Diagnostic characteristics of a test system for the detection of viral hepatitis B by real-time PCR from the results of analysis of clinical samples
- Authors: Moroz A.S.1,2, Toropov V.A.2, Romanov A.S.2, Idutova M.K.2, Lisok A.V.1,2, Bolshakov V.N.1,2, Aronova E.B.2
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Affiliations:
- Alkor Bio Group of Companies
- Peter the Great St. Petersburg Polytechnic University
- Issue: Vol 28, No 12 (2025)
- Pages: 84-89
- Section: Medical chemistry
- URL: https://ogarev-online.ru/1560-9596/article/view/362639
- DOI: https://doi.org/10.29296/25877313-2025-12-10
- ID: 362639
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Abstract
Introduction. PCR method is important in the clinical diagnostics of hepatitis B virus (HBV), especially at low viral load, while monitoring the dynamics of treatment and when identifying the occult form of infection. There are strict requirements for the diagnostic sensitivity and specificity of PCR test systems used in clinical practice.
The aim of the study was to determine the diagnostic characteristics of the developed by us test system for PCR diagnosis of hepatitis B virus (HBV) on 837 human plasma samples.
Material and methods. 465 human plasma samples obtained from people with a confirmed diagnosis of HBV infection were examined, as well as 372 blood plasma samples obtained from people with a confirmed absence of HBV in blood plasma. All samples were obtained from an accredited laboratory. The commercial “RealBest HBV PCR kit (form 2)” (JSC Vector-Best, Russia) was used as a comparison kit. The RealBest Deltamag HBV/HCV/HIV kit (JSC Vector-Best, Russia) was used to isolate nucleic acids on Auto-Pure96 automatic station (Allsheng, China). To evaluate the effectiveness of nucleic acid isolation, internal control sample was also added to the human blood plasma sample.
Results. Developed by us test system was compared with the "RealBest HCV PCR" test system. From the analysis of clinical samples of human blood plasma using both test systems, the diagnostic characteristics of the developed by us test system were determined as 96.39% diagnostic sensitivity and 98.33% diagnostic specificity.
Conclusions. The statistical analysis of Bland-Altman showed a high degree of similarity of sensitivity of both test systems used. The developed by us test system can be recommended for use in the clinical diagnosis of HBV.
About the authors
A. S. Moroz
Alkor Bio Group of Companies; Peter the Great St. Petersburg Polytechnic University
Author for correspondence.
Email: anny-nice@mail.ru
ORCID iD: 0000-0002-4693-623X
SPIN-code: 4721-1020
Post-graduate Student, Higher School of Biotechnology and Food Production, Research Engineer
Russian Federation, 40a Zheleznodorozhny ave., Saint Petersburg, 192148; 48 Novorossyskaya str., Saint Petersburg, 194021V. A. Toropov
Peter the Great St. Petersburg Polytechnic University
Email: anny-nice@mail.ru
ORCID iD: 0009-0005-1993-5572
Leading Research Engineer
Russian Federation, 48 Novorossyskaya str., Saint Petersburg, 194021A. S. Romanov
Peter the Great St. Petersburg Polytechnic University
Email: anny-nice@mail.ru
ORCID iD: 0009-0009-3726-8346
Research-Laborant
Russian Federation, 48 Novorossyskaya str., Saint Petersburg, 194021M. K. Idutova
Peter the Great St. Petersburg Polytechnic University
Email: anny-nice@mail.ru
ORCID iD: 0009-0002-9104-4457
Leading Research Engineer
Russian Federation, 48 Novorossyskaya str., Saint Petersburg, 194021A. V. Lisok
Alkor Bio Group of Companies; Peter the Great St. Petersburg Polytechnic University
Email: anny-nice@mail.ru
ORCID iD: 0000-0002-3134-1970
Post-graduate Student, Higher School of Biotechnology and Food Production, Head of the Laboratory of PCR
Russian Federation, 40a Zheleznodorozhny ave., Saint Petersburg, 192148; 48 Novorossyskaya str., Saint Petersburg, 194021V. N. Bolshakov
Alkor Bio Group of Companies; Peter the Great St. Petersburg Polytechnic University
Email: anny-nice@mail.ru
ORCID iD: 0009-0007-5126-6035
Ph.D. (Biol.), Associate Professor, Associate Professor of the Higher School of Biotechnology and Food Production, Head of the Laboratory of Molecular Diagnostics
Russian Federation, 40a Zheleznodorozhny ave., Saint Petersburg, 192148; 48 Novorossyskaya str., Saint Petersburg, 194021E. B. Aronova
Peter the Great St. Petersburg Polytechnic University
Email: anny-nice@mail.ru
ORCID iD: 0000-0003-4376-2972
SPIN-code: 7288-6820
Ph.D. (Tech.), Associate Professor, Associate Professor of the Higher School of Biotechnology and Food Production
Russian Federation, 48 Novorossyskaya str., Saint Petersburg, 194021References
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