title: Defining the needs for next generation assays for tuberculosis.
abstract: To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets.
authors.affiliation: FIND, Geneva, Switzerland Division of Infectious Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Denkinger
authors.affiliation: McGill International TB Centre and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada.
authors.forename: Sandra V
authors.initials: SV
authors.lastname: Kik
authors.affiliation: IRCCS Ospedale San Raffaele, Milan, Italy.
authors.forename: Daniela Maria
authors.initials: DM
authors.lastname: Cirillo
authors.affiliation: Médecins sans Frontières, Geneva, Switzerland.
authors.forename: Martina
authors.initials: M
authors.lastname: Casenghi
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Thomas
authors.initials: T
authors.lastname: Shinnick
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Karin
authors.initials: K
authors.lastname: Weyer
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Chris
authors.initials: C
authors.lastname: Gilpin
authors.affiliation: FIND, Geneva, Switzerland.
authors.forename: Catharina C
authors.initials: CC
authors.lastname: Boehme
authors.affiliation: HJF-DAIDS, A division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland.
authors.forename: Marco
authors.initials: M
authors.lastname: Schito
authors.affiliation: Bill and Melinda Gates Foundation, Seattle, Washington.
authors.forename: Michael
authors.initials: M
authors.lastname: Kimerling
authors.affiliation: McGill International TB Centre and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada.
authors.forename: Madhukar
authors.initials: M
authors.lastname: Pai
mesh_terms: D015415:Biomarkers / Q000032:analysis; D035843:Biomedical Research / Q000191:economics / Q000639:trends; D003955:Diagnostic Tests, Routine / Q000379:methods* / Q000639:trends; D006292:Health Priorities; D006801:Humans; D008826:Microbial Sensitivity Tests / Q000379:methods; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000639:trends; D013183:Sputum / Q000382:microbiology; D014376:Tuberculosis / Q000175:diagnosis*
chemical_list: D015415:Biomarkers
keywords: diagnosis; point-of-care; prioritization; target product profiles; tuberculosis