Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA Assay
The analytical performance of the new <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test (Vircell S.L.) was compared to the Platelia™ <i>Aspergillus</i> Ag ELISA assay (Bio-Rad). Prospective serum and bronchoalveolar lavage (BAL) samples from patien...
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2024-11-01
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| author | Giuliana Lo Cascio Valentina Lepera Annarita Sorrentino Domenico Caleca Paolo Gigante Gabriella Tocci Alda Bazaj Annalisa Mancini Marina Bolzoni Evelina Cattadori Davide Gibellini Chiara Gorrini Claudio Farina Roberta Schiavo on behalf of the Medical Mycology Committee (CoSM)—Italian Association of Clinical Microbiology (AMCLI) |
| author_facet | Giuliana Lo Cascio Valentina Lepera Annarita Sorrentino Domenico Caleca Paolo Gigante Gabriella Tocci Alda Bazaj Annalisa Mancini Marina Bolzoni Evelina Cattadori Davide Gibellini Chiara Gorrini Claudio Farina Roberta Schiavo on behalf of the Medical Mycology Committee (CoSM)—Italian Association of Clinical Microbiology (AMCLI) |
| author_sort | Giuliana Lo Cascio |
| collection | DOAJ |
| description | The analytical performance of the new <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test (Vircell S.L.) was compared to the Platelia™ <i>Aspergillus</i> 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 <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test and the Platelia™ <i>Aspergillus</i> 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 <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test and the Platelia™ <i>Aspergillus</i> Ag ELISA assay was 87.8%, with a Cohen’s kappa of 0.75. The sensitivity and specificity of the <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> 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 <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test demonstrated an area under the curve (AUC) of 0.87, and the Youden index at the manufacturer’s established cutoff was 0.73. This new <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test exhibited adequate analytical and clinical performance, showing good correlation with the Platelia™ <i>Aspergillus</i> 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. |
| format | Article |
| id | doaj-art-c40d16873c9b4d53b69ab02ec5295843 |
| institution | DOAJ |
| issn | 2309-608X |
| language | English |
| publishDate | 2024-11-01 |
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| spelling | doaj-art-c40d16873c9b4d53b69ab02ec52958432025-08-20T02:47:58ZengMDPI AGJournal of Fungi2309-608X2024-11-01101179310.3390/jof10110793Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA AssayGiuliana Lo Cascio0Valentina Lepera1Annarita Sorrentino2Domenico Caleca3Paolo Gigante4Gabriella Tocci5Alda Bazaj6Annalisa Mancini7Marina Bolzoni8Evelina Cattadori9Davide Gibellini10Chiara Gorrini11Claudio Farina12Roberta Schiavo13on behalf of the Medical Mycology Committee (CoSM)—Italian Association of Clinical Microbiology (AMCLI)Clinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyClinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyClinical Microbiology and Virology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, ItalyClinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyClinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyClinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyClinical Microbiology and Virology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, ItalyQuality & Research Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyQuality & Research Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyQuality & Research Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyClinical Microbiology and Virology Unit, Azienda Ospedaliera Universitaria Integrata, 37134 Verona, ItalyClinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyMedical Mycology Committee (CoSM)—Italian Association of Clinical Microbiology (AMCLI), 20159 Milano, ItalyClinical Microbiology and Virology Unit, Azienda USL di Piacenza, 29121 Piacenza, ItalyThe analytical performance of the new <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test (Vircell S.L.) was compared to the Platelia™ <i>Aspergillus</i> 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 <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test and the Platelia™ <i>Aspergillus</i> 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 <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test and the Platelia™ <i>Aspergillus</i> Ag ELISA assay was 87.8%, with a Cohen’s kappa of 0.75. The sensitivity and specificity of the <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> 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 <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test demonstrated an area under the curve (AUC) of 0.87, and the Youden index at the manufacturer’s established cutoff was 0.73. This new <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> mono-test exhibited adequate analytical and clinical performance, showing good correlation with the Platelia™ <i>Aspergillus</i> 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.https://www.mdpi.com/2309-608X/10/11/793Galactomannan AgPlatelia AspergillusVirClia <i>Aspergillus</i> Galactomannan antigen |
| spellingShingle | Giuliana Lo Cascio Valentina Lepera Annarita Sorrentino Domenico Caleca Paolo Gigante Gabriella Tocci Alda Bazaj Annalisa Mancini Marina Bolzoni Evelina Cattadori Davide Gibellini Chiara Gorrini Claudio Farina Roberta Schiavo on behalf of the Medical Mycology Committee (CoSM)—Italian Association of Clinical Microbiology (AMCLI) Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA Assay Journal of Fungi Galactomannan Ag Platelia Aspergillus VirClia <i>Aspergillus</i> Galactomannan antigen |
| title | Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA Assay |
| title_full | Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA Assay |
| title_fullStr | Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA Assay |
| title_full_unstemmed | Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA Assay |
| title_short | Evaluation of a New Automated Mono-Test for the Detection of <i>Aspergillus</i> Galactomannan: Comparison of <i>Aspergillus</i> Galactomannan Ag VirCLIA<sup>®</sup> Mono-Test with Platelia<sup>TM</sup> <i>Aspergillus</i> Ag ELISA Assay |
| title_sort | evaluation of a new automated mono test for the detection of i aspergillus i galactomannan comparison of i aspergillus i galactomannan ag virclia sup r sup mono test with platelia sup tm sup i aspergillus i ag elisa assay |
| topic | Galactomannan Ag Platelia Aspergillus VirClia <i>Aspergillus</i> Galactomannan antigen |
| url | https://www.mdpi.com/2309-608X/10/11/793 |
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