Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Completed · Not applicable
Conditions studied: COVID-19
In brief
The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.
Key facts
- Study ID
- NCT05334758
- Run by
- BioTeke USA, LLC
- People needed
- 282
- Starts
- 2022-05-12
- Expected to finish
- 2022-07-25
- Last updated by the study team
- 2024-03-12
Who can join
Age: 2 and older, up to 94. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- An Institutional Review Board (IRB) approved informed consent and assent, if applicable, is signed and dated prior to any study-related activities.
- Male and female Subjects 2 years of age and older.
- Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)
- Subject is willing to have a nasal swab collected by a healthcare professional.
- Subject agrees to complete all aspects of the study.
You may not qualify if…
- Subject has a visual impairment that cannot be restored with glasses or contact lenses.
- Subject has prior medical or laboratory training.
- Subject had a positive COVID-19 test in past three (3) months.
- Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.
Where it is running
- L&A Morales Healthcare, Inc. — Miami, Florida, United States
- CDR Health — Tallahassee, Florida, United States
- Centennial Medical — Elkridge, Maryland, United States
Full record on ClinicalTrials.gov
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