Trial Outcomes & Findings for Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test (NCT NCT04904510)
NCT ID: NCT04904510
Last Updated: 2023-02-15
Results Overview
The concordance with the INDICAID COVID-19 Rapid Antigen Test with an EUA PCR test
Recruitment status
COMPLETED
Target enrollment
297 participants
Primary outcome timeframe
Day 1
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
Study Cohort
Participants were recruited from people testing for SARS-CoV-2. Those that met eligibility criteria were recruited. Among those willing to partake in the study, sample specimens were collected to assess the diagnostic device. Those results were compared to an EUA SARS-CoV-2 assay.
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|---|---|
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Overall Study
STARTED
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297
|
|
Overall Study
COMPLETED
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297
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test
Baseline characteristics by cohort
| Measure |
Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test
n=297 Participants
Sample specimens were collected from participants testing for SARS-CoV-2. Results from the diagnostic test were compared to the EUA SARS-CoV-2 assay.
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|---|---|
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Age, Continuous
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32 years
n=5 Participants
|
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Sex: Female, Male
Female
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158 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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231 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
259 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
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Region of Enrollment
United States
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297 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1The concordance with the INDICAID COVID-19 Rapid Antigen Test with an EUA PCR test
Outcome measures
| Measure |
Sample Collection
n=349 Participants
People routinely testing for COVID-19 would have an extra sample collected to assess the diagnostic device.
INDICAID™ COVID-19 Rapid Antigen Test: The diagnostic assay will be compared to a EUA SARS-CoV-2 assay
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|---|---|
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Test Concordance
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85.3 positive percent agreement
Interval 75.6 to 91.6
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Adverse Events
Sample Collection
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