1. Technical and Operational Considerations for Scaling Up
HIV Viral Load Testing
John Nkengasong, PhD
Associate Director for Laboratory Sciences &
Chief, International Laboratory Branch
Division of Global HIV/AIDS
CDC , Atlanta, Georgia
Center for Global Health
Division of Global HIV/AIDS

3. Phased Implementation of
Viral Load Testing
Phase I: Planning
Policies and Leadership
Harmonization
Algorithm
Mapping and Forecasting
Assess Capacity
Costing
Specimen and Product Selection Equipment Procurement
Phase II: Scale Up
Phase In
Human Resources
Training and Supervision
Quality Management System
Phase III: Sustainability
Partner Harmonization
M&E
Data Collection
Operational Research

4. Phase I: Planning Policies and Leadership Harmonization Algorithm
Mapping and Forecasting
Assess Capacity
Costing
Specimen and Product Selection
Equipment 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 Referral
Key Elements for Viral Load Networks
Sustain Program Implementation
Equipment
Information Management Systems
Quality Management Systems
M & E
Technology Evaluation
Policy & Strategic Planning and Coverage
Impact 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 ASSAY
Sensitivity (mean %)
Specificity (mean %) n
Abbott Molecular: Abbott RealTime HIV-1 (manual, m24sp and m2000sp) assays with m2000rt platform 95 92
1529
Biocentric: Generic HIV Charge Virale 55
531
bioMérieux: NucliSENS EasyQ® HIV-1 v2.0 84
1062
Roche Molecular Systems: COBAS® AmpliPrep/Taqman® HIV-1 Test, Version 2.0 [free virus elution protocol] 81 97
229
Siemens VERSANT® HIV-1 RNA 1.0 Assay (kPCR) 91 88
144

8. Advantage of Using Plasma or DBS for Viral Load Testing
Plasma Specimens
Gold standard to determine viral failure
Requires stringent processing and storage conditions
Accurate on all platforms
DBS Specimens
Easy preparation using whole blood
Minimal transportation requirements; not considered biohazardous
Not as time and temperature sensitive as whole blood or plasma

9. Technologies for Scaling Up Viral Load Networks
Key Messages
Options for viral load scale up
Selection criteria
Impact of point-of-care technologies
Dried blood spots
Centralized platforms
Point 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 control
Continual training and competence assessment
Quality managers
Data quality checks
Monitoring and evaluation system

12. Phase III: Sustainability Partner Harmonization
M&E
Data Collection
Operational Research

13. Harmonization Among Partners
Coordination among all stakeholders
Harmonize existing capacity
Streamlined efforts
Joint targeted support

14. Concluding Remarks
Developing a robust and sustainable HIV viral load testing network involves:
Leadership of Ministries of Health
Systematic approach for implementing viral load networks (Phases I-III)
Critical role of partnerships
A sustainable viral load network improves: patient outcome, treatment adherence, and viral load suppression.