COVID-19NCT05334758

Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test

A study testing Bio-Self COVID-19 Antigen Home Test and RT-PCR Test in people with COVID-19, run by BioTeke USA, LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 to 94 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Bio-Self COVID-19 Antigen Home Test and RT-PCR Test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 282 participants
Where: 3 sitesUnited States
Study dates: 12 May 2022to 25 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 94 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Centennial Medical
Elkridge, Maryland, 21075
L&A Morales Healthcare, Inc.
Miami, Florida, 33142
CDR Health
Tallahassee, Florida, 32308

Other trials in United States

About this study

Read the 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.

Conditions: COVID-19
Being tested: Bio-Self COVID-19 Antigen Home Test, Standard of Care COVID-19 Test, RT-PCR Test
Keywords: Covid, Covid 19, Virus
Medical subject headings: COVID-19, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 TestDiagnostic test
High Sensitivity RT-PCR COVID-19 Test

Study groups in NCT05334758
Study group	Role	What they receive
At least 30 children between 2 - 13 years of age	Experimental	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. Receives: Device: Bio-Self COVID-19 Antigen Home Test; Device: Standard of Care COVID-19 Test; Diagnostic Test: RT-PCR Test
Subjects 14 - 90 years of age	Experimental	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. Receives: Device: Bio-Self COVID-19 Antigen Home Test; Device: Standard of Care COVID-19 Test; Diagnostic Test: RT-PCR Test

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive Percent Agreement - Sensitivity
The sensitivity is computed as the proportion of positive samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also positive as called by the Bio-Self COVID-19 Antigen Home Test.
Measured: 48 hours
Negative Percent Agreement - Specificity
The specificity is computed as the proportion of negative samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also negative as called by the Bio-Self COVID-19 Antigen Home Test.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 202225 Jul 2022

First posted19 Apr 2022
Study start12 May 2022
Primary completion25 Jul 2022
Study completion25 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
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 \[(NPA) specificity\].
Masking: None (open label)
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05334758
Sponsor's protocol ID: BTK-01-1002
Status last verified: Mar 2024
First submitted: 15 Apr 2022
Last updated: 12 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
ClinicalTrials.gov ID: NCT05334758
Acronym / sponsor ID: BTK-01-1002
Conditions: COVID-19
Keywords: Covid, Covid 19, Virus
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: BioTeke USA, LLCIndustry (pharma, biotech, devices)
Collaborators: CSSi Life Sciences
Study start: 12 May 2022 (actual)
Primary completion: 25 Jul 2022 (actual)
Study completion: 25 Jul 2022 (actual)
First posted: 19 Apr 2022 (actual)
Results: Posted 12 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
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].

Arm	Type	Receives
At least 30 children between 2 - 13 years of age	Experimental	Device: Bio-Self COVID-19 Antigen Home Test, Device: Standard of Care COVID-19 Test, Diagnostic Test: RT-PCR TestSubjects 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.
Subjects 14 - 90 years of age	Experimental	Device: Bio-Self COVID-19 Antigen Home Test, Device: Standard of Care COVID-19 Test, Diagnostic Test: RT-PCR TestThe 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.

Who may qualify

Ages: 2 to 94 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bio-Self COVID-19 Antigen Home TestAt home COVID-19 antigen test kit	Device	At least 30 children between 2 - 13 years of age, Subjects 14 - 90 years of age
Standard of Care COVID-19 TestStandard of care	Device	At least 30 children between 2 - 13 years of age, Subjects 14 - 90 years of age
RT-PCR TestHigh Sensitivity RT-PCR COVID-19 Test	Diagnostic test	At least 30 children between 2 - 13 years of age, Subjects 14 - 90 years of age

Primary outcome

Positive Percent Agreement - Sensitivity
Time frame: 48 hours
The sensitivity is computed as the proportion of positive samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also positive as called by the Bio-Self COVID-19 Antigen Home Test.
Negative Percent Agreement - Specificity
Time frame: 48 hours
The specificity is computed as the proportion of negative samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also negative as called by the Bio-Self COVID-19 Antigen Home Test.

Results and safety

Results posted to the registry on 12 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
At Least 30 Children Between 2 - 13 Years of Age	30	30
Subjects 14 - 90 Years of Age	252	252

Primary outcome: Positive Percent Agreement - Sensitivity

Time frame: 48 hours. Number (95% Confidence Interval). Unit: percent probability

Measure	Performance Data Set n = 155
Value	96.2 (87.2 to 99)

Population analysed: Symptomatic Subjects

Primary outcome: Negative Percent Agreement - Specificity

Time frame: 48 hours. Number (95% Confidence Interval). Unit: percent probability

Measure	Performance Data Set n = 155
Value	100 (96.4 to 100)

Population analysed: Specificity for symptomatic subjects

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
At Least 30 Children Between 2 - 13 Years of Age	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Subjects 14 - 90 Years of Age	0 of 252 (0%)	0 of 252 (0%)	0 of 252

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Geller, MD principal investigator

Centennial Medical Group

Enrique Villa, MD principal investigator

L&A Morales Healthcare

Narendra Kini, MD principal investigator

CDR Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bio-Self COVID-19 Antigen Home Test and RT-PCR Test in people with COVID-19, run by BioTeke USA, LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Percent Agreement - Sensitivity (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05334758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.