title: Results from early programmatic implementation of Xpert MTB/RIF testing in nine countries.
abstract: BACKGROUND
  The Xpert MTB/RIF assay has garnered significant interest as a sensitive and rapid diagnostic tool to improve detection of sensitive and drug resistant tuberculosis. However, most existing literature has described the performance of MTB/RIF testing only in study conditions; little information is available on its use in routine case finding. TB REACH is a multi-country initiative focusing on innovative ways to improve case notification.
  
  
  METHODS
  We selected a convenience sample of nine TB REACH projects for inclusion to cover a range of implementers, regions and approaches. Standard quarterly reports and machine data from the first 12 months of MTB/RIF implementation in each project were utilized to analyze patient yields, rifampicin resistance, and failed tests. Data was collected from September 2011 to March 2013. A questionnaire was implemented and semi-structured interviews with project staff were conducted to gather information on user experiences and challenges.
  
  
  RESULTS
  All projects used MTB/RIF testing for people with suspected TB, as opposed to testing for drug resistance among already diagnosed patients. The projects placed 65 machines (196 modules) in a variety of facilities and employed numerous case-finding strategies and testing algorithms. The projects consumed 47,973 MTB/RIF tests. Of valid tests, 7,195 (16.8%) were positive for MTB. A total of 982 rifampicin resistant results were found (13.6% of positive tests). Of all tests conducted, 10.6% failed. The need for continuous power supply was noted by all projects and most used locally procured solutions. There was considerable heterogeneity in how results were reported and recorded, reflecting the lack of standardized guidance in some countries.
  
  
  CONCLUSIONS
  The findings of this study begin to fill the gaps among guidelines, research findings, and real-world implementation of MTB/RIF testing. Testing with Xpert MTB/RIF detected a large number of people with TB that routine services failed to detect. The study demonstrates the versatility and impact of the technology, but also outlines various surmountable barriers to implementation. The study is not representative of all early implementer experiences with MTB/RIF testing but rather provides an overview of the shared issues as well as the many different approaches to programmatic MTB/RIF implementation.
authors.affiliation: Stop TB Partnership, Secretariat, Geneva, Switzerland. creswellj@who.int.
authors.forename: Jacob
authors.initials: J
authors.lastname: Creswell
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Codlin
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Andre
authors.forename: Mark A
authors.initials: MA
authors.lastname: Micek
authors.forename: Ahmed
authors.initials: A
authors.lastname: Bedru
authors.forename: E Jane
authors.initials: EJ
authors.lastname: Carter
authors.forename: Rajendra-Prasad
authors.initials: RP
authors.lastname: Yadav
authors.forename: Andrei
authors.initials: A
authors.lastname: Mosneaga
authors.forename: Bishwa
authors.initials: B
authors.lastname: Rai
authors.forename: Sayera
authors.initials: S
authors.lastname: Banu
authors.forename: Miranda
authors.initials: M
authors.lastname: Brouwer
authors.forename: Lucie
authors.initials: L
authors.lastname: Blok
authors.forename: Suvanand
authors.initials: S
authors.lastname: Sahu
authors.forename: Lucica
authors.initials: L
authors.lastname: Ditiu
mesh_terms: D000328:Adult; D000465:Algorithms; D000904:Antibiotics, Antitubercular; D024881:Drug Resistance, Bacterial; D006297:Health Services Accessibility; D006801:Humans; D038622:Internationality; D025202:Molecular Diagnostic Techniques / Q000295:instrumentation; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification* / Q000502:physiology; D012293:Rifampin; D012680:Sensitivity and Specificity; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*
chemical_list: D000904:Antibiotics, Antitubercular; D012293:Rifampin