POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
NCT ID: NCT05119530
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-12-06
2022-01-31
Brief Summary
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The AcuVid COVID-19 Rapid Antigen Saliva Test performance will be compared to a high sensitivity FDA EUA approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) swab results will be collected from subjects by healthcare providers at CLIA Waived COVID-19 Testing Centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers.
This prospective, observational, study will test up to 300 participants to establish the performance characteristics of the AcuVid test on saliva specimens.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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AcuVid COVID-19 Rapid Antigen Saliva Test
The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens
Eligibility Criteria
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Inclusion Criteria
* Age ≥12 and parents or legal guardians must consent as required by law.
* Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab sample.
* Participant is willing to provide a self-collected saliva sample.
Exclusion Criteria
12 Years
ALL
No
Sponsors
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Therma Bright Inc
INDUSTRY
Responsible Party
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Locations
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Covid Clinic Inc.
Modesto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Hazel Flores
Role: primary
Other Identifiers
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TB20-03
Identifier Type: -
Identifier Source: org_study_id
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