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Rigshospitalet - a part of Copenhagen University Hospital
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SARS-CoV-2 in saliva, oropharyngeal and nasopharyngeal specimens

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INTRODUCTION: The reference test to evaluate patients with suspected respiratory virus infection is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal swab (NPS). However, other specimen collection methods such as an oropharyngeal swab (OPS) or saliva specimen are also used for SARS-CoV-2 testing during the ongoing COVID-19 pandemic. However, it remains unclear if rates of SARS-CoV-2 detection differ between sampling methods. This study will compare the rates of SARS-CoV-2 detection by saliva, OPS, and NPS sampling in a public setting.

METHODS: Individuals referred for outpatient SARS-CoV-2 testing will be invited to participate in a prospective clinical study. They will have saliva, OPS and NPS specimens collected that will be analysed separately for SARS-CoV-2 RNA by RT-PCR. The rate of SARS-CoV-2 detection in saliva, OPS and NPS will be compared using a logistic regression mixed-effect model analysis. A sample of 19,110 participants is required at an expected 1.5% test-positive rate in order to detect a 25.6% difference. The total sample size will be adjusted as the test-positive rate changes.

CONCLUSIONS: This study will provide evidence for the optimal site of specimen collection to detect SARS-CoV-2. The results may help guide the health authorities.

FUNDING: This is an investigator-initiated trial based on an unrestricted grant from the Novo Nordisk Foundation and the Aage og Johanne Louis-Hansens Fond. The foundations have had no say in the decisions on study design or reporting.

TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT04715607).

Original languageEnglish
JournalDanish Medical Journal
Volume68
Issue number5
ISSN1603-9629
Publication statusPublished - 7 Apr 2021

    Research areas

  • COVID-19/diagnosis, COVID-19 Nucleic Acid Testing, Humans, Logistic Models, Nasopharynx/virology, Oropharynx/virology, Reverse Transcriptase Polymerase Chain Reaction, SARS-CoV-2/isolation & purification, Saliva/virology, Specimen Handling

ID: 65563264