The analytical performance of the new Aspergillus Galactomannan Ag VirCLIA (R) mono-test (Vircell S.L.) was compared to the Platelia (TM) 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 (R) mono-test and the Platelia (TM) 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 (R) mono-test and the Platelia (TM) 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 (R) 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 (R) 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 (R) mono-test exhibited adequate analytical and clinical performance, showing good correlation with the Platelia (TM) 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.

Evaluation of a New Automated Mono-Test for the Detection of Aspergillus Galactomannan: Comparison of Aspergillus Galactomannan Ag VirCLIA® Mono-Test with PlateliaTM Aspergillus Ag ELISA Assay / Lo Cascio, G.; Lepera, V.; Sorrentino, A.; Caleca, D.; Gigante, P.; Tocci, G.; Bazaj, A.; Mancini, A.; Bolzoni, M.; Cattadori, E.; Gibellini, D.; Gorrini, C.; Farina, C.; Schiavo, R.. - In: JOURNAL OF FUNGI. - ISSN 2309-608X. - 10:11(2024). [10.3390/jof10110793]

Evaluation of a New Automated Mono-Test for the Detection of Aspergillus Galactomannan: Comparison of Aspergillus Galactomannan Ag VirCLIA® Mono-Test with PlateliaTM Aspergillus Ag ELISA Assay

Lo Cascio G.
;
Caleca D.;Gigante P.;Bolzoni M.;Cattadori E.;Gorrini C.;Farina C.;
2024-01-01

Abstract

The analytical performance of the new Aspergillus Galactomannan Ag VirCLIA (R) mono-test (Vircell S.L.) was compared to the Platelia (TM) 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 (R) mono-test and the Platelia (TM) 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 (R) mono-test and the Platelia (TM) 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 (R) 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 (R) 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 (R) mono-test exhibited adequate analytical and clinical performance, showing good correlation with the Platelia (TM) 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.
2024
Evaluation of a New Automated Mono-Test for the Detection of Aspergillus Galactomannan: Comparison of Aspergillus Galactomannan Ag VirCLIA® Mono-Test with PlateliaTM Aspergillus Ag ELISA Assay / Lo Cascio, G.; Lepera, V.; Sorrentino, A.; Caleca, D.; Gigante, P.; Tocci, G.; Bazaj, A.; Mancini, A.; Bolzoni, M.; Cattadori, E.; Gibellini, D.; Gorrini, C.; Farina, C.; Schiavo, R.. - In: JOURNAL OF FUNGI. - ISSN 2309-608X. - 10:11(2024). [10.3390/jof10110793]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/3013937
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