title: Utility of rapid antibody tests to exclude HIV-1 infection among infants and children aged <18 months in a low-resource setting.
abstract: BACKGROUND
  Excluding HIV infection among infants and young children in resource-poor settings where nucleic acid amplification tests (NAAT) are not routinely available remains a considerable challenge.
  
  
  OBJECTIVE
  To assess the performance of two rapid HIV antibody tests (RT) used alone and in parallel for excluding HIV infection among acutely ill infants and children <18 months in comparison to NAAT in a region where maternal HIV prevalence was approximately 7%.
  
  
  METHODS
  Infants and children ≥2<18 months admitted to hospital with an acute febrile illness had two rapid antibody tests in parallel, with single and parallel results subsequently compared against NAAT.
  
  
  RESULTS
  HIV prevalence among 1602 enrolled infants was 3.4%. All 1526 infants with 2 negative RT were HIV negative by NAAT. All 46 infants with 2 positive RT were HIV positive by NAAT. The overall specificity of two rapid tests for excluding HIV infection was 99.5%. Sensitivity and specificity were ≥99% and >98%, respectively, across all age brackets ≥2<18 months. Overall sensitivity and specificity for a single RT was 98.2% and 99%, respectively, for Determine, and 85.5% and 99.6%, respectively, for Capillus.
  
  
  CONCLUSIONS
  In a setting with a maternal HIV prevalence rate of <10%, a single negative RT had excellent specificity and two negative RT performed in parallel had a perfect negative predictive value for HIV infection among acutely ill patients <18 months of age. In this and similar settings, RT could assist with excluding HIV infection with much lower complexity and cost than NAAT.
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, Duke University Medical Center, Durham, NC, USA. ann.buchanan@duke.edu
authors.forename: Ann M
authors.initials: AM
authors.lastname: Buchanan
authors.forename: Behzad
authors.initials: B
authors.lastname: Nadjm
authors.forename: Ben
authors.initials: B
authors.lastname: Amos
authors.forename: George
authors.initials: G
authors.lastname: Mtove
authors.forename: David
authors.initials: D
authors.lastname: Sifuna
authors.forename: Coleen K
authors.initials: CK
authors.lastname: Cunningham
authors.forename: John A
authors.initials: JA
authors.lastname: Crump
authors.forename: Hugh
authors.initials: H
authors.lastname: Reyburn
mesh_terms: D003906:Developing Countries; D005260:Female; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods; D014773:Virology / Q000379:methods*
chemical_list: D015483:HIV Antibodies