This document was prepared by Karin Weyer, Fuad Mirzayev, Wayne van Gemert and Christopher Gilpin (WHO Stop TB Department) on the basis of consensus at an international Expert Group Meeting convened by WHO in Geneva on 22 July 2010.

WHO gratefully acknowledges the contributions of the Chair of the Expert Group (Holger Schünemann) and the members of the Expert Group (Annex 1) who developed the recommendations.

The findings and recommendations from the Expert Group Meeting were presented to the WHO Strategic and Technical Advisory Group for Tuberculosis (STAG-TB, Annex 2), in September 2010 (http://www.who.int/tb/advisory_bodies/stag/en/). STAG-TB acknowledged a compelling evidence base and large body of work demonstrating the poor performance of commercial serodiagnostics and the adverse impact of misdiagnosis and wasted resources on patients and health services using these tests for the diagnosis of active TB.

STAG TB endorsed the findings of the Expert Group and supported the strategic approach to develop ‘negative’ WHO policy recommendations to discourage and prevent the use of commercial TB serodiagnostics.

This document was finalized following consideration of all comments and suggestions from the participants of the Expert Group and STAG-TB.

USAID is acknowledged for funding the development of these guidelines through USAID-WHO Consolidated Grant No. GHA-G-00-09-00003. TDR is acknowledged for sponsoring the systematic review commissioned in advance of the Expert Group meeting.