title: Which new diagnostics for tuberculosis, and when?
abstract: Recently, new diagnostic tools for tuberculosis detection and resistance testing have become available. The World Health Organization endorses new tuberculosis diagnostics by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. This endorsement process takes place when limited evidence beyond test accuracy is available. There is a need to provide guidance to tuberculosis programs about which new diagnostics to scale up and how best to position them in diagnostic algorithms. To speed adoption of new diagnostics for tuberculosis, the policy recommendation process should be revised to consist of 2 steps: technical recommendation and programmatic recommendation. Technical recommendation would follow the GRADE process and be based on accuracy with limited cost and feasibility data, while programmatic recommendation would include patient-important outcomes, cost-effectiveness when implemented under routine conditions, and factors critical to successful scale-up. The evidence for both steps should be systematically collected, but each requires different study designs.
authors.affiliation: Department of Global Health, Academic Medical Center; and Amsterdam Institute of Global Health and Development, Amsterdam, the Netherlands. f.cobelens@aighd.org
authors.forename: Frank
authors.initials: F
authors.lastname: Cobelens
authors.forename: Susan
authors.initials: S
authors.lastname: van den Hof
authors.forename: Madhukar
authors.initials: M
authors.lastname: Pai
authors.forename: S Bertel
authors.initials: SB
authors.lastname: Squire
authors.forename: Andrew
authors.initials: A
authors.lastname: Ramsay
authors.forename: Michael E
authors.initials: ME
authors.lastname: Kimerling
mesh_terms: D000995:Antitubercular Agents / Q000627:therapeutic use; D001431:Bacteriological Techniques / Q000191:economics / Q000379:methods / Q000639:trends; D003906:Developing Countries; D005069:Evaluation Studies as Topic; D006291:Health Policy; D006801:Humans; D014376:Tuberculosis / Q000175:diagnosis* / Q000188:drug therapy; D014944:World Health Organization
chemical_list: D000995:Antitubercular Agents