NCT05087524

BinaxNOW for Evaluating Children for Infection With SARS-CoV-2 (COVID-19)

Feasibility and Specificity of BinaxNOW for Diagnosis and Surveillance of Infection With SARS-CoV-2 in Schoolchildren

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• SARS-CoV2 Infection
• COVID-19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-01-09
• Primary completion: 2021-04-08
• Completion: 2021-04-08
• First posted: 2021-10-21
• Last updated: 2022-01-28
• Results posted: 2022-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study