Davis, CA – May 12, 2020. Gold Standard Diagnostics Inc. today announced the EUA submission of a Multiplex Real-Time, reverse-transcriptase polymerase chain reaction (RT-PCR) assay for the direct qualitative pathogen detection of the novel coronavirus (SARS-CoV-2). The assay is available now for purchase in the U.S. Particularly in the early phase of COVID-19 infection, the direct and precise diagnostic of the pathogen is critical. PCR is the method of choice to detect acute coronavirus infections.
The GSD NovaPrime® SARS-CoV-2 (COVID-19) is a Multiplex Real-Time PCR for the direct qualitative pathogen detection of SARS-CoV-2. The assay simultaneously detects two target sequences inside the N gene. The Multiplex PCR allows a streamlined workflow in one reaction and provides results in approximately two hours. An extraction/inhibition control and a positive control is included in the reagents.
The PCR assay demonstrates excellent performance with a 100% negative and positive percent agreement (NPA, PPA) for all tested samples and no cross-reactivity with other common widely spread coronaviruses. The analytic sensitivity shows a limit of detection of 3.75 copies/reaction.
The development of the assay is spearheaded by affiliate companies Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH and NovaTec Immundiagnostica GmbH. These specialized diagnostic technologies companies are well-established providers of testing solutions with a strong focus on scientific excellence in infectious-diseases testing. They have been collaborating closely with Eurofins scientists around the world in the design and validation of the new product.
The launch of the GSD NovaPrime® SARS-CoV-2 (COVID-19) Real-Time PCR is the second product line released by GSD in the last month following the CE-IVD marked serology-based antibody detection COVID-19 ELISA kits that were successfully launched in April 2020.