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Completed

NCT Number: NCT04715607

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

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.

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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

16 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valby COVID-19 teststed

Copenhagen, Valby, 2500, Denmark

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 48 hours after testing

    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.

Secondary outcomes

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

    Time frame: 48 hours after testing

    Ct values are compared between testing methods

  2. OPS, NPS and saliva test discomfort and likelihood to get retested

    Time frame: immediately after testing (10 minutes)

    Discomfort scores (1-10) and likelihood to get retested are compared between testing methods

  3. Ratio of mutations in SARS-CoV-2

    Time frame: 48 hours after testing

    Detection rate of any mutations in SARS-CoV-2

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Hvidovre University Hospital
  • Region Hovedstadens Apotek

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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