Gold Standard Diagnostics Launches COVID-19 Antibody Tests

The Gold Standard Diagnostics Group {(GSD) Davis, CA, USA), which comprises Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH, have launched three different serological assays for the detection of antibodies against the novel coronavirus SARS-CoV-2, following Emergency Use Authorization (EUA) granted by the Food and Drug Administration (FDA).

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 re-infection of patients having previously contracted COVID-19 and recovered, antibodies testing may provide information about statistically reduced contagion risks of and from these persons. Hence, 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. The ability to support antibody testing should increase understanding of the disease and support health authorities in protecting the health of the population.

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The Gold Standard Diagnostics Group