Status:
COMPLETED
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Lead Sponsor:
BioTeke USA, LLC
Collaborating Sponsors:
CSSi Life Sciences
Conditions:
COVID-19
Eligibility:
All Genders
2-94 years
Phase:
NA
Brief Summary
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 environm...
Detailed Description
The Bio-Self COVID-19 Antigen Home Test is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen from individuals with or without symptoms or other epidemiologica...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT05334758
Start Date
May 12 2022
End Date
July 25 2022
Last Update
March 12 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
L&A Morales Healthcare, Inc.
Miami, Florida, United States, 33142
2
CDR Health
Tallahassee, Florida, United States, 32308
3
Centennial Medical
Elkridge, Maryland, United States, 21075