COVID-19 Tests With Saliva Specimens
- Conditions
- Covid19
- Interventions
- Other: Saliva collection
- Registration Number
- NCT04567953
- Lead Sponsor
- Paradigm Laboratories LLC
- Brief Summary
Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
-
Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and
- Is able to give informed consent
- Is able to understand oral or written instructions, and
- Is able to mentally and physically perform self-collection of saliva using the provided collection device.
-
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Employees of Paradigm lab and the assisted living facilities involved in the study
- Members of other vulnerable populations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Saliva and NP paired specimen collection Saliva collection -
- Primary Outcome Measures
Name Time Method The clinical evaluation of saliva as specimen for COVID-19 molecular test 1 hour We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Paradigm Laboratories
🇺🇸Tucson, Arizona, United States