Feasibility and Specificity of BinaxNOW for Diagnosis and Surveillance of Infection With SARS-CoV-2 in Schoolchildren
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Tests Taken Per Participant
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Children < 5 years or > 16 years
- •Teachers and other school staff < 20 years or > 65 years
研究组 & 干预措施
BinaxNOW Surveillance
Participants 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. Madison Metropolitan School District (MMSD) has obtained a Clinical Laboratory Improvement Amendments (CLIA) waiver for collection of samples. When there is a positive test, a saliva sample will be collected for testing with a standard polymerase chain reaction (PCR) method. The standard PCR samples will be processed at University of Wisconsin (UW) Clinical Laboratory.
干预措施: BinaxNOW Ag Card (Diagnostic Test)
结局指标
主要结局
Number of Tests Taken Per Participant
时间窗: 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
时间窗: up to 5 weeks
The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing.
次要结局
未报告次要终点