Inpatient COVID-19 Lollipop Study

Not Applicable

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
COVID-19 Positive Participants	Lollipop	Determined by NP PCR test

Primary Outcome Measures

Name	Time	Method
Sensitivity: True Positive Rate	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	1 study visit (data collected in 20 seconds)	Count of tests that detected COVID-19.

Secondary Outcome Measures

Name	Time	Method
Summary of COVID-19 Clinical Characteristics by Participant Count	1 study visit (data collected up to 15 minutes)	Count of participants who were: asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.
Summary of COVID-19 Clinical Characteristics by Discordant Results	1 study visit (data collected in up to 10 minutes)	Of those with discordant results, how many were asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, or reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.
Number of Participants With Discordant Test Results	1 study visit (data collected in 20 seconds)	All participants were confirmed COVID-19 positive by nasal-swab PCR test to be eligible for this study. Participants all took a COVID-19 test via lollipop-swab. Reported here are the number of participants who did not test positive for COVID-19 via the lollipop-swab device (discordant results).