A new ELISA test DIA®-SARS-CoV-2-nAb for qualitative and semi-quantitative detection of spike neutralizing antibodies in human serum and plasma has been launched. The assay can be used to determine the immune status of recovered COVID-19 patients as well as to assess protective humoral immunity after COVID-19 vaccination. The advantage of this test is the determination of neutralizing antibodies that prevent the virus binding to cells.
The test was included on 07.07.2021 in the "Register of persons responsible for the introduction of medical devices, active implantable medical devices, and medical devices for in vitro diagnostics into circulation" under No. 9405.