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验证和部署一种基于直接唾液样本的实时 RT-PCR 检测方法,用于 COVID-19 监测检测的样本混样检测。

Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing.

机构信息

Department of Microbiology, Miami University, Oxford, Ohio, United States of America.

Department of Kinesiology, Nutrition, and Health, Miami University, Oxford, Ohio, United States of America.

出版信息

PLoS One. 2021 Dec 30;16(12):e0261956. doi: 10.1371/journal.pone.0261956. eCollection 2021.

DOI:10.1371/journal.pone.0261956
PMID:34969053
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8718011/
Abstract

A direct, real-time reverse transcriptase PCR test on pooled saliva was validated in 2,786 participants against oropharyngeal swabs. Among asymptomatic/pre-symptomatic participants, the test was found to be in 99.21% agreement and 45% more sensitive than contemporaneous oropharyngeal swabs. The test was then used for surveillance testing on 44,242 saliva samples from asymptomatic participants. Those whose saliva showed evidence of SARS-CoV-2 within 50 cycles of amplification were referred for confirmatory testing, with 87% of those tested by nasal swab within 72 hours receiving a positive diagnostic result on Abbott ID NOW or real-time PCR platforms. Median Ct values on the saliva PCR for those with a positive and negative confirmatory tests was 30.67 and 35.92 respectively, however, binary logistic regression analysis of the saliva Ct values indicates that Ct thresholds as high as 47 may be useful in a surveillance setting. Overall, data indicate that direct RT-PCR testing of pooled saliva samples is an effective method of SARS-CoV-2 surveillance.

摘要

在 2786 名参与者中,对汇集的唾液进行直接、实时逆转录聚合酶链反应(RT-PCR)检测,并与咽拭子进行了对比。在无症状/症状前参与者中,该检测的一致性为 99.21%,比同期的咽拭子检测更敏感 45%。随后,该检测用于对 44242 名无症状参与者的唾液样本进行监测检测。那些在扩增 50 个循环内显示 SARS-CoV-2 证据的唾液样本被转介进行确认性检测,在 72 小时内通过鼻拭子进行检测的 87%的人在雅培 ID NOW 或实时 PCR 平台上获得了阳性诊断结果。在有阳性和阴性确认性检测的患者中,唾液 PCR 的中位 Ct 值分别为 30.67 和 35.92,但对唾液 Ct 值的二元逻辑回归分析表明,Ct 阈值高达 47 在监测环境中可能是有用的。总的来说,数据表明,直接 RT-PCR 检测汇集的唾液样本是一种有效的 SARS-CoV-2 监测方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ae/8718011/0982cb43dc39/pone.0261956.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ae/8718011/8e75940524c6/pone.0261956.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ae/8718011/0982cb43dc39/pone.0261956.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ae/8718011/8e75940524c6/pone.0261956.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ae/8718011/0982cb43dc39/pone.0261956.g002.jpg

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