to the AUCs of other hs-cTn assays.
Lack of standardization of hs-cTnI assays across manufacturers is evident. The VITROS hs-cTnI assay yields lower concentrations compared to other hs-cTnI assays. Important differences exist between Li-Hep plasma and serum, with evidence of stability and excellent clinical performance comparable to other hs-cTn assays.
分析比较 Ortho 临床诊断公司 VITROS 高敏心肌肌钙蛋白 I（hs-cTnI）检测试剂盒在特定基质中的检测性能，与其他 hs-cTn 检测试剂盒进行比较。
检测 VITROS hs-cTnI 检测试剂盒在血清和锂肝素（Li-Hep）血浆中的检测限（LoD）、不精密度、干扰和稳定性。对 VITROS hs-cTnI 检测试剂盒在两种样本类型间进行 Passing-Bablok 回归分析，并与 Abbott ARCHITECT、Beckman Access 和 Siemens ADVIA Centaur hs-cTnI 检测试剂盒进行比较。同时，在一项包含 131 名患者的急诊（ED）研究人群中，进行受试者工作特征（ROC）曲线分析，计算曲线下面积（AUC），评估 VITROS hs-cTnI 检测试剂盒对心肌梗死（MI）的诊断价值。
VITROS hs-cTnI 的 LoD 为 0.73ng/L（血清）和 1.4ng/L（Li-Hep）。VITROS hs-cTnI 检测试剂盒在 5 次冻融循环中表现出稳定性，在室温下，血清样本中的分析物稳定性优于 Li-Hep，且严重溶血也会影响 Li-Hep 血浆 hs-cTnI 检测结果。在 202 例 Li-Hep 与血清浓度的比较中，VITROS hs-cTnI 检测试剂盒在血浆中检测到的浓度比例较低（斜率=0.85；95%置信区间[CI]：0.83-0.88）。在血清中，VITROS hs-cTnI 检测试剂盒与其他 hs-cTnI 检测试剂盒相比，检测浓度比例较低，在样本冷冻<-70°C 17 年（ED 研究）或 2020 年时，各检测试剂盒之间观察到相似的斜率。在 ED 研究中，VITROS hs-cTnI 检测试剂盒对 MI 的 AUC 为 0.974（95%CI：0.929-0.994），与其他 hs-cTn 检测试剂盒的 AUC 相似。
不同制造商生产的 hs-cTnI 检测试剂盒缺乏标准化是显而易见的。VITROS hs-cTnI 检测试剂盒与其他 hs-cTnI 检测试剂盒相比，检测结果较低。Li-Hep 血浆与血清之间存在重要差异，VITROS hs-cTnI 检测试剂盒稳定性良好，且临床性能优异，与其他 hs-cTn 检测试剂盒相当。
