Eurofins Technologies announces 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.

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.

With the continued rise of new COVID-19 cases around the world, rapid, highly-sensitive, and cost-effective point-of-care testing is an essential component of healthcare measures to address the pandemic. The introduction of INgezim COVID-19 CROM is a demonstration of Eurofins´ commitment to supporting healthcare providers and national and state authorities in their ongoing efforts to mitigate the spread and impact of the virus.

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 labor- and equipment-intensive methods. The tests are intended for use by healthcare professionals, not for self-diagnosis.

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.

Development of the testing devices was led by Eurofins Ingenasa. For more than 35 years, Eurofins Ingenasa has developed diagnostic tests supporting the control of infectious diseases in both veterinary and, more recently, human diagnostics. Eurofins Ingenasa is a member of the Eurofins Technologies group of companies.