Inpatient COVID-19 Lollipop Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Utility of Lollipop Oral Swabs in the Diagnosis of COVID-19 in an Inpatient Setting

Conditions
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COVID-19, Diagnostic Test

Intervention / Treatment
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* Device: Lollipop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 Positive Children<br>Determined by NP PCR test | Device: Lollipop<br>* An oral lollipop swab will be obtained by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop<br>* Other names: Lollipop collection swab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity: True Positive Rate | 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. Subgroup analysis of sensitivity of lollipop swabs will be calculated for asymptomatic, symptomatic (<7 days), and symptomatic (>7 days) individuals. | 1 study visit (data collected in 20 seconds) | 
| Specificity: True Negative Rate | NP vs. lollipop swab-based PCR COVID-19 tests. The True Negative Rate is the number of true negative test results divided by the number of true negative and false positives. Subgroup analysis of specificity of lollipop swabs will be calculated for asymptomatic, symptomatic (<7 days), and symptomatic (>7 days) individuals. | 1 study visit (data collected in 20 seconds) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with discordant test results | A correlation of clinical characteristics to participants with discordant test results will be analyzed to better understand the efficacy of the diagnostic test. | 1 study visit (data collected in 20 seconds) |