Centro di Referenza Nazionale per l'analisi e studio di correlazione tra ambiente, animale e uomo, Istituto Zooprofilattico Sperimentale del Mezzogiorno, Naples, Italy.
Department of Food Microbiology, Istituto Zooprofilattico Sperimentale del Mezzogiorno, Naples, Italy.
Front Public Health. 2022 Apr 4;10:840996. doi: 10.3389/fpubh.2022.840996. eCollection 2022.
The aim of the present study is to assess saliva as a reliable specimen for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection by real-time reverse transcription-PCR (RT-PCR), especially in community mass screening programs. The performance analysis considered 1,221 total samples [nasopharyngeal (NP) swabs and corresponding saliva], tested by means of a reference diagnostic real-time RT-PCR assay. Conflicting results were further investigated with a second, more sensitive, reference assay. Analysis of agreement showed a good concordance (95.82%), with a k coefficient value of.74 ( < 0.001); moreover, a follow-up analysis revealed the presence of viral gene targets in saliva samples at the time point the corresponding NP swabs turned negative. Data obtained prove the reliability of this alternative biofluid for SARS-CoV-2 detection in real-time RT-PCR. Considering the role of saliva in the coronavirus disease 2019 (COVID-19) transmission and pathogenesis, and the advantages in the use of salivary diagnostics, the present validation supports the use of saliva as an optimal choice in large-scale population screening and monitoring of the SARS-CoV-2 virus.
本研究旨在评估唾液作为实时逆转录聚合酶链反应（RT-PCR）检测严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的可靠标本，特别是在社区大规模筛查项目中。性能分析考虑了 1221 份总样本[鼻咽（NP）拭子和相应的唾液]，采用参考诊断实时 RT-PCR 检测方法进行检测。进一步用第二种更敏感的参考检测方法对有争议的结果进行了调查。分析一致性显示出良好的一致性（95.82%），kappa 系数值为.74（<0.001）；此外，后续分析显示，在相应的 NP 拭子转为阴性时，唾液样本中存在病毒基因靶标。获得的数据证明了这种替代生物液在实时 RT-PCR 中检测 SARS-CoV-2 的可靠性。鉴于唾液在 2019 年冠状病毒病（COVID-19）传播和发病机制中的作用，以及唾液诊断的优势，本验证支持在大规模人群筛查和 SARS-CoV-2 病毒监测中使用唾液作为最佳选择。
