Clinical Microbiology Service, Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States.
Clinical Microbiology Service, Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Departments of Laboratory Medicine and Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States.
J Clin Virol. 2021 May;138:104790. doi: 10.1016/j.jcv.2021.104790. Epub 2021 Mar 10.
The Roche Cobas SARS-CoV-2 test recently received an Emergency Use Authorization from the U.S. Food and Drug Administration UA for pooling of up to six nasopharyngeal swab samples (NPS). We evaluated the 6-pool approach on both NPS and saliva samples using 564 samples (20 positive NPS and saliva samples each and 262 negative NPS and saliva samples each). The sensitivity of the Roche SARS-CoV-2 RNA test for pooled NPS samples was 100 % (95 %CI: 83.2-100 %) and the sensitivity for pooled saliva samples was 90 % (95 % CI: 68.3-98.8 %). Given the high throughput of the Roche Cobas 6800, pooling of 6 samples has the potential to significantly increase testing capacity without significant loss in sensitivity.
罗氏 cobas SARS-CoV-2 检测试剂最近获得了美国食品和药物管理局（FDA）的紧急使用授权（EUA），可将多达 6 份鼻咽拭子样本（NPS）混合检测。我们使用 564 份样本（每份 20 份阳性 NPS 和唾液样本，每份 262 份阴性 NPS 和唾液样本）对 NPS 和唾液样本的 6 份混合检测方法进行了评估。罗氏 SARS-CoV-2 RNA 检测试剂对混合 NPS 样本的敏感性为 100%（95%CI：83.2-100%），对混合唾液样本的敏感性为 90%（95%CI：68.3-98.8%）。鉴于罗氏 cobas 6800 的高通量，混合 6 个样本具有在不显著降低敏感性的情况下显著提高检测能力的潜力。
