Department of Infectious Diseases, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan.
Department of Infectious Diseases, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan; 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.
J Infect Chemother. 2023 Jul;29(7):654-659. doi: 10.1016/j.jiac.2023.03.005. Epub 2023 Mar 7.
Rapid qualitative antigen testing has been widely used for the laboratory diagnosis of COVID-19 with nasopharyngeal samples. Saliva samples have been used as alternative samples, but the analytical performance of those samples for qualitative antigen testing has not been sufficiently evaluated.
A prospective observational study evaluated the analytical performance of three In Vitro Diagnostics (IVD) approved COVID-19 rapid antigen detection kits for saliva between June 2022 and July 2022 in Japan using real-time reverse transcription polymerase chain reaction (RT-qPCR) as a reference. A nasopharyngeal sample and a saliva sample were simultaneously obtained, and RT-qPCR was performed.
In total, saliva samples and nasopharyngeal samples were collected from 471 individuals (RT-qPCR-positive, n = 145) for the analysis. Of these, 96.6% were symptomatic. The median copy numbers were 1.7 × 10 copies/mL for saliva samples and 1.2 × 10 copies/mL for nasopharyngeal samples (p < 0.001). Compared with the reference, the sensitivity and specificity were 44.8% and 99.7% for ImunoAce SARS-CoV-2 Saliva, 57.2% and 99.1% for Espline SARS-CoV-2 N, and 60.0% and 99.1% for QuickChaser Auto SARS-CoV-2, respectively. The sensitivities of all antigen testing kit were 100% for saliva samples with a high viral load (>10 copies/mL), whereas the sensitivities were <70% for high-viral-load nasopharyngeal samples (>10 copies/mL).
COVID-19 rapid antigen detection kits with saliva showed high specificity, but the sensitivity varied among kits, and were also insufficient for the detection of symptomatic COVID-19 patients.
快速定性抗原检测已广泛应用于鼻咽拭子样本的 COVID-19 实验室诊断。唾液样本已被用作替代样本，但这些样本用于定性抗原检测的分析性能尚未得到充分评估。
一项前瞻性观察性研究于 2022 年 6 月至 2022 年 7 月在日本使用实时逆转录聚合酶链反应（RT-qPCR）作为参考，评估了三种经批准的体外诊断（IVD）COVID-19 快速抗原检测试剂盒对唾液的分析性能。同时采集鼻咽拭子和唾液样本，并进行 RT-qPCR。
共对 471 名个体（RT-qPCR 阳性，n=145）的唾液样本和鼻咽拭子样本进行了分析。其中，96.6%的个体有症状。唾液样本的中位拷贝数为 1.7×10 拷贝/mL，鼻咽拭子样本的中位拷贝数为 1.2×10 拷贝/mL（p<0.001）。与参考相比，ImunoAce SARS-CoV-2 Saliva 的灵敏度和特异性分别为 44.8%和 99.7%，Espinel SARS-CoV-2 N 的灵敏度和特异性分别为 57.2%和 99.1%，QuickChaser Auto SARS-CoV-2 的灵敏度和特异性分别为 60.0%和 99.1%。所有抗原检测试剂盒对高病毒载量（>10 拷贝/mL）的唾液样本的灵敏度均为 100%，但对高病毒载量（>10 拷贝/mL）的鼻咽拭子样本的灵敏度均<70%。
COVID-19 快速抗原检测试剂盒用于唾液样本具有高特异性，但试剂盒之间的灵敏度存在差异，对有症状的 COVID-19 患者的检测也不够充分。
