At a glance
ClinicalIndex Comparison RecordN/ACompleted· 282 enrolled
Drug / intervention
Bio-Self COVID-19 Antigen Home Test +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
In Brief
A clinical study evaluating Bio-Self COVID-19 Antigen Home Test, Standard of Care COVID-19 Test, and 1 other intervention for COVID-19. Completed, enrolled 282 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
CollaboratorsCSSi Life Sciences
Timeline
N/ACompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartMay 2022
Primary CompletionJul 2022
TodayJul 2026
First PostedApr 19, 2022
Enrollment StartMay 12, 2022
Primary CompletionJul 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.2 years ago
Interventions
Bio-Self COVID-19 Antigen Home Testdevice
At home COVID-19 antigen test kit
Standard of Care COVID-19 Testdevice
Standard of care
RT-PCR Testother
High Sensitivity RT-PCR COVID-19 Test