title: Timing of HIV Seroreversion Among HIV-Exposed, Breastfed Infants in Malawi: Type of HIV Rapid Test Matters.
abstract: Introduction Rapid HIV serological tests are a cost-effective, point-of-care test among HIV exposed infants but cannot distinguish between maternal and infant antibodies. The lack of data on the timing of decay of maternal antibodies in young infants hinders the potential use of rapid tests in exposed infants. We aimed to determine the time to seroreversion for two commonly used rapid tests in a prospective cohort of HIV-exposed breastfeeding infants ages 3-18 months of life. Methods We collected data on the performance of two commonly used rapid tests (Determine and Unigold) in Malawi between 2008 and 2012 or at the University of North Carolina between 2014 and 2015. Time to seroreversion was estimated for both rapid tests using the Kaplan-Meier product limit estimator which allows for interval censored data. Results At 3 months of age, 3 % of infants had seroreverted according to Determine and 7 % had seroreverted according to Unigold. About one in four infants had achieved seroreversion by 4 months using Unigold, but only about one in twelve infants by 4 months when using Determine. More than 95 % of all infants had seroverted by 7 months according to Unigold and by 12 months according to the Determine assay. Discussion We show that the time of seroreversion depends greatly on the type of test used. Our results highlight the need for recommendations to specify the timing and type of test used in the context of infant HIV detection in resource-poor settings, and base the interpretation of test result on knowledge of time to seroreversion of the selected test.
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA. emily.smith1@duke.edu.
authors.forename: Emily R
authors.initials: ER
authors.lastname: Smith
authors.affiliation: Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Hudgens
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Anna D
authors.initials: AD
authors.lastname: Sheahan
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.|Division of Infectious Diseases, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Miller
authors.affiliation: Department of Health Policy and Management, Gillings Schools of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Wheeler
authors.affiliation: Department of Microbiology and Immunology, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Julie A E
authors.initials: JAE
authors.lastname: Nelson
authors.affiliation: Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital, Blantyre, Malawi.
authors.forename: Queen
authors.initials: Q
authors.lastname: Dube
authors.affiliation: Epidemiology and Social Medicine, University of Antwerp, Antwerp, Belgium.
authors.forename: Annelies
authors.initials: A
authors.lastname: Van Rie
mesh_terms: D000328:Adult; D001942:Breast Feeding / Q000009:adverse effects* / Q000379:methods; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D006679:HIV Seropositivity / Q000175:diagnosis*; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008295:Malawi; D008297:Male; D008403:Mass Screening / Q000379:methods / Q000639:trends; D000067716:Point-of-Care Testing / Q000592:standards* / Q000639:trends
keywords: Breastfeeding; Diagnostic testing; Early infant diagnosis; HIV transmission; Prevention of mother-to-child transmission