STUDY OF DIAGNOSTIC ACCURACY OF XPERT MTB/RIF IN PULMONARY TUBERCULOSIS IN A TERTIARY CARE TEACHING HOSPITAL, SVIMS, TIRUPATI, ANDHRA PRADESH
DOI:
https://doi.org/10.22159/ijcpr.2025v17i2.6077Keywords:
Diagnostic accuracy, Mycobacterium tuberculosis, Pulmonary tuberculosis, Rifampicin resistance, Xpert MTB/EIFAbstract
Objective: Tuberculosis is one of the major global health problems, while India contributing to a major chunk of the disease burden. A molecular method, the Xpert MTB/RIF (Cepheid, USA) can detect the presence of Mycobacterium tuberculosis DNA and the diagnostic accuracy of Xpert MTB/RIF in pulmonary tuberculosis was evaluated.
Methods: This prospective study was conducted from September 2019 to September 2020. Sputum specimens were collected and processed for Ziehl Neelsen staining technique, culture on solid Lowenstein Jensen medium and Xpert MTB/RIF. Differentiation of NTM’s from MTB by was done by performing Rapid test method using TB antigen MPT64 immunoprotein antigen. Drug susceptibility testing by proportion method was performed. The data was compiled and analyzed statistically. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of Xpert MTB/RIF was calculated using sputum culture for Mycobacterium tuberculosis as a gold standard test.
Results: A total of 435 samples satisfying the inclusion criteria were processed and analyzed. Considering Mycobacterial culture as a “gold standard” the sensitivity, specificity and accuracy of Xpert MTB/RIF in the diagnosis of pulmonary tuberculosis was noted as 96.4% (95% CI 87.4%-99.5%), 93.3% (95%CI 93.8%-97.9%) and 96.3% (95% CI 94%-97.8%) respectively. Among 9 rifampicin resistance samples detected by Xpert MTB/RIF, only 7 (77.8%) were rifampicin resistant by DST; additional 2 samples were detected by Xpert MTB/RIF alone.
Conclusion: The current study concluded that Xpert MTB/RIF is a first-line diagnostic tool in pulmonary tuberculosis which can be used in field settings as a point-of-care test and to be compared with clinical aspect of the patient as a part of National Tuberculosis Elimination Programme.
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References
Global tuberculosis report 2020. Geneva: World Health Organization; 2020. Available from: www.who.int/tb/publications/global_report/en/. [Last accessed on 27 Oct 2020].
Shenoi SV, Escombe AR, Friedland G. Transmission of drug-susceptible and drug-resistant tuberculosis and the critical importance of airborne infection control in the era of HIV infection and highly active antiretroviral therapy rollouts. Clin Infect Dis. 2010;50 Suppl 3:S231-7. doi: 10.1086/651496, PMID 20397953.
Lawn SD, Nicol MP. Xpert® MTB/RIF assay: development evaluation and implementation of a new rapid molecular diagnostic for tuberculosis and rifampicin resistance. Future Microbiol. 2011;6(9):1067-82. doi: 10.2217/fmb.11.84, PMID 21958145.
Index TB Guidelines Guidelines on Extra Pulmonary Tuberculosis for India. Initiative of Central TB Division. Ministry of Health and Family welfare Government of India; 2016. Available from: https://tbcindia.gov.in/showfile.php?lid=3245. [Last accessed on 14 Dec 2018].
Piatek AS, Van Cleeff M, Alexander H, Coggin WL, Rehr M, Van Kampen S. GeneXpert for TB diagnosis: planned and purposeful implementation. Glob Health Sci Pract. 2013;1(1):18-23. doi: 10.9745/GHSP-D-12-00004, PMID 25276513.
Baratloo A, Hosseini M, Negida A, El Ashal G. Part 1: simple definition and calculation of accuracy sensitivity and specificity-part 1: simple definition and calculation of accuracy sensitivity and specificity. Emerg (Tehran). 2015;3(2):48-9. PMID 26495380.
Tb Cindia. Revised national TB control programme for mycobacterium tuberculosis culture and drug susceptibility testing; 2009.
Vadwai V, Boehme C, Nabeta P, Shetty A, Alland D, Rodrigues C. Xpert MTB/RIF: a new pillar in diagnosis of extrapulmonary tuberculosis? J Clin Microbiol. 2011;49(7):2540-5. doi: 10.1128/JCM.02319-10, PMID 21593262.
Sharma SK, Kohli M, Yadav RN, Chaubey J, Bhasin D, Sreenivas V. Evaluating the diagnostic accuracy of Xpert MTB/RIF assay in pulmonary tuberculosis. Plos One. 2015;10(10):e0141011. doi: 10.1371/journal.pone.0141011, PMID 26496123.
Barman TK, Roy S, Hossain MA, Bhuiyan GR, Abedin S. Clinical presentation of adult pulmonary tuberculosis (PTB): a study of 103 cases from a tertiary care hospital. Mymensingh Med J. 2017;26(2):235-40. PMID 28588156.
Agrawal M, Bajaj A, Bhatia V, Dutt S. Comparative study of genexpert with zn stain and culture in samples of suspected pulmonary tuberculosis. J Clin Diagn Res. 2016;10(5):DC09-12. doi: 10.7860/JCDR/2016/18837.7755, PMID 27437212.
Lee HS, Kee SJ, Shin JH, Kwon YS, Chun S, Lee JH. Xpert MTB/RIF assay as a substitute for smear microscopy in an intermediate burden setting. Am J Respir Crit Care Med. 2019;199(6):784-94. doi: 10.1164/rccm.201804-0654OC, PMID 30252496.
Rachow A, Zumla A, Heinrich N, Rojas Ponce G, Mtafya B, Reither K. Rapid and accurate detection of mycobacterium tuberculosis in sputum samples by cepheidXpert MTB/RIF assay a clinical validation study. Plos One. 2011;6(6):e20458. doi: 10.1371/journal.pone.0020458, PMID 21738575.
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