Consolidated Guidelines

The target audience for these guidelines includes laboratory managers, clinicians and other health care staff, HIV and TB programme managers, policymakers, technical agencies, donors and implementing partners supporting the use of TB diagnostics in resource-limited settings.

Individuals responsible for programme planning, budgeting, mobilizing resources and implementing training activities for the programmatic management of DR-TB may also find this document useful.

This document provides background, justification and recommendations on novel diagnostic tools for detecting MTBC, the presence or absence of mutations in target genes proven to be associated with anti-TB drug resistance, and TB infection.

The target audience for these guidelines includes laboratory managers, clinicians and other health care staff, HIV and TB programme managers, policy-makers, technical agencies, donors and implementing partners supporting the use of TB diagnostic tests in resource-limited settings.

The document may also be of use to individuals responsible for programme planning, budgeting, mobilizing resources and implementing training activities for the programmatic management of drug-resistant TB (DR-TB).

This document provides background, justification and recommendations for novel diagnostic tools for detecting MTBC, the presence or absence of mutations in target genes proven to be associated with anti-TB drug resistance, and TB infection.

As highlighted above, all technologies with a WHO/GTB recommendation are expected to undergo prequalification assessment, as available. Successful assessment will be required to maintain a WHO/GTB recommendation. The current set of TB diagnostic testing classes and included products are listed in Table 1.1.1, and the two new classes are discussed below.

Over the past 16 years, WHO has endorsed a range of diagnostic technologies (Table 1.1.1). The WHO assessment process for TB diagnostics has recently evolved to focus on evaluating classes of TB diagnostic technologies rather than specific products. Class determination is managed by WHO/GTB for new diagnostic testing technologies, and it includes an evaluation of the following characteristics: