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Quality issues

Dr Gaby Vercauteren

Essential Health TechnologiesWorld Health Organization

HIV/AIDS HIV/AIDS DIAGNOSTIC DIAGNOSTIC

SUPPORTSUPPORT

INCREASED ACCESS TO HIV ARV THERAPY ….

INCREASED ACCESS TO LABORATORY SERVICES …

BUT WHAT ABOUT QUALITY ?

Why is QUALITY of diagnostic support important?

BLOOD SAFETYSURVEILLANCE - prevalence, drug resistanceDIAGNOSIS - VCT, PMTCMONITORING - safety and efficacy of ARV therapyQUALITY OF CARE - opportunistic infections

Quality health care

Effective treatment

Diagnosis

Diagnostic testing is the entry Diagnostic testing is the entry point for provision of high point for provision of high quality, cost effective health carequality, cost effective health care

Provision of Quality Healthcare

This is only true

if the laboratory provides accurate and reliable results

HIV tests

CD4 counts

viral load

basic laboratory tests

QUALITY

The strategy

3. Capacity building

2. Affordable prices

1. Appropriate technology

4. Reliable laboratory systems

HDS

Appropriate technology

Evaluate the quality of HIV diagnostic tests

HIV test kits, whole blood, urine, saliva

Develop appropriate testing strategies for VCT services

Whole blood (fingerprick)

Appropriate technologyAppropriate technology

CD4 T-cell enumeration technologies: operational researchMulti centre evaluation of CD4 methods : • Panleucogating, • Cyflow green or counter (Partec). Guave• Dynabeads ( light microscope versus IF, different staining

solutions ), • Cytosphere, Sembio

Viral load tests:real time PCR, p 24 antigen tests dried blood spot

Novel technologiesEasyCount (back to drawing board), Dipstick CD4 Dipstick NAT tests (principle of concept supported)

Appropriate technologyAppropriate technology

WHO providing information on appropriate diagnostics for resource poor countriesFocus Focus -- resource limited settingsresource limited settings

•SIMPLICITY -- HIV cartridge testsHIV cartridge tests•HIGH QUALITY -- evaluated by WHOevaluated by WHO•APPROPRIATE -- no equipment or electricity requiredno equipment or electricity required•ESSENTIAL -- very useful in VCT and antenatal clinicsvery useful in VCT and antenatal clinics

Affordable prices

Access to commoditiesAccess to commodities

WHO Bulk Procurement list reviewed annually CONSIDERABLE SAVINGS

2004 list will include:- HIV tests - CD4 technologies - Viral Load tests- HIV DNA test (early detection neonates)

- Equipment + maintenance contracts - Sources and Prices 2004 documentProcurement and supply management guide

Capacity building

Guidelines for appropriate laboratory monitoring of ARV therapyTraining materials for CD4 and Viral Load testing Workshops on CD4 technologies are being conducted

2003: 2 workshop in Africa and 1 workshop in SEA region2004: 2 workshops in South America and WP region

Workshops on Viral load testing planned 2005Training for basic laboratory tests and diagnosis of opportunistic infectionsTraining in procurement and supplies managementTraining in maintenanceDevelop strategies for implementation of HIV/AIDS diagnostic support

Building capacity Building capacity

Strengthening clinical laboratory services

Screening for anaemiaBasic clinical laboratory tests including liver and renal function testsManagement of opportunistic infectionsQuality assurance and equipment maintenance (including microscopes)

Reliable laboratory systems

Implementation of Quality ManagementMonitor the quality of laboratory performance

EQAS for HIV testing Internal Quality Control Samples EQAS for CD4 measurements

QC for manual CD4 methods

Reference preparations HIV NAT testingQC samples for Viral Load tests

Reliable laboratory systemsReliable laboratory systems

Future perspectives

Scaling up diagnostic support related to VCTContinue to ensure safe blood through appropriate diagnosticsExpand bulk procurement scheme and supplies managementReinforce basic laboratory services, including laboratory monitoring of ARV therapy at district and centralized hospitalsScaling up activities related to HIVAIDS diagnostic support and laboratory issues

ACCURATE DIAGNOSIS - EFFECTIVE TREATMENT- QUALITY OF CARE

2004 2004 -- 2005 and beyond2005 and beyond

Conclusion:Conclusion:

Access to safe, appropriate Access to safe, appropriate and reliable laboratory and and reliable laboratory and diagnostic services are diagnostic services are essential to the provision ofessential to the provision ofquality health care,quality health care, which which ultimately leads to the ultimately leads to the reduction of poverty and to reduction of poverty and to economic developmenteconomic development