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

Status unconfirmed

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05119530

Run by

Therma Bright Inc

People needed

300

Starts

2021-12-06

Expected to finish

2022-01-01

Last updated by the study team

2022-01-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Covid Clinic Inc. — Modesto, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.