TY - JOUR

T1 - Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils

T2 - Protocol for a Multicenter Randomized Controlled Trial

AU - Hartvigsen, Benedikte

AU - Jakobsen, Kathrine Kronberg

AU - Benfield, Thomas

AU - Gredal, Niels Tobias

AU - Ersbøll, Annette Kjær

AU - Grønlund, Mathias Waldemar

AU - Bundgaard, Henning

AU - Andersen, Mikkel Porsborg

AU - Steenhard, Nina

AU - von Buchwald, Christian

AU - Todsen, Tobias

N1 - Publisher Copyright: ©Benedikte Hartvigsen, Kathrine Kronberg Jakobsen, Thomas Benfield, Niels Tobias Gredal, Annette Kjær Ersbøll, Mathias Waldemar Grønlund, Henning Bundgaard, Mikkel Porsborg Andersen, Nina Steenhard, Christian von Buchwald, Tobias Todsen.

PY - 2024

Y1 - 2024

N2 - 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.

AB - 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.

KW - clinical laboratory techniques

KW - COVID-19

KW - COVID-19 detection

KW - COVID-19 testing

KW - detection

KW - diagnostic

KW - diagnostic accuracy

KW - diagnostic procedure

KW - diagnostic technique

KW - laboratory

KW - microbiology

KW - molecular biology

KW - molecular detection

KW - nasal swab

KW - nasal swabs

KW - oropharyngeal

KW - oropharyngeal sampling

KW - oropharyngeal swab

KW - oropharyngeal swabs

KW - palatine tonsil

KW - pandemic

KW - PCR

KW - PCR analysis

KW - polymerase chain reaction

KW - SARS-CoV-2

KW - swab

KW - swabs

KW - testing

KW - tonsil

KW - tool

KW - virology

U2 - 10.2196/47446

DO - 10.2196/47446

M3 - Journal article

C2 - 38865190

AN - SCOPUS:85196971601

VL - 13

JO - J M I R Research Protocols

JF - J M I R Research Protocols

SN - 1929-0748

M1 - e47446

ER -