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Evaluation and implementation of rapid HIV tests: the
experience in eleven African countries
Dr. Stefan WiktorChief, Surveillance and Infrastructure Development Branch
Global AIDS ProgramCDC/HHS
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Adults and children estimated to be living Adults and children estimated to be living with HIV/AIDS - 2004with HIV/AIDS - 2004
Total: 34 – 46 million
Western Europe520 000 – 680
000North Africa &
Middle East470 000 – 730
000Sub-Saharan Africa25.0 – 28.2 million
Eastern Europe & Central Asia1.2 – 1.8 million
South & South-East Asia4.6 – 8.2 million
Australia & New Zealand
12 000 – 18 000
North America790 000 – 1.2 million
Caribbean350 000 – 590
000Latin America
1.3 – 1.9 million
East Asia & Pacific700 000 – 1.3
million
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World Bank Multi-country AIDS Program (MAP)
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President’s Emergency Plan for AIDS Relief
• Announced January 28, 2003
• 15 focus countries• Goals:
Prevent 7 million new HIV infections
Treat 2 million HIV-infected people
Provide care for 10 million HIV-infected people and AIDS orphans
Overall budget for global AIDS: $15 billion over 5 years ($10 billion new money, including $1billion for Global Fund)
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HaitiHaiti
GuyanaGuyana
Côte d’IvoireCôte d’Ivoire
NigeriaNigeria
EthiopiaEthiopia
KenyaKenya
UgandaUganda
RwandaRwanda
TanzaniaTanzania
MozambiqueMozambique
ZambiaZambia
South AfricaSouth Africa
BotswanaBotswana
NamibiaNamibia
President’s Emergency Plan for AIDS Relief15 Focus Countries
Vietnam added 7/04
Vietnam added 7/04
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The role of HIV testing to meet the goals of the Emergency Plan
• Massive scale-up of testing capacity needed: 30-100 million persons tested
• Broad range of testing sites with personnel of varying levels of training/experience
• Lack of infrastructure or environment for quality assurance
• CDC-GAP focus on expanding access to HIV testing with focus on rapid tests
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Emergency Plan strategy to improve access and quality of rapid HIV
testing• Facilitate procurement• Develop guidelines• Strengthen/develop national reference
laboratory Advocacy Renovations, equipment Technical assistance External quality assurance
• Provide training – WHO/CDC rapid HIV test curriculum
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HIV testing is expanding rapidly(Number of HIV tests performed in CDC/GAP supported programs)
0
0.5
1
1.5
2
2.5
2002 2003 2004
# H
IV t
est
s (m
illiio
ns)
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HIV testing is expanding rapidly(Number of CDC/GAP supported sites qualified to perform HIV
testing)
0
200
400
600
800
1000
1200
1400
1600
1800
2000
2002 2003 2004
No.
of
site
s
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WHO-AFRO/HHS-CDC/APHL GuidelinesFor AppropriateEvaluations of HIV Testing Technologiesin Africa
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Steps to in-country rapid HIV test evaluation and implementation
Serum panel: Collect, characterize, store
Evaluate tests, select 2-or-3 test algorithm
Pilot testing algorithm in testing sites
EQA and ongoing monitoring of testing
Phase I
Phase II
Phase III
National Reference Lab
Point-of-service site
National Reference Lab/Point of service site
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Evaluation and implementation of rapid HIV tests in 11 African countries
Côte d’IvoireCôte d’Ivoire
EthiopiaEthiopia
KenyaKenyaUgandaUganda
RwandaRwanda
TanzaniaTanzania
MozambiqueMozambique
BotswanaBotswanaNamibiaNamibia
SenegalSenegal
AngolaAngola
• Country contacts identified – working group created
• Questionnaire administered concerning evaluations: Process Results Implementation
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Rapid HIV tests evaluated
• Determine• Delta HIV ½• Doublecheck • Genie II• Hema-Strip• Hexagon• HIV Spot• ImmunComb• Instant CHEK
• InstantScreen Rapid• MultiSpot• Oraquick• Sero-Strip• Swift• Stat-Pak• UniGold• Virocheck
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Phase I evaluations
• Conducted in national reference or hospital laboratories
• Serum panels created: Median 506 samples (range 51-2000) Median HIV prevalence 38% (range 14-78%)
• Median duration 6 months (range 2-26 months)
• Results: Median sensitivity >99% for 12 tests Median specificity >99% for 14 tests
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Median sensitivity of rapid HIV tests in evaluations conducted in central reference
laboratories in 11 African countries
90919293949596979899
100
Perc
ent
11 11 10
10 6# of evals: 3 3 2 2
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Median specificity of rapid HIV tests in evaluations conducted in central reference
laboratories in 11 African countries
90919293949596979899
100
Perc
ent
11 11 10
10 6# of evals: 3 3 2 2
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Phase II evaluations
• Conducted in variety of settings (VCT, blood donation centers, hospitals)
• Whole-blood samples; on-site testing with repeat testing at reference laboratory
• Median 566 samples (range 209-3,791)
• Results comparable to Phase I evaluations
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Phase III: status of rapid HIV test implementation
• National algorithm selected in 10 countries: Serial algorithm - 6 countries Parallel algorithm - 4 countries Screening: Determine and Unigold – 7 countries Tie-breaker or retesting
• External quality assurance – 6 countries Site visits Retesting of specimens at reference laboratory External proficiency testing (Zimbabwe)
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Phase III: Status of rapid test implementation, 2003
Country Sites # Persons tested
Angola 13 VCT, 3 TB, hospitals 15,000 (VCT)
Botswana 16 VCT 51,000
Ethiopia VCT, blood bank N/A
Kenya 200 VCT, 50 PMCT, blood bank 315,000
Ivory Coast 27 PMCT, 6 VCT, 2 hospitals 93,000
Mozambique
85 blood bank, 66 VCT, 14 PMCT 130,000
Rwanda VCT, PMCT (60 total) 132,000
Senegal 6 VCT 4,700
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External quality assurance: comparison of results of on-site rapid HIV testing with central laboratory
EIA/WB testing
50
60
70
80
90
100
Botswana Kenya Rwanda Zimbabwe
Per
cent
conco
rdan
ce
Concordance positive Concordance negative
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Conclusions
• Testing needs are huge• HIV testing is scaling up rapidly • HIV rapid tests work• Testing is conducted in variety of
sites by persons with varying levels of experience
• Quality assurance: a major and growing challenge
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Acknowledgements:Rapid HIV Test Evaluation Working Group
Co-ordinating groupK. Bond, B. Branson, P. Crippen, A. Demby, T. Diaz, M. Downer, G. Gershy-Damet , T. Granade, T. Hearn, K. Lewis, T. Merlin, D. PlateM. Rayfield, R. Respess J. Ridderhof A. Tanuri, S. Wiktor
In-country Collaborators Angola: C. Fernandes, F. da Silva, M. Francisco, F. del Castillo, J. CoxBotswana: T. Roels, L. Povinelli, P. KilmarxEthiopia: B. Tegbaru, A. Geyed, M. Fekadu, J. Mengistu, T. WuhibIvory Coast: C. Maurice, A. Tehe, D. YavoKenya: J. Nyamongo, N. Achola, K. Mandaliya, P. Tukei, L. Marum, K. DeCockMozambique: A. Barreto, S. Stakteas, K. Marsh, A. VergaraNamibia: C. Weiss, H. Kaura, T. KenyonRwanda: P. Rugimbanya, E. Rusanganwa, J. Hanson, V. KoscelnikSenegal: M. Gueye, S. Mboup, C. MurrillTanzania: E. Lyamuya, Y. Ipuge, C. Kagoma, C. ScottZimbabwe: J. Mudzori, Z. Ziyambi, K. Mutasa, E. Burke, M. St. Louis