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

2013Journal article Open access
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dc.contributor.authorMühlbacher, A
dc.contributor.authorSchennach, H
dc.contributor.authorvan Helden, J
dc.contributor.authorHebell, T
dc.contributor.authorPantaleo, G
dc.contributor.authorBürgisser, P
dc.contributor.authorSousa, JG, et al.
dc.date.accessioned2014-01-29T15:40:33Z
dc.date.available2014-01-29T15:40:33Z
dc.date.issued2013
dc.description.abstractEducation 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.por
dc.identifier.citationMed Microbiol Immunol. 2013 Feb;202(1):77-86por
dc.identifier.issn1432-1831
dc.identifier.urihttp://hdl.handle.net/10400.10/1061
dc.language.isoengpor
dc.peerreviewedyespor
dc.publisherSpringerpor
dc.relation.publisherversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3562432/por
dc.subjectHIV antibodiespor
dc.subjectHIV infectionspor
dc.subjectClinical laboratory techniquespor
dc.titlePerformance evaluation of a new fourth-generation HIV combination antigen-antibody assaypor
dc.typejournal article
dspace.entity.typePublication
oaire.citation.conferencePlaceBerlinpor
oaire.citation.endPage86por
oaire.citation.startPage77por
oaire.citation.titleMedical microbiology and immunologypor
oaire.citation.volume202por
rcaap.rightsopenAccesspor
rcaap.typearticlepor

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