Kavsak Peter A, Mondoux Shawn E, Martin Janet, Hewitt Mark K, Clark Lorna, Caruso Nadia, Mark Ching-Tong, Chetty V Tony, Ainsworth Craig, Worster Andrew
Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON L8S 4L8, Canada.
Hamilton Regional Laboratory Medicine Program, Juravinski Hospital, Hamilton, ON L8V 1C3, Canada.
J Cardiovasc Dev Dis. 2021 Mar 23;8(3):31. doi: 10.3390/jcdd8030031.
Differences in patient classification of myocardial injury between high-sensitivity cardiac troponin (hs-cTn) assays have largely been attributed to assay design and analytical sensitivity aspects. Our objective was to compare Ortho Clinical Diagnostics' (OCD) hs-cTnI assay to OCD's contemporary/conventional assay (cTnI ES) and another hs-cTnI assay (Abbott hs-cTnI) in samples obtained from different emergency departments (EDs). Two different sample types were evaluated (lithium heparin and ethylenediaminetetraacetic acid (EDTA) plasma) in a non-selected ED population (study 1, = 469 samples) and in patients for which ED physicians ordered cardiac troponin testing (study 2, = 1147 samples), from five different EDs. The incidence of injury in study 1 was higher with the OCD hs-cTnI assay (30.9%; 95% CI: 26.9 to 35.2) compared to that of the Abbott hs-cTnI (17.3%; 95% CI: 14.1 to 21.0) and the OCD cTnI ES (15.4%; 95% CI: 12.4 to 18.9) assays, with repeat testing identifying 4.8% (95% CI: 3.0 to 7.5) of the OCD hs-cTnI results with poor reproducibility. In study 2, 4.6% (95% CI: 3.5 to 6.0) of the results were not reported for the OCD hs-cTnI assay (i.e., poor reproducibility) with 12.7% (95%CI: 8.7 to 17.8) of the OCD hs-cTnI results positive for injury being negative for injury with the Abbott hs-cTnI assay. In summary, the OCD hs-cTnI assay yields higher rates of biochemical injury with a higher rate of poor reproducible results in different ED populations.
高敏心肌肌钙蛋白（hs-cTn）检测在心肌损伤患者分类方面的差异很大程度上归因于检测方法设计和分析灵敏度等方面。我们的目标是在来自不同急诊科（ED）的样本中，将奥瑟临床诊断公司（OCD）的hs-cTnI检测与OCD的当代/传统检测方法（cTnI ES）以及另一种hs-cTnI检测方法（雅培hs-cTnI）进行比较。在一个非选择性的ED人群（研究1，n = 469个样本）以及ED医生开具心肌肌钙蛋白检测的患者中（研究2，n = 1147个样本），对两种不同的样本类型（肝素锂和乙二胺四乙酸（EDTA）血浆）进行了评估，这些样本来自五个不同的ED。与雅培hs-cTnI检测（17.3%；95%置信区间：14.1至21.0）和OCD的cTnI ES检测（15.4%；95%置信区间：12.4至18.9）相比，在研究1中，OCD的hs-cTnI检测的损伤发生率更高（30.9%；95%置信区间：26.9至35.2），重复检测发现OCD的hs-cTnI检测结果中有4.8%（95%置信区间：3.0至7.5）的重复性较差。在研究2中，OCD的hs-cTnI检测有4.6%（95%置信区间：3.5至6.0）的结果未报告（即重复性差），OCD的hs-cTnI检测结果中损伤呈阳性的有12.7%（95%置信区间：8.7至17.8）在用雅培hs-cTnI检测时损伤呈阴性。总之，在不同的ED人群中，OCD的hs-cTnI检测产生更高的生化损伤率以及更高的重复性差结果发生率。
