Saliva as Source of Detection for SARS-CoV-2

  • STATUS
    Recruiting
  • participants needed
    5000
  • sponsor
    National Institutes of Health Clinical Center (CC)
Send
Updated on 16 February 2024
See if I qualify
discomfort
SARS
nasopharyngeal swab
nasal swab
acute respiratory syndrome (sars)

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....

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 swab samples to validate their use for SARS-CoV-2 detection.

Details
Condition Covid 19
Age 18years - 100years
Clinical Study IdentifierNCT04424446
SponsorNational Institutes of Health Clinical Center (CC)
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'To be eligible to participate in this study, an individual must meet all of the following'
b'criteria:'
b'NIH staff member participating in NIH CC SARS-CoV-2 surveillance.'
b'Age greater than or equal to 18 years.'
b'Able to provide informed consent.'

Exclusion Criteria

b'An individual who meets any of the following criteria will be excluded from participation'
b'in this study:'
b'Inability or unwillingness to have NP sampling or midturbinate sampling.'
b'Inability or unwillingness to provide saliva sample.'
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

discomfort
SARS
nasopharyngeal swab
nasal swab
acute respiratory syndrome (sars)

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.