Eurofins Technologies 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.