Background: Data on the performance and utility of rapid
serological tests in infants to determine HIV exposure are unclear
and in some instances contradictory. This study sought to understand
the performance of rapid serological tests in high HIV burden, high
Option B+ coverage settings to be used as an HIV exposure
screening tool.
Methods: A total of 3600 infants up to 24 months of age at 4
regional hospitals in Uganda were systematically enrolled and tested
simultaneously using both HIV rapid serological and nucleic acid–
based tests.
Results: Only 58 of the 94 HIV-positive infants who received both
rapid serological and nucleic acid–based tests were positive with the
rapid serological test (sensitivity: 61.7%; 95% confidence interval:
51.1 to 71.5). Using rapid serological tests to screen infants for
exposure to HIV and follow-up nucleic acid-based testing would
have missed 38.3% (36 of 94) of HIV-positive infants. Finally,
several HIV-positive infants who were negative by rapid serological
test presented to well-child entry points and were considered healthy.
All 3 HIV-positive infants presenting to outreach and immunization
were negative by rapid serological testing and 73% (8 of 11)
presenting to outpatient.
Conclusions: These data suggest that the use of rapid serological
tests may have inadequate performance as an indicator of exposure
and potential HIV infection among infants presenting at both wellchild
(immunization and community outreach) and sick-infant
(nutrition and inpatient) entry points. To improve the identification
of HIV-positive infants, nucleic acid–based testing should instead be
considered in infants aged younger than 18 months.
