Clinical Evaluation of the cobas SARS-CoV-2 Test and a Diagnostic Platform Switch during 48 Hours in the Midst o the COVID-19 Pandemic
Clinical Evaluation of the cobas SARS-CoV-2 Test and a Diagnostic Platform Switch during 48 Hours in the Midst o the COVID-19 Pandemic
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DOI：
10.1128/jcm.00599-20
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发表时间：
2020-06-01
影响因子：
9.4
通讯作者：
Petrovec, Miroslav
中科院分区：
文献类型：
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作者：
Poljak, Mario;Korva, Misa;Petrovec, Miroslav
目前，全球实验室对及时诊断严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）感染所需的采样设备、试剂、耗材和诊断仪器的需求异常旺盛。随着疫情的蔓延，为了满足诊断需求，美国食品和药物管理局（FDA）最近批准了几项商业SARS-CoV-2测试的紧急使用授权（EUA），但独立于制造商的评估数据很少。我们对cobas 6800 SARS-CoV-2 （cobas）全自动样品到结果双靶标检测（罗氏分子系统公司，新泽西州布兰奇堡）进行了首次独立于制造商的评估，该检测于2020年3月12日获得了美国FDA的EUA。比较物是标准化的3小时SARS-CoV-2方案，包括使用自动便携式仪器提取RNA，然后进行双靶点反转录实时PCR (RT-PCR)，我们的实验室自2020年1月以来一直常规使用（V. M. Corman， O. Landt， M. Kaiser， R. Molenkamp等，Euro Surveill 25(3):pii =2000045, 2020, https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045）。Cobas和比较者在由217个特征良好的回顾性样本组成的内部验证面板上显示出98.1%的总体一致性和0.95的kappa值。对502个样本进行了即时前瞻性头对头比较评估，诊断方法的总体一致性为99.6%，kappa值为0.98。观察到cobas获得的sars - cov -2特异性靶点的周期阈值与比较物之间具有良好的相关性（r(2) = 0.96）。我们的研究结果表明，cobas是一种可靠的方法，可用于在通用传输介质系统（UTM-RT）（意大利布雷西亚Copan）收集的鼻咽拭子样本中定性检测SARS-CoV-2。在全球实验室面临的特殊情况下，如果精心规划和执行，在COVID-19大流行期间，仅在48小时内就可以实现安全的诊断平台切换。
Laboratories are currently witnessing extraordinary demand globally for sampling devices, reagents, consumables, and diagnostic instruments needed for timely diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To meet diagnostic needs as the pandemic grows, the U.S. Food and Drug Administration (FDA) recently granted several commercial SARS-CoV-2 tests Emergency Use Authorization (EUA), but manufacturer-independent evaluation data are scarce. We performed the first manufacturer-independent evaluation of the fully automated sample-to-result two-target test cobas 6800 SARS-CoV-2 (cobas) (Roche Molecular Systems, Branchburg, NJ), which received U.S. FDA EUA on 12 March 2020. The comparator was a standardized 3-h SARS-CoV-2 protocol, consisting of RNA extraction using an automated portable instrument, followed by a two-target reverse transcription real-time PCR (RT-PCR), which our laboratory has routinely used since January 2020 (V. M. Corman, O. Landt, M. Kaiser, R. Molenkamp, et al., Euro Surveill 25(3):pii =2000045, 2020, https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045) . cobas and the comparator showed overall agreement of 98.1% and a kappa value of 0.95 on an in-house validation panel consisting of 217 well-characterized retrospective samples. Immediate prospective head-to-head comparative evaluation followed on 502 samples, and the diagnostic approaches showed overall agreement of 99.6% and a kappa value of 0.98. A good correlation (r(2) = 0.96) between cycle threshold values for SARS-CoV-2-specific targets obtained by cobas and the comparator was observed. Our results showed that cobas is a reliable assay for qualitative detection of SARS-CoV-2 in nasopharyngeal swab samples collected in the Universal Transport Medium System (UTM-RT) (Copan, Brescia, Italy). Under the extraordinary circumstances that laboratories are facing worldwide, a safe diagnostic platform switch is feasible in only 48 h and in the midst of the COVID-19 pandemic if carefully planned and executed.