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

December 21, 2021 updated by: Therma Bright Inc

U.S. POC Study to Evaluate the Performance of the 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 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Modesto, California, United States, 95356
        • Recruiting
        • Covid Clinic Inc.
        • Contact:
          • Hazel Flores
          • Phone Number: 909-462-4161
        • Principal Investigator:
          • Matthew Abinante, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Therma Bright Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 6, 2021

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 11, 2021

First Posted (ACTUAL)

November 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB20-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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