Saliva as Source of Detection for SARS-CoV-2

NCT ID: NCT04424446

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 456 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2020-09-04

Brief Summary

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.

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.

Conditions

COVID-19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

NIH staff

NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples.

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen M Frank, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Locations

Washington Hospital Center

Washington D.C., District of Columbia, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-CC-0128.html

NIH Clinical Center Detailed Web Page

Other Identifiers

20-CC-0128

Identifier Type: -

Identifier Source: secondary_id

200128

Identifier Type: -

Identifier Source: org_study_id