Overview

Worldwide, in 2008, an estimated 430 000 [240 000–610 000] new infections due to the human immunodeficiency virus (HIV) occurred in children, of which 90% were acquired through motherto- child transmission (MTCT) of HIV. Of the 430 000 new infections, between 280 000 and 360 000 were acquired during labour and in the pre-partum period. Of the remaining new infections, the majority were acquired during breastfeeding.

In infants who acquire HIV around the time of delivery, disease progression occurs very rapidly in the first few months of life, often leading to death. 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. As not all mothers are given HIV tests, very few HIV-exposed infants are identified and very few infants are known to be gaining access to early diagnosis, the necessary prerequisite to ‘timely’ initiation of antiretroviral therapy (ART). Currently, only an estimated 15% of HIV-exposed infants needing testing are tested in the first two months of life.

Recently published data confirming dramatic survival benefits for infants started on ART as early as possible after the diagnosis of HIV, prompted a review of the World Health Organization (WHO) paediatric treatment guidelines. In June 2008, new guidance was issued, which recommends prompt initiation of ART in infants diagnosed with HIV infection. In order to identify those infants who will need immediate ART, early confirmation of HIV infection is required. In November 2008, a meeting was convened to review recommendations by WHO for the diagnostic testing of HIV infection in infants and children. The meeting brought together the guideline review group that had developed the initial recommendations in 2005.

The guideline review group followed the grading of recommendations assessment, development and evaluation (GRADE) approach in reviewing the recommendations for early detection of HIV infection according to the current WHO Guidelines for Guidelines. This document contains the new recommendations. The full document, including GRADE evidence profiles and the factors that have been taken into account in the group's decision-making with respect to the strength of the recommendations, is available in the annexes.

Contents

• ACKNOWLEDGEMENTS
• ACRONYMS AND ABBREVIATIONS
• 1. EXECUTIVE SUMMARY
  • 1.1 Recommendations
• 2. INTRODUCTION
• 3. BACKGROUND
  • 3.1 Objective
  • 3.2 Audience for the guidelines
  • 3.3 Preparatory work
  • 3.4 Guideline review group
  • 3.5 Process
  • 3.6 Review date
• 4. KEY RECOMMENDATIONS
  • 4.1 Performance requirements of commercial and non-commercial HIV assays
  • 4.2 Tests to diagnose HIV in infants and children below 18 months of age
  • 4.3 Identifying exposure to HIV
  • 4.4 Testing symptomatic infants and children less than 18 months of age
  • 4.5 Testing infants who are breastfeeding
  • 4.6 Tests required to diagnose HIV in children 18 months or older
  • 4.7 Performance of clinical algorithms where virological testing is not available
  • 4.8 Summary tables
• 5. LABORATORY METHODS FOR DIAGNOSIS OF HIV INFECTION IN INFANTS AND CHILDREN
  • 5.1 Laboratory quality assurance
  • 5.2 Commercially versus non-commercially available tests
  • 5.3 Serological testing
  • 5.4 Virological testing
• 6. NEXT STEPS
  • 6.1 Dissemination and implementation
  • 6.2 Outstanding issues for further research
  • 6.3 New products or technologies required
  • 6.4 Technical assistance, tools and advocacy required
• REFERENCES
• ANNEX 1 Summary of findings and quality of evidence evaluation for the use of virological testing
• ANNEX 2 GRADE profiles for clinical algorithms
• ANNEX 3 Summary of guideline group decisions regarding evidence and risk–benefit analyses
• ANNEX 4 Characteristics of a screening test
• ANNEX 5 Studies reporting the prevalence of HIV infection in populations of infants and children undergoing HIV testing
• ANNEX 6 List of the guideline group members

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