Trial Outcomes & Findings for BinaxNOW for Evaluating Children for Infection With SARS-CoV-2 (COVID-19) (NCT NCT05087524)
NCT ID: NCT05087524
Last Updated: 2022-01-28
Results Overview
Feasibility BinaxNOW surveillance testing will be measured by the number of test taken per participant. Greater than 1 test per participant is an indicator of compliance with repeat surveillance testing.
TERMINATED
NA
65 participants
up to 8 weeks
2022-01-28
Participant Flow
Madison Metropolitan School District (MMSD) Student and Staff Participants were enrolled from January to April 2021.
Participant milestones
| Measure |
BinaxNOW Surveillance
Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting. MMSD has obtained a Clinical Laboratory Improvement Amendments (CLIA) waiver for collection of samples. When there is a positive test, a saliva sample will be collected for testing with a standard polymerase chain reaction (PCR) method. The standard PCR samples will be processed at University of Wisconsin (UW) Clinical Laboratory.
BinaxNOW Ag Card: A nasal swab specimen is collected from the participant, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The participant sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines.
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|---|---|
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Overall Study
STARTED
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65
|
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Overall Study
COMPLETED
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65
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BinaxNOW Surveillance
n=65 Participants
Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting.
|
|---|---|
|
Age, Categorical
<=18 years
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22 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
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43 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=65 Participants
|
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Region of Enrollment
United States
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65 participants
n=65 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksFeasibility BinaxNOW surveillance testing will be measured by the number of test taken per participant. Greater than 1 test per participant is an indicator of compliance with repeat surveillance testing.
Outcome measures
| Measure |
BinaxNOW Surveillance
n=65 Participants
Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting.
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|---|---|
|
Number of Tests Taken Per Participant
|
5.11 tests taken
Standard Deviation 2.56
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PRIMARY outcome
Timeframe: up to 5 weeksThe specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing.
Outcome measures
| Measure |
BinaxNOW Surveillance
n=65 Participants
Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting.
|
|---|---|
|
Number of Positive SARS-CoV-2 BinaxNOW Tests Confirmed by PCR Testing
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0 positive tests
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Adverse Events
BinaxNOW Surveillance
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