评估用于检测曲霉菌半乳甘露聚糖的新型自动单一检测法：曲霉菌半乳甘露聚糖 Ag VirCLIA® Mono-Test 与 PlateliaTMAspergillus Ag ELISA Assay 的比较。

IF 4.2 2区生物学 Q2 MICROBIOLOGY

Journal of Fungi Pub Date : 2024-11-15 DOI:10.3390/jof10110793

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

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引用次数: 0

摘要

将新型曲霉菌半乳甘露聚糖Ag VirCLIA® 单检测试剂盒（Vircell S.L.公司）的分析性能与Platelia™曲霉菌Ag ELISA检测试剂盒（Bio-Rad公司）进行了比较。使用曲霉菌半乳甘露聚糖 Ag VirCLIA® 单项检测法和 Platelia™ 曲霉菌 Ag ELISA 检测法检测了有侵袭性曲霉菌病（IA）风险的患者的前瞻性血清和支气管肺泡灌洗液（BAL）样本。使用制造商推荐的临界值计算了一致性、灵敏度、特异性以及阳性和阴性预测值。为确定最佳临界值，还进行了接收者操作特征（ROC）分析和尤登指数（Youden index）分析。两种检测方法共分析了 187 份血清样本和 73 份 BAL 样本。曲霉菌半乳甘露聚糖 Ag VirCLIA® 单检测法与 Platelia™ 曲霉菌 Ag ELISA 检测法的一致性为 87.8%，科恩卡帕值为 0.75。曲霉菌半乳甘露聚糖 Ag VirCLIA® 单项检测的灵敏度和特异性分别为 78.6% 和 96.2%，阳性和阴性预测值分别为 94.8% 和 83.3%。曲霉菌半乳甘露聚糖 Ag VirCLIA® 单检测试剂盒的 ROC 曲线显示曲线下面积 (AUC) 为 0.87，在制造商设定的临界值下，尤登指数为 0.73。这种新型曲霉菌半乳甘露聚糖 Ag VirCLIA® 单检测试剂盒具有良好的分析和临床性能，与 Platelia™ 曲霉菌 Ag ELISA 检测试剂盒具有良好的相关性。这种单样品半自动检测方法操作简便，小型实验室可按需进行检测，无需批量评估，为临床医生及时提供诊断支持提供了有用的解决方案。

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

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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来源期刊

Journal of Fungi Medicine-Microbiology (medical)

CiteScore

6.70

自引率

14.90%

发文量

1151

审稿时长

11 weeks

期刊介绍： Journal of Fungi (ISSN 2309-608X) is an international, peer-reviewed scientific open access journal that provides an advanced forum for studies related to pathogenic fungi, fungal biology, and all other aspects of fungal research. The journal publishes reviews, regular research papers, and communications in quarterly issues. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. Therefore, there is no restriction on paper length. Full experimental details must be provided so that the results can be reproduced.