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PMTCT, and National's - Health Systems Trust

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DISCUSSION<br />

HIV Diagnosis in Infants<br />

The purpose of testing perinatally exposed infants is three fold: firstly, on an individual level<br />

to determine an infant’s true HIV infection status in order to make clinical management<br />

decisions; secondly, to determine the relative efficacy of various interventions to reduce vertical<br />

transmission; <strong>and</strong> finally, at a population level, to evaluate the effectiveness of the <strong>PMTCT</strong><br />

programme.<br />

The diagnosis of HIV infection in infants requires careful timing of the initial HIV antibody<br />

based (ELISA) diagnostic test (including the Abbott Determine HIV-1/2 <strong>and</strong> other rapid tests<br />

which are currently used at <strong>PMTCT</strong> sites). This is due to the presence <strong>and</strong> persistence of<br />

maternal HIV-specific antibodies in all perinatally exposed infants for many months after birth.<br />

Sero-reversion may occur as early as 9 months (40-60%) but maternal HIV antibodies have<br />

been shown to persist for up to 18 months 2 . To accurately assess the effectiveness of the <strong>PMTCT</strong><br />

programme, accurate, affordable <strong>and</strong> timeous infant HIV diagnostic protocols are required.<br />

General Principles of HIV Testing in Infants<br />

1. Diagnosis needs to be made in the clinical context of the case, with knowledge of the<br />

various test options <strong>and</strong> their interpretation depending on the age of the child.<br />

2. Different protocols may be needed for different areas depending on accessibility to<br />

laboratory tests. However, data presented here proposes that where testing can be<br />

centralized to a reference laboratory, an HIV DNA PCR test is recommended.<br />

3. Infant feeding must be taken into consideration. In the case of a woman who has chosen<br />

to breastfeed, early HIV testing (using an HIV DNA PCR) to determine status may serve<br />

as (a) an incentive to stop breastfeeding if child is negative or (b) encouragement to<br />

continue breastfeeding if the child is already positive, or (c) a guide to considering relactation<br />

if the woman has not been breastfeeding <strong>and</strong> the child is already positive.<br />

CURRENTLY AVAILABLE INFANT HIV TESTS<br />

Antibody Tests<br />

A. Serum HIV ELISA Tests<br />

These tests include onsite rapid tests <strong>and</strong> laboratory based analyzer assays. The later in life<br />

they are performed in infants the more accurate the results, but this means longer periods of<br />

follow up of large numbers of HIV exposed children, most of whom will be negative. To date<br />

this has resulted in enormous loss to follow up.<br />

The Abbott Diagnostics Determine HIV-1/2 Rapid Test can be purchased at US$0.85/test or<br />

provided free of charge through the company’s <strong>PMTCT</strong> support programme. Confirmatory<br />

Rapid tests like Unigold which confirm initial rapid positive results cost about R25.00. Less<br />

than1% of these rapid tests are discordant. Laboratory based HIV-1/2 ELISA tests requested<br />

from the NHLS cost the state R33.50/test. The advantage of rapid tests is that they can be<br />

performed on site rapidly by both lay counsellors (the screening test) <strong>and</strong> nurses, <strong>and</strong> do not<br />

require specimen transport to a laboratory except in the case of ELISA confirmation.<br />

B. Oral fluid Based HIV ELISA Tests<br />

Oral fluid contains lower concentrations of antibodies, including anti-HIV antibodies, than<br />

serum. Waning maternal anti-HIV antibodies at 12 months of age in HIV uninfected children<br />

are therefore less likely to give false positive HIV ELISA tests results when measured in oral<br />

fluid as compared to serum. Oral fluid tests are currently not recommended for diagnostic<br />

purposes <strong>and</strong> have not been evaluated in children under 13 years of age. Both sensitivity <strong>and</strong><br />

specificity on 204 patients using OraSure is 94%.<br />

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