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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
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