The Utility of "Lollipop" Oral Swabs in the Diagnosis of COVID-19 in an Inpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Sensitivity: True Positive Rate
研究概览
简要总结
This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.
详细描述
This is a prospective quantitative study evaluating the utility of a novel method of saliva collection for COVID-19 testing.
Primary Objective
- To determine the performance characteristics of oral lollipop swabs compared to Nasal Pharyngeal (NP) swabs for diagnosing COVID-19 via PCR molecular testing.
Secondary Objectives
- To identify clinical characteristics of patients when there are discordant results for NP and oral lollipop test results.
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to provide verbal informed consent, if 18 years or older. If 4-17 years old, ability to understand and the willingness to provide verbal assent, plus have a parent or legal guardian present who can provide verbal informed consent.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Admitted to UW Health University Hospital or UW Health Kids American Family Children's Hospital.
- •Individuals at least 4 years of age.
- •Verified COVID-19 according to positive NP PCR test criteria.
- •Enroll within 47 hours of the diagnostic NP swab; lollipop swab collected within 48 hours of the diagnostic NP swab.
- •Either personally able or have a parent or legal guardian able to verbally answer questions in English about clinical symptoms, exposures, and other health and demographic information.
排除标准
- •Unable to suck on a swab.
- •Previous participation in this study.
- •Require translation services for medical care.
- •Not suitable for study participation due to other reasons at the discretion of the investigators or their designee.
结局指标
主要结局
Sensitivity: True Positive Rate
时间窗: 1 study visit (data collected in 20 seconds)
NP vs. lollipop swab-based PCR COVID-19 tests. The True Positive Rate is the number of True Positive test results divided by the number of true positives and false negatives.
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests
时间窗: 1 study visit (data collected in 20 seconds)
Count of tests that detected COVID-19.
次要结局
- Summary of COVID-19 Clinical Characteristics by Participant Count(1 study visit (data collected up to 15 minutes))
- Summary of COVID-19 Clinical Characteristics by Discordant Results(1 study visit (data collected in up to 10 minutes))
- Number of Participants With Discordant Test Results(1 study visit (data collected in 20 seconds))