Eurofins Technologies (Paris:ERF), a global provider of fast, reliable, and easy to use diagnostic test kits and instruments in the fields of bioanalytical testing for the food, feed, environmental, biopharma and clinical industries, announced on Tuesday the launch of CE-IVD marked rapid point-of-care testing devices to identify a person's past exposure to COVID-19 (SARS-CoV-2) in only 10 minutes.

The serology-based, finger-prick tests detect virus antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms.

According to the company, the CE-IVD marked INgezim COVID-19 CROM dual-recognition immunochromatographic assays determine the presence of total antibodies (IgG, IgA and IgM) specific to SARS-CoV-2 in a single blood, serum, and plasma sample by using nucleoprotein (N protein) as an antigen for detection of virus antibodies. The N protein is one of the most abundant early-onset proteins of the virus and is highly immunogenic, making it a reliable antigen candidate for the diagnosis of SARS-CoV-2.

The CE-IVD marked kits include all materials required to perform the finger-prick test. The analysis can be performed outside of the laboratory, representing significant cost and time savings compared to other labour- and equipment-intensive methods. The tests are intended for use by healthcare professionals, not for self-diagnosis.

Also, validation of the assays was determined with a panel of more than 400 well characterised sera samples. No cross-reactivity with other respiratory coronaviruses (229E, NL63, OC43 and HKU1) was detected and a specificity of 99.3% was determined, the company added.