Histology is widely applied to the diagnosis of TB where the technical expertise exists, but this is technically demanding, time-consuming and it lacks specificity. However, limited laboratory facilities in resource-limited settings and prolonged culturing period restrict the utility of culture-based diagnosis in clinical practice. Solid and/or liquid culture is generally considered as the standard reference for TB diagnosis. Less than 3% of patients who are diagnosed with TB infection are proved to have certain pattern of drug resistance. Furthermore, the ratio of patients with undiagnosed multi-drug resistant TB remains much staggering (~75%). In fact, approximately 35% of all the worldwide TB infections are undiagnosed. However, rapid and accurate diagnosis of TB can be difficult due to the paucibacillary characteristics of the disease (especially for cases with smear-negative, co-infection with HIV and drug-resistance) and the challenge of sample collection from deep-seated tissues. Notably, of the 1.5 million deceased cases, 360,000 recorded among people with HIV infection.ĭespite of its life-threating pathogenesis, TB is a curable disease when it is correctly diagnosed and effectively treated. Importantly, these recent epidemiological estimates are higher than what were previously estimated. In 2013, an estimated 9.0 million people were infected with TB disease and 1.5 million (approximately 17%) died from this disease. Tuberculosis (TB) is a serious global health problem and is one of the leading causes of death worldwide. The overall sensitivity was lower in countries with high TB prevalence than countries with middle/low prevalence (0.84, 95% CI: 0.80–0.88 versus 0.89, 95% CI: 0.84–0.93). The overall pooled sensitivity and specificity of Xpert MTB/RIF was 0.85 (95% confidence interval 0.82–0.88) and 0.98 (95% CI 0.96–0.98), respectively, compared to culture while it was 0.59 (95% CI 0.44–0.72) and 0.99 (95% CI 0.97–1.00) compared to CRS. Additionally, selected studies were further subgrouped in four groups based on sample’s type, subject’s age, status of HIV co-infection and smear-positivity. Diagnostic accuracy of Xpert MTB/RIF for TB detection was validated against either culture or a composite reference standard (CRS). Accordingly, 106 studies included 52,410 samples were selected.