Clinical trial NCT05334758: Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Official title: Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Covid, Covid 19, Virus
Lead sponsor: BioTeke USA, LLC
Sponsor class: INDUSTRY
Collaborators: name: CSSi Life Sciences
First posted: 2022-04-19
Enrollment: 282
Sex: ALL
Minimum age (years): 2
Maximum age (years): 94
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label, prospective study to evaluate the sensitivity and specificity of the Bio-Self COVID-19 Antigen Home Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the performance of the Bio-Self COVID-19 Antigen Home Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement \[(PPA) sensitivity\] and negative percent agreement \[(NPA) specificity\].
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. An Institutional Review Board (IRB) approved informed consent and assent, if applicable, is signed and dated prior to any study-related activities.
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:

1. Subject has a visual impairment that cannot be restored with glasses or contact lenses.
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.

Primary outcomes:
measure: Positive Percent Agreement - Sensitivity
timeFrame: 48 hours
measure: Negative Percent Agreement - Specificity
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: L&A Morales Healthcare, Inc.
state: Florida
city: Tallahassee
country: United States
facility: CDR Health
state: Florida
city: Elkridge
country: United States
facility: Centennial Medical
state: Maryland
Study officials:
affiliation: Centennial Medical Group
name: Steven Geller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: L&A Morales Healthcare
name: Enrique Villa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CDR Health
name: Narendra Kini, MD
role: PRINCIPAL_INVESTIGATOR
References: