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Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings

NCT05213897 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2022-06-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.

Conditions

Interventions

DEVICE

SARS-CoV-2 Antigen Assay

To demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity and specificity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples.

Sponsors & Collaborators

  • CSSi Life Sciences

    collaborator INDUSTRY

  • Freedom For All Diagnostics

    lead INDUSTRY

Principal Investigators

  • Steven Geller, MD · Centennial Medical Group

Eligibility

Min Age
2 Years
Max Age
94 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05213897 on ClinicalTrials.gov