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严重急性呼吸综合征冠状病毒 2 实时 RT-PCR 检测在口腔冲洗液和唾液样本中的性能。

Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Real-Time RT-PCR Tests on Oral Rinses and Saliva Samples.

机构信息

Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York; Department Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

出版信息

J Mol Diagn. 2021 Jan;23(1):3-9. doi: 10.1016/j.jmoldx.2020.10.018. Epub 2020 Nov 17.

Abstract

Access to rapid and accurate detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA is essential for controlling the current global pandemic of coronavirus disease 2019. In this study, the use of oral rinses (ORs) and posterior oropharyngeal saliva as an alternative to swab collection methods from symptomatic and asymptomatic health care workers for the detection of SARS-CoV-2 RNA by RT-PCR was evaluated. For saliva samples, the overall agreement with oropharyngeal swabs was 93% (Ƙ = 0.84), with a sensitivity of 96.7% (95% CI, 83.3%-99.8%). The agreement between saliva and nasopharyngeal swabs was 97.7% (Ƙ = 0.93), with a sensitivity of 94.1% (95% CI, 73.0%-99.7%). ORs were compared with nasopharyngeal swabs only, with an overall agreement of 85.7% (Ƙ = 0.65), and a sensitivity of 63% (95% CI, 46.6%-77.8%). The agreement between a laboratory-developed test based on the CDC RT-PCR and two commercial assays, the Xpert Xpress SARS-CoV-2 and the Cobas SARS-CoV-2, was also evaluated. The overall agreement was >90%. Finally, SARS-CoV-2 RNA in saliva samples was shown to be stable, with no changes in viral loads over 24 hours at both room temperature and 4°C. Although the dilution of SARS-CoV-2 in ORs precluded its acceptability as a sample type, posterior oropharyngeal saliva was an acceptable alternative sample type for SARS-CoV-2 RNA detection.

摘要

快速准确地检测严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)RNA 对于控制当前全球 2019 年冠状病毒病(COVID-19)大流行至关重要。在这项研究中,评估了使用口腔冲洗液(OR)和后咽唾液替代拭子收集方法,从有症状和无症状的医护人员中检测 SARS-CoV-2 RNA 的 RT-PCR 方法。对于唾液样本,与咽拭子的总体一致性为 93%(Ƙ=0.84),敏感性为 96.7%(95%CI,83.3%-99.8%)。唾液与鼻咽拭子的一致性为 97.7%(Ƙ=0.93),敏感性为 94.1%(95%CI,73.0%-99.7%)。仅将 OR 与鼻咽拭子进行比较,总一致性为 85.7%(Ƙ=0.65),敏感性为 63%(95%CI,46.6%-77.8%)。还评估了基于 CDC RT-PCR 的实验室开发的测试与两种商业检测方法,即 Xpert Xpress SARS-CoV-2 和 Cobas SARS-CoV-2 之间的一致性。总一致性>90%。最后,表明唾液样本中的 SARS-CoV-2 RNA 稳定,在室温下和 4°C 下 24 小时内病毒载量没有变化。尽管 OR 中 SARS-CoV-2 的稀释度使其不能作为一种可接受的样本类型,但后咽唾液是 SARS-CoV-2 RNA 检测的一种可接受的替代样本类型。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d479/7786098/66bd71aff8d8/gr1.jpg

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