COVID-19 Tests With Saliva Specimens
1 other identifier
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Jul 2020
1 active site
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
Study Start
First participant enrolled
July 28, 2020
CompletedFirst Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2021
CompletedSeptember 29, 2020
September 1, 2020
6 months
September 25, 2020
September 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The clinical evaluation of saliva as specimen for COVID-19 molecular test
We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.
1 hour
Study Arms (1)
Saliva and NP paired specimen collection
EXPERIMENTALInterventions
Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paradigm Laboratories
Tucson, Arizona, 85712, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenli Zhou, PhD
Paradigm Laboratories
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
September 29, 2020
Study Start
July 28, 2020
Primary Completion
January 30, 2021
Study Completion
June 27, 2021
Last Updated
September 29, 2020
Record last verified: 2020-09