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Assessment of the Xpert assay among adult pulmonary tuberculosis suspects with and without diabetes mellitus

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SETTING: Pune and Pimpri-Chinchwad Municipal Corporation area, Maharashtra State, India.

OBJECTIVE: To assess the sensitivity and specificity of the Xpert® MTB/RIF assay among adults with suspected pulmonary tuberculosis (PTB) and with or without diabetes (DM).

DESIGN: As part of a prospective cohort study, we screened 2359 adults presumed to have PTB with no history of TB. All individuals underwent testing for two sputum smears, culture, Xpert, glycated haemoglobin and fasting blood sugar. We calculated sensitivity and specificity of Xpert by comparing it with TB sputum culture result as a gold standard.

RESULTS: Among screened individuals, 483 (20%) were diagnosed with DM and 1153 (49%) with pre-DM; 723 (31%) had no DM. Overall sensitivity of Xpert was 96% (95%CI 95–97) and specificity was 91% (95%CI 89–93). Xpert sensitivity was significantly higher among DM group (98%) than in the ‘No DM' (95%; P < 0.01) and pre-DM (96%; P < 0.05) groups. Among sputum smear-negative individuals, Xpert sensitivity was higher in the DM group than in the No DM (92% vs. 82%; P = 0.054) and pre-DM group (92% vs. 82%; P = 0.037).

CONCLUSION: High sensitivity and specificity of Xpert underscores the need for its rapid scale up for the early detection of TB in settings with a high dual burden of TB and DM.
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Keywords: blood sugar; culture; early detection

Document Type: Research Article

Affiliations: 1: Byramjee-Jeejeebhoy Medical College Clinical Research Site, Pune, India, Johns Hopkins University, Centre for Clinical Global Health Education, Baltimore, MD, USA 2: Johns Hopkins University, Centre for Clinical Global Health Education, Baltimore, MD, USA, Dr D Y Patil Medical College Hospital and Research Centre, Dr D Y Patil Vidyapeeth, Pune, India 3: Byramjee-Jeejeebhoy Medical College Clinical Research Site, Pune, India 4: Dr D Y Patil Medical College Hospital and Research Centre, Dr D Y Patil Vidyapeeth, Pune, India 5: Byramjee-Jeejeebhoy Medical College Clinical Research Site, Pune, India, Johns Hopkins School of Medicine, Baltimore, MD, USA 6: Byramjee-Jeejeebhoy Government Medical College, Pune India 7: Johns Hopkins University, Centre for Clinical Global Health Education, Baltimore, MD, USA, Johns Hopkins School of Medicine, Baltimore, MD, USA 8: Johns Hopkins School of Medicine, Baltimore, MD, USA

Publication date: January 1, 2020

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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