ICMR-National AIDS Research Institute, Pune, India.
Old Bhosari Hospital, Pune, India.
APMIS. 2022 Nov;130(11):671-677. doi: 10.1111/apm.13266. Epub 2022 Sep 8.
The present study was conducted to compare the performance of patient self-collected oral swab (OS) with healthcare worker (HCW)-collected nasopharyngeal swab (NPS) for SARS-CoV-2 detection by reverse transcription polymerase chain reaction (RT-PCR) in real-world setting. Paired OS and NPS were collected from 485 consecutive individuals presenting with symptoms of coronavirus disease-19 (COVID-19) or asymptomatic contacts of COVID-19 cases. Both specimens were processed for RT-PCR and cycle threshold (Ct) value for each test was obtained. Positive percent agreement (PPA), negative percent agreement (NPA), overall percent agreement (OPA) and kappa were calculated for OS RT-PCR compared with NPS RT-PCR as reference. A total of 116/485 (23.9%) participants were positive by NPS RT-PCR. OS had PPA of 71.6%, NPA of 98.8%, OPA of 92.4% and kappa of 0.771. Almost all participants (483/485, 99.6%) reported OS as a convenient and comfortable sample for SARS-CoV-2 testing over NPS. All participants with Ct values <25 and majority (90.8%) with Ct values <30 were detected by OS. To conclude, OS self-sampling was preferred in comparison with NPS due the ease and comfort during collection. The performance of OS RT-PCR for SARS-CoV-2 detection, however, was sub-optimal in comparison with NPS RT-PCR.
本研究旨在比较患者自行采集的口腔拭子(OS)与医护人员(HCW)采集的鼻咽拭子(NPS)在实际环境中通过逆转录聚合酶链反应(RT-PCR)检测 SARS-CoV-2 的性能。从 485 名出现冠状病毒病 19(COVID-19)症状或 COVID-19 病例无症状接触者的连续个体中采集了配对的 OS 和 NPS。对两种标本均进行 RT-PCR 处理,并获得了每个检测的循环阈值(Ct)值。与 NPS RT-PCR 作为参考相比,计算了 OS RT-PCR 的阳性百分一致率(PPA)、阴性百分一致率(NPA)、总百分一致率(OPA)和kappa。共有 116/485(23.9%)名参与者通过 NPS RT-PCR 呈阳性。OS 的 PPA 为 71.6%,NPA 为 98.8%,OPA 为 92.4%,kappa 为 0.771。几乎所有参与者(483/485,99.6%)报告 OS 比 NPS 更方便舒适用于 SARS-CoV-2 检测。所有 Ct 值<25 的参与者(483/485,99.6%)和大多数(90.8%)Ct 值<30 的参与者均通过 OS 检测到。总之,与 NPS 相比,OS 自我采样由于采集过程中的简便和舒适而更受青睐。然而,与 NPS RT-PCR 相比,OS RT-PCR 检测 SARS-CoV-2 的性能并不理想。