DOI: http://dx.doi.org/10.18203/2320-6012.ijrms20195183

Diagnostic yield of cartridge based nucleic acid amplification test in Mycobacterium tuberculosis in a tertiary care medical college and hospital of Southern Odisha, India

Dash Manoranjan, Satyajit Samal, Swain Trupti Rekha, Behera Bibhuprasad, Sahu Swapnasarit, Mahapatra Sweekruti

Abstract


Background: Tuberculosis is the ninth leading cause of death worldwide. India contributes to about one fifth of global TB burden. It is very important to diagnose early and treat tuberculosis to cut down transmission of tuberculosis.

Methods: Author conducted a retrospective study in Department of Pulmonary Medicine SLN Medical College, Koraput, Odisha to analyze the utility and yield of CBNAAT. Study period was from April 2018 to March 2019. Inclusion criteria was all patients whose samples were subjected to CBNAAT were included in our study.  Sputum samples from pulmonary tuberculosis patients, and extra pulmonary samples (pleural fluid, ascitic fluid, CSF, synovial fluid and gastric lavage etc. were included in our study population. Exclusion criteria was patients who were under anti tubercular therapy for pulmonary, extra pulmonary and MDR TB were excluded from this study. Data were collected from Pulmonary Medicine Department, ART center, DOTS center and CBNAAT center. Total number of samples tested for CBNAAT, different sample collection sites, age and sex distribution of patients, HIV status of all patients, result of smear microscopy for AFB and CBNAAT and Rifampicin resistance status were analyzed.

The detail statistical analysis was done in tabulation form.

Results: A total of 2621 samples were tested in CBNAAT during the study period. Mean age of the study population was 38.03 years. 1881 tested were negative and 740 samples were positive for CBNAAT. Of these 2621 samples, 2526 were pulmonary samples (sputum, pleural fluid samples) and 95 were extra pulmonary samples. Author found rifampicin resistance rate of 0.54% (4/740)) in pulmonary tuberculosis cases. There was no rifampicin resistance detected in extra pulmonary samples. CBNAAT could identify 536 cases (23.2%) that were smear negative. Author found TB- HIV co-infection rate of 6.22%.

Conclusions: CBNAAT is an important diagnostic modality especially in sputum negative patients for early diagnosis and treatment. In our study it detected Mycobacterium tuberculosis in 23.2% of patients with negative smear for microscopy. Rifampicin resistance rate detected was very low compared to other studies.

Keywords


Cartridge based nucleic acid amplification test, People living with HIV, Smear negative, Tuberculosis

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References


WHO Global tuberculosis report 2017. Available at: http://www.who.int/tb/publications/global_report/en/. Accessed March 8, 2019.

TB Statistics India National, treatment outcome and state statistics TB Facts.org. Available at: https://www.tbfacts.org/tb-statistics-india/. Accessed March 8, 2019.

Weyer K, Mirzayev F, Migliori GB, Van Gemert W, D'Ambrosio L, Zignol M, et al. Rapid molecular TB diagnosis: evidence, policy making and global implementation of Xpert MTB/RIF. Eur Resp J. 2013 Jul 1;42(1):252-71.

Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, Hoffner S. Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infe Dis. 2013 Dec;13(1):507.

Chihota VN, Grant AD, Fielding K, Ndibongo B, Van Zyl A, Muirhead D, et al. Liquid vs. solid culture for tuberculosis: performance and cost in a resource-constrained setting. Int J Tubercul lung Dis. 2010 Aug 1;14(8):1024-31.

TB Online. Drug susceptibility testing the MGIT system. Available at: http://tbonline.info/posts/2011/11/29/drug-susceptibilitytesting-mgit-system/. Accessed March 21, 2019.

Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm. Accessed April 4, 2019.

WHO | Using the Xpert MTB/RIF assay to detect pulmonary and extra pulmonary tuberculosis and rifampicin resistance in adults and children. Available at: http://www.who.int/tb/publications/xpertmtb-rif-assay-diagnosis-meeting-report/en/. Accessed April 4, 2019.

Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and rifampin resistance. New Eng J Med. 2010 Sep 9;363(11):1005-15.

Arora D, Jindal N, Bansal R, Arora S. Rapid Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert Assay: A Clinical Study. J Clin Diagn Res. 2015;9(5):DC03-C05.

Dewan R, Anuradha S, Khanna A, Garg S, Singla S, Ish P, et al. Role of cartridge-based nucleic acid amplification test (CBNAAT) for early diagnosis of pulmonary tuberculosis in HIV. J Indian Acad Clin Med. 2015 Apr;16:114-7.

Medicine (US) I of. Drug-Resistant TB in India. National Academies Press (US); 2012.Available at: https://www.ncbi.nlm.nih.gov/books/NBK100386/. Accessed April 4, 2019.

Sharma S, Kaushik G, Jha B, George N, Arora S, Gupta D, et al. Prevalence of multidrug-resistant tuberculosis among newly diagnosed cases of sputum-positive pulmonary tuberculosis. Ind J Med Res. 2011 Mar 1;133(3):308.