Feasibility and Specificity of BinaxNOW for Diagnosis and Surveillance of Infection With SARS-CoV-2 in Schoolchildren
Phase: NA
Conditions: SARS-CoV2 Infection, COVID-19
Sponsor: University of Wisconsin, Madison

Feasibility and Specificity of BinaxNOW for Diagnosis and 
Surveillance of Infection with SARS-CoV-2 in Schoolchildren 
UW-Madison Health Sciences IRB #2020-1521 
ClinicalTrials.gov NCT05087524 
Protocol Version 2.0, March 4, 2021 
A. Background 
  The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 
virus, is a worldwide pandemic that has resulted in large scale quarantines 
in cities, states and countries throughout the world. SARS-CoV-2 is a 
respiratory virus that is most commonly spread via contact with infective 
respiratory droplets and aerosols produced by coughing, sneezing, talking, 
and singing. Daycare centers and schools are known to be locations with 
high burdens of viral respiratory tract infections associated with horizontal 
transmission of infection to the children, teachers and their attendants. The 
role which children in daycare centers and schools play in the transmission 
of COVID-19 to each other as well as their parents and day care workers is 
unknown.  Furthermore, the most effective strategies to limit those 
infections and thereby maintain children and their teachers/daycare 
workers within their educational setting and their parents at their place of 
employment have not been studied.  
Disparities in health outcomes. Disparities in health outcomes to COVID-
19 in minority populations have become evident in the United States. The 
burden of disease, both morbidity and mortality, experienced by Hispanics 
and Blacks has far exceeded their proportion in the general population. The 
CDC and other groups report that there are more COVID-19 cases, 
hospitalizations, and deaths in areas where racial and ethnic minority 
groups live and that community strategies to slow the spread of COVID-19 
may cause unintentional harm, such as lost wages, reduced access to 
services, and increased stress for some racial and ethnic minority groups 
Role of School Children.  In most early investigations, the source of 
family outbreaks has been the adult members of the household.  However, 
schools/daycares were closed very early as a reflexive response to the 
pandemic in most locations. Accordingly, the question regarding children 
has been, in large part, whether they will be a source of infection for each 

other, their parents, teachers and daycare workers, therefore exerting a 
multiplier effect on the proportions of the pandemic. 
The two-fold importance of daycare and school attendance. The 
importance of the availability of school and daycare to the ability to re-open 
the economy cannot be overemphasized. A substantial portion of the front-
line work force, including both health care personnel and other essential 
workers, have families with children of school or pre-school age. 
Furthermore, the contributions of school attendance to the overall well- 
being of the physical and mental health of children in addition to their 
nutrition, guidance, emotional support, socialization and education is 
universally recognized. 
Current strategies for prevention of infection in schools. Current 
strategies for the prevention of infection both in and outside of schools 
have included physical distancing, use of face masks, frequent 
handwashing and self-exclusion at the sign/symptoms of even minor 
illness. One of the difficulties imposed by infection with SARS-CoV-2 has 
been the consistent demonstration that transmission of infection precedes 
the development of symptoms, thereby allowing the “silent” transmission of 
infection in most cases even before the onset of symptoms. In addition, 
many children infected by SARS-CoV-2 are completely asymptomatic but 
nevertheless very effectively transmit the virus. Therefore, the key to 
maintaining attendance at school and daycare is rapid identification of 
both symptomatic and asymptomatic children, teachers and other 
school staff for exclusion.    Many respiratory infections in the coming 
respiratory season will not be caused by SARS-CoV-2 but rather by other 
common respiratory viruses.  Therefore, prompt diagnostic testing will be 
the key to documenting that children with mild respiratory symptoms, 
usually not qualifying for exclusion from school, actually do NOT have 
SARS-CoV-2 but rather another more benign respiratory viral infection.  
 
BinaxNOW Covid-19 Ag Card. The means to rapidly identify and exclude 
symptomatic and asymptomatic children, teachers and other school staff 
from the classroom is potentially available as a rapid, easy to perform, 
relatively inexpensive test called BinaxNOW Covid-19 Ag Card 
manufactured by Abbott. The Food and Drug Administration (FDA) has 

granted emergency use authorization for this test.  We are requesting a 
Non-Significant Risk determination from the IRB for its use in this study, 
which is going to be outside of the EUA's indications. It works with a nasal 
swab sample and a credit card sized reactive card to detect the 
nucleocapsid protein antigen from SARS-CoV-2 (using a lateral flow assay) 
and results are available in 15 minutes. The emergency use authorization 
is for use of the BinaxNow Covid-19 card for symptomatic adult patients 
within 7 days of the onset of their illness. There is very good reason to 
believe that this technology will be effective in creating “safe schools”, 
however, there are no data to prove that.  The ‘cards’ have been reported 
to be reasonably sensitive (85 to 95% as sensitive as polymerase chain 
assays for the spike protein of the virus) but have not been tested in 
children or broadly in the US. Accordingly, we are proposing a two-step 
investigation to establish the effectiveness of a strategy built on the 
availability of both diagnostic testing of symptomatic individuals and 
screening twice weekly of asymptomatic children and teachers.  In step 1, 
we will demonstrate the feasibility and specificity of using BinaxNOW in 
school children and their teachers.  In step 2, we will demonstrate the 
effectiveness of this strategy in maximizing school/work attendance for 
children and families receiving this intervention compared to students and 
teachers for whom this intervention is not available.     
 
Purpose and Research Goal 
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).   
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 
We 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 COVID19 cards for 
diagnosis and surveillance of infection with SARS-CoV-2 in teachers, other 
school staff, and school children.  
The specific aims are to determine: 
a. 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 with symptoms compatible with a 
diagnosis of COVID-19.  
b. 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. 
c. 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.  
We propose to implement STEP 1 now as a pilot study and STEP 2 at a 
later date. 
B. Methods for STEP 1. 
240 students and 80 teachers/other school staff will be recruited from 
schools within the Madison Metropolitan School District.  The schools 
will email families and teachers a letter explaining the study and 
inviting them to participate in a virtual information session which 

includes a question answer opportunity. The virtual information 
sessions will describe the process of sample collection so that 
students and teachers know what to expect. If parents, teachers and 
other school staff are interested in enrolling in the study, they can 
contact the school at which time they will be asked if they agree to 
have study staff contact them.  Research personnel will not directly 
contact parents, students, teachers or other school staff regarding 
initial recruitment for the study.  All subjects 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. The Madison Metropolitan School District has obtained a 
CLIA waiver for collection of samples. When there is a positive test, a 
saliva sample will be collected for testing with a standard PCR 
method. The standard PCR samples will be processed at UW Clinical 
Laboratory. 
 
All subjects will be followed for 8 weeks. Children and staff will not receive 
compensation for their participation in the study. Subjects are free to 
withdraw from the study at any time. 
 
At the conclusion of this portion of the study, we will understand the 
feasibility and specificity of the testing procedures.  
Data Collection: 
We will collect the following data elements from subjects; name, address, 
date of birth, and gender.  
Confidentiality 
Electronic data will be stored in a password protected database on a 
password protected server.  Subjects will receive a study ID. The key code 
linking the subject’s name and study ID will be stored separately on the 
Department of Pediatrics password protected server and only available to 
research staff. Samples sent to the UW Clinical Laboratory will be labeled 
with the subject/study ID, date of birth and date of collection. 
 
 
 

Reporting of test results 
Research personnel who are on site at the schools will report positive 
results from the BinaxNOW test to the subjects.  School nurses will then 
notify parents of positive results immediately by phone and offer 
information about available resources, next steps and respond to 
questions. 
In accordance with the Wisconsin Department of Health infectious disease 
reporting requirements, research staff will notify the local health office 
immediately with all positive results.  In addition to the immediate report, 
research staff will complete and submit a case report form within 24 hours 
of a positive result. 
The standard PCR samples that are processed at UW Clinical Laboratory 
will be labeled with a subject ID, date of birth and date of collection. The 
UW Clinical Laboratory will report positive test results to research staff who 
will then notify the school nurse.