Today Eurofins Technologies announced 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 disease 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 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.