Research Article | | Peer-Reviewed

Experience of Using Pcr in the Diagnosis of Leprosy in Russia

Received: 19 September 2026     Accepted: 5 October 2026     Published: 23 October 2026
Views:       Downloads:
Abstract

Background: Early diagnosis of leprosy is still a serious problem due to the low sensitivity of standard diagnostic methods and the inability to cultivate Mycobacterium leprae. Identification of M.leprae and determination of her viability on basis of PCR- technology can assistance to solve the issues of early diagnosis and the optimal duration and effectiveness of treatment of leprosy. Objectives: to investigate the performance of polymerase chain reaction (PCR) in various clinical samples for leprosy diagnosis and monitoring effectiveness of treatment. Methods: Extraction of DNA/RNA of Mycobacterium leprae were performed from various clinical specimens (biopsies and SSS, scrapes from nasal pharynx, etc.) The primers and probes were designed for the 16S rRNA of M. leprae. The test system is adapted to DT-96 Real-time Thermal cycler (DNA-Technology, Moscow, Russia). The test system contains an internal control (IC). The specificity and sensitivity of the PCR test system were performed on 15 strains of different species of mycobacteria and clinical samples from 32 leprosy patients and 15 healthy household contacts. Results: Established 100% specificity and sensitivity of detection of Mycobacterium leprae in skin biopsies by PCR compared with standard microscopy method (88.9%). In all other clinical samples were also determined higher sensitivity developed PCR test-system. Conclusions: The test system, using primers to the 16S rRNA of M. leprae has shown high sensitivity and specificity for fast identification and determination of viability of Mycobacterium leprae.

Published in Science Discovery Medicine (Volume 1, Issue 3)
DOI 10.11648/j.sdmed.20260103.11
Page(s) 111-117
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2026. Published by Science Publishing Group

Keywords

Leprosy, 16S rRNA M.leprae, Real-Time Polymerase Chain Reaction

References
[1] World Health Organization. Global leprosy: situation 2016-2020. 2016: 1-20.
[2] Duiko V. V., Naumov V. Z., Saroyants L. V., Astafurova A. P. Leprosy incidence in the Caspian region. Current issues of modern medicine: Proceedings of the III international conference of the Caspian states. Astrakhan, Russia, 2018, pp. 64-66.
[3] Martinez A. N., Talhari C., Moraes M. O., Talhari S. PCR-Based Techniques for Leprosy Diagnosis: From the Laboratory to the Clinic. PLoS Negl Trop Dis. 2014, 8(4): e2655.
[4] Turankar R. P., Pandey S., Lanania M., Singh I., Nigam A., Darlong J., Darlong F., Sengupta U. Comparative evaluation of PCR amplification of RLEP, 16S rRNA, rpoT and sod a gene targets for detection of M. leprae DNA from clinical and environmental samples. Int J Mycobacteriol. 2015; 4: 54–59.
[5] Haiqin J., Lemuel T., Hongsheng W. Loop-mediated isothermal amplification (LAMP) assay targeting RLEP for detection of Mycobacterium leprae in leprosy patients. Int J of Infect Dis. 2021; 107: 145-152.
[6] Tatipally S., Srikantam A. and Kasetty S. Polymerase Chain Reaction (PCR) as a Potential Point of Care Laboratory Test for Leprosy Diagnosis—A Systematic Review. Trop Med Infect Dis. 2018, 3(4), 107.
[7] Singh V., Turankar R. P., Goel A. Real-time PCR-based quantitation of viable Mycobacterium leprae strain from clinical samples and environmental sources and its genotype in multi-case leprosy families of India. Eur J Clin Microbiol Infect Dis. 2020; 39(11): 2045-2055.
[8] Beissner M., Woestemeier A., Saar M. Development of a combined RLEP/16S rRNA (RT) qPCR assay for the detection of viable M. leprae from nasal swab samples. BMC Infect Dis. 2019; 19(1): 753.
[9] Martinez N. A., Lahiri R., Pittman L. T., Scollard D., Truman R., Moraes M. O., Williams D. L. Molecular determination of Mycobacterium leprae viability by use of real-time PCR. J Clin Microbiol. 2009; 47 (7): 2124-2130.
[10] Ridley D. S., Jopling W. H. Classification of leprosy according to immunity. A five-group system. Int J Lepr Other Mycobact Dis. 1966; 34(3): 255-257.
[11] Martinez A. N., Ribeiro-Alves M., Sarno E. N., Moraes M. O. Evaluation of qPCR-Based Assays for Leprosy Diagnosis Directly in Clinical Specimens. PLoS Negl Trop Dis. 2011, 5(10): e1354.
[12] Turenne C. Y., Tschetter L., Wolfe J., Kabani A. Necessity of quality-controlled 16S rRNA gene sequence databases: identifying nontuberculous Mycobacterium species. J Clin Microbiol. 2001 Oct; 39(10): 3637-3648.
[13] Singh V., Kumari G., Kumar M., Vijayasimha M., Kumar Jha R. Assessment of the viability of Mycobacterium Leprae by 16S rRNA using different methods for rapid extraction of rRNA. Journal of Advances and Scholarly Researches in Allied Education.. 2019, 16 (5): 345–352.
[14] Manta F. S. N., Barbieri R. R., Moreira S. J. M., Santos P. T. S., Nery J. A. C., Duppre N. C., Sales A. M., Pacheco A. G., Hacker M. A/, Machado A. M., Sarno E. N., Moraes M. O. Quantitative PCR for leprosy diagnosis and monitoring in household contacts: A follow-up study, 2011-2018. Sci Rep. 2019 Nov 13; 9(1): 16675.
[15] Kamal R., Dayal R., Gaidhankar K., Biswas S., Gupta S. B., Kumar N., Kumar R., Pengoria R., Chauhan D. S., Katoch K., Katoch V. M., Singh. R. K. RLEP PCR as a definitive diagnostic test for leprosy from skin smear samples in childhood and adolescent leprosy. Indian J Lepr. 2016; 88 (4): 193–197.
[16] Scollard D. Leprosy research is a necessity. Lepr Rev. 2019; 90: 232–236.
[17] Martinez A. N., Britto C. F. P. C., Nery J. A. C., Sampaio E. P., Jardim M. R., Sarno E. N., Moraes M. O. Evaluation of real‑time and conventional PCR targeting complex 85 genes for detection of Mycobacterium leprae DNA in skin biopsy samples from patients diagnosed with leprosy. J Clin Microbiol. 2006; 44: 3154–3159.
[18] Kampirapap K., Singtham N., Klaster P. R. et al. DNA amplification for detection of leprosy and assessment of efficacy of leprosy chemotherapy. Int J Lepr Other Mycobact Dis. 1998; 66(1): 16-21.
[19] Santos A. R., Balassiano V., Oliveira M. L., da Silva Pereira M. A. Barros P. Detection of Mycobacterium leprae DNA by polymerase chain reaction in the blood of individuals, eight years after completion of anti-leprosy therapy. Mem Inst Oswaldo Cruz. Nov. 2001; 96(8): 1129-1133.
[20] Phetsuksiri B., Rudeeaneksin J., Supapkul P., Wachapong S., Mahotarn K., Brennan P. J. (2006) A simplified reverse transcriptase PCR for rapid detection of Mycobacterium leprae in skin specimens. FEMS Immunol Med Microbiol. 2006, 48(3): 319–328.
[21] Lini N., Shankernarayan N. P,. Dharmalingam K. Quantitative real-time PCR analysis of Mycobacterium leprae DNA and mRNA in human biopsy material from leprosy and reactional cases. J Med Microbiol. 2009, 5: 753-759.
[22] Lavania M., Rupendra J., Vedithi S. C., Turankar R. H., Selvasekhar A., Das L., Darlong F., Hambrom U. & Kumar, Sandip & Sengupta, Utpal. Drug resistance patterns in M. leprae isolates from relapsed leprosy patients attending The Leprosy Mission India (TLM) hospitals in India. Lep Rrev. 2014, 85(3): 177-185.
[23] Chokkakula S., Chen Z., Wang L., Jiang H., Chen Y., Shi Y., Zhang W., Gao W., Yang J., Li J, Li X, Shui T, He J, Shen L, Liu J, Wang D, Wang H, Chen H, Kuang Y, Li B, Chen Z, Wu A, Yu M, Yan L, Suryadevara NC, Vissa V, Liu W, Wang H. Molecular surveillance of antimicrobial resistance and transmission pattern of Mycobacterium leprae in Chinese leprosy patients. Emerg Microbes Infect. 2019; 8(1): 1479-1489.
Cite This Article
  • APA Style

    Saroyants, L. V., Arnaudova, K. S., Naumov, A. V. (2026). Experience of Using Pcr in the Diagnosis of Leprosy in Russia. Science Discovery Medicine, 1(3), 111-117. https://doi.org/10.11648/j.sdmed.20260103.11

    Copy | Download

    ACS Style

    Saroyants, L. V.; Arnaudova, K. S.; Naumov, A. V. Experience of Using Pcr in the Diagnosis of Leprosy in Russia. Sci. Discov. Med. 2026, 1(3), 111-117. doi: 10.11648/j.sdmed.20260103.11

    Copy | Download

    AMA Style

    Saroyants LV, Arnaudova KS, Naumov AV. Experience of Using Pcr in the Diagnosis of Leprosy in Russia. Sci Discov Med. 2026;1(3):111-117. doi: 10.11648/j.sdmed.20260103.11

    Copy | Download

  • @article{10.11648/j.sdmed.20260103.11,
      author = {Lyudmila Valentinovna Saroyants and Kristina Shotaevna Arnaudova and Andrey Valentinovich Naumov},
      title = {Experience of Using Pcr in the Diagnosis of Leprosy in Russia},
      journal = {Science Discovery Medicine},
      volume = {1},
      number = {3},
      pages = {111-117},
      doi = {10.11648/j.sdmed.20260103.11},
      url = {https://doi.org/10.11648/j.sdmed.20260103.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sdmed.20260103.11},
      abstract = {Background: Early diagnosis of leprosy is still a serious problem due to the low sensitivity of standard diagnostic methods and the inability to cultivate Mycobacterium leprae. Identification of M.leprae and determination of her viability on basis of PCR- technology can assistance to solve the issues of early diagnosis and the optimal duration and effectiveness of treatment of leprosy. Objectives: to investigate the performance of polymerase chain reaction (PCR) in various clinical samples for leprosy diagnosis and monitoring effectiveness of treatment. Methods: Extraction of DNA/RNA of Mycobacterium leprae were performed from various clinical specimens (biopsies and SSS, scrapes from nasal pharynx, etc.) The primers and probes were designed for the 16S rRNA of M. leprae. The test system is adapted to DT-96 Real-time Thermal cycler (DNA-Technology, Moscow, Russia). The test system contains an internal control (IC). The specificity and sensitivity of the PCR test system were performed on 15 strains of different species of mycobacteria and clinical samples from 32 leprosy patients and 15 healthy household contacts. Results: Established 100% specificity and sensitivity of detection of Mycobacterium leprae in skin biopsies by PCR compared with standard microscopy method (88.9%). In all other clinical samples were also determined higher sensitivity developed PCR test-system. Conclusions: The test system, using primers to the 16S rRNA of M. leprae has shown high sensitivity and specificity for fast identification and determination of viability of Mycobacterium leprae.},
     year = {2026}
    }
    

    Copy | Download

  • TY  - JOUR
    T1  - Experience of Using Pcr in the Diagnosis of Leprosy in Russia
    AU  - Lyudmila Valentinovna Saroyants
    AU  - Kristina Shotaevna Arnaudova
    AU  - Andrey Valentinovich Naumov
    Y1  - 2026/10/23
    PY  - 2026
    N1  - https://doi.org/10.11648/j.sdmed.20260103.11
    DO  - 10.11648/j.sdmed.20260103.11
    T2  - Science Discovery Medicine
    JF  - Science Discovery Medicine
    JO  - Science Discovery Medicine
    SP  - 111
    EP  - 117
    PB  - Science Publishing Group
    SN  - 3142-8517
    UR  - https://doi.org/10.11648/j.sdmed.20260103.11
    AB  - Background: Early diagnosis of leprosy is still a serious problem due to the low sensitivity of standard diagnostic methods and the inability to cultivate Mycobacterium leprae. Identification of M.leprae and determination of her viability on basis of PCR- technology can assistance to solve the issues of early diagnosis and the optimal duration and effectiveness of treatment of leprosy. Objectives: to investigate the performance of polymerase chain reaction (PCR) in various clinical samples for leprosy diagnosis and monitoring effectiveness of treatment. Methods: Extraction of DNA/RNA of Mycobacterium leprae were performed from various clinical specimens (biopsies and SSS, scrapes from nasal pharynx, etc.) The primers and probes were designed for the 16S rRNA of M. leprae. The test system is adapted to DT-96 Real-time Thermal cycler (DNA-Technology, Moscow, Russia). The test system contains an internal control (IC). The specificity and sensitivity of the PCR test system were performed on 15 strains of different species of mycobacteria and clinical samples from 32 leprosy patients and 15 healthy household contacts. Results: Established 100% specificity and sensitivity of detection of Mycobacterium leprae in skin biopsies by PCR compared with standard microscopy method (88.9%). In all other clinical samples were also determined higher sensitivity developed PCR test-system. Conclusions: The test system, using primers to the 16S rRNA of M. leprae has shown high sensitivity and specificity for fast identification and determination of viability of Mycobacterium leprae.
    VL  - 1
    IS  - 3
    ER  - 

    Copy | Download

Author Information
  • Sections