POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test

Last updated: December 21, 2021
Sponsor: Therma Bright Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05119530
TB20-03
  • Ages > 12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 swabsample.
  • Participant is willing to provide a self-collected saliva sample.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 300
Study Start date:
December 06, 2021
Estimated Completion Date:
January 31, 2022

Connect with a study center

  • Covid Clinic Inc.

    Modesto, California 95356
    United States

    Active - Recruiting

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