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

Therma Bright

Status: Unknown

Conditions: COVID-19

Treatments: Diagnostic Test: AcuVid COVID-19 Rapid Antigen Saliva Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05119530

TB20-03

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.