ADMA Biologics, Ramsey, NJ, has launched Covid-19 ImmunoRank Neutralization Micro-ELISA, a proprietary, fully validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank was developed in collaboration with Leinco Technologies, Boca Raton, Fla. ImmunoRank is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV 2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV 2 neutralizing antibodies in human plasma of all immune globulin classes. ImmunoRank is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes. An emergency use authorization (EUA) submission is currently being prepared for review and potential approval by the FDA. ADMA has submitted patents for ImmunoRank in the United States and certain foreign markets. Both ADMA and Leinco are named as co-inventors on the patents. “We are confident the ImmunoRank assay will be an efficient and effective tool for selecting high titer convalescent plasma units containing neutralizing antibodies to SARS-CoV-2 both for the treatment of covid-19 patients as well as identifying plasma that can be used for development and production of hyperimmune globulins to treat covid-19,” says Adam Grossman, president and chief executive officer of ADMA. “Current screening methods to identify circulating SARS-CoV-2 neutralizing antibodies are labor and cost intensive and take multiple days to complete. This assay can be run in approximately 80 minutes, resulting in numerous tests per day, and can be performed at a fraction of the cost of other, more laborious assays. We believe this proprietary assay will result in important potential product and business development opportunities as we continue to seek out meaningful ways to help patients battling covid-19.” For more information, visit ADMA and Leinco Technologies.
September 9, 2008