Go to View > Master > Slide Master to edit Place, Month Year GLI and Global Fund focal point Feedback and updates Rachel Bauquerez

Go to View > Master > Slide Master to edit Place, Month Year Objectives: to review results from studies of automated nucleic acid amplification technology. Recommendations presented to the WHO STAG for possible endorsement. Possible development of a WHO policy for dissemination to Member States for implementation in TB programs at the country level. (not yet done) Expert meeting for Xpert/MTB/RIF

Go to View > Master > Slide Master to edit Place, Month Year Strengths of the test Easy to use and requires only one laboratory technician Requires basic training Little risk of contamination – minimal biosafety requirements Sensitivity and Specificity are comparable to the smear microscopy for culture positive sputum positive cases Able to perform up to 16 molecular tests concurrently, which may start at different times Results can be provided under 2 hours Able to be used for other diseases

Go to View > Master > Slide Master to edit Place, Month Year District and sub-district levels, but positioning of the test in existing diagnostic algorithms should be done on a per-country basis. Requirements - Reasonably steady power supply; –Storage space for the machine itself, the computer, cartridges, and bulky reagents; –Functional supply chain for replacing cartridges and reagents; –Waste management system for non-degradable cartridges and potential hazardous waste; –Mandatory annual calibration for optimal performance. Implementation at country level

Go to View > Master > Slide Master to edit Place, Month Year Issues for consideration for INAT subgroup – and GF Information on programmatic resources is not available yet: –Need for evaluation of the test in different screening and diagnostic algorithm -Cost effectiveness and cost benefit in different settings -Stability of xpert and cartridges (stabilization from varying or high temperatures) The warranty is limited. Storage and waste management system Need for annual calibration is an important consideration. No clear information has been provided on the way the technology would be operationalized in the context of a program. If the test will be mainly used for the identification of possible MDR cases, then another test should be used for all rifampicin resistant cases identified by this test to confirm isoniziad resistance. Possible huge impact on Global Fund funding proposals, review, monitoring and procurement plans.