Approbation of the Technology for Constructing Means of Express Indication of New Especially Dangerous

Catastrophic pandemic of the particularly dangerous coronavirus SARS-CoV-2 in 2020–2022 and the unexpected  spread of the monkeypox pathogen from Africa in 2022, demonstrate the need for an adequate response to biological  threats that have exotic infections as their source, overcome the interspecies barrier between animals and humans  and have high rates of virulence and contagiousness in relation to the latter. The purpose of the article is to create  a technology for constructing means for the express indication of new especially dangerous and exotic infections,  which makes it possible to quickly develop a gene diagnostic tool, evaluate its characteristics and launch large-scale  production. Materials and methods. The authors used technologies for constructing means for express indication  of new especially dangerous and exotic infections based on real-time polymerase chain reaction (RT-PCR-RT-Flu/ Coronavirus) methods, suitable for multiplex identification of coronavirus RNA. The discussion of the results. The  developed technology for constructing means for express indication of new especially dangerous and exotic infections  was successfully tested at the laboratory base of the FSBЕ «48 Central Research Institute» of the Ministry of Defense  of the Russian Federation using the example of designing a «Set of reagents for detecting the RNA of coronaviruses  SARS-CoV, MERS-CoV, SARS-CoV-2 and virus influenza A by real-time polymerase chain reaction (RT-PCR-RT-Flu/Coronavirus)», suitable for multiplex identification of coronavirus RNA. Conclusion. As a result of the research  carried out to evaluate the equipment available at the laboratory base of the FSBЕ «48 Central Research Institute» of  the Ministry of Defense of the Russian Federation, the adaptation and implementation of key production processes,  the development and production of express-indication reagents, as well as testing the technology for constructing  express-indication means for new especially dangerous and exotic infections, using the example of designing a set of  RT-PCR-RV-Flu/Coronavirus reagents, a gene diagnostic platform was created for the development of reagents for the  express indication of new especially dangerous and exotic infections.

1. Jin YH, Cai L, Cheng ZS, Cheng H, Deng T, Fan Y-P, et al. A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Mil Med Res. 2020;7:4. https://doi.org/10.1186/s40779-020-0233-6

2. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections – the state of the art. Emerging Microbes Infections. 2020;9:747–56. https://doi.org/10.1080/22221751.2020.1745095

3. Tahamtan A, Ardebili A. Real-time RT-PCR in COVID-19 detection: issues affecting the results. Expert Rev Mol Diagn. 2020;20(5):453–4. https://doi.org/10.1080/14737159.2020.1757437

4. Vashist SK. In vitro diagnostic assays for COVID-19: recent advances and emerging trends. Diagnostics. 2020;10(4):202. https://doi.org/10.3390/diagnostics10040202

5. Chan JF, Yip CC, To KK, Tang TH, Wong SC, Leung KH, et al. Improved molecular diagnosis of COVID-19 by the novel, highly sensitive and specific COVID-19-RdRp/Hel real-time reverse transcription-PCR assay validated in vitro and with clinical specimens. J Clin Microbiol. 2020;58(5):e00310-20. https://doi.org/10.1128/jcm.00310-20

6. Lu X, Wang L, Sakthivel SK, Whitaker B, Murray J, Kamili S, et al. US CDC real-time reverse transcription PCR panel for detection of severe acute respiratory syndrome Coronavirus 2. Emerg Infect Dis. 2020;26(8)1654–65. https://doi.org/10.3201/eid2608.201246

7. Dhama K, Khan S, Tiwari R, Sircar S, Bhat S, Malik YS, et al. Coronavirus disease 2019–COVID-19. Clin Microbiol Rev. 2020;33(4):e00028-e20. https://doi.org/10.1128/CMR.00028-20

8. Yüce M, Filiztekin E, Özkaya KG. COVID-19 diagnosis – a review of current methods. Biosens Bioelectron. 2021;172:112752. https://doi.org/10.1016/j.bios.2020.112752

9. Islam KU, Iqbal J. An update on molecular diagnostics for COVID-19. Front Cell Infect Microbiol. 2020;10:560616. https://doi.org/10.3389/fcimb.2020.560616

10. Rai P, Kumar BK, Kumar DV, Kumar P, Kumar A, Shetty SK, Maiti B. The evolution of COVID-19 diagnostics. In: COVID-19: From Bench to Bedside. Barh D, Lundstrom K, Eds. Chapter 6 Boca Raton: CRC Press; 2022. 238 p. https://doi.org/10.1201/9781003190394

11. Rai P, Kumar BK, Deekshit VK, Karunasagar I, Karunasagar I. Detection technologies and recent developments in the diagnosis of COVID-19 infection. Appl Microbiol Biotechnol. 2021;105:441–55. https://doi.org/10.1007/s00253-020-11061-5

12. Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020;395(10223):514–23. https://doi.org/10.1016/S0140-6736(20)30154-9

13. Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus – infected pneumonia. N Engl J Med. 2020;382(13):1199–207. https://doi.org/10.1056/NEJMoa2001316

14. Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, et al. Genomic characterization and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020;395(10224):565–74. https://doi.org/10.1016/S0140-6736(20)30251-8

15. Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, et al. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020;579(7798):270–3. https://doi.org/10.1038/s41586-020-2012-7

16. Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506. https://doi.org/10.1016/S0140-6736(20)30183-5

17. Sharma A, Ahmad Farouk I, Lal SK. COVID-19: a review on the novel coronavirus disease evolution, transmission, detection, control and prevention. Viruses. 2021;13(2):202. https://doi.org/10.3390/v13020202

18. Jin Y, Yang H, Ji W, Wu W, Chen S, Zhang W, Duan G. Virology, epidemiology, pathogenesis, and control of COVID-19. Viruses. 2020;12(4):372. https://doi.org/10.3390/v12040372

19. Umakanthan S, Sahu P, Ranade AV, Bukelo MM, Rao JS, Abrahao-Machado LF, et al. Origin, transmission, diagnosis and management of coronavirus disease 2019 (COVID-19). Postgrad Med J. 2020;96(1142):753–8. https://doi.org/10.1136/postgradmedj-2020-138234

20. Sharma A, Balda S, Apreja M, Kataria K, Capalash N, Sharma P. COVID-19 diagnosis: current and future techniques. Int J Biol Macromol. 2021;193(Pt B):1835–44. https://doi.org/10.1016/j.ijbiomac.2021.11.016

21. Mughees M, Chugh H, Naqvi SH, Wajid S. COVID-19 threat to the world: current and possible diagnostic/ treatment strategies. Crit Rev Biomed Eng. 2021;49(1):21–33. https://doi.org/10.1615/CritRevBiomedEng.2021036595