Saliva as Source of Detection for SARS-CoV-2

May 31, 2021 updated by: National Institutes of Health Clinical Center (CC)

Evaluation of Saliva as Source of Detection for SARS-CoV-2

Background:

Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab is inserted deep into the back of the nose to collect a sample. It can cause discomfort for most people. Researchers want to find an easier way to collect samples.

Objective:

To learn if testing for SARSCoV-2 with a saliva sample only, a nasal swab from just the front part of the nostril only, or a saliva sample plus a nasal swab gives results that are as accurate as the NP swab.

Eligibility:

NIH staff members age 18 and older who are taking part in NIH CC SARS-CoV-2 surveillance.

Design:

The Occupational Medical Service (OMS) collects NP swabs as part of standard NIH staff screening. Participants will give 1 or 2 saliva samples and 1 or 2 nasal swabs when their NP swab is collected by OMS. If their NP swab was already collected, their OMS record will be reviewed for the result.

If the NP swab result is positive, the participant will have another NP swab. At that time, they will also give 1 or 2 saliva samples and 1 or 2 nasal swabs. If the NP swab result is negative, they will give 1 or 2 saliva samples and 1 or 2 nasal swabs the next time they have an NP swab.

For the saliva sample, participants will spit into a tube.

For the nasal swab, the inside of the front part of the nostril will be swabbed.

Participation ends after the study samples are collected. Participants can choose to keep giving saliva and nasal swab samples each time they have an NP swab.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Because of the inconvenience of nasopharyngeal (NP) testing for SARS-CoV-2 detection, we are interested in identifying different strategies for detecting infection. A technique that is less intrusive would put individuals undergoing testing at lower risk for complications, would likely increase compliance with subsequent tests, and would decrease risk to the providers who are conducting the test. For asymptomatic screening, some institutions are using midturbinate swabs instead of NP swabs, for increased compliance due to decreased discomfort. The NIH has switched to midturbinate collection in asymptomatic collections only. A test that would require only expectorating saliva and/or collection of a midturbinate swab would address the issues of NP collection discomfort. Saliva is the most preferred by patients or asymptomatic staff due to no collection in the nasal cavity at all. Although the CDC lists midturbinate swab as an acceptable specimen type, there are minimal data about the sensitivity of this collection for SARS-CoV-2, and decisions to use midturbinate swabs are based in part on experience with other respiratory viruses. Also, if saliva were found to be equivalent to NP for patient testing, there will be a benefit to future patients in providing this option for testing. Therefore, we propose to validate these sample types for SARS-CoV-2 detection. The RT-PCR results based on a saliva sample alone or a saliva sample coupled with a midturbinate swab, will be correlated with the results using surveillance or diagnostic swab samples to validate their use for SARS-CoV-2 detection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NIH staff undergoing standard NIH COVID-19 screening

Description

  • INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Is one of the following:

    1. An NIH staff member participating in NIH CC SARS-CoV-2 surveillance, or
    2. A WHC patient who had or is having a diagnostic NP RT-PCR test for SARS-CoV-2.
  2. Age greater than or equal to 18 years.
  3. Able to provide informed consent.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Inability or unwillingness to have NP sampling or midturbinate sampling (applies to NIH site only).
  2. Inability or unwillingness to provide saliva sample (applies to both NIH and WHC sites).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
NIH staff
NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Saliva SARS-CoV-2 RT-PCR test results
Time Frame: Screening
Validate saliva or nasal swab as a source of detection for SARS-CoV-2.
Screening

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Saliva and midturbinate swab SARS-CoV-2 RT-PCR test results
Time Frame: Screening
Validate saliva coupled with a nasal swab as a source of detection for SARS-CoV-2.
Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200128
  • 20-CC-0128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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