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1

Choerunisa, Towifah Fauziah, Leni Lismayanti, Tiene Rostini, Ryan Bayusantika, and Ida Parwati. "Comparison of Line Probe Assay (LPA) and Mycobacterium Growth Indicator Tubes (MGIT) Assay for Second-line TB Drug Susceptibility Testing." Indonesian Biomedical Journal 13, no. 3 (2021): 256–60. http://dx.doi.org/10.18585/inabj.v13i3.1521.

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BACKGROUND: Tuberculosis (TB) infection is one of the most prominent health issues in the world, including in Indonesia. TB is evolving into multidrug-resistant tuberculosis (MDR-TB) and requiring second-line TB drugs. Mycobacterium growth indicator tube (MGIT) is the gold standard for susceptibility testing of second-line TB drugs. Alternatively, line probe assay (LPA), which detects genes resistant to second-line TB drugs, takes a shorter time to run. This study aims to compare MGIT and LPA's ability to detect TB resistance to second-line TB drugs and observe mutation patterns of genes encoding second-line TB drugs.METHODS: This was an observational analytic study, using cross-sectional method. The data were acquired from the MDR-TB clinic’s medical records at the Dr. Hasan Sadikin Hospital from September to December 2019. LPA and MGIT test were conducted at the Health Laboratory Hall of West Java Province, then tested using Kolmogorov-Smirnov and chi-square statistic.RESULTS: From 121 subjects, 113 people were not resistant to the second-line TB drugs, which was examined using both LPA and MGIT (93.4%), p=0.991. Mutations were found in gyrA and rrs gene. There was no significant difference between the proportion of subjects resistant to the second-line of TB drugs tested using LPA and MGIT.CONCLUSION: LPA is an alternative method to MGIT because it requires a shorter time and reduces the risk of exposure that will improve MDR-TB patients management.KEYWORDS: line probe assay (LPA), multidrug-resistant TB, mycobacterium growth indicator tube (MGIT), second-line TB drugs
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2

Tania, Tryna, Pratiwi Sudarmono, R. Lia Kusumawati, et al. "Whole-genome sequencing analysis of multidrug-resistant Mycobacterium tuberculosis from Java, Indonesia." Journal of Medical Microbiology 69, no. 7 (2020): 1013–19. http://dx.doi.org/10.1099/jmm.0.001221.

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Introduction. Multidrug-resistant tuberculosis (MDR-TB) is a major public health problem globally, including in Indonesia. Whole-genome sequencing (WGS) analysis has rarely been used for the study of TB and MDR-TB in Indonesia. Aim. We evaluated the use of WGS for drug-susceptibility testing (DST) and to investigate the population structure of drug-resistant Mycobacterium tuberculosis in Java, Indonesia. Methodology. Thirty suspected MDR-TB isolates were subjected to MGIT 960 system (MGIT)-based DST and to WGS. Phylogenetic analysis was done using the WGS data. Results obtained using MGIT-based DST and WGS-based DST were compared. Results. Agreement between WGS and MGIT was 93.33 % for rifampicin, 83.33 % for isoniazid and 76.67 % for streptomycin but only 63.33 % for ethambutol. Moderate WGS–MGIT agreement was found for second-line drugs including amikacin, kanamycin and fluoroquinolone (73.33–76.67 %). MDR-TB was more common in isolates of the East Asian Lineage (63.3%). No evidence of clonal transmission of DR-TB was found among members of the tested population. Conclusion. Our study demonstrated the applicability of WGS for DST and molecular epidemiology of DR-TB in Java, Indonesia. We found no transmission of DR-TB in Indonesia.
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3

Zhao, Ping, Qin Yu, and Yu Zhang. "Evaluation of a manual identification system for detection of Mycobacterium tuberculosis in a primary tuberculosis laboratory in China." Journal of International Medical Research 47, no. 6 (2019): 2666–73. http://dx.doi.org/10.1177/0300060519844399.

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Objective To compare the diagnostic performance of the manual BACTEC™ Mycobacteria Growth Indicator Tube (MGIT™) system (M-MGIT) with the automated BACTEC™ MGIT™ 960 system (A-MGIT) and Löwenstein-Jensen (L-J) culture method in detecting mycobacteria in sputum specimens from patients with suspected pulmonary tuberculosis (TB). Methods For this cross-sectional study, sputum samples were taken from patients aged ≥18 years attending a TB clinic in Beijing, China between July 2015 and October 2016. Processed sputum samples were inoculated into the MGIT systems and L-J medium for up to 6 and 8 weeks, respectively. Results The M-MGIT and A-MGIT methods detected significantly more Mycobacterium tuberculosis complex (MTC) isolates than L-J culture from the 565 sputum samples (39%, 40% and 32%, respectively). Using a positive result from any of the three culture systems as reference, the sensitivity of M-MGIT, A-MGIT and L-J methods were 92%, 94%, and 74%, respectively. The time-to-detection of mycobacteria was 12.9±4.2 days for M-MGIT, 11.8±5.2 days for A-MGIT and 24.2±8.7 days for L-J. Conclusions M-MGIT has a similar diagnostic performance to A-MGIT, and is a fast and reliable alternative to conventional culture methods in the diagnosis of pulmonary TB in a developing country.
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Hanna, Bruce A., Adeleh Ebrahimzadeh, L. Bruce Elliott, et al. "Multicenter Evaluation of the BACTEC MGIT 960 System for Recovery of Mycobacteria." Journal of Clinical Microbiology 37, no. 3 (1999): 748–52. http://dx.doi.org/10.1128/jcm.37.3.748-752.1999.

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We evaluated the BACTEC MGIT 960 system, which is a fully automated, noninvasive system for the growth and detection of mycobacteria with a capacity to incubate and continuously monitor 960 7-ml culture tubes. We studied 3,330 specimens, 2,210 respiratory and 1,120 nonrespiratory specimens, collected from 2,346 patients treated at six sites. Processed specimens were inoculated into the BACTEC MGIT 960 and BACTEC 460 TB systems, as well as onto Lowenstein-Jensen slants and Middlebrook 7H11/7H11 selective plates. From all culture systems, a total of 362 isolates of mycobacteria were recovered; these were recovered from 353 specimens collected from 247 patients. The greatest number of isolates of mycobacteria (289, or 80% of the 362 isolates) was recovered with the BACTEC MGIT 960, followed by the BACTEC 460 TB (271, or 75%) and solid media (250, or 69%). From all culture systems a total of 132 isolates of Mycobacterium tuberculosiscomplex were recovered. The greatest number of isolates of M. tuberculosis complex was recovered when liquid medium was combined with conventional solid media; the number recovered with BACTEC 460 TB plus solid media was 128 (97%), that recovered with BACTEC MGIT 960 plus solid media was 121 (92%), that recovered with BACTEC 460 TB was 119 (90%) and that recovered with all solid media combined was 105 (79%). The recovery with BACTEC MGIT 960 alone was 102 (77%). The mean times to detection (TTD) for M. tuberculosis complex were 14.4 days for BACTEC MGIT, 15.2 days for BACTEC 460 TB, and 24.1 days for solid media. The numbers of isolates of Mycobacterium avium complex (MAC) recovered were 172 (100%) for all systems, 147 (85%) for BACTEC MGIT 960, 123 (72%) for BACTEC 460 TB, and 106 (62%) for all solid media combined. The TTD for MAC in each system were 10.0 days for BACTEC MGIT 960, 10.4 days for BACTEC 460 TB, and 25.9 days for solid media. Breakthrough contamination rates (percentages of isolates) for each of the systems were 8.1% for BACTEC MGIT 960, 4.9% for BACTEC 460 TB, and 21.1% for all solid media combined.
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Jorwal, Pankaj, Binit Kumar Singh, Ankita Anand, et al. "Diagnostics Evaluation of Smart Sure™ Mycobacterium tuberculosis Screening Kit and Smart Sure™ Multidrug-resistant Tuberculosis Detection Kit on Nonsputum Specimens at a Tertiary Care Center of North India." International Journal of Mycobacteriology 13, no. 3 (2024): 275–81. http://dx.doi.org/10.4103/ijmy.ijmy_140_24.

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Background: Tuberculosis (TB) is caused due to the infection of Mycobacterium tuberculosis (MTB) and it can infect the various parts of the human body. The disease is highly prevalent and is the second most common cause of death worldwide after COVID-19. Apart from sputum specimen, it is exceedingly difficult to diagnose due to its paucibacillary nature. The current study was intended to evaluate the accuracy of Smart Sure™ MTB and multidrug-resistant-TB (MDR-TB) kits (Genetix Biotech Asia Pvt. Ltd., India) with Xpert ultra and Mycobacterium growth indicator tube (MGIT) culture on nonsputum specimens from TB suspects. Methods: A total of 205 nonsputum specimens were received between October 2023 and May 2024 at Intermediate Reference Laboratory, Department of Medicine, All India Institute of Medical Sciences, New Delhi, India. Xpert ultra and Smart Sure™ MTB and MDR-TB tests were done directly on samples. However, processed specimens were used for MGIT culture and drug-susceptibility testing (DST). Invalid and MGIT contaminated specimens were excluded from the final calculation. Results: Overall, sensitivity and specificity of Smart Sure™ MTB screening kit was 71.59% and 98.28%, respectively, with Xpert ultra and 68.35% and 90.83%, respectively, with MGIT culture. While comparing with both Xpert ultra and MGIT-DST to detect rifampicin (RIF) resistant, Smart Sure™ MDR-TB kits showed sensitivity of 75.0% and 100% of specificity. However, for isoniazid (INH) resistance, Smart Sure™ MDR-TB kits showed 100% of sensitivity and specificity with MGIT-DST. Conclusion: For the detection of MTB and its drug-resistance patterns (RIF and INH) in the specimens other than sputum, Smart Sure™ MTB and MDR-TB kits could play a vital role in TB endemic countries. While comparing the set-ups and skilled staffs, it required almost same as compared with previously approved WHO diagnostics used in resource-limited countries.
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Makamure, Beauty, Salome Makumbirofa, Tsitsi Bandason, et al. "A suggested algorithm for detection of multi drug-resistant tuberculosis in Zimbabwe." Journal of Infection in Developing Countries 11, no. 08 (2017): 611–18. http://dx.doi.org/10.3855/jidc.8009.

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Introduction: Rapid genotypic and phenotypic methods for multi-drug-resistant-tuberculosis (MDR-TB) detection are now widely available. Zimbabwe adopted the use of GeneXpert-MTB/RIF, microscopic-observation-drug-susceptibility-assay (MODS) and Mycobacteria-Growth-Indicator-Tube (MGIT) drug-susceptibility-testing (DST). Data is limited on the ideal combination of use of these methods in resource limited settings.
 Methodology: Between August 2014 to July 2015, 211 sputa from MDR-TB suspects were tested with GeneXpert-MTB/RIF, MODS, manual-MGIT and Lowenstein-Jensen (LJ)-DST to determine diagnostic accuracy and turnaround-time (TAT), with LJ-DST as the gold standard. A performance score ranking table for diagnostic accuracy, TAT, costs, facilities and expertise requirements, was used to determine the most favourable tool.
 Results: GeneXpert-MTB/RIF sensitivity was 96% (95%CI:80-100) and specificity was 95% (95%CI:90-97). MODS sensitivity was 88% (95%CI:68-97) and specificity was 97% (95%CI:87-100). Manual MGIT-DST had slightly lower sensitivity of 80% (95%CI:59-93). Median time to detection of MDR-TB was <1 day (IQR:0-0) for Xpert, 14 days (IQR:11-31) for MODS, 21 days (IQR:7-22) for MGIT-DST and 28 days (IQR:25-28) for LJ-DST. Operational costs for MODS, MGIT-DST, and GeneXpert-MTB/RIF were $21.20, $27.52 and $39.76 respectively. From a summation of scores including facility and expertise requirements per diagnostic technique, GeneXpert-MTB/RIF was the most favourable tool, followed by MODS and MGIT-DST.
 Conclusions: For best scale-up of MDR-TB diagnosis in Zimbabwe, GeneXpert-MTB/RIF can be used for rapid detection of TB in smear negative cases, RIF-susceptibility for early treatment initiation and probable MDR-TB. MODS can rapidly confirm probable MDR-TB detected by GeneXpert-MTB/RIF, manual-MGIT can provide early results for susceptibility to other antibiotics, with affordable costs, with LJ-DST confirming discordant DSTs.
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7

Rahman, S. M. Mazidur, Md Fahim Ather, Rumana Nasrin, et al. "Performance of WHO-Endorsed Rapid Tests for Detection of Susceptibility to First-Line Drugs in Patients with Pulmonary Tuberculosis in Bangladesh." Diagnostics 12, no. 2 (2022): 410. http://dx.doi.org/10.3390/diagnostics12020410.

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The fast and accurate detection of susceptibility in drugs is a major challenge for a successful tuberculosis (TB) control programme. This study evaluated the performance of WHO-endorsed rapid diagnostic tools, such as BACTEC MGIT 960 SIRE (MGIT SIRE), GenoType MTBDRplus (MTBDRplus) and Xpert MTB/RIF (Xpert), for detecting susceptibility to first-line anti-TB drugs among pulmonary TB patients in Bangladesh. A total of 825 sputum samples with results from drug susceptibility testing (DST) against first-line anti-TB drugs in the MGIT SIRE, MTBDRplus and Xpert assays were evaluated and compared with the gold standard proportion susceptibility method of the Lowenstein–Jensen (LJ) medium. The overall sensitivities of MGIT SIRE were 97.6%, 90.0%, 61.3% and 44.9%, while specificities were 89.9%, 94.5%, 91.3% and 92.2% for detection of susceptibility to isoniazid (INH), rifampicin (RIF), streptomycin (STR) and ethambutol (EMB), respectively. For MTBDRplus, the sensitivities were 88.0% and 88.7%, and the specificities were 97.4% and 97.8% for the detection of susceptibility to INH and RIF, respectively. Xpert demonstrated a sensitivity and specificity of 94.8% and 99.5%, respectively, for the detection of RIF susceptibility. All tests performed significantly better in retreated TB patients compared with primary TB cases. For detection of RIF and INH susceptibility, all three assays showed almost perfect agreement with the LJ method, although MGIT SIRE exhibited low agreement for STR and EMB. Considering the high performance, shorter turnaround time and ease of use, molecular-based approaches Xpert and MTBDRplus can be widely implemented throughout the country for the rapid detection of drug-resistant TB.
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Rajani, Monika, and Molay Banerjee. "Evaluation of Various Diagnostic Techniques for the Diagnosis of Pulmonary and Extra Pulmonary Tuberculosis at a Tertiary Care Center in North India." Infectious Disorders - Drug Targets 20, no. 4 (2020): 433–39. http://dx.doi.org/10.2174/1871526519666191011165702.

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Introduction: Tuberculosis (TB) is a one of the main causes of mortality and morbidity worldwide. Bactec MGIT (Mycobacteria Growth Indicator Tube) system is a rapid, reliable automated system for early diagnosis of pulmonary and extra pulmonary TB in setups where purchase of expensive instruments is not possible. The present study was thus carried out to evaluate AFB microscopy, culture on Lowenstein Jensen media and micro MGIT system for early and accurate diagnosis of Tuberculosis. Methods: A total of 280 samples were processed for direct AFB smear examination, and culture on micro MGIT and LJ media. The identification of Mycobacterium tuberculosis complex in positive cultures was done by MPT64 Ag card test (BD MGIT TBC Identification Test). Results: Out of the processed samples, (47.1%) 132/280 were positive for Mycobacterium spp by Micro MGIT, (35%) 98/280 on LJ medium and (25.7%) 72/280 by AFB smear. A total of (48.5%) 136 samples were positive by a combination of Micro MGIT and LJ medium. Among the total positive samples (136/280), Micro MGIT was found to be positive in 97% (132/136) of samples, LJ was positive in 72% (98/136), while 52.9% (72/136) were positive by AFB smear. Conclusion: Manual MGIT System is a simple and efficient, safe to use the diagnostic system. It does not require any expensive/special instrumentation other than the UV lamp for the detection of fluorescence. In areas with limited resources where the purchase of expensive instruments such as the MGIT 960 is out of scope, the use of manual MGIT for rapid susceptibility testing for MDR-TB could be an option. We would recommend testing MGIT 960 using first and secondline drugs to determine DST.
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Vater, Maria Claudia, Mário Motta Maximo, Adriana da Silva Rezende Moreira, Suely Conceição Alves da Silva, Isabela Neves de Almeida, and Afrânio Lineu Kritski. "Cost Analysis for Patients with Presumed Pulmonary Tuberculosis Attended in the Public Health System of Rio de Janeiro, Brazil." International Journal of Mycobacteriology 10, no. 2 (2021): 136–41. http://dx.doi.org/10.4103/ijmy.ijmy_58_21.

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Background: In last years, few attention has given to the patient's prediagnostic costs when evaluating the introduction of new technologies for tuberculosis (TB) and in this context, this study evaluated patient's costs and cost-effectiveness incurred with TB diagnosis comparing BactecTMMGITTM960 system (MGIT) to the Löwestein–Jensen (LJ) culture in a health center and in a university hospital, in Rio de Janeiro City, Brazil. Methods: Patient's mean costs were evaluated during the diagnosis process and cost-effectiveness based on mean time in days for the adoption of appropriate clinical anti-TB treatment in two health units comparing culture by means LJ and MGIT. Results: The mean cost of LJ and MGIT in the health center was U. S. dollars (US$) 26.6 and US$ 45.13, respectively, and in university hospital was US$ 206.87 and US$ 285.48, respectively. Comparing the two approaches for TB diagnosis incurred by the patients, the incremental cost-effectiveness of MGIT compared to LJ was US$ 0.88 and US$ 4.03 per patient, respectively, to reduce the average time to adopt appropriate treatment. Conclusions: The culture method directly impacts patient costs while waiting for the correct diagnosis and contributing to aggravating costs with patients with TB.
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Mittal, Vineeta, Manoj Kumar, and Ajay Kumar Singh. "TB LAMP assay, a beneficial tool for the diagnosis of Tubercular meningitis in resource-limited settings." Journal of Infection in Developing Countries 18, no. 03 (2024): 435–40. http://dx.doi.org/10.3855/jidc.18115.

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Introduction: Tubercular meningitis (TBM) is a serious public health problem in developing countries as it leads to significant mortality and residual neurological sequelae. The estimated mortality due to TBM in India is 1.5 per 100,000 population. In resource-limited settings, only the Ziehl-Neelsen (ZN) stain, which has very little sensitivity, is available. The World Health Organization recommended the Loop Mediated Isothermal Amplification (TB LAMP) assay for pulmonary tuberculosis only. We evaluated this test for tubercular meningitis as well. Methodology: In a cross-sectional study of 2-year duration, we have taken 239 cerebrospinal fluid samples from suspected cases of tubercular meningitis patients. ZN staining along with Mycobacteria Growth Indicator Tube (MGIT) TB culture, Xpert MTB/RIF Ultra assay, and commercial TB LAMP assay were performed for each sample. Results: Out of 239 samples, 40 samples (16.73%) were found TB LAMP assay positive, 48 samples (20.08%) were found Xpert ultra-assay positive, 12 samples (5.02%) were MGIT TB culture positive and acid-fast bacillus smear positive in ten samples (4.18 %). Out of 12 MGIT-positive samples, all samples (100%) were TB LAMP and Xpert ultra positive and one sample (8.33%) was ZN smear positive. In 199 negative samples from the TB LAMP assay, eight samples were positive by Xpert, none by MGIT TB culture and AFB smear. Sensitivity and specificity were found as 100% and 87.66%, respectively, for the TB LAMP assay. Conclusion: TB LAMP assay is a rapid, cost-effective, sensitive, and specific test for tubercular meningitis infection in resource-limited settings.
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Ssengooba, Willy, David P. Kateete, Anne Wajja, et al. "An Early Morning Sputum Sample Is Necessary for the Diagnosis of Pulmonary Tuberculosis, Even with More Sensitive Techniques: A Prospective Cohort Study among Adolescent TB-Suspects in Uganda." Tuberculosis Research and Treatment 2012 (2012): 1–6. http://dx.doi.org/10.1155/2012/970203.

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The World Health Organization (WHO) recommends collection of two sputum samples for tuberculosis (TB) diagnosis, with at least one being an early morning (EM) using smear microscopy. It remains unclear whether this is necessary even when sputum culture is employed. Here, we determined the diagnostic yield from spot and the incremental yield from the EM sputum sample cultures among TB-suspected adolescents from rural Uganda. Sputum samples (both spot and early-morning) from 1862 adolescents were cultured by the Lowenstein-Jensen (LJ) and Mycobacterium Growth Indicator Tube (MGIT) methods. For spot samples, the diagnostic yields for TB were 19.0% and 57.1% with LJ and MGIT, respectively, whereas the incremental yields (not totals) of the early-morning sample were 9.5% and 42.9% (P<0.001) with LJ and MGIT, respectively. Among TB-suspected adolescents in rural Uganda, the EM sputum culture has a high incremental diagnostic yield. Therefore, EM sputum in addition to spot sample culture is necessary for improved TB case detection.
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Sessolo, Abdulwahab, Emmanuel Musisi, Sylvia Kaswabuli, et al. "Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda." PLOS ONE 18, no. 4 (2023): e0284041. http://dx.doi.org/10.1371/journal.pone.0284041.

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Background Stool is a potential sample for diagnosing Mycobacterium tuberculosis (Mtb) in patients with difficulty in expectorating. However, high mycobacterial culture contamination rates and Xpert MTB/RIF Ultra test error rates on stool samples have limited its use. OMNIgene SPUTUM (OM-S) is a sample transport reagent with characteristics of sputum decontamination while maintaining viable Mtb. We evaluated the impact of OM-S on Mtb diagnostic yield from stool using smear microscopy, Xpert MTB/RIF Ultra, and culture among presumptive TB patients. Methods Paired stool and expectorated sputum samples were collected from consecutive Ugandan adults undergoing diagnostic evaluation for pulmonary TB between June 2018 and June 2019. Stool was divided into 2 portions: one was homogenized in OM-S (OM-S stool) and the other in PBS (PBS stool) as control. Both sputum and processed stool were tested for Mtb using concentrated smear fluorescence microscopy (CFM), Xpert MTB/RIF Ultra (Xpert) and Mycobacteria Growth Indicator Tube (MGIT) culture. Sensitivity, specificity, and predictive values for each test were calculated against sputum MGIT culture as the reference standard. Results Of the 200 participants, 120 (60%) were male, 73 (37%) were HIV positive (median CD4 120 cells/uL (IQR 43–297)) and 128 (64%) had confirmed pulmonary TB by sputum MGIT culture. Seven (4%) OM-S stool Xpert samples reported errors while 47 (25%) and 103 (61%) were contaminated on OM-S stool MGIT and PBS stool MGIT, respectively. OM-S stool MGIT was able to accurately diagnose 56 of the contaminated PBS stool MGIT samples compared to only 5 of the contaminated OM-S stool MGIT samples diagnosed by PBS stool MGIT. Sensitivity (95% Confidence Interval, CI) 89% (83–94) for OM-S stool Xpert was higher compared to that of OM-S stool MGIT 60% (51–69) and PBS stool MGIT 42% (32–52). Specificity (95%CI) 91% (82–97) was also higher for OM-S stool Xpert compared to OM-S stool MGIT 64% (51–75) and PBS stool MGIT 26% (16–38). Conclusion Stool processed with OM-S showed potential to improve Mtb diagnostic yield and reduce rates of indeterminate results when tested on Xpert and MGIT culture. The method may thus be of value in Mtb detection among patients with difficulty to expectorate.
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Qiu, Chaochao, Ning Pan, Yueying Zhou, et al. "Application Value of SAT-TB Combined with Acid-Fast Staining in the Diagnosis and Treatment of Pulmonary Tuberculosis." BioMed Research International 2020 (November 3, 2020): 1–5. http://dx.doi.org/10.1155/2020/3620425.

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Objectives. This study is aimed at evaluating the clinical application value of RNA simultaneous amplification and testing method for Mycobacterium tuberculosis (SAT-TB) combined with acid-fast staining in the diagnosis and treatment of pulmonary tuberculosis (PTB). Methods. This paper included 168 suspected and confirmed PTB sufferers admitted to The Sixth People’s Hospital of Wenzhou from December 2018 to December 2019, whose sputum was collected and tested using SAT-TB, smear acid-fast staining method, and the BACTEC MGIT 960 system. With the MGIT 960 culture test method as the gold standard, the application value of SAT-TB, acid-fast staining, or SAT-TB combined with acid-fast staining in the diagnosis and treatment of PTB was assessed. Results. With the MGIT 960 culture as the gold standard, the sensitivity, specificity, positive predictive value, and negative predictive value of SAT-TB for the diagnosis of PTB were 57.3%, 92.5%, 84.3%, and 73.5%, respectively. The conformity was 76.8%, and the Kappa value was 0.515, suggesting a statistically significant difference ( χ 2 = 7.314 , p < 0.05 ) and a general consistency degree. Additionally, the sensitivity, specificity, positive predictive value, and negative predictive value of SAT-TB combined with sputum smear acid-fast staining were 81.3%, 86.0%, 88.4%, and 80.8%, respectively, with the MGIT 960 culture still the gold standard. The conformity and Kappa value were 83.9% and 0.672, respectively, showing no statistically significant difference ( χ 2 = 0.438 , p > 0.05 ) and a relatively high consistency degree. Conclusion. SAT-TB combined with acid-fast staining had a similar detection rate to that of the MGIT 960 culture test with a high consistency degree, which could be applied in the diagnosis of PTB efficiently and accurately.
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SHAH, IRA, RASIKA BHAMRE, and NAMAN S. SHETTY. "Accuracy of Xpert® MTB/RIF in diagnosing extrapulmonary tuberculosis in Indian children." National Medical Journal of India 35 (April 28, 2023): 334–37. http://dx.doi.org/10.25259/nmji_35_6_334.

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Background Diagnosing extrapulmonary tuberculosis (EPTB) can be challenging because of a variety of presentations. We assessed the accuracy of the Xpert MTB/RIF assay in diagnosing EPTB in children. Methods Of the 255 children diagnosed to have tuberculosis (TB) who underwent testing by the Xpert MTB/ RIF assay at the TB clinic from December 2014 to April 2017, 182 had EPTB and were included in the study. The diagnostic accuracy, specificity and sensitivity of the Xpert assay were calculated with Mycobacterium growth indicator tube (MGIT) as a reference standard. Results Lymph node TB was present in 58 (32%) children, 37 (20%) had neurological TB, 36 (20%) had bone TB, 31 (17%) had pleural TB, 15 (8%) had abdominal TB, 2 (1%) had abscess, 2 (1%) had congenital TB and disseminated TB was seen in 1 (0.4%) child. Xpert MTB/RIF assay was positive in 84 (46.2%) patients. The sensitivity and specificity of the Xpert MTB/RIF assay were 72% and 72.04%, respectively. Compared to MGIT, a kappa coefficient of 0.44 shows moderate agreement between the Xpert assay and MGIT. The sensitivity of Xpert MTB/RIF assay in abdominal TB, bone TB, lymph node TB, neurological TB and pleural TB was 50% (15%–85%), 72.7% (15.9%– 86.9%), 80.8% (62.1%–91.5%), 75% (50.5%–90%) and 25% (4.6%–70%), respectively. The specificity of abdominal TB, bone TB, lymph node TB, neurological TB and pleural TB was 83.3% (43.7%–97%), 69.2% (42.4%– 87.3%), 55.2% (37.6%–71.6%), 85% (64%–94.8%) and 82.6% (62.9%–93%), respectively. Forty-seven (26%) patients had drug-resistant TB (DR-TB), of which 15 (8%) were rifampicin-resistant (RR), 2 (1%) were polyresistant, 14 (8%) had multi-DR (MDR), 15 (8%) had pre-extremely DR (XDR) and 1 (1%) had XDR-TB. Of the 15 patients with MDR-TB, Xpert MTB/RIF assay detected only 10 (71%) as RR (p=0.06). Of the 15 pre-XDR cases, Xpert MTB/RIF detected only 8 (53%) as RR (p=0.02). Conclusion Xpert MTB/RIF assay is useful in the diagnosis of EPTB. It shows good concordance with MGIT. However, it may be negative in patients with DR-TB.
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Rufai, Syed Beenish, Sarman Singh, Amit Singh, Parveen Kumar, Jitendra Singh, and Anand Vishal. "Performance of Xpert MTB/RIF on Ascitic Fluid Samples for Detection of Abdominal Tuberculosis." Journal of Laboratory Physicians 9, no. 01 (2017): 047–52. http://dx.doi.org/10.4103/0974-2727.187927.

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ABSTRACT Background: Diagnosis of abdominal tuberculosis (TB) from ascitic fluid samples using routinely available diagnostic methods is challenging due to its paucibacillary nature. Although performance of Xpert MTB/RIF assay has been evaluated extensively on pulmonary samples, its performance on extrapulmonary samples is still under evaluation. Objectives: The objective of this study was to find out the performance of Xpert MTB/RIF on ascitic fluid samples obtained from suspected cases of abdominal TB. Performance was compared with Mycobacterium growth indicator tube-960 (MGIT-960) culture and in-house multiplex polymerase chain reaction (PCR). The latter detects and differentiates Mycobacterium tuberculosis and nontuberculous mycobacteria simultaneously. Materials and Methods: Sixty-seven patients suspected of probable/possible abdominal TB were included in this observational, prospective study. All samples were tested by Ziehl–Neelsen staining, MGIT-960 culture, in-house multiplex PCR, and Xpert MTB/RIF assay. Results: All 67 samples were smear negative. Seventeen (25.4%) were MGIT-960 culture positive while 12 (17.9%) were detected positive by the Xpert MTB/RIF assay and 9 (13.4%) by in-house multiplex PCR. Sensitivity and specificity of the Xpert MTB/RIF assay compared with the MGIT-960 culture were 70.6% (95%, confidence interval [CI]: 44.1–89.7) and 100% (95%, CI: 92.8–100) and that of in-house multiplex PCR were 52.9% (95%, CI: 30.9–73.8) and 100% (95%, CI: 92.8–100), respectively. Conclusions: Diagnostic yield of Xpert MTB/RIF assay on ascitic fluid samples was lower than MGIT-960 culture. We thus emphasize on the need for urgent discovery of new biomarkers for paucibacillary TB.
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Muzanyi, Grace, Aber Peace, Bonny Wamuntu, Akol Joseph, and Joanita Nassali. "The threat of persistent bacteria and fungi contamination in tuberculosis sputum cultures." African Health Sciences 21, no. 2 (2021): 628–32. http://dx.doi.org/10.4314/ahs.v21i2.18.

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Background: Tuberculosis (TB) sputum culture contaminants make it difficult to obtain pure TB isolates.We aimed to study and identify persistent TB sputum culture contaminants post the standard laboratory pre-culture sample decontamination techniques. Methods: This was a longitudinal study of TB sputum culture contamination for a cohort of TB patients on standard treatment at: baseline, during TB treatment and post TB treatment. Sputum samples were decontaminated with 1.5%NaOH and neutralized using 6.8 Phosphate buffer solution.Sputum was then inoculated into MGIT (mycobactrial growth indicator tube) supplemented with 0.8ml PANTA. A drop of each positive MGIT culture was sub cultured onto blood agar and incu- bated for 48 hours at 35 -37OC.Any growth was identified using growth characteristics and colony morphology. Results: From October 2017 through May 2019;we collected 8645 sputum samples of which 8624(99.8%) were eligible and inoculated into MGIT where 2444(28.3%)samples were TB culture positive and 255(10.4%)were positive for contam- inants:237 none-tuberculosis bacteria, 12 fungi and 6 mixed(none-tuberculous bacteria+fungi).There was no statistically significant difference between none tuberculosis bacteria and fungi in the treatment (OR=1.4,95%CI:0.26–7.47,p=0.690) and the post treatment TB phases(OR=2.02,95%CI:0.38–10.79,p=0.411)Vs baseline. Conclusion: None-tuberculous bacteria and fungi dominate the plethora of TB sputum culture contamination and persist beyond the standard laboratory pre-culture decontamination algorithm.
 Keywords: Bacteria; Fungi; Inoculation; PANTA (Polymyxin B; Amphotericin B; Nalidixic acid; Trimethoprim; Azlocillin).
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de Almeida, Isabela Neves, Suely Conceição Alves da Silva, Haliton Alves de Oliveira Junior, et al. "The Activity-Based Cost of Drug-Susceptibility Test of Mycobacterium tuberculosis Through Kit SIRE Nitratase® Plastlabor." International Journal of Mycobacteriology 9, no. 1 (2020): 24–28. http://dx.doi.org/10.4103/ijmy.ijmy_8_20.

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Background: Drug-resistant tuberculosis (TB) is an ongoing health threat, and the greatest challenge to adequate control of TB in many countries lies in the lack of proper laboratory drug-susceptibility test. The aim of this study was to evaluate the activity-based costs (ABC) of Kit SIRE Nitratase® (Kit SIRE) and compare its values with the conventional drug-susceptibility test. Methods: The ABC was calculated for three different approaches: Kit SIRE (clinical samples and cultures), proportion methods in Lowenstein Jensen (PM-LJ), and the Bactec™ MGIT™ 960 system based on Mycobacterial Research Laboratory's routine. Results: The ABC of Kit SIRE from cultures was US$ 148.54, while from clinical samples was US$ 136.12. In the case of conventional tests, the ABC of Bactec™ MGIT™ 960 was US$ 227.63 and of the PM-LJ was US$ 132.64. The Kit SIRE has a lower ABC when clinical samples are used instead of cultures. Compared to conventional tests, the ABC is similar to the PM-LJ and lower the Bactec™ MGIT™ 960. Conclusion: The Kit SIRE should be used as a screening method in clinical specimens and in culture for laboratories that do not have Bactec™ MGIT™ 960. Therefore, it can be incorporated into the routine of laboratories in countries with low resources and a high burden of TB and drug-resistant TB.
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Kumar, Chanchal, Kamal Shrivastava, Anupriya Singh, Naresh Kumar Sharma, Jitender Yadav, and Mandira Varma-Basil. "The MPB64 immunochromatography assay: an analysis of doubtful results." Tropical Doctor 50, no. 4 (2020): 340–43. http://dx.doi.org/10.1177/0049475520934353.

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Culture remains the gold standard for tuberculosis (TB) diagnosis, and the mycobacteria growth indicator tube (MGIT), endorsed by the World Health Organization (WHO), is widely used. Further identification of a positive culture is done with the help of an immunochromatography assay, which often shows faint bands that are difficult to interpret. We analysed 125 BACTEC MGIT culture positive results, of which 11/16 (68.7%) of the doubtful assays, analysed by MGIT™ TBc Identification test (TBcId), were positive for Mycobacterium tuberculosis complex (MTBC), the remaining being non-tuberculous mycobacteria as determined by an in-house duplex polymerase chain reaction and line probe assay. Guidelines on faint or doubtful bands in immunochromatography assays are important so as not to overlook true-positive cases of TB.
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Paweninggalih, Resti Enggar, Ni Made Mertaniasih, Eko Budi Koendhori, and Soedarsono Soedarsono. "Time to detection of Mycobacterium tuberculosis using culture filtrate H37rv supplementation on MGIT 960 System." Bali Medical Journal 12, no. 1 (2023): 228–34. http://dx.doi.org/10.15562/bmj.v12i1.3833.

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Background: The fundamental priority program for controlling Tuberculosis (TB) is accurate and rapid diagnosis. Variable Mycobacterium tuberculosis (MTB) phenotypes were discovered in sputum samples from pulmonary TB (PTB) patients. Active replicating bacteria and differentially culturable tubercle bacteria (DCTB) are present in the sputum. Differentially culturable tubercle bacilli did not grow on the standard medium. Culture filtrate (CF) H37Rv supplementation containing resuscitation-promoting factors (Rpfs) has the potential to increase sensitivity and reduce time to detection (TTD) on culture-based diagnostics. Methods: This study was a true experimental laboratory. A clinical sample was taken from the sputum of 15 PTB patients, which was "MTB detected" by Xpert MTB/RIF assay. Sputum samples were divided into two groups and inoculated on MGIT 960 in one group with CF-H37Rv supplementation and without in the other as standard MGIT medium. Results: On both standard MGIT medium and MGIT+CF H37Rv, the recovery rate was 100%. Seven samples (47%) show a growth promotion effect with CF H37Rv supplementation (ΔTTD > 10 hours), while eight samples (53%) show no change in TTD (ΔTTD < 10 hours). There is no evidence that CF H37Rv supplementation inhibits growth. Six of the seven samples with ΔTTD > 10 jam (85,7%) were dominated by samples with acid-fast bacilli (AFB) grading 1+, which could be an assumption related to re-treatment PTB cases, chronic cases, treatment stages, TB-HIV, or follow up of treatments. Conclusion: There was no difference in recovery rate or TTD between standard MGIT medium and MGIT+CF H37Rv. The supplementation of culture filtrate H37Rv has a greater advantage on samples with low bacterial load (AFB 1+).
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Thuansuwan, Waraporn, Charoen Chuchottaworn, Chie Nakajima, Yasuhiko Suzuki, and Nuntaree Chaichanawongsaroj. "Biphasic Medium Using Nicotinamide for Detection of Pyrazinamide Resistance in Mycobacterium tuberculosis." Antibiotics 13, no. 6 (2024): 563. http://dx.doi.org/10.3390/antibiotics13060563.

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Reliable drug susceptibility testing of pyrazinamide (PZA) is technically difficult, since PZA activity is pH sensitive. The aim of this study was to evaluate a biphasic medium assay (BMA) for the reliable detection of PZA resistance in Mycobacterium tuberculosis (MTB) using nicotinamide (NIC) as a surrogate for PZA and identifying the appropriate cut-off value for the assay. The PZA susceptibility of 122 multidrug-resistant tuberculosis (MDR-TB) isolates and 39 drug-susceptible tuberculosis (DS-TB) isolates was examined using the BMA with NIC at four different concentrations (250, 500, 1000, and 2000 mg/L) and comparing the results with results from the BACTEC MGIT 960 reference method. Out of 122 MDR-TB isolates, 40 were identified as resistant by the BACTEC MGIT 960 system, of which 92.5% contained mutations within their pncA gene plus promoter region. A minimum inhibitory concentration of NIC ≥ 1000 mg/L was used as the cut-off concentration to define resistance in correlation with the MGIT 960 outcomes. NIC-BMA had a sensitivity of 90.91%, a specificity of 100%, and an accuracy of 97.52% compared with the MGIT 960 method. NIC-BMA is a promising assay to screen PZA resistance in microbiological laboratories without automation or advanced molecular instruments.
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Chin, Kai Ling. "Molecular Characterization of Mycobacterium species Isolates from Patients with Pulmonary Tuberculosis in Sabah, Malaysia." Medicine & Health 17, no. 1 (2022): 198–210. http://dx.doi.org/10.17576/mh.2022.1701.15.

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Tuberculosis (TB) is one of the deadliest diseases worldwide, caused by members of Mycobacterium tuberculosis complex (MTBC), commonly by Mycobacterium tuberculosis (Mtb) and Mycobacterium bovis. In Malaysia, Sabah is one of the states of public health concern with the highest TB cases. Clinical presentations of TB and non-tuberculous mycobacteria (NTM) lung disease are similar, and mycobacteria appear to be identical under standard diagnosis with sputum smear microscopy, causing difficulty to diagnose TB. Identification of Mycobacterium species is essential for effective management of mycobacterial diseases treatment and their control strategy. Thus, this study aimed to identify the Mycobacterium species from suspected TB patients in Sabah using molecular methods. Sputum samples (n=595) were screened with GeneXpert MTB/RIF (Xpert), and positive TB samples (n=67) were processed and cultured in BACTEC MGIT. Forty-five isolates were successfully recovered in MGIT and characterisation of the mycobacterial isolates using PCR and/or sequencing with rpoB, RD9, hsp65, and 16S rRNA genes confirmed the presence of Mtb in 41 samples, and four non-mycobacteria, i.e. Microbacterium laevaniformans, Streptomyces sp., Streptomyces misionensis and Gordonia sp. These non-mycobacteria isolates showed negative results when tested directly with Xpert. In conclusion, Mtb is the predominant species of MTBC circulating in Sabah. The presence of non-mycobacteria in this study was due to bacterial contamination in MGIT, not bacterial cross-reactivity in Xpert, implying the high sensitivity and specificity of Xpert for diagnosis of TB.
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Domotenko, L. V., T. P. Morozova, I. G. Shemyakin, and A. P. Shepelin. "EXPERIENCE OF USING TB TEST KIT FOR THE RAPID DRUG SUSCEPTIBILITY TESTING OF M. TUBERCULOSIS." Russian Clinical Laboratory Diagnostics 65, no. 2 (2020): 122–30. http://dx.doi.org/10.18821/0869-2084-2020-65-2-122-130.

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The results of the comparative testing of the susceptibility of M. tuberculosis clinical strains to isoniazid, streptomycin, rifampicin and ethambutol using the TB test kit, developed in SCRAMB, (Obolensk) and the absolute concentrations method; the TB test kit and the BACTEC MGIT 960 automated system are presented in the study. A total of 629 and 220 strains, respectively, were tested. A high degree of agreement of the results was shown: 89.1-98.6% for isoniazid, 96.2-98.0% for rifampicin, 91.5-98.2% for streptomycin and 89.1-95.9% for ethambutol. The smallest number of discrepancies in the results was obtained when comparing the TB test kit and BACTEC MGIT 960. The discrepant results analysis was performed by the proportion method, PCR sequencing, or re-testing on new lots of the TB test kit and Lowenstein-Jensen medium with anti-tuberculosis drugs, after which the sensitivity, the specificity and the efficiency of the TB test kit have exceeded 95 % for all anti-tuberculosis drugs. The turnaround time with the TB test kit (median 9.25-9.9 days, ranged from 8 to13 days) was significantly shorter than that with the absolute concentration method (median 21-23 days, ranged from 20 to 28 days) and is commensurate with the turnaround time with BACTEC MGIT 960 (average 7.2 days, ranged from 5 to 12 days). The TB test kit is easy to use, does not require expensive equipment and special staff training.
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Wahyuningrum, Retno, Ritmaleni Ritmaleni, Tatang Irianti, Subagus Wahyuono, and Takushi Kaneko. "ANTITUBERCULOSIS ACTIVITY OF EXTRACT AND FRACTIONS OF TINOSPORA CRISPA AGAINST MYCOBACTERIUM TUBERCULOSIS H37RV USING MYCOBACTERIA GROWTH INDICATOR TUBE AND AGAR PROPORTION METHOD." Asian Journal of Pharmaceutical and Clinical Research 11, no. 3 (2018): 132. http://dx.doi.org/10.22159/ajpcr.2018.v11i3.22587.

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Objective: The increasing incidence of multidrug-resistant tuberculosis (TB) has created a need to discover a new anti-TB drug candidates. The aim of this study was to screen extract and fractions of Tinospora crispa for activity against Mycobacterium tuberculosis H37Rv.Methods: The dried and pulverized T. crispa stem was extracted by maceration method using ethanol (96%). The anti-TB activity was carried out using mycobacteria growth indicator tube (MGIT) system and agar proportion method with Lowenstein–Jensen (LJ) medium.Result: The result of this study showed that ethanolic extract and fractions of T. Crispa did not exhibit anti-TB activity in the range of 100–1000 μg/ml with MGIT method, while with agar proportion method, there were M. tuberculosis colonies growth on the LJ containing 1000 μg/ml extract slants.Conclusion: The tested extract and fractions of T. crispa have no anti-TB activity against M. tuberculosis until 1000 μg/ml.
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Umpeleva, T. V., E. A. Mazurina, D. V. Vakhrusheva, and N. I. Eremeeva. "Comparison of Different Methods for Drug Susceptibility Testing of Mycobacterium tuberculosis to Rifampicin." Tuberculosis and Lung Diseases 100, no. 1 (2022): 41–48. http://dx.doi.org/10.21292/2075-1230-2022-100-1-41-48.

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The objective: to compare results of drug susceptibility testing to rifampicin by molecular genetic methods and phenotypic tests of Mycobacterium tuberculosis isolates obtained from clinical specimens of tuberculosis patients.Subjects and Methods. 915 samples of M. tuberculosis DNA and 426 cultures were used in this study. Genotypic tests (TB-TEST (BIOCIP-IMB, Russia), GenoType MTBDRplusV2) and phenotypic technologies (absolute concentration method, Bactec MGIT 960 system, Sensititre Myco TB kit) were used.Results. A high percentage (98.7%; CI 97.7-99.7%) of confirmation of the results of the molecular genetic test (TB-TEST) by the phenotypic test (absolute concentration method) was demonstrated. In some cases, the Bactec MGIT 960 system as well as the absolute concentration method were shown to produce false negative results of rifampicin resistance in some cases.
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Pedro, Heloisa da Silveira Paro, Andrea Gobetti Vieira Coelho, Susilene Maria Tonelli Nardi, et al. "Desempenho da cultura líquida MGIT após implementação em uma rede de laboratórios públicos do estado de São Paulo." Revista do Instituto Adolfo Lutz 76 (January 1, 2017): 1–9. http://dx.doi.org/10.53393/rial.2017.v76.33542.

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A OMS, em 2007, recomendou a implementação da cultura líquida para o diagnóstico da tuberculose (TB) e teste de sensibilidade para países de baixa e média renda. Neste estudo foi avaliado o desempenho da cultura líquida MGIT em condição de rotina após dois anos de implantação em uma rede de laboratórios públicos. Foi efetuada análise retrospectiva de dados da cultura líquida, realizadas em dez laboratórios regionais do Instituto Adolfo Lutz, de janeiro a março de 2010. Foram incluídas amostras submetidas a baciloscopia, cultura líquida MGIT automatizada ou manual e identificação presuntiva do complexo Mycobacterium tuberculosis (CMTB). Foram detectadas 1.159 culturas positivas. Destas, 113 (9,7%) contaminaram, e 1.046 foram analisadas, sendo 850 (81,3%) CMTB, 116 (11,1%) micobactérias não tuberculosas e 6 (0,6%) Nocardia sp. A taxa de contaminação foi de 2,2% e o acréscimo da cultura para o diagnóstico da TB foi de 29,9%. A média do tempo de detecção da cultura foi de 14,7 dias (DP+/- 11,7 dias). A acurácia da identificação presuntiva foi de 91,3%. A cultura líquida MGIT demonstrou ser excelente alternativa para efetuar diagnóstico da TB e das micobacterioses, em razão da rapidez possibilitando uma intervenção rápida e eficaz no tratamento.
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Rambi, Elne Vieke, Dyan R. Sukandar, Linda Augustien Makalew, Yohanis Tomastola, and Ketrina Konoralma. "Multi drugs resistance to Diabetes Mellitus patients with tuberculosis in Manado City." Jurnal Teknologi Laboratorium 10, no. 1 (2021): 40–45. http://dx.doi.org/10.29238/teknolabjournal.v10i1.286.

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Diabetes mellitus (DM) with pulmonary tuberculosis (TB) is an infectious disease if not educated regularly, there will be a high risk of drug resistance and even some anti-tuberculosis drugs. This study aims to identify anti-tuberculosis drug resistance in DM patients with TB in Manado City. The population in the study types 2 DM patients as amount 80 patients. Based on TCM/GenExpert examination from 47 respondents, there were 17 respondents positive multi drugs resistance rifampicin (RR). Sampling taking based on inclusion criteria, i.e., have had type DM for five years, had suffered TB MDR RR based on GenXpert examination as much as 17 respondents followed in the resistance test with Sputum TB culture and MGIT method. The result of the study showed that MDR DM-TB with MGIT method as followed is obtained from 17 samples, six samples (35.30%) resistance INH 0.4 mg and 1 sample (5.88%) MDR canamycin, and still sensitive INH 0.4 mg and camaycin is ten samples (58.82%). This study results could be used to program planning of prevention and controlling efforts TB-DM in this treatment obedience and regimen anti-tuberculosis medicine for MDR-TB patients.
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Lugonzo, George O., Ezekiel M. Njeru, William Songock, Albert A. Okumu, and Eric M. Ndombi. "Epidemiology of multi-drug resistant Tuberculosis in the western region of Kenya." AIMS Microbiology 10, no. 2 (2024): 273–87. http://dx.doi.org/10.3934/microbiol.2024014.

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<abstract> <p>Multidrug-resistant tuberculosis (TB) (MDR-TB), or TB that is simultaneously resistant to both isoniazid (INH) and rifampicin (RIF), is a barrier to successful TB control and treatment. Stratified data on MDR-TB, particularly in the high-burden western Kenya region, remain unknown. This data is important to monitor the efficacy of TB control and treatment efforts. Herein, we determined the molecular epidemiology of drug-resistant TB and associated risk factors in western Kenya. This was a non-experimental, population-based, cross-sectional study conducted between January and August 2018. Morning sputum samples of individuals suspected of pulmonary TB were collected, processed, and screened for <italic>Mycobacterium tuberculosis</italic> (Mtb) and drug resistance using line probe assay (LPA) and <italic>Mycobacterium</italic> growth indicator tubes (MGIT) culture. MGIT-positive samples were cultured on brain heart infusion (BHII) agar media, and the presence of Mtb was validated using Immunochromatographic assay (ICA). Drug sensitivity was performed on MGIT and ICA-positive but BHI-negative samples. Statistical significance was set at <italic>P</italic> < 0.05. Of the 622 Mtb isolates, 536 (86.2%) were susceptible to RIF and INH. The rest, 86 (13.83%), were resistant to either drugs or both. A two-sample proportional equality test revealed that the MDR-TB prevalence in western Kenya (5%) did not vary significantly from the global MDR-TB estimate (3.9%) (P = 0.196). Men comprised the majority of susceptible and resistant TB (75.9% and 77.4%%, respectively). Also, compared with healthy individuals, the prevalence of HIV was significantly higher in MDR-TB patients (35.9% vs 5.6%). Finally, TB prevalence was highest in individuals aged 25–44 years, who accounted for 58.4% of the total TB cases. Evidently, the prevalence of MDRTB in western Kenya is high. Particular attention should be paid to men, young adults, and those with HIV, who bear the greatest burden of resistant TB. Overall, there is a need to refine TB control and treatment programs in the region to yield better outcomes.</p> </abstract>
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Poddar, Chandan Kumar, Narmata Kumari, Rakesh Kumar, Shivendra Kumar Shahi, Naresh Kumar, and Shailesh Kumar. "Estimation of genotype MTBDRPLUS line probe assay in detection of rifampicin and isoniazid resistance in comparison to liquid culture (BACTEC-960) drug susceptibility testing in a tertiary care hospital from Eastern India." Biomedicine 41, no. 2 (2021): 472–76. http://dx.doi.org/10.51248/.v41i2.1060.

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Introduction and Aim: India has the uppermost trouble of Multidrug resistant tuberculosis (MDR-TB) is a major challenge controlling resistance, reducing transmission and improving handling outcomes in MDR-TB patients is dependent on susceptibility testing. Isoniazid (INH) and rifampicin (Rif) are the key first-line antituberculosis drugs, and resistance to these drugs i.e., MDR-TB, is likely to result in treatment failure and poor clinical outcomes. The present study was done to compare the performance of line probe assay test (GenoType® MTBDRplus) with liquid culture (MGIT 960) system for the detection of resistance to first-line drugs.
 
 Materials and Methods: We estimate the performance of LPAs to BACTEC MGIT 960 system for susceptibility testing of bacterial resistance to first-line drugs: rifampicin (RIF), isoniazid (INH).
 
 Results: We performing Drug susceptibility testing (DST), 219/258 MTB cultures were viable after subculture the results of DST using the MGIT 960 system were compared to those obtained by line probe assay. LPA detected a total 46/258 (17.81%) samples as drug resistant, of which 35/258 (13.70%) were resistant to both rifampicin and isoniazid (MDR), 6/258 (2.28%) were rifampicin mono?resistant samples and 11/258 (4.11%) were isoniazid mono?resistant. Out of the culture?positive samples (219), LPA detected 39/219 (17.83%) as drug?resistant, of which 31/219 (14.2%) were resistant to both rifampicin and isoniazid, 5/193 (2.08%) were rifampicin mono?resistant and 8/219 (3.7%) were isoniazid mono?resistant.
 Conclusion: Drug resistant TB poses an enormous threat to TB control programs worldwide. Effective treatment of MDR-TB is very expensive, particularly in middle income countries such as India.
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Kalawadia, Dhruv, Darshini Gandhi, Tsering Y. Dirkhipa, et al. "Effect of delamanid on interim outcomes of bacteriological conversion amongst pediatric drug resistant tuberculosis cases in India." Lung India 41, no. 1 (2024): 35–39. http://dx.doi.org/10.4103/lungindia.lungindia_72_23.

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Aim: To determine the bacteriological conversion rate after 6 months of Delamanid (DLM) based treatment in children with drug-resistant tuberculosis (DR-TB) and determine factors associated with bacteriological conversion. Methods: This is a descriptive retrospective study done in children between the age of 6-17 years with DR-TB who received DLM-based therapy from October 2018 to May 2021. The drug resistance pattern of TB was detected using Xpert RIF/MTB and phenotypic drug sensitivity testing (DST) on TB-MGIT culture reports. Follow-up sputum TB MGIT culture was carried out monthly after DLM initiation for 6 months. Factors associated with sputum bacteriological conversion such as age, gender, pulmonary TB (PTB) versus disseminated TB, unilateral or bilateral lung involvement, type of DR-TB, prior treatment failure, and type of DR-TB regimen were analyzed. Results: Sixty patients received DLM of which two had extrapulmonary TB (EPTB) and sputum conversion could not be assessed. The mean age at presentation was 12.69 ± 3.03 years. Five patients (8.3%) died while on DLM treatment. On follow-up, 8 (13.7%) out of 58 patients had no sputum bacteriological conversion after 6 months of DLM initiation of which three patients were on salvage therapy; 46 (79.3%) had sputum bacteriological conversion within 6 months of DLM initiation. Conclusion: Sputum bacteriological conversion rate was almost 80% at the end of 6 months of DLM-based treatment.
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Mapamba, Daniel Adon, Elingarami Sauli, Julieth Lalashowi, et al. "Performance of Tuberculosis Molecular Bacterial Load Assay Compared to Alere TB-LAM in Urine of Pulmonary Tuberculosis Patients with HIV Co-Infections." International Journal of Molecular Sciences 24, no. 4 (2023): 3715. http://dx.doi.org/10.3390/ijms24043715.

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Alternative tools are needed to improve the detection of M. tuberculosis (M. tb) in HIV co-infections. We evaluated the utility of Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) compared to lipoarabinomannan (LAM) to detect M. tb in urine. Sputum Xpert MTB/RIF-positive patients were consented to provide urine at baseline, weeks 2, 8, 16, and 24 of treatment for TB-MBLA, culture, and LAM. Results were compared with sputum cultures and microscopy. Initial M. tb. H37Rv spiking experiments were performed to validate the tests. A total of 63 urine samples from 47 patients were analyzed. The median age (IQR) was 38 (30–41) years; 25 (53.2%) were male, 3 (6.5%) had urine for all visits, 45 (95.7%) were HIV positive, of whom 18 (40%) had CD4 cell counts below 200 cells/µL, and 33 (73.3%) were on ART at enrollment. Overall urine LAM positivity was 14.3% compared to 4.8% with TB-MBLA. Culture and microscopy of their sputum counterparts were positive in 20.6% and 12.7% of patients, respectively. Of the three patients with urine and sputum at baseline, one (33.33%) had urine TB-MBLA and LAM positive compared to 100% with sputum MGIT culture positive. Spearman’s rank correction coefficient (r) between TB-MBLA and MGIT was −0.85 and 0.89 with a solid culture, p > 0.05. TB-MBLA has the promising potential to improve M. tb detection in urine of HIV-co-infected patients and complement current TB diagnostics.
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Barik, Braja Sundar, Shritam Das, Khusbu Singh, et al. "Diagnostic Accuracy of The TrueNat MTB/RIF Assay And Comparison With The Reference Standards To Detect Pulmonary Tuberculosis And Rifampicin Resistance in Sputum Samples From Patients Attending A Tertiary Care Hospital in Bhubaneswar, India." National Journal of Community Medicine 15, no. 03 (2024): 175–81. http://dx.doi.org/10.55489/njcm.150320243413.

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Background: A rapid and accurate diagnostic tool is necessary for correct diagnosis and treatment of TB. This study evaluated and compared the sensitivity, specificity and concordance of TrueNAT MTB/RIF assay with smear microscopy, Xpert MTB/RIF and MGIT culture. Methods: In all, 4500 patients (1500 each of patients with Diabetes, elderly and HIV-positive patients) attending the Chest and TB department of Capital Hospital, Bhubaneswar were screened. 392 sputum samples were collected from presumptive TB patients. Standard diagnostic procedures (Smear Microscopy, Xpert MTB/RIF, TrueNAT MTB tests and MGIT culture) were performed. Results: This diagnostic efficiency of rapid molecular TrueNAT MTB/RIF assays have similar properties as Xpert MTB/RIF and may be used for the diagnosis of TB and Rifampicin resistance. Among participants, the TrueNAT MTB shows the sensitivity of 80%, 100% and 78.26% while the specificity was 97.9%, 95.83% and 100%. The concordance rates between all tests were calculated and the TrueNAT MTB showed good agreement with the culture method among study participants (κ = 0.793, 0.554, and 0.862, respectively). Conclusion: The TrueNAT assays are sensitive for diagnosis of TB patients with faster turnabout time from testing to treatment and economical.
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R Lia Kusumawati, Mirzan Hasibuan, Nisrina Tari, Kyaw Ko Ko Htet, and Nyi Nyi Zayar. "Comparison of GeneXpert and line probe assay for the detection of Mycobacterium tuberculosis in direct sputum samples." Indonesian Journal of Biomedicine and Clinical Sciences 57, no. 1 (2025): 1–10. https://doi.org/10.22146/inajbcs.v57i1.16720.

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Tuberculosis (TB) remains a major global health issue, particularly in low-and- middle-income countries (LMICs) like Indonesia. Diagnostic methods for TB and multidrug-resistant TB (MDR-TB) such as Lowenstein-Jensen (LJ) solid media and Mycobacterium Growth Indicator Tube (MGIT), are time-consuming, causing delays in patient management. Rapid molecular diagnostics, like the GeneXpert MTB/RIF ultra assay and line probe assay (LPA), offer faster and more accurate detection of Mycobacterium tuberculosis and drug resistance. This study aimed to compare the efficacy of GeneXpert and LPA in detecting M. tuberculosis and assessing drug resistance in sputum samples from 20 patients with confirmed TB. The samples were categorized into four groups based on GeneXpert results: very low, low, medium, and high DNA concentration. GeneXpert identified 20% of samples as rifampicin-resistant, while LPA identified 35%. Additionally, LPA detected isoniazid resistance in 10% of samples. The five discordance results between GeneXpert and LPA, from samples with very low DNA concentrations, were confirmed using MGIT 960 culture DST as the gold standard. The LPA successfully identified 2 (10%) Hr-TB among TB cases detected by the GeneXpert TB/ RIF. While LPA demonstrates superior performance characteristics, particularly in detecting isoniazid, GeneXpert demonstrated better sensitivity and specificity, making it a more reliable diagnostic tool under suboptimal conditions, followed by culture-based DST to assure accuracy and examine resistance to other drugs.
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Murcia Aranguren, Martha Isabel, Clara Viviana Mape, Mario Alejandro Vega Marin, et al. "High prevalence of pulmonary tuberculosis in the indigenous population of Puerto Nariño, Colombian Amazonia." Revista de Salud Pública 27, no. 1 (2025): 1–8. https://doi.org/10.15446/rsap.v27n1.117145.

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Tuberculosis (tb) remains a significant public health challenge, disproportionately impacting vulnerable groups, particularly indigenous populations. Objetive To investigate the epidemiological behavior of tb among the indigenous communities in Puerto Nariño, Amazonas. Materials and Methods Descriptive cross-sectional study across 23 indigenous communities, employing an active case-finding approach through house-to-house medical consultations. Respiratory symptomatic (rs) individuals, defined as those with a cough of any duration, were identified and assessed. Diagnostic evaluations included serial sputum smear microscopy and cultures using mgit™ liquid and Löwenstein-Jensen (lj) solid media. Cultures identified as Mycobacterium tuberculosis complex underwent drug susceptibility testing for first-line anti-tbmedications. Confirmed tb cases were reported to the healthcare system. The study excluded non-indigenous individuals from the analysis and categorized cases by age. The indigenous communities and tb cases were geographically mapped. Results Of the population examined, 95% (5,837 individuals) were indigenous, with 16.7% (972/5837) identified as rs. Seventy-six tb cases were diagnosed, with childhood tb accounting for 43.4% of the cases. mgit™ cultures were positive in all tb cases, and 18.2% (6/33) of children under 15 had positive sputum smears. Notably, one case of multidrug-resistant tb (mdr-tb) was reported in a child. Conclusions The prevalence of tb was almost 50 times higher in the indigenous , than in the general Colombian population according to official reports. The findings highlight a critical public health concern, with tb prevalence significantly higher among indigenous populations in Puerto Nariño compared to the general Colombian population. Targeted interventions are urgently needed to address this disparity.
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Handayani, Diah, Budi Haryanto, Galoeh Adyasiwi, et al. "Diagnostic Accuracy and Clinical Utility of InaTB-Rif, Locally Developed Molecular Test for Tuberculosis, in Comparison with Xpert MTB/RIF in Indonesia." Jurnal Respirologi Indonesia 45, no. 2 (2025): 136–43. https://doi.org/10.36497/jri.v45i2.907.

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Background: Tuberculosis (TB) remains a significant public health issue in Indonesia. Early and accurate diagnosis and drug susceptibility testing are essential for TB management. This study compared the diagnostic accuracy of the locally developed InaTB-Rif molecular test and Xpert MTB/RIF, using Mycobacterium Growth Indicator Tube (MGIT) culture as the reference standard. Methods: A cross-sectional study was conducted at Persahabatan Hospital, Jakarta, from February to August 2023. Presumptive pulmonary TB patients were recruited and tested using Xpert MTB/RIF, InaTB-Rif, and MGIT culture. The study assessed the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and agreement between InaTB-Rif and Xpert MTB/RIF for Mycobacterium tuberculosis (MTB) detection and rifampicin resistance. Diagnostic accuracy was compared using receiver operating characteristic (ROC) curves. Results: MGIT culture identified 29 TB-positive and 26 TB-negative cases. InaTB-RIF showed a sensitivity of 93.1% (95% CI=0.77-0.99), specificity of 76.9% (95% CI=0.56-0.91), PPV of 81.8% (95% CI=0.64-0.93), and NPV of 90.9% (95% CI=0.70-0.98). Xpert MTB/RIF had a sensitivity of 89.7% (95% CI=0.726-0.978), specificity of 80.8% (95% CI=0.606-0.93), PPV of 83.9% (95% CI=0.66-0.94), and NPV of 87.5% (95% CI=0.67-0.97). The area under the curve (AUC) was 0.8501 for InaTB-RIF and 0.8521 for Xpert MTB/RIF, with no significant difference in accuracy (P=0.965). The kappa value for MTB detection was 0.776, indicating substantial agreement, while the kappa value for rifampicin resistance detection was 0.517, indicating moderate agreement. Conclusions: InaTB-RIF demonstrates comparable diagnostic accuracy to Xpert MTB/RIF with good diagnostic performance and agreement for detecting MTB and moderate agreement for rifampicin resistance detection.
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Heysell, Scott K., Suporn Pholwat, Stellah G. Mpagama, et al. "Sensititre MycoTB Plate Compared to Bactec MGIT 960 for First- and Second-Line Antituberculosis Drug Susceptibility Testing in Tanzania: a Call To Operationalize MICs." Antimicrobial Agents and Chemotherapy 59, no. 11 (2015): 7104–8. http://dx.doi.org/10.1128/aac.01117-15.

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ABSTRACTMIC testing forMycobacterium tuberculosisis now commercially available. Drug susceptibility testing by the MycoTB MIC plate has not been directly compared to that by the Bactec MGIT 960. We describe a case of extensively drug-resistant tuberculosis (XDR-TB) in Tanzania where initial MIC testing may have prevented acquired resistance. From testing on archived isolates, the accuracy with the MycoTB plate was >90% for important first- and second-line drugs compared to that with the MGIT 960, and clinically useful quantitative interpretation was also provided.
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Oliveira, Gabriel Da Silva, Glaura Regina de Castro e. Caldo Lima, Joaquim Xavier da Silva, Janeth De Oliveira Silva Naves, and Carlos Maximiliano do Rêgo Monteiro Filho. "Identificação laboratorial de micobactérias em amostras respiratórias de pacientes com suspeita de tuberculose pulmonar no Laboratório Central de Saúde Pública do Distrito Federal (LACEN-DF)Laboratory identification of mycobacteria from respiratory samples of patients with suspected pulmonary tuberculosis in samples isolated at the Central Laboratory of Public Health of the Federal District (LACEN-DF)doi:10.12662/2317-3076jhbs.v4i3.712.p187-192.2016." Journal of Health & Biological Sciences 4, no. 3 (2016): 187. http://dx.doi.org/10.12662/2317-3076jhbs.v4i3.712.p187-192.2016.

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Introdução: O diagnóstico rápido e preciso da tuberculose (TB) e o início precoce do tratamento são fatores de grande importância para reduzir e minimizar o risco de contágio pelo Mycobacterium tuberculosis. Nesse contexto, as principais metodologias empregadas no Brasil para o diagnóstico da TB são os testes de baciloscopia e de cultura. Objetivo: O presente estudo tem como objetivo descrever os resultados de três técnicas laboratoriais para o diagnóstico da TB pulmonar. Métodos: Foram analisados dados de baciloscopias e culturas de 10.418 prontuários de pacientes de ambos os sexos, diferentes idades e locais de residência, no período de janeiro de 2011 a junho de 2014. Resultados: Foram analisados os prontuários de 284 pacientes com resultado positivo para o Complexo Mycobacterium Tuberculosis (CMTB). Dos 284 pacientes positivos para o CMTB, 210 apresentaram BAAR positivos (73,9%) e 74 negativos (26,1%). Nos cultivos em meio LJ, 255 amostras foram positivas (89,7%) e 29 negativas (10,3%), enquanto no meio de cultivo líquido Bactec MGIT® a positividade foi de 276 (97,1%) e 8 negativas (2,9 %). Conclusões: Observou-se que a identificação de BAAR em exame direto continua a ser de suma importância no diagnóstico precoce da TB. Os métodos de cultura, principalmente o sistema Bactec-MGIT®, mostraram neste estudo um incremento de 23,2% no diagnóstico da TB pulmonar.
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Champatiray, Jyotiranjan, and G. Dharmaraj Patra. "Diagnosis of paediatric tuberculosis by cartridge based nucleic acid amplification test and its effectiveness as compared to the other conventional diagnostic methods." International Journal of Contemporary Pediatrics 6, no. 3 (2019): 1204. http://dx.doi.org/10.18203/2349-3291.ijcp20192013.

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Background: Childhood TB constitutes 10-20% of all TB cases in high burden countries like India and accounting for 8-20% of TB related deaths. Diagnosis of TB in children is difficult. One test, CBNAAT which was recently endorsed by WHO has the potential to lead a revolution in diagnosis of active TB disease.Methods: A cross sectional study in SCB MCH and SVPPGIP, Cuttack in all the suspected TB patients admitted during the period from January 2016 to October 2017.Results: A total of 100 suspicious patients admitted to the Department of Pediatrics in SCB MCH and SVPPGIP during the study period. Of these 45 were diagnosed TB and rest others were diagnosed otherwise than TB. Diagnosis of TB was established on basis of Microscopy, CBNAAT, culture, biochemistry, cytology, clinical findings, neuroimaging, FNAC/biopsy, USG abdomen. Out of 45 TB patients 30 were CBNAAT positive taking the body fluid samples other than blood, urine and stool with a sensitivity of 66.7% and specificity of 100%. Out of 45 TB patients 14 were having ZN Smear positive taking the same fluid sample with a sensitivity of 31.1% and specificity of 100%. Whereas out of these 45 TB patients 32 were MGIT culture positive taking the same sample with a sensitivity of 71.1% and specificity of 100%. When diagnostic performances of CBNAAT and MGIT culture were compared, it was found to be statistically insignificant with a P value 0.54.Conclusions: The CBNAAT is able to confirm a diagnosis of TB with 66.7% sensitivity and 100% specificity within 2 hours. We can use CBNAAT as a diagnostic method as it provides rapid result and simultaneous better sensitive result, it can be helpful in starting ATT in sick patients and also in outdoor patients.
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Kania, Katarzyna, Katarzyna Wójcik, Kamil Drożdż, and Karolina Klesiewicz. "Utility of Rapid Molecular Assays for Detecting Multidrug-Resistant Mycobacterium tuberculosis in Extrapulmonary Samples." Diagnostics 15, no. 9 (2025): 1113. https://doi.org/10.3390/diagnostics15091113.

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Background: Extrapulmonary tuberculosis (TB) presents significant diagnostic challenges, particularly in the context of multidrug-resistant (MDR) strains. This study assessed the utility of the WHO-recommended rapid molecular assays, originally validated for pulmonary TB, in diagnosing extrapulmonary TB and detecting the MDR Mycobacterium tuberculosis complex (MTBC). Materials and Methods: A total of 6274 clinical samples, including 4891 pulmonary and 1383 extrapulmonary samples, were analyzed between 2019 and 2022 using the BD MAX™ MDR-TB assay (BD MAX), the Xpert® MTB/RIF assay (Xpert MTB/RIF), the Xpert® MTB/XDR assay (Xpert MTB/XDR), FluoroType MTB, and phenotypic drug susceptibility testing (DST). Results: MTBC was detected in 426 samples using BD MAX (376 pulmonary and 50 extrapulmonary), of which 277 were culture-confirmed. Phenotypic testing confirmed 299 positive cultures on Löwenstein–Jensen (LJ) medium and 347 in BD BACTEC™ MGIT™ (BACTEC MGIT) mycobacterial growth indicator tube (BBL) liquid culture. BD MAX showed high sensitivity and specificity for extrapulmonary TB detection (93.1% and 98.4%, respectively). Resistance to isoniazid or rifampicin was identified in 11% of MTBC-positive cases, whereas 3.69% were confirmed as MDR-TB. The molecular assays effectively detected resistance-associated mutations (katG, inhA, and rpoB), with high concordance to phenotypic tests (DST) (κ = 0.69–0.89). Conclusions: This study demonstrates that molecular assays, although validated for pulmonary TB, are also reliable for extrapulmonary TB detection and drug resistance profiling. Their rapid turnaround and robust accuracy support broader implementation in routine diagnostics, especially for challenging extrapulmonary specimens where early detection is critical for targeted therapy.
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Yana, Dewi, Ni Made Mertaniasih, Eko Budi Koendhori, and Rosy Setiawati. "The radiologic findings, positivity rate of culture method examinations, correlation with the type of lower respiratory secretion of adult pulmonary Tuberculosis (TB) patients." Bali Medical Journal 12, no. 1 (2023): 1152–57. http://dx.doi.org/10.15562/bmj.v12i1.4090.

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Background: There are active and latent tuberculosis types, a global public health concern. Test confirmation is required to distinguish between active tuberculosis and nontuberculous mycobacterial infection. This study aims to evaluate the relationship between the type of lower airway secretion specimen, Mycobacterium tuberculosis positivity rate of MGIT-LJ, as well as the relationship between the Mycobacterium tuberculosis positivity rate in MGIT-LJ and radiological findings. Methods: This study is cross-sectional with a prospective design. The sample is the result of the examination of the MGIT-LJ method and medical record data of patients suspected of Pulmonary TB at Dr. Soetomo Academic Hospital Surabaya Indonesia that meets the inclusion criteria, analysis of the culture results of MGIT-LJ method and radiological findings were carried out to assess the relationship between the character of sputum, the positivity rate of Mycobacterium tuberculosis and radiological findings. Result: A total of 137 from June 2022 till November 2022 found 88 (64.2%) with spontaneous sputum, 6 (4,4%) aspirate ETT, and 43 (31.4%) BAL. The positivity rate of the MGIT-LJ culture method of the spontaneous sputum specimen to detect Mycobacterium tuberculosis was 20.5% higher than ETT or BAL specimens because the implementation of clinical indication to request MGIT-LJ culture method of ETT and BAL specimens is still confusing. The specificity of the chest radiography diagnostic test from all specimens type of 61.86%, with a weak accuracy rate. Conclusion: In this study, the positivity rate of the MGIT-LJ culture method of the spontaneous sputum specimen to detect Mycobacterium tuberculosis was 20.5% higher than ETT or BAL specimens. Chest radiography has a weak accuracy level and must be complemented test with the culture method.
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Dwivedi, Dharm Prakash, Amrita Shukla, Vinod Raveendran, and Muthuraj Muthaiah. "Prevalence of primary INH and Rifampicin resistance among treatment Naïve tuberculosis cases in tertiary care teaching hospital in Puducherry: A prospective cross-sectional study." IP Indian Journal of Immunology and Respiratory Medicine 7, no. 4 (2023): 154–60. http://dx.doi.org/10.18231/j.ijirm.2022.035.

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India contributes to approximately one-third of total global tuberculosis (TB) and one-fourth of all Multi-Drug Resistant TB (MDR-TB) burden respectively. The First National drug resistance survey (2014-16) showed MDRTB rates of 6.19% overall and 2.14% in newly diagnosed TB cases. With the above problem of primary drug resistance among newly diagnosed tuberculosis cases, the present study was planned to find the prevalence of Isoniazid (INH) and Rifampicin resistance in the treatment naïve new tuberculosis cases.: Study design: Prospective, cross-sectional.: Treatment naive newly diagnosed pulmonary tuberculosis cases.: 125.: After informed written consent, Sputum samples were collected and subjected to culture in MGIT 960 and positive cultures were recorded and subjected to drug sensitivity testing for INH (0.1 μg/ml) and Rifampicin (1 μg/ml) and a parallel non-drug MGIT was run as a control.: Most cases were males and belonged to the 20-59 years age group. Isoniazid (INH) resistance was found in 7 out of 125 samples, none had resistance to rifampicin. None of the categorical variables or grading of smear were having any statistically significant correlation with INH resistance.: INH resistance was found to be low (5.6%) with negligible MDR in the current study. Regular and large studies are needed to quantify and tackle the problem of primary MDR TB.
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Widaningsih, Yuyun, Ismawati Amin, Nurhayana Sennang, Uleng Bahrun, and Mansyur Arif. "MYCOBACTERIUM TUBERCULOSIS DAN PCR." INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY 18, no. 3 (2016): 179. http://dx.doi.org/10.24293/ijcpml.v18i3.756.

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TB’s coinfection in HIV and AIDS is on the increase together with the high mortality rate. The disseminated TB infection (in blood) of HIV and AIDS patients in Africa (2005) is about 10−25%. The aim of this study was to identify M.tb disseminated infection in HIV and AIDS patients. In this study was done in six HIV and AIDS patients suffering from suspected TB co infection. The sputum was tested using Fast Acid Bacilli and culture (using LJ and MGIT media) and DST. The identification of M.tb in blood used PCR with IS6110 primer (123 bp). The study was done at Dr. Wahidin Sudirohusodo Hospital, Labuang Baji Hospital, NEHCRI and at the Biomolecular Laboratory of the Medical Faculty, Hasanuddin University. From the six patients, four of them had CD4<50 sel/μL, two patients had FAB positive, three patients had positive LJ culture on day 41–47, three patients had positive MGIT culture on day 9–47 and four patients had positive PCR. In this study there was one case of negative FAB but LJ, MGIT and PCR were positive. There were two cases with positive FAB, culture and PCR, one case with negative FAB and culture but positive PCR. The M.tb disseminated infection was 66.7% in six HIV and AIDS patients.
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Azam, Khalide, Nureisha Cadir, Carla Madeira, Stephen H. Gillespie, and Wilber Sabiiti. "OMNIgene.SPUTUM suppresses contaminants while maintainingMycobacterium tuberculosisviability and obviates cold-chain transport." ERJ Open Research 4, no. 1 (2018): 00074–2017. http://dx.doi.org/10.1183/23120541.00074-2017.

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Tuberculosis (TB) diagnostics are centralised, requiring long-distance transportation of specimens in most resource-limited settings. We evaluated the ability of OMNIgene.SPUTUM (OM-S) to obviate cold-chain transport of TB specimens.A two-arm (same-day and after 5 days sample processing) study was conducted to assess contamination rates andMycobacterium tuberculosisviability in OM-S-treated samples against the standard decontamination procedure (SDP) in Mozambique, using Lowenstein Jensen (LJ) and mycobacterial growth indicator tube (MGIT) culture and molecular bacterial load assay.270 specimens were processed using OM-S and SDP in same-day and 5-day arms. Contamination was lower in OM-S-treated than SDP-treated cultures: 12%versus15% and 2%versus27% in the same-day and 5-day arms, respectively.M. tuberculosisrecovery in OM-S-treated LJ cultures was 10% and 56% higher in the same-day and 5-day arms, respectively, than SDP-treated cultures, but lower in MGIT (52% and 28% lower in the same-day and 5-day arms, respectively).M. tuberculosisviable count was 1log estimated CFU·mL−1lower in 5-day OM-S-treated sputa. OM-S was more effective at liquefying sputum with a shorter sample processing time: 22 min for culture.OM-S is simple to use and has demonstrated a high potency to suppress contaminants, maintenance of viability at ambient temperatures and higherM. tuberculosisrecovery, particularly in the solid LJ cultures. Optimisation of OM-S to achieve higher MGIT culture positivity and shorter time to result will increase its application and utility in the clinical management of TB.
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Puyén, Zully M., David Santos-Lázaro, Aiko N. Vigo, et al. "Whole Genome Sequencing of Mycobacterium tuberculosis under routine conditions in a high-burden area of multidrug-resistant tuberculosis in Peru." PLOS ONE 19, no. 6 (2024): e0304130. http://dx.doi.org/10.1371/journal.pone.0304130.

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Whole Genome Sequencing (WGS) is a promising tool in the global fight against tuberculosis (TB). The aim of this study was to evaluate the use of WGS in routine conditions for detection of drug resistance markers and transmission clusters in a multidrug-resistant TB hot-spot area in Peru. For this, 140 drug-resistant Mycobacterium tuberculosis strains from Lima and Callao were prospectively selected and processed through routine (GenoType MTBDRsl and BACTEC MGIT) and WGS workflows, simultaneously. Resistance was determined in accordance with the World Health Organization mutation catalogue. Agreements between WGS and BACTEC results were calculated for rifampicin, isoniazid, pyrazinamide, moxifloxacin, levofloxacin, amikacin and capreomycin. Transmission clusters were determined using different cut-off values of Single Nucleotide Polymorphism differences. 100% (140/140) of strains had valid WGS results for 13 anti-TB drugs. However, the availability of final, definitive phenotypic BACTEC MGIT results varied by drug with 10–17% of invalid results for the seven compared drugs. The median time to obtain results of WGS for the complete set of drugs was 11.5 days, compared to 28.6–52.6 days for the routine workflow. Overall categorical agreement by WGS and BACTEC MGIT for the compared drugs was 96.5%. Kappa index was good (0.65≤k≤1.00), except for moxifloxacin, but the sensitivity and specificity values were high for all cases. 97.9% (137/140) of strains were characterized with only one sublineage (134 belonging to “lineage 4” and 3 to “lineage 2”), and 2.1% (3/140) were mixed strains presenting two different sublineages. Clustering rates of 3.6% (5/140), 17.9% (25/140) and 22.1% (31/140) were obtained for 5, 10 and 12 SNP cut-off values, respectively. In conclusion, routine WGS has a high diagnostic accuracy to detect resistance against key current anti-TB drugs, allowing results to be obtained through a single analysis and helping to cut quickly the chain of transmission of drug-resistant TB in Peru.
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Jajou, Rana, Tridia van der Laan, Rina de Zwaan, et al. "WGS more accurately predicts susceptibility of Mycobacterium tuberculosis to first-line drugs than phenotypic testing." Journal of Antimicrobial Chemotherapy 74, no. 9 (2019): 2605–16. http://dx.doi.org/10.1093/jac/dkz215.

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Abstract Background Drug-susceptibility testing (DST) of Mycobacterium tuberculosis complex (MTBC) isolates by the Mycobacteria Growth Indicator Tube (MGIT) approach is the most widely applied reference standard. However, the use of WGS is increasing in many developed countries to detect resistance and predict susceptibility. We investigated the reliability of WGS in predicting drug susceptibility, and analysed the discrepancies between WGS and MGIT against the first-line drugs rifampicin, isoniazid, ethambutol and pyrazinamide. Methods DST by MGIT and WGS was performed on MTBC isolates received in 2016/2017. Nine genes and/or their promotor regions were investigated for resistance-associated mutations: rpoB, katG, fabG1, ahpC, inhA, embA, embB, pncA and rpsA. Isolates that were discrepant in their MGIT/WGS results and a control group with concordant results were retested in the MGIT, at the critical concentration and a lower concentration, and incubated for up to 45 days after the control tube became positive in the MGIT. Results In total, 1136 isolates were included, of which 1121 were routine MTBC isolates from the Netherlands. The negative predictive value of WGS was ≥99.3% for all four first-line antibiotics. The majority of discrepancies for isoniazid and ethambutol were explained by growth at the lower concentrations, and for rifampicin by prolonged incubation in the MGIT, both indicating low-level resistance. Conclusions Applying WGS in a country like the Netherlands, with a low TB incidence and low prevalence of resistance, can reduce the need for phenotypic DST for ∼90% of isolates and accurately detect mutations associated with low-level resistance, often missed in conventional DST.
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Firoz, Shehraz, and Sonia Bhatt. "Diagnostic value of polymerase chain reaction targeting insertion sequence IS1081 for the diagnosis of pediatric tuberculosis." International Journal of Contemporary Pediatrics 7, no. 4 (2020): 905. http://dx.doi.org/10.18203/2349-3291.ijcp20201152.

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Background: Aim of this study was to evaluate the efficacy of PCR targeting IS1081in diagnosis of pediatric tuberculosis and compare the results with MGIT culture.Methods: This prospective study was conducted in the department of pediatrics, S.N. medical college, Agra. 100 subjects (28 pulmonary 72 extra pulmonary) were registered in study. The specimens obtained from these cases were subjected to Ziehl–Neelsen staining (ZN), MGIT 960 TB culture and PCR targeting insertion sequence IS1081. Sensitivity, specificity, PPV and NPV of PCR were calculated in pulmonary and extra pulmonary specimens. The results of PCR IS1081 were compared to MGIT culture.Results: Microscopy with ZN staining was positive in 12 (12%) samples. MGIT culture was positive in 44% samples with maximum positivity in sputum (70%). PCR IS1081 has shown 93.3% sensitivity in pulmonary tuberculosis, while PCR IS1081 has shown 93.1% sensitivity in extra pulmonary tuberculosis. In diagnosis of childhood tuberculosis PCR IS1081 was found to be statistically significant (p value <0.05) as compared with MGIT culture. Result was statistically significant (p value <0.05) in CSF samples only.Conclusions: The study concluded that the PCR targeting sequence IS1081 technique is the most sensitive technique for a quick identification of MTB in pulmonary and extra pulmonary tuberculosis.
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Krishnan, Manju Y., Elizabeth J. B. Manning, and Michael T. Collins. "Stability of antibacterial agents in MGIT™ Para TB Medium." International Journal of Antimicrobial Agents 33, no. 2 (2009): 186–87. http://dx.doi.org/10.1016/j.ijantimicag.2008.07.027.

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Borodulina, E. A., A. T. Inkova, B. E. Borodulin, and L. V. Povalyaeva. "WAYS TO OPTIMIZE DETECTION OF TUBERCULOSIS IN A PULMONOLOGY UNIT." Tuberculosis and Lung Diseases 96, no. 5 (2018): 22–26. http://dx.doi.org/10.21292/2075-1230-2018-96-5-22-26.

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The objective: to optimize detection of tuberculosis in a pulmonology unit.Subjects and methods.In a pulmonology unit, patients suspected of having tuberculosis had a minimum number of diagnostic tests: a skin test with tuberculous recombinant allergen, three consecutive Ziel-Nelson microscopies of sputum and fluids of bronchoalveolar lavage, and in the laboratory of TB services they performed GeneXpert MTB/RIF, Bactec MGIT. Results of the diagnostics were analyzed in 70 patients with etiologic confirmation of diagnosis.Results.A targeted inquiry and taking the patient's history were informative in 4% of cases, skin test with TRA – in 27.1%, GeneXpert MTB/RIF – в in 100%, and Bactec MGIT – in 97.1%. Introduction of express diagnostic methods to a pulmonology unit reduced the average number of bed-days from admission to diagnostics of tuberculosis and transfer to a TB in-patient unit down to 9.80 ± 4.72 days. Molecular genetic methods can be recommended for introduction to general medical services as a diagnostic minimum when examining patients with a high risk of tuberculosis.
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Wang, Linwei, Sohaib H. Mohammad, Boonchai Chaiyasirinroje, et al. "Evaluating the Auto-MODS Assay, a Novel Tool for Tuberculosis Diagnosis for Use in Resource-Limited Settings." Journal of Clinical Microbiology 53, no. 1 (2014): 172–78. http://dx.doi.org/10.1128/jcm.01946-14.

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There is an urgent need for simple, rapid, and affordable diagnostic tests for tuberculosis (TB) to combat the great burden of the disease in developing countries. The microscopic observation drug susceptibility assay (MODS) is a promising tool to fill this need, but it is not widely used due to concerns regarding its biosafety and efficiency. This study evaluated the automated MODS (Auto-MODS), which operates on principles similar to those of MODS but with several key modifications, making it an appealing alternative to MODS in resource-limited settings. In the operational setting of Chiang Rai, Thailand, we compared the performance of Auto-MODS with the gold standard liquid culture method in Thailand, mycobacterial growth indicator tube (MGIT) 960 plus the SD Bioline TB Ag MPT64 test, in terms of accuracy and efficiency in differentiating TB and non-TB samples as well as distinguishing TB and multidrug-resistant (MDR) TB samples. Sputum samples from clinically diagnosed TB and non-TB subjects across 17 hospitals in Chiang Rai were consecutively collected from May 2011 to September 2012. A total of 360 samples were available for evaluation, of which 221 (61.4%) were positive and 139 (38.6%) were negative for mycobacterial cultures according to MGIT 960. Of the 221 true-positive samples, Auto-MODS identified 212 as positive and 9 as negative (sensitivity, 95.9%; 95% confidence interval [CI], 92.4% to 98.1%). Of the 139 true-negative samples, Auto-MODS identified 135 as negative and 4 as positive (specificity, 97.1%; 95% CI, 92.8% to 99.2%). The median time to culture positivity was 10 days, with an interquartile range of 8 to 13 days for Auto-MODS. Auto-MODS is an effective and cost-sensitive alternative diagnostic tool for TB diagnosis in resource-limited settings.
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Kadhim, Afraa Ali, Mohammed Faraj AL-Marjan, Kadhim Ali Kadhim, and Ahmed Asmar Manki. "Isolation of Mycobacterium tuberculosis and testing their susceptibility to antimicrobial agents by using Bactec 960." Al Mustansiriyah Journal of Pharmaceutical Sciences 13, no. 1 (2013): 175–81. http://dx.doi.org/10.32947/ajps.v13i1.213.

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This study was done from 3/7/2011 to 1/1/2012 , different clinical samples were collected from (1235) patients that coming to the Specialized center for chest and respiratory diseases / Baghdad to investigate Mycobacterium tuberculosis and study their resistant to first and second line antimicrobial agents by using Bactec 960.The results obtained from direct smear examination with Ziehl – Neelsen stain in (294) patients that indicated these patients are Infected with tuberculosis . These samples has been cultured on solid medium Lowenstein Jensen media (L.J.) and liquid medium ( middle brook 7H8 broth base) in the Mycobacteria Growth Indicator Tubes (MGIT) using a device (BACTEC MGIT 960 System).Results of (275) samples that represented (22.27%) from total samples were showed a significant real growth that belong to bacteria Mycobacterium tuberculosis. From (275) isolates tested to 1st line anti TB (streptomycin (SM), isoniazid (INH),rifampin (RMP) and ethambutol (EMB)), (196) isolates were resistant to the first line antimicrobial agents that used in the treatment of tuberculosis by using Bactec 960. (125) isolates (63.77%) showed resistance to multiple antimicrobial drugs (MDR-TB).Furthermore, the sensitivity test was done on thirty isolates that characterized by multiple drug resistance criteria (MDR-TB) on second line antimicrobial agents to investigate Extensively Drug-Resistant Tuberculosis(XDR-TB) between these isolates. The results showed that the bestantibiotics in their impact on the isolates (MDR-TB) is (PAS) P-aminosalicylic acid as the percentage of resistance was (3.3%).
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Shetye, Shamma, P. Chheda, A. Lad, and S. Matkar. "PERFORMANCE OF XPERT MTB/RIF ASSAY FOR DETECTION OF M.TB IN PULMONARY AND EXTRA-PULMONARY SAMPLES IN INDIAN PATIENTS." SAARC Journal of Tuberculosis, Lung Diseases and HIV/AIDS 14, no. 1 (2017): 7–13. http://dx.doi.org/10.3126/saarctb.v14i1.17720.

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Introduction: Conventional methods like Ziehl-Neelsen (ZN) staining and liquid culture have been the mainstay for diagnosis of Tuberculosis (TB). The gold standard Liquid Culture method has a longer turnaround time. In the wake of the TB catastrophe, newer rapid and easily accessible methods of detection are the need of the hour. A molecular method like the Xpert MTB/RIF assay has revolutionized the early and rapid diagnosis of TB. Objective of the current study was to assess the performance and utility of Xpert MTB/RIF assay for the diagnosis of M. tuberculosis in pulmonary and extra-pulmonary clinical specimens in a large Indian reference laboratory.Methodology: The reference methods used were MGIT Liquid Culture system and ZN smear microscopy. Our study was performed in Global Reference Laboratory, Metropolis Healthcare, Mumbai, India for a period of 18 months with consecutive one thousand and forty two (518 Pulmonary + 524 extra-pulmonaryspecimens) clinical specimens obtained from the patients with clinical suspicion of tuberculosis. Diagnostic performance (sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the three methods were calculated with standard formulae.Results: In comparison to MGIT Liquid culture, sensitivity of Xpert MTB/RIF assay for pulmonary and extra pulmonary specimens were 87.18% and 68.92%, respectively while in comparison to ZN smear microscopy the sensitivity of Xpert MTB/RIF assay for pulmonary and extra pulmonary specimens were 92.67% and 83.81%, respectively.Conclusion: Our study concludes that in combination with the MGIT culture, Xpert MTB/RIF assay will significantly improve the detection rate of MTB bacteria.SAARC J TUBER LUNG DIS HIV/AIDS, 2017; XIV(1), page: 7-13
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