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Title: Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay
Authors: A. Mühlbacher
H. Schennach
J. Van Helden
T. Hebell
G. Pantaleo
P. Bürgisser
C. Cellerai
P. Permpikul
M. I. Rodriguez
A. Eiras
F. Alborino
P. Cunningham
M. Axelsson
S. Andersson
O. Wetlitzky
C. Kaiser
P. Möller
G. De Sousa
Central Institute for Blood Transfusion and Immunology
MVZ Stein und Partner
Humanmedizin und Pathologie GmbH
Centre Hospitalier Universitaire Vaudois
Mahidol University
Centro de Transfusion de Galicia
Ospedaliero di Dolo
St. Vincent's Hospital Sydney
Swedish Institute for Infectious Disease Control
MVZ Labor München Zentrum
Hospital Fernando Fonseca
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Feb-2013
Citation: Medical Microbiology and Immunology. Vol.202, No.1 (2013), 77-86
Abstract: Education and diagnostic tests capable of early detection represent our most effective means of preventing transmission of human immunodeficiency virus (HIV). The importance of early detection is underlined by studies demonstrating increased life expectancy following early initiation of antiviral treatment. The Elecsys® HIV combi PT assay is a fourth-generation antigen-antibody combination assay developed to allow earlier detection of seroconversion, and to have increased sensitivity and improved specificity. We aimed to determine how early the assay could detect infection compared with existing assays; whether all HIV variants could be detected; and the assay's specificity using samples from blood donors, routine specimens, and patients with potential cross-reacting factors. Samples were identified as positive by the Elecsys® assay 4.9 days after a positive polymerase chain reaction result (as determined by the panel supplier), which was earlier than the 5.3-7.1 days observed with comparators. The analytical sensitivity of the Elecsys® HIV combi PT assay for the HIV-1 p24 antigen was 1.05 IU/mL, which compares favorably with the comparator assays. In addition, the Elecsys® assay identified all screened HIV subtypes and displayed greater sensitivity to HIV-2 homologous antigen and antibodies to HIV-1 E and O and HIV-2 than the other assays. Overall, the specificity of the Elecsys® assay was 99.88 % using samples from blood donors and 99.81 % when analyzing unselected samples. Potential cross-reacting factors did not interfere with assay performance. The Elecsys® HIV combi PT assay is a sensitive and specific assay that has been granted the CE mark according to Directive 2009/886/EC. © 2012 The Author(s).
ISSN: 14321831
Appears in Collections:Scopus 2011-2015

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