Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay.

Détails

Ressource 1Télécharger: BIB_95AE603EC052.P001.pdf (224.67 [Ko])
Etat: Public
Version: de l'auteur
ID Serval
serval:BIB_95AE603EC052
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay.
Périodique
Medical Microbiology and Immunology
Auteur(s)
Mühlbacher A., Schennach H., van Helden J., Hebell T., Pantaleo G., Bürgisser P., Cellerai C., Permpikul P., Rodriguez M.I., Eiras A., Alborino F., Cunningham P., Axelsson M., Andersson S., Wetlitzky O., Kaiser C., Möller P., de Sousa G.
ISSN
1432-1831 (Electronic)
ISSN-L
0300-8584
Statut éditorial
Publié
Date de publication
2013
Volume
202
Numéro
1
Pages
77-86
Langue
anglais
Notes
Publication types: Journal Article Publication Status: ppublish PDF type: Article
Résumé
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.
Pubmed
Web of science
Open Access
Oui
Création de la notice
05/02/2013 11:50
Dernière modification de la notice
20/08/2019 15:58
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