Commercial Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Molecular Assays Superior Analytical Sensitivity of cobas SARS-CoV-2 Relative to NxTAG CoV Extended Panel and ID NOW COVID-19 Test
Commercial Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Molecular Assays Superior Analytical Sensitivity of cobas SARS-CoV-2 Relative to NxTAG CoV Extended Panel and ID NOW COVID-19 Test
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DOI：
10.5858/arpa.2020-0283-sa
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发表时间：
2020-11-01
影响因子：
4.6
通讯作者：
Wang, Zixuan
中科院分区：
文献类型：
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作者：
Jin, Run;Pettengill, Matthew A.;Wang, Zixuan
背景。由于在大流行的早期阶段，严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）的检测试剂盒供应有限，我们实施了多个核酸扩增检测平台。不同平台生成的结果的解释和测试算法的优先级需要交叉比较。为了比较3种商业SARS-CoV-2分子检测试剂的分析灵敏度，选择的样本与Cobas SARS-CoV-2检测试剂、NxTAG CoV Extended Panel和ID NOW COVID-19检测试剂平行研究。本研究共纳入2020年3月22日至4月19日期间进行的8043例SARS-CoV-2检测。对于cobas SARS-CoV-2检测试剂检出的所有1794份阳性标本，手动跟踪循环阈值（C-t）并绘图，以显示样本病毒水平的分布。此外，分别使用NxTAG和ID NOW检测了50和63份低阳性标本（C-t值>32）以及50和61份cobas检测的连续阳性标本，以估计其相对灵敏度。cobas SARS-CoV-2阳性样本的C-t值均匀分布，ORF 1和E基因靶标的C-t值分别为13.32至39.50（平均值，25.06）和13.60至42.49（平均值，26.45）。NxTAG仅可靠地检测E基因C-t值低于33的标本，估计可检测cobas检测试剂盒检出的阳性标本的89.4%。ID NOW的性能变化与C-t值无关，估计可检测83.5%的cobas阳性。临床标本表现出广泛的病毒负荷，其中很大一部分处于低水平。检测平台的分析灵敏度对于SARS-CoV-2的可靠检测和对患者的统一护理至关重要。
Context.-We implemented multiple nucleic acid amplification test platforms because of the limited availability of test kits for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the early stages of the pandemic. Interpretation of results generated by different platforms and prioritization for testing algorithms required cross-comparison.Objective.-To compare the analytical sensitivity of 3 commercial SARS-CoV-2 molecular assays, selected samples were studied in parallel with Cobas SARS-CoV-2 test, NxTAG CoV Extended Panel, and ID NOW COVID-19 assays.Design.-A total of 8043 SARS-CoV-2 tests performed from March 22 to April 19, 2020, were included in this study. For all 1794 positive specimens detected by the cobas SARS-CoV-2 assay, the cycle threshold (C-t) values were manually tracked and plotted to demonstrate the distribution of sample viral levels. Additionally, 50 and 63 low-positive specimens (C-t values >32) as well as 50 and 61 consecutive positive specimens by the cobas assay were tested with NxTAG and ID NOW, respectively, to estimate their relative sensitivities.Results.-The C-t values of cobas SARS-CoV-2-positive samples were evenly distributed throughout ranges of 13.32 to 39.50 (mean, 25.06) and 13.60 to 42.49 (mean, 26.45) for ORF1 and E gene targets, respectively. NxTAG reliably detected only specimens with E gene C-t values lower than 33, and is estimated to detect 89.4% of positive specimens detected by cobas assay. ID NOW had performance variation independent of C-t value and is estimated to detect 83.5% of cobas positives.Conclusions.-Clinical specimens exhibit a wide range of viral burden, with a significant portion at low levels. Analytical sensitivity of testing platforms is critical for reliable detection of SARS-CoV-2 and uniform care to patients.