***GSD Serology Update: Gold Standard Diagnostics SARS-COV-2 ELISA kits have been submitted to the FDA for EUA.***

GOLD STANDARD DIAGNOSTICS SARS-COV-2 CLINICAL DIAGNOSTIC KITS – QUICK AND EFFECTIVE

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 detection of antibodies to SARS-CoV-2.  The portfolio includes a separate IgG and IgA assay, as well as a total antibody 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).  The assays are available for immediate sale in the US.

All assays utilize the SARS-CoV-2 nucleoprotein (N protein) as the antigen for the detection of antibodies to SARS-CoV-2 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 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.

COVID-19 IGG AND IGA ELISA ASSAYS

Assay Features

- Separate Detection of IgG and IgA Antibodies
- Advantages of GSD Reagent System
- Total incubation under 2 hours Ready to use controls
- Assay procedure is easy to automate

Ordering Info:

Art. NO.

GSD01-1028

GSD01-1029

Product

SARS-CoV-2 IgG

SARS-CoV-2 IgA

COVID-10 TOTAL ANTIBODY ELISA

Assay Features

- Double recognition ELISA for the determination of total antibodies in serum samples. Capable of detecting all isotypes (IgG, IgM, and IgA) in a single sample
- Total incubation: 1 hour and 15 minutes
- No sample pre-dilution required
- Assay procedure is easy to automate

Art. NO.

GSD.R.50.CoV.K0

Product

GSD INgezym COVID 19 DR