Presentation is loading. Please wait.

Presentation is loading. Please wait.

Evaluation and implementation of rapid HIV tests: the experience in eleven African countries Dr. Stefan Wiktor Chief, Surveillance and Infrastructure Development.

Similar presentations


Presentation on theme: "Evaluation and implementation of rapid HIV tests: the experience in eleven African countries Dr. Stefan Wiktor Chief, Surveillance and Infrastructure Development."— Presentation transcript:

1 Evaluation and implementation of rapid HIV tests: the experience in eleven African countries Dr. Stefan Wiktor Chief, Surveillance and Infrastructure Development Branch Global AIDS Program CDC/HHS

2 Adults and children estimated to be living with HIV/AIDS Total: 34 – 46 million Western Europe – North Africa & Middle East – Sub-Saharan Africa 25.0 – 28.2 million Eastern Europe & Central Asia 1.2 – 1.8 million South & South-East Asia 4.6 – 8.2 million Australia & New Zealand – North America – 1.2 million Caribbean – Latin America 1.3 – 1.9 million East Asia & Pacific – 1.3 million

3 World Bank Multi-country AIDS Program (MAP )

4 President’s Emergency Plan for AIDS Relief Announced January 28, 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)

5 Haiti Guyana Côte d’Ivoire Nigeria Ethiopia Kenya Uganda Rwanda Tanzania Mozambique Zambia South Africa Botswana Namibia President’s Emergency Plan for AIDS Relief 15 Focus Countries Vietnam added 7/04

6 The role of HIV testing to meet the goals of the Emergency Plan Massive scale-up of testing capacity needed: 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

7 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

8 HIV testing is expanding rapidly (Number of HIV tests performed in CDC/GAP supported programs)

9 HIV testing is expanding rapidly (Number of CDC/GAP supported sites qualified to perform HIV testing)

10 WHO-AFRO/HHS- CDC/APHL Guidelines For Appropriate Evaluations of HIV Testing Technologies in Africa

11 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

12 Evaluation and implementation of rapid HIV tests in 11 African countries Côte d’Ivoire Ethiopia Kenya Uganda Rwanda Tanzania Mozambique Botswana Namibia Senegal Angola Country contacts identified – working group created Questionnaire administered concerning evaluations:  Process  Results  Implementation

13 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

14 Phase I evaluations Conducted in national reference or hospital laboratories Serum panels created:  Median 506 samples (range )  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

15 Median sensitivity of rapid HIV tests in evaluations conducted in central reference laboratories in 11 African countries # of evals:3322

16 Median specificity of rapid HIV tests in evaluations conducted in central reference laboratories in 11 African countries # of evals:3322

17 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

18 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)

19 Phase III: Status of rapid test implementation, 2003 CountrySites# Persons tested Angola13 VCT, 3 TB, hospitals15,000 (VCT) Botswana16 VCT51,000 EthiopiaVCT, blood bankN/A Kenya200 VCT, 50 PMCT, blood bank315,000 Ivory Coast27 PMCT, 6 VCT, 2 hospitals93,000 Mozambique85 blood bank, 66 VCT, 14 PMCT130,000 RwandaVCT, PMCT (60 total)132,000 Senegal6 VCT4,700

20 External quality assurance: comparison of results of on-site rapid HIV testing with central laboratory EIA/WB testing

21 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

22 Acknowledgements:Rapid HIV Test Evaluation Working Group Co-ordinating group K. Bond, B. Branson, P. Crippen, A. Demby, T. Diaz, M. Downer, G. Gershy-Damet, T. Granade, T. Hearn, K. Lewis, T. Merlin, D. Plate M. Rayfield, R. Respess J. Ridderhof A. Tanuri, S. Wiktor In-country Collaborators Angola: C. Fernandes, F. da Silva, M. Francisco, F. del Castillo, J. Cox Botswana: T. Roels, L. Povinelli, P. Kilmarx Ethiopia: B. Tegbaru, A. Geyed, M. Fekadu, J. Mengistu, T. Wuhib Ivory Coast: C. Maurice, A. Tehe, D. Yavo Kenya: J. Nyamongo, N. Achola, K. Mandaliya, P. Tukei, L. Marum, K. DeCock Mozambique: A. Barreto, S. Stakteas, K. Marsh, A. Vergara Namibia: C. Weiss, H. Kaura, T. Kenyon Rwanda: P. Rugimbanya, E. Rusanganwa, J. Hanson, V. Koscelnik Senegal: M. Gueye, S. Mboup, C. Murrill Tanzania: E. Lyamuya, Y. Ipuge, C. Kagoma, C. Scott Zimbabwe: J. Mudzori, Z. Ziyambi, K. Mutasa, E. Burke, M. St. Louis


Download ppt "Evaluation and implementation of rapid HIV tests: the experience in eleven African countries Dr. Stefan Wiktor Chief, Surveillance and Infrastructure Development."

Similar presentations


Ads by Google