Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2
Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2
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DOI：
10.1128/jcm.00783-20
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发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Berry, Gregory J.
中科院分区：
文献类型：
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作者：
Zhen, Wei;Smith, Elizabeth;Berry, Gregory J.
严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 现已在全球传播。作为全球应对措施的一部分，许多分子诊断平台已获得美国食品和药物管理局 (FDA) 的紧急使用授权 (EUA)，以识别 SARS-CoV-2 阳性患者。我们的目标是评估三个从样本到答案的分子诊断平台（Cepheid Xpert Xpress SARS-CoV-2 (Xpert Xpress)、Abbott ID NOW COVID-19 [ID NOW] 和 GenMark ePlex SARS-CoV-2 Test [ePlex]），以确定在 108 名有症状患者的鼻咽拭子中检测 SARS-CoV-2 的分析灵敏度、临床性能和工作流程。我们发现 Xpert Xpress 的检测限最低（100 拷贝/毫升时 100% 检测），其次是 ePlex（1,000 拷贝/毫升时 100% 检测）和 ID NOW（20,000 拷贝/毫升）。与我们的参考标准 (98.3%) 相比，Xpert Xpress 的阳性一致性百分比 (PPA) 也最高，其次是 ePlex (91.4%) 和 ID NOW (87.7%)。所有三种检测均显示 100% 阴性一致性百分比 (NPA)。在工作流程分析中，与 Xpert Xpress（大约 46 分钟）和 ePlex（大约 1.5 小时）相比，ID NOW 在每个样本上获得结果的时间最短（大约 17 分钟），但 ID NOW 在快速获得结果方面获得的成果却在分析和临床性能方面有所下降。 ePlex 获得结果的时间最长，并且 PPA 比 ID NOW 略有改善。有关这些检测的临床和分析性能以及工作流程的信息对于在测试平台上做出明智且及时的决策至关重要。
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert Xpress SARS-CoV-2 (Xpert Xpress), Abbott ID NOW COVID-19 [ID NOW), and GenMark ePlex SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/ml), followed by ePlex (100% detection at 1,000 copies/ml), and ID NOW (20,000 copies/ml). Xpert Xpress also had highest positive percent agreement (PPA) compared to our reference standard (98.3%) followed by ePlex (91.4%) and ID NOW (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, ID NOW produced the lowest time to result per specimen (similar to 17 min) compared to Xpert Xpress (similar to 46 min) and ePlex (similar to 1.5 h), but what ID NOW gained in rapid results, it lost in analytical and clinical performance. ePlex had the longest time to results and showed a slight improvement in PPA over ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platforms.