Eurofins Launches CE-IVD Marked Multiplex Real-Time PCR Assay for SARS-CoV-2 Detection

Eurofins Technologies (Budapest, Hungary) has launched 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).

The launch of Eurofins’ new 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. 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 has been spearheaded by affiliate companies, Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH and NovaTec Immundiagnostica GmbH, who are well-established providers of testing solutions with a strong focus on scientific excellence in infectious diseases testing. The affiliate companies have been collaborating closely with Eurofins scientists around the world in the design and validation of the new product.