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Open Access Publications from the University of California

Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening.

  • Author(s): Piwowar-Manning, Estelle
  • Fogel, Jessica M
  • Laeyendecker, Oliver
  • Wolf, Shauna
  • Cummings, Vanessa
  • Marzinke, Mark A
  • Clarke, William
  • Breaud, Autumn
  • Wendel, Sarah
  • Wang, Lei
  • Swanson, Priscilla
  • Hackett, John
  • Mannheimer, Sharon
  • Del Rio, Carlos
  • Kuo, Irene
  • Harawa, Nina T
  • Koblin, Beryl A
  • Moore, Richard
  • Blankson, Joel N
  • Eshleman, Susan H
  • et al.

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BACKGROUND:In the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing. OBJECTIVES:To evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression. METHODS:Plasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay. RESULTS:Of the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test. CONCLUSIONS:In clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections.

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