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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213897
• Other study ID #: FFA-CV19_1006
• Status: Completed
• Start date: January 27, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Freedom For All Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 2 Years to 94 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19

Intervention

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.

Locations

Country	Name	City	State
United States	Centennial Medical	Elkridge	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Freedom For All Diagnostics	CSSi Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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