The Gold Standard Diagnostics Group, including Gold Standard Diagnostics Inc, VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH, is proud to announce the availability of the SARS-CoV-2 ELISA IgG assay. 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 (May 11, 2020). This assay are available for immediate sale in the US.
The SARS-CoV-2 IgG ELISA assay utilizes the SARS-CoV-2 nucleoprotein (N protein) as the antigen for the detection of antibodies to SARS-CoV-2 and has been tested against numerous cross-reactive viral species. Several hundred samples have been run on the assay from healthy blood donors, cross-reactive samples, positive COVID-19 patients, and negative COVID-19 patients. The N protein is one of the most abundant early-onset proteins of the virus, as well as being highly immunogenic and therefore a good candidate antigen for the diagnosis of COVID-19. Thus, it is a complementary technique to PCR, especially in those cases where PCR gives a negative result.
The Gold Standard Diagnostics Group takes a deliberate approach to assay development to ensure that performance and supply will meet our customer’s expectations.
- Detection of IgG Antibodies
- Advantages of GSD Reagent System
- Total incubation under 2 hours Ready to use controls
- Assay procedure is easy to automate