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


OBJECTIVE
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.
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Estelle
E
Piwowar-Manning
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Jessica M
JM
Fogel
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.
Oliver
O
Laeyendecker
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Shauna
S
Wolf
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Vanessa
V
Cummings
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Mark A
MA
Marzinke
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
William
W
Clarke
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Autumn
A
Breaud
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Sarah
S
Wendel
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Lei
L
Wang
Infectious Disease Research, Abbott Diagnostics, Abbott Park, Illinois.
Priscilla
P
Swanson
Infectious Disease Research, Abbott Diagnostics, Abbott Park, Illinois.
John
J
Hackett
Department of Medicine, Harlem Hospital, Columbia University, Mailman School of Public Health, New York, New York.
Sharon
S
Mannheimer
Department of Global Health, Emory University Rollins School of Public Health, Atlanta, Georgia.
Carlos
C
Del Rio
Department of Epidemiology and Biostatistics, The George Washington University, Washington, DC.
Irene
I
Kuo
Department of Research, Charles R. Drew University of Medicine and Science, Los Angeles, California.
Nina T
NT
Harawa
Laboratory of Infectious Disease Prevention, Lindsley F. Kimball Research Institute, New York Blood Center, New York, New York.
Beryl A
BA
Koblin
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Richard
R
Moore
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Joel N
JN
Blankson
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Susan H
SH
Eshleman
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D000914:Antibodies, Viral / Q000097:blood; D015153:Blotting, Western / Q000592:standards; D015331:Cohort Studies; D005188:False Negative Reactions; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000592:standards; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012680:Sensitivity and Specificity; D019562:Viral Load
D019380:Anti-HIV Agents; D000914:Antibodies, Viral; D012367:RNA, Viral
HIV; antiretroviral therapy; elite controller; rapid test; viral suppression