title: Detection of individuals with acute HIV-1 infection using the ARCHITECT HIV Ag/Ab Combo assay.
abstract: BACKGROUND
  We evaluated use of the ARCHITECT HIV Ag/Ab Combo assay (HIV Combo; Abbott Diagnostics; available for sale outside the United States only) for detection of acute HIV infection.
  
  
  METHODS
  Samples were obtained from a behavioral intervention study (EXPLORE). HIV-uninfected men who have sex with men were enrolled and tested for HIV infection every 6 months. Samples from seroconverters collected at their last seronegative visit (n = 217) were tested individually using 2 HIV RNA assays. Samples with detectable HIV RNA were classified as acute and were tested with HIV Combo. Samples from the enrollment visit (n = 83) and the time of HIV seroconversion (n = 219) were tested with HIV Combo as controls.
  
  
  RESULTS
  Twenty-one samples (9.7%) from the last seronegative visit had detectable HIV RNA and were classified as acute. HIV Combo was positive for 13 of the acute samples (61.9%). Samples not detected by HIV Combo had viral loads of 724-15,130 copies per milliliter. Expected results were obtained for positive and negative controls tested with HIV Combo.
  
  
  CONCLUSIONS
  HIV Combo detected nearly two thirds of acute HIV infections identified in this high-risk population by non-pooled HIV RNA assays. HIV Combo may be useful for high-throughput screening to identify individuals with acute HIV infection.
authors.affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA. seshlem@jhmi.edu
authors.forename: Susan H
authors.initials: SH
authors.lastname: Eshleman
authors.forename: Leila
authors.initials: L
authors.lastname: Khaki
authors.forename: Oliver
authors.initials: O
authors.lastname: Laeyendecker
authors.forename: Estelle
authors.initials: E
authors.lastname: Piwowar-Manning
authors.forename: LeTanya
authors.initials: L
authors.lastname: Johnson-Lewis
authors.forename: Marla
authors.initials: M
authors.lastname: Husnik
authors.forename: Beryl
authors.initials: B
authors.lastname: Koblin
authors.forename: Thomas
authors.initials: T
authors.lastname: Coates
authors.forename: Margaret
authors.initials: M
authors.lastname: Chesney
authors.forename: Ana
authors.initials: A
authors.lastname: Vallari
authors.forename: Sushil G
authors.initials: SG
authors.lastname: Devare
authors.forename: John
authors.initials: J
authors.lastname: Hackett
mesh_terms: D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay; D008297:Male; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic