title: Use of Xpert MTB/RIF in Decentralized Public Health Settings and Its Effect on Pulmonary TB and DR-TB Case Finding in India.
abstract: BACKGROUND
  Xpert 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.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  Introduction 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.
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: Kuldeep Singh
authors.initials: KS
authors.lastname: Sachdeva
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Neeraj
authors.initials: N
authors.lastname: Raizada
authors.affiliation: World Health Organization, India Country Office, New Delhi, India.
authors.forename: Achuthan
authors.initials: A
authors.lastname: Sreenivas
authors.affiliation: Department of Global Health, Academic Medical Center and Amsterdam Institute of Global Health and Development, Amsterdam, The Netherlands.
authors.forename: Anna H
authors.initials: AH
authors.lastname: Van't Hoog
authors.affiliation: Department of Global Health, Academic Medical Center and Amsterdam Institute of Global Health and Development, Amsterdam, The Netherlands; KNCV Tuberculosis Foundation, The Hague, The Netherlands.
authors.forename: Susan
authors.initials: S
authors.lastname: van den Hof
authors.affiliation: World Health Organization, India Country Office, New Delhi, India.
authors.forename: Puneet K
authors.initials: PK
authors.lastname: Dewan
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Rahul
authors.initials: R
authors.lastname: Thakur
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: R S
authors.initials: RS
authors.lastname: Gupta
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Shubhangi
authors.initials: S
authors.lastname: Kulsange
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Bhavin
authors.initials: B
authors.lastname: Vadera
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Ameet
authors.initials: A
authors.lastname: Babre
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Christen
authors.initials: C
authors.lastname: Gray
authors.affiliation: World Health Organization, India Country Office, New Delhi, India.
authors.forename: Malik
authors.initials: M
authors.lastname: Parmar
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: Mayank
authors.initials: M
authors.lastname: Ghedia
authors.affiliation: World Health Organization, India Country Office, New Delhi, India.
authors.forename: Ranjani
authors.initials: R
authors.lastname: Ramachandran
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Umesh
authors.initials: U
authors.lastname: Alavadi
authors.affiliation: Department of Infectious Disease Epidemiology, School of Public Health, Imperial College, London, United Kingdom.
authors.forename: Nimalan
authors.initials: N
authors.lastname: Arinaminpathy
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Claudia
authors.initials: C
authors.lastname: Denkinger
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Catharina
authors.initials: C
authors.lastname: Boehme
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: C N
authors.initials: CN
authors.lastname: Paramasivan
mesh_terms: D000995:Antitubercular Agents / Q000494:pharmacology; D024901:Drug Resistance, Multiple, Bacterial; D005260:Female; D062306:Geography, Medical; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008826:Microbial Sensitivity Tests; D025202:Molecular Diagnostic Techniques; D062486:Public Health Surveillance; D012293:Rifampin / Q000494:pharmacology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology*
chemical_list: D000995:Antitubercular Agents; D012293:Rifampin