N/A
N=282
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05334758 ↗Enrolled (actual)
282
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Positive Percent Agreement - Sensitivity — 96.2 percent probability
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bio-Self COVID-19 Antigen Home Test (Device); Standard of Care COVID-19 Test (Device); RT-PCR Test (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- BioTeke USA, LLC
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Percent Agreement - Sensitivity |
96.2 | — |
| PRIMARY Negative Percent Agreement - Specificity |
100 | — |
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 environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05334758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.