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

2. Why?

3. 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. CriteriaMinimum Specifications Required Medical decisionTreatment 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) SpecificityAdults: 95% compared to culture Children: 95% compared to culture 90% for culture negative, probable TB (noting the lack of a gold standard) Time to resultsMaximum 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.

6. 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.

7. What is needed? Addressing the funding shortfall. In 2007 was 12% of total TB funding- TB R&D 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.