Point of care testing’s immediate results can be transformational in how we treat and diagnose conditions. However, historical challenges in implementation as well as performance have kept POCT from reaching its full impact. But with recent advancements in testing technology as well as shifting demand and expectations around testing, in part due to COVID-19, that’s changing. In this talk Dr. Brian DuChateau will review the advancements in testing technology, how this addresses past pain points, and what this symbolizes for the future of healthcare.

The COVID-19 pandemic has become the top priority for diagnostic test manufacturers, clinical laboratories, research scientists and regulatory agencies. This focused attention, along with the urgency of delivering diagnostic solutions, has led to the rapid development and implementation of novel technologies. This session will highlight how the COVID-19 pandemic created an environment poised to advance diagnostic innovation, and how we can learn from this experience to more rapidly respond to future global healthcare challenges.

The COVID-19 Pandemic presented clinical laboratories with immense challenges. This presentation will review how clinical laboratories had to think outside the box and innovate to manage these challenges and provide, increase and maintain accurate diagnostic testing for SARS-CoV-2 in a CLIA environment.

Diagnosis of COVID-19 relies primarily on nucleic acid amplification or antigen testing. In this presentation, metabolomic methods for the diagnosis and monitoring of SARS-CoV-2 and other respiratory viruses will be described.

COVID-19 pandemic matured an incipient revolution in viral diagnostics. While point-of-care diagnostics for common viral diseases may have made it to the front door of the hospital, they largely had not crossed the rubicon into the home and pharmacy counter. This talk will cover some of the new point-of-care technologies that became authorized for testing during the COVID-19 pandemic and handicap their future possibilities.

The presentation will focus on a brief update on the emerging epidemiology, contemporary challenges, and preparation facing diagnostic laboratories in 2021 and 2022.

Attendees should be able to understand:

• How the emerging epidemiology is affecting diagnostic testing
• Incorporate unique PCR chemistries into assays that can co-detect multiple circulating viruses
• Apply laboratory preparedness to changing demands of laboratory testing 

This session will consider many of the aspects of testing from the SARS-CoV-2 pandemic, focusing on lessons learned with the intention of process improvement. Diagnostic testing has played a critical role in the pandemic response and has been central to patient care. The speaker will compare and contrast select assays for SARS-CoV-2 examined early in the pandemic, and touch on home testing options. A review of the strengths, limitations and operational challenges associated with the testing of clinical specimen pools and the testing alternate specimens, such as saliva, will be described.

Next-generation sequencing is an integral component of molecular genetics and molecular oncology testing. Some sequencing applications in the field of molecular infectious disease are gaining a foothold in the clinical laboratory as well. Using sequencing to detect and monitor variation in the SARS-CoV-2 genome provides valuable information for the clinical laboratory, patient care and the greater scientific community.

This presentation will discuss the application of Oxford Nanopore sequencing to complicated wound specimens to identify select pathogens and antimicrobial resistance determinants. Sequencing data will be correlated with culture and clinical management of patients with complicated wound specimens.

Staying ahead of emerging and re-emerging infections in diagnosis and blood donor screening requires innovation in diagnostic and testing platforms. Research in our laboratory has evaluated three fundamentally different approaches that have proven effective in sensitive, specific and multiplex detection and identification of viral, bacterial and protozoan parasites in blood or plasma. The diversity of the technology of these three platforms will be contrasted and test results using laboratory spiked and clinical specimens for each platform will be presented.

As we are in the second year of battling COVID-19, there is a growing interest in assessing SARS-CoV-2 viral load for specific situations. However, in the absence of an approved or emergency authorized test, viral load testing remains controversial. Outside of reporting Ct values, which has its own challenges and pitfalls, laboratories developing quantitative testing are faced with a myriad of issues and limitations. Current needs and potential approaches and limitations will be discussed.

Dr Huang will introduce AnteoBind™ nanocoating technology. Covering common issues in bio-conjugation, followed by describing the impact of the conjugate physical characteristics (particle size control, dispersity, surface charge) on assay performance, and procedure detail for using AnteoBind™ activated Estapor® europium microspheres for development of lateral flow immunoassays. He will also discuss the performance of the AnteoBind™ activated Estapor europium conjugates in rapid diagnostic test development including SARS-CoV-2, Flu and Sepsis.

SARS-CoV-2 first appeared in December 2019 in Wuhan China and has infected over 120 million people and caused 2.6 million death globally as of March 2020. The available COVID testing capability in the US at the first half of 2020 was grossly below demand with mismatched testing platforms and turnaround time too long to control the spread of COVID-19. In May 2020, NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to increase testing capability in and to speed development of rapid and widely accessible COVID-19 testing. In this session, we will review the progress of the RADx program and to showcase a few of the successful developments.