Original Article

Diagnostic evaluation of Tru-Nat MTB/Rif test in comparison with microscopy for diagnosis of pulmonary tuberculosis at tertiary care hospital of eastern Uttar Pradesh

Abstract

Background and Objectives: This study evaluated the efficacy of the TrueLab™ Real Time mini-PCR system in providing rapid and accurate diagnostic results for tuberculosis (TB) detection in India. The goal is to improve case detection and accelerate treatment in settings with limited resources.
Materials and Methods: This prospective study was conducted by the Department of Microbiology on 120 patients, age ranging from >=15 years with at least two clinical symptoms of pulmonary TB. Molbio and Universal Cartridge Based Sample Prep were the 2 methods used for processing sputum samples. The diagnosis was based on the MTB Real Time PCR test, which has a detection limit of 100 CFU/mL. Patients under 15 years, samples lacking clinical background, saliva specimens or extra-pulmonary TB cases were excluded from the study.
Results: A total of 44.17% samples were positive for TB with maximum positivity in the age group 31-45 years. Positivity rate was found to be higher in females. In 4.17% of cases there was rifampicin resistance, which was significantly high in previously treated cases. Comparison of Truenat with Ziehl-Neelsen and fluorescent method revealed that it was more sensitive and less time consuming.
Conclusion: Truenat MTB/RIF is a sensitive detection system for TB with rapid results, which serves as an important tool in the early management of tuberculosis patients and drug-resistant-TB cases.

1. World Health Organization (‎2017)‎. Global tuberculosis report 2017. World Health Organization. https://iris.who.int/handle/10665/259366
2. Central TB Division. TB India 2017: Revised National Tuberculosis Control Programme: annual status report. New Delhi, India: Directorate General of Health Services, Ministry of Health and Family Welfare; 2017.
3. Miller MB, Popowitch EB, Backlund MG, Ager EP. Performance of Xpert MTB/RIF RUO assay and IS6110 real time PCR for Mycobacterium tuberculosis detection in clinical samples. J Clin Microbiol 2011; 49: 3458-3462.
4. Abayneh M, HaileMariam S, Asres A. Low tuberculosis (TB) case detection: A health Facility-Based study of possible obstacles in kaffa zone, southwest district of ethiopia. Can J Infect Dis Med Microbiol 2020; 2020: 7029458.
5. Gopinath K, Singh S. Multiplex PCR assay for simultaneous detection and differentiation of Mycobacterium tuberculosis, Mycobacterium avium complexes and other Mycobacterial species directly from clinical specimens. J Appl Microbiol 2009; 107: 425-435.
6. Golub JE, Mohan CI, Comstock GW, Chaisson RE. Active case finding of Tuberculosis: historical perspective and future prospects. Int J Tuberc Lung Dis 2005; 9: 1183-1203.
7. Denkinger CM, Kik SV, Cirillo DM, Casenghi M, Shinnick T, Weyer K, et al. Defining the needs for next generation assays for tuberculosis. J Infect Dis 2015; 211 Suppl 2(Suppl 2): S29-S38.
8. Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and Rifampicin resistance. N Engl J Med 2010; 363: 1005-1015.
9. Nikam C, Jagannath M, Narayanan MM, Ramanabhiraman V, Kazi M, Shetty A, et al. Rapid diagnosis of Mycobacterium tuberculosis with Truenat MTB: a near-care approach. PLoS One 2013; 8(1): e51121.
10. Drain PK, Hyle EP, Noubary F, Freedberg KA, Wilson D, Bishai WR, et al. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis 2014; 14: 239-249.
11. Nikam C, Kazi M, Nair C, Jaggannath M, M M, R V, et al. Evaluation of the Indian TrueNAT micro RT-PCR device with GeneXpert for case detection of pulmonary tuberculosis. Int J Mycobacteriol 2014; 3: 205-210.
12. World Health Organization (2015). Tuberculosis control in the South-East Asia region. https://iris.who.int/handle/10665/154550
13. Hooja S, Pal N, Malhotra B, Goyal S, Kumar V, Vyas L. Comparison of Ziehl Neelsen & Auramine O staining methods on direct and concentrated smears in clinical specimens. Indian J Tuberc 2011;58:72-76.
14. Nikam C, Jagannath M, Narayanan MM, Ramanabhiraman V, Kazi M, Shetty A, et al. Rapid diagnosis of Mycobacterium tuberculosis with Truenat MTB: a near-care approach. PLoS One 2013;8(1):e51121.
15. New Delhi: RNTCP Status Report, Central TB Division, DGHS; 2007. Central TB Division, Directorate General of Health Services (DGHS).
16. Mahadev B, Kumar P, Agarwal SP, Chauhan LS, Srikantaramu N. Surveillance of drug resistance to anti- tuberculosis drugs in districts of Hooghly in West Bengal and Mayurbhanj in Orissa. Indian J Tuberc 2005; 52: 5-10.
17. Tuberculosis Research Centre, Chennai. Trends in initial drug resistance over three decades in a rural community in South India. Indian J Tuberc 2003; 50: 75-86.
18. Dalal A, Pawaskar A, Das M, Desai R, Prabhudesai P, Chhajed P, et al. Resistance patterns among multidrug- resistant tuberculosis patients in greater metropolitan Mumbai: trends over time. PLoS One 2015; 10(1): e0116798.
19. Brennan PJ. Structure, function, and biogenesis of the cell wall of Mycobacterium tuberculosis. Tuberculosis (Edinb) 2003; 83: 91-97.
20. Tille PM (2021). Bailey & Scott's diagnostic microbiology, 15th edition, Elsevier Health Sciences.
21. Mishra GP, Mulani JD. First National anti-tuberculosis drug resistance survey (NDRS) from India - An Eye Opener. J Infect 2018; 1: 26-29.
Files
IssueVol 16 No 4 (2024) QRcode
SectionOriginal Article(s)
DOI https://doi.org/10.18502/ijm.v16i4.16305
Keywords
Microscopy; Diagnostic accuracy; Point-of-care testing; Tuberculosis; Rapid testing; Infectious diseases

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
1.
Ranjan P, Rukadikar A, Hada V, Mohanty A, Singh P. Diagnostic evaluation of Tru-Nat MTB/Rif test in comparison with microscopy for diagnosis of pulmonary tuberculosis at tertiary care hospital of eastern Uttar Pradesh. Iran J Microbiol. 2024;16(4):470-476.