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Itinai.com biomedical laboratory close up still scene close u fd75bc8f 7c64 495f bcb3 944db9509d75 3

Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial

Molecular Detection of SARS-CoV-2 From Throat Swabs: Practical Solutions and Value

Background

Testing for SARS-CoV-2 is crucial for early COVID-19 treatment and controlling the spread of infection. Proper upper respiratory specimen collection is vital for accurate diagnosis. Throat swabs are commonly used for mass testing, but their sensitivity for SARS-CoV-2 diagnosis varies.

Objective

This study aims to compare the sensitivity and patient discomfort of throat swabs including palatine tonsil specimens versus swabs from the posterior oropharyngeal wall only for SARS-CoV-2 testing.

Methods

We will conduct a randomized controlled study to compare the molecular detection rate of SARS-CoV-2 using throat swabs from the posterior oropharyngeal wall and palatine tonsils versus swabs from the posterior oropharyngeal wall only. Participants will be randomized in a 1:1 ratio.

Results

A total of 2315 participants were enrolled in this study between November 10, 2022, and December 22, 2022. Results from the follow-up questionnaire are expected to be completed at the beginning of 2024.

Conclusions

This clinical trial will provide information on whether including palatine tonsil specimens in throat swabs improves the diagnostic sensitivity for SARS-CoV-2 molecular detection, potentially influencing future testing recommendations and providing insights into SARS-CoV-2 tissue tropism.

Trial Registration

ClinicalTrials.gov NCT05611203; ClinicalTrials.gov/study/NCT05611203

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