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Field ExperiencesAccordia Global Health Foundation,
Infectious Diseases Institute
September 17, 2010
Accordia Global Health Foundation
• Bring together global resources to
fight infectious disease in Africa
• Strengthen in-country capabilities to
offer health training, research,
prevention, and care
• Create evidence-based models that
are immediately relevant in resource-
limited settings and can be replicated
throughout Africa
Infectious Diseases Institute
• Established in 2004
• Public Private Partnership (Makerere
University owned NGO) with major
support from Pfizer
• 3 major programs: Research,
Training, Prevention Care Treatment
• CAP certified core laboratory
• Translational diagnostics laboratory
The Continuum: Diagnostics Research to Practice
Research (Rapid, POC, new
products)
Clondiag CD4Urinary LAM
TB Diagnostics
Impact(On-site
supervision)
Monitoring & evaluation
Rx consistent with national policy
Core Lab Validation
Validation against other known
approved test
Testing methodology (sequential vs
parallel)
Quality Management Plan
(QA/QC)Sustainability
Outcomes(Field
Implementation)
Team approach to malaria case management
Rational use of lab testing
Diagnosis based medical
management (rational drug use)Accountability for
outcomes (surveillance & data
management)
Research: PIMA CD4 Point-of Care Testing
• Absolute CD4 in whole blood
• Cartridge: integrated capillary for
5 µl blood, dried reagents
• Disposable, no instrument contact
with blood
• Portable size, battery pack
Diagnostic Research Trial at IDI
• Venous PIMA vs
venous FACScaliber
• PIMA consistently
slightly lower, but
good agreement
(Passing-Bablok)
Diagnostic Research Trial at IDI• Capillary PIMA vs
venous FACScaliber
• PIMA consistently
slightly lower, outliers
(Passing-Bablok)
• Method correlation 0.93
• Mean bias -68.5 cell/µL
ranging from -12.2 (for
the 0-200 cell/µL
range) to -121.7 cell/µL
(for the >500 cell/µL
range)
Diagnostic Research Trial at IDI
• Capillary PIMA vs venous PIMA (Bland Altman)
Diagnostic Research Trial at IDI
• Capillary PIMA vs
venous PIMA
• Capillary PIMA with
more frequent
outliers (Passing-
Bablok)
• Led to modification
of the EDTA and
capillary part of the
cartridge
Lateral Flow Urinary LAM TB Diagnostic
• Results in 25 minutes
• ELISA results promising in smear(-), HIV(+),
CD4<200 cells/µl (problematic population)
• Urine based, non-invasive
• Room temperature storage, easy transport
• Individualized foil strip packaging
• Inbuilt procedural control
Research: Urinary LAM Test Procedure
• 500 TB suspects
diagnostic trial just initiated
at IDI
• Broad definition of TB
suspect in HIV(+) (fever,
weight loss)
• Comparison to ELISA LAM
and TB sputum and blood
culture gold standards
The Continuum: Research to Practice
Research (Rapid, POC, new
products)
Clondiag CD4Urinary LAM
TB Diagnostics
Impact(On-site
supervision)
Monitoring & evaluation
Rx consistent with national policy
Core Lab Validation
Validation against other known
approved test
Testing methodology (sequential vs
parallel)
Quality Management Plan
(QA/QC)Sustainability
Outcomes(Field
Implementation)
Team approach to malaria case management
Rational use of lab testing
Diagnosis based medical
management (rational drug use)Accountability for
outcomes (surveillance & data
management)
• Makerere University-Johns Hopkins University
collaboration since 1989
• Supports clinical trials
• College of American Pathologists certified as well
as UK NEQAS, VQA
• 40 qualified professionals
• Validation of all tests offered on test menu
MU-JHU Clinical Core Lab
• Parallel vs sequential HIV rapid testing
• Validation of all tests offered on test menu
• Maintains a high QA/QC standard with continuous
quality improvement
• Sustainable model for high quality lab testing
– Cost per test includes technical cost, reagent, supply
chain, management, QA/QC, and capital replacement
– Not for profit
MU-JHU Clinical Core Lab
Elbireer et al. Lab Medicine 2010 41:429-433
MU-JHU Clinical Core Lab
MLO Lab of the Year 2010: First Runner Up
The Continuum: Research to Practice
Research (Rapid, POC, new
products)
Clondiag CD4Urinary LAM
TB Diagnostics
Impact(On-site
supervision)
Monitoring & evaluation
Rx consistent with national policy
Core Lab Validation
Validation against other known
approved test
Testing methodology (sequential vs
parallel)
Quality Management Plan
(QA/QC)Sustainability
Outcomes(Field
Implementation)
Team approach to malaria case management
Rational use of lab testing
Diagnosis based medical
management (rational drug use)Accountability for
outcomes (surveillance & data
management)
Outcomes: Joint Ugandan Malaria Program
• Accordia initiative with financial
support from ExxonMobil
• Partnership beginning 2006
– IDI, Uganda Malaria Surveillance Project
(UMSP), MU-UCSF malaria Research
collaboration, National Malaria control
program of Ministry of Health
JUMP
• Integrated management
• On-site training
• Team approach (clinicians, lab and records staff)
• Training on smear microscopy and rapid diagnostic
tests for fever
• Test diagnosis-based targeted treatment
• Avoids misdiagnosis, overuse of antimalarials, and
delays in treatment of other illnesses
Akokoro
Omugo
KasambyaIganga
WalukubaKyenjojo
Kabale
Nagongera
Kiryandongo
Kamwezi
KIhihi
Aboke
Apac
Aduku
Aber
BuwengeMukujju
Mulanda
Bugembe
Ogur
Amac
AlebtongAnyeke
Orum
Kibalinga & Butawata HCII
Wakitaka & Megamaga
Paya & Kisoko HCW
KisoroDistrict HCW
Rukungiri District HCIIs
OliAdumi
Aroi
NebbiPakwach
St Paul
Kilembe
Exxon Cascade IMM sitesExxon RDT sites
Exxon IMM Sites trained at IDI
PMI IMM Sites trained at IDI
IDRC RDT sitesWHO RDT sites
The whole district
The whole districtWas trained The whole
district was trained
The Continuum: Research to Practice
Research (Rapid, POC, new
products)
Clondiag CD4Urinary LAM
TB Diagnostics
Impact(On-site
supervision)
Monitoring & evaluation
Rx consistent with national policy
Core Lab Validation
Validation against other known
approved test
Testing methodology (sequential vs
parallel)
Quality Management Plan
(QA/QC)Sustainability
Outcomes(Field
Implementation)
Team approach to malaria case management
Rational use of lab testing
Diagnosis based medical
management (rational drug use)Accountability for
outcomes (surveillance & data
management)
Impact: JUMP On-Site Follow-Up
• Developed a monitoring and evaluation system that
demonstrates the impact of training and capacity
building on improved case management for malaria at
health facility level
• Improved surveillance systems and data collection in
the target health facilities.
• QA/QC for 45 Districts by 2013
Impact: JUMP On-Site Follow-Up
Indicator Baseline 6 wks ARR(CI) 12 wks ARR(CI)
Proper Hx 20% 42% 1.41
(0.48-2.35)
60% 2.71
(1.54-3.88)
Proper PE 18% 57% 1.94
(1.18-2.71)
82% 3.28
(2.30-4.26)
Correct Dx 47% 96% 3.41
(2.03-4.78)
97% 3.66
(2.05-5.26)
C/W Nat’l
Policy
42% 86% 2.27
(1.51-3.05)
92% 2.96
(1.94-3.97)
Adequate pt
education
17% 83% 4.36
(2.71-6.02)
87% 4.68
(2.92-6.44)
Impact: JUMP On-Site Follow-Up
Indicator Baseline 6 wks 12 wks
%BS prepared correctly 22% 67% 63%
%BS read correctly 49% 71% 70%
%(+)BS read correctly 49% 71% 70%
%(-)BS read correctly 72% 77% 91%
Ssekabira Am J Trop Med Hyg, Dec 2008; 79: 826 - 833
Impact of RDT training intervention
on antimalarial prescribing
*Generalized estimating equations controlling for history of fever and age, adjustment for repeated measures on the same day.
Site
Relative change in proportion of
patients prescribed antimalarialAntimalarial
doses saved per
1000 patientsRR (95% CI)* p-value
Mubende 0.32 (0.29 – 0.36) <0.001 420
Jinja 0.44 (0.39 – 0.50) <0.001 358
Tororo 0.73 (0.70 – 0.77) <0.001 183
Conclusions: Diagnostics Research to Practice
• Accordia Global Health Foundation through the IDI has
participated in the continuum of diagnostics from
research, clinical core lab validation and field
implementation.
• Innovative post-training on-site supervision has led to
sustainable, high quality testing that influences clinical
decision making
• Has moved empiric algorithm-based treatment to rapid
test-confirmed diagnoses with targeted treatment
Acknowledgements
• IDI /Accordia
• Alex Coutinho, ED IDI
• Carol Spahn, ED Accordia
• Lydia Mpanga Sebuyira
• Umaru Ssekabira
• Kelly Willis
• MU-JHU Core laboratory
• Clondiag – Ralf Lalburger
• TB-CDRC – Jerrold Ellner, Susan Dorman