title: Operational lessons drawn from pilot implementation of Xpert MTB/Rif in Brazil.
abstract: OBJECTIVE
  The World Health Organization has endorsed the Xpert MTB/RIF (Xpert), an automated polymerase-chain-reaction-based assay, for the rapid diagnosis of tuberculosis. However, large-scale use of a new technology calls for preparation and adaptation.
  
  
  METHODS
  A pilot implementation study was conducted in two Brazilian cities to explore the replacement of sputum smear microscopy with Xpert. The laboratories included covered 70% of the tuberculosis cases diagnosed, had no overlap in population catchment areas, handled different workloads and were randomly shifted to Xpert. Sputum samples were collected through the same routine procedures. Before the study the medical information system was prepared for the recording of Xpert results. Laboratory technicians were trained to operate Xpert machines and health workers were taught how to interpret the results.
  
  
  METHODS
  The average annual tuberculosis incidence in Brazil is around 90 cases per 100,000 population. However, co-infection with the human immunodeficiency virus and multidrug resistance are relatively infrequent (10% and < 2%, respectively).
  
  
  RESULTS
  Of the tested sputum samples, 7.3% were too scanty for Xpert and had to be examined microscopically. Ten per cent of Xpert equipment needed replacement, but spare parts were not readily available in the country. Absence of patient identification numbers led to the introduction of errors in the medical information system.
  
  
  CONCLUSIONS
  For nationwide scale-up, a local service provider is needed to maintain the Xpert system. Ensuring cartridge availability is also essential. The capacity to perform smear microscopy should be retained. The medical information system needs updating to allow efficient use of Xpert.
authors.affiliation: Rio de Janeiro Municipal Health Secretariat, Rio de Janeiro, Brazil .
authors.forename: Betina
authors.initials: B
authors.lastname: Durovni
authors.affiliation: Rio de Janeiro Municipal Health Secretariat, Rio de Janeiro, Brazil .
authors.forename: Valeria
authors.initials: V
authors.lastname: Saraceni
authors.affiliation: Infectious Diseases Graduate Programme, Tropical Medicine Foundation Dr Heitor Vieira Dourado, Manaus, Brazil .
authors.forename: Marcelo
authors.initials: M
authors.lastname: Cordeiro-Santos
authors.affiliation: Rio de Janeiro Municipal Health Secretariat, Rio de Janeiro, Brazil .
authors.forename: Solange
authors.initials: S
authors.lastname: Cavalcante
authors.affiliation: Rio de Janeiro Municipal Health Secretariat, Rio de Janeiro, Brazil .
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Soares
authors.affiliation: Evandro Chagas Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil .
authors.forename: Cristina
authors.initials: C
authors.lastname: Lourenço
authors.affiliation: Global Health Strategies, Rio de Janeiro, Brazil .
authors.forename: Alexandre
authors.initials: A
authors.lastname: Menezes
authors.affiliation: KNCV Tuberculosis Foundation, The Hague, Netherlands .
authors.forename: Susan
authors.initials: S
authors.lastname: van den Hof
authors.affiliation: Department of Global Health, Amsterdam Institute of Global Health and Development, Amsterdam, Netherlands .
authors.forename: Frank
authors.initials: F
authors.lastname: Cobelens
authors.affiliation: Internal Medicine Graduate Programme, Rio de Janeiro Federal University, Av Brigadeiro Trompowsky s/nº,11th floor, Ilha do Fundão, Rio de Janeiro, 21941-50, Brazil .
authors.forename: Anete
authors.initials: A
authors.lastname: Trajman
mesh_terms: D001938:Brazil / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D010865:Pilot Projects; D016133:Polymerase Chain Reaction / Q000379:methods*; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000453:epidemiology