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

NCT05119530 | Unknown

• 1 other identifier: TB20-03
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Interventions

AcuVid COVID-19 Rapid Antigen Saliva Test DIAGNOSTIC_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 Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will come from individuals visiting COVID-19 testing Centers for the purpose of obtaining a COVID-19 RT-PCR test results. Individuals will be approached to determine eligibility and obtain consent after they have provided a NP swab sample for their COVID-19 RT-PCR test.

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.

Sponsors & Collaborators

• Therma Bright Inc: lead

Study Sites (1)

Covid Clinic Inc.

Modesto, California, 95356, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Hazel Flores

CONTACT

909-462-4161; hazel@covidclinic.org

Angela Hall

CONTACT

949-287-8191; angela@covidclinic.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 15, 2021
• Study Start: December 6, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)