一项使用前鼻拭子的 SARS-CoV-2 快速抗原检测诊断准确性的前瞻性临床评估。
A prospective clinical evaluation of the diagnostic accuracy of the SARS-CoV-2 rapid antigen test using anterior nasal samples.
机构信息
Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan; Akashi Internal Medicine Clinic, 3-1-63 Asahigaoka, Kashiwara, Osaka, 582-0026, Japan.
Roche Diagnostics K.K, Medical, Quality & Regulatory, Shinagawa Season Terrace 1-2-70, Konan, Minato-ku, Tokyo, 108-0075, Japan.
出版信息
J Infect Chemother. 2022 Jun;28(6):780-785. doi: 10.1016/j.jiac.2022.02.016. Epub 2022 Feb 24.
INTRODUCTION
The diagnostic accuracy of antigen testing of anterior nasal (AN) samples for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has not been evaluated in the Japanese population. This study assessed the diagnostic accuracy of the Roche SARS-CoV-2 rapid antigen test (rapid antigen test) using AN samples.
METHODS
Two AN samples and one nasopharyngeal (NP) sample were collected from individuals undergoing screening for SARS-CoV-2 infection. The results of the rapid antigen test and the reverse-transcription polymerase chain reaction (RT-PCR) test using AN samples were compared to those of RT-PCR tests using NP samples.
RESULTS
Samples were collected from 800 participants, 95 and 110 of whom tested positive for SARS-CoV-2 on RT-PCR tests of AN and NP samples, respectively. The overall sensitivity/specificity of the AN rapid antigen test and AN RT-PCR were 72.7%/100% and 86.4%/100%, respectively. In symptomatic cases, the sensitivities of the AN rapid antigen test and AN RT-PCR were 84.7% and 94.9%, respectively. In asymptomatic cases, the sensitivities of the AN rapid antigen test and AN RT-PCR were 58.8% and 76.5%, respectively. The sensitivity of the AN rapid antigen test was over 80% in cases with cycle threshold (Ct) values < 25; it significantly decreased with an increase in the Ct values (p < 0.001).
CONCLUSION
The rapid antigen test with AN samples had a favorable sensitivity, especially in symptomatic cases or in cases with Ct values < 25. It gave no false-positive results. Compared with AN-RT PCR, the AN rapid antigen test had a modestly lower sensitivity in asymptomatic cases.
简介
针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染，抗原检测在前鼻（AN）样本中的诊断准确性尚未在日本人群中得到评估。本研究评估了罗氏 SARS-CoV-2 快速抗原检测（快速抗原检测）使用 AN 样本的诊断准确性。
方法
从接受 SARS-CoV-2 感染筛查的个体中采集了两个 AN 样本和一个鼻咽（NP）样本。比较了快速抗原检测和使用 AN 样本的逆转录聚合酶链反应（RT-PCR）检测与使用 NP 样本的 RT-PCR 检测的结果。
结果
共采集了 800 名参与者的样本，其中 95 名和 110 名分别在 AN 和 NP 样本的 RT-PCR 检测中检测到 SARS-CoV-2 阳性。AN 快速抗原检测和 AN RT-PCR 的总敏感性/特异性分别为 72.7%/100%和 86.4%/100%。在有症状的病例中，AN 快速抗原检测和 AN RT-PCR 的敏感性分别为 84.7%和 94.9%。在无症状病例中，AN 快速抗原检测和 AN RT-PCR 的敏感性分别为 58.8%和 76.5%。在 Ct 值<25 的情况下，AN 快速抗原检测的敏感性超过 80%；随着 Ct 值的增加，敏感性显著降低（p<0.001）。
结论
使用 AN 样本的快速抗原检测具有良好的敏感性，尤其是在有症状的病例或 Ct 值<25 的病例中。它没有假阳性结果。与 AN-RT-PCR 相比，AN 快速抗原检测在无症状病例中的敏感性略低。
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