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Advocacy for TB POC Diagnostic

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Title: Advocacy for TB POC Diagnostic


1
Advocacy for TB POC Diagnostic
Javid Syed TB/HIV 15th Core Group Meeting Nov
3-4, 2009. Geneva
2
Why?
3
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.

4
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.

5
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.
6
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

7
What is needed? Addressing the funding
shortfall. In 2007 was 12 of total TB funding-
TB RD Report 2005-2008.
8
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.
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