Role of the Laboratory in Ensuring Global Access to ARV Treatment for HIV-Infected Children: Consensus Statement on the Performance of Laboratory Assays for Early Infant Diagnosis

W. Stevens1, G. Sherman11, R. Downing2, L.M. Parsons3, C.-Y. Ou3, S. Crowley4, G.M. Gershy-Damet5, K. Fransen6, M. Bulterys7, L. Lu2, J. Homsy3, T. Finkbeiner33, J.N. Nkengasong3, *
1 University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa, Global AIDS Program
2 U.S. Centers for Disease Control and Prevention, Kampala, Uganda, Global AIDS Program,
3 U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, USA, Global AIDS Program,
4 World Health Organization, Geneva, Switzerland,
5 World Health Organization, Harare, Zimbabwe
6 Institute of Tropical Medicine, Antwerp, Belgium
7 Global AIDS Program, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia

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open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestrictive use, distribution, and reproduction in any medium, provided the original work is properly cited.

* Address correspondence to this author the U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, USA, Global AIDS Program, USA; E-mail:


A two day meeting hosted by the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) was held in May 2006 in Entebbe, Uganda to review the laboratory performance of virologic molecular methods, particularly the Roche Amplicor DNA PCR version 1.5 assay, in the diagnosis of HIV-1 infection in infants. The meeting was attended by approximately 60 participants from 17 countries. Data on the performance and limitations of the HIV-1 DNA PCR assay from 9 African countries with high-burdens of HIV/AIDS were shared with respect to different settings and HIV- subtypes. A consensus statement on the use of the assay for early infant diagnosis was developed and areas of needed operational research were identified. In addition, consensus was reached on the usefulness of dried blood spot (DBS) specimens in childhood as a means for ensuring greater accessibility to serologic and virologic HIV testing for the paediatric population.

Keywords: : HIV infection, early infant diagnosis, laboratory assays, HIV DNA PCR.