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
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
World Bank Multi-country AIDS Program (MAP)
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)
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
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
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
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)
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
WHO-AFRO/HHS-CDC/APHL GuidelinesFor AppropriateEvaluations of HIV Testing Technologiesin Africa
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
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
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
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
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
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
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
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)
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
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
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
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