Eurofins Launches Range of ELISA Testing Kits for COVID-19 Antibody Detection

Eurofins Technologies (Budapest, Hungary), a provider of diagnostic technologies in the field of immunoassays and molecular detection methods, has launched a 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 its affiliate companies Gold Standard Diagnostics Inc., Virotech Diagnostics GmbH, NovaTec Immundiagnostica GmbH and Ingenasa (Inmunologia Y Genetica Aplicada SA). These are specialized diagnostic technologies companies who provide testing solutions with a focus on scientific excellence in infectious disease testing and immunology. The first ELISA assays are expected to receive the CE-IVD mark by April 16, 2020 and will also be submitted to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).

Over the last six weeks, in close collaboration with leading research hospitals and many of Eurofins human clinical testing laboratories around the world, Eurofins Technologies has been working to develop a broad range of testing methods to support healthcare providers around the world. The company plans to release antibody tests for IgG, IgM, and IgA with very good specificity and sensitivity for use on any open ELISA platform. As an additional option with fast turnaround time, it is also developing and validating an easy-to-use rapid lateral flow antibodies test. The company’s affiliate, Gold Standard Diagnostics is offering a suite of instruments for the seamless automation of ELISA assay testing in any laboratory.

Additionally, Eurofins laboratories around the world have developed a range of RT-PCR tests for the qualitative detection of SARS-CoV-2. These tests are designed to meet the region-specific requirements for COVID-19 targets. Viracor Eurofins has already received FDA EUA for its SARS-CoV-2 Laboratory Developed Test (LDT). Other Eurofins laboratories around the world have developed alternative RT-PCR options to meet local regulatory obligations and mitigate reagent supply chain issues to enable Eurofins to continue to significantly increase the testing capacity it offers to health authorities fighting the disease.

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