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 B. Laeyendecker, Shauna Wolf, Vanessa Cummings, Mark A 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 D Moore, Joel N Blankson, Susan Eshleman

Research output: Contribution to journalArticle

Abstract

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
Volume15
Issue number2
DOIs
StatePublished - Jan 1 2014

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Clinical Trials
HIV
HIV Infections
Infection
HIV-2
Immunoassay
Western Blotting
RNA
Pharmaceutical Preparations

Keywords

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

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening. / Piwowar-Manning, Estelle; Fogel, Jessica Marie Louise; Laeyendecker, Oliver B.; 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; Koblin, Beryl; Moore, Richard D; Blankson, Joel N; Eshleman, Susan.

In: HIV Clinical Trials, Vol. 15, No. 2, 01.01.2014, p. 62-68.

Research output: Contribution to journalArticle

Piwowar-Manning, E, Fogel, JML, Laeyendecker, OB, Wolf, S, Cummings, V, Marzinke, MA, Clarke, W, Breaud, A, Wendel, S, Wang, L, Swanson, P, Hackett, J, Mannheimer, S, Del Rio, C, Kuo, I, Harawa, N, Koblin, B, Moore, RD, Blankson, JN & Eshleman, S 2014, 'Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening', HIV Clinical Trials, vol. 15, no. 2, pp. 62-68. https://doi.org/10.1310/hct1502-62
Piwowar-Manning, Estelle ; Fogel, Jessica Marie Louise ; Laeyendecker, Oliver B. ; 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 ; Koblin, Beryl ; Moore, Richard D ; Blankson, Joel N ; Eshleman, Susan. / Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening. In: HIV Clinical Trials. 2014 ; Vol. 15, No. 2. pp. 62-68.
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abstract = "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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AU - Fogel, Jessica Marie Louise

AU - Laeyendecker, Oliver B.

AU - Wolf, Shauna

AU - Cummings, Vanessa

AU - Marzinke, Mark A

AU - Clarke, William

AU - Breaud, Autumn

AU - Wendel, Sarah

AU - Wang, Lei

AU - Swanson, Priscilla

AU - Hackett, John

AU - Mannheimer, Sharon

AU - Del Rio, Carlos

AU - Kuo, Irene

AU - Harawa, Nina

AU - Koblin, Beryl

AU - Moore, Richard D

AU - Blankson, Joel N

AU - Eshleman, Susan

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N2 - 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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