title: Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM.
abstract: OBJECTIVE
  The rapid test study was a real-time comparison of point-of-care (POC) HIV tests to determine their abilities to detect early HIV infection.
  
  
  METHODS
  Men and transgender persons reporting sex with men in the prior year were recruited at the Public Health-Seattle & King County STD Clinic, Gay City Health Project, and University of Washington Primary Infection Clinic. Study tests included the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids and tests performed on fingerstick whole blood specimens including OraQuick, Uni-Gold Recombigen HIV test, Determine HIV-1/2 Ag/Ab Combo, and INSTI HIV-1 Rapid Antibody Test. Specimens from subjects with negative results were sent for EIA and nucleic acid amplification testing. McNemar's exact tests compared the numbers of HIV-infected subjects detected.
  
  
  RESULTS
  Between February 2010 and August 2014, there were 3438 study visits. Twenty-four subjects had discordant POC results with at least one reactive and one non-reactive test, including one subject with a reactive Determine p24 antigen. OraQuick performed on oral fluids identified fewer persons compared to all fingerstick tests. OraQuick performed on fingerstick whole blood detected fewer persons compared to the Determine Combo antibody component (p=.008) and Combo overall (p=.004), and there was a trend when compared to INSTI (p=.06). The Determine Combo specificity was 98.99%.
  
  
  CONCLUSIONS
  As reported by others, Determine Combo underperforms compared to laboratory-based testing, but it did detect one acute infection. If these results are validated, the specificity of Determine Combo may limit its usefulness in populations with lower HIV incidence.
authors.affiliation: Departments of Medicine, University of Washington, Seattle, WA, United States; Departments 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: Departments of Medicine, University of Washington, Seattle, WA, United States.
authors.forename: George
authors.initials: G
authors.lastname: Ure
authors.affiliation: San Francisco AIDS Foundation, San Francisco, CA, 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: Departments of Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Janine
authors.initials: J
authors.lastname: Maenza
authors.affiliation: Departments of Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Claire
authors.initials: C
authors.lastname: Stevens
authors.affiliation: Departments of Medicine, University of Washington, Seattle, WA, United States; Departments of Laboratory Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Coombs
authors.affiliation: Departments of Laboratory Medicine, University of Washington, Seattle, WA, United States.
authors.forename: Joan
authors.initials: J
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: Departments of Medicine, University of Washington, Seattle, WA, United States; Departments 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
mesh_terms: D015492:AIDS Serodiagnosis / Q000592:standards*; D000208:Acute Disease; D000328:Adult; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology*; D015497:HIV-1 / Q000276:immunology; D018451:Homosexuality, Male; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D019095:Point-of-Care Systems / Q000592:standards*; D011933:Reagent Kits, Diagnostic; D012463:Saliva / Q000276:immunology / Q000821:virology; D012680:Sensitivity and Specificity; D014861:Washington / Q000453:epidemiology
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic
keywords: Background; HIV testing; Oral fluids; Rapid HIV test