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

Sponsor
Freedom For All Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT05213897
Collaborator
CSSi Life Sciences (Industry)
232
1
4.1
56.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
232 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Performance Evaluation of SARS-CoV-2 Antigen Assay in Point of Care Settings
Actual Study Start Date :
Jan 27, 2022
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay) [48 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 94 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centennial Medical Elkridge Maryland United States 21075

Sponsors and Collaborators

  • Freedom For All Diagnostics
  • CSSi Life Sciences

Investigators

  • Principal Investigator: Steven Geller, MD, Centennial Medical Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Freedom For All Diagnostics
ClinicalTrials.gov Identifier:
NCT05213897
Other Study ID Numbers:
  • FFA-CV19_1006
First Posted:
Jan 28, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022