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HIV Clin Trials. 2014 Mar-Apr;15(2):62-8. doi: 10.1310/hct1502-62.

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

Author information

1
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
2
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
3
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
4
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
5
Infectious Disease Research, Abbott Diagnostics, Abbott Park, Illinois.
6
Department of Medicine, Harlem Hospital, Columbia University, Mailman School of Public Health, New York, New York.
7
Department of Global Health, Emory University Rollins School of Public Health, Atlanta, Georgia.
8
Department of Epidemiology and Biostatistics, The George Washington University, Washington, DC.
9
Department of Research, Charles R. Drew University of Medicine and Science, Los Angeles, California.
10
Laboratory of Infectious Disease Prevention, Lindsley F. Kimball Research Institute, New York Blood Center, New York, New York.
11
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.

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.

KEYWORDS:

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

PMID:
24710920
PMCID:
PMC4167641
DOI:
10.1310/hct1502-62
[Indexed for MEDLINE]
Free PMC Article

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