Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
NCT ID: NCT05334758
Last Updated: 2024-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2022-05-12
2022-07-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Bio-Self COVID-19 Antigen Home Test
At home COVID-19 antigen test kit
Standard of Care COVID-19 Test
Standard of care
RT-PCR Test
High Sensitivity RT-PCR COVID-19 Test
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.
Bio-Self COVID-19 Antigen Home Test
At home COVID-19 antigen test kit
Standard of Care COVID-19 Test
Standard of care
RT-PCR Test
High Sensitivity RT-PCR COVID-19 Test
Interventions
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Bio-Self COVID-19 Antigen Home Test
At home COVID-19 antigen test kit
Standard of Care COVID-19 Test
Standard of care
RT-PCR Test
High Sensitivity RT-PCR COVID-19 Test
Eligibility Criteria
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Inclusion Criteria
2. Male and female Subjects 2 years of age and older.
3. 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.)
4. Subject is willing to have a nasal swab collected by a healthcare professional.
5. Subject agrees to complete all aspects of the study.
Exclusion Criteria
2. Subject has prior medical or laboratory training.
3. Subject had a positive COVID-19 test in past three (3) months.
4. Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.
2 Years
94 Years
ALL
Yes
Sponsors
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CSSi Life Sciences
INDUSTRY
BioTeke USA, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Geller, MD
Role: PRINCIPAL_INVESTIGATOR
Centennial Medical Group
Enrique Villa, MD
Role: PRINCIPAL_INVESTIGATOR
L&A Morales Healthcare
Narendra Kini, MD
Role: PRINCIPAL_INVESTIGATOR
CDR Health
Locations
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L&A Morales Healthcare, Inc.
Miami, Florida, United States
CDR Health
Tallahassee, Florida, United States
Centennial Medical
Elkridge, Maryland, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BTK-01-1002
Identifier Type: -
Identifier Source: org_study_id
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