Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier F-34295 cédex 5, France.
Laboratoire de Biochimie et Hormonologie, CHU Montpellier, Univ Montpellier 1, Montpellier F-34295 cédex 5, France; Laboratoire de Biochimie et Hormonologie, PhyMedExp, Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France.
Clin Chim Acta. 2021 Aug;519:111-117. doi: 10.1016/j.cca.2021.04.003. Epub 2021 Apr 8.
Recently, Ortho Clinical Diagnostics have launched a high sensitivity cardiac troponin I assay adapted on Vitros3600 / 5600. We aimed at evaluating the analytical and clinical performances using the 0/3-hour algorithm, of the Ortho hs-cTnI assay on the Vitros 3600® (Ortho Clinical Diagnostics, Illkirch, France) analyzer with comparison to Roche hs-cTnT assay on the Cobas8000/e801® module (Roche diagnostics, Meylan, France) and the Abbott STAT hs-cTnI assay on the Alinity i® (Abbott, Rungis, France) analyzer.
Imprecision studies, linearity, limit of detection, and the interference to hemolysis were performed for Ortho hs-cTnI assay. The concordance study was based on results of troponin obtained from 160 patients with chest pain to the emergency department. Testing was performed simultaneously measuring the Roche hs-cTnT and the Ortho hs-cTnI, then on remaining sample the concentration of Abbott hs-cTnI (n = 150). We applied the 0/3h algorithm to rule out/rule in, in acute myocardial infarction.
Analytical performances were acceptable and in accordance with manufacturer's data. For late presenters 100, 92.8 and 88.8% patients could be rule-out with Roche, Ortho and Abbott assay, respectively with one NSTEMI missed with both hs-TnI assays. Applying the hs-cTn cut-offs from 0/3-hour algorithm, 107 (66.8%) could be rule out with Roche hs-cTnT with no AMI missed (sensitivity 100% [95%CI: 90.5 to 100] and NPV 100%); 89 with Ortho hs-cTnI (sensitivity 97.3% [95%CI: 85.8-99.9] and NPV 98.8% [95%CI:92.7-99.8]); and 61 with Abbott hs-cTnI (sensitivity 97% [95%CI: 84.2-99.9] and NPV 98.4% [95%CI: 89.8-99.7]). For rule-in, 23.7% (n = 37) from the total population would be designated in this group, with a specificity of 86.9% (95%CI: 79.7-92.4) and PPV of 69.8% (95%CI: 59.4-78.5) vs specificity of 72.3% (95%CI:63.5-80.0) and PPV of 51.4% (95%CI: 44.1-58.2)with Roche hs-cTnT vs Ortho hs-cTnI respectively; and with Abbott, 33 patients had constitued this group with a specificity of 52.1% (95%CI:42.7-61.4) and PPV of 36.4% (95%CI: 32.0-41.0).
In conclusion, according to ESC guidelines, our results indicate that the Ortho hs-cTnI assay for the Vitros 3600 instrument is a method that may be used in the clinical practice using 0/3-hour algorithm.
最近，Ortho Clinical Diagnostics 推出了一种适用于 Vitros3600/5600 的高灵敏度心肌肌钙蛋白 I 检测方法。我们旨在使用 0/3 小时算法评估 Ortho hs-cTnI 检测方法在 Vitros 3600®（Ortho Clinical Diagnostics，Illkirch，法国）分析仪上的分析和临床性能，并与 Roche hs-cTnT 检测方法在 Cobas8000/e801®模块（Roche diagnostics，Meylan，法国）和 Abbott STAT hs-cTnI 检测方法在 Alinity i®（Abbott，Rungis，法国）分析仪上进行比较。
我们对 Ortho hs-cTnI 检测方法进行了不精密度研究、线性度、检测限和对溶血的干扰。基于胸痛到急诊科的 160 名患者的肌钙蛋白检测结果进行了一致性研究。同时测量 Roche hs-cTnT 和 Ortho hs-cTnI 进行检测，然后对剩余样本进行 Abbott hs-cTnI（n=150）的浓度检测。我们应用 0/3 小时算法来排除/确诊急性心肌梗死。
分析性能符合制造商的数据要求。对于迟发患者，罗氏、Ortho 和 Abbott 检测分别有 100%、92.8%和 88.8%的患者可以排除，两种 hs-TnI 检测均漏诊了 1 例非 ST 段抬高型心肌梗死。应用 hs-cTn 0/3 小时算法的截止值，罗氏 hs-cTnT 可排除 107 例（无 AMI 漏诊，灵敏度 100%[95%CI：90.5-100]，NPV 100%）；Ortho hs-cTnI 排除 89 例（灵敏度 97.3%[95%CI：85.8-99.9]，NPV 98.8%[95%CI：92.7-99.8]）；Abbott hs-cTnI 排除 61 例（灵敏度 97%[95%CI：84.2-99.9]，NPV 98.4%[95%CI：89.8-99.7]）。对于确诊，在总人群中有 23.7%（n=37）会被归为这一组，特异性为 86.9%（95%CI：79.7-92.4），PPV 为 69.8%（95%CI：59.4-78.5），与罗氏 hs-cTnT 相比，特异性分别为 72.3%（95%CI：63.5-80.0）和 PPV 为 51.4%（95%CI：44.1-58.2）；与 Abbott 相比，有 33 例患者构成了这一组，特异性为 52.1%（95%CI：42.7-61.4），PPV 为 36.4%（95%CI：32.0-41.0）。
根据 ESC 指南，我们的结果表明，Vitros 3600 仪器上的 Ortho hs-cTnI 检测方法可用于临床实践中使用 0/3 小时算法。
