Introduction. The current severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) pandemic has stressed the global supply chain for specialized equipment, including flocked swabs. Hypothesis. Saliva could be a potential alternative specimen source for diagnosis of SARS-CoV-2 infection by reverse-transcriptase PCR (RT-PCR). Aim. To compare the detection efficiency of SARS-CoV-2 RNA in saliva and oro-nasopharyngeal swab (ONPS) specimens. Methodology. Patients recruited from hospital provided paired saliva and ONPS specimens. We performed manual or automated RT-PCR with prior proteinase K treatment without RNA extraction using the Seegene Allplex 2019 nCoV assay. Results. Of the 773 specimen pairs, 165 (21.3 %) had at least one positive sample. Additionally, 138 specimens tested positive by both sampling methods. Fifteen and 12 cases were detected only by nasopharyngeal swab and saliva, respectively. The sensitivity of ONPS (153/165; 92.7 %; 95 % CI: 88.8–96.7) was similar to that of saliva (150/165; 90.9 %; 95 % CI: 86.5–95.3; P=0.5). In patients with symptoms for ≤ 10 days, the sensitivity of ONPS (118/126; 93.7 %; 95 % CI: 89.4–97.9) was similar to that of saliva (122/126; 96.8 %; 95 % CI: 93.8–99.9 %; P=0.9). However, the sensitivity of ONPS (20/22; 95.2 %; 95 % CI: 86.1–100) was higher than that of saliva (16/22; 71.4 %; 95 % CI: 52.1–90.8) in patients with symptoms for more than 10 days. Conclusions. Saliva sampling is an acceptable alternative to ONPS for diagnosing SARS-CoV-2 infection in symptomatic individuals displaying symptoms for ≤ 10 days. These results reinforce the need to expand the use of saliva samples, which are self-collected and do not require swabs.

中文翻译：

---

使用未提取的 rRT-PCR 和 Allplex 2019-nCoV 检测验证唾液采样作为口鼻咽拭子检测 SARS-CoV-2 的替代方法


介绍。当前严重急性呼吸综合征相关冠状病毒 2 (SARS-CoV-2) 大流行给包括植绒拭子在内的专用设备的全球供应链带来了压力。假设。唾液可能是通过逆转录酶 PCR (RT-PCR) 诊断 SARS-CoV-2 感染的潜在替代样本来源。目的。比较唾液和口鼻咽拭子 (ONPS) 标本中 SARS-CoV-2 RNA 的检测效率。方法论。从医院招募的患者提供了配对的唾液和 ONPS 样本。我们使用 Seegene Allplex 2019 nCoV 检测进行手动或自动 RT-PCR，并使用先前的蛋白酶 K 处理，无需提取 RNA。结果。在 773 对样本中，165 对 (21.3%) 至少有一个阳性样本。此外，两种采样方法均检测出 138 份样本呈阳性。仅通过鼻咽拭子和唾液检测的病例分别为 15 例和 12 例。 ONPS 的敏感性 (153/165; 92.7 %; 95 % CI: 88.8–96.7) 与唾液的敏感性相似 (150/165; 90.9 %; 95 % CI: 86.5–95.3; P = 0.5)。在症状持续 ≤ 10 天的患者中，ONPS 的敏感性 (118/126; 93.7 %; 95 % CI: 89.4–97.9) 与唾液的敏感性 (122/126; 96.8 %; 95 % CI: 93.8–99.9) 相似%； P =0.9)。然而，对于症状持续时间较长的患者，ONPS 的敏感性 (20/22; 95.2 %; 95 % CI: 86.1–100) 高于唾液 (16/22; 71.4 %; 95 % CI: 52.1–90.8)。超过10天。结论。唾液采样是 ONPS 的可接受替代方案，用于诊断出现症状 ≤ 10 天的有症状个体的 SARS-CoV-2 感染。 这些结果强调了扩大唾液样本使用的必要性，唾液样本是自行采集的，不需要拭子。