Gold Standard Diagnostics products

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 GSD NovaPrime® TSP SARS-CoV-2 (COVID-19) is intended for the qualitative determination of SARS-CoV-2 genomic RNA in several respiratory sample types to aid in the diagnosis of COVID-19. This product represents an improvement in comparison to its former version GSD NovaPrime® SARS-CoV-2.

The GSD NovaType Detect + Select K417N SARS-CoV-2 is a research use only (RUO) real-time reverse transcription PCR (RT-PCR) assay designed for the simultaneous qualitative detection of SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) genomic RNA and identification of the spike (S) gene mutation K417N. It is intended to aid in the identification of SARS-CoV-2 variant of concern (VOC) Omicron.

CE marked, rapid and reliable RT-PCR assay for the differentiation of Omicron from other VOCs (Beta, Gamma, and Delta). GSD NovaType IV SARS-CoV-2 specifically identifies S gene mutations K417N, E484K, and L452R. Screening for S gene mutations K417N and L452R allows for active surveillance of variants Omicron and Delta, respectively.

Respiratory diseases caused by SARS-CoV-2, RSV, and Influenza virus have similar first clinical symptoms, and accurate identification is crucial for better patient care. Gold Standard Diagnostics’ new multiplex assays have been specifically designed to detect and differentiate these viral infections in the same PCR run. The Mplex SARS-CoV-2+, Flu A, Flu B (C1) RT-PCR assay allows to differentiate in a single reaction between Influenza A and B, and simultaneously detects two independent gene targets in SARS-CoV-2 (N-gene + RdRP-gene).

The AIX1000 is the world’s first fully automated system for nontreponemal RPR Syphilis testing. Simply load your reagents and up to 192 samples, then walk away. The AIX automates the processing, analysis, reporting and archival of results for both RPR screens and titers. Process and Machine for Automated Agglutination Assays with Image Automated Evaluation.

A one-plate ELISA+CLIA processor, the Bolt shares many features of the ThunderBolt, but with a more customizable, lower throughput, cost-effective design. The Bolt is a single compact machine that serves as all of the tools for processing an ELISA or CLIA assay (pipette, washer, incubator, shaker, reader). Our interactive user-friendly software provides a simple laboratory experience for instrument operation.

This flexible and convenient instrument is the ideal solution for full automation, from sample addition to strip scanning. With fast and quiet operation, and a user friendly interface, the Roboblot provides the laboratory with a reliable and robust solution for walk-away strip processing.