Evaluating the diagnostic accuracy of gene xpert analysis in pediatric pulmonary tuberculosis: a prospective clinical study in North-Western India
DOI:
https://doi.org/10.18203/2349-3291.ijcp20211083Keywords:
Children, Pulmonary tuberculosis, Tuberculosis, Tuberculin test, Xpert analysisAbstract
Background: The diagnosis of tuberculosis (TB) by microbiological tests is a major challenge particularly in children. The use of Xpert analysis, a rapid genetic testing modality is not widely reported in our locality. The aim of the study to evaluate the diagnostic accuracy of Gene xpert analysis in diagnosis of pediatric Pulmonary TB.
Methods: A prospective hospital-based study was conducted among 140 participants with symptomatology pertaining to pulmonary TB as per Revised national tuberculosis control program (RNTCP, India) criteria. The Xpert testing (GXT) was performed as per standards and was compared with erythrocyte sedimentation rate (ESR), tuberculin test (TT) and chest X-rays (CXR). The obtained results were reported in terms of Sensitivity %, Specificity %, Positive Predictive Value % (PPV) and Negative Predictive Value % (NPV) for comparisons. The receiver operating curve (ROC) analysis was employed to evaluate the accuracy of diagnosis.
Results: The GXT was positive (10.71 %) in suspected TB patients. TT has significantly (10 %) with a73.33% sensitivity, 93.60% specificity and a PPV of 57.89 % when compared with xpert. The ESR showed a sensitivity of 53.33% and a specificity of 56%. The CXR showed sensitivity of 93.33%. The ROC analysis showed that TT had a higher confidence interval (0.699-0.970) t5`han other methods. The Rifampicin resistance was found 7.5% (n=2) of 15 GXT positive cases.
Conclusions: The xpert based diagnosis of gastric lavage samples after a tuberculin test (TT) had high sensitivity and specificity, followed by chest X ray while the ESR had lower clinical accuracy. The ‘gene xpert analysis’ is highly useful rapid tool for diagnosis of children with TB.
References
MacNeil A, Glaziou P, Sismanidis C, Maloney S, Floyd K. Global epidemiology of tuberculosis and progress toward achieving global targets—2017. MMWR. 2019;68(11):263.
World Health Organization (2015) Global tuberculosis report. Available at: https://www.who.int/tb/publications/global_report/gtbr15_main_text.pdf. Accessed on 30 November, 2020.
World Health Organization (2013) Roadmap for childhood tuberculosis: towards zero deaths. Geneva: WHO. Available at: https://www.who.int/tb/areas-of-work/children/roadmap/en/. Accessed on 30 November, 2020.
Kumar A, Gupta D, Nagaraja SB, Singh V, Sethi GR, Prasad J. Updated national guidelines for pediatric tuberculosis in India, 2012. Indian Pediatr. 2013;50:301 6.
Swaminathan S, Rekha B. Pediatric tuberculosis: Global overview and challenges. Clin Infect Dis. 2010;50(Suppl 3):S184 94.
Marais BJ, Pai M. New approaches and emerging technologies in the diagnosis of childhood tuberculosis. Paediatr Respir Rev. 2007;8:124 33.
Ahmed T, Sobhan F, Ahmed AM, Banu S, Mahmood AM, Hyder KA, et al. Childhood tuberculosis: a review of epidemiology, diagnosis and management. Infect Dis J Pakistan. 2008;17(2):52-60.
Jereb JA, Kelly GD, Porterfield DS. The epidemiology of tuberculosis in children. Sem Pediatr Infect Dis. 1993;4:220-31.
Bloch A, Snider D. How much tuberculosis in children continue to be neglected? Am J Public Health. 1986;76:14-15.
Lawn SD, Nicol MP. Xpert MTB/RIF assay: development, evaluation and implementation of a new rapid molecular diagnostic for tuberculosis and rifampicin resistance. Future Microbiology. 2011;6(9):1067-1082.
World Health Organization. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB. World Health Organization. 2013.
Bates M, O'Grady J, Maeurer M, Tembo J, Chilukutu L, Chabala C et al. Assessment of the Xpert MTB/RIF assay for diagnosis of tuberculosis with gastric lavage aspirates in children in sub-Saharan Africa: a prospective descriptive study. Lancet Infect Dis. 2013;13(1):36-42.
Rachow A, Clowes P, Saathoff E, Mtafya B, Michael E, Ntinginya EN, et al: A prospective cohort study. Clin Infect Dis. 2012;54(10):1388-1396.
Nicol MP, Workman L, Isaacs W, Munro J, Black F, Eley B, et al. Accuracy of the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in children admitted to hospital in Cape Town, South Africa: a descriptive study. Lancet Infect Dis. 2011;11(11):819-24.
Nicol MP, Spiers K, Workman L, Isaacs W, Munro J, Black F et al. Xpert MTB/RIF testing of stool samples for the diagnosis of pulmonary tuberculosis in children. Clin Infect Dis. 2013;57(3):e18-e21.
Zhang M, Xue M, He JQ. Diagnostic accuracy of the new Xpert MTB/RIF Ultra for tuberculosis disease: A preliminary systematic review and meta-analysis. Int J Infect Dis. 2020;90:35-45.
Sood AK, Bajaj M, Kumar R, Kanga A. Utility of GeneXpert for Detection of Mycobacterium tuberculosis and Rifampicin Resistance in Pediatric Tuberculosis. Pediat Infect Dis. 2019;1(4):138.
Wang SF, Ou XC, Li Q, Zheng HW, Wang YF, Zhao YL, et al. The Abbott RealTime MTB assay and the Cepheid GeneXpert assay show comparable performance for the detection of Mycobacterium tuberculosis in sputum specimens. Int J Infect Dis. 2016;45:78-80.
Chadha VK, Kumar P, Satyanarayanan AV, Chauhan LS, Gupta J, Singh S, et al. Annual risk of tuberculosis infection in Andhra Pradesh, India. Indian J Tuberc. 2007;54(4):177-83.
Rao VG, Gopi PG, Yadav R, Subramani R, Bhat J, Anvikar AR, et al. Annual risk of tuberculosis infection among tribal population of Central India. Trop Med Int Heal. 2008;13(11):1372-7.
Caiaffa WT, Graham NM, Galai N, Rizzo RT, Nelson KE, Vlahov D, et al. Instability of DelayedType Hypersensitivity Skin-Test Anergy in Human Immunodeficiency-Virus Infection. Arch Int Med. 1995;155(19):2111-7.
Pandey D, Yadav A. Efficacy of gene xpert over other diagnostic modalities of tuberculosis among children. Int J Contemp Pediatr. 2019;6(4):1545-1551.
Gandra GN, Gali JH. GeneXpert: a game changer in the detection and diagnosis of childhood tuberculosis. Int J Contemp Pediatr. 2018;5(1):35-41.
Sorsa A. The Diagnostic Performance of Chest-X-Ray and Erythrocyte Sedimentation Rate in Comparison with GeneXpert® for Tuberculosis Case Notification Among Patients Living with Human Immunodeficiency Virus in a Resource-Limited Setting: A Cross-Sectional Study. Risk Manag Healthc Policy. 2020;13:1639-1646.
Creswell J, Qin ZZ, Gurung R, Lamichhane B, Yadav DK, Prasai MK et al. The performance and yield of tuberculosis testing algorithms using microscopy, chest x-ray, and Xpert MTB/RIF. J Clin Tuberc Other Mycobact Dis. 2018;14:1-6.
Wekesa C, Kirenga BJ, Joloba ML, Bwanga F, Katamba A, Kamya MR, et al. Chest X-ray vs. Xpert® MTB/RIF assay for the diagnosis of sputum smear-negative tuberculosis in Uganda. Int J Tuberc Lung Dis. 2014;18(2):216-9.
Nadiah Z, Koesoemadinata RC, McAllister SM, et al. Early chest X-ray in persons with presumptive tuberculosis increases Xpert® MTB/RIF diagnostic yield and efficiency. Public Health Action. 2020;10(1):17-20.
Sun L, Zhu Y, Fang M, Shi Y, Peng X, Liao Q, et al. Evaluation of Xpert MTB/RIF Ultra Assay for Diagnosis of Childhood Tuberculosis: a Multicenter Accuracy Study. J Clin Microbiol. 2020;58(9):e00702-20.
