title: Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.
abstract: BACKGROUND
  Current laboratory and point-of-care tests for HIV detect different analytes and use different sample types. Some have fast turnaround times (<1 hour). We investigated how HIV test choice could impact case finding by testing programs.
  
  
  METHODS
  We analyzed 21,234 consecutive HIV tests with venous blood obtained by San Francisco HIV testing programs from 2003 to 2008. For a subset, oral fluid (n = 6446) or fingerstick blood (n = 8127) samples were also obtained for rapid testing. In all cases, HIV status was determined using an HIV antibody-plus-RNA test algorithm. We assessed how the screening antibody tests performed individually versus the gold standard of the full algorithm. We then evaluated the potential ability of other tests (including new tests) to detect more cases, by re-testing all specimens that had negative/discrepant antibody results on initial screening.
  
  
  RESULTS
  The antibody-RNA algorithm identified 58 acute and 703 established HIV infection cases. 1(st)-generation (Vironostika) and 3(rd)-generation (Genetic Systems) immunoassays had 92 and 96 percent sensitivity, respectively. The Oraquick rapid test had clinical sensitivity of only 86 percent on oral fluid samples, but 92 percent on finger-stick blood. Newer 4(th)-generation, antigen-antibody combo rapid immunoassay (ARCHITECT) detected HIV in 87 percent of all the acute cases that had been missed by one of the previous screening assays. A point-of-care 4(th) generation antigen-antibody combo rapid test (Determine) detected about 54 percent of such acute cases.
  
  
  CONCLUSIONS
  Our study suggests that some rapid antibody blood tests will give similar case detection to laboratory antibody tests, but that oral fluid testing greatly reduces ability to detect HIV. New 4(th)-generation combo tests can detect the majority of acute infections detectable by HIV RNA but with rapid results. Using these tests as a primary screening assay in high-risk HIV testing programs could reduce or eliminate the need for HIV RNA testing.
authors.affiliation: HIV/AIDS Division, University of California San Francisco, San Francisco, California, United States of America.
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Pilcher
authors.affiliation: Public Health Laboratory, San Francisco Department of Public Health, San Francisco, California, United States of America.
authors.forename: Brian
authors.initials: B
authors.lastname: Louie
authors.affiliation: HIV/AIDS Division, University of California San Francisco, San Francisco, California, United States of America ; HIV Prevention Section, San Francisco Department of Public Health, San Francisco, California, United States of America.
authors.forename: Shelley
authors.initials: S
authors.lastname: Facente
authors.affiliation: Blood Systems Research Institute, San Francisco, California, United States of America.
authors.forename: Sheila
authors.initials: S
authors.lastname: Keating
authors.affiliation: Abbott Diagnostics, Abbott Park, Illinois, United States of America.
authors.forename: John
authors.initials: J
authors.lastname: Hackett
authors.affiliation: Abbott Diagnostics, Abbott Park, Illinois, United States of America.
authors.forename: Ana
authors.initials: A
authors.lastname: Vallari
authors.affiliation: Magnet Community Health Center, San Francisco, California, United States of America.
authors.forename: Chris
authors.initials: C
authors.lastname: Hall
authors.affiliation: HIV Prevention Section, San Francisco Department of Public Health, San Francisco, California, United States of America.
authors.forename: Teri
authors.initials: T
authors.lastname: Dowling
authors.affiliation: Blood Systems Research Institute, San Francisco, California, United States of America.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Busch
authors.affiliation: HIV/AIDS Division, University of California San Francisco, San Francisco, California, United States of America ; STD Prevention and Control Services Section, San Francisco Department of Public Health, San Francisco, California, United States of America.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Klausner
authors.affiliation: HIV/AIDS Division, University of California San Francisco, San Francisco, California, United States of America.
authors.forename: Frederick M
authors.initials: FM
authors.lastname: Hecht
authors.affiliation: Public Health Laboratory, San Francisco Department of Public Health, San Francisco, California, United States of America.
authors.forename: Sally
authors.initials: S
authors.lastname: Liska
authors.affiliation: Public Health Laboratory, San Francisco Department of Public Health, San Francisco, California, United States of America.
authors.forename: Mark W
authors.initials: MW
authors.lastname: Pandori
mesh_terms: D000465:Algorithms; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay; D012495:San Francisco; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies