Presentation on theme: "Technical and Operational Considerations for Scaling Up"— Presentation transcript:
1 Technical and Operational Considerations for Scaling Up HIV Viral Load TestingJohn Nkengasong, PhDAssociate Director for Laboratory Sciences &Chief, International Laboratory BranchDivision of Global HIV/AIDSCDC , Atlanta, GeorgiaCenter for Global HealthDivision of Global HIV/AIDS
3 Phased Implementation of Viral Load TestingPhase I: PlanningPolicies and LeadershipHarmonizationAlgorithmMapping and ForecastingAssess CapacityCostingSpecimen and Product Selection Equipment ProcurementPhase II: Scale UpPhase InHuman ResourcesTraining and SupervisionQuality Management SystemPhase III: SustainabilityPartner HarmonizationM&EData CollectionOperational Research
4 Phase I: Planning Policies and Leadership Harmonization Algorithm Mapping and ForecastingAssess CapacityCostingSpecimen and Product SelectionEquipment Procurement
5 Developing an Algorithm for Monitoring Viral Load• Frequency of viral load testing• Definition of viral failure• Repeat testing with viral failure• Specimen type• Population-specific testing algorithms• Projected number of people on ART
6 Framework for Developing a Sustainable Viral Load Network Specimen ReferralKey Elements for Viral Load NetworksSustain Program ImplementationEquipmentInformation Management SystemsQuality Management SystemsM & ETechnology EvaluationPolicy & Strategic Planning and CoverageImpact on Patient Monitoring, Treatment Adherence, and Viral Load Suppression
7 Performance Characteristics of DBS Viral Load Testing by Different Platforms [at 1000 Copies/mL]VIRAL LOAD ASSAYSensitivity (mean %)Specificity (mean %)nAbbott Molecular: Abbott RealTime HIV-1 (manual, m24sp and m2000sp) assays with m2000rt platform95921529Biocentric: Generic HIV Charge Virale55531bioMérieux: NucliSENS EasyQ® HIV-1 v2.0841062Roche Molecular Systems: COBAS® AmpliPrep/Taqman® HIV-1 Test, Version 2.0 [free virus elution protocol]8197229Siemens VERSANT® HIV-1 RNA 1.0 Assay (kPCR)9188144
8 Advantage of Using Plasma or DBS for Viral Load Testing Plasma SpecimensGold standard to determine viral failureRequires stringent processing and storage conditionsAccurate on all platformsDBS SpecimensEasy preparation using whole bloodMinimal transportation requirements; not considered biohazardousNot as time and temperature sensitive as whole blood or plasma
9 Technologies for Scaling Up Viral Load Networks Key MessagesOptions for viral load scale upSelection criteriaImpact of point-of-care technologiesDried blood spotsCentralized platformsPoint of care
10 Phase II: Scale Up Phase In Human Resources Training and Supervision Quality Management System
11 Quality Management System for Viral Load Networks Proficiency testing and quality controlContinual training and competence assessmentQuality managersData quality checksMonitoring and evaluation system
12 Phase III: Sustainability Partner Harmonization M&EData CollectionOperational Research
13 Harmonization Among Partners Coordination among all stakeholdersHarmonize existing capacityStreamlined effortsJoint targeted support
14 Concluding RemarksDeveloping a robust and sustainable HIV viral load testing network involves:Leadership of Ministries of HealthSystematic approach for implementing viral load networks (Phases I-III)Critical role of partnershipsA sustainable viral load network improves: patient outcome, treatment adherence, and viral load suppression.
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