Saito Nobuyuki, Kosaihira Seiji
Division of Infection Control and Prevention, Nippon Medical School Chiba Hokusoh Hospital.
Department of Emergency and Critical Care Medicine, Nippon Medical School Chiba Hokusoh Hospital.
J Nippon Med Sch. 2022 Nov 9;89(5):500-505. doi: 10.1272/jnms.JNMS.2022_89-509. Epub 2022 May 30.
Nasopharyngeal swabs (NPS) are generally used as specimen samples for antigen qualitative tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The principle of the reaction to the antigen protein is the same when saliva is used, and saliva samples were reported to be as accurate as NPS for real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) testing to identify SARS-CoV-2. Unlike NPS collection, self-collected saliva does not expose healthcare workers to the risk of infection. In this study, we evaluated the feasibility of using saliva samples for a SARS-CoV-2 antigen qualitative test (TA2107SA) under development.
Saliva samples were collected from patients with confirmed or suspected COVID-19 infection and analyzed. The sensitivity, specificity, and concordance index of the antigen qualitative test were calculated using an RT-qPCR test as reference.
Saliva samples were collected from 105 patients. The mean interval from onset to specimen collection was 5.7 days. The mean cycle threshold (Ct) value of RT-qPCR was 31.3. The sensitivity, specificity, and concordance index were 70.7%, 100%, and 0.85, respectively. In 33 patients with Ct values <30, the results of both the RT-qPCR and antigen tests were positive. The sensitivity of the saliva-based TA2107SA SARS-CoV-2 antigen qualitative test was slightly lower than that of the conventional antigen qualitative test using NPS samples from the same patient.
Saliva-based antigen qualitative tests for SARS-CoV-2 are an alternative option during a pandemic.
鼻咽拭子（NPS）通常用作严重急性呼吸综合征冠状病毒2（SARS-CoV-2）抗原定性检测的样本。使用唾液时对抗原蛋白的反应原理相同，据报道，在通过实时逆转录定量聚合酶链反应（RT-qPCR）检测来识别SARS-CoV-2方面，唾液样本与鼻咽拭子一样准确。与采集鼻咽拭子不同，自行采集唾液不会使医护人员面临感染风险。在本研究中，我们评估了使用唾液样本进行正在开发的SARS-CoV-2抗原定性检测（TA2107SA）的可行性。
从确诊或疑似新型冠状病毒肺炎（COVID-19）感染的患者中采集唾液样本并进行分析。以RT-qPCR检测为参考，计算抗原定性检测的灵敏度、特异性和一致性指数。
从105名患者中采集了唾液样本。从发病到样本采集的平均间隔时间为5.7天。RT-qPCR的平均循环阈值（Ct）值为31.3。灵敏度、特异性和一致性指数分别为70.7%、100%和0.85。在33名Ct值<30的患者中，RT-qPCR和抗原检测结果均为阳性。基于唾液的TA2107SA SARS-CoV-2抗原定性检测的灵敏度略低于使用同一患者的鼻咽拭子样本进行的传统抗原定性检测。
基于唾液的SARS-CoV-2抗原定性检测是大流行期间的一种替代选择。
