1. Ilesh V. Jani, MD PhD Instituto Nacional de Saúde Maputo, Mozambique

2. The Pipeline of HIV-Related Point-Of- Care Tests is Growing 20102011 2012 2013 2014 2009 0 2012 2013 2014 20152016 2017 Viral detection Examples: CD4 test Examples:

3. Evidence of the Impact of Some Point-Of- Care Tests in Pilot Studies is Also Mounting Source: Jani et al (2011)

4. There is a Need for Normative Guidance for New Point-Of-Care Testing Point-of-care test deployment at full scale will take significant investment Public health benefits may be reduced if implementation is not well planned and executed Policies and guidelines for new POC test adoption and implementation need to be developed from a health system perspective Challenges: Multiple new products and regulatory weaknesses Increased decentralization of testing and care into community and informal settings Appropriate usage of test results and linkage into care

5. Some Examples of Previous HIV Testing Guidance

6. Extensive Guidance May Be Needed to Ensure Optimal Deployment Defining “Point Of Care”: Where, How, By Whom, For Whom? 1 Cost-effectiveness of POC Testing in Different Settings 3 Evaluating and Selecting New POC Technologies 2 Integrating POC into Lab Networks and Clinic Operations 4 Clinical Interpretation/New Patient Management Algorithms 5

7. What Is Required to Develop Normative Guidance on Point-Of-Care Testing? Consensus-based analysis of product utility Technical performance studies, clinical trials, implementation pilots, operational research and cost- effectiveness studies Evaluate different patient populations, test operators, clinical settings and deployment approaches Use evidence-based criteria Health system perspective Strengthening of regulatory frameworks on diagnostics

8. WHO Working Group The WHO has convened a Working Group to develop short and medium term product development priorities for HIV- related diagnostics The Group met in October 2011 and May 2012

9. WHO Working Group Collated expert consensus on ideal current platforms for: o Serological testing for HIV infection o Early diagnosis of HIV infection in infants o CD4 cell counting o HIV viral load testing o HIV drug resistance testing o Hepatitis B and C testing o Multiplex platforms (HIV + TB, syphilis, hepatitis) o Improvements in logistics (results transfer and sample collection) o Rapid diagnostic test readers

10. WHO Working Group Needs of patient care considered at five levels of health service delivery : o Community outreach setting o Primary care setting o District o Regional or provincial o National Priorities for generalized and concentrated epidemic settings considered separately 2 Meeting Reports Development of additional WHO guidance to be informed by relevant operational research

11. Conclusions Operational research is key to development of guidance Health system perspective is critical if deployment is to generate meaningful impact Efficiency of research needs to be maximized by data sharing, prevention of research duplication and strengthening of regulatory framework WHO Working Group will play an important role in the development of further guidance

12. Acknowledgements Trevor Peter, CHAI Colleagues at Mozambique’s Instituto Nacional de Saúde and Ministry of Health