Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
Department of Biotechnology and Laboratory Science in Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.
J Chin Med Assoc. 2021 Dec 1;84(12):1120-1125. doi: 10.1097/JCMA.0000000000000456.
Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become a global pandemic. Our laboratory initially used a two-step molecular assay, first reported by Corman et al, for SARS-CoV-2 identification (the Taiwan Center for Disease Control [T-CDC] method). As rapid and accurate diagnosis of COVID-19 is required to control the spread of this infectious disease, the current study evaluated three commercially available assays, including the TaqPath COVID-19 Combo kit, the cobas SARS-CoV-2 test, and the Rendu 2019-nCoV Assay kit, to establish diagnostic algorithms for clinical laboratories.
A total of 790 clinical specimens, including nasopharyngeal swabs, throat swabs, sputum, saliva, stool, endotracheal aspirate, and serum were obtained from patients who were suspected or already confirmed to have COVID-19 at the Taipei Veterans General Hospital from February to May 2020. These specimens were tested for SARS-CoV-2 using the different assays and the performance variance between the assays was analyzed.
Of the assays we evaluated, the T-CDC method and the TaqPath COVID-19 Combo kit require lots of hands-on practical laboratory work, while the cobas SARS-CoV-2 test and the Rendu 2019-nCoV Assay kit are fully automated detection systems. The T-CDC method and the TaqPath COVID-19 Combo kit showed similar detection sensitivity; however, the T-CDC method frequently delivered false-positive signals for envelope (E) and/or RNA-dependent RNA polymerase (RdRP) gene detection, thus increasing the risk of reporting false-positive results. A manual test-based testing strategy combining the T-CDC method and the TaqPath COVID-19 Combo kit was developed, which demonstrated excellent concordance rates (>99%) with the cobas and Rendu automatic systems. There were a few cases showing discrepant results, which may be due to the varied detection sensitivities as well as targets among the different platforms. Moreover, the concordance rate between the cobas and Rendu assays was 100%.
Based on our evaluation, two SARS-CoV-2 diagnostic algorithms, one focusing on the manual assays and the other on the automatic platforms, were proposed. Our results provide valuable information that allows clinical laboratories to implement optimal diagnostic strategies for SARS-CoV-2 testing based on their clinical needs, such as test volume, turn-around time, and staff/resource limitations.
由严重急性呼吸系统综合征冠状病毒 2 型（SARS-CoV-2）引起的 2019 年冠状病毒病（COVID-19）已成为全球大流行。我们的实验室最初使用两步法分子检测法，由 Corman 等人首次报道，用于 SARS-CoV-2 鉴定（台湾疾病管制署 [TCDC] 方法）。为了快速准确地诊断 COVID-19，以控制这种传染病的传播，本研究评估了三种市售检测试剂盒，包括 TaqPath COVID-19 Combo 试剂盒、cobas SARS-CoV-2 检测试剂盒和 Rendu 2019-nCoV 检测试剂盒，为临床实验室建立诊断算法。
本研究共纳入 2020 年 2 月至 5 月期间台北荣民总医院疑似或已确诊 COVID-19 患者的 790 份临床标本，包括鼻咽拭子、咽拭子、痰、唾液、粪便、气管吸出物和血清。使用不同的检测试剂盒检测 SARS-CoV-2，并分析检测试剂盒之间的性能差异。
在我们评估的检测试剂盒中，TCDC 方法和 TaqPath COVID-19 Combo 试剂盒需要大量的实际实验室工作，而 cobas SARS-CoV-2 检测试剂盒和 Rendu 2019-nCoV 检测试剂盒是全自动检测系统。TCDC 方法和 TaqPath COVID-19 Combo 试剂盒的检测灵敏度相似；然而，TCDC 方法经常对包膜（E）和/或 RNA 依赖性 RNA 聚合酶（RdRP）基因检测产生假阳性信号，从而增加报告假阳性结果的风险。我们制定了一种基于手动检测的 TCDC 方法和 TaqPath COVID-19 Combo 试剂盒的联合检测策略，与 cobas 和 Rendu 自动系统具有极好的一致性（>99%）。有几例检测结果不一致，可能是由于不同平台的检测灵敏度和靶点不同。此外，cobas 和 Rendu 检测试剂盒之间的一致性为 100%。
基于我们的评估，提出了两种 SARS-CoV-2 诊断算法，一种侧重于手动检测，另一种侧重于自动平台。我们的结果提供了有价值的信息，使临床实验室能够根据其临床需求，如检测量、周转时间和人员/资源限制，实施最佳的 SARS-CoV-2 检测诊断策略。
