Boutros Jacques, Benzaquen Jonathan, Marquette Charles Hugo, Ilié Marius, Labaky Mickelina, Benchetrit Didier, Lavrut Thibaut, Leroy Sylvie, Chemla Richard, Carles Michel, Tanga Virginie, Maniel Charlotte, Bordone Olivier, Allégra Maryline, Lespinet Virginie, Fayada Julien, Griffonnet Jennifer, Hofman Véronique, Hofman Paul
Dept of Pulmonary Medicine and Thoracic Oncology, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, FHU OncoAge, Nice, France.
Université Côte d'Azur, CNRS, INSERM, Institute of Research on Cancer and Aging, Nice, France.
ERJ Open Res. 2021 Dec 6;7(4). doi: 10.1183/23120541.00396-2021. eCollection 2021 Oct.
The current diagnostic standard for coronavirus disease 2019 (COVID-19) is reverse transcriptase-polymerase chain reaction (RT-PCR) testing with nasopharyngeal (NP) swabs. The invasiveness and need for trained personnel make the NP technique unsuited for repeated community-based mass screening. We developed a technique to collect saliva in a simple and easy way with the sponges that are usually used for tamponade of epistaxis. This study was carried out to validate the clinical performance of oral sponge (OS) sampling for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing.
Over a period of 22 weeks, we collected prospectively 409 paired NP and OS samples from consecutive subjects presenting to a public community-based free screening centre. Subjects were referred by their attending physician because of recent COVID-19 symptoms (n = 147) or by the contact tracing staff of the French public health insurance because they were considered as close contacts of a laboratory-confirmed COVID-19 case (n = 262).
In symptomatic subjects, RT-PCR SARS-CoV-2 testing with OS showed a 96.5% (95% CI: 89.6-94.8) concordance with NP testing, and a 93.2% (95% CI: 89.1-97.3) sensitivity when using the IdyllaTM platform and a sensitivity of 76.3% (95% CI: 69.4-83.2) on the Synlab Barla laboratory platform. In close contacts the NP-OS concordance (93.8%, 95% CI: 90.9-96.7) and OS sensitivity (71.9%, 95% CI: 66.5-77.3) were slightly lower.
These results strongly suggest that OS testing is a straightforward, low-cost and high-throughput sampling method that can be used for frequent RT-PCR testing of COVID-19 patients and mass screening of populations.
2019冠状病毒病（COVID-19）目前的诊断标准是使用鼻咽拭子进行逆转录聚合酶链反应（RT-PCR）检测。鼻咽拭子技术具有侵入性且需要专业人员操作，因此不适合用于基于社区的重复大规模筛查。我们开发了一种技术，使用通常用于鼻出血填塞的海绵以简单便捷的方式收集唾液。本研究旨在验证口腔海绵（OS）采样用于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）检测的临床性能。
在22周的时间里，我们前瞻性地从一家基于社区的免费公共筛查中心的连续就诊者中收集了409对鼻咽拭子和口腔海绵样本。受试者因近期出现COVID-19症状（n = 147）由主治医生转诊，或因被法国公共医疗保险的接触者追踪工作人员认定为实验室确诊COVID-19病例的密切接触者（n = 262）而转诊。
在有症状的受试者中，使用口腔海绵进行RT-PCR SARS-CoV-2检测与鼻咽拭子检测的一致性为96.5%（95%可信区间：89.6 - 94.8），使用IdyllaTM平台时敏感性为93.2%（95%可信区间：89.1 - 97.3），在Synlab Barla实验室平台上敏感性为76.3%（95%可信区间：69.4 - 83.2）。在密切接触者中，鼻咽拭子与口腔海绵的一致性（93.8%，95%可信区间：90.9 - 96.7）和口腔海绵的敏感性（71.9%，95%可信区间：66.5 - 77.3）略低。
这些结果有力地表明，口腔海绵检测是一种简单、低成本且高通量的采样方法，可用于对COVID-19患者进行频繁的RT-PCR检测和人群大规模筛查。
