Comparison of Two High-Throughput Reverse Transcription-PCR Systems for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2
Comparison of Two High-Throughput Reverse Transcription-PCR Systems for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2
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DOI：
10.1128/jcm.00890-20
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发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Westblade, Lars F.
中科院分区：
文献类型：
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作者：
Craney, Arryn R.;Velu, Priya D.;Westblade, Lars F.
严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）已成为全球大流行的原因。许多商业化的SARS-CoV-2逆转录pcr （RT-PCR）检测方法已获得美国食品和药物管理局的紧急使用授权。然而，描述其性能的数据有限，特别是高通量SARS-CoV-2 RT-PCR系统的性能。我们分析了cobas 6800和Panther Fusion两种高通量系统的诊断性能，以及它们相关的RT-PCR分析，收集了389份鼻咽标本。平台之间的总体一致性为96.4%（375/389）。Cohen的kappa分析将两个平台之间的一致性强度评为“几乎完美”（kappa = 0.922；标准误差为0.051）。两种系统产生的相应周期阈值差异无统计学意义（P值= 0.88;Student’st检验）。综上所述，这些数据表明这两种平台在临床表现上是可以比较的。我们相信，这些信息将对那些已经采用这些平台或正在寻求实施高通量RT-PCR检测以阻止SARS-CoV-2大流行的人有用。
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as the cause of a worldwide pandemic. Many commercial SARS-CoV-2 reverse transcription-PCR (RT-PCR) assays have received Emergency Use Authorization from the U.S. Food and Drug Administration. However, there are limited data describing their performance, in particular the performance of high-throughput SARS-CoV-2 RT-PCR systems. We analyzed the diagnostic performance of two high-throughput systems: cobas 6800 and Panther Fusion, and their associated RT-PCR assays, with a collection of 389 nasopharyngeal specimens. The overall agreement between the platforms was 96.4% (375/389). Cohen's kappa analysis rated the strength of agreement between the two platforms as "almost perfect" (kappa = 0.922; standard error, 0.051). Furthermore, there was no significant difference between corresponding cycle threshold values generated on the two systems (P value = 0.88; Student's t test). Taken together, these data imply that the two platforms can be considered comparable in terms of their clinical performance. We believe that this information will be useful for those who have already adopted these platforms or are seeking to implement high-throughput RT-PCR testing to stem the SARS-CoV-2 pandemic.