鼻咽拭子、鼻拭子和唾液拭子样本用于 RT-PCR 检测 SARS-CoV-2 的诊断准确性。

Diagnostic accuracy of nasopharyngeal swab, nasal swab and saliva swab samples for the detection of SARS-CoV-2 using RT-PCR.

机构信息

Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.

Center for Clinical Science, National National Center for Global Health and Medicine, Tokyo, Japan.

出版信息

Infect Dis (Lond). 2021 Aug;53(8):581-589. doi: 10.1080/23744235.2021.1903550. Epub 2021 Mar 24.

DOI:10.1080/23744235.2021.1903550

PMID:33760699

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8006266/

Abstract

BACKGROUND

The current gold standard in coronavirus disease (COVID-19) diagnostics is the real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in nasopharyngeal swab (NPS) samples. Alternatively, nasal swab (NS) or saliva swab (SS) specimens are used, although available data on test accuracy are limited. We examined the diagnostic accuracy of NPS/NS/SS samples for this purpose.

METHODS

Ten patients were included after being tested positive for SARS-CoV-2 RT-PCR in NPS samples according to the National Institute of Infectious Disease guidelines. In comparison with this conventional diagnostic method, NPS/NS/SS samples were tested using the cobas 6800 systems RT-PCR device. To investigate the usefulness of the cobas method and the difference among sample types, the agreement and sensitivity were calculated. Five to six samples were collected over a total period of 5-6 d from each patient.

RESULTS

Fifty-seven sets of NPS/NS/SS samples were collected, of which 40 tested positive for COVID-19 by the conventional method. Overall, the concordance rates using the conventional method were 86.0%/70.2%/54.4% for NPS/NS/SS samples (cobas); however, for samples collected up to and including on Day 9 after disease onset (22 negative and one positive specimens), the corresponding rates were 95.7%/87.0%/65.2%. The overall sensitivity estimates were 100.0%/67.5%/37.5% for NPS/NS/SS samples (cobas). For samples up to 9 d after onset, the corresponding values were 100.0%/86.4%/63.6%.

CONCLUSIONS

NS samples are more reliable than SS samples and can be an alternative to NPS samples. They can be a useful diagnostic method in the future.

摘要

背景

目前，冠状病毒病（COVID-19）诊断的金标准是实时逆转录-聚合酶链反应（RT-PCR）检测鼻咽拭子（NPS）样本中严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）RNA。或者使用鼻拭子（NS）或唾液拭子（SS）标本，但关于检测准确性的可用数据有限。我们为此目的检查了 NPS/NS/SS 样本的诊断准确性。

方法

根据国家传染病研究所的指南，在 NPS 样本中检测到 SARS-CoV-2 RT-PCR 阳性的 10 名患者被纳入研究。与这种常规诊断方法相比，使用 cobas 6800 系统 RT-PCR 设备对 NPS/NS/SS 样本进行了检测。为了研究 cobas 方法的有用性和样本类型之间的差异，计算了一致性和敏感性。每位患者总共在 5-6 天内采集了 5-6 个样本。

结果

共采集了 57 组 NPS/NS/SS 样本，其中 40 组通过常规方法检测到 COVID-19 阳性。总体而言，使用常规方法时，NPS/NS/SS 样本的一致性率分别为 86.0%/70.2%/54.4%（cobas）；然而，对于发病后第 9 天内采集的样本（22 个阴性和 1 个阳性样本），相应的比率分别为 95.7%/87.0%/65.2%。NPS/NS/SS 样本（cobas）的总体敏感性估计值分别为 100.0%/67.5%/37.5%。对于发病后 9 天内的样本，相应的值分别为 100.0%/86.4%/63.6%。