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Feasibility and Specificity of BinaxNOW for Diagnosis and Surveillance of Infection With SARS-CoV-2 in Schoolchildren
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.
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).
Age
5 - 65 years
Sex
ALL
Healthy Volunteers
Yes
University of Wisconsin
Madison, Wisconsin, United States
Start Date
January 9, 2021
Primary Completion Date
April 8, 2021
Completion Date
April 8, 2021
Last Updated
January 28, 2022
65
ACTUAL participants
BinaxNOW Ag Card
DIAGNOSTIC_TEST
Lead Sponsor
University of Wisconsin, Madison
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287