EUROFINS
Regulatory News:
Eurofins Technologies (Paris:ERF) announces the launch of its CE-IVD marked multiplex Real-Time RT-PCR (reverse-transcriptase polymerase chain reaction) assay for the direct qualitative pathogen detection of the novel coronavirus (SARS-CoV-2). Particularly in the early phase of COVID-19 infection, the direct and precise diagnostic of the pathogen is key. PCR is the method of choice to detect acute coronavirus infections.
The development of the assay has been 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 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 are 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 launch of the GSD NovaPrime® SARS-CoV-2 (COVID-19) Real-Time PCR follows the commercialization of CE-IVD marked serology-based antibody detection ELISA kits that were successfully launched in April 2020.
For more information on the COVID-19 solutions, please visit: www.goldstandarddiagnostics.com
Notes for the editor:
About Eurofins Technologies – a fast growing provider of diagnostic technologies in the field of immunoassays and molecular detection methods
Building on the experience and scientific excellence of the Eurofins Group, Eurofins Technologies is a fast growing global provider of diagnostic technologies and industry-leading ELISA-based instruments in the field of bioanalytical testing for the food, feed, environmental, animal health, and clinical diagnostics industries.
Its R&D teams located at various sites around the world share their expertise in developing a wide range of innovative methods and applications with a focus on immunoassays and molecular testing. For further information, please visit the Eurofins Technologies website.
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