title: Target product profile of a molecular drug-susceptibility test for use in microscopy centers.
abstract: BACKGROUND
  Current phenotypic testing for drug resistance in patients with tuberculosis is inadequate primarily with respect to turnaround time. Molecular tests hold the promise of an improved time to diagnosis.
  
  
  METHODS
  A target product profile for a molecular drug-susceptibility test (DST) was developed on the basis of a collaborative effort that included opinions gathered from researchers, clinicians, policy makers, and test developers on optimal clinical and operational characteristics in settings of intended use. In addition, the current diagnostic ecosystem and the diagnostic development landscape were mapped.
  
  
  RESULTS
  Molecular DSTs for detecting tuberculosis in microscopy centers should ideally evaluate for resistance to rifampin, fluoroquinolones, isoniazid, and pyrazinamide and enable the selection of the most appropriate treatment regimen. Performance characteristics of DSTs need to be optimized, but compromises can be made that depend on the trade-off between a false-positive result and a false-negative result. The operational requirements of a test will vary depending on the site of implementation. However, the most-important considerations pertain to quality control, maintenance and calibration, and the ability to export data.
  
  
  CONCLUSIONS
  This target product profile defines the needs as perceived by the tuberculosis stakeholder community and attempts to provide a means of communication with test developers to ensure that fit-for-purpose DSTs are being developed.
authors.affiliation: FIND Division of Infectious Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Denkinger
authors.affiliation: FIND.
authors.forename: David
authors.initials: D
authors.lastname: Dolinger
authors.affiliation: Division of AIDS, Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland.
authors.forename: Marco
authors.initials: M
authors.lastname: Schito
authors.affiliation: TB Alliance, New York, New York.
authors.forename: William
authors.initials: W
authors.lastname: Wells
authors.affiliation: KNCV Tuberculosis Foundation, the Hague Amsterdam Institute for Global Health and Development, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: Cobelens
authors.affiliation: McGill International TB Centre Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada.
authors.forename: Madhukar
authors.initials: M
authors.lastname: Pai
authors.affiliation: World Health Organization.
authors.forename: Matteo
authors.initials: M
authors.lastname: Zignol
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Daniela Maria
authors.initials: DM
authors.lastname: Cirillo
authors.affiliation: Rutgers University, New Brunswick, New Jersey.
authors.forename: David
authors.initials: D
authors.lastname: Alland
authors.affiliation: Médecins sans Frontières, Geneva, Switzerland.
authors.forename: Martina
authors.initials: M
authors.lastname: Casenghi
authors.affiliation: Bill and Melinda Gates Foundation, Seattle, Washington.
authors.forename: Jim
authors.initials: J
authors.lastname: Gallarda
authors.affiliation: FIND.
authors.forename: Catharina C
authors.initials: CC
authors.lastname: Boehme
authors.affiliation: FIND.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Perkins
mesh_terms: D000995:Antitubercular Agents / Q000494:pharmacology* / Q000627:therapeutic use; D003955:Diagnostic Tests, Routine / Q000379:methods* / Q000592:standards; D006801:Humans; D008826:Microbial Sensitivity Tests / Q000379:methods* / Q000592:standards; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000592:standards; D011786:Quality Control; D013997:Time Factors; D014376:Tuberculosis / Q000175:diagnosis* / Q000188:drug therapy
chemical_list: D000995:Antitubercular Agents
keywords: diagnostics; molecular testing; point of care; tuberculosis