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Center for Innovation in Global Health Technologies
Industry
Academia
Philanthropy
Key Contributions: • Technology, Manufacturing, Regulatory,
Distribution, Current Partners:
Key Contributions: • Project Coordination, New Technology, Market Research and
Product Development, Field Experience Current Partners: • McCormick School of Engineering – Center for Innovation in
Global Health Technology (CIGHT) • Kellogg School of Management – Global Health Initiative (GHI) • Feinberg School of Medicine
Key Contributions: • R&D Funding, Mission,
Field Experience Partners:
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Northwestern Global Health Foundation
¡ Researches markets ¡ Funds technology transfer ¡ Contracts with device manufacturers ¡ Conducts field evaluations ¡ Supports and services products
Non-profit distributor of medical devices in developing world
Need for point-of-care
early infant HIV diagnostic, EID
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¡ 1.4 million infants were born to HIV-positive women in 2007 ¡ 390 thousand infants infected ¡ If not diagnosed and started on antiretroviral therapy,
35% of infected infants will die by age 1 year, 52% by age 2
¡ 2.8 million adjusted life years could be saved annually assuming 100% sensitivity and availability of ART
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National and Private Hospitals & Reference Lab, Research
Institute
Regional or Provincial Hospital
District Hospital /
Urban Hospitals
County Hospital
Outreach Programs
Rural Health Care Center or VCT
Level:
Testing sites in the developing world
Source: 2008 Kellogg field research
EID test volumes in Uganda
Tests per Day per Facility
% o
f all
test
s
Cum
ulat
ive
%
• Across health facilities, test volumes ranged from 1 to 14 tests per day
• Overall, health facilities had a median volume of 1 test per day (IQR:1, 2)
• 96.8% of all tests performed took place on days where the facility performed 5 tests or less
Uganda Daily Testing Analysis
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¡ Obtain plasma without centrifuge ¡ Disrupt immune complex ¡ Add liquids without pipets ¡ Detect pM concentrations of p24 antigen ¡ Turnaround time < 1 hr. ¡ Function in ambient temperatures > 40C ¡ Send results to central lab
Technical challenges
Effects of heat shock
¡ Disrupts antibody -antigen complex
¡ 90-95 °C for 5 min required for high avidity patients
¡ p24 antigen refolds, epitopes of test antibodies intact
¡ Gel forms in specimens with high IgG levels
ICA components
• Antibody coated carbon nanoparticles • Biotinylated capture antibody • SA on capture line • Anti-mouse IgG on control line • pM limit of detection
p24 antigen ICA clinical performance
¡ 389 samples tested in NHLS lab in Cape Town South Africa ¡ 24 (6.2%) were positive by PCR ¡ p24 antigen ICA detected 23 for
sensitivity of 95.8% (95% confidence limits: 79.8 – 99.3%) ¡ 2 false positives for specificity of 99.4% (95% CI: 98.0 –
99.8%), ¡ Turnaround time 45 min.
p24 antigen correlation with viral load
¡ 18 samples tested with viral loads 345 to 2 million ¡ All samples positive except the 3 with the lowest viral loads ¡ Lowest viral load detected was 6,580 copies/ml
Global temperature ranges
Timbuktu, Mali http://www.world66.com/africa/mali/timbuktu/lib/climate
-20
-10
0
10
20
30
40
J F M A M J J A S O N D
Lhasa, Tibet http://www.asia-planet.net/china/temperature2.htm
Communicate with central lab
• Cellular modem with SIM card • Push buttons to enter P, N, I • Results stored in flash memory • Phones lab at pre-scheduled time • Transmits results
Kenya planned communica2ons network
Roche CAP/CTM Analyzer(EID and Viral Load)
Online SQL database on Server rendered by PHP to any web browser
Health Facility: USSD/ SMS Query for test results
Health Facility: PCs accessing data over the Internet
PC software controlling the analyzer
Becton Dickenson FACSCalibur for CD4 testing
SYSMEX Hematology analyzer
Reference Laboratories
Health Facility: GSM Printers on GPRS or SMS
EMR Patient test results
p24 plans
¡ Transfer production to contract manufacturers ¡ Test in Mozambique & Malawi clinics 3rd quarter
FDA export certificate required ¡ Conduct studies in Zambia, Uganda, Kenya, Nigeria, India ¡ Develop test strip reader
Need for point-of-care HIV viral load monitor
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¡ 34M people living with AIDS ¡ 23M in sub-Saharan Africa ¡ 15M in need of anti-retroviral therapy ¡ 6.6M receiving ART
Need for point-of-care
TB diagnostic
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¡ 8.8M new TB cases in 2010 ¡ 22 high burden countries ¡ Multi-drug resistant, MDR ¡ Extensively drug-resistant XDR
¡ Viral load PCR detection limit HIV VL 50c/ml ¡ Viral load precision to monitor changes ¡ Obtain plasma without centrifugation ¡ TB culture detection limit 10 cfu/ml ¡ Safe handling of TB sputum specimens ¡ Workloads in large treatment clinics ¡ TB turnaround time < 1 hr ¡ HIV turnaround time < 2 hrs
NAT Technical Challenges