COVID-19, COVID-19 Pandemic, SARS CoV 2 Infection
Conditions
Keywords
saliva collection
Brief 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.
Interventions
DIAGNOSTIC_TESTLollipop 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Sample Collection Preference | Day 1 (up to 10 minutes) | 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. |
| Number of Positive COVID-19 Diagnoses | Day 1 (up to 10 minutes) | The investigators will compare results of the lollipop swab and nasal swab to assess the efficacy of the lollipop swab to diagnose COVID-19. |
Countries
United States
Outcome results
None listed