Сomparative study

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

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