SARS-CoV-2 is the etiologic agent of coronavirus disease 2019 (COVID-19) and is mainly detected by RT-PCR methods from upper respiratory specimens, as recommended by the World Health Organization. Oro/nasopharyngeal swabbing can be discomfortable to the patients, requires trained healthcare personnel and may generate aerosol, increasing the risk of nosocomial infections. In this study, we describe two SARS-CoV-2 RNA extraction-free single RT-PCR protocols on saliva samples and compared the results with the paired oro/nasopharyngeal swab specimens from 400 patients. The two saliva protocols demonstrated a substantial agreement when compared to the oro/nasopharyngeal swab protocol. Moreover, the positivity rate of saliva protocols increased according to the disease period. The 95 % limit of detection of one of the therefore implemented saliva protocol was determined as 9441 copies/mL. Our results support the conclusion that RNA extraction-free RT-PCR using self-collected saliva specimens is an alternative to nasopharyngeal swabs, especially in the early phase of symptom onset.

SARS-CoV-2 是 2019 年冠状病毒病 (COVID-19) 的病原体，主要通过世界卫生组织推荐的 RT-PCR 方法从上呼吸道标本中检测出来。口腔/鼻咽拭子可能会使患者感到不适，需要经过培训的医护人员，并且可能会产生气溶胶，从而增加院内感染的风险。在这项研究中，我们描述了两种针对唾液样本的无 SARS-CoV-2 RNA 提取的单一 RT-PCR 方案，并将结果与​​来自 400 名患者的成对口腔/鼻咽拭子样本进行了比较。与口腔/鼻咽拭子方案相比，这两种唾液方案表现出实质性的一致性。此外，唾液方案的阳性率根据疾病时期而增加。因此实施的唾液方案之一的 95% 检测限被确定为 9441 拷贝/mL。我们的结果支持这样的结论，即使用自收集唾液标本的无 RNA 提取 RT-PCR 是鼻咽拭子的替代方法，尤其是在症状出现的早期阶段。