Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: At least 30 children between 2 - 13 years of age Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team. |
Device: Bio-Self COVID-19 Antigen Home Test
At home COVID-19 antigen test kit
Device: Standard of Care COVID-19 Test
Standard of care
Diagnostic Test: RT-PCR Test
High Sensitivity RT-PCR COVID-19 Test
|
| Experimental: Subjects 14 - 90 years of age The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team. |
Device: Bio-Self COVID-19 Antigen Home Test
At home COVID-19 antigen test kit
Device: Standard of Care COVID-19 Test
Standard of care
Diagnostic Test: RT-PCR Test
High Sensitivity RT-PCR COVID-19 Test
|
Outcome Measures
Primary Outcome Measures
- Positive Percent Agreement [48 hours]
comparison between the Bio-Self Test and the RT-PCR Test results
- Negative Percent Agreement [48 hours]
comparison between the Bio-Self Test and the RT-PCR Test results
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- BioTeke USA, LLC
- CSSi Life Sciences
Investigators
- Principal Investigator: Steven Geller, MD, Centennial Medical Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BTK-01-1002