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

Estelle Piwowar-Manning, Jessica Marie Louise Fogel, Oliver Laeyendecker, Shauna Wolf, Vanessa Cummings, Mark Marzinke, William Clarke, Autumn Breaud, Sarah Wendel, Lei Wang, Priscilla Swanson, John Hackett, Sharon Mannheimer, Carlos Del Rio, Irene Kuo, Nina Harawa, Beryl Koblin, Richard Moore, Joel Blankson, Susan Eshleman

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)62-68
Number of pages7
JournalHIV Clinical Trials
Issue number2
StatePublished - Jan 1 2014


  • HIV
  • antiretroviral therapy
  • elite controller
  • rapid test
  • viral suppression

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)


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