On 20 January 2017, World Health Organization (WHO) convened a Technical Expert Consultation to assess the performance of the new Ultra assay compared with the Xpert MTB/RIF assay in a multi-centre diagnostic accuracy study coordinated by FIND in ten study sites in eight countries. The Technical Expert Group found that the Ultra assay is non-inferior to the Xpert MTB/RIF assay for the detection of Mycobacterium tuberculosis (MTB) and for the detection of rifampicin resistance. This means that the new Ultra cartridge is at least as good for the detection of MTB and rifampicin resistance as Xpert MTB/RIF.
In certain populations, the Ultra performs better for MTB detection especially for individuals whose specimens are frequently paucibacillary. The Ultra cartridge showed better performance for the detection of MTB in smear-negative culture-positive specimens, paediatric specimens, extra-pulmonary specimens (notably cerebrospinal fluid) and in testing smear-negative culture-positive specimens from HIV-positive individuals.
The current WHO recommendations for the use of Xpert MTB/RIF now also apply to the use of Ultra as the initial diagnostic test for all adults and children with signs and symptoms of TB and in the testing of selected extrapulmonary specimens (CSF, lymph nodes and tissue specimens).
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