COVID SAFE 2.0: COVID-19 Screening Program

Background: The coronavirus disease (COVID-19) pandemic has resulted in close to 300,000,000 reported cases worldwide, including more than 58,000,000 reported cases and 800,000 deaths in the United States [1,2]. Initial efforts to address the COVID-19 pandemic were aimed at testing symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity to meet surge demands [3]. Currently, we are going through an unprecedented surge in the total number of cases - mostly due to the spread of the Omicron variant. While we continue to confront the current crisis, a complete lockdown as seen in 2020 is not desirable or being planned. We must address the current issue and also plan for the future by putting in place tools to enhance our ability to conduct effective screening, containment, and case management. Future variants may cause similar delays in testing availability.

Widespread COVID-19 testing is needed to safely and effectively operate schools, workplaces, and businesses across the US. However, currently approved clinical testing options require reagents that are limited in supply and expensive quantitative polymerase chain reaction (qPCR) machines, severely hindering scalability [4] coupled with acute shortage of person-power. In response to limited clinical testing options, rapid antigen tests that are available to purchase over-the-counter and can be self-administered have become recently a popular testing approach; however, these tests are expensive, in short supply, and may not be as sensitive in detecting Omicron variant compared to polymerase chain reaction (PCR) tests [5]. Emerging evidence indicates that saliva testing with the option of self-administration of testing can accurately identify COVID-19 viral infection [6]. Moreover, this approach provides an option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital, or testing site. Point of care testing (i.e. using saliva-based self-collection to administer screening for COVID-19 in one's own laboratory setting) utilizes testing equipment that is readily available to our workforce, leverages their existing training, and benefits from existing institutional health and safety infrastructure.

Self-administration of saliva testing also reduces exposure of health care workers to the virus and preserves limited personal protective equipment [7]. Additional diagnostic testing options will continue to increase staff access.

For these reasons, we propose to evaluate the implementation of a COVID-19 POC screening program that uses saliva-based self-testing and to pilot test approaches to improve program enrollment.

Objective: The primary objective of the study is to evaluate the use, acceptability, appropriateness, and feasibility of implementing a voluntary COVID-19 Point of Care (POC) screening program with Penn faculty, staff, and trainees that uses saliva-based self-collection followed by testing in their own PSOM laboratories. A secondary objective is to learn about self-reported test results, program usability, user burden, participant experience, program ease, program continuation and availability. Another secondary objective is to learn about individual's perspectives about the program.