Eurofins Technologies (Paris:ERF) announces the launch of a serology-based total antibody (IgG, IgA and IgM) detection ELISA assay for indirect diagnostic of past exposure to COVID-19. The development of the assay has been led by Eurofins Ingenasa, a Eurofins Technologies company involved in the development of diagnostic tests for over 35 years.
The CE-IVD marked INgezim COVID 19 DR is a dual recognition enzyme-linked immunosorbent assay (ELISA) capable of detecting semi-quantitatively total SARS-CoV-2 specific antibodies (IgG, IgM and IgA) in a single human serum or plasma sample. The assays use the SARS-CoV-2 nucleoprotein (N protein) as antigen for the detection of antibodies to SARS-CoV-2. The N protein is one of the most abundant early-onset proteins of the virus, as well as being highly immunogenic and therefore a good candidate antigen for the diagnosis of COVID-19.
Validation of the assay with a panel of 332 well characterized sera samples confirmed an analytical sensitivity of 100% from day 17 after symptoms onset (85% between days 7 and 16) and a specificity of 99.2%. No cross-reactivity with other respiratory coronaviruses (229E, NL63, OC43 and HKU1) was detected and no interferences have been found for antibodies for respiratory viruses such as Influenza or RSV.
These ELISA assays are compatible with various open-platform ELISA analysers.
Eurofins Technologies companies NovaTec, VIROTECH and Gold Standard Diagnostics have previously launched serological tests for the individual determination of IgG, IgM and IgA antibodies in April 2020. Today’s announcement completes the Group’s offering for antibody testing by ELISA.
For more information on the assay, please visit the Eurofins Technologies webpage and https://www.eurofins.com/media-centre/press-releases/2020-06-03/.
About Eurofins – the global leader in bio-analysis
Eurofins is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global market leaders in testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in esoteric and molecular clinical diagnostic testing.
With over 47,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods.
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