Inpatient COVID-19 Lollipop Study

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

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.

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.

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.