College of Medicine and Philippine General Hospital, University of the Philippines Manila, Pedro Gil Street, Ermita, 1000, Manila, National Capital Region, Philippines.
Medical Center Manila, Manila, National Capital Region, Philippines.
Sci Rep. 2022 Jul 23;12(1):12612. doi: 10.1038/s41598-022-16849-1.
Saliva has been demonstrated as feasible alternative to naso-oropharyngeal swab (NOS) for SARS-CoV-2 detection through reverse transcription quantitative/real-time polymerase chain reaction (RT-qPCR). This study compared the diagnostic agreement of conventional NOS, saliva with RNA extraction (SE) and saliva without RNA extraction (SalivaDirect) processing for RT-qPCR in identifying SARS-CoV-2. All techniques were also compared, as separate index tests, to a composite reference standard (CRS) where positive and negative results were defined as SARS-CoV-2 detection in either one or no sample, respectively. Of 517 paired samples, SARS-CoV-2 was detected in 150 (29.01%) NOS and 151 (29.21%) saliva specimens. The saliva-based tests were noted to have a sensitivity, specificity and accuracy (95% confidence interval) of 92.67% (87.26%, 96.28%), 97.55% (95.40%, 98.87%) and 96.13% (94.09%, 97.62%), respectively, for SE RT-qPCR and 91.33% (85.64%, 95.30%), 98.91% (97.23%, 99.70%) and 96.71% (94.79%, 98.07%), respectively, for SalivaDirect RT-qPCR compared to NOS RT-qPCR. Compared to CRS, all platforms demonstrated statistically similar diagnostic performance. These findings suggest that both conventional and streamlined saliva RT-qPCR are at least non-inferior to conventional NOS RT-qPCR in detecting SARS-CoV-2.
唾液已被证明是通过逆转录定量/实时聚合酶链反应(RT-qPCR)检测 SARS-CoV-2 的可行替代鼻咽拭子(NOS)。本研究比较了常规 NOS、带 RNA 提取(SE)的唾液和不带 RNA 提取(SalivaDirect)的唾液处理的 RT-qPCR 在识别 SARS-CoV-2 方面的诊断一致性。所有技术也作为单独的指标测试与复合参考标准(CRS)进行了比较,阳性和阴性结果分别定义为在一个或没有样本中检测到 SARS-CoV-2。在 517 对配对样本中,NOS 检测到 150 例(29.01%)和唾液样本 151 例(29.21%)的 SARS-CoV-2。基于唾液的检测的灵敏度、特异性和准确性(95%置信区间)分别为 SE RT-qPCR 的 92.67%(87.26%,96.28%)、97.55%(95.40%,98.87%)和 96.13%(94.09%,97.62%),以及 SalivaDirect RT-qPCR 的 91.33%(85.64%,95.30%)、98.91%(97.23%,99.70%)和 96.71%(94.79%,98.07%)与 NOS RT-qPCR 相比。与 CRS 相比,所有平台的诊断性能均具有统计学意义上的相似性。这些发现表明,常规和简化的唾液 RT-qPCR 在检测 SARS-CoV-2 方面至少不逊于常规 NOS RT-qPCR。