这项研究旨在评估用胍基或无胍灭活剂处理的唾液样品中SARS-CoV-2RNA检测的诊断准确性。使用鼻咽拭子样本(NPS)作为参考。根据NPS逆转录-聚合酶链反应(RT-PCR)结果,参与者被分为有或没有COVID-19.包含NPS的50套样品,自我收集的原始唾液,和以胍为基础的唾液,并收集各组无胍灭活剂。在COVID-19患者中,使用原始唾液和用基于胍且无胍的灭活剂处理的唾液进行直接RT-PCR的敏感性为100.0%,65.9%,和82.9%,分别,相应的一致率为94.3%(κ=88.5),82.8%(κ=64.8),和92.0%(κ=83.7)。在NPS样本中PCRCt值<30的患者中,三个样本的阳性预测值为100.0%,80.0%,和96.0%,分别。灭活唾液中SARS-CoV-2RNA检测的灵敏度低于原始唾液,而基于胍的灭活剂处理的样品中SARS-CoV-2RNA检测的灵敏度低于无胍灭活剂。然而,在导致感染传播的个体中,灭活的唾液显示出足够的准确性,无论使用哪种灭活剂。可以将灭活剂添加到收集用于RT-PCR的唾液样品中以降低病毒传播风险,同时保持足够的诊断准确性。
This study aimed to evaluate diagnostic accuracy of SARS-CoV-2 RNA detection in saliva samples treated with a guanidine-based or guanidine-free
inactivator, using nasopharyngeal swab samples (NPS) as referents. Based on the NPS reverse transcription-polymerase chain reaction (RT-PCR) results, participants were classified as with or without COVID-19. Fifty sets of samples comprising NPS, self-collected raw saliva, and saliva with a guanidine-based, and guanidine-free
inactivator were collected from each group. In patients with COVID-19, the sensitivity of direct RT-PCR using raw saliva and saliva treated with a guanidine-based and guanidine-free
inactivator was 100.0%, 65.9%, and 82.9%, respectively, with corresponding concordance rates of 94.3% (κ=88.5), 82.8% (κ=64.8), and 92.0% (κ=83.7). Among patients with a PCR Ct value of <30 in the NPS sample, the positive predictive value for the three samples was 100.0%, 80.0%, and 96.0%, respectively. The sensitivity of SARS-CoV-2 RNA detection was lower in inactivated saliva than in raw saliva and lower in samples treated with a guanidine-based than with a guanidine-free
inactivator. However, in individuals contributing to infection spread, inactivated saliva showed adequate accuracy regardless of the
inactivator used. Inactivators can be added to saliva samples collected for RT-PCR to reduce viral transmission risk while maintaining adequate diagnostic accuracy.