Point-Of-Care Testing: How Do We Go About Developing Normative Guidance?

1. Point-Of-Care Testing: How Do We Go About Developing Normative Guidance? Ilesh V. Jani, MD PhD Instituto Nacional de Saúde Maputo, Mozambique

2. The Pipeline of HIV-Related Point-Of-Care Tests is Growing Viral detection Examples: 2012 2017 2013 2015 2016 2014 CD4 test Examples: 2014 0 2013 2012 2009 2010 2011

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

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: • Serological testing for HIV infection • Early diagnosis of HIV infection in infants • CD4 cell counting • HIV viral load testing • HIV drug resistance testing • Hepatitis B and C testing • Multiplex platforms (HIV + TB, syphilis, hepatitis) • Improvements in logistics (results transfer and sample collection) • Rapid diagnostic test readers

10. WHO Working Group • Needs of patient care considered at five levels of health service delivery : • Community outreach setting • Primary care setting • District • Regional or provincial • 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