Lollipop COVID-19 Testing Study

Study Overview
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Brief Summary
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This study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with PCR testing. The study will be open to enrollment for both children and adults in the Madison community who have at least one COVID-19 symptom that has presented in the last 5 days and who have not had a positive COVID-19 test for a previous illness within the past 3 months. Participants can expect to be in the study for the duration of the swabbing, approximately 10 minutes.

Detailed Description
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This study will test the hypothesis that lollipop swabs are more acceptable to individuals and PCR testing is non-inferior to performing PCR on nasal swabs. To test this hypothesis, the study team will work with local community testing sites to incorporate a lollipop swab for PCR at the time a symptomatic individual receives a nasal swab for PCR that is part of the DHS program. The study will address the following two key questions: Are lollipop swabs more acceptable to individuals when compared to nasal swabs? Will lollipop swabs perform as well as nasal swabs with PCR-based testing? Participants with at least one COVID-19 symptom will be asked to suck on a swab for 20 seconds, like sucking on a lollipop. They then will be asked which COVID-19 PCR testing they would prefer if they had to do the testing again, nasal PCR versus lollipop PCR.

Official Title
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Saliva Testing for SARS-CoV-2 With Lollipop Swab

Conditions
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COVID-19, SARS CoV 2 Infection, COVID-19 Pandemic

Intervention / Treatment
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* Diagnostic Test: Lollipop Swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4 years or above Have at least one COVID-19 symptom that has presented in the last 5 days and will undergo a nasal PCR test at a local community testing site Exclusion Criteria: Positive COVID-19 test in the past 3 months for a previous illness

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: Participants with COVID-19 Symptom(s)<br>Participants 4 years old or older with at least one COVID-19 symptom being tested for the virus | Diagnostic Test: Lollipop Swab<br>* The lollipop swab is a typical swab that would be used to obtain routine pharyngeal samples. Participants are instructed to suck on the swab for 20 second, as they would suck on a lollipop.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Sample Collection Preference | The acceptance of the lollipop swab relative to nasal swab collection will be measured by asking participants which sample collection method they prefer. Count of participants for each sample collection method will be reported. | Day 1 (up to 10 minutes) | 
| Number of Positive COVID-19 Diagnoses | The investigators will compare results of the lollipop swab and nasal swab to assess the efficacy of the lollipop swab to diagnose COVID-19. | Day 1 (up to 10 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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saliva collection