Department of Clinical Laboratory Medicine, Saitama Medical University Hospital, Saitama, Japan.
Department of Clinical Laboratory Medicine, Saitama Medical University Hospital, Saitama, Japan.
J Infect Chemother. 2023 Jun;29(6):586-591. doi: 10.1016/j.jiac.2023.02.011. Epub 2023 Feb 26.
In the context of the coronavirus disease 2019 (COVID-19) pandemic, a rapid and reliable point-of-care test is an essential tool for controlling the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In particular, an immunochromatography test (ICT) that uses saliva specimens for rapid antigen detection not only reduces the risk of secondary infections but also reduces the burden on medical personnel.
The newly developed salivary antigen test kit "Inspecter Kowa® SARS-CoV-2" is an ICT to which saliva specimens can be directly applied. We evaluated its usefulness in comparison with reverse transcription quantitative PCR (RT-qPCR) and the Espline® SARS-CoV-2 Kit for the detection of SARS-CoV-2 using nasopharyngeal swab specimens. In this study, 140 patients with suspected symptomatic COVID-19 who visited our hospital were enrolled, and nasopharyngeal swab and saliva specimens were collected after they consented to participate in the study.
Inspector Kowa SARS-CoV-2 was positive in 45 of 61 (73.8%) saliva that were positive by RT-qPCR and the Espline® SARS-CoV-2 Kit was also positive in 56 of 60 (93.3%) Np swabs that were positive by RT-qPCR. Good antigen detection was achieved by ICT with saliva and nasopharyngeal swab specimens when viral load was ≥10 copies/mL, whereas detection sensitivity was low when viral load was <10 copies/mL, especially in saliva specimens.
This ICT for the detection of SARS-CoV-2 salivary antigen is an attractive tool that does not require specialized equipment and allows patients to perform the entire process from sample collection to self-diagnose and to reduce the burden on medical care during a pandemic.
在 2019 年冠状病毒病（COVID-19）大流行的背景下，快速可靠的即时检测是控制严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）传播的重要工具。特别是，使用唾液标本进行快速抗原检测的免疫层析检测（ICT）不仅降低了二次感染的风险，而且减轻了医务人员的负担。
新开发的唾液抗原检测试剂盒“Inspector Kowa® SARS-CoV-2”是一种可以直接应用于唾液标本的 ICT。我们将其与逆转录定量 PCR（RT-qPCR）和 Espline® SARS-CoV-2 试剂盒进行比较，以检测鼻咽拭子标本中的 SARS-CoV-2。本研究纳入了 140 名有症状 COVID-19 疑似患者，他们在同意参与研究后采集了鼻咽拭子和唾液标本。
Inspector Kowa SARS-CoV-2 在 RT-qPCR 阳性的 61 份唾液标本中有 45 份（73.8%）阳性，Espline® SARS-CoV-2 试剂盒在 RT-qPCR 阳性的 60 份鼻咽拭子标本中有 56 份（93.3%）阳性。当病毒载量≥10 拷贝/mL 时，ICT 对唾液和鼻咽拭子标本中的 SARS-CoV-2 抗原检测效果良好，而当病毒载量<10 拷贝/mL 时，检测敏感性较低，尤其是在唾液标本中。
这种用于检测 SARS-CoV-2 唾液抗原的 ICT 是一种很有吸引力的工具，不需要专门的设备，允许患者从样本采集到自我诊断的整个过程，并减轻大流行期间医疗保健的负担。
