Belgium's Federal Agency for Medicines and Health Products (FAMHP) has recommended Novatec's COVID-19 ELISA test after excellent clinical performances were reported in its first external validation at the Iris Sud Hospitals, Brussels.

Using 208 samples from 48 RT-qPCR confirmed COVID-19 positive individuals, Novatec's NovaLisa^® IgG test and IgA test demonstrated a sensitivity of 94.9% for IgG and 89.7% IgA.

Furthermore, the validation used non-SARS-CoV-2 sera, with a potential for cross-reactivity to assess the tests' specificity, in which it showed a 96.2% specificity for IgG and 98.7% for IgA. 

These tests are CE-IVD marked and immediately available. The development of the assays has been spearheaded by affiliate companies Gold Standard Diagnostics Inc., NovaTec Immundiagnostica GmbH, and VIROTECH Diagnostics GmbH.

The NovaLisa^® SARS-CoV-2 (COVID-19) ELISA serological assays feature separate detection of IgG, IgA, and IgM antibodies. These three assays use the nucleocapsid protein (N protein) as antigen for the detection of antibodies to SARS-CoV-2, as it plays an important role in viral pathogenesis, replication and RNA packaging. NovaLisa® assays can be automated on several open ELISA systems providing quick results.

For further information, please go to novatec-id.com or use the 'Request Information' button provided below.