Consolidated Guidelines

There are significant burdens of tuberculosis in people living with HIV and children, particularly in low- and middle-income countries (LMICs). Persons living with HIV are at substantially higher risk of developing TB disease due to immunosuppression, with TB being a leading cause of death among this population. Children, especially those under five, are at high risk of progression from TB infection to TB disease and rapid disease progression and often present with broad respiratory symptoms, which complicate diagnosis and increase morbidity and mortality if not promptly treated.

A new class of low-complexity manual NAATs (LC-mNAATs) has now emerged for alternative molecular solutions that have improved accuracy when compared with smear microscopy and very basic infrastructure, power and equipment requirements (e.g. heat block). LC-mNAATs can be performed at the microscopy level and are currently cheaper than other molecular tests. Collectively, these characteristics are useful for testing in constrained settings.

2.1.1 LC-aNAATs for detection of TB and resistance to rifampicinNEW 

Rapid detection of TB and rifampicin resistance is a critical global priority.

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: