Recruiting

AcuVid Test

Sponsor:

Therma Bright Inc

Code:

NCT05119530

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

AcuVid COVID-19 Rapid Antigen Saliva Test

Study Details

Brief 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.

Conditions

COVID-19

Study ID

NCT05119530

Start date

Dec 6, 2021

Status verified date

Dec, 2021

Completion date

Jan, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Hazel Flores

909-462-4161hazel@covidclinic.org

Angela Hall

949-287-8191angela@covidclinic.org

Locations

Covid Clinic Inc.

Recruiting

Modesto, California, United States, 95356

Contacts

Hazel Flores

909-462-4161

Principal Investigator:

Matthew Abinante, MD

More Information

Sponsor

Therma Bright Inc

Last update posted

Jan 11, 2022

Last verified

Dec, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Therma Bright Inc on 2022-01-11.