PJSC “SPC “Diaproph-Med” in accordance with the requirements of the international quality
management standard ISO13485, conducted a comparative study of amino acid sequences of
recombinant antigens SARS-CoV-2 of its own production and nucleocapsid (NP), surface (S), envelope (E)
and membrane (M) proteins of SARS-CoV-2 strain "OMICRON" (B.1.1.529) according to the European
Center for Disease Prevention and Control (ECDC) risk assessment report 1 .
The genome of the strain OMICRON SARS-CoV-2 does not contain large deletions in diagnostically
important sites, but has a large number of point substitutions (mutations) in the gene responsible for
the synthesis of surface protein SPIKE.
Thus, the nucleocapsid protein (NP) SARS-CoV-2 of own production and the nucleocapsid protein (NP)
SARS-CoV-2 "OMICRON" B.1.1.529 variant GenBank accession No. UFT26509.1 has a match of 98.6%.
Surface protein (SPIKE) SARS-CoV-2 of own production and Surface protein (SPIKE) SARS-CoV-2 SPIKE
"OMICRON" B.1.1.529 variant GenBank accession No. UFT26501.1 has a match of 89.4%.
Membrane protein (M) SARS-CoV-2 of own production and Membrane protein (M) SARS-CoV-2
«OMICRON» B.1.1.529 variant GenBank accession No. UFT26504.1 has a match of 98.6%.
Envelope protein (E) SARS-CoV-2 of own production and Shell protein (E) SARS-CoV-2 "OMICRON"
B.1.1.529 variant GenBank accession No. UFT26503.1 has a match of 98.7%.
The comparison shows the absence of a significant threat of reducing the diagnostic sensitivity of test
systems manufactured by PJSC “SPC “Diaproph-Med” for the detection of coronavirus disease due to
mutations in variants of the strain "OMICRON" (B.1.1.529) SARSCoV-2.
Introduction of multi-target test systems such as DIA®-SARS-CoV-2-NP-S-IgM for qualitative detection of
IgM antibodies to nucleoprotein (nucleocapsid antigen, NP) and surface (spike-protein, S) antigens of
coronavirus SARS-CoV -2, DIA®-SARS-CoV-2-different for differential detection of antibodies to all
structural proteins of the virus - NP, S, M and E provides a tool for diagnostic laboratories for in-depth
research in the face of new mutations in the virus.
Specialists of PJSC “SPC “Diaproph-Med” are constantly monitoring SARS-CoV-2 mutations and the
emergence of new variants of the virus in order to improve the design of test systems to ensure
maximum sensitivity and specificity.
1 - https://www.ecdc.europa.eu/sites/default/files/documents/threat-assessment-covid-19-
emergence-sars-cov-2-variant-omicron-december-2021.pdf