NCT05472077

Lollipop COVID-19 Testing Study

Saliva Testing for SARS-CoV-2 With Lollipop Swab

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. Are lollipop swabs more acceptable to individuals when compared to nasal swabs? 2. 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.

Conditions

• COVID-19
• SARS CoV 2 Infection
• COVID-19 Pandemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lollipop Swab	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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-07-25
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study