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

Comparison of Detection Rate of SARS-CoV-2 in Saliva, Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting

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.

Study Overview

• Status: Completed
• Conditions: Covid19; SARS-CoV Infection; Coronavirus
• Intervention / Treatment: Diagnostic test: Sequence of testing.

Detailed Description

The reference test to evaluate patients with suspected respiratory infection caused by virus is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal swab (NPS). However, other specimen collection methods like oropharyngeal swabs (OPS) and a saliva specimen collection have also been accepted by the Centers for Disease Control and Prevention for SARS-CoV-2 testing during the current coronavirus disease 19 (COVID-19) pandemic. It is unclear how much the SARS-CoV-2 detection rate differs when using different sampling methods and the aim of this study is to compare the expected COVID-19 detection rate using saliva, oropharyngeal swabs or nasopharyngeal swab in a public setting.

We, therefore, aim to investigate the detection rate of SARS-CoV-2 in Saliva, oropharyngeal swab, and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic individuals tested for COVID-19 in a public test center during the COVID-19 pandemic.

Individuals referred for outpatient COVID-19 testing center will be invited to participate in a prospective clinical study. They will have saliva, OPS, and NPS specimen collection performed at the same time and analyzed separately for SARS-CoV-2. The rate for SARS-CoV-2 detection in saliva, OPS, and NPS will be compared using a logistic regression mixed-effect analysis. A Sample Size Calculation estimated that a sample of 18,000 participants would be needed for the trial with 80% power at a significance level of 5%.

• Study Type: Interventional
• Enrollment (Actual): 27947
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Valby
    • Copenhagen, Valby, Denmark, 2500
      • Valby COVID-19 teststed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 120 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nasopharyngeal swab, oropharyngeal swab, and salvia collection; 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.; 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.
ACTIVE_COMPARATOR: Oropharyngeal swab, salvia collection, and nasopharyngeal swab; 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.; 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.
ACTIVE_COMPARATOR: Salvia collection, nasopharyngeal swab, and oropharyngeal swab; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 RT-PCR cycle threshold (Ct) values	Ct values are compared between testing methods	48 hours after testing
OPS, NPS and saliva test discomfort and likelihood to get retested	Discomfort scores (1-10) and likelihood to get retested are compared between testing methods	immediately after testing (10 minutes)
Ratio of mutations in SARS-CoV-2	Detection rate of any mutations in SARS-CoV-2	48 hours after testing

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Hvidovre University Hospital; Region Hovedstadens Apotek
• Investigators: Principal Investigator: Tobias Todsen, MD, PhD, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet; Study Director: Nikolai Kirkby, MD, PhD, Department of Clinical Microbiology, Rigshospitalet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2021
• Primary Completion (ACTUAL): May 30, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (ACTUAL): January 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: 2021-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No