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

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.

journal_name

HIV Clin Trials

journal_title

HIV clinical trials

authors

Piwowar-Manning E,Fogel JM,Laeyendecker O,Wolf S,Cummings V,Marzinke MA,Clarke W,Breaud A,Wendel S,Wang L,Swanson P,Hackett J Jr,Mannheimer S,Del Rio C,Kuo I,Harawa NT,Koblin BA,Moore R,Blankson JN,Eshleman SH

doi

10.1310/hct1502-62

subject

Has Abstract

pub_date

2014-03-01 00:00:00

pages

62-8

issue

2

eissn

1528-4336

issn

1945-5771

pii

R266563G853J6214

journal_volume

15

pub_type

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