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. 2015 Oct 23;10(10):e0141011.
doi: 10.1371/journal.pone.0141011. eCollection 2015.

Evaluating the Diagnostic Accuracy of Xpert MTB/RIF Assay in Pulmonary Tuberculosis

Surendra K Sharma  1 , Mikashmi Kohli  1 , Raj Narayan Yadav  1 , Jigyasa Chaubey  1 , Dinkar Bhasin  1 , Vishnubhatla Sreenivas  2 , Rohini Sharma  1 , Binit K Singh  1
Affiliations

Evaluating the Diagnostic Accuracy of Xpert MTB/RIF Assay in Pulmonary Tuberculosis

Surendra K Sharma et al. PLoS One. .

Abstract

Pulmonary tuberculosis still remains a major communicable disease worldwide. In 2013, 9 million people developed TB and 1.5 million people died from the disease. India constitutes 24% of the total TB burden. Early detection of TB cases is the key to successful treatment and reduction of disease transmission. Xpert MTB/RIF, an automated cartridge-based molecular technique detects Mycobacterium tuberculosis and rifampicin resistance within two hours has been endorsed by WHO for rapid diagnosis of TB. Our study is the first study from India with a large sample size to evaluate the performance of Xpert MTB/RIF assay in PTB samples. The test showed an overall sensitivity and specificity of 95.7% (430/449) and 99.3% (984/990) respectively. In smear negative-culture positive cases, the test had a sensitivity of 77.7%. The sensitivity and specificity for detecting rifampicin resistance was 94.5% and 97.7% respectively with respect to culture as reference standard. However, after resolving the discrepant samples with gene sequencing, the sensitivity and specificity rose to 99.0% and 99.3% respectively. Hence, while solid culture still forms the foundation of TB diagnosis, Xpert MTB/RIF proposes to be a strong first line diagnostic tool for pulmonary TB cases.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Study Design.
*A total of 47 cultures were contaminated including three samples with invalid result by Xpert MTB/RIF and one sample with error by Xpert MTB/RIF. Two other samples which gave “error” by Xpert MTB/RIF were culture negative but were excluded from the study.
See this image and copyright information in PMC

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