Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CSSi Life Sciences | INDUSTRY |
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-Self COVID-19 Antigen Home Test | Device | At home COVID-19 antigen test kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Geller, MD | Centennial Medical Group | Principal Investigator |
| Enrique Villa, MD | L&A Morales Healthcare | Principal Investigator |
| Narendra Kini, MD | CDR Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L&A Morales Healthcare, Inc. | Miami | Florida | 33142 | United States | ||
| CDR Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Date of First Enrollment: 12 May 2022 Date of Last Completed: 25 July 2022
The first 50 subjects presenting to the sites for COVID-19 testing were consecutively enrolled (i.e., all comers) including those who were either asymptomatic or symptomatic for COVID-19. Following this enrollment, only subjects who were symptomatic for COVID-19 were enrolled until 30 RT-PCR confirmed positive samples were collected. Then enrollment resumed for all comers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Performance analysis was based on 253 subjects rather than the 282 enrolled due to loss of samples. See Arm/Group Description for more details.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Performance Data Set | In the initial PEUA, the Agency confirmed that the EUA authorized high-sensitivity PerkinElmer New Coronavirus Nucleic Acid Detection Kit was an acceptable RT-PCR comparator for this study. In a follow-up email to the Agency on 18 July 2022, BioTeke asked if the chosen PerkinElmer RT-PCR kit could be utilized with a separately authorized extraction method (i.e., ThermoFisher KingFisher), which had been internally validated by the CLIA laboratory but was not included in the PerkinElmer's Instructions for Use. Of note, the initial subject samples had been tested using this extraction kit. The FDA responded that this would not be an acceptable approach, as the comparator method had to use the authorized extraction method outlined in the manufacturer's authorized instructions. In response to the Agency's decision, the central CLIA testing laboratory, DevLab Bio, internally validated the extraction method using the Chemagic 360 as specified in the PerkinElmer instructions. The intent was to re-test those samples previously tested using the ThermoFisher extraction method and test all future samples using only this authorized process. When preparing to re-test the initial subject samples, it was found that a number of samples had been discarded in error. These samples were not included in the performance analysis. Performance analysis was based on 253 subjects rather than the 282 enrolled. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Symptomatic Subjects | Posted | Number | 95% Confidence Interval | percent probability | 48 hours |
|
24 hours
This study was deemed to have a less than significant risk by IRB assessment, and no sites reported any adverse events during or after the study enrollment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chang Turkmani | BioTeke USA | 202-679-2112 | chang@themegaco.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2022 | Feb 12, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
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].
Not provided
Not provided
Not provided
Not provided
| Standard of Care COVID-19 Test | Device | Standard of care |
|
| RT-PCR Test | Diagnostic Test | High Sensitivity RT-PCR COVID-19 Test |
|
| Tallahassee |
| Florida |
| 32308 |
| United States |
| Centennial Medical | Elkridge | Maryland | 21075 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Symptomatic | Count of Participants | Participants |
|
|
|
| Primary | 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. | Specificity for symptomatic subjects | Posted | Number | 95% Confidence Interval | percent probability | 48 hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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 | 0 | 252 | 0 | 252 | 0 | 252 |
Not provided
Not provided
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |