1:00 Antibody Testing for COVID-19

Alan H.B. Wu, PhD, Professor, Laboratory Medicine, University of California, San Francisco; Chief, Chemistry and Toxicology, San Francisco General Hospital

Individuals who are infected with SARS-CoV-2 first produce IgM within 7-10 days, followed by IgG antibodies a few days later. While the presence of antibodies confers an infection, it does not necessarily mean an individual is immune towards a future a re-infection. Antibodies that demonstrate virus neutralization will be required for better adoption of this test.

1:20 The Critical Role of Antigens and Antibodies in SARS-CoV-2 Serological Test Development

Yinan Jiang, PhD, Product Development Manager, ACROBiosystems

High-quality recombinant SARS-CoV-2 antigens and antibodies are key reagents in the development of SARS-CoV-2 serological test kits. ACROBiosystems has developed a series of SARS-CoV-2 antigen and antibody products that can be used in serological tests. ACROBiosytems has launched well-folded SARS-CoV-2 spike protein that have been verified as trimer by MALS and nsEM. The use of optimized RBD protein and biotinylated spike protein provided by ACROBiosytems can improve diagnostic sensitivity and specificity. Neutralizing Anti-SARS-CoV-2 antibodies and matched antibody pairs developed by ACROBiosytems can be utilized as quality control in antibody test development and as detecting reagents in antigen test development, respectively.

1:40 Antigen Selection for the Development of a Semi-Quantitative SARS-CoV-2 IgG Automated Immunoassay LDT

Chris DiPasquale, Director, Assay Development, Babson Diagnostics

SARS-CoV-2 serology testing is a promising tool for understanding and monitoring COVID-19 immune response, re-opening the shuttered economy, and restoring the community’s way of life. As COVID-19 cases increase, and the global race to develop effective therapeutics and vaccines intensifies, antibody testing may become a necessity. Quantitative serology tests, in particular, may act as essential companion diagnostic tools for vaccine development and monitoring, disease management, and epidemiological studies. Antigen selection plays a critical role in developing serology assays capable of supporting these endeavors, and consequently, Babson Diagnostics is actively comparing commercially available antigens and investigating their role in clinical sensitivity, specificity, and detection of neutralizing antibodies.

On June 23, 2020, Babson Diagnostics received Emergency Use Authorization from the FDA for its fully automated, high-throughput qualitative IgG antibody test, Babson Diagnostics aC19G1, which demonstrated 100% sensitivity and 100% specificity in clinical performance evaluation. Babson’s second-generation serology test, a quantitative IgG antibody test called aC19G2, is currently in development. The company is using their commercialized and investigational tests in a series of clinical studies aimed at improving understanding of SARS-CoV-2 immune response over time.

Speaker Biographies

Alan H.B. Wu, PhD
Professor, Laboratory Medicine, University of California, San Francisco; Chief, Chemistry and Toxicology, San Francisco General Hospital

Alan H.B. Wu is Chief of Chemistry and Toxicology at San Francisco General Hospital Professor of Lab Medicine, University of California, San Francisco. He is certified by the American Board of Clinical Chemistry in Clinical Chemistry and Toxicological Chemistry. His research interests include pharmacogenomics, clinical toxicology, cardiac biomarkers, point-of-care testing, and more recently, COVID-19 testing. Dr. Wu has over 400 publications in peer-reviewed journals. He has also written five paperback books consisting of short stories designed to promote the value of the clinical laboratory to the general public.

Yinan Jiang, PhD
Product Development Manager, ACROBiosystems

Dr. Yinan Jiang is an expert on structural studies of protein complexes involved in virus-host interaction. His research focuses on elucidating the molecular mechanism of virus cell entry and viral immune evasion, including coronaviruses and influenza viruses. He has published research papers in high-profile journals such as Cell Research and Protein Cell. Dr. Jiang is currently working as Product Development Manager at ACROBiosystems. He is in charge of developing SARS-CoV-2 antigen proteins and kits for research use. Dr. Jiang received his bachelor’s degree in Biochemistry from Jilin University and completed his PhD studies in Structural Biology at Tsinghua University.

Chris DiPasquale
Director, Assay Development, Babson Diagnostics

Chris DiPasquale is the Director of Assay Development for Babson Diagnostics. Chris holds more than a decade of experience in clinical assay R&D from Siemens Healthineers with a heavy focus on reagent optimization, method integration, and verification. He has applied Six Sigma principles to develop commercialized products used in laboratories across the globe, including Vitamin D, ELF, and high-sensitivity Troponin I. Chris is responsible for designing, verifying, and validating the laboratory-developed tests deployed in Babson Diagnostics’ CAP-accredited, high-complexity CLIA laboratory in Central Texas. Chris earned his bachelor's degree in biotechnology and biochemistry from Rutgers University in New Brunswick, New Jersey. When he's not working in the lab, you can find hiking, gardening, bird watching or playing guitar.