First, Ebola virus disease and now, COVID-19, demonstrate unequivocally the need for, and value of point-of-care testing. Starting from several pandemic papers published in the Archives of Pathology and Laboratory Medicine, this lecture leaps to the future of a new field, onsite practitioners, and global solutions. Together, we will journey along a roadmap of performance expectations and point-of-care strategies that will deal with the next crisis swiftly and effectively.

In this talk I will present a novel ultrasensitive SARS-CoV-2 antigen detection technology and device that is developed and validated in my laboratory at University of Pennsylvania. The Microbubbling Digital Antigen Assay can detect as few as 8-9 SARS-CoV-2 viral copies/reaction, demonstrating analytical sensitivity comparable to many rRT-PCR methods and high specificity towards SARS-CoV-2. The Microbubbling Digital Antigen Assay demonstrated high clinical sensitivity and specificity in both symptomatic and asymptomatic individuals early in the infection course.

Qorvo Biotechnologies aims to bring a unique approach to the diagnostic landscape. Using high volume Bulk Acoustic Wave (BAW) technology (in billions of mobile phones globally), the Omnia^TM platform is designed to facilitate the delivery of central laboratory performance in a point-of-care setting. This talk will present the background technology and discuss the COVID-19 antibody and antigen product development and what it presents to aid in the national testing strategy

In this short talk, we will discuss the opportunity afforded by the use of COVID-19 point of care diagnostics in the emergency department and acute episodic care settings. We will highlight barriers and facilitators to their implementation and will highlight a successful implementation and workflow considerations for COVID-19 POCT in a large academic setting. Finally, we will discuss how POCT might address remaining gaps in diagnostics for POCT in COVID-19.

This presentation will discuss ultrafast PCR system that we have developed for COVID-19 diagnosis. Based on a novel heating method, this system enables RT-PCR within 12 minutes, enabling point-of-care, onsite tests.

The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program has funded over 70 projects across the U.S. to overcome barriers to COVID-19 testing in communities most affected by the pandemic. Key to the success of these projects is a coordinated approach to data collection, testing selection, and approaches to community engagement. Learn how the coordination of these activities and the leveraging of local partnerships can serve as a model for advancing diagnostics both during and after the pandemic.

The pandemic highlighted the need for diagnostic test cartridges being developed and brought to market in a short amount of time. How has it been possible to speed up the development and commercialization of tests and how to apply this to your consumable project. 

Whether to guide treatment of an individual’s infection, to monitor an ongoing pandemic, or to prevent the next one, “ubiquitous diagnostics” based on paper microfluidics can bring laboratory-grade diagnostic capabilities to homes. We are developing a simple low-cost self-testing platform for nucleic acid amplification tests (UbiNAAT); the first product will be a self-test for the presence of SARS-CoV-2, RSV and influenza viruses at levels that allows detection of presymptomatic cases. 

The COVID-19 pandemic has highlighted a need to expand diagnostic screening beyond traditional healthcare settings. This year has resulted in a dramatic increase in activities related to community-based SARS-Co-V-2 testing programs. During this session, platforms for PCR, antigen, and serology will be discussed and federal guidance related to the use of these tests will be reviewed.

Wearable devices have tremendous potential for real-time monitoring and disease detection for the current COVID-19 global pandemic. We can detect COVID-19 in >80% of cases using RHR from a smartwatch and detection occurs up to 10 days prior to symptom onset (median 4 days). We have developed a realtime alarming system to detect onset of COVID-19 and other RVIs and launched a large scale study to enroll >1M participants globally.

The programmable nature of sequence-specific targeting by CRISPR-Cas nucleases has revolutionized a wide range of genomic applications and is now emerging as a new method for nucleic acid detection. This talk will explore the current efforts and future potential for CRISPR-based detection and its impact across a continuum of diagnostic applications, particularly as it relates to the COVID-19 pandemic.

Attendees will learn the efficiency of standardizing point-of-care testing in their institution. Limiting each test to a sole manufacturer can consolidate management challenges and benefits all sites with volume discount purchasing. Attendees will find tips on harmonization of policies, validation of devices, and operator training and competency learned through implementation of POCT in a large academic health system.

During the COVID-19 pandemic, many non-urgent medical visits (e.g., wellness exam, eye exam, dental exam) are often postponed for various reasons. This resulted in more care gaps, as well as delayed diagnosis and treatment. At this presentation, we will discuss some of these care gaps from the laboratory perspective and explore new strategies to close these gaps.

Loosening of regulations across the U.S. has opened the door for pharmacists to test and provide treatment for acute infectious diseases, theoretically making POC testing accessible in every community in the U.S. The question is: are community pharmacies ready to scale POC testing? Researchers at the University of Tennessee and University of Washington conducted a series of in-depth interviews with chain and independent pharmacy leadership across the U.S. to answer this important question.

COVID-19 has raised awareness of point-of-care testing. This is particularly true of pharmacy-based testing, which has seen regulatory and other changes take place that reduce previous barriers to pharmacy-based testing. Many of the changes to both reimbursement and clinical regulations are likely to persist beyond the pandemic and to other testing services. This session will discuss payer and regulatory changes that have occurred and the opportunities they create for the future of pharmacy-based testing.