Nguyen-Kim Hanh, Beckmann Christiane, Redondo Maurice, Ziliox Jérémy, Vallet Virginie, Berger-Sturm Karin, Overbeck Jan Von, Alberi Auber Lavinia
Swiss Integrative Center for Human Health, Fribourg, Switzerland.
Viollier, Baselland, Switzerland.
J Med Virol. 2022 Sep;94(9):4277-4286. doi: 10.1002/jmv.27883. Epub 2022 Jun 2.
Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, molecular diagnostics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have taken center stage in the detection of infected individuals for isolation purposes but also in the mass surveillance as a preventive strategy to contain the virus spread. While nasopharyngeal swabs (NPS) have remained the golden standard substrate, salivary diagnostic for SARS-CoV-2 has been proposed as an alternative and noninvasive measure in vulnerable individuals. Nevertheless, there is a widespread assumption that salivary reverse-transcription polymerase chain reaction (RT-PCR) does not match the quality of testing using NPS and particular care should be taken in respect to food or beverage intake, when sampling saliva. Our study indicates that without any precaution in the selection of 190 patients, nor restriction over the time window of sampling, there is 99% match in the COVID-19 positivity between NPS and saliva when using RT-PCR, with a reported Delta in thermal cycles (Cts) values for the viral genes Envelope (E) and Open reading frame 1ab (Orf1ab) between 0 and 2, a 98.7% sensitivity and 100% specificity. This high accuracy is maintained in pooling configurations that can be used for mass-testing purposes in professional and educational settings. The further advantage to using crude saliva as compared to NPS or mouthwash is that direct methods yield robust results. Overall, our study validates and promotes the use of salivary diagnostic for COVID-19 eliminating the need of a medical practitioner for the sampling, resolving the unpleasantness of the NPS intervention and empowering the patient to do self-testing in times of need.
自2019年冠状病毒病(COVID-19)大流行开始以来,严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的分子诊断在检测感染个体以进行隔离方面占据了核心地位,同时在大规模监测中作为遏制病毒传播的预防策略也发挥着重要作用。虽然鼻咽拭子(NPS)仍然是金标准样本,但对于SARS-CoV-2的唾液诊断已被提议作为对易感个体的一种替代且非侵入性的检测方法。然而,人们普遍认为唾液逆转录聚合酶链反应(RT-PCR)检测的质量不如使用NPS检测,并且在采集唾液样本时,应特别注意食物或饮料的摄入情况。我们的研究表明,在选择190名患者时没有采取任何预防措施,也没有对采样时间窗口进行限制,使用RT-PCR检测时,NPS和唾液样本在COVID-19阳性结果上的匹配率为99%,病毒基因包膜(E)和开放阅读框1ab(Orf1ab)的热循环(Cts)值差异在0到2之间,灵敏度为98.7%,特异性为100%。这种高精度在混合样本配置中得以保持,可用于专业和教育环境中的大规模检测。与NPS或漱口水相比,使用未经处理的唾液样本的另一个优势是直接检测方法能产生可靠的结果。总体而言,我们的研究验证并推广了用于COVID-19的唾液诊断方法,无需医生进行采样,解决了鼻咽拭子检测带来的不适,使患者在需要时能够自行检测。