GENERIUM became the first company registered a unique combination of high-precision tests for the detection of antibodies of three classes to the SARS-CoV-2 coronavirus (COVID-19)

All three test systems were developed by Medical Biological Union LLC and will be manufactured by GENERIUM JSC in partnership with Medical Biological Union LLC. These test systems allow for high-accuracy determination of fast response immunoglobulins, such as А (IgA) and М (IgM), as well as immunoglobulins G indicative of a stable immune response (IgG):

• The first test Antigma-screen allows detecting antibodies of all three classes to the SARS-CoV-2 coronavirus (COVID-19). This test makes it possible to identify all patients who have ever met an infection, including those who have recovered and asymptomatic ones.

• The second test Antigma-A is intended for the qualitative detection of IgA antibodies to the SARS-CoV-2 coronavirus. Taking into account that in COVID-19 IgA antibodies in many cases act as early antibodies and are determined in human blood earlier and more often than IgM antibodies, this test allows for disease diagnosis at early stages and can be used in patients with appropriate symptoms. Antigma-A is currently the first Russian test system developed for the detection of class A antibodies (IgA) in COVID-19 patients.

• The third test Antigma-G is intended for the quantitative detection of class G antibodies (IgG) to the SARS-CoV-2 virus. This test allows detecting patients who have immunity to COVID-19 and to evaluating the level of collective (herd) immunity in the society.

All three tests are based on the enzyme-linked immunosorbent assay (ELISA). High sensitivity and specificity of the test systems have been proved in clinical and laboratory studies. The test takes only 1 hour and can be performed manually or using an automatic analyser. So, it is suitable for laboratory facilities of any level of equipment.

Thanks to this development, the possibilities for diagnosing the COVID-19 infection and its consequences are significantly expanding in Russia.

D.A. Kudlay, prof., General Director of GENERIUM JSC, 'Antigma tests have antigens to the S1 protein and to the nucleocapsid, which makes them highly sensitive and informative. This allows for conducting a qualitative analysis of biomaterials and disease diagnosing at various stages. In current conditions, supplying the needs of the Russian healthcare system with high-precision and highly efficient test systems is a relevant example of a benefit of practical biotechnology for the country. In combination with the previously developed test system that is based on the amplification method, a universal set of solutions for all antibodies A, M and G allows us to segment our fellow citizens epidemiologically and economically with regard to the COVID-19. It will help us clearly determine treatment and rehabilitation regimen for some categories of citizens and the degree of participation in economic processes for others'.

About the company:

GENERIUM is a biotechnology company, the leader in the Russian pharmaceutical market for orphan diseases. The Company possesses its own R&D park, which is capable of developing any biotech product, from molecule design to commercial production. GENERIUM's manufacturing facilities are organised in strict compliance with international GMP standards. The Company's plants produce a unique variety of biotech products and are capable of manufacturing any kind of biomedical cell products.

www.generium.ru

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