Abstract
BackgroundXpert MTB/RIF, the first automated molecular test for tuberculosis, is transforming the diagnostic landscape in high-burden settings. This study assessed the impact of up-front Xpert MTB/RIF testing on detection of pulmonary tuberculosis (PTB) and rifampicin-resistant PTB (DR-TB) cases in India.MethodsThis demonstration study was implemented in 18 sub-district level TB programme units (TUs) in India in diverse geographic and demographic settings covering a population of 8.8 million. A baseline phase in 14 TUs captured programmatic baseline data, and an intervention phase in 18 TUs had Xpert MTB/RIF offered to all presumptive TB patients. We estimated changes in detection of TB and DR-TB, the former using binomial regression models to adjust for clustering and covariates.ResultsIn the 14 study TUs, which participated in both phases, 10,675 and 70,556 presumptive TB patients were enrolled in the baseline and intervention phase, respectively, and 1,532 (14.4%) and 14,299 (20.3%) bacteriologically confirmed PTB cases were detected. The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases (adjusted incidence rate ratio [aIRR] 1.39; CI 1.18-1.64), and proportion of bacteriological confirmed TB cases among presumptive TB cases (adjusted risk ratio (aRR) 1.33; CI 1.6-1.52). Compared with the baseline strategy of selective drug-susceptibility testing only for PTB cases at high risk of drug-resistant TB, Xpert MTB/RIF implementation increased rifampicin resistant TB case detection by over fivefold. Among, 2765 rifampicin resistance cases detected, 1055 were retested with conventional drug susceptibility testing (DST). Positive predictive value (PPV) of rifampicin resistance detected by Xpert MTB/RIF was 94.7% (CI 91.3-98.1), in comparison to conventional DST.ConclusionIntroduction of Xpert MTB/RIF as initial diagnostic test for TB in public health facilities significantly increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold.
Highlights
Tuberculosis (TB) remains a major global public health problem even today
In the 14 study TB programme units (TUs), which participated in both phases, 10,675 and 70,556 presumptive TB patients were enrolled in the baseline and intervention phase, respectively, and 1,532 (14.4%) and 14,299 (20.3%) bacteriologically confirmed pulmonary tuberculosis (PTB) cases were detected
The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases, and proportion of bacteriological confirmed TB cases among presumptive TB cases
Summary
Tuberculosis (TB) remains a major global public health problem even today. Despite longstanding availability of treatment, an estimated 8.6 million TB cases and 1.3 million TB deaths were reported in 2012 [1]. In December 2010, the World Health Organization (WHO) endorsed the Xpert MTB/RIF (Cepheid, Sunnyvale, CA, USA) [2] assay, which has demonstrated high sensitivity and specificity for both detection of pulmonary TB and rifampicin resistance [3]. In 2013, WHO released revised policy guidelines on the use of Xpert MTB/RIF in adults and children These guidelines recommend that, Xpert MTB/RIF may be used rather than conventional microscopy and culture as the initial diagnostic test in all adults presumed to have TB (conditional recommendation acknowledging resource implications, high-quality evidence) [2,3,4]. This study assessed the impact of up-front Xpert MTB/RIF testing on detection of pulmonary tuberculosis (PTB) and rifampicin-resistant PTB (DR-TB) cases in India
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