背景:SARS-CoV-2的检测对于为重症高危人群提供早期COVID-19治疗和限制感染在社会中的传播至关重要。正确收集上呼吸道标本是在公共场所诊断SARS-CoV-2病毒的最关键步骤,在COVID-19大流行期间,在许多国家/地区,咽拭子是用于大规模检测的首选标本。然而,关于咽喉拭子是否对SARS-CoV-2诊断测试具有足够高的灵敏度仍然存在讨论,正如以前的研究报道的那样,灵敏度从52%到100%存在很大的差异。许多以前探索咽拭子诊断准确性的研究缺乏对采样技术的详细描述,这使得很难比较不同的诊断准确性结果。一些研究仅通过从口咽后壁收集标本来进行咽喉拭子,而其他人还包括用于SARS-CoV-2测试的pat扁桃体拭子。然而,研究表明,扁桃体可能对SARS-CoV-2具有组织嗜性,这可能会改善采样过程中SARS-CoV-2的检测。这可以解释报告的灵敏度变化,但是还没有临床研究探讨在咽喉拭子期间是否包括腭扁桃体的敏感性和患者不适的差异。
目的:本研究的目的是检查包括腭扁桃体在内的咽喉拭子的敏感性和患者不适,而在SARS-CoV-2的分子测试中,仅擦拭后口咽壁。
方法:我们将进行一项随机对照研究,比较从口咽后壁和腭扁桃体(干预组)或仅在口咽后壁(对照组)进行的咽拭子对SARS-CoV-2的分子检出率。参与者将以1:1的比例随机分配。所有参与者在参加试验时填写基线问卷,检查他们被测试的原因,症状,和以前的扁桃体切除术。随访问卷将发送给参与者,以探索测试后症状的发展。
结果:在2022年11月10日至2022年12月22日期间,共有2315名参与者参加了这项研究。后续问卷的结果预计将于2024年初完成。
结论:这项随机临床试验将为我们提供关于咽喉拭子(包括腭扁桃体标本)是否会提高SARS-CoV-2分子检测的诊断敏感性的信息。这些结果可以,因此,用于改进未来的测试建议,并提供有关SARS-CoV-2的组织嗜性的其他信息。
背景:ClinicalTrials.govNCT05611203;https://clinicaltrials.gov/study/NCT05611203。
■DERR1-10.2196/47446。
BACKGROUND: Testing for SARS-CoV-2 is essential to provide early COVID-19 treatment for people at high risk of severe illness and to limit the spread of infection in society. Proper upper respiratory specimen collection is the most critical step in the diagnosis of the SARS-CoV-2 virus in public settings, and throat swabs were the preferred specimens used for mass testing in many countries during the COVID-19 pandemic. However, there is still a discussion about whether throat swabs have a high enough sensitivity for SARS-CoV-2 diagnostic testing, as previous studies have reported a large variability in the sensitivity from 52% to 100%. Many previous studies exploring the diagnostic accuracy of throat swabs lack a detailed description of the sampling technique, which makes it difficult to compare the different diagnostic accuracy results. Some studies perform a throat swab by only collecting specimens from the posterior oropharyngeal wall, while others also include a swab of the palatine tonsils for SARS-CoV-2 testing. However, studies suggest that the palatine tonsils could have a tissue tropism for SARS-CoV-2 that may improve the SARS-CoV-2 detection during sampling. This may explain the variation of sensitivity reported, but no clinical studies have yet explored the differences in sensitivity and patient discomfort whether the palatine tonsils are included during the throat swab or not.
OBJECTIVE: The objective of this
study is to examine the sensitivity and patient discomfort of a throat swab including the palatine tonsils compared to only swabbing the posterior oropharyngeal wall in molecular testing for SARS-CoV-2.
METHODS: We will conduct a randomized controlled
study to compare the molecular detection rate of SARS-CoV-2 by a throat swab performed from the posterior oropharyngeal wall and the palatine tonsils (intervention group) or the posterior oropharyngeal wall only (control group). Participants will be randomized in a 1:1 ratio. All participants fill out a baseline questionnaire upon enrollment in the
trial, examining their reason for being tested, symptoms, and previous tonsillectomy. A follow-up questionnaire will be sent to participants to explore the development of symptoms after testing.
RESULTS: A total of 2315 participants were enrolled in this study between November 10, 2022, and December 22, 2022. The results from the follow-up questionnaire are expected to be completed at the beginning of 2024.
CONCLUSIONS: This randomized clinical
trial will provide us with information about whether throat swabs including specimens from the palatine tonsils will improve the diagnostic sensitivity for SARS-CoV-2 molecular detection. These results can, therefore, be used to improve future testing recommendations and provide additional information about tissue tropism for SARS-CoV-2.
BACKGROUND: ClinicalTrials.gov NCT05611203; https://clinicaltrials.gov/
study/NCT05611203.
UNASSIGNED: DERR1-10.2196/47446.