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      Assessing the utility of Truenat in extrapulmonary tuberculosis diagnosis – A NRL’s experience

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          Abstract

          Background

          Diagnosis of extra pulmonary TB (EPTB) remains a big challenge. While data on utility of Xpert testing in EPTB diagnosis is enormous, there is limited data on Truenat MTB testing.

          Aim

          In this study we aimed to evaluate the usefulness of Truenat in EPTB diagnosis.

          Materials and methods

          The study included patients suspected and/or treated for EPTB located from Chennai district during the year 2021–2022. All processed EPTB samples were subjected to smear microscopy, culture and Truenat MTB testing.

          Results

          Of the 195 samples tested, 38 (19.4%) samples were positive for EPTB by any one of the diagnostic methods (smear, culture, microscopy). Out of these 38, 16 (42.1 %) were positive for MTB by Truenat and negative by Culture, 12 (31.5%) were positive by culture but negative by Truenat and 8 (21%) were positive by both Truenat and/or smear and culture. The sensitivity and specificity of the test was calculated with the composite reference standard (Culture (exclusion of colonies as positives), clinical conditions, and smear) and was found to be 60% and 100% respectively.

          Conclusion

          Truenat MTB test is a cost-effective rapid molecular test that can be used only for the diagnosis of presumptive EPTB and not on follow-up samples.

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          Most cited references9

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          Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis.

          Xpert MTB/RIF (Cepheid, Sunnyvale, CA, USA) is endorsed for the detection of pulmonary tuberculosis (TB). We performed a systematic review and meta-analysis to assess the accuracy of Xpert for the detection of extrapulmonary TB. We searched multiple databases to October 15, 2013. We determined the accuracy of Xpert compared with culture and a composite reference standard (CRS). We grouped data by sample type and performed meta-analyses using a bivariate random-effects model. We assessed sources of heterogeneity using meta-regression for predefined covariates. We identified 18 studies involving 4461 samples. Sample processing varied greatly among the studies. Xpert sensitivity differed substantially between sample types. In lymph node tissues or aspirates, Xpert pooled sensitivity was 83.1% (95% CI 71.4-90.7%) versus culture and 81.2% (95% CI 72.4-87.7%) versus CRS. In cerebrospinal fluid, Xpert pooled sensitivity was 80.5% (95% CI 59.0-92.2%) against culture and 62.8% (95% CI 47.7-75.8%) against CRS. In pleural fluid, pooled sensitivity was 46.4% (95% CI 26.3-67.8%) against culture and 21.4% (95% CI 8.8-33.9%) against CRS. Xpert pooled specificity was consistently >98.7% against CRS across different sample types. Based on this systematic review, the World Health Organization now recommends Xpert over conventional tests for diagnosis of TB in lymph nodes and other tissues, and as the preferred initial test for diagnosis of TB meningitis. ©ERS 2014.
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            Laboratory Diagnosis of Extra-pulmonary Tuberculosis (EPTB) in Resource-constrained Setting: State of the Art, Challenges and the Need.

            During the last decade, remarkable progress has been made in the diagnostics of pulmonary tuberculosis; however, diagnostic challenges in extra-pulmonary tuberculosis (EPTB) remain to be addressed. Diagnosis of EPTB is difficult due to the pauci-bacillary nature of disease, the variable clinical presentation, and need for invasive procedures to secure appropriate sample, and lack of laboratory facilities in the resource-limited settings. A more accurate test to diagnose various forms of EPTB, which can easily be incorporated in the routine TB control programme, would contribute significantly towards improving EPTB case-detection and thus reducing the morbidity and mortality. In this overview, we describe the status of current conventional and newer methods available for laboratory diagnosis of EPTB and discuss the challenges in their implementation in the resource-limited settings, and suggestion for better EPTB diagnostic algorithms, which can be incorporated in the routine TB control programmes.
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              Evaluation of the Xpert MTB/RIF Ultra Assay for Direct Detection of Mycobacterium tuberculosis Complex in Smear-Negative Extrapulmonary Samples

              The rapid detection of Mycobacterium tuberculosis complex (MTUBC) in clinical samples is essential for successful treatment. New techniques such as real-time PCR have been developed in order to facilitate rapid diagnosis, but their sensitivity is low in extrapulmonary specimens, due to the low bacillary load in such samples. A next-generation assay has recently been developed to try to overcome this limitation. The aim of this study was to analyze the effectiveness of the Xpert MTB/RIF Ultra (GX-Ultra) for the detection of MTUBC DNA in 108 smear-negative extrapulmonary specimens that were MTUBC culture positive. In addition, 40 extrapulmonary culture-negative samples and 20 samples with nontuberculous mycobacteria were tested to evaluate the specificity of the assay. All samples were collected between May 1999 and May 2017. The GX-Ultra detected DNA of MTUBC in 82 extrapulmonary specimens that were MTUBC culture positive (75.9% sensitivity; 95% confidence interval [CI], 66.6 to 83.4%). The assay was negative for all clinical specimens that were MTUBC culture negative and the samples with nontuberculous mycobacteria (100% specificity). Furthermore, two (1.8%) samples presented mutations related to rifampin resistance. The highest sensitivity was obtained in samples of lymph nodes (94.1%) and nonsterile fluids (93.7%), followed by tissue specimens (86.6%), stool material (80%), abscess aspirates (64.7%), and sterile fluids (60.5%). Pleural fluids, one of the least optimal samples for detecting DNA of MTUBC, were GX-Ultra positive in 10/21 (47.6%) of cases. In summary, GX-Ultra showed excellent specificity and high sensitivity in paubacillary specimens, making it a useful tool for rapid diagnosis of extrapulmonary tuberculosis.
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                Author and article information

                Journal
                J Clin Tuberc Other Mycobact Dis
                J Clin Tuberc Other Mycobact Dis
                Journal of Clinical Tuberculosis and Other Mycobacterial Diseases
                Elsevier
                2405-5794
                20 February 2024
                May 2024
                20 February 2024
                : 35
                : 100420
                Affiliations
                [a ]ICMR -National Institute for Research in Tuberculosis, Chennai, India
                [b ]District Tuberculosis Office, National Tuberculosis Elimination Programme, Chennai, India
                [c ]State Tuberculosis Office, National Tuberculosis Elimination Programme, Chennai, India
                Author notes
                [* ]Corresponding author at: Department of Bacteriology, ICMR -National Institute for Research in Tuberculosis, Chetpet, Chennai-31, India.
                Article
                S2405-5794(24)00007-X 100420
                10.1016/j.jctube.2024.100420
                10909875
                38440213
                38cd3cda-f5d6-4537-beea-333fb5316887
                © 2024 Published by Elsevier Ltd.

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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                Categories
                Article

                extrapulmonary,tuberculosis,truenat,smear,culture
                extrapulmonary, tuberculosis, truenat, smear, culture

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