Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence.
Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence.
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DOI：
10.2147/idr.s328327
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发表时间：
2021
影响因子：
3.9
通讯作者：
Shang HS
中科院分区：
文献类型：
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作者：
Jian MJ;Chung HY;Chang CK;Lin JC;Yeh KM;Chen CW;Li SY;Hsieh SS;Liu MT;Yang JR;Tang SH;Perng CL;Chang FY;Shang HS
流行病学研究和支持感染控制措施都需要精确的分子诊断检测方法来检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）（COVID-19的病原体）。我们使用325例有症状患者的鼻咽拭子临床样本，评估了三种样本到答案分子诊断系统检测SARS-CoV-2的分析灵敏度和临床性能。对已获得美国FDA紧急使用授权的BioFire Respiratory Panel 2.1（RP2.1）、cobas Liat SARS-CoV-2和Influenza A/B以及Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV平台进行了检测和比较。三种床旁检测系统的阳性一致率、阴性一致率和总体一致率为98- 100%，包括野生型SARS-CoV-2（非B.1.1.7）和关注变体（B.1.1.7）。值得注意的是，由于刺突蛋白突变，BioFire RP2.1可能无法检测B.1.1.7谱系中的SARS-CoV-2 S基因。所有这三种即时检测平台都为快速检测SARS-CoV-2提供了高度灵敏、稳健和几乎准确的结果。这些自动化分子诊断分析可以提高传染病控制和预防措施的有效性。
Accurate molecular diagnostic assays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, are needed for epidemiology studies and to support infection-control measures. We evaluated the analytical sensitivity and clinical performance of three sample-to-answer molecular-diagnostics systems for detecting SARS-CoV-2 using 325 nasopharyngeal swab clinical samples from symptomatic patients. The BioFire Respiratory Panel 2.1 (RP2.1), cobas Liat SARS-CoV-2 and Influenza A/B, and Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV platforms, which have been granted emergency-use authorization by the US FDA, were tested and compared. The positive percent agreement, negative percent agreement, and overall percent agreement among the three point of care testing systems were 98–100%, including for the wild-type SARS-CoV-2 (non-B.1.1.7) and a variant of concern (B.1.1.7). Notably, the BioFire RP2.1 may fail to detect the SARS-CoV-2 S gene in the B.1.1.7 lineage because of the spike protein mutation. All three point of care testing platforms provided highly sensitive, robust, and almost accurate results for rapidly detecting SARS-CoV-2. These automated molecular diagnostic assays can increase the effectiveness of control and prevention measures for infectious diseases.