Feasibility and Specificity of BinaxNOW for Diagnosis and Surveillance of Infection With SARS-CoV-2 in Schoolchildren
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- Number of Tests Taken Per Participant
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Number of Tests Taken Per Participant
Time Frame: 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
Time Frame: up to 5 weeks
The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing.
Secondary Outcomes
No secondary outcomes reported