title: Repeat confirmatory testing for persons with discordant whole blood and oral fluid rapid HIV test results: findings from post marketing surveillance.
abstract: BACKGROUND
  Reactive oral fluid and whole blood rapid HIV tests must be followed with a confirmatory test (Western blot (WB), immunofluorescent assay (IFA) or approved nucleic acid amplification test (NAAT)). When the confirmatory result is negative or indeterminate (i.e. discordant with rapid result), repeat confirmatory testing should be conducted using a follow-up specimen. Previous reports have not described whether repeat testing adequately resolves the HIV-infection status of persons with discordant results.
  
  
  METHODS
  Post-marketing surveillance was conducted in 368 testing sites affiliated with 14 state and 2 city health departments from August 11, 2004 to June 30, 2005 and one health department through December 31, 2005. For persons with discordant results, data were collected on demographics, risk behaviors, HIV test results and specimen types. Persons with repeat confirmatory results were classified as HIV-infected or uninfected. Regression models were created to assess risk factors for not having repeat testing.
  
  
  RESULTS
  Of 167,371 rapid tests conducted, 2589 (1.6%) were reactive: of these, 2417 (93%) had positive WB/IFA, 172 (7%) had negative or indeterminate WB/IFA. Of 89/172 (52%) persons with a repeat confirmatory test: 17 (19%) were HIV-infected, including 3 with indeterminate WB and positive NAAT; 72 (81%) were uninfected, including 12 with repeat indeterminate WB. Factors associated with HIV-infection included having an initial indeterminate WB/IFA (vs. negative) (p<0.001) and having an initial oral fluid WB (vs. serum) (p<0.001). Persons who had male-female sex (vs. male-male sex) were at increased risk for not having a repeat test [adjusted OR 2.6, 95% CI (1.3, 4.9)].
  
  
  CONCLUSIONS
  Though only half of persons with discordant results had repeat confirmatory testing, of those who did, nearly one in five were HIV-infected. These findings underscore the need for rapid HIV testing programs to increase repeat confirmatory testing for persons with discordant results. Because of the lower sensitivity of oral fluid WBs, confirmatory testing following a reactive rapid test should be conducted using serum or plasma, when possible.
authors.affiliation: Division of HIV/AIDS Prevention, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. lig7@cdc.gov
authors.forename: Laura G
authors.initials: LG
authors.lastname: Wesolowski
authors.forename: Duncan A
authors.initials: DA
authors.lastname: Mackellar
authors.forename: Steven F
authors.initials: SF
authors.lastname: Ethridge
authors.forename: Julia H
authors.initials: JH
authors.lastname: Zhu
authors.forename: S Michele
authors.initials: SM
authors.lastname: Owen
authors.forename: Patrick S
authors.initials: PS
authors.lastname: Sullivan
mesh_terms: D015153:Blotting, Western; D003951:Diagnostic Errors; D005260:Female; D005455:Fluorescent Antibody Technique; D015483:HIV Antibodies / Q000032:analysis / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D008297:Male; D021141:Nucleic Acid Amplification Techniques; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic