Point-Of-Care Testing: How Do We Go About

Developing Normative Guidance?

Ilesh V. Jani, MD PhD

Instituto Nacional de Saúde

Maputo, Mozambique

The Pipeline of HIV-Related Point-Of-Care Tests is Growing

2010 2011 2012 2013

2014

2009 0

2012 2013 2014 2015 2016 2017

Viral detection Examples:

CD4 test Examples:

Evidence of the Impact of Some Point-Of-Care Tests in Pilot Studies is Also Mounting

Source: Jani et al (2011)

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 settingsAppropriate usage of test results and linkage into care

Some Examples of Previous HIV Testing Guidance

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 Settings3

Evaluating and Selecting New POC Technologies2

Integrating POC into Lab Networks and Clinic Operations4

Clinical Interpretation/New Patient Management Algorithms5

What Is Required to Develop Normative Guidance on Point-Of-Care Testing?

Consensus-based analysis of product utilityTechnical 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 criteriaHealth system perspectiveStrengthening of regulatory frameworks on diagnostics

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

WHO Working Group

Collated expert consensus on ideal current platforms for:o Serological testing for HIV infectiono Early diagnosis of HIV infection in infantso CD4 cell countingo HIV viral load testingo HIV drug resistance testingo Hepatitis B and C testingo Multiplex platforms (HIV + TB, syphilis, hepatitis)o Improvements in logistics (results transfer and sample

collection)o Rapid diagnostic test readers

WHO Working Group

Needs of patient care considered at five levels of health service delivery : o Community outreach settingo Primary care settingo Districto Regional or provincialo National

Priorities for generalized and concentrated epidemic settings considered separately

2 Meeting ReportsDevelopment of additional WHO guidance to be informed

by relevant operational research

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

Acknowledgements

Trevor Peter, CHAIColleagues at Mozambique’s Instituto Nacional de

Saúde and Ministry of Health