{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T06:08:00Z","timestamp":1784614080076,"version":"3.55.0"},"reference-count":21,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2024,11,15]],"date-time":"2024-11-15T00:00:00Z","timestamp":1731628800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JoF"],"abstract":"<jats:p>The analytical performance of the new Aspergillus Galactomannan Ag VirCLIA\u00ae mono-test (Vircell S.L.) was compared to the Platelia\u2122 Aspergillus Ag ELISA assay (Bio-Rad). Prospective serum and bronchoalveolar lavage (BAL) samples from patients at risk of invasive aspergillosis (IA) were tested using both the Aspergillus Galactomannan Ag VirCLIA\u00ae mono-test and the Platelia\u2122 Aspergillus Ag ELISA assay. Concordance, sensitivity, specificity, and positive and negative predictive values were calculated using the manufacturer-recommended cutoff levels. Receiver operating characteristic (ROC) analysis and the Youden index were performed to determine the optimal cutoff. A total of 187 serum samples and 73 BAL samples were analyzed with both assays. The concordance between the Aspergillus Galactomannan Ag VirCLIA\u00ae mono-test and the Platelia\u2122 Aspergillus Ag ELISA assay was 87.8%, with a Cohen\u2019s kappa of 0.75. The sensitivity and specificity of the Aspergillus Galactomannan Ag VirCLIA\u00ae mono-test were 78.6% and 96.2%, respectively, with positive and negative predictive values of 94.8% and 83.3%. The ROC curve for the Aspergillus Galactomannan Ag VirCLIA\u00ae mono-test demonstrated an area under the curve (AUC) of 0.87, and the Youden index at the manufacturer\u2019s established cutoff was 0.73. This new Aspergillus Galactomannan Ag VirCLIA\u00ae mono-test exhibited adequate analytical and clinical performance, showing good correlation with the Platelia\u2122 Aspergillus Ag ELISA assay. The single-sample, semi-automated test is user-friendly, allowing small laboratories to perform the test on demand without the need for batch evaluations, providing a useful solution for timely diagnostic support for clinicians.<\/jats:p>","DOI":"10.3390\/jof10110793","type":"journal-article","created":{"date-parts":[[2024,11,15]],"date-time":"2024-11-15T05:33:04Z","timestamp":1731648784000},"page":"793","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Evaluation of a New Automated Mono-Test for the Detection of Aspergillus Galactomannan: Comparison of Aspergillus Galactomannan Ag VirCLIA\u00ae Mono-Test with PlateliaTM\u00a0Aspergillus Ag ELISA Assay"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3971-2008","authenticated-orcid":false,"given":"Giuliana","family":"Lo Cascio","sequence":"first","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"},{"name":"Department of Medicine and Surgery, University of Parma, 43125 Parma, Italy"},{"name":"Medical Mycology Committee (CoSM)\u2014Italian Association of Clinical Microbiology (AMCLI), 20159 Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6269-3330","authenticated-orcid":false,"given":"Valentina","family":"Lepera","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annarita","family":"Sorrentino","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico","family":"Caleca","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Gigante","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"Tocci","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alda","family":"Bazaj","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalisa","family":"Mancini","sequence":"additional","affiliation":[{"name":"Quality & Research Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0821-8093","authenticated-orcid":false,"given":"Marina","family":"Bolzoni","sequence":"additional","affiliation":[{"name":"Quality & Research Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evelina","family":"Cattadori","sequence":"additional","affiliation":[{"name":"Quality & Research Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davide","family":"Gibellini","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Gorrini","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2298-4293","authenticated-orcid":false,"given":"Claudio","family":"Farina","sequence":"additional","affiliation":[{"name":"Medical Mycology Committee (CoSM)\u2014Italian Association of Clinical Microbiology (AMCLI), 20159 Milano, Italy"},{"name":"Clinical Microbiology and Virology Unit, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0286-039X","authenticated-orcid":false,"given":"Roberta","family":"Schiavo","sequence":"additional","affiliation":[{"name":"Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the Medical Mycology Committee (CoSM)\u2014Italian Association of Clinical Microbiology (AMCLI)","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,11,15]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"165rv13","DOI":"10.1126\/scitranslmed.3004404","article-title":"Hidden Killers: Human Fungal Infections","volume":"4","author":"Brown","year":"2012","journal-title":"Sci. Transl. Med."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1524","DOI":"10.1007\/s00134-020-06091-6","article-title":"Review of influenza-associated pulmonary aspergillosis in ICU patients and proposal for a case definition: An expert opinion","volume":"46","author":"Verweij","year":"2020","journal-title":"Intensive Care. Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1111\/myc.13096","article-title":"COVID-19 associated pulmonary aspergillosis","volume":"63","author":"Koehler","year":"2020","journal-title":"Mycoses"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1016\/j.jointm.2021.07.001","article-title":"COVID-19-Associated Pulmonary Aspergillosis (CAPA)","volume":"1","author":"Dimopoulos","year":"2021","journal-title":"J. Intensiv. Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"580","DOI":"10.1016\/j.cmi.2021.08.014","article-title":"Risk factors and outcome of pulmonary aspergillosis in critically ill coronavirus disease 2019 patients\u2014A multinational observational study by the European Confederation of Medical Mycology","volume":"28","author":"Prattes","year":"2022","journal-title":"Clin. Microbiol. Infect."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1093\/cid\/ciw326","article-title":"Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America","volume":"63","author":"Patterson","year":"2016","journal-title":"Clin. Infect. Dis."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1016\/j.cmi.2018.01.002","article-title":"Diagnosis and management of Aspergillus diseases: Executive summary of the 2017 ESCMID-ECMM-ERS guideline","volume":"24","author":"Ullmann","year":"2018","journal-title":"Clin. Microbiol. Infect."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Patterson, T.F., and Donnelly, J.P. (2019). New Concepts in Diagnostics for Invasive Mycoses: Non-Culture-Based Methodologies. J. Fungi., 5.","DOI":"10.3390\/jof5010009"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1051","DOI":"10.1128\/JCM.05946-11","article-title":"Cross-Reactivity of Fusarium spp. in the Aspergillus Galactomannan Enzyme-Linked Immunosorbent Assay","volume":"50","author":"Tortorano","year":"2012","journal-title":"J. Clin. Microbiol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"e00140-18","DOI":"10.1128\/CMR.00140-18","article-title":"Aspergillus fumigatus and Aspergillosis in 2019","volume":"33","author":"Chamilos","year":"2019","journal-title":"Clin. Microbiol. Rev."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Fontaine, T., and Latg\u00e9, J.-P. (2020). Galactomannan Produced by Aspergillus. fumigatus: An Update on the Structure, Biosynthesis and Biological Functions of an Emblematic Fungal Biomarker. J. Fungi., 6.","DOI":"10.3390\/jof6040283"},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Calero, A.L., Alonso, R., Gadea, I., Vega, M.D.M., Garc\u00eda, M.M., Mu\u00f1oz, P., Machado, M., Bouza, E., and Garc\u00eda-Rodr\u00edguez, J. (2022). Comparison of the Performance of Two Galactomannan Detection Tests: Platelia Aspergillus Ag and Aspergillus Galactomannan Ag Virclia Monotest. Microbiol. Spectr., 10.","DOI":"10.1128\/spectrum.02626-21"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1367","DOI":"10.1093\/cid\/ciz1008","article-title":"Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium","volume":"71","author":"Donnelly","year":"2020","journal-title":"Clin. Infect. Dis."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"826","DOI":"10.1148\/radiol.2015151516","article-title":"STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies","volume":"277","author":"Bossuyt","year":"2015","journal-title":"Radiology"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"420","DOI":"10.1111\/myc.13056","article-title":"Invasive pulmonary aspergillosis treatment duration in haematology patients in Europe: An EFISG, IDWP-EBMT, EORTC-IDG and SEIFEM survey","volume":"63","author":"Lanternier","year":"2020","journal-title":"Mycoses"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"2153","DOI":"10.1128\/JCM.00345-17","article-title":"Diagnostic Value of Galactomannan Antigen Test in Serum and Bronchoalveolar Lavage Fluid Samples from Patients with Nonneutropenic Invasive Pulmonary Aspergillosis","volume":"55","author":"Zhou","year":"2017","journal-title":"J. Clin. Microbiol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1094","DOI":"10.1016\/j.rmed.2013.04.007","article-title":"The utility of galactomannan antigen in the bronchial washing and serum for diagnosing pulmonary aspergillosis","volume":"107","author":"Kono","year":"2013","journal-title":"Respir. Med."},{"key":"ref_18","doi-asserted-by":"crossref","unstructured":"Zhang, S.X., Babady, N.E., Hanson, K.E., Harrington, A.T., Larkin, P.M.K., Leal, S.M., Luethy, P.M., Martin, I.W., Pancholi, P., and Procop, G.W. (2021). Recognition of Diagnostic Gaps for Laboratory Diagnosis of Fungal Diseases: Expert Opinion from the Fungal Diagnostics Laboratories Consortium (FDLC). J. Clin. Microbiol., 59.","DOI":"10.1128\/JCM.01784-20"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"2858","DOI":"10.1128\/JCM.00050-07","article-title":"Detection of Circulating Galactomannan in Serum Samples for Diagnosis of Penicillium marneffei Infection and Cryptococcosis among Patients Infected with Human Immunodeficiency Virus","volume":"45","author":"Huang","year":"2007","journal-title":"J. Clin. Microbiol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1095","DOI":"10.1128\/CVI.00068-08","article-title":"Development of an Immunochromatographic Lateral-Flow Device for Rapid Serodiagnosis of Invasive Aspergillosis","volume":"15","author":"Thornton","year":"2008","journal-title":"Clin. Vaccine. Immunol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"e00136-19","DOI":"10.1128\/JCM.00136-19","article-title":"Evaluation of a Novel Aspergillus. Antigen Enzyme-Linked Immunosorbent Assay","volume":"57","author":"Dichtl","year":"2019","journal-title":"J. Clin. Microbiol."}],"container-title":["Journal of Fungi"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2309-608X\/10\/11\/793\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T16:32:47Z","timestamp":1760113967000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2309-608X\/10\/11\/793"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,15]]},"references-count":21,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2024,11]]}},"alternative-id":["jof10110793"],"URL":"https:\/\/doi.org\/10.3390\/jof10110793","relation":{},"ISSN":["2309-608X"],"issn-type":[{"value":"2309-608X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,15]]}}}