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

N/AUnknownNCT05119530

Therma Bright Inc300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

COVID-19

Interventions

AcuVid COVID-19 Rapid Antigen Saliva TestDIAGNOSTIC_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

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test

To establish the performance characteristics of the AcuVid COVID-19 Rapid Antigen Saliva Test in a point-of-care (POC) CLIA Waived setting with lay users (no laboratory experience) testing a participant that has self-collected a saliva specimen. Clinical accuracy of the AcuVid Test will be compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the AcuVid Test and the comparator RT-PCR test.

Time frame: 1 day