COVID-19 pandemic has fundamentally changed the way people live and work around the world. Millions of people have been infected with no end in sight. There is a huge demand to expand the diagnostic capacity, and PCR-based tests alone can hardly meet the requirement.
Immunodiagnostic methods are valid alternatives to the PCR test. The target for immunodiagnostics can be either SARS-CoV-2 antigens (antigen test), or antibodies against these antigens (antibody test). So far, the FDA has approved 25 antibody tests under EUA. Most of the tests are built on lateral flow assay format. The antibody tests reveal the history of exposure and can be helpful for sero-surveillance studies. However, the presence of antibodies doesn't mean the person is carrying the SARS-CoV-2 virus, nor does it mean she's protected against future infection. Hence, the use of antibody tests is limited, and the result from such tests must be interpreted with caution.
Antigen tests can specifically tell whether the tested individual carries the virus or not. However, there are many challenges to develop antigen tests. The detection sensitivity issue is prominent, as the quantity of viral antigens is very low. Besides, the antigen assay depends on the availability of very specific antibodies. So far, only Quidel and Becton Dickinson (BD)'s antigen tests have received FDA EUA. The sensitivity of both products is around ~85%. Regardless of the challenges, antigen tests are of greater interest because it directly tells the presence of the infection. It's a faster, easier, and less expensive alternative to the PCR-testing.
The overarching goal of this webinar series is to provide a platform where new technologies can be shared among research and industrial leaders. The invited speakers are industrial and academic scientists working on a variety of novel diagnostic assays. The scope of the webinars include assays that:
1. detect the virus itself, or viral antigens, with high specificity and sensitivity
2. can allow high-throughput testing
3. can simultaneously detect multiple antigens and/or antibodies
4. use different detection systems than colloidal gold
These webinars are over now. To watch on-demand, please click the ”Watch” button below.
July 21, 2020 | 2 p.m. ESTAdarza BiosystemsAnalyzing the Human Antibody Response to Pandemic Respiratory Viruses with Adarza's New ZIVA™ Platform and High Definition Antigen Arrays: A Case Study on COVID-19
|Benjamin Miller, Ph.D.|
| Founder, Adarza Biosystems
Dean's Professor of Dermatology, Biochemistry and Biophysics, Biomedical Engineering, and Optics, University of Rochester
Detection of antibodies to upper respiratory pathogens is critical to surveillance, assessment of the immune status of individuals, vaccine development, and basic biology. The urgent need for antibody detection tools has proven particularly acute in the COVID-19 era. While most clinical diagnostics have focused on detection of antibodies to single antigens, array-based tools are desirable as methods for assessing broader patterns of antigen-specific responses, as well as providing information on SARS-CoV-2 immunity in the context of pre-existing immunity to other viruses. To that end, this talk will describe a multiplex label-free antigen microarray on the Arrayed Imaging Reflectometry (AIR) platform for detection of antibodies to SARS-CoV-2, SARS-CoV-1, MERS, three circulating coronavirus strains (HKU1, 229E, OC43) and three strains of influenza. As a label-free technology, AIR as implemented on the ZIVA™ platform provides rapid sample analysis via a simple, "one-step" workflow. The array is readily able to distinguish uninfected from convalescent COVID-19 subjects, and provides quantitative information about total Ig, as well as IgG- and IgM-specific responses.
July 23, 2020 | 2 p.m. ESTQuanterix | Institut PasteurCytokine Biomarkers of Inflammatory Response in COVID-19 Patients
| President, Chairman and CEO
|Dan Sikkema, Ph.D.|
|Vice President, Accelerator
and Pharma Services
|Darragh Duffy, Ph.D.|
LabEx Milieu Interieur, Institut Pasteur
Ultrasensitive SIMOA™ Immunoassays Impacting COVID-19, Infectious Diseases, and Immunology
As COVID-19 pandemic preparedness initiatives ramp up to address the current crisis, one area of focus has been the improvement of testing methods to re-open society. Differentiating early symptoms from other respiratory pathogens that have a similar clinical presentation, identifying those patients at risk for severe symptoms such as "cytokine storm," and determining immunity status have been hallmarks of scientific efforts over the past several months. The Quanterix SIMOA™ platform is an ultra-sensitive immunoassay system that is typically 100-1000-fold more sensitive than most ELISA systems. This level of sensitivity offers the ability to detect and quantitate key cytokines involved early in the disease progression and provides insight like "a radar system" into "prediction" of subsequent immune complications. Here we describe efforts around frontline immunological and serologic assessments of COVID-19 patients and examples of historical approaches for auto-immune, vaccine, and infectious disease research using SIMOA technology.
Impaired Type I Interferon Activity and Exacerbated Inflammatory Responses in Severe Covid-19 Patients
Coronavirus disease 2019 (Covid-19) is characterized by distinct patterns of disease progression implying diverse host immune responses. We performed an integrated immune analysis on a cohort of fifty Covid19 patients with various disease severity. A unique phenotype in severe and critical patients was identified. It consisted of a profoundly impaired interferon (IFN) type I response characterized by no IFN-b and low IFN-a production and activity, associated with a persistent blood virus load and exacerbated inflammatory response. The cytokine storm was partially driven by the transcriptional factor NFkB and characterized by increased tumor necrosis factor (TNF)- a and interleukin (IL)-6 production and signaling. We propose that type-I IFN def.
July 28, 2020 | 2 p.m. ESTGyros Protein TechnologiesMicrofluidic, Nanoliter-scale Immunoassays for Rapid SARS-CoV-2 Antibody Analysis in Serology Testing, and Vaccine and Biotherapeutics Development
|Rob Durham, Ph.D.|
| Director of Service and Scientific Support
Gyros Protein Technologies
The unprecedented vaccine and therapeutic development efforts in response to the COVID-19 pandemic has created an urgent need for rapid, accurate, and sensitive assays to measure antibody responses to the SARS-CoV-2 virus. To meet this need, a microfluidic, nanoliter-scale immunoassay for qualitative detection of total antibodies generated against the spike protein (RBD) of SARS-CoV-2 in human serum samples has been developed using Gyrolab immunoassay platform. The assay shows specificity towards SARS-CoV-2 antibodies in serum samples, and a broad range of approximately 40 to 200,000 ng/mL. With an assay completion time of one hour for 112 data points, high-throughput analysis is possible for serology tests and for immunoassays during vaccine or antibody therapeutic development.
July 30, 2020 | 2 p.m. ESTUniversity of MichiganRapid and Quantitative Detection of SARS-CoV-2 Specific IgG for Convalescent Plasma Therapy
|Xiaotian Tan, Ph.D.|
| Research Fellow
University of Michigan
COVID-19 pandemic has caused more than a half-million of deaths and is now a severe threat to global health. Clinical practice has demonstrated that the SARS-CoV-2 S1 specific antibodies (especially IgG) can be used as a prognostic marker of COVID-19. More importantly, neutralization IgG is the major effective ingredient in convalescent plasma therapy. Thus, knowing the concentration of SARS-CoV-2 S1-specific IgGis important for selecting appropriate convalescent plasma donors. However, the popular point-of-care biomarker detection technologies, such as the lateral-flow test strips, provide only yes/no information and have very limited sensitivities. Thus, it cannot be used for the quantitative evaluation of the therapeutic efficacy of the recovered patient's plasma/serum. Conventional ELISA (enzyme-linked immunosorbent assay), on the other hand, can provide quantitative, accurate, and sensitive results, but it involves complicated and expensive instruments and long assay time. In addition, samples need to be sent to centralized labs, which significantly increases the turn-around time. Here, we present a microfluidic ELISA technology for rapid (<15 min), quantitative, sensitive detection of SARS-CoV-2 S1 specific IgG in human serum. We also characterized various humanized monoclonal IgG and identified a candidate, D006, which has a high binding affinity and a relatively high specificity towards SARS-CoV-2 S1 protein that can serve as the calibration standard of anti-SARS-CoV-2 S1 IgG in serological analyses. With the aforementioned technology, we demonstrated that we were able to identify the best donor candidate for the convalescent plasma therapy, with a tiny drop of blood sample (<8 µL) and a fixed dilution factor (200 X). In addition, we also demonstrated that our microfluidic ELISA technology can sensitively detect SARS-CoV-2 antigens (S1 and N proteins) with LLODs at ~10 pg/mL in <40 minutes. Therefore, our technology will greatly facilitate rapid and quantitative analysis of COVID-19 related markers for both therapeutic and diagnostic purposes.
August 4, 2020 | 2 p.m. ESTE25BioFrequency of Direct Antigen Rapid Testing for COVID-19 Reduces Transmission
|Bobby Brooke Herrera, Ph.D.|
| Co-founder & Interim CEO, CSO, E25Bio, Inc.
Visiting Scientist, Harvard T.H. Chan School of Public Health
SARS-CoV-2, the causative agent of COVID-19, can spread from individuals with pre-symptomatic, symptomatic, and asymptomatic infections. As such, the COVID-19 pandemic has created a global public health crisis. Re-opening of societies and the control of virus spread will be facilitated by wide-scale surveillance. This talk describes development of an immunochromatographic assay for rapid detection of SARS-CoV-2 antigen, highlighting analytical and clinical performances. The talk also describes mathematical models of COVID-19 transmission in a major U.S. city, demonstrating that effective surveillance depends largely on frequency and coverage of testing.
August 6, 2020 | 2 p.m. ESTNirmidas Biotech | Stanford UniversityHigh-Accuracy Multiplexed SARS-CoV-2 Antibody Assay with Avidity and Saliva Capability on a Nano-Plasmonic Platform
|Meijie Tang, Ph.D.|
Nirmidas Biotech Inc.
|Hongjie Dai, Ph.D.|
Department of Chemistry and
Bio-X, Stanford University
The outbreak and rapid spread of SARS-CoV-2 virus has led to a dire global pandemic with millions of people infected and ~ 400,000 deaths thus far. Highly accurate detection of antibodies for COVID-19 is an indispensable part of the effort to combat the pandemic. In this talk I will present two-plex antibody detection against SARS-CoV-2 spike proteins (the S1 subunit and receptor binding domain RBD) in human serum and saliva on a near-infrared nano-plasmonic gold (pGOLD) platform. By testing nearly 600 serum samples, pGOLD COVID-19 assay achieved ~ 99.78 % specificity for detecting both IgG and IgM with 100 % sensitivity in sera collected > 14 days post disease symptom onset, with zero cross-reactivity to other diseases. Two-plex correlation analysis revealed higher binding of serum IgM to RBD than to S1. IgG antibody avidity toward multiple antigens were measured, shedding light on antibody maturation in COVID-19 patients and affording a powerful tool for differentiating recent from remote infections and identifying re-infection by SARS-CoV-2. Just as important, due to high analytical sensitivity, the pGOLD COVID-19 assay detected minute amounts of antibodies in human saliva, offering the first non-invasive detection of SARS-CoV-2 antibodies. If time permits, this talk will also briefly present a rapid test of IgG/IgM assay for SARS-CoV-2 developed by the Nirmidas Team.
August 13, 2020 | 2 p.m. ESTGator BioNext Generation BLI: Novel Applications in the Fight against COVID-19
|Hong Tan, Ph.D.|
Biolayer Interferometry (BLI) is widely accepted in the biopharmaceutical industry for quantitation and kinetics analysis of biomolecules. Gator Bio, a company started by the founder of ForteBio and the inventors of Octet, has created the next generation of BLI technology. This presentation will introduce the Gator instruments and associated biosensing probes, and highlight how Gator can help scientists research SARS-CoV-2 virus and develop COVID-19 drugs and vaccines. Several application examples will be presented to demonstrate Gator's capability to generate high-quality, information-rich datasets.