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      Comparison of Sofia Legionella FIA and BinaxNOW® Legionella urinary antigen card in two national reference centers

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          Abstract

          The Sofia Legionella Fluorescence Immunoassay (FIA; Quidel) is a recently introduced rapid immunochromatographic diagnostic test for Legionnaires’ disease using immunofluorescence technology designed to enhance its sensitivity. The aim of this study was to evaluate its performance for the detection of urinary antigens for Legionella pneumophila serogroup 1 in two National Reference Centers for Legionella. The sensitivity and specificity of the Sofia Legionella FIA test were determined in concentrated and nonconcentrated urine samples, before and after boiling, in comparison with the BinaxNOW® Legionella Urinary Antigen Card (UAC; Alere). Compared with BinaxNOW® Legionella UAC, the sensitivity of the Sofia Legionella test was slightly higher in nonconcentrated urine samples and was identical in concentrated urine samples. The specificity of the Sofia Legionella FIA test was highly reduced by the concentration of urine samples. In nonconcentrated samples, a lack of specificity was observed in 2.3 % of samples, all of them resolved by heat treatment. The Sofia Legionella FIA is a sensitive test for detecting Legionella urinary antigens with no previous urine concentration. However, all positive samples have to be re-tested after boiling to reach a high specificity. The reading is automatized on the Sofia analyzer, which can be connected to laboratory information systems, facilitating accurate and rapid reporting of results.

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          Legionnaires disease in Europe, 2009-2010.

          J. BEAUTÉ, P. ZUCS, B de Jong (2013)
          The surveillance of Legionnaires' disease (LD) in Europe is carried out by the European Legionnaires' Disease Surveillance Network (ELDSNet) and coordinated by the European Centre for Disease Prevention and Control (ECDC). All cases reported in 2009 and 2010 and meeting the European case definition were electronically transmitted to The European Surveillance System (TESSy) database. A total of 5,551 and 6,305 cases were reported by 29 European countries in 2009 and 2010, respectively. The age-standardised rate of all cases was 1.20 per 100,000 inhabitants in 2010, 12% higher than in 2009, which was consistent with the increasing trend observed since 2005. Most of this increase consisted of community-acquired cases reported by France, Germany and the Netherlands with dates of onset in August–September. The exceptionally hot summer of 2010 in some parts of Europe may have played a role in this increase.
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            Sensitivity of three urinary antigen tests associated with clinical severity in a large outbreak of Legionnaires' disease in The Netherlands.

            Marcel Peeters, Kamilla Lettinga, W Boer … (2002)
            In 1999 an outbreak involving 188 patients with Legionnaires' disease (LD) occurred among visitors to a flower show in the Netherlands. Two enzyme immunoassays (Binax and Biotest) and one immunochromatographic assay (Binax NOW) were tested, using urine samples from LD patients from the 1999 outbreak. Sensitivity was calculated using positive culture and/or seroconversion as the "gold standard" in outbreak-related patients with radiographically confirmed pneumonia who fulfilled the epidemiological critera. The Binax EIA, Biotest EIA, and Binax NOW assay showed overall sensitivities of 69, 71, and 72%, respectively. When the tests were performed with concentrated urine samples, the overall sensitivities increased to 79, 74, and 81%, respectively. Using multiple logistic regression analysis with backward elimination, a statistically significant association was found between clinical severity and test sensitivity for all tests. For patients with mild LD, the test sensitivities ranged from 40 to 53%, whereas for patients with severe LD who needed immediate special medical care, the sensitivities reached 88 to 100%. These findings have major implications for the diagnostic process in patients with mild pneumonia and suggest that patients with mild pneumonia may go underdiagnosed if urine antigen tests alone are used.
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              Evaluation of Sofia fluorescent immunoassay analyzer for influenza A/B virus.

              Chang Kyu Lee, Chi Hyun Cho, Mi Woo … (2012)
              The influenza virus causes seasonal epidemics which are associated with high morbidity and mortality. Rapid diagnostics tests (RDT) are frequently used to make a quick influenza diagnosis to confirm the clinical suspicion, despite their low sensitivity. Assess the performance of the Sofia Influenza A+B Fluorescence Immunoassay (Quidel, San Diego, CA). Nasopharyngeal swabs, taken from 241 patients (influenza A (n=73)/B (n=72), negative samples (n=96)) were analyzed using the Sofia Influenza A+B Fluorescence Immunoassay, BinaxNOW Influenza A/B antigen kit (Alere Inc., USA), Directigen EZ Flu A and B (Becton Dickinson, USA), real-time RT-PCR and an influenza virus culture. There was a significant difference between the performance of rapid antigen tests and the Sofia FIA, when compared to the RT-PCR, in the detection of influenza strain A and B. Indeed, the Sofia FIA displayed sensitivities of 82.2% and 77.8% for strains A and B respectively, whereas sensitivities of BinaxNOW Influenza A/B antigen kit, and Directigen Flu A and B were 54.8%, and 68.5% for influenza A, and 62.5%, and 52.8% for influenza B respectively. The average RT-PCR threshold cycle (C(t)) (±SD) for the Sofia Influenza A+B Fluorescence Immunoassay-positive specimens was higher than those of the BinaxNOW Influenza A/B antigen and the Directigen EZ Flu A and B kit positive specimens. Compared to other RDTs, the Sofia Influenza A+B Fluorescence Immunoassay is a sensitive, and rapid method for the detection and discrimination between influenza A and B. Copyright © 2012 Elsevier B.V. All rights reserved.
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                Author and article information

                Contributors
                S. Jarraud: sophie.jarraud@univ-lyon1.fr
                Journal
                Journal ID (nlm-ta): Eur J Clin Microbiol Infect Dis
                Journal ID (iso-abbrev): Eur. J. Clin. Microbiol. Infect. Dis
                Title: European Journal of Clinical Microbiology & Infectious Diseases
                Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )
                ISSN (Print): 0934-9723
                ISSN (Electronic): 1435-4373
                Publication date (Electronic): 20 June 2015
                Publication date PMC-release: 20 June 2015
                Publication date (Print): 2015
                Volume: 34
                Issue: 9
                Pages: 1803-1807
                Affiliations
                [ ]French Reference Center for Legionella, Laboratory of Microbiology, Groupe Hospitalier Est, Hospices Civils de Lyon, Lyon, France
                [ ]CIRI, International Center for Infectiology Research, Inserm, U1111 ; CNRS ; UMR5308, Université Lyon 1 ; École Normale Supérieure de Lyon, Lyon, F-69008 France
                [ ]Reference Center for Legionella, Laboratory of Microbiology, Department of Laboratory Medecine, Ente Ospedaliero Cantonale, Bellinzona, Switzerland
                Article
                Publisher ID: 2415
                DOI: 10.1007/s10096-015-2415-9
                PMC ID: 4545177
                PubMed ID: 26092030
                SO-VID: 1652495e-5cae-4af3-b031-b48c13c2a151
                Copyright © © The Author(s) 2015
                License:

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Date received : 8 April 2015
                Date accepted : 17 May 2015
                Categories
                Subject: Article
                Custom metadata
                issue-copyright-statement © Springer-Verlag Berlin Heidelberg 2015

                ScienceOpen disciplines: Infectious disease & Microbiology
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology

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