Mikrobiologisches Institut-Klinische Mikrobiologie, Immunologie und Hygiene, Universitätsklinikum Erlangen und Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.
Department für Hämatologie/Onkologie, Medizinische Klinik 5, Universitätsklinikum Erlangen und Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.
Mycoses. 2024 Aug;67(8):e13782. doi: 10.1111/myc.13782.
Rapid galactomannan tests, such as the sõna Aspergillus GM Lateral Flow Assay (GM-LFA) and the Aspergillus Galactomannan Ag VIRCLIA® Monotest (GM-Monotest), which are suitable for the analysis of single samples, have the potential to accelerate diagnosis of invasive aspergillosis (IA).
To compare the performance of the GM-Monotest and the GM-LFA for the diagnosis of IA.
PATIENTS/METHODS: Two patient cohorts were analysed: adults who had received an allogeneic haematopoietic stem-cell transplant (alloHSCT-cohort) and patients with proven/probable IA from a 5-year period (cross-sectional IA-cohort). In the alloHSCT-cohort, weekly serum samples were tested, whereas in the cross-sectional IA-cohort sera and bronchoalveolar lavage fluids were analysed. The diagnostic performance was calculated using two definitions for positivity: (1) a single positive GM result and (2) at least two positive GM results from consecutive samples. IA classification followed EORTC/MSG 2019.
The alloHSCT-cohort included 101 patients. Four had proven/probable IA, 26 possible IA and 71 no IA. The specificity for one positive serum and two consecutively positive sera was 88.7% and 100% (GM-Monotest) and 85.9% and 98.6% (GM-LFA). Comparison of ROC curves in the alloHSCT-cohort showed no significant difference. The cross-sectional IA-cohort included 59 patients with proven/probable IA. The sensitivity for one positive sample and two consecutively positive samples was 83.1% and 55.1% (GM-Monotest) and 86.4% and 71.4% (GM-LFA).
Both assays showed comparable diagnostic performance with a higher sensitivity for the GM-LFA if two consecutive positive samples were required for positivity. However, due to poor reproducibility, positive GM-LFA results should always be confirmed.
适用于单个样本分析的快速半乳甘露聚糖检测，如 sõna 曲霉 GM 侧向流动检测（GM-LFA）和曲霉半乳甘露聚糖 Ag VIRCLIA® 单测试（GM-Monotest），具有加速侵袭性曲霉病（IA）诊断的潜力。
比较 GM-Monotest 和 GM-LFA 对 IA 诊断的性能。
患者/方法：分析了两个患者队列：接受异基因造血干细胞移植（alloHSCT-队列）的成年人和来自 5 年期间的确诊/可能 IA 患者（横断面 IA-队列）。在 alloHSCT 队列中，每周检测血清样本，而在横断面 IA 队列中，分析血清和支气管肺泡灌洗液。使用两种阳性定义计算诊断性能：（1）单个 GM 阳性结果和（2）连续样本中的至少两个 GM 阳性结果。IA 分类遵循 EORTC/MSG 2019。
alloHSCT 队列包括 101 名患者。4 例确诊/可能 IA，26 例可能 IA，71 例无 IA。一个阳性血清和两个连续阳性血清的特异性分别为 88.7%和 100%（GM-Monotest）和 85.9%和 98.6%（GM-LFA）。在 alloHSCT 队列中比较 ROC 曲线显示无显著差异。横断面 IA 队列包括 59 例确诊/可能 IA 患者。一个阳性样本和两个连续阳性样本的敏感性分别为 83.1%和 55.1%（GM-Monotest）和 86.4%和 71.4%（GM-LFA）。
两种检测方法均具有相当的诊断性能，如果需要两个连续阳性样本才能确定阳性，则 GM-LFA 的敏感性更高。然而，由于重现性差，GM-LFA 的阳性结果应始终得到确认。
