GLI and Global Fund focal point Feedback and updates

1
GLI and Global Fund focal pointFeedback and
updates

• Rachel Bauquerez

2
Expert meeting for Xpert/MTB/RIF

• 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)

3
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

4
Implementation at country level

• 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.

5
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.