title: Costs of novel tuberculosis diagnostics--will countries be able to afford it?
abstract: BACKGROUND
  Four priority target product profiles for the development of diagnostic tests for tuberculosis were identified: 1) Rapid sputum-based (RSP), 2) non-sputum Biomarker-based (BMT), 3) triage test followed by confirmatory test (TT), and 4) drug-susceptibility testing (DST).
  
  
  METHODS
  We assessed the cost of the new tests in suitable strategies and of the conventional diagnosis of tuberculosis as per World Health Organization guidelines, in 36 high tuberculosis and MDR burden countries. Costs were then compared to the available funding for tuberculosis at country level.
  
  
  RESULTS
  Costs of diagnosing tuberculosis using RSP ranged US$93-187 million/year; if RSP unit cost is of US$2-4 it would be lower/similar cost than conventional strategy with sputum smear microscopy (US$ 119 million/year). Using BMT (with unit cost of US$2-4) would cost US$70-121 million/year and be lower/comparable cost than conventional diagnostics. Using TT with TPP characteristics (unit cost of US$1-2) followed by Xpert would reduce diagnostic costs up to US$36 million/year. Costs of using different novel DST strategies for the diagnosis of drug resistance would be higher compared with conventional diagnosis.
  
  
  CONCLUSIONS
  Introducing a TT or a biomarker test with optimal characteristics would be affordable from a cost and affordability perspective at the current available funding for tuberculosis. Additional domestic or donor funding would be needed in most countries to achieve affordability for other new diagnostic tests.
authors.affiliation: Independent consultant for FIND, Zürich, Switzerland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Pantoja
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: FIND, Geneva, Switzerland.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Denkinger
mesh_terms: D002202:Capital Financing; D003955:Diagnostic Tests, Routine / Q000191:economics* / Q000379:methods*; D017048:Health Care Costs; D019981:Health Care Sector; D006297:Health Services Accessibility; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000191:economics* / Q000379:methods*; D014376:Tuberculosis / Q000175:diagnosis* / Q000453:epidemiology
keywords: affordability; costs; diagnostics; multidrug-resistant tuberculosis; tuberculosis