The global COVID-19 pandemic has led to the rapid development of tests for detection of SARS-CoV-2. Studies are required to assess the relative performance of different assays. Here, we compared the performance of two commercial assays, the cobas® SARS-CoV-2 (Roche Diagnostics) and Xpert® Xpress SARS-CoV-2 (Cepheid®) tests, and a laboratory developed RT-PCR test adapted for use on the Hologic® Panther Fusion® (Hologic®) instrument as well as Bio-Rad and QIAGEN real-time PCR detection systems. Performance characteristics for each test were determined by testing clinical specimens and reference material. All assays detect the pan-Sarbecovirus E (envelope structural protein) gene plus a SARS-CoV-2-specific target. The limit of detection for the E gene target varied from ∼2 copies/reaction to >30 copies/reaction. Due to assay-specific differences in sample processing and nucleic acid extraction, the overall analytical sensitivity ranged from 24 copies/mL specimen to 574 copies/mL specimen. Despite these differences, there was 100 % agreement between the commercial and laboratory developed tests. No false-negative or false-positive SARS-CoV-2 results were observed and there was no cross-reactivity with common respiratory viruses, including endemic coronaviruses.

全球COVID-19大流行导致检测SARS-CoV-2的检测方法的迅速发展。需要进行研究以评估不同测定的相对性能。在这里，我们比较了两种商业测定的性能，即cobas®SARS-CoV-2（Roche Diagnostics）和Xpert®Xpress SARS-CoV-2（Cepheid®）测试，以及实验室开发的RT-PCR测试，适用于Hologic®PantherFusion®（Hologic®）仪器以及Bio-Rad和QIAGEN实时PCR检测系统。通过测试临床样本和参考材料来确定每个测试的性能特征。所有检测方法均检测泛Sarbecovirus E（包膜结构蛋白）基因以及SARS-CoV-2特异性靶标。E基因靶标的检出限从〜2拷贝/反应到＞ 30拷贝/反应。由于样品处理和核酸提取的检测特异性差异，总的分析灵敏度范围为24拷贝/ mL样品至574拷贝/ mL样品。尽管存在这些差异，但商业测试和实验室开发的测试之间还是有100％的一致性。没有观察到假阴性或假阳性的SARS-CoV-2结果，与常见的呼吸道病毒，包括地方性冠状病毒，也没有交叉反应。