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Title: Performance of a redesigned HIV selectest enzyme-linked immunosorbent assay optimized to minimize vaccine-induced seropositivity in HIV vaccine trial participants
Authors: Oksana Penezina
Neil X. Krueger
Isaac R. Rodriguez-Chavez
Michael P. Busch
John Hural
Jerome H. Kim
Robert J. O'Connell
Eric Hunter
Said Aboud
Keith Higgins
Victor Kovalenko
David Clapham
David Crane
Andrew E. Levin
Supachai Rerks-Ngarm
Punnee Pitisuttithum
Sorachai Nitayaphan
Jaranit Kaewkungwal
Charla Andrews
William Kilembe
Etienne Karita
Susan Allen
Patricia Munseri
Agricola Joachim
Muhammad Bakari
Fred Mhalu
Eric Aris
Charlotta Nilsson
Gunnel Biberfeld
Merlin Robb
Mary Marovich
Eric Sandstrom
Immunetics, Inc.
National Institute of Dental and Craniofacial Research
Blood Systems Research Institute
Fred Hutchinson Cancer Research Center
Walter Reed Army Institute of Research
Armed Forces Research Institute of Medical Sciences, Thailand
Emory University
Muhimbili University of Health and Allied Sciences
Global Solutions for Infectious Diseases
Thailand Ministry of Public Health
Mahidol University
Muhimbili National Hospital
Karolinska Institutet
Swedish Institute for Communicable Disease Control
Keywords: Biochemistry, Genetics and Molecular Biology;Immunology and Microbiology;Medicine
Issue Date: 1-Jan-2014
Citation: Clinical and Vaccine Immunology. Vol.21, No.3 (2014), 391-398
Abstract: Vaccine-induced seropositivity (VISP) or seroreactivity (VISR), defined as the reaction of antibodies elicited by HIV vaccines with antigens used in HIV diagnostic immunoassays, can result in reactive assay results for vaccinated but uninfected individuals, with subsequent misclassification of their infection status. The eventual licensure of a vaccine will magnify this issue and calls for the development of mitigating solutions in advance. An immunoassay that discriminates between antibodies elicited by vaccine antigens and those elicited by infection has been developed to address this laboratory testing need. The HIV Selectest is based on consensus and clade-specific HIV peptides that are omitted in many HIV vaccine constructs. The assay was redesigned to enhance performance across worldwide clades and to simplify routine use via a standard kit format. The redesigned assay was evaluated with sera from vaccine trial participants, HIV-infected and uninfected individuals, and healthy controls. The HIV Selectest exhibited specificities of 99.5% with sera from uninfected recipients of 6 different HIV vaccines and 100% with sera from normal donors, while detecting HIV-1 infections, including intercurrent infections, with 95 to 100% sensitivity depending on the clade, with the highest sensitivities for clades A and C. HIV Selectest sensitivity decreased in very early seroconversion specimens, which possibly explains the slightly lower sensitivity observed for asymptomatic blood donors than for clinical HIV cases. Thus, the HIV Selectest provides a new laboratory tool for use in vaccine settings to distinguish the immune response to HIV vaccine antigens from that due to true infection. Copyright © 2014, American Society for Microbiology. All Rights Reserved.
ISSN: 1556679X
Appears in Collections:Scopus 2011-2015

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