Access Biologicals

Sep 4, 2020

Published on   Access Biologicals, Vista, Calif, announced it has completed the first commercially available covid-19 seroconversion panel to confirm the presence of anti-SARS-CoV-2 antibodies. Efforts to contain the spread of covid-19 rely in part on serological tests to identify the presence of anti-SARS-CoV-2 antibodies in people who have had the illness. Until now, however, many of these tests have been developed rapidly and without the independent data to help assess their analytical performance and enable comparisons between different testing methods. With Access Biologicals’ seroconversion panel, diagnostic manufacturers, clinical laboratories, and researchers will have a reliable benchmark against which they can develop, validate, and troubleshoot other covid-19 serological assays and testing. “An effective, sensitive, and specific way to identify and confirm the SARS-CoV-2 infection is urgently needed,” says Mike Crowley, managing director of Access Biologicals. “Our covid-19 seroconversion panel will help serological assays bridge the gap through precise validation, establishing sensitivity and helping determine the pre-seroconversion window period, which is the time after infection and before seroconversion, when antibodies appear.” Collected in a longitudinal series, the Access Biologicals covid-19 seroconversion panel consists of 14 members (units) of a unique human plasma sample drawn from a single donor during a developing SARS-CoV-2 infection. The panel illustrates the onset and decline of IgM, IgG, and Ig total SARS-CoV-2 virus antibody titers over a period of 87 days. The covid-19 seroconversion panel was tested against enzyme-linked immunosorbent assays and chemiluminescent assays to track anti-SARS-CoV-2 antibody generation over time. Anti-SARS-CoV-2 antibody detection is a valuable tool for identifying covid-19 immune responses, particularly in asymptomatic and convalescent patients. The covid-19 seroconversion panel has already been included as an assessment tool for commercial covid-19 serological diagnostic kits in a US Centers for Disease Control and Prevention project. Access Biologicals will have further discussions with the CDC to find ways to use it in the convalescent-plasma development research field. Featured image: Testing for the novel coronavirus, SARS-CoV-2 (shown here in an electron microscopy image), can help scientists trace the pathogen’s spread and stop the chain of transmission. Courtesy National Institute of Allergy and Infectious Diseases, NIH.