advocacy for tb poc diagnostic javid syed tb/hiv 15th core group meeting nov 3-4, 2009. geneva
TRANSCRIPT
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Advocacy for TB POC Diagnostic
Javid SyedTB/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
Sensitivity—adults (regardless of HIV status)
Pulmonary TB: Smear positive, culture positive: 95% Smear negative, culture positive: 60–80% (no agreement on a minimum) (Detection of extrapulmonary TB preferred but not required)
Sensitivity—children (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 <15 minutes)
PIH, MSF and TAG Meeting on TB POC Meeting. March 17-18, 2009.
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• 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
What is needed? Advocating to address the bottlenecks.
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What is needed? Addressing the funding shortfall. In 2007 was 12% of total TB funding- TB R&D 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.