COVID-19: SARS-CoV-2 Detection in Saliva, Oropharyngeal and Nasopharyngeal Specimens

NCT04715607 | Completed DMC

• 1 other identifier: 2021-01
• Study Type: interventional
• Target: 27,947
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the SARS-CoV-2 detection rate using either a Saliva, oropharyngeal swabs or nasopharyngeal swab method for specimen collection.

Conditions

SARS-CoV Infection; Covid19; Coronavirus

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection.

  Due to the high specificity of RT-PCR, we will define a participant with an RT-PCR positive result from either Saliva, OPS or NPS as having a COVID-19 infection. The combined Saliva/OPS/NPS result will therefore be used as the diagnostic reference standard to calculate the sensitivity for the Saliva, OPS and NPS tests.

  48 hours after testing

Secondary Outcomes (3)

• SARS-CoV-2 RT-PCR cycle threshold (Ct) values

  48 hours after testing

• OPS, NPS and saliva test discomfort and likelihood to get retested

  immediately after testing (10 minutes)

• Ratio of mutations in SARS-CoV-2

  48 hours after testing

Study Arms (3)

Nasopharyngeal swab, oropharyngeal swab, and salvia collection

ACTIVE COMPARATOR

The participants will first be tested with nasopharyngeal swabs followed by oropharyngeal swab and saliva collection. The collection material, virus transport medium and laboratory equipment for each method is the same in both arms

Diagnostic Test: Sequence of testing.

Oropharyngeal swab, salvia collection, and nasopharyngeal swab

ACTIVE COMPARATOR

The participants will first be tested with oropharyngeal swabs followed by saliva collection and nasopharyngeal swab. The collection material, virus transport medium and laboratory equipment for each method is the same in both arms

Diagnostic Test: Sequence of testing.

Salvia collection, nasopharyngeal swab, and oropharyngeal swab

ACTIVE COMPARATOR

The participants will first be tested with saliva collection followed by nasopharyngeal swab and oropharyngeal swabs. The collection material, virus transport medium and laboratory equipment for each method is the same in both arms

Diagnostic Test: Sequence of testing.

Interventions

Sequence of testing. DIAGNOSTIC_TEST

The participants will be tested in the following sequences of sampling technique: (1) nasopharyngeal swab, oropharyngeal swab, and salvia collection OR (2) oropharyngeal swab, salvia collection, and nasopharyngeal swab OR (3) salvia collection, nasopharyngeal swab, and oropharyngeal swab. Only the sequence is different in the different arm, while the sampling technique for each method is the same in all arms.

Nasopharyngeal swab, oropharyngeal swab, and salvia collection; Oropharyngeal swab, salvia collection, and nasopharyngeal swab; Salvia collection, nasopharyngeal swab, and oropharyngeal swab

Eligibility Criteria

• Age: 16 Years - 120 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• volunteers, who are attending the COVID-19 test facilities to obtain a RT-PCR test.
• oral and written informed consent to participate before entering the study.

You may not qualify if:

• Failure to understand and provide informed consent.
• Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Hvidovre University Hospital: collaborator
• Region Hovedstadens Apotek: collaborator

Study Sites (1)

Valby COVID-19 teststed

Copenhagen, Valby, 2500, Denmark

Location

Related Publications (2)

• Todsen T, Tolsgaard MG, Benfield T, Folke F, Jakobsen KK, Gredal NT, Ersboll AK, von Buchwald C, Kirkby N. Higher SARS-CoV-2 detection of oropharyngeal compared with nasopharyngeal or saliva specimen for molecular testing: a multicentre randomised comparative accuracy study. Thorax. 2023 Oct;78(10):1028-1034. doi: 10.1136/thorax-2022-219599. Epub 2023 May 19.

  PMID: 37208187 DERIVED

• Todsen T, Tolsgaard M, Folke F, Jakobsen KK, Ersboll AK, Benfield T, von Buchwald C, Kirkby N. SARS-CoV-2 in saliva, oropharyngeal and nasopharyngeal specimens. Dan Med J. 2021 Apr 7;68(5):A01210087.

  PMID: 33832565 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Tobias Todsen, MD, PhD

  Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Nikolai Kirkby, MD, PhD

  Department of Clinical Microbiology, Rigshospitalet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant professor Tobias Todsen

Model Details: All participants will have Saliva collected and recieve nasopharyngeal swabs and oropharyngeal swabs for SARS-COV2. To avoid systematic bias we plan to randomize the sequence of testing.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 20, 2021
• Study Start: January 22, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 31, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

DK (1)