The Gold Standard Diagnostics Group (GSD) including Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH today announced the immediate availability of three different serological assays for detection of antibodies against the novel coronavirus SARS-CoV-2. GSD followed the FDA’s Emergency Use Notification process as provided in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (March 16, 2020). These kits are now available worldwide. The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories each with a total incubation time of 90 minutes at room temperature with ready to use controls. The kits are designed to be run manually and on any open automated EIA platform. Several hundred samples were run in development studies including PCR confirmed patients, cross-reactive samples, and convalescent sample draws. According to experts, there is a large range of applications for serologic testing. As knowledge develops about the immunity to potential reinfection of patients having previously contracted COVID-19 and recovered, antibodies testing may provide information about statistically reduced contagion risks of and from these persons. Therefore, reliable detection of these antibodies will play an important role in combating the disease and preventing the spread of infections. GSD’s COVID-19 serology assays are designed to help patients and doctors and will be a valuable tool for epidemiological studies. Working with talented scientists who always put the patient first, and never compromise on quality has allowed Gold Standard Diagnostics to fast track high quality antibody assays to support global COVID-19 testing efforts. The ability to support antibody testing should increase our understanding of the disease and support health authorities in protecting the health of the population. Source
