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 percent was determined.