Evaluation of Point-Of-Care CD4 and Toxicity
Monitoring for Resource-Limited ART Clinic
Settings in Mozambique
Ilesh V. Jani1, Nádia Sitoe1, Patrina Chongo1,
Jorge Quevedo2, Ocean Tobaiwa2,
Jonathan Lehe2, Trevor Peter2
1Instituto
Nacional da Saúde, Maputo, Moçambique
2Clinton Health Access Initiative, Maputo, Moçambique
INS
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
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
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
Reviewing the Market for CD4, Clinical
Chemistry and Haematology Technologies
50 Technologies
Feasible POC in
Remote NonLaboratory Settings
Required Testing
Parameters
Local Availability
Affordable
Pricing
18
Technologies
INS
Quantitative Review of 18 Technologies
Based on Objective Criteria
• Description of technology and
parameters
• Type of technology (disposable,
handheld, tabletop)
• Technical Sophistication
• Mobility & Size
• 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
• Routine Maintenance Requirements
• Instrument Throughput
• Power Source
• Alternate Power Source Availability
• Capital Cost of Equipment
Technology
Attributes
30%
Reagents
&
Supplies
20%
Testing
Procedures
40%
Other
Company
Information
10%
30 Criteria
Across 4
Categories
• Heat and Humidity
• Type of Sample Tubes
• Need for Centrifuge
• Reagent & Control
Preparation
• Expiration Period
• Reagent and Consumable
Cost
• Service and Maintenance
• Supply Chain and
Distribution
• Timing & Regulatory
Status
• Installation
Quantitative Review of 18 Technologies
Based on Objective Criteria
High-Scoring Technologies Were Prioritized
For Technical Evaluation
• 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
INS
Evaluation of PIMA CD4 When Operated by
Laboratory Technicians and Nurses (N=140)*
PIMA CD4 (Capillary, Lab Tech) PIMA CD4 (Capillary, Nurse)
-248.8 to +147.7
-313.5 to +257.4
PIMA CD4 (Venous, Nurse)
-219.0 to +97.0
* BD FACSCalibur
as the reference
method
INS
Comparison of Capillary and Venous Blood
for CD4+ T-Cell Counting on PIMA
When Operated by Lab Tech
When Operated by Nurse
Replicate Testing on FACSCalibur (Venous)
• 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
Evaluation of Reflotron (ALT) When Operated by
Laboratory Technicians and Nurses (N=140)*
Reflotron (Capillary, Lab Tech) Reflotron (Capillary, Nurse)
• Bias
• Lab Tech: -4.8 IU/L
• Nurse: -0.2IU/L
* Selectra Junior as
the reference
method
• Limits of Agreement
• Lab Tech: -35.6 to +25.9 IU/L
• Nurse: -10.5 to +10.0 IU/L
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Evaluation of HemoCue When Operated by
Laboratory Technicians and Nurses (N=100)*
HemoCue (Capillary, Lab Tech) HemoCue (Capillary, Nurse)
• Bias
• Lab Tech: +0.395 g/dL
• Nurse: +0.950 g/dL
* Sysmex SF3000 as
the reference
method
• Limits of Agreement
• Lab Tech: -1.504 to +2.294 g/dL
• Nurse: -0.825 to +2.724 g/dL
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Conclusions
– 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.
INS
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
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
A Glimpse into the Future:
the Busy Life of Non-Laboratory Staff
?
?
CD4
Which one was it?
Viral Load
Hb
HIV
HBV
HCV
ALT
Glu