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Among 105 countries possessing representative data on resistance to fluoroquinolones from the past 15 years, the proportion of MDR/RR-TB cases with resistance to any fluoroquinolone for which testing was done was 20.1% (95% CI: 15.5–25.0%) (1). Thus, rapid and early testing for the detection of fluoroquinolone resistance is essential for determining eligibility for treatment with the all-oral 9–12 month standardized shorter regimen for MDR/RR-TB.
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.
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.