The objectives of this study were to evaluate the performance of the recently released IMMY Aspergillus galactomannan enzyme immunoassay (IMMY GM-EIA) when testing serum samples and to identify the optimal galactomannan index (GMI) positivity threshold for the diagnosis of invasive aspergillosis (IA). This was a retrospective case/control study, comprising 175 serum samples obtained from 131 patients, 35 of whom had probable or possible invasive fungal disease (IFD) as categorized using recently revised, internationally accepted definitions. The IMMY GM-EIA was performed following the manufacturer’s instructions. Performance parameters were determined and receiver operator characteristic analysis was used to identify an optimal GMI threshold. Concordance with the Bio-Rad Aspergillus Ag assay (Bio Rad GM-EIA) and IMMY sona Aspergillus lateral flow assay was assessed. The median GMIs generated by the IMMY GM-EIA for samples originating from probable IA/IFD cases (n = 31), possible IFD (n = 4), and control patients (n = 100) were 0.61, 0.11, and 0.14, respectively, and were comparable to those of the Bio-Rad GM-EIA (0.70, 0.04, and 0.04, respectively). Overall qualitative observed sample agreement between the IMMY GM-EIA and Bio-Rad GM-EIA was 94.7%, generating a kappa statistic of 0.820. At a GMI positivity threshold of ≥0.5, the IMMY GM-EIA had a sensitivity and specificity of 71% and 98%, respectively. Reducing the threshold to ≥0.27 generated sensitivity and specificity of 90% and 92%, respectively. The IMMY GM-EIA provides a comparable alternative to the Bio-Rad GM-EIA when testing serum samples. Further prospective, multicenter evaluations are required to confirm the optimal threshold and associated clinical performance.

中文翻译：

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评估 IMMY 曲霉半乳甘露聚糖酶联免疫吸附试验在检测血清以帮助诊断侵袭性曲霉病时的性能。

本研究的目的是评估最近发布的 IMMY曲霉半乳甘露聚糖酶免疫测定法 (IMMY GM-EIA) 在检测血清样本时的性能，并确定诊断侵袭性曲霉病 (IA) 的最佳半乳甘露聚糖指数 (GMI) 阳性阈值. 这是一项回顾性病例/对照研究，包括从 131 名患者中获得的 175 份血清样本，其中 35 名患者可能或可能患有侵袭性真菌病 (IFD)，使用最近修订的国际公认定义进行分类。IMMY GM-EIA 是按照制造商的说明进行的。确定了性能参数，并使用接收器操作员特征分析来确定最佳 GMI 阈值。与 Bio-Rad曲霉一致评估了 Ag 测定 (Bio Rad GM-EIA) 和 IMMY sona Aspergillus横向流动测定。IMMY GM-EIA 为来自可能的 IA/IFD 病例 ( n = 31)、可能的 IFD ( n = 4) 和对照患者 ( n= 100) 分别为 0.61、0.11 和 0.14，与 Bio-Rad GM-EIA 的值相当（分别为 0.70、0.04 和 0.04）。IMMY GM-EIA 和 Bio-Rad GM-EIA 之间的总体定性观察样本一致性为 94.7%，产生 0.820 的 kappa 统计量。在 GMI 阳性阈值≥0.5 时，IMMY GM-EIA 的敏感性和特异性分别为 71% 和 98%。将阈值降低到 ≥0.27 分别产生 90% 和 92% 的敏感性和特异性。在测试血清样本时，IMMY GM-EIA 提供了与 Bio-Rad GM-EIA 相当的替代方案。需要进一步的前瞻性、多中心评估来确认最佳阈值和相关的临床表现。