1. Evaluation of Point-Of-Care CD4 and Toxicity Monitoring for Resource-Limited ART Clinic Settings in Mozambique Ilesh V. Jani 1, Nádia Sitoe 1, Patrina Chongo 1, Jorge Quevedo 2, Ocean Tobaiwa 2, Jonathan Lehe 2, Trevor Peter 2 1 Instituto Nacional da Saúde, Maputo, Moçambique 2 Clinton Health Access Initiative, Maputo, Moçambique INS

2. The Need for Point-Of-Care Diagnostics in Resource-Poor Settings Access to classical laboratory diagnosis is problematic due to limitations in funding, health systems, infrastructure and human resources. Scaling-up of medical services, such as anti-retroviral therapy (ART), is hampered by limited access to laboratory assays. Point-Of-Care type assays may provide a solution by increasing access to medical services and lowering inequities in health systems. INS

3. Selecting The Right Technology In Resource-Limited Settings CHALLENGES Limited capacity to perform formal evaluations Aggressive marketing Many technologies inappropriate for resource-limited settings Selection often based solely on cost Lack of standardized, objective selection criteria and evaluation protocols CHALLENGES Limited capacity to perform formal evaluations Aggressive marketing Many technologies inappropriate for resource-limited settings Selection often based solely on cost Lack of standardized, objective selection criteria and evaluation protocols SOLUTIONS Develop standard objective processes for identifying appropriate technology Pre-select promising technologies based on objective and quantitative criteria Perform technical evaluations to compare performance with existing methods SOLUTIONS Develop standard objective processes for identifying appropriate technology Pre-select promising technologies based on objective and quantitative criteria Perform technical evaluations to compare performance with existing methods

4. Reviewing the Market for CD4, Clinical Chemistry and Haematology Technologies 18 Technologies Feasible POC in Remote Non- Laboratory Settings Required Testing Parameters Local Availability Affordable Pricing 50 Technologies INS

5. Other Company Information 10% Testing Procedures 40% Reagents & Supplies 20% Technology Attributes 30% Heat and Humidity Type of Sample Tubes Need for Centrifuge Reagent & Control Preparation Expiration Period Reagent and Consumable Cost Internal Quality Control External Quality Control Daily Calibration Requirements Number of Steps in Procedure Type of Sample Required Precise Sample Measurement Requirements Batching Result Delivery Result Storage Instrument Connectivity Waste Generation Service and Maintenance Supply Chain and Distribution Timing & Regulatory Status Installation Description of technology and parameters Type of technology (disposable, handheld, tabletop) Technical Sophistication Mobility & Size Routine Maintenance Requirements Instrument Throughput Power Source Alternate Power Source Availability Capital Cost of Equipment Quantitative Review of 18 Technologies Based on Objective Criteria 30 Criteria Across 4 Categories

6. Quantitative Review of 18 Technologies Based on Objective Criteria

7. CD4+ T-Cell Counting PIMA (Alere) 3.38/5.00 Clinical Chemistry Reflotron (Roche Diagnostics) 3.89/5.00 Haematology HemoCue HB201+ (HemoCue) 4.17/5.00 High-Scoring Technologies Were Prioritized For Technical Evaluation INS

8. Evaluation of PIMA CD4 When Operated by Laboratory Technicians and Nurses (N=140)* PIMA CD4 (Capillary, Lab Tech) PIMA CD4 (Venous, Nurse) PIMA CD4 (Capillary, Nurse) INS * BD FACSCalibur as the reference method -313.5 to +257.4 -248.8 to +147.7 -219.0 to +97.0

9. Comparison of Capillary and Venous Blood for CD4+ T-Cell Counting on PIMA Limits Of Agreement BD FACSCalibur: -139.8 to +129.6 PIMA (nurses): -169.0 to +149.3 PIMA (lab techs): -159.9 to +147.4 Limits Of Agreement BD FACSCalibur: -139.8 to +129.6 PIMA (nurses): -169.0 to +149.3 PIMA (lab techs): -159.9 to +147.4 Replicate Testing on FACSCalibur (Venous) When Operated by Lab TechWhen Operated by Nurse

10. Evaluation of Reflotron (ALT) When Operated by Laboratory Technicians and Nurses (N=140)* Bias Lab Tech: -4.8 IU/L Nurse: -0.2IU/L Limits of Agreement Lab Tech: -35.6 to +25.9 IU/L Nurse: -10.5 to +10.0 IU/L Bias Lab Tech: -4.8 IU/L Nurse: -0.2IU/L Limits of Agreement Lab Tech: -35.6 to +25.9 IU/L Nurse: -10.5 to +10.0 IU/L * Selectra Junior as the reference method Reflotron (Capillary, Lab Tech)Reflotron (Capillary, Nurse) INS

11. Evaluation of HemoCue When Operated by Laboratory Technicians and Nurses (N=100)* Bias Lab Tech: +0.395 g/dL Nurse: +0.950 g/dL Limits of Agreement Lab Tech: -1.504 to +2.294 g/dL Nurse: -0.825 to +2.724 g/dL Bias Lab Tech: +0.395 g/dL Nurse: +0.950 g/dL Limits of Agreement Lab Tech: -1.504 to +2.294 g/dL Nurse: -0.825 to +2.724 g/dL * Sysmex SF3000 as the reference method INS HemoCue (Capillary, Lab Tech)HemoCue (Capillary, Nurse)

12. –The review process based on quantitative scoring of laboratory technologies (despite its limitations), is a useful approach when selecting technologies for evaluation. –All three Point-Of-Care technologies that were formally evaluated in Mozambique performed to the same standard as conventional CD4, clinical chemistry, and haematology instruments. –These Point-Of-Care technologies can be used by nurses (and perhaps other non-laboratory personnel) in primary health care settings. –Training on capillary blood collection is an important issue to be considered when implementing some of the Point-Of-Care technologies. Conclusions INS

13. Next Steps Pilot implementation in 7 sites in Mozambique (Abstract FRLBE101) Measure impact of implementation on patient important outcomes Measure impact on the health system Perform cost-efficiency analysis Investigate needs (e.g. human resources) for large-scale implementation of Point-Of-Care type technologies INS

14. Acknowledgements Patients Provincial Health Directorates (Maputo City, Maputo Province, Sofala, Niassa) Staff at Health Centres and Pilot Sites INS Staff CHAI Staff MSF-Belgium MSF-Switzerland ARK UNITAID

15. ? CD4 Hb ALT Glu Viral Load HIV HBV HCV ? A Glimpse into the Future: the Busy Life of Non-Laboratory Staff Which one was it?