The COVID-19 pandemic has resulted in demand for population scale pathogen screening. The most sensitive and reliable method for detecting SARS-CoV-2 remains reverse transcription PCR (RT-PCR). However, current platforms for SARS-CoV-2 RNA detection have not yet met the demand for large scale, rapid testing. Here, we present an ultra-fast PCR platform, NEXTGENPCR, which accelerates RT-PCR assays. The NEXTGENPCR machine provides a small footprint capable of running PCR in 96 or 384 well plates in less than 10 minutes; and RT-PCR in less than 16 minutes. Come learn how you can accelerate RT-PCR for direct detection or sequencing applications.

Learning Objectives:

1. Understand how NEXTGENPCR accelerates SARS-CoV-2 assays and chemistries

2. Considerations for setting up an efficient workflow to process >1,000 per hour

3. Understand how accelerated cycling yields equivalent assay performance

COVID-19 has developed into a crisis of global proportions. COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Key to SARS-CoV-2 therapeutic development is unraveling the mechanisms driving high infectivity, broad tissue tropism and severe pathology. SARS-CoV-2 is decorated by multiple copies of a glycoprotein, called Spike, which is key to infectivity. Using cryo-electron microscopy and cloud computing, we discovered a potentially druggable pocket within the SARS-CoV-2 Spike, which appears to be likewise present in the highly pathogenic coronaviruses that caused the previous SARS and MERS outbreaks. Our discovery provides, for the first time, a structural link between COVID-19 pathology and the virus itself, setting the stage for developing new therapeutic interventions to combat and defeat COVID-19.

Learning Objectives:

1. Learn about the high-tech science technologies and techniques being used to defeat the global COVID-19 epidemic

2. Learn about a novel discovery of a druggable pocket in SARS-CoV-2 spike protein for drug development

There are an urgent need for antivirals to treat the newly emerged SARS-CoV-2. We set out to develop cell-based screens to repurpose existing drugs for use against SARS-CoV-2. Our goal was to identify both direct-acting and host-targeted antivirals. We have screened an in-house repurposing library of ~3,000 drugs in three distinct cell types permissive to SARS-CoV-2 infection: monkey kidney cells (Vero), human hepatocytes (Huh7.5) and human lung epithelial cells (Calu-3). There were 6 actives in Vero, 33 in Huh7.5 and 88 in Calu-3, with little overlap. While direct-acting antivirals such as remdesivir are active in all three cell types, we found few antivirals that were broadly active suggesting that the host dependencies are distinct in different cell types. Indeed, exploring entry pathways  revealed that in in lung epithelial Calu-3 cells entry is pH-independent and cathepsin-independent but requires TMPRSS2,. In contrast entry in Vero and Huh7.5 cells requires low pH and triggering by acid-dependent cathepsin proteases and is independent of TMPRSS2. Moreover, we found 9 drugs are antiviral in both hepatocytes and lung cells, 7 of which have been tested in humans, and 3 are FDA approved including Cyclosporine which we found is targeting Cyclophilin rather than Calcineurin for its antiviral activity revealing essential host targets that have the potential for rapid clinical implementation Specifically, I will discuss antiviral screening strategies and validation paradigms and discuss the implications of the cell type specificity. In addition, I will discuss some of our antivirals and mechanisms by which they function to block SARS-CoV-2 infection.

Learning Objectives:

1. Strategies for antiviral screening

2. Importance of cell types in antiviral discovery

3. Cellular dependencies of SARS-CoV-2 in the lung epithelium

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19) and responsible for the current pandemic.  Here, we present an in-depth study of SARS-CoV-2 infection, associated disease, transmission and reinfection dynamics in domestic cats.  Six 4- to 5-month-old cats were challenged with SARS-CoV-2 via intranasal and oral routes simultaneously.  One day post challenge (DPC), two sentinel contact cats were co-mingled with the principal infected animals.  Animals were monitored for clinical signs, clinicopathological abnormalities (blood cell counts, serum biochemistry) and viral shedding throughout a 21 DPC observation period.  On 21 DPC, three cats were reinfected with SARS-CoV-2. Animals were sacrificed and post mortem examinations performed at 4, 7, 21 DPC and 4 days post second challenge (DP2C) to investigate disease progression in various organ systems and tissues.  Viral RNA was not detected in blood but transiently in nasal, oropharyngeal and rectal swabs in principal infected, sentinel and reinfected animals, as well as in bronchoalveolar lavage fluid at 4 and 7 DPC and in various organs/tissues of primary infected and reinfected animals.  Lung lesions associated with the presence of viral RNA and antigen were observed in primary infected cats on 4 and 7 DPC, but not on 21 DPC and 4 DP2C. Serology showed that both, principal and sentinel cats developed SARS-CoV-2-specific and neutralizing antibodies to SARS-CoV-2 starting at 7 DPC or 10 DPC, respectively. All animals were clinically asymptomatic during the course of the study; primary infected but not reinfected cats were capable of transmitting SARS-CoV-2 to contact animals within 2 days of comingling. The results of this study are critical: (i) for our understanding of the clinical course of SARS-CoV-2 in a naturally susceptible host species; (ii) for evaluating whether a SARS-CoV-2 infection can protect against reinfection; (iii) for the development of an alternative preclinical COVID-19 animal model; and (iv) for risk assessment of SARS-CoV-2 infections in felines and transmission to other animals and humans.

Learning Objectives:

1. Be aware of SARS-CoV-2 infections in companion animals

2. How to diagnose SARS-CoV-2 infections in companion animals

Next-generation sequencing (NGS) is the primary technology used to identify genomic targets for vaccine development, detect emerging viral strains and monitor transmission patterns. Enhanced options for NGS on Illumina systems from the Invitrogen Collibri portfolio of library prep technology now make it possible to identify multiple potentially pathogenic strains of a disease and understand the rate of evolution quickly, with improved precision.

Learning Objectives:

1. Learn how to enable rapid sequencing SARS-CoV-2 samples for real-time monitoring of transmission patterns and emerging strains

2. Why do some people become severely ill compared to those who do not, even when infected with the same viral strain? Learn about new tools to investigate differences in gene expression among these groups

Therapeutic antibody can provide key protection or lifesaving treatment for those who haven't been or can’t be vaccinated, or when vaccines don’t “take". We galvanized a Gates- and NIAID-funded consortium to understand which antibodies are most protective and why, to learn which in vitro assays best correlate with in vivo success, and to broadly mobilize therapeutics where needed.

Learning Objectives:

1. The different mechanisms by which antibodies protect against viral infection

2. How a multidisciplinary, multi-investigator study can offer new information

Choosing the right solution for your laboratory’s SARS-CoV-2 testing needs can be a difficult decision. With the dynamic demand on labs, making the wrong choice could be catastrophic. In this presentation, we will be discussing the critical factors to consider when choosing the set up for your testing needs:

• Assay sensitivity and reliability

• Availability of reagents

• Throughput and labor requirements

• Sample-to-solution workflow

• Support

Learning Objectives:

1. Specialized work flows required for launching a RT-PCR COVID-19 assay

2. Validation of COVID-19 RT-PCR assays following FDA guidance

3. Requirements and process for submitting for EUA approval

In less than nine months, the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has killed hundreds of thousands of people, including >23,000 in New York City (NYC) alone. The pandemic’s sudden emergence highlights clinical needs to detect infection, track strain evolution, and identify biomarkers of disease course. To address these challenges, we designed a fast (30-minute) colorimetric test (LAMP) for SARS-CoV-2 infection from naso/oropharyngeal swabs and a large-scale shotgun metatranscriptomics platform (total-RNA-seq) for host, viral, and microbial profiling. We applied these methods to clinical specimens gathered from 669 patients in New York City during the first two months of the outbreak, yielding a broad molecular portrait of the emerging COVID-19 disease. We find significant enrichment of a NYC-distinctive clade of the virus (20C), as well as host responses in interferon, ACE, hematological, and olfaction pathways. In addition, clinical data from 50,821 patients shows evidence of a protective impact of patients taking ACE inhibitors, which is distinct from other drugs. Finally, spatial transcriptomic data from COVID-19 patient autopsy tissues reveal distinct ACE2 expression loci, with macrophage and neutrophil infiltration in the lungs. These findings can inform public health and may help develop and drive new SARS-CoV-2 diagnostic, prevention, and treatment strategies.

Learning Objectives:

1. List several ways to profile the SARS-CoV-2 virus'

2. Describe the host and viral responses from infection for SARS-CoV-2

Infectious diseases, such as COVID-19, are challenging to study in animal models due to species differences, and conventional 2D cell-based systems lack the complexity to appropriately model the disease or immune response in humans. Organs-on-Chips offer a human relevant system that can recreate key disease phenotypes in a more physiological microenvironment due to their complex 3D architecture and mechanical forces induced by flow and stretch. In this webinar, we discuss how the Airway Lung-Chip and Alveolus Lung-Chip can be used to study viral infection and accelerate the development of new therapeutics.

Learning Objectives:

1. Learn how Organs-on-Chips technology can be applied to recreate key aspects of pulmonary physiology, specifically the creation of Airway and Alveolus Lung-Chip models

2. Review data demonstrating how the Airway Lung-Chip can be used to study viral infection and evaluate the efficacy of therapeutic interventions

Learning Objectives:

1. Drug Repurposing Strategies for SARS-CoV2

2. Validation pipeline for SARS-CoV-2 antiviral

3. Outlook for SARS-CoV-2 therapeutics

Part I:  Introduction and history coronaviruses dating back to the 1980s and coronavirus biology. I will describe the coronavirus life cycle pointing steps that may serve as targets of antiviral therapies that may effective against most if not all coronaviruses.

Part II. Coronaviruses are highly effective in antagonizing host innate immune responses, more specifically interferon (IFN) induction and signaling pathways. MERS-CoV and SARS-CoV fail to induce IFN early in infections of humans and in mouse models while IFN production in late disease may be pathogenic. Antagonism of host responses is carried out through expression of multiple viral accessory proteins as well as conserved replicase encoded proteins, sometimes with redundant activities. Our lab focuses on the double-stranded RNA induced antiviral pathways: type I and types III IFNs, oligoadenylate synthetase-ribonuclease (OAS-RNase L) and protein kinase R (PKR). Activation of these pathways leads to inhibition of viral replication, shut down of protein synthesis and apoptotic cell death. I will discuss coronavirus antagonism of these pathways using examples from our previous studies of the betacoronaviruses murine coronavirus MHV and MERS-CoV and recent data on SARS-CoV-2.

Learning Objectives:

1. Coronaviruses enter cells by two pathways, at the plasma membrane fusion or through endosomes

2. Coronaviruses encode 16 conserved non-structural proteins in the replicase locus, potential targets for pan coronavirus antivirals

3. Coronaviruses are adept at antagonizing activation of dsRNA induced antiviral pathways, including interferon signaling, OAS-RNase L and PKR

PerkinElmer is a global leader in the development of instrumentation and probes for small animal non-invasive imaging, including optical and µCT imaging. Through optical imaging, we have developed a technology which allows biological processes, including gene expression that is temporally and spatially defined, to be non-invasively monitored both longitudinally and in real-time. Genes encoding optical reporters, luciferases and fluorescent proteins, are engineered into cells and pathogens (e.g., bacteria, viruses), or directly into animals (e.g., monitoring host responses) to enable the generation of light that can be visualized through the tissues of a live animal. PerkinElmer has optimized this technique to allow true three-dimensional optical imaging and tomographic multimodality imaging (e.g., through co-registration of optical imaging with µCT and MRI). Furthermore, this technique is equally applicable to imaging of fluorescent dyes and particles, allowing fluorescently tagged biological events (e.g., tracking of antibodies, peptides and viral capsids) to be monitored both independently and in combination with genetically tagged events. An overview of optical imaging in viral and bacterial disease research will be presented, showing how this approach can be used to refine and improve fundamental biological research, as well as drug development and clinical translation strategies.

Learning Objectives:

1. Understand the principle of non-invasive preclinical optical imaging as it relates to infectious disease research

2. Recognize different molecular imaging techniques for visualizing host-pathogen interactions

In recent months, we have seen a large part of the global scientific community shift to infectious disease research. In response, researchers are exploring safer and easier methods to handle, isolate, and analyze cells from hazardous materials. Mitigating risk while achieving highly pure, viable cells is essential to understanding the immune system’s role in COVID-19 infection and recovery. When it comes to cell sorting, samples, such as SARS-CoV-2 convalescent samples, virus-infected human cells (e.g., from HIV-positive donors), or bacteria, can escape the fluidic system of a traditional droplet-based cell sorter as aerosols.  Our multi-parametric cell sorting platform offers a solution with its unique closed, single-use, and disposable sorting cartridge. This cartridge provides an increased level of biocontainment and can mitigate the risk when implementing a fluorescent-activated cell sorter in BSL-3 or BSL-2+ level laboratories.

Learning Objectives:

1. Scientists utilizing cell sorting to obtain high quality cell populations from biohazardous samples

2. Mitigating risk while sorting hazardous samples though leveraging a microfluidic-based fluorescent-activated cell sorter

3. GMP-compliant cell sorting options available for your translational research

The forecast IHME released on March 26, 2020, was geared to helping hospitals plan for a surge in demand for their resources (e.g., beds, ICUs, ventilators) to fight COVID-19. With many locations seeing a second peak of COVID-19 infections and deaths, attention is now on how best to prevent and manage a resurgence of the disease while safely enabling people to get back to work and school. To help with policy decisions, IHME is now providing a reference scenario and two additional forecasts for daily and total deaths. In this seminar, we will provide and Introduction to the IHME model, its limitations, projections for our region, how can the countries use these estimates, and looking ahead.

Learning Objectives:

1. The main drivers of the increased cases and deaths?

2. How we could control this pandemic

3. The scenarios for this coming winter and the impact of seasonality

The United States has had the worst response to COVID-19 among any country in the world. We are approaching nearly 200K deaths and more than 6 million known infections. The US government’s response to the pandemic from early on was a mixture of denial and incompetence. This includes a failure to set up an effective testing infrastructure to let the nation identity who was infected and who was not; downplaying the seriousness of the infection like comparing it with the flu when everyone knew it was far more deadly; the large campaign of misinformation through platforms like Facebook and much of the misinformation being augmented by our federal political leaders has led to a dramatically uneven response across the nation. As we look towards the fall and winter, despite progress on therapeutics and vaccines on the horizon, we will need a coordinated and effective federal response if we are to avoid hundreds of thousands of people dying from this disease.

Learning Objectives:

1. To understand the role of the US federal government in testing and other disease containment strategies

2. To understand how US federalism led to a diversity of responses and outcomes in this pandemic

As part of a large collaborative effort, we have used systems biology approaches to identify host factors that participate in SARS-CoV-2 replication.  Protein-protein interactions maps between viral and host proteins and  global landscapes on protein phosphorylation changes taking place in SARS-CoV-2 infected cells were used as guides for the identification of host processes that could be targeted for antiviral therapeutic intervention. Drugs known to interact with these host processes and with known clinical profiles were tested for their ability to inhibit SARS-CV-2 replication in tissue culture.   As a result, we found several promising therapeutic candidates to be evaluated in vivo for the treatment of COVID-19.

Learning Objectives:

1. Understand the concept of drug re-purposing

2. Gain insights on the use of system biology approaches for the discovery of antivirals

3. Gain insights on the host-virus protein interactions contributing to SARS-CoV-2 replication

This presentation will discuss the use of the FDA EUA process to implement SARS-CoV-2 assays to address the COVID-19 pandemic.  The use of a team-based approach, through an Incident Command structure, to optimally address all the operational challenges in validating, implementing and maintaining SARS-CoV-2 testing for the patient population in a large tertiary care referral center.  The presentation we review a comparison of five SARS-CoV-2 assays.   Evaluation of the changes in viral load thoughout the time course of COVID-19 infections will be reviewed, and how this related back to the five test comparison will be discussed.  The importance of the population tested (i.e. high versus low prevalence) will be reviewed, as diagnostic tests are being used as screening tests.  The presentation will review the testing of saliva as an alternate diagnostic specimen, and will explain the benefits and limitations of pool testing of diagnostic specimens.  In conclusion, the presentation will describe how testing is integrated with mitigation strategies necessary to curtail the COVID-19 pandemic.

Learning Objectives:

1. Describe the optimal uses for the various types of SARS-CoV-2 tests (i.e. antigen, antibody, & different nucleic acid amplification assays)

2. Discuss the molecular detection of SARS-CoV-2 during COVID-19 convalescence

3. Discuss the impact of utilizing a test with high (95%) specificity in a diagnostic setting versus screening setting

4. Review the benefits and limitations of testing alternate specimen types (e.g. saliva) and utilizing alternate testing strategies (e.g. pooling) for the detection of SARS-CoV-2

As the spread of infectious diseases, current pandemic, and growing antimicrobial resistance (AMR) continues globally, next-generation sequencing (NGS) became a tool to diagnose infectious diseases. The rapid identification of pathogens providing key information on species, strains, genetic variants and geographic origin, NGS and artificial intelligence-based approach enables emerging pathogen and strain identification, patient risk stratification, AMR tracking, clinical interpretation and outcome prediction.

Learning Objectives:

1. Understanding the next-generation sequencing (NGS) and how NGS can be used to fight against infectious diseases and the current pandemic

2. Facilitate in-depth knowledge about harnessing microbial genetic information to develop breakthrough diagnostic and surveillance tools

3. Leverage insights gathered from the microbiome and virome to fight against infectious diseases through the development of precision diagnostics

4. Understanding how NGS and the SARS-CoV-2 viral genome can be used for pandemic surveillance

Accelerated development of mRNA-based vaccine has necessitated the transformation of standard, research grade in vitro transcription reagents into raw material specifically designed and manufactured under advanced quality standards. The TheraPure grade reagents for mRNA-based vaccine represents Thermo Fisher Scientific’s highest level of purity for mRNA synthesis reagents, with products manufactured using high-definition analytics and tightly controlled purity standards. The TheraPure grade portfolio offers a unique integrated solution for mRNA synthesis, including animal origin-free and ampicillin-free enzymes. Here, we will discuss the quality requirements for critical raw material for commercial mRNA production and ongoing projects to optimize the entire mRNA portfolio to meet fit-for-purpose standards.

The fast spread of SARS-Cov-2 sparked much interest in understanding the underlying genomics of this 30,000bp Coronavirus. Thus far, thousands of genome assemblies are available, yet they feature only a relatively small number of single nucleotide polymorphisms (SNPs) that differentiate the main SARS-CoV-2 clades that have evolved while rapidly spreading throughout the world. In this talk, I will describe the mutational landscape of thousands of SARS-Cov-2 genomes and take a deep dive into the intrahost diversity of this devastating virus. Specifically, I will discuss within-host minor variants that are found across hosts and describe population-wide structural variations that highlight this underexplored intrahost diversity. Implications of these findings include both high false-negative rates of qPCR-based tests and as a key tool in transmission analyses.

Learning Objectives:
1. Differentiating consensus-level vs within-host variation of SARS-CoV-2

2. Discovering the potential impact of single nucleotide variation on COVID-19 diagnostics

3. Understanding the utility of minor variants on tracking SARS-CoV-2 transmission

When producing a quality vaccine, all manufacturers must confirm the purity as well as the stability of their formulation and final product. Sample quantity and measurement time are often the throughput bottlenecks encountered during the process. As PerkinElmer’s LabChip GXII Touch addresses these specific gaps, we’ve developed a literature-centric webinar. In this webinar you will learn:

Learning Objectives:

1. The vaccine development and manufacturing process

2. The key applications of microfluidic CE in vaccine process development

Analysis of antigen- and virus-specific T cells is essential to the understanding of fundamental immunological processes in the contexts of e.g. infectious diseases, immuno-oncology, as well as immune tolerance.

However, working with antigen- and virus-specific T cells poses several challenges to researchers. Their low frequencies often hamper a reliable analysis. Specificity, inflammatory environment, subtype as well as detection limit and background are determining factors and thus require optimized procedures in order to facilitate a successful experiment.

Our enrichment and analysis solutions are perfectly suited for the examination of rare antigen- and virus-specific T cells and will assist you in even the most challenging research projects and your work on viral threats like SARS-CoV-2 in COVID-19.

It’s all about finding the needle in the haystack!

Learning Objectives:
1. Virus-specific stimulation of T cells

2. Enrichment of rare virus-specific T cells

3. Multiparameter analysis of virus-specific T cells

Bringing a new research surgical model into production is always a challenging endeavor, and it has become much more challenging with the emergence of the Covid-19 pandemic. The virus’s impact on supply chains, personnel and other resources, and the effects of stress and uncertainty on the people involved forced creativity and in many cases brought the best from these same people. In this presentation, we will discuss the obstacles that we faced and how we ultimately overcame them, along with lessons learned for future rounds of this pandemic.

Learning Objectives:
1. Participants will learn of some of the hidden and unexpected pitfalls in supply chains during the pandemic

2. Participants will learn of specific fast response accommodations made to protect personnel during the pandemic

The COVID-19 pandemic has resulted in over 7 million cases and more than 428000 cases to date. While public health interventions and social distancing measures have been effective in slowing transmission, a vaccine is urgently needed. Currently, there are over 100 vaccine candidates, using multiple platforms and vectors, in various stages of development increasing the likelihood that a successful candidate will be found. This development is proceeding at an unprecedented pace, and this may be due to lessons learned from vaccines against other emerging pathogens. This presentation will review several of the leading candidates as well as highlight lessons learned from previous vaccines and identify challenges that remain in the development process.

Learning Objectives:

1. To provide an overview of several current vaccine candidates and technologies

2. Illustrate lessons learned from previous vaccines

3. Describe challenges and opportunities in vaccine development

The 2020 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to rage. While PCR-based assays are used for viral diagnosis, high through-put, rapid serologic methods are needed to assess the prevalence of COVID19, the disease caused by SARS-CoV-2, and to identify persons previously infected.  In particular, high through-put antibody (Ab) assays are needed for mass screening.  A Luminex binding assay is described that simultaneously assesses the presence and level of circulating Abs specific for the S protein of SARS-CoV-2 and for its receptor binding domain (RBD). For this, fluorochrome-labeled magnetic beads are coated with a recombinant soluble stabilized trimeric form of the SARS-CoV-2 S protein ectodomain or with the RBD. Coated beads are incubated with serum or plasma, biotinylated anti-human Abs specific for total immunoglobulins, and phycoerythrin-labeled streptavidin, followed by a read-out using a Luminex analyzer. Isotypes of the Abs are quantified by using isotype-specific biotinylated secondary Abs (anti-IgG, -IgG1, -IgG2, -IgG3, -IgG4, -IgA1, -IgA2, and -IgM). The COVID19 Luminex Ab assay is both qualitative (binary) and quantitative. There was a statistically significant difference in total immunoglobulin anti-S and anti-RBD Ab levels when comparing serum or plasma from >140 COVID-infected and uninfected individuals (p<0.0001). The advantages of the Luminex over the ELISA platform include: (a) the use of 20-fold less antigen per test, (b) a 2.5-fold faster run time, (c) a turn-around time of ½ day vs. 2 days, (d) performance of the RBD screen and S protein titration simultaneously rather than sequentially, and (e) a sensitivity 5-10x greater than that of ELISA, resulting in far fewer false negative results.  Delineation of COVID19 Ab isotypes using the Luminex platform also showed  differences in the patterns of IgG, IgA, and IgM from patient-to-patient, and IgA and IgM Ab response rates which are higher than IgG response rates.

Learning Objectives:

1. Impart need for and ways to perform mass COVID19 antibody screening

2. Educate about the isotypes of antibodies being induced by SARS-CoV-2 infections

Choosing the right solution for your laboratory’s SARS-CoV-2 testing needs can be a difficult decision. With the dynamic demand on labs, making the wrong choice could be catastrophic. In this presentation, we will be discussing the critical factors to consider when choosing the set up for your testing needs:

• Assay sensitivity and reliability

• Availability of reagents

• Throughput and labor requirements

• Sample-to-solution workflow

• Support

Learning Objectives:

1. Considerations for choosing an RT-PCR assay for SARS-CoV-2 testing

2. Components of the SARS-CoV-2 testing workflow

The COVID-19 pandemic is caused by a newly discovered coronavirus, SARS-CoV-2. To characterize and detect this new virus, antibodies to support scientific research, diagnosis and vaccine development are in urgent need. Sino Biological, Inc. develops specific S and N antibodies to SARS-CoV-2 by several antibody generation platforms, including hybridoma, B cell antibody cloning and antibody phage display library. Meanwhile, we also obtained antibodies to recognize all 7 strains of coronaviruses that infected humans. Several candidates are selected for further analysis in research, potential diagnosis applications, and to facilitate vaccine development.

Learning Objectives:

1. Applications of SARS-CoV-2 antibodies

2. Strategies and technology platforms for developing SARS-CoV-2 antibodies

3. Challenges and case studies of SARS-CoV-2 antibody generation

Emerging infectious diseases” are those that are rapidly increasing in incidence or geographic range.  Most are zoonotic, entering the human population from other animal species.  None exemplifies this better than the coronaviruses.  The first three decades of the 21st Century have seen three zoonotic coronaviruses introduced into the human population.  The first zoonotic human coronavirus, SARS-CoV (Severe Acute Respiratory Syndrome coronavirus), first appeared in China in late 2002, and spread worldwide from a single patient in Hong Kong in February 2003. When the epidemic was ended, in June 2003, there had been 8,098 cases (with 774 deaths), in 19 countries, including mainland China, Taiwan, Vietnam, Singapore, and Canada.  The natural host of SARS-CoV was a small bat (Rhinolophus), and the virus probably reached humans through live animal markets in south China.  Further investigation identified a number of related viruses in the same and other bat species.  A decade later, in 2012, Middle East Respiratory Syndrome (MERS) coronavirus appeared, with clinical presentation similar to SARS.  The epidemic is still ongoing, with over 2,500 cases (> 870 deaths, case-fatality ratio ~34%); approximately 80% of the cases are in Saudi Arabia.  Healthcare associated transmission accounted for most cases of SARS and MERS.  In late 2019, patients were hospitalized with atypical pneumonia in Wuhan, China.  The cause was identified as a coronavirus, subsequently named SARS-CoV-2 because of its close relationship to SARS (the disease is called Coronavirus Disease 2019, abbreviated as COVID-19).  Unlike SARS, SARS-CoV-2 could transmit readily from person to person by the respiratory route, allowing it to reach pandemic proportions.  With both SARS and SARS-CoV-2, the infections came to global attention through ProMED-mail (a system for Internet reporting and discussion of emerging infections).  The global response galvanized by SARS in 2003 makes an interesting comparison with the current response to SARS-CoV-2.

Learning Objectives:

1. Discuss 2 similarities and 2 differences between SARS-CoV-2 (COVID-19) and the earlier zoonotic coronaviruses (SARS and MERS-CoV)

2. Evaluate the likelihood of future pandemic coronaviruses

Coronavirus disease 2019 (Covid-19) is a global pandemic that has impacted the lives of the entire world’s population. Accurate and effective testing mechanisms to identify those with active infections or have convalesced is necessary to properly monitor and control this infectious agent. To this end, we have recently developed a serological method for assessment of an immune response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen based on simultaneous evaluation of four viral antigens, including the Spike, Nucleocapsid, Membrane, and Envelope glycoproteins, and built on the Luminex immunobead platform. Validation studies against 1042 patients have provided test performance characteristics of 100% Sensitivity, 99.6% Specificity, and 99.62% overall accuracy, relative to PCR-based assignments. This quantitative method is highly effective in applications that include diagnosis of those with past infections (symptomatic or asymptomatic), epidemiological studies/ guidance for policy decisions, monitoring titers during vaccine trials, and rationalized donor selection for therapeutic ‘convalescent plasmapheresis’ strategies.

Learning Objectives:

1. To understand the best testing strategy to survey COVID-19 in population in order to constrain the disease and prepare for safe reopening

2. To understand the advantage of multiplexing technology to improve testing accuracy and sensitivity

Next-generation sequencing (NGS) is the primary technology used to identify genomic targets for vaccine development, detect emerging viral strains and monitor transmission patterns. Enhanced options for NGS on Illumina systems from the Invitrogen Collibri portfolio of library prep technology now make it possible to identify multiple potentially pathogenic strains of a disease and understand the rate of evolution quickly, with improved precision. The most current application of NGS technology is to rapidly map differences in gene expression profiles to research variance in immune response among infected individuals.

Learning Objectives:

1. Considerations to choose between RNA-seq and whole-genome sequencing when studying RNA viruses

2. Criteria to choose among three RNA sequencing methods

3. Tools to improve the quality of viral sequencing data

With more than 6 million infections and more than 300,000 deaths (as of end of May 2020), the current COVID-19 pandemic has led to large scale lockdown around the world to prevent further spread of the disease.

From the initial effort of rapid diagnosis and containment, the international community is now facing the challenge of an effective and pragmatic “exit” strategy to balance the public health risk versus the huge economic losses as a result of the travel ban and lockdown measures globally.

Among the many challenges of onging COVID-19 investigation and repsonses, the follwong three stands out as the most pressing: 1) A good understanding of protective immunity and longevity of immunity to better advise/design “exit” strategy and policy; 2) Rapid development and deployment of COVID-19 vaccine(s) and a reliable testing platform capable of assessing and monitoring vaccine efficacy en masse; and 3) Investigation of virus origin and the early animal-to-human transmission events to prevent future outbreaks.

Serology will play a key role in all three areas. In this presentation, different serological platforms currently used for COVID-19 testing will be reviewed and compared together with the introduction of a novel platfom, the surrogate virus neutralization test (sVNT), that we have developed recently.

Learning Objectives:
1. Challenges for next phase of COVID-19 outbreak

2. Role of serology in meeting some of these challenges

Staying informed on diagnostic tools for SARS-CoV-2 can be challenging.  Because the results of the various test have different clinical implications it is important to understand the design and intended use of the available test. At the end of the session, the participant will be able to:

Learning Objectives:

1. Describe the diagnostic tools available for healthcare providers for SARS-CoV-2

2. Explain how diagnostics will aid with identifying infections and surveillance

3. Understand the difference between a molecular assay, an antigen assay, and serology test.

With over 6.7 million cases and over 213 countries and territories affected worldwide, the novel coronavirus (COVID-19) has challenged the world in several ways. As the global pandemic spreads across communities, there is an urgent need to test suspected COVID-19 persons at a mass level. Proper and quick diagnostic testing of COVID-19 specimens is important for early detection, and in turn, for a check on virus spread. The need for mass testing has increased the need for establishing coronavirus (COVID-19) diagnostic testing labs across the globe.

COVID-19 diagnostic testing laboratories perform varied tests, such as Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), serological tests for the detection of IgG/IgM antibodies, Enzyme-linked Immunosorbent Assay (ELISA), neutralization tests, and Rapid Diagnostic Tests (RDT). COVID-19 testing laboratories face several challenges on a day-to-day basis. Some of the challenges include:

• Recruiting experienced staff and training new in handling infectious specimens
• Standardizing and validating new test methods before testing COVID-19 specimens
• Procuring analytical equipment and lab supplies
• Reporting test results as per FDA and CDC guidelines
• Following international regulatory guidelines, such as CLIA, ISO 15189:2012, and HIPAA

Whether your diagnostic facility is expanding services to test COVID-19 specimens or you are establishing a new COVID-19 diagnostic testing laboratory, you need a Laboratory Information Management System (LIMS). A LIMS not only automates laboratory workflows but also helps securely manage sensitive patient data, plan training and mark staff competency, schedule instrument calibration, manage documents, such as SOPs, generate custom test reports, and follow regulatory guidelines, such as CLIA, ISO 15189:2012, and HIPAA.

Learning Objectives:

1. The talk delves into the major challenges faced by COVID-19 diagnostic testing laboratories and the urgent need for rapid testing of COVID-19 specimens

2. The talk describes the role of a LIMS in automating workflows, right from specimen collection to disposal. Furthermore, the talk delineates the significance of a LIMS in safeguarding sensitive patient data, validating test results, tracking turnaround time, generating reports as per FDA and CDC guidelines, sharing reports with physicians in real-time, and maintaining Quality Control (QC), and following regulatory guidelines such as CLIA, ISO 15189, and HIPAA.

Scientists worldwide are actively working to tame the COVID-19 pandemic by developing therapies for patients with severe disease and a vaccine to stem transmission. Accomplishing these two goals will require high resolution genetic information on both the SARS-Cov-2 virus and the host response to infection, beyond what suffices for diagnostic testing.

PacBio highly accurate long-read sequencing data is one tool scientists can use in their COVID-19 research. PacBio sequencing is unique in that it produces HiFi reads that are both long (up to 15 kb) and have very high base-level accuracy (>99.9%). These qualities are advantageous for applications that require phasing of SNVs across DNA amplicons and for resolving individual variants within complex populations of highly similar sequences. For example, in order to develop a broadly efficacious therapeutic or vaccine, scientists will need to understand how SARS-CoV-2 evolves within a host, over time in a community, and across geographic regions. An examination of currently public SARS-CoV-2 genomes shows how challenging getting high quality data can be with other sequencing approaches. Similarly, when mining the immune repertoire of recovered patients for therapeutics, researchers will need accurate and complete information on B cell receptors that can carry SNVs and indels along the entire length of the variable region. Furthermore, PacBio sequencing can directly detect and phase the germline IGH locus from which B cell receptors are derived, allowing researchers to connect phenotype to genotype without inference. In this presentation, we will discuss what PacBio sequencing can offer COVID-19 researchers as they strive to understand the biology underlying this global pandemic.

Learning Objectives:

1. Understanding how highly accurate long reads can be used to obtain high quality SARS-CoV-2 genomes with no gaps, and how this connects to virus research goals

2. Understand how highly accurate long reads can be used to understand the host immune response to SARS-CoV-2 infection.

As the outbreak of 2019 Novel Coronavirus, also known as COVID-19, makes headlines on a daily basis, molecular diagnostic firms are rapidly responding by developing tests that assist in diagnosing the disease and support outbreak control. The process from development to bringing a test to market is often complex and lengthy and the need to identify the SARS-CoV-2 pathogen that causes coronavirus disease 2019 is pushing diagnostics firms and their suppliers to perform at the top of their capabilities.

In this webinar, Dr. Geert Koene from Biosearch Technologies will share the perspective of a component supplier and will discuss details of the company's proprietary BHQ technology, experience in reacting to outbreaks, and the importance of a collaborative partnership.

This session introduces the keypoints in validating RT-PCR testing of SARS-CoV-2, and presents findings at a provincial center of CoVID-19 on positive rate of molecular testing from multiple specimen sources.

This presentation is provided in collaboration with: 

N  A  C  C  C  A

North American Chinese Clinical Chemists Association

The North American Chinese Clinical Chemistry Association (NACCCA) is a non-profit organization that currently serves hundreds of clinical chemists, scientists, physicians, and physicians from many different countries.

This presentation was organized by NACCCA and includes both this presentation and another scientific presentation, as well as a panel discussion. Laboratory methods, positive rate on various specimens, and method validation process will be introduced. The panel forum will focus on specimen collection process and safety for laboratory professionals.

Since the outbreak of CoVID-19 in Wuhan, China last December, the medical professional community have accumulated numerous experience that potentially will benefit other regions battling the disease. This session covers epidemiology and biology of SARS-CoV-2, nucleic acid and immunologic tests for SARS-CoV-2, and discharge criteria for recovered patients.

This presentation is provided in collaboration with: 

N  A  C  C  C  A

North American Chinese Clinical Chemists Association

The North American Chinese Clinical Chemistry Association (NACCCA) is a non-profit organization that currently serves hundreds of clinical chemists, scientists, physicians, and physicians from many different countries.

This presentation was organized by NACCCA and includes both this presentation and another scientific presentation, as well as a panel discussion. Laboratory methods, positive rate on various specimens, and method validation process will be introduced. The panel forum will focus on specimen collection process and safety for laboratory professionals.

The ongoing unprecedented outbreak of pneumonia caused by a novel coronavirus (SARS-CoV-2) in Wuhan, China has highlighted the necessity for readily available, accurate and rapid diagnostic testing methods. The laboratory diagnostic methods for human coronavirus infections have evolved substantially, with the development of novel assays as well as the availability of updated tests for emerging ones. Newer laboratory methods are rapid, highly sensitive and specific, and are gradually replacing the conventional gold standards. This presentation reviews the current laboratory methods available for testing coronaviruses by focusing on the SARS-CoV-2 outbreak going on in Wuhan. Viral pneumonias typically do not result in the production of purulent sputum. Thus, a nasopharyngeal swab is usually the collection method used to obtain a specimen for testing. Nasopharyngeal specimens may miss early infection; a deeper specimen may need to be obtained by bronchoscopy. While real-time PCR run on separately extracted nucleic acids has been urgently used with uncertain accuracy, serology may facilitate etiology diagnosis and ultimately play a major role in determining the epidemiology of this outbreak. Alternatively, repeated testing can be used because over time, the likelihood of the SARS-CoV-2 being present in the nasal-pharynx increases. Several integrated, random-access, point-of-care molecular devices are developing for rapid and accurate diagnosis of SARS-CoV-2 infections. These assays are simple, rapid and safe and can be used in the local hospitals and clinics bearing the burden of identifying and treating patients.

Humans are susceptible to many life-threatening viruses such as HIV, influenza and Ebola. The current coronavirus pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and was recognized as a pandemic by the World Health Organization (WHO) on March 11, 2020.  Rapid discovery and development of new therapeutics is therefore an absolute necessity to combat these viruses.

B cells from exposed patients are a potential source of viral neutralizing antibodies. We will demonstrate how B Cell Antibody Discovery on the Beacon® system can be used to rapidly screen human B cells to identify anti-viral antigen-specific antibodies in under a week.  B cells can be screened from both acute and convalescent patients. Our collaborators have already leveraged the speed of our platform to discover >500 antibodies to SARS-CoV-2 in a single day.

This workflow has the potential to enable rapid discovery of antibodies against difficult therapeutic targets such as SARS-CoV-2 and other viruses.

Learning Objectives:

1. Rapid discovery of antibodies against SARS-CoV-2 and other pandemic viruses
2. Screening of B cells to identify novel therapeutic antibodies
3. Rapid down-selection of lead candidates

With the discovery of idiopathic pneumonia in December 2019 began what is now the global pandemic of COVID-19.  Initially named 2019-nCoV, this disease is the clinical manifestation of a novel coronavirus first reported in Wuhan, China.  Coronaviruses are not new to humans, but their recent evolution has become a threat to them. How did all this lead to the present-day situation?  To understand that, this talk clearly explains the relevant variables in the equation: the science; the statistics; and the clinical profile, including management solutions and investigational agents.

Learning Objectives:

1. What kind of virus is the coronavirus? Where is its greatest vulnerability and why?

2. What differentiated the HCoVs discovered in the 1960s from the SARS-CoV and MERS-CoV?

3. What are the 4 structural proteins of coronaviruses and what are their functions? Which part is responsible for host cell receptor identification? S Which anchors the viral RNA? M What is the 5th structural protein found in beta coronaviruses?

The Year of Rat is unfortunately dominated by bats due to the COVID-19 outbreak. Although we are not 100% certain that this is a bat virus, all the evidence suggests that there is a high chance that it originated from bats.  This is a “SARS-like event caused be a SARS-like virus” based on the following: 1) the onset of the oubreak is in the Chinese winter (November – December); 2) the major transmission event(s) have a strong epidemiological link to wildlife market; 3) the virus belongs to the same species, SARS relative coronavirus (SARSr-CoV), as SARS-CoV; 4) a bat CoV genome detected in a horseshoe bat (RaTG13) is 96% identical in sequence to 2019-nCoV.
    
In exactly 25 years, we have had multiple zoonotic diseases outbreaks caused by bat-borne viruses or probable bat viruses:  Hendra in Australia (first detected in 1994), Nipah in Malaysia/Singapore (1998/9), SARS outbreak (2002/3), MERS outbreak (2012), large scale Ebola virus outbreak (2014) and the Covid-19 (2019/20).  

We have discovered that the bat’s innnate defense and tolerance responses are better balanced in comparison to other mammals.  On one hand, they have high basal level defense systems (such as DNA damage repair, heat shock, memberane efflux pumps) switched on before encountering danger signals.  On the other hand, they have evolved sophiscated mechnisms to prevent over reaction (such as over inflammation) upon viral infection and other cell stress signals.

It is now well recognized that bats are a special group of mammals execetptionally fit as natural reservoir of many different viruses.  If we don’t change the way we live, farm and eat, it is almost certain that such outbreak will happen again in the not to distant future.

Next-generation sequencing (NGS) is the primary technology used to identify genomic targets for vaccine development. Enhanced options for NGS on Illumina systems now make it possible to identify multiple potentially pathogenic strains of a disease and understand the rate of evolution quickly, with improved precision.

Two complementary sequencing methods are used to identify targets for vaccine development. Whole-genome sequencing using the Invitrogen Collibri DNA Library Prep Kits provide the entire genomic assembly, offering an improvement over older transposomic methods. Collibri 3ʹ mRNA Library Prep kits provide gene expression insights into pathogen, host and host-pathogen interactions that can be used to refine genomic targets for vaccine development.