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WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children. Geneva: World Health Organization; 2010.

Cover of WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children

WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children.

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3BACKGROUND

Improved assays to detect viral components, such as HIV-1 DNA and RNA, and p24 antigen (p24 Ag), are now available, as well as enhanced technologies for rapid testing for HIV antibodies. In addition, the successful use of filter papers to transfer specimens (dried blood spots [DBS]) from remote sites to more advanced testing laboratories means that early infant testing and subsequent initiation of immediate ART is fast becoming feasible for infants in resource-limited settings.

WHO has previously published recommendations for the diagnosis of HIV infection in infants and children (12, 13), and recommendations for implementation of provider-initiated HIV testing (14). In 2008, a meeting was held to review and update infant HIV treatment guidelines and recommendations for initiating ART in HIV-infected infants (11). The optimal timing of initial testing as part of follow up for HIV-exposed infants was also reviewed.

Immediate initiation of ART, without waiting for clinical or immunological disease progression in infants, is now recommended, and therefore early diagnostic testing should be performed with the aim of identifying as many HIV-infected infants as early as possible. To enable antiretroviral (ARV) prophylaxis to be given to infants as soon as possible after birth, all infants should have their HIV exposure status known at birth. Evidence and experience from national programmes and research on early infant diagnosis mean that new data are now available and WHO has therefore updated recommendations for diagnosis of HIV in infants and young children.

Recommendations on the use of appropriate HIV testing technologies and diagnostic approaches, and clear and simple testing strategies, are necessary to facilitate early infant diagnosis, and contain and efficiently manage public health resources. Diagnostic testing methods including HIV serological (= antibody testing = rapid testing = HIV serology = HIV enzyme immunoassay [EIA]) and virological testing (including HIV RNA, HIV DNA and HIV p24 Ag) were reviewed, as well as approaches to the clinical diagnosis of HIV infection in settings where virological testing is not (yet) available. The timing of testing was reviewed as well as the actions that need to be taken following the availability of results from each of the diagnostic approaches recommended.

Note: HIV antibody assays detect antibodies to HIV-1/2. HIV serological testing can be performed using ‘rapid test devices’, or ‘HIV EIA’, and is also sometimes referred to as ‘HIV serology’. For consistency, this document will use the term HIV serological testing wherever tests for HIV antibody are referred to. HIV virological assays detect the presence of HIV nucleic acids in the form of HIV DNA or HIV RNA, or HIV viral antigen such as p24 (p24 Ag). A clinical diagnosis of HIV may be made based on the presenting symptoms and signs. Many of these are nonspecific in infants and younger children, and HIV serological and virological testing is therefore essential to support the clinical diagnosis of HIV.

3.1. Objective

This publication summarizes current knowledge on the methods of diagnosing HIV infection in infants and children and sets out recommendations for practice and policy. Recommendations are designed to improve clinical management of the HIV-exposed and -infected child, and improve programme efforts at early identification of HIV-exposed and -infected children.

WHO HIV case definitions for clinical and surveillance purposes were revised in 2006 (13); HIV cases diagnosed and not previously reported in a country should be reported according to a standard national case definition. Countries are therefore encouraged to develop and regularly review their testing algorithms based on the recommendations provided, in accordance with their prevailing resource situation.

3.2. Audience for the guidelines

This publication is primarily intended for use by national advisory boards, national reference laboratories, national HIV/AIDS and child health programme managers, and other senior policy-makers who are involved in the planning of national child survival and HIV prevention and care strategies for infants and children in resource-limited countries. They may also be used by child health-care providers, professional bodies advising national programmes and developing treatment and care guidelines. Separate guidance and tools for implementation for national programmes and laboratories is referenced.

3.3. Preparatory work

Key population, intervention, comparator and outcome (PICO) questions were identified and a series of grading of recommendations assessment, development and evaluation (GRADE) evidence profiles and summary-of-findings tables prepared to guide the development of the recommendations (Table 1) (15).

Table 1. Grading of recommendations and levels of evidence.

Table 1

Grading of recommendations and levels of evidence.

Existing WHO recommendations were supplemented with draft recommendations developed from the above GRADE profiles for consideration by the guideline review group.

3.4. Guideline review group

A guideline review group was selected from the expert group that developed the initial WHO recommendations in 2005, with additional HIV laboratory experts, methodological experts and non-HIV GRADE experts in accordance with the WHO procedures for guideline development. These experts reviewed and assessed scientific evidence and experiences, and reviewed the evidence draft recommendations at a consultation in Geneva in November 2008, and then worked remotely to complete the recommendations and guideline. The consultation provided the basis for the present recommendations. The list of guideline group members is given in Annex 6.

3.5. Process

Potential declarations of interest were assessed prior to developing recommendations and in advance of the guideline meeting. Completed declarations of interest forms were reviewed by the WHO technical staff and all participants were again asked to clarify their potential conflicts of interest with the expert panel at the guideline meeting. Based on the completed forms and the discussions held at the meeting, no guideline group members with conflicts of interest were identified.

For each of the key recommendations, plenary review of the evidence profiles was followed by plenary discussion and assessment of the existing and draft recommendations. Discussions focused on consideration of costs, values, preference, feasibility and the balance of evidence for desirable and undesirable effects (risk–benefit assessment). Consensus was achieved in the plenary sessions on the wording and strength of the recommendations. The factors and decision-making of the guideline group are documented in Annex 3; decisions were agreed upon when a consensus was obtained. There were no areas where the group was unable to reach a consensus. The guideline panel subsequently reviewed and approved the recommendations and annexes. Peer review of the recommendations was undertaken throughout March–June 2009. Suggested modifications and clarifications were discussed by the original guideline group.

3.6. Review date

Each recommendation made has a date by which it should be reviewed and the full document will be reviewed in 2012.

Copyright © 2010, World Health Organization.

All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: tni.ohw@snoissimrep).

Bookshelf ID: NBK138560
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