John Nkengasong, PhDAssociate Director for Laboratory Sciences &

Chief, International Laboratory BranchDivision of Global HIV/AIDS

CDC , Atlanta, Georgia

Technical and Operational Considerations for Scaling Up

HIV Viral Load Testing

Center for Global Health

Division of Global HIV/AIDS

Phased Implementation of Viral Load Testing

Phase I: PlanningPolicies and Leadership

Harmonization Algorithm

Mapping and Forecasting Assess Capacity

Costing Specimen and Product Selection

Equipment Procurement

Phase II: Scale UpPhase In

Human Resources Training and Supervision

Quality Management System

Phase III: SustainabilityPartner Harmonization

M&E Data Collection

Operational Research

Policies and Leadership

Harmonization

Algorithm

Mapping and Forecasting

Assess Capacity

Costing

Specimen and Product Selection

Equipment Procurement

Phase I: Planning

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

Framework for Developing a Sustainable Viral Load Network

Key E

lem

ents

for

Vir

al Lo

ad

Netw

ork

s

Impact on Patient Monitoring, Treatment Adherence, and Viral Load Suppression

Equipment

Information Management Systems

Quality Management Systems

M & E

Technology Evaluation

Policy & Strategic Planning and Coverage

Specimen ReferralSusta

in P

rog

ram

Imple

menta

tion

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 95 55 531

bioMérieux: NucliSENS EasyQ® HIV-1 v2.0 84 95 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

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

Technologies for Scaling Up Viral Load Networks

Key Messages

• Options for viral load scale up

• Selection criteria

• Impact of point-of-care technologies

Centralized platforms

Dried blood spots

Point of care

Phase II: Scale Up

Phase In

Human Resources

Training and Supervision

Quality Management System

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

Phase III: Sustainability

Partner Harmonization

M&E

Data Collection

Operational Research

Harmonization Among Partners

• Coordination among all stakeholders

• Harmonize existing capacity

• Streamlined efforts

• Joint targeted support

Concluding Remarks

• Leadership of Ministries of Health

• Systematic approach for implementing viral load networks (Phases I-III)

• Critical role of partnerships

Developing a robust and sustainable HIV viral load testing network involves:

A sustainable viral load network improves: patient outcome, treatment adherence, and viral load suppression.