Journal of Fungi (Nov 2024)

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

  • 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)

DOI
https://doi.org/10.3390/jof10110793
Journal volume & issue
Vol. 10, no. 11
p. 793

Abstract

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The analytical performance of the new Aspergillus Galactomannan Ag VirCLIA® mono-test (Vircell S.L.) was compared to the Platelia™ 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® mono-test and the Platelia™ 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® mono-test and the Platelia™ Aspergillus Ag ELISA assay was 87.8%, with a Cohen’s kappa of 0.75. The sensitivity and specificity of the Aspergillus Galactomannan Ag VirCLIA® 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® 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 Aspergillus Galactomannan Ag VirCLIA® mono-test exhibited adequate analytical and clinical performance, showing good correlation with the Platelia™ 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.

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