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. 2008:2:17-25.
doi: 10.2174/1874613600802010017. Epub 2008 Mar 10.

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 Stevens  1 , G Sherman, R Downing, L M Parsons, C-Y Ou, S Crowley, G M Gershy-Damet, K Fransen, M Bulterys, L Lu, J Homsy, T Finkbeiner, J N Nkengasong
Affiliations

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 Stevens et al. Open AIDS J. 2008.

Abstract

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 DNA PCR; HIV infection; early infant diagnosis; laboratory assays.

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Figures

Fig. (1).Age-Stratified diagnostic pathways for well infants known to be HIV-exposed.
Fig. (1).Age-Stratified diagnostic pathways for well infants known to be HIV-exposed.
Different approaches are recommended for testing HIV-exposed infants based on age (35). Infants between ages 6 weeks and 9 months should not be diagnosed using an HIV Rapid test algorithm, but should be diagnosed by HIV DNA PCR. Children between 9 and 18 months should first be tested using an HIV Rapid test algorithm with positive tests confirmed by HIV DNA PCR (with immediate referral for care after a positive rapid test if there are long delays for the confirmatory test results). In children older 18 months of age, a positive result in the HIV Rapid test algorithm is indicative of HIV infection.
Fig. (2).Age-Stratified diagnostic pathways for sick infants where HIV exposure-status is unknown.
Fig. (2).Age-Stratified diagnostic pathways for sick infants where HIV exposure-status is unknown.
Different approaches are recommended for testing sick children based on age (34). All sick children should be tested first in an HIV Rapid test algorithm. A positive HIV Rapid test result in children under 18 months should be confirmed by HIV DNA PCR (with immediate referral for care after a positive rapid test if there are long delays for the confirmatory test results), while a positive HIV in children over 18 months of age is definitive of infection with HIV.
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