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