NANOLEK was awarded market authorizations for test kits to determine IgM and IgG antibodies against SARS-CoV-2 antigen in blood serum. Records RZN 2020/10959 (IgG) and RZN 2020/10963 (IgM) were included in the register on the website of Roszdravnadzor. These are the first market authorizations of NANOLEK for medical devices.
Diagnostic test kits help determine your immune response to COVID-19 using ELISA method (biomaterial: blood). The presence of a minimum reference quantity of IgM antibodies may point to the onset and acute phase of the disease. The presence of IgG antibodies indicates the start of production of antibodies in blood against COVID-19 and a past disease that was asymptomatic or occurred with mild symptoms (similar to ARVI).
Maxim Stetsyuk, Executive Director of NANOLEK:
“Not so long ago the whole world and our country started returning slowly to normal life and usual rhythm. However, the media often publishes data and facts about asymptomatic transmission of COVID-19, people want to know information, and therefore it is important and necessary to pass antibody tests. We stay always in touch with our regional representatives in various regions of Russia and are well aware of their needs. In particular, we have received many times requests for diagnostic test kits. Therefore, it was decided to supply such systems to meet the demand in market in order to diagnose COVID-19, including in the Russian regions. There are signs that the pandemic is on the decline, but there is a great need for high-quality diagnostic and rapid test systems which we can use to quickly find out the presence or absence of IgG and IgM antibodies.”