Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings
Completed
Conditions studied: Covid-19
In brief
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.
Key facts
- Study ID
- NCT05213897
- Run by
- Freedom For All Diagnostics
- People needed
- 232
- Starts
- 2022-01-27
- Expected to finish
- 2022-06-01
- Last updated by the study team
- 2022-06-02
Who can join
Age: 2 and older, up to 94. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Centennial Medical — Elkridge, Maryland, United States
Full record on ClinicalTrials.gov
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