Advocacy for TB POC Diagnostic

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Advocacy for TB POC Diagnostic
Javid Syed TB/HIV 15th Core Group Meeting Nov
3-4, 2009. Geneva
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Why?
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Why?

• The clinic and health post serve 60, Peripheral
  health centers serve 25, and Referral
  laboratories serve 15.
• Most diagnostic tools in the pipeline promise
  improvements for higher level health systems-
  MODS, Gene Xpert, MGIT. LED FM which is the one
  that is likely to improve diagnostics available
  at microscopy/clinic level services only promises
  10 improvement.

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What is needed? Improved Coordination

• Number of research efforts such as the Public
  Health Research Institute, FIND, and others have
  screened the entire TB proteome to identify and
  purify 19 priority target proteins.
• Biomarker identification work is being carried
  out at the Max Planck Institute, the London
  School of Hygiene and Tropical Medicine, and New
  York University, among others.
• The biomarkers and technologies for detecting
  them must also be assessed.

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What is needed? Definition of POC Test Minimal
Requirements.
Criteria Minimum Specifications Required
Medical decision Treatment initiation
Sensitivityadults (regardless of HIV status) Pulmonary TB Smear positive, culture positive 95 Smear negative, culture positive 6080 (no agreement on a minimum) (Detection of extrapulmonary TB preferred but not required)
Sensitivitychildren (regardless of HIV status) 80 compared to culture of any specimen and 60 of probable TB (noting the lack of a gold standard)
Sensitivity extrapulmonary TB (regardless of HIV status) 80 compared to culture of any specimen and 60 of probable TB (noting the lack of a gold standard)
Specificity Adults 95 compared to culture Children 95 compared to culture 90 for culture negative, probable TB (noting the lack of a gold standard)
Time to results Maximum 3 hours (patient must same day results, desirable would be lt15 minutes)
PIH, MSF and TAG Meeting on TB POC Meeting.
March 17-18, 2009.
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What is needed? Advocating to address the
bottlenecks.

• Improving Global Plan Research Component for new
  diagnostic tool (to adequately address basic
  science and implementation research needs)-
  Participating in rewriting the plans.
• Creating community demand for improved
  diagnostics- Advocacy trainings and TB
  Diagnostics Pipeline
• Assessing the need for sample banks, state of
  research for biomarker and antigens useful for
  POC diagnostics, and technology platforms- TAG,
  MSF, and STBP contract with Imperial College

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What is needed? Addressing the funding
shortfall. In 2007 was 12 of total TB funding-
TB RD Report 2005-2008.
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Advocacy Strategy

• Needs to be evidence based.
• Needs to happen on all levels- build ground up
  advocacy demand for improved diagnostics while
  also creating a national and global environment
  that will expedite research.
• Advocacy should target specific bottlenecks that
  impede POC diagnostic research- funding, specimen
  banks, coordination between research efforts.