The coronavirus pandemic of 2019-20, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has indelibly altered our modern world. While we continue to adapt our test offerings to the changing needs of our patients and challenges of our supply chains, we are faced with the need for additional information, and the reality that we must develop the infrastructure to prepare us for future outbreaks.

The SARS-CoV-2 pandemic created sudden, unprecedented challenges to diagnostic testing, including major supply chain issues, critical testing personnel shortages, and a general paucity of knowledge for this new human pathogen. The aim of this presentation will be to cover how we successfully managed these challenges early in the pandemic in order to rapidly operationalize diagnostic COVID-19 testing and provide essential results for patient care and infection control.

Next Generation DNA Sequencing (NGS) is a relatively untapped diagnostics resource for SARS-CoV-2. We developed an ultra-high-throughput NGS SARS-CoV-2 saliva assay that may analyze 1,152 samples, simultaneously. The assay utilizes PCR to amplify, index, and adapt SARS-CoV-2 sequencing targets in a single step. The high-throughput capabilities of NGS creates opportunities and challenges that require integration of scalable solutions like liquid-to-liquid RNA extraction, tipless liquid handling, and magnetic bead library preparation.

Accurate and timely molecular testing for SARS-CoV-2 has been crucial for informing patient management, contact tracing, and infection control. There are many variables that may contribute to the yield of a positive or negative result including age, time of collection, presence of symptoms, sample type and test performed. This session will discuss how these variables must be taken into account when making informed decisions on testing approaches.

This talk will discuss the current and future landscape of diagnostic and surveillance testing for SARS-CoV-2 and beyond. We will cover where we’ve been, where we’re going, and how to prevent the next pandemics that will inevitably arise.

I will discuss the development, implementation and challenges of COVID-19 molecular diagnostics at the beginning of the COVID-19 pandemic in New York City, one of the early epicenters of the U.S. pandemic.

A growing diagnostic armamentarium now exists for COVID-19. However, co-infections affect disease severity and their detection still relies on culture. Genomic profiling informs pathogen discovery, surveillance, vaccine development, and infection prevention but involves specialized laboratories, often remaining an afterthought. Metagenomics provides a future-proof, unified alternative that can address new diagnostic challenges via software updates rather than re-designed tests. Rapid and economical targeted NGS workflows will accelerate broad adoption.

COVID-19 is a severe disease that caused > 1 million deaths in under one year. As this disease is novel, the molecular and cellular underpinnings of the progressive tissue injury is poorly understood, as is the role of direct versus indirect viral-induced injury. This study interrogated spatially-resolved gene expression in fixed lung tissue from COVID-19 autopsies with high and low viral loads to patients who suffered from other respiratory diseases (Flu, non-viral acute respiratory distress syndrome [ARDS]) and normal lung tissue.

The SomaScan Assay is a proteomic platform that uses single-stranded DNA engineered with aromatic hydrocarbon side chains for binding to protein targets.  The SomaScan Assay has been used to identify signals as surrogates for clinical outcomes, discover proteins associated with disease states, and correlate protein measurements with genetic variants. 

The ability to implement, scale-up and sustain COVID-19 testing presents a critical problem for many clinical labs. This talk overviews the COVID-19 clinical lab partnership program jointly offered by BGI and MGI. Real world successes will be illustrated by showcasing how the companies’ total lab solution enabled massive COVID testing.   

Quantification of viral load has become an indispensable factor in the management of patients with various acute and chronic viral infections, including initiation, adjustment, and discontinuation of treatment. In the fight against the global COVID-19 pandemic, reliable and interpretable methods of quantification of SARS-CoV-2 may have some utility. However, technical and interpretive challenges remain as major hurdles in developing and implementing a robust and useful quantitative assay.

Wisconsin had one of the first travel-associated cases of SARS-CoV-2 in early 2020 and exploded into a global epicenter of infections following the return of University students to classes in fall, 2020. Here Dr. O’Connor will describe insights from a novel non-diagnostic SARS-CoV-2 surveillance testing program and extensive genomic surveillance of SARS-CoV-2 from Wisconsin communities.

The current coronavirus, COVID-19, pandemic is a generational impact that continues to shape public health and centralized hospital laboratory responses. This talk will focus on an update on the current perspective of centralized laboratory testing, including current and future challenges faced in providing high-throughput testing solutions.

We have developed a competitive ACE2 ELISA assay (Byrnes et al., mSphere, 2020) that is useful to quantitatively measure the potency of patient neutralizing antibodies to SARS-CoV-2 utilizing a high affinity ACE2 receptor trap (Glasgow et al., PNAS 2020). We have also devised a solution-based antibody assay using a split luciferase (spLUC) fused to either the S or N viral proteins (Elledge et al., MedRxiv 2020). The spLUC assay is fast, inexpensive, with specificity and sensitivity over 95% that can be read using hand-held luminometer thus suitable for broad point-of-care use.

Understanding the science behind antibody development in response to SARS-CoV-2 infection is important to understanding how and when to use serology testing. There are currently over 60 serology tests with EUA authorization. The differences between these assays include methodology, measuring different antibody isotypes, and use in different settings. The arrival of SARS-CoV-2 vaccines will further complicate the serology testing landscape. This session will provide a summary of the scientific data that is critical to our understanding of antibody development in the context of SARS-CoV-2 infection and an overview of the practical aspects of laboratory SARS-CoV-2 antibody testing.

It is important for COVID-19 survivors, vaccine recipients, and public to know whether they have developed neutralizing antibodies or immunity. We present a practical POCT detecting SARS-CoV-2 neutralizing antibodies and its comparison with ELISA and pseudovirus based neutralization assays, as well as analyses and reviews of 100 plasma specimens tested during the development.  This POCT will serve as a convenient diagnostic tool in management of COVID-19 disease.

The detection of SARS-CoV2 antibodies is important to determine who has been infected, when did it occur, are they immune, and have they been re-infected (for someone who has re-tested positive for virus). Early in the pandemic, there were two major SARS-CoV2 strains, therefore, genotyping was useful to assess a re-infection. Antibody testing of women during pregnancy, cord blood, and newborns is useful to determine route of exposure and assess immunity.

This talk will describe UW Virology's experience with bringing on SARS-CoV-2 testing from early March 2020 until the present day. We will give a month-by-month synopsis of lessons learned and forecast future trends in the clinical virology laboratory based on the incredible changes wrought by SARS-CoV-2 testing.

The coronavirus disease 2019 (COVID-19) pandemic has resulted in a significant amount of innovation focused on developing and validating novel testing methods to diagnose and manage the disease. Although laboratory-based molecular tests remained the primary diagnostic method throughout 2020, new technologies have emerged that will allow for testing to be performed in a decentralized and rapid fashion. This presentation will provide an overview of the evolution of testing methods for COVID-19 and summarize some of the latest developments in diagnostics to identify those infected with SARS-CoV-2.

The utilization of novel non-invasive diagnostics would address many of the supply-chain and logistical deficiencies in the current pandemic testing environment. In conjunction with a CLIA-certified saliva-optimized omics target detection platform electric field induced release and measurement (EFIRM), we hypothesize that EFIRM assays to COVID-19 RNA, viral load and host immunity (IgG, IgM, IgA) can be the clinical platform for concurrent detection of SARS-CoV2 viral infection and host immunity, in a sample of saliva, in 1.5 hours, deployable at the population, epidemiological level. EFIRM is the only technology that can quantitatively detect antibodies in saliva.

Explore the technologies and analytes that will drive the next stage of COVID-19 R&D. Whether predicting disease severity and response, or assessing disease progression, gain valuable insights into the right technologies, partners, and strategies to get from bench to market.

Learn about:

• The biomarkers driving COVID-19 monitoring & response
• The expanding applications for COVID-19 diagnostics 
• Insights into how to prepare your R&D to thrive in 2021 

Biodesix is a leading lung-focused diagnostics company. In response to the COVID-19 pandemic, Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab test to support widespread testing for healthcare providers, employers, universities, athletic programs, and the State of Colorado. This presentation will walk you through Biodesix’s experience commercializing two COVID-19 diagnostic tests, highlight the key to operational success, and finally provide a peek into ongoing COVID-19 diagnostic research.