Saliva as Source of Detection for SARS-CoV-2
Evaluation of Saliva as Source of Detection for SARS-CoV-2
2 other identifiers
observational
456
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2020
CompletedJune 2, 2021
May 1, 2021
2 months
June 9, 2020
May 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Saliva SARS-CoV-2 RT-PCR test results
Validate saliva or nasal swab as a source of detection for SARS-CoV-2.
Screening
Secondary Outcomes (1)
Saliva and midturbinate swab SARS-CoV-2 RT-PCR test results
Screening
Study Arms (1)
NIH staff
NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples.
Eligibility Criteria
NIH staff undergoing standard NIH COVID-19 screening
You may qualify if:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Is one of the following:
- An NIH staff member participating in NIH CC SARS-CoV-2 surveillance, or
- A WHC patient who had or is having a diagnostic NP RT-PCR test for SARS-CoV-2.
- Age greater than or equal to 18 years.
- Able to provide informed consent.
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability or unwillingness to have NP sampling or midturbinate sampling (applies to NIH site only).
- Inability or unwillingness to provide saliva sample (applies to both NIH and WHC sites).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen M Frank, M.D.
National Institutes of Health Clinical Center (CC)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 11, 2020
Study Start
July 13, 2020
Primary Completion
September 4, 2020
Study Completion
September 4, 2020
Last Updated
June 2, 2021
Record last verified: 2021-05