Comparison of Commercially Available and Laboratory-Developed Assays for In Vitro Detection of SARS-CoV-2 in Clinical Laboratories
Comparison of Commercially Available and Laboratory-Developed Assays for In Vitro Detection of SARS-CoV-2 in Clinical Laboratories
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DOI：
10.1128/jcm.00821-20
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发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Greninger, Alexander L.
中科院分区：
文献类型：
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作者：
Lieberman, Joshua A.;Pepper, Gregory;Greninger, Alexander L.
已经出现了多种实验室开发的测试 (LDT) 和市售化验方法，以满足与严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 大流行相关的诊断需求。迄今为止，这些不同测试平台的比较数据有限。我们比较了我们临床实验室基于 CDC 引物组开发的 LDT 和四种市售的 FDA 紧急使用授权的 SARS-CoV-2 检测方法（Cepheid、DiaSorin、Hologic Panther 和 Roche Cobas）对总共 169 个鼻咽拭子的分析性能。 LDT 和 Cepheid Xpert Xpress SARS-CoV-2 检测是 SARS-CoV-2 最灵敏的检测，样本间一致性达 100%。 Hologic Panther Fusion、DiaSorin Simplexa 和 Roche Cobas 6800 未能检测到阳性样本，仅接近我们基于 CDC 的 LDT 检测的检测限。所有检测都是 100% 特异性的，使用我们基于 CDC 的 LDT 作为金标准。我们的结果提供了 SARS-CoV-2 逆转录 PCR (RT-PCR) 的初步测试性能特征，并强调了在公共卫生紧急情况下拥有多个病毒检测测试平台的重要性。
Multiple laboratory-developed tests (LDTs) and commercially available assays have emerged to meet diagnostic needs related to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. To date, there is limited comparison data for these different testing platforms. We compared the analytical performance of a LDT developed in our clinical laboratory based on CDC primer sets and four commercially available, FDA emergency use authorized assays for SARS-CoV-2 (Cepheid, DiaSorin, Hologic Panther, and Roche Cobas) on a total of 169 nasopharyngeal swabs. The LDT and Cepheid Xpert Xpress SARS-CoV-2 assays were the most sensitive assays for SARS-CoV-2 with 100% agreement across specimens. The Hologic Panther Fusion, DiaSorin Simplexa, and Roche Cobas 6800 failed to detect positive specimens only near the limit of detection of our CDC-based LDT assay. All assays were 100% specific, using our CDC-based LDT as the gold standard. Our results provide initial test performance characteristics for SARS-CoV-2 reverse transcription-PCR (RT-PCR) and highlight the importance of having multiple viral detection testing platforms available in a public health emergency.