Access Biologicals completes first-ever commercial COVID-19 seroconversion panel to validate SARS-CoV-2 antibody assays
VISTA, Calif., Sept. 3, 2020 /PRNewswire/ -- Access Biologicals, a market leader in the collection and manufacturing of biologicals products, today announced it has completed the first-ever 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," said Mike Crowley, Managing Director 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 (ELISA) and chemiluminescent assays (CLIA) 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 U.S. Centers for Disease Control and Prevention (CDC) project. Access Biologicals will have further discussions with the CDC to find ways to use it in the convalescent-plasma development research field.
About Access Biologicals
Access Biologicals is recognized as the gold standard in plasma and blood collection, manufacturing and worldwide distribution. Licensed and registered by the FDA, CLIA and ISO certified, the company has a separate, closed-loop supply of human-based blood products and serves the diagnostic and life-sciences industries. Access Biologicals works in close collaboration with Grifols, a global healthcare company and leading producer of plasma therapies.
For more information on the growing Access Biologicals inclusive portfolio visit www.accessbiologicals.com
SOURCE Access Biologicals LLC