title: Relative accuracy of serum, whole blood, and oral fluid HIV tests among Seattle men who have sex with men.
abstract: BACKGROUND
  Point-of-care (POC) rapid HIV tests have sensitivity during the "window period" comparable only to earliest generation EIAs. To date, it is unclear whether any POC test performs significantly better than others.
  
  
  OBJECTIVE
  Compare abilities of POC tests to detect early infection in real time.
  
  
  METHODS
  Men who have sex with men (MSM) were recruited into a prospective, cross-sectional study at two HIV testing sites and a research clinic. Procedures compared four POC tests: one performed on oral fluids and three on fingerstick whole blood specimens. Specimens from participants with negative POC results were tested by EIA and pooled nucleic acid amplification testing (NAAT). McNemar's exact tests compared numbers of HIV-infected participants detected.
  
  
  RESULTS
  Between February 2010 and May 2013, 104 men tested HIV-positive during 2479 visits. Eighty-two participants had concordant reactive POC results, 3 participants had concordant non-reactive POC tests but reactive EIAs, and 8 participants had acute infection. Of 12 participants with discordant POC results, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids identified fewer infections than OraQuick performed on fingerstick (p = .005), Uni-Gold Recombigen HIV test (p = .01), and determine HIV-1/2 Ag/Ab combo (p = .005).
  
  
  CONCLUSIONS
  These data confirm that oral fluid POC testing detects fewer infections than other methods and is best reserved for circumstances precluding fingerstick or venipuncture. Regardless of specimen type, POC tests failed to identify many HIV-infected MSM in Seattle. In populations with high HIV incidence, the currently approved POC antibody tests are inadequate unless supplemented with p24 antigen tests or NAAT.
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, United States; Department of Epidemiology, University of Washington, Seattle, WA, United States; Public Health - Seattle & King County, Seattle, WA, United States. Electronic address: jstekler@uw.edu.
authors.forename: Joanne D
authors.initials: JD
authors.lastname: Stekler
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Joshua D
authors.initials: JD
authors.lastname: O'Neal
authors.affiliation: Public Health - Seattle & King County, Seattle, WA, United States.
authors.forename: Aric
authors.initials: A
authors.lastname: Lane
authors.affiliation: Gay City Health Project, Seattle, WA, United States.
authors.forename: Fred
authors.initials: F
authors.lastname: Swanson
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Janine
authors.initials: J
authors.lastname: Maenza
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Claire E
authors.initials: CE
authors.lastname: Stevens
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, United States; Department of Laboratory Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Coombs
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Joan A
authors.initials: JA
authors.lastname: Dragavon
authors.affiliation: Public Health - Seattle & King County, Seattle, WA, United States.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Swenson
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, United States; Department of Epidemiology, University of Washington, Seattle, WA, United States; Public Health - Seattle & King County, Seattle, WA, United States.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Golden
authors.affiliation: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Bernard M
authors.initials: BM
authors.lastname: Branson
mesh_terms: D001769:Blood / Q000276:immunology*; D003430:Cross-Sectional Studies; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D015483:HIV Antibodies / Q000032:analysis* / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000276:immunology*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D019095:Point-of-Care Systems; D011446:Prospective Studies; D012463:Saliva / Q000276:immunology*; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods; D014861:Washington
chemical_list: D015483:HIV Antibodies
keywords: HIV testing; Oral fluids; Rapid HIV test