Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection
Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection
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DOI：
10.1093/ajcp/aqaa221
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发表时间：
2021-02-01
影响因子：
3.5
通讯作者：
Yeo, Kiang-Teck J.
中科院分区：
文献类型：
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作者：
Chan, Clarence W.;Shahul, Sajid;Yeo, Kiang-Teck J.
目的：评价Truvian Easy Check冠状病毒病2019 (COVID-19) IgM/IgG抗严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）抗体检测的分析和临床效果。在当前的COVID-19全球大流行中，通过食品和药物管理局的紧急使用授权，血清学分析越来越多地用于监测。然而，血清学分析的广泛应用受到检测错误或不准确报告的限制。因此。COVID-19快速抗体检测在实施前需要经过彻底验证。方法：对Easy Check装置进行分析评价，并与Roche Elecsys抗sars - cov -2抗体测定法进行比较。使用感染其他病毒的患者的血清，进一步表征了该试验的交叉反应性。使用聚合酶链反应确认的样本和2015年大流行前参考样本集分析临床表现。结果：Easy Check装置具有良好的分析性能，与Roche Elecsys抗体测定法的总体一致性为98.6%。临床表现敏感性为96.6%，特异性为98.2%，总体准确率为98.1%。结论：Easy Check装置是一种简便、可靠、快速的SARS-CoV-2血清阳性检测方法，其性能优于罗氏Elecsys抗体自动检测方法。
Objectives: To evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test.Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore. rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation.Methods: The Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set.Results: The Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%.Conclusions: The Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.