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

NCT ID: NCT05213897

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2022-06-01

Brief 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.

Detailed Description

The objective of this study is 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 when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples. This study is designed as a prospective, blinded study to evaluate the sensitivity and specificity of the SARS-CoV-2 Antigen Assay when non-laboratory personnel conduct testing on Subjects presenting with symptoms of COVID-19.

A minimum of 30 positive and 30 negative samples are required in order to meet EUA submission guidelines. Enrollment will continue until both minimum requirements have been achieved.

Conditions

Covid-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

30 subjects testing positive for Covid-19

30 subjects testing positive for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay

SARS-CoV-2 Antigen Assay

Intervention Type: DEVICE

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.

30 subjects testing negative for Covid-19

30 subjects testing negative for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay

SARS-CoV-2 Antigen Assay

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject suspected of having COVID-19 infection and within 7 days of symptom onset. This will include at least one of the following:

• Fever or chills
• Cough
• Shortness of breath or difficulty breathing
• Fatigue
• Muscle or body aches
• Headache
• New loss of taste or smell
• Sore throat
• Congestion or runny nose
• In addition to the above primary symptoms, the Subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the Subject in the study.
• Subject is willing to provide consent/assent.
• Subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs

Exclusion Criteria

To be enrolled in the study, each Subject must not meet:

• Subject unable or unwilling to provide informed consent/assent.
• Subject tested positive for SARS-CoV-2 within the past 3 months.
• Subject has already participated in this study.
• Subject is a vulnerable population and deemed inappropriate for study by site Principal Investigator and/or IRB.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 94 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSSi Life Sciences

INDUSTRY

Sponsor Role: collaborator

Freedom For All Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Geller, MD

Role: PRINCIPAL_INVESTIGATOR

Centennial Medical Group

Locations

Centennial Medical

Elkridge, Maryland, United States

Countries

United States

Other Identifiers

FFA-CV19_1006

Identifier Type: -

Identifier Source: org_study_id