St. Petersburg Pasteur Institute has developed and registered the first ELISA assay in the Russian Federation for the quantitative detection of antibodies to SARS-CoV-2 in the blood of people who have gone through this infection or simply previously had contact with SARS-CoV-2 but no clinical symptoms. Unlike other similar test kits, it allows to assess not only the presence of antibodies itself, but also the concentration of specific antibodies, which is very important for understanding the level of protection of the person against reinfection.
This diagnostic kit is used to assess the development of humoral immunity to SARS-CoV-2 throughout the course of treatment in patients with COVID-19, as well as to assess the degree of antibody response in recovered patients and to assess the level of population immunity in healthy people.
The quantitative content of antibodies in clinical samples is determined using a calibration curve. The antibody concentration is calculated in arbitrary units (AU/mL). This assay has a high analytical sensitivity. It can be used to assess antibody immune response levels from very low to very high, which makes this assay indispensable for making a decision on additional vaccination against SARS-CoV-2.
Clinical and laboratory tests have confirmed the effectiveness of the diagnostic kit for assessing the quantitative content of IgG antibodies to SARS-CoV-2 N-protein in positive serum and plasma samples.
Thus, the latest data of scientific literature regarding studies which proved a high positive correlation between the level of IgG antibodies to the N-protein in the blood of patients who were infected with COVID-19 and the level of SARS-CoV-2 neutralizing antibodies was confirmed.
Registration certificate for “ELISA Kit for quantitative determination of human IgG antibodies to SARS-CoV-2 N protein (N-CoV-2-IgG PS), series 001” No. RZN 2021/14085 dated 04/14/2021, valid by 01.01.2022.
This ELISA Kit is approved for circulation on the territory of the Russian Federation.