Which new diagnostics for tuberculosis, and when?

J Infect Dis. 2012 May 15:205 Suppl 2:S191-8. doi: 10.1093/infdis/jis188. Epub 2012 Apr 3.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antitubercular Agents / therapeutic use
  • Bacteriological Techniques / economics
  • Bacteriological Techniques / methods
  • Bacteriological Techniques / trends
  • Developing Countries
  • Evaluation Studies as Topic
  • Health Policy
  • Humans
  • Tuberculosis / diagnosis*
  • Tuberculosis / drug therapy
  • World Health Organization*

Substances

  • Antitubercular Agents