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

Clinical Performance Evaluation of SARS-CoV-2 Antigen Assay in Point of Care Settings

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.

Study Overview

• Status: Completed
• Conditions: Covid-19
• Intervention / Treatment: Device: SARS-CoV-2 Antigen Assay

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.

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 94 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients experiencing symptoms and presenting for testing of Covid-19.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
30 subjects testing positive for Covid-19; 30 subjects testing positive for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay	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.
30 subjects testing negative for Covid-19; 30 subjects testing negative for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay)	SARS-CoV-2 Antigen investigational assay shall have an observed sensitivity of at least 80% when the EUA SARS-CoV-2 RT-PCR assay for nasopharyngeal swabs is used as a reference method.	48 hours

Collaborators and Investigators

• Sponsor: Freedom For All Diagnostics
• Collaborators: CSSi Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FFA-CV19_1006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No