Status:
COMPLETED
Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings
Lead Sponsor:
Freedom For All Diagnostics
Collaborating Sponsors:
CSSi Life Sciences
Conditions:
Covid-19
Eligibility:
All Genders
2-94 years
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-sensit...
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 demonstr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT05213897
Start Date
January 27 2022
End Date
June 1 2022
Last Update
June 2 2022
Active Locations (1)
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1
Centennial Medical
Elkridge, Maryland, United States, 21075