Guideline Development Group meeting “Molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB in adults and children. Policy Update”, 3-6 December, 2019, Geneva, Switzerland
Tuberculosis (TB) causes 10 million cases and 1.5 million deaths annually and it is estimated that 3 million cases go undiagnosed each year. WHO-endorsed rapid TB diagnostics and drug susceptibility testing (DST) should be available to all persons with signs and symptoms of TB to meet the targets of the End TB Strategy.
The development of the Xpert® MTB/RIF assay (Cepheid, Sunnyvale, USA) was a major step forward for improving the diagnosis of TB and rifampicin resistance (RR) detection globally. In 2011, WHO endorsed the use of Xpert MTB/RIF for diagnosis of TB and detection of RR, and recommended that it be used as the initial diagnostic test in individuals living with HIV and/or suspected of having drug-resistant TB. The Xpert® MTB/RIF Ultra assay (Ultra) has been developed by Cepheid as the next-generation assay to overcome these limitations, which uses the same GeneXpert® platform as Xpert MTB/RIF. Furthermore, new molecular assay Molbio TrueNat MTB/Rif was developed in India, which potentially may be used at the same health system level as Xpert MTB/RIF, and be used as an initial test for TB.
WHO will convene a Guideline Development Group (GDG) to meet 3-6 December 2019 in accordance with the WHO processes and procedures for guideline development, to assess the available evidence on the use of Xpert® MTB/RIF, Ultra and Molbio TrueNat MTB/Rif for the diagnosis of active TB (pulmonary and extra-pulmonary) and rifampicin-resistance in adults, adolescents and children with signs and symptoms of TB, as well as people being screened for TB which will be later disseminated as the updated WHO guidelines.
News and events
In settings where laboratory testing has been traditionally organized by disease programme, the introduction of multidisease testing devices brings new opportunities for collaboration and integration, which can provide significant system efficiencies and cost savings, increase patient access, and ultimately improve quality of care.
A framework of indicators and targets has been launched measuring programmes’ capacity to detect TB using new diagnostics, provide universal DST, and ensure the quality of testing under the End TB Strategy.
Rapid diagnostic test and shorter, cheaper treatment signal new hope for multidrug-resistant tuberculosis patients
New WHO recommendations aim to speed up detection and improve treatment outcomes for multidrug resistant tuberculosis (MDR-TB) through use of a novel rapid diagnostic test and a shorter, cheaper treatment regimen.
Tests based on the detection of mycobacterial lipoarabinomannan (LAM) antigen in urine have emerged as potential point-of-care tests for TB. WHO has issued recommendations on the use of a lateral flow LAM assay for the diagnosis and screening of active TB in people living with HIV.
Bridging the growing gap between diagnosis and treatment in multidrug-resistant tuberculosis (MDR-TB)
An unprecedented scale-up in test development and laboratory strengthening has been seen since 2009, when the World Health Assembly called for universal access to tuberculosis (TB) drug susceptibility testing (DST) and treatment of all patients with drug-resistant disease.
- Consensus Meeting Report: Development of a Target Product Profile (TPP) and a framework for evaluation for a test for predicting progression from tuberculosis infection to active disease
- Technical Expert Group Meeting Report: Commercial products for preserving clinical specimens for the diagnosis of tuberculosis.
- High-priority target product profiles for new tuberculosis diagnostics
- WHO policies on diagnostics and laboratory strengthening
- WHO Framework of indicators and targets for laboratory strengthening
- Framework for implementing TB diagnostics
Policy guidance on the molecular second-line line-probe assay