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

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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Main Authors: 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)
Format: Article
Language:English
Published: MDPI AG 2024-11-01
Series:Journal of Fungi
Subjects:
Galactomannan Ag
Platelia Aspergillus
VirClia <i>Aspergillus</i> Galactomannan antigen
Online Access:https://www.mdpi.com/2309-608X/10/11/793
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Summary: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.
ISSN:2309-608X

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