***GSD Serology Update: Gold Standard Diagnostics SARS-COV-2 ELISA kits have been submitted to the FDA for EUA.***
GSD’s COVID-19 EIA IgA, IgG, and IgM Assays Are Available!
The Gold Standard Diagnostics Group, including Gold Standard Diagnostics Inc, VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH, is proud to announce the availability of multiple immunoassays for the separate detection of IgA, IgG, and IgM antibodies to 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). The assays are available for immediate sale in the US.
These assays utilize a SARS-CoV-2 recombinant antigen and have 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 assay workflow is a simple 30:30:30-minute timing scheme at room temperature for ease of use on any open ELISA automation platform.
The Gold Standard Diagnostics Group takes a deliberate approach to assay development to ensure that performance and supply will meet our customer’s expectations.
Sample matrix: Serum
Incubation time: 30min/30min/30min
Incubation Temperature: Room temperature
Antigen: Recombinant antigen for excellent sensitivity and specificity