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

NCT05087524 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-01-28

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Ellen R Wald, MD · UW School of Medicine and Public Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-09
Primary Completion
2021-04-08
Completion
2021-04-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087524 on ClinicalTrials.gov