Validation of a developed immunoenzyme test system for laboratory diagnostics of acute viral hepatitis E
I. S. Zadora,
S. V. Zhavoronok,
A. I. Shcherban,
A. I. Alatortseva,
L. N. Pritvorova,
L. N. Nesterenko,
L. A. Anisko,
T. A. Rogacheva,
N. G. Bayur,
N. V. Shchuka,
V. V. Simirsky,
M. I. Mikhailov,
V. V. Zverev https://doi.org/10.51523/2708-6011.2025-22-4-08
Abstract
Objective. To determine the specificity and sensitivity of the developed domestic enzyme-linked immunosorbent assay kit “ELISA-anti-HEV IgM” for detecting M class immunoglobulins to the hepatitis E virus (HEV) in human serum under real clinical conditions.
Materials and methods. To determine the sensitivity and specificity, we used registered industrial samples of the “ELISA-anti-HEV IgM” kit, produced by Unitary Enterprise “Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus” in accordance with TU BY 100185093.093-2023. 214 blood serum samples from patients with established presence of antibodies to hepatitis A virus, hepatitis C virus, hepatitis B virus antigen, hyperlipidemia, class M antibodies to cytomegalovirus and increased content of rheumatoid factor were examined on the basis of the clinical and diagnostic laboratory of the healthcare institution “City Clinical Infectious Diseases Hospital” of Minsk. To determine the sensitivity and specificity of the set, 72 serum samples were examined in parallel with reference sets “Vecto gep E-IgM”.
Results. When using the industrially released “ELISA-anti-HEV IgM” (TU BY 100185093.093-2023), the absence of non-specific cross-interaction between the sorbed recombinant polypeptides ORF2 and ORF3 of hepatitis E virus genotype 3 and proteins in samples of patients with antibodies to hepatitis C, hepatitis A, hepatitis B virus antigen, blood plasma with hemolysis and chylosis, samples with an increased content of rheumatoid factor and the presence of class M antibodies to cytomegalovirus. When evaluating sensitivity and specificity indicators on blood sera under real clinical conditions, high sensitivity indicators were established – at least 99% and specificity – at least 99%, which indicates the possibility of using the kit in the practical activities of laboratories of healthcare institutions.
Conclusion. The registered and manufactured first domestic test system for the determination of class M immunoglobulins against hepatitis E virus (HЕV) in human blood serum “ELISA-anti-HEV IgM” by indirect enzyme immunoassay has high analytical reliability: sensitivity is at least 99%, specificity is at least 99%,
Supporting agencies: The authors thank chief physician Yurovsky N.N., the staff of the clinical diagnostic laboratory of the City Clinical Infectious Diseases Hospital for assistance in organizing and conducting the research (Dolbuz O.N., Metlitskaya E.A., Malinovskaya N.V.). This research work was carried out within the framework of the funded activity 13 “Develop a technology for the industrial production of test systems for the detection of IgG and IgM class antibodies to the hepatitis E virus in humans and animals using the enzyme immunoassay method and organize their production” subprogram 5 “Chemical products and molecular technologies” of the State Program “High-tech and technology” for 2021-2025, state registration number 20213143.
About the Authors
I. S. Zadora
Belarusian State Medical University; Unitary Enterprise «Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus»
Беларусь
Беларусь
Ilona S. Zadora - senior lecturer of microbiology, virology, immunology department in Belarusian State Medical University, junior scientific researcher Unitary Enterprise «Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus».
Minsk
S. V. Zhavoronok
Belarusian State Medical University
Беларусь
Беларусь
Sergey V. Zhavoronok - D. Sci. (Med.), Professor, Professor department of infectious diseases, Belarusian State Medical University.
Minsk
A. I. Shcherban
Unitary Enterprise «Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus»
Беларусь
Беларусь
Aleksandr I. Shcherban - Candidate of Biological Sciences, Head of the Scientific and Technical Department, Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus.
Minsk
A. I. Alatortseva
Federal State Budgetary Scientific Institution «I. Mechnikov Research Institute of Vaccines and Sera»
Россия
Россия
Galina I. Alatortseva - Cand. Sci. (Biol.), Head, Laboratory for cloning viral genomes, I. Mechnikov Research Institute for Vaccines and Sera.
Moscow
L. N. Pritvorova
Federal State Budgetary Scientific Institution «I. Mechnikov Research Institute of Vaccines and Sera»
Россия
Россия
Lyudmila N. Pritvorova - Cand. Sci. (Med.), leading researcher of the laboratory of cloning of viral genomes, I. Mechnikov Research Institute for Vaccines and Sera.
Moscow
L. N. Nesterenko
Federal State Budgetary Scientific Institution «I. Mechnikov Research Institute of Vaccines and Sera»
Россия
Россия
Lyubov N. Nesterenko - Cand. Sci. (Chem.), Leading Researcher of the Laboratory of Cloning of Viral Genomes of the I.I. Mechnikov Research Institute of Vaccines and Serums.
Moscow
L. A. Anisko
Belarusian State Medical University; City Clinical Infectious Diseases Hospital
Беларусь
Беларусь
Lyudmila A. Anisko - Candidate of Medical Sciences, Associate professor, Associate professor at the Departments of Infectious Diseases, Belarusian State Medical University; Board Certified Physician, Head of the Laboratory, City Clinical Hospital of Infectious Diseases.
Minsk
T. A. Rogacheva
City Clinical Infectious Diseases Hospital
Беларусь
Беларусь
Tamara A. Rogacheva - Cand. Sci. (Med.), associate professor, highly qualified laboratory diagnostics doctor, City Clinical Infectious Diseases Hospital.
Minsk
N. G. Bayur
Belarusian State Medical University; City Clinical Infectious Diseases Hospital
Беларусь
Беларусь
Nadzeya G. Bayur - External Part-timer of the Department of Infectious Diseases, Belarusian State Medical University; Biologists at the Clinical Diagnostic Laboratory, City Clinical Hospital of Infectious Diseases.
Minsk
N. V. Shchuka
Unitary Enterprise «Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus»
Беларусь
Беларусь
Natalia V. Shchuka - researcher in Unitary Enterprise «Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus».
Minsk
V. V. Simirsky
Unitary Enterprise «Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus»
Беларусь
Беларусь
Vladimir V. Simirsky - Cand. Sci. (Chem.), Director Unitary Enterprise «Pilot Production of the Institute of Bioorganic Chemistry National Academy of Sciences of Belarus».
Minsk
M. I. Mikhailov
Federal State Budgetary Scientific Institution «I. Mechnikov Research Institute of Vaccines and Sera»; Federal Budgetary Scientific Institution Central Research Institute of Epidemiology of Rospotrebnadzor
Россия
Россия
Mikhail I. Mikhailov - Doctor of Medical Sciences, Professor, Corresponding Member of the Russian Academy of Sciences, Chief Researcher, Head of the Laboratory of Viral Hepatitis of the Federal State Budgetary Scientific Institution “I.I. Mechnikov Research Institute of Vaccines and Sera”; Chief Researcher Federal Budgetary Scientific Institution “Central Research Institute of Epidemiology” of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing.
Moscow
V. V. Zverev
Federal State Budgetary Scientific Institution «I. Mechnikov Research Institute of Vaccines and Sera»; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Россия
Россия
Vitaly V. Zverev - Doctor of Biological Sciences, Professor, Academician of the Russian Academy of Sciences, Head of the Department of Microbiology, Virology and Immunology of the Federal State Autonomous Educational Institution of Higher Education “First Moscow State Medical University named after I.M. Sechenov” of the Ministry of Health of the Russian Federation; Scientific Director of the Federal State Budgetary Scientific Institution Research Institute of Vaccines and Serum Syndrome named after I.I. Mechnikov.
Moscow
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For citations:
Zadora I.S., Zhavoronok S.V., Shcherban A.I., Alatortseva A.I., Pritvorova L.N., Nesterenko L.N., Anisko L.A., Rogacheva T.A., Bayur N.G., Shchuka N.V., Simirsky V.V., Mikhailov M.I., Zverev V.V. Validation of a developed immunoenzyme test system for laboratory diagnostics of acute viral hepatitis E. Health and Ecology Issues. 2025;22(4):60-67. (In Russ.) https://doi.org/10.51523/2708-6011.2025-22-4-08
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