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Purpose

The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect. 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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant is willing to sign verbal informed consent form. - 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

  • Participant has previously tested positive for COVID-19 within the past 90 days.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Recruiting Locations

Covid Clinic Inc.
Modesto, California 95356
Contact:
Hazel Flores
909-462-4161

More Details

NCT ID
NCT05119530
Status
Unknown status
Sponsor
Therma Bright Inc

Study Contact

Hazel Flores
909-462-4161
hazel@covidclinic.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.