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唾液样本的 SARS-CoV-2 自动化分子检测。

Automated molecular testing of saliva for SARS-CoV-2 detection.

机构信息

Division of Medical Microbiology and Virology, St. Paul's Hospital, Vancouver, Canada; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.

Division of Medical Microbiology and Virology, St. Paul's Hospital, Vancouver, Canada.

出版信息

Diagn Microbiol Infect Dis. 2021 May;100(1):115324. doi: 10.1016/j.diagmicrobio.2021.115324. Epub 2021 Jan 23.

DOI:10.1016/j.diagmicrobio.2021.115324
PMID:33529938
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7826079/
Abstract

With surging global demand for SARS-CoV-2 testing capacity, laboratories seek automated, high-throughput molecular solutions, particularly for specimens not requiring specialized collection devices or viral transport media. Saliva specimens submitted from patients under investigation for COVID-19 from March to July 2020 were processed in the laboratory with sterile phosphate-buffered saline in a 1:2 dilution and tested using manual extraction and a commercial assay for detection of the SARS-CoV-2 E gene (LightMix®) in comparison to the Roche cobas® SARS-CoV-2 Test on the cobas® 6800 instrument. 34.4% (22/64) of saliva samples were positive for SARS-CoV-2. Positive and negative concordance between the LightMix® and cobas® assays were 100%. The overall invalid rate for saliva on the cobas® 6800 (1/128, 0.78%) was similar to the baseline invalid rate observed for nasopharyngeal swabs/viral transport media. Saliva is a feasible specimen type for SARS-CoV-2 testing on the cobas® 6800 platform, with potential to improve turnaround time and enhance testing capacity.

摘要

随着全球对 SARS-CoV-2 检测能力的需求不断增长,实验室正在寻求自动化、高通量的分子解决方案,特别是对于不需要特殊采集设备或病毒运输介质的标本。2020 年 3 月至 7 月期间,实验室用无菌磷酸盐缓冲盐水按 1:2 的比例对来自 COVID-19 待检患者的唾液标本进行处理,采用手动提取法和商业检测试剂盒(LightMix®)检测 SARS-CoV-2 E 基因(与 Roche cobas® SARS-CoV-2 Test 在 cobas® 6800 仪器上的检测结果进行比较)。结果显示,64 份唾液样本中有 34.4%(22/64)为 SARS-CoV-2 阳性。LightMix® 和 cobas® 检测方法的阳性和阴性符合率均为 100%。cobas® 6800 上唾液的总无效率(1/128,0.78%)与鼻咽拭子/病毒运输介质的基线无效率相似。唾液是 cobas® 6800 平台上 SARS-CoV-2 检测的一种可行标本类型,具有缩短检测周转时间和提高检测能力的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/397c/7826079/3d12d92ed271/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/397c/7826079/3d12d92ed271/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/397c/7826079/3d12d92ed271/gr1_lrg.jpg

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本文引用的文献

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Practical challenges to the clinical implementation of saliva for SARS-CoV-2 detection.唾液用于 SARS-CoV-2 检测的临床实施面临的实际挑战。
Eur J Clin Microbiol Infect Dis. 2021 Feb;40(2):447-450. doi: 10.1007/s10096-020-04090-5. Epub 2020 Nov 25.
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SARS-CoV-2 molecular testing for the diagnosis of COVID-19: One test does not fit all.用于诊断新型冠状病毒肺炎的严重急性呼吸综合征冠状病毒2分子检测:一种检测方法并不适用于所有情况。
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评估唾液样本在新冠病毒监测中的可靠性。
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Saliva as a testing specimen with or without pooling for SARS-CoV-2 detection by multiplex RT-PCR test.使用或不使用混合 RT-PCR 检测 SARS-CoV-2 的唾液作为检测样本。
PLoS One. 2021 Feb 23;16(2):e0243183. doi: 10.1371/journal.pone.0243183. eCollection 2021.
用于检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的唾液或鼻咽拭子样本
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Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription-Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19.临床评价:定量逆转录实时聚合酶链反应(RT-qPCR)、直接 RT-qPCR、逆转录环介导等温扩增和快速抗原检测在诊断 COVID-19 中的应用。
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