COVID-19, SARS-CoV2 Infection
Conditions
Keywords
diagnostic, diagnosis, schools, BinaxNOW, surveillance
Brief summary
This is a study of the BinaxNOW Covid-19 Ag Card as a method to rapidly identify SARS-CoV-2 infection in asymptomatic children, teachers, and other school staff for exclusion. 240 students and 80 teachers in the Madison Metropolitan School District (MMSD) will be enrolled and can expect to be on study for up to 8 weeks.
Detailed description
The overall purpose and research goal of this project is to understand how the virus SARS-CoV-2 is spread in the K-8 setting, decrease secondary cases of COVID-19, improve attendance and educational opportunities for children, teachers and other school staff, and decrease time away from work for parents (with threat of loss of employment and other benefits). The investigators hypothesize that prompt diagnostic testing for SARS-CoV-2 in symptomatic children and twice weekly surveillance of asymptomatic children (with appropriate exclusion of children with positive tests) will be effective as a strategy to achieve maximum attendance in school and minimal disruption of the associated workforce. STEP 1: Determine feasibility of using BinaxNOW COVID-19 cards for surveillance of infection with SARS-CoV-2 in teachers, other school staff, and school children. The specific aims are to determine: * if it is feasible to obtain nasal samples to be used with the BinaxNOW COVID-19 for diagnosis of COVID-19 in children or teachers/other school staff. * if it is feasible to obtain nasal samples twice weekly to be used with BinaxNOW COVID-19 for surveillance of infection with SARS-CoV-2. * The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing. STEP 2: Determine effectiveness of prompt diagnostic testing and twice weekly surveillance for SARS-CoV-2 among children and school faculty/staff to reduce the rate of positive cases (symptomatic) of COVID-19 in an elementary school setting resulting in an ultimate decrease in absenteeism for students and an increase in attendance for their parents at the workplace. This is a record of the pilot study (STEP 1).
Interventions
DIAGNOSTIC_TESTBinaxNOW 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 5 - 15 years inclusive * Currently attending school K-8 at one of the designated schools of the Madison Metropolitan School District * Teachers and other school staff aged 20-65 years
Exclusion criteria
* Children \< 5 years or \> 16 years * Teachers and other school staff \< 20 years or \> 65 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tests Taken Per Participant | up to 8 weeks | 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. |
| Number of Positive SARS-CoV-2 BinaxNOW Tests Confirmed by PCR Testing | up to 5 weeks | The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing. |
Countries
United States
Participant flow
Recruitment details
Madison Metropolitan School District (MMSD) Student and Staff Participants were enrolled from January to April 2021.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | BinaxNOW Surveillance | — |
|---|---|---|
| Age, Categorical <=18 years | 22 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 43 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 65 participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Positive SARS-CoV-2 BinaxNOW Tests Confirmed by PCR Testing
The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing.
Time frame: up to 5 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BinaxNOW Surveillance | Number of Positive SARS-CoV-2 BinaxNOW Tests Confirmed by PCR Testing | 0 positive tests |
Primary
Number of Tests Taken Per Participant
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.
Time frame: up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BinaxNOW Surveillance | Number of Tests Taken Per Participant | 5.11 tests taken | Standard Deviation 2.56 |