In a continued effort to help fight the COVID-19 crisis, Eurofins Technologies announces the CE-IVD marking of a first range of testing kits for serology-based antibody detection by ELISA of patients who have been exposed to COVID-19. The development of the assays has been spearheaded by affiliate companies Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, NovaTec Immundiagnostica GmbH and Ingenasa (Inmunologia Y Genetica Aplicada SA). Those specialized diagnostic technologies companies are well-established providers of testing solutions with a strong focus on scientific excellence in infectious diseases testing and immunology.
According to experts, there is a large range of applications for serologic testing. Serology can be used to complement the PCR swab testing that detects the virus to help diagnose acute infections status and its evolution. It can help estimate the timing of infection. As knowledge develops about the immunity to potential reinfection of patients having previously contracted COVID-19 and recovered, antibodies testing may provide information about statistically reduced contagion risks of and from these persons. It could help identify donors of plasma from recovered patients that can be transfused into COVID-19 patients as a potential treatment. Long-term, serologic tools can contribute to discriminating between vaccine-induced antibodies and natural infection. As the pandemic unfolds, serosurveys can enable tracking closely what percentage of the population has become infected in each city or region. Serosurveys may also help efforts to develop vaccines and therapies.
The novel antibody tests for IgG, IgM, and IgA are intended for the qualitative detection of IgG, IgA and IgM antibodies to SARS-CoV-2 virus in human serum to aid in the identification of persons having been exposed to SARS-CoV-2, the virus causing COVID-19. Initial testing on more than 200 healthy and potentially cross reacting samples, demonstrated a very high specificity. These tests can be used to provide valuable information on individual patients as well as larger cohorts. The assays are compatible with many open high-throughput automation platforms and can therefore provide important cost-efficient testing capacity at scale.
As the understanding of the virus and the associated immune response will improve over the next weeks, Eurofins Technologies scientific experts will continue to work on the development of additional serological tests.
“This launch is the result of the strong devotion of our scientists to our fight against COVID-19. They worked round the clock over the last six weeks to develop and optimise tests with very high specificity. This is important in order to minimise risks of false positive detections. We are very pleased to provide this additional testing option in a time when many governments around the world are considering suitable step-wise paths out of their lockdowns. Better understanding the epidemiology and spread of the virus is an important element in the fight against this pandemic. Eurofins Technologies companies will immediately start shipments in significant quantities and we will at the same time offer these tests as a service in Eurofins clinical laboratories around the world. Our four factories and partners are ramping up to produce kits to carry out over 10 million tests per month” commented Dr. Gilles Martin, Chief Executive Officer.
For more information on the solutions, please visit: www.goldstandarddiagnostics.com