Trial Outcomes & Findings for Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test (NCT NCT05334758)
NCT ID: NCT05334758
Last Updated: 2024-03-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
282 participants
Primary outcome timeframe
48 hours
Results posted on
2024-03-12
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
252
|
|
Overall Study
COMPLETED
|
30
|
252
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Baseline characteristics by cohort
| Measure |
Performance Data Set
n=253 Participants
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.
|
|---|---|
|
Age, Customized
Age · < 14 years
|
27 Participants
n=5 Participants
|
|
Age, Customized
Age · 14 - 24 years
|
24 Participants
n=5 Participants
|
|
Age, Customized
Age · 25 - 64 years
|
108 Participants
n=5 Participants
|
|
Age, Customized
Age · ≥ 65 years
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
222 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
253 participants
n=5 Participants
|
|
Symptomatic
|
155 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Symptomatic Subjects
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.
Outcome measures
| Measure |
Performance Data Set
n=155 Participants
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.
|
|---|---|
|
Positive Percent Agreement - Sensitivity
|
96.2 percent probability
Interval 87.2 to 99.0
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Specificity for symptomatic subjects
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.
Outcome measures
| Measure |
Performance Data Set
n=155 Participants
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.
|
|---|---|
|
Negative Percent Agreement - Specificity
|
100 percent probability
Interval 96.4 to 100.0
|
Adverse Events
At Least 30 Children Between 2 - 13 Years of Age
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects 14 - 90 Years of Age
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place