Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 3:05 AM
Study NCT ID:
NCT05334758
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2022-04-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Sponsor:
BioTeke USA, LLC
Organization:
Study Overview
Official Title:
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.
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 epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals ages 2 to 13.
The primary objective of this study is to determine the accuracy of the Bio-Self COVID-19 Antigen Home Test when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.
The primary objective of this study is to determine the accuracy of the Bio-Self COVID-19 Antigen Home Test when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: