Development of Automated System for Monitoring of Coronavirus Antigens on the Basis of Immunochromatographic Analysis

The purpose of research is the development of a project for an express analyzer device for the determination of antigens of the coronavirus family.

Methods. Theoretical approaches in the design of the express analysis device were based on the theory of virology, the application of the applied theory of finite automata, general systems theory, statistical analysis, differential-integral calculus, set and graph theory. The Co V antigen detection assay runs in a solid phase immuno-chromatographic state. The construction of the device model and the simulation of the program operation were performed using CX-One Software.

Results. At the end of 2019, an outbreak of a new coronavirus infection occurred in the People's Republic of China with an epicenter in the city of Wuhan, the causative agent of which was given the temporary name 2019-nCoV. In 2020, the World Health Organization registered a pandemic caused by a coronavirus infection and classified the new coronavirus as SARS-Co V-2. The end of 2021 was characterized by a further mutation of the coronavirus and the emergence of the Omicron strain. In March 2022, the Omicron BA.2 (stealth-Omicron) strain was recorded, the nature of the disease in which also proceeds according to the type of acute catarrhal syndrome or acute respiratory disease. A feature of the new strains is a higher reproduction rate. In the period 2022-2023, new strains of the SARS-CoV-2 coronavirus are expected to appear, which makes the development of an express analyzer relevant. A technique for express analysis of infection with the coronavirus family using special diagnostic probes based on the use of secondary immobilized antibodies has been studied. A technological map of the device being designed has been developed. Logic equations and relay-contact control circuits implemented on the OMRON software and hardware complex have been developed. The construction of a device for express diagnosis of coronavirus infection will solve the problem of safety, efficiency and reduce the epidemiological situation.

Conclusion. The production of express analyzers for the presence of coronavirus antigens will make it possible to quickly determine infection on coronavirus RNA.

1. Shchelkanov M. Yu., Kolobukhina L. V., Lvov D. K. Koronavirusy cheloveka (Nidovirales, Coronaviridae): vozrosshij uroven' epidemicheskoj opasnosti [Human coronaviruses (Nidovirales, Coronaviridae): an increased level of epidemic danger]. Lechashchij vrach = Attending Physician, 2013, no. 10, p. 49.

2. Gripp (sezonnyi, ptichii, pandemicheskii) i drugie ORVI [Influenza (seasonal, avian, pandemic) and other SARS]; ed. by V. P. Malogo, M. A. Andreychina. Moscow, GEOTAR- Media Publ., 2013. 320 p.

3. Vremennye metodicheskie rekomendacii "Profilaktika, diagnostika i lechenie novoj koronavirusnoj infekcii (COVID-19). Versiya 7 (03.06.2020)" [Temporary guidelines. Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19). Version 7 (06.03.2020)]. Available at: https://legalacts.ru/doc/vremennye-metodicheskie-rekomendatsii-profilaktika-diagnostika-i-trechenie-novoi-koronavirusnoi_4/. (accessed 14.05.2022)

4. Perevezentsev O. A., Kholodnaya T. O., Burtsev D. V. Zarubezhnyj opyt molekulyarno-geneticheskoj i immunologicheskoj diagnostiki SARS-COV-2 (Obzor) [Foreign experience in molecular genetic and immunological diagnostics of SARS-COV-2 (Review)]. Laboratornaya sluzhba= Laboratory Service, 2021, vol. 10, no. 4, pp. 47-54.

5. Shanchev A. A. Rol' KDL v diagnostike i lechenii pacientov s SARS-COV-2 [The role of CDL in the diagnosis and treatment of patients with SARS-COV-2]. Spravochnik zaveduyushchego KDL = Handbook of the Head of CDL, 2020, no. 6, pp. 51-56.

6. Grigoryeva T. D., Falileeva M. Yu., Gorokhova A. I. Opredelenie antitel klassa IGG k SARS-COV-2 metodom IFA: mneniya laboranta i eksperta [Determination of IGG antibodies to SARS-COV-2 by ELISA: opinions of a laboratory assistant and an expert]. Spravochnik zaveduyushchego KDL = Handbook of the Head of the CDL, 2021, no. 1, pp. 36-40.

7. Borsukov A. V., eds. Mul'timodal'naya differentsial'naya diagnostika virusnoi pnevmonii v usloviyakh pandemii SARS-CoV2 (klinicheskoe nablyudenie) [Multimodal differential diagnostics of viral pneumonia in SARS-CoV2 pandemic conditions (clinical case)]. Meditsinskii alfavit = Medical Alphabet, 2021, no. 13, pp. 31-35. https://doi. org/10.33667/2078-5631-2021-13-31-35

8. Takeuchi Y., eds. Diagnostic performance and characteristics of anterior nasal collection for the SARS-CoV-2 antigen test: a prospective study. Scientific Reports, 2021, vol. 11, no. 1 (1), p. 10519.

9. Fotis C., eds. Accurate SARS-CoV-2 seroprevalence surveys require robust multiantigen assays. Scientific Reports, 2021, vol. 11( 1), p. 6614.

10. Ricks S., eds. Quantifying the potential value of antigen-detection rapid diagnostic tests for COVID-19: a modelling analysis. BMC Medicine, 2021, vol. 19 (1), p. 75.

11. Assis de R. R., eds. Analysis of SARS-CoV-2 antibodies in COVID-19 convalescent blood using a coronavirus antigen microarray. Nature Communications, 2021, vol. 12, no. 1, p. 6.

12. Saeed U., eds. Evaluation of SARS-CoV-2 antigen-based rapid diagnostic kits in Pakistan: formulation of COVID-19 national testing strategy. Virology Journal, 2021, vol. 18, no. 1, p. 34.

13. Kowada A. Greater public health impact of COVID-19 antigen detection tests. BMC Medicine, 2021, vol. 19(1), p. 82.

14. Smorkalov A. Yu., eds. Osobennosti realizacii programmy dopolnitel'noj podgotovki vrachej po special'nosti "Anesteziologiya-reanimatologiya", "Intensivnaya terapiya oslozhnennyh form novoj koronavirusnoj infekcii" [Features of the implementation of the program of additional training for doctors in the specialty "Anesthesiology and Resuscitation", "Intensive Care of Complicated Forms of a New Coronavirus Infection"]. Virtual'nye tekhnologii v medicine = Virtual Technologies in Medicine, 2020, no. 2 (24), pp. 42-47.

15. Sinitsyn S. O., eds. Svidetel'stvo o registratsii programmy dlya EVM 2022612845. Polymorphism analysis of russian SARS-COV-2 (PARUS) [Polymorphism analysis of russian SARS-COV-2 (PARUS)]. Certificate RF, no. 2022612845, 2020.

16. Kostarev S. N., Kochetova O. V., Sereda T. G. Programma dlya avtomatizacii analiza serologicheskih markerov antitel immunoglobulinov IGG i IGM COVID-19 [Program for automating the analysis of serological markers of IGG and IGM COVID-19 immunoglobulin antibodies (Express analysis of IGG and IGM COVID-19 antibodies)]. Patent RF, no. 2021667302, 2021.

17. Kostarev S. N., Kochetova O. V., Tatarnikova N. A., Sereda T. G. Razrabotka sistemy avtomaticheskogo diagnoza na nalichie antitel immunoglobulinov IGG i IGM SARS-COV-2 [Development of an automatic diagnosis system for the presence of immunoglobulin IgG and IgM antibodies SARS - CoV-2]. Izvestiya Yugo-Zapadnogo gosudarstvennogo universiteta. Seriya: Upravlenie, vychislitel'naya tekhnika, informatika. Meditsinskoe priborostroenie = Proceedings of the Southwest State University. Series: Control, Computer Engineering, Information Science. Medical Instruments Engineering, 2021, vol. 11(2), pp. 8-24.

18. Tyumentsev A. I., eds. Sistema CRISPR-CAS12 dlya vyyavleniya RNK virusa SARS-COV-2 v ul'tranizkih koncentraciyah [CRISPR-CAS12 system for detection of SARS- COV-2 virus RNA at ultra-low concentrations]. Patent RF, no. 2764023 C1, 2022.

19. Minnullin T. I., eds. Immunological aspects of SARS-COV-2 coronavirus infection [Immunologicheskie aspekty porazheniya koronavirusom SARS-COV-2]. Vestnik Rossijskoj Voenno-medicinskoj akademii = Bulletin of the Russian Military Medical Academy, 2021, no. 2 (74), pp. 187-198.

20. Kurosh A. G. Kurs vysshej algebry [Course of higher algebra]. St. Petersburg, Lan' Publ., 2006. 432 p.

21. Khusanov Kh. I., Shevkoplyas L. A. Sravnitel'nyj analiz SARS-COV-2, SARS-COV I MERS-COV [Comparative analysis of SARS-COV-2, SARS-COV AND MERS-COV]. Innovacii. Nauka. Obrazovanie = Innovation. The Science. Education. 2020, vol. 21, pp. 15971607.

22. UniProt. Available at: https://www.uniprot.org/proteomes/UP000464024. Accessed 18.05.2022)

23. Akinshina Yu. A., Mardanly S. S., Kiseleva V. A. Immuno-hromatograficheskaya test-sistema dlya differencirovannogo vyyavleniya antitel klassov M i G k koronavirusu SARS-COV-2 [Immunochromatographic test system for the differentiated detection of antibodies of classes M and G to the SARS-COV-2 coronavirus]. Izvestiya GGTU. Medicina, farmaciya = Proceedings GSTU. Medicine, Pharmacy, 2020, no. 3, pp. 12-16.

24. Akinshina Yu. A., Mardanly S. S., Kiseleva V. A. Immunohromatograficheskij test dlya differencirovannogo vyyavleniya antitel klassov M i G k koronavirusu SARS-COV-2 [Immunochromatographic test for differential detection of antibodies of classes M and G to SARS-COV-2 coronavirus]. Klinicheskaya laboratornaya diagnostika = Clinical Laboratory Diagnostics, 2020, vol. 65, no. 11, pp. 688-692.