Abstract：
BACKGROUND: 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).
OBJECTIVE: To compare the performance of the GM-Monotest and the GM-LFA for the diagnosis of IA.
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.
RESULTS: 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).
CONCLUSIONS: 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.
OBJECTIVE: To compare the performance of the GM-Monotest and the GM-LFA for the diagnosis of IA.
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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
背景：快速半乳甘露聚糖测试，例如sna曲霉GM侧流测定(GM-LFA)和曲霉半乳甘露聚糖AgVIRCLIA®Monotest(GM-Monotest),适用于单个样品的分析，有可能加速侵袭性曲霉病（IA）的诊断。
目的：比较GM-Monotest和GM-LFA诊断IA的性能。
方法：分析了两个患者队列：接受异基因造血干细胞移植的成人（alloHSCT队列）和5年后证实/可能患有IA的患者（横断面IA队列）。在alloHSCT队列中，每周检测血清样本，而在横截面IA队列中，分析了血清和支气管肺泡灌洗液。使用两个阳性定义计算诊断性能:(1)单个阳性GM结果和(2)来自连续样品的至少两个阳性GM结果。IA分类遵循EORTC/MSG2019。
结果：alloHSCT队列包括101例患者。四个已经证明/可能的IA，26个可能的IA和71个没有IA。一种阳性血清和两种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）。alloHSCT队列中ROC曲线的比较没有显着差异。横断面IA队列包括59例确诊/可能的IA患者。一个阳性样本和两个连续阳性样本的灵敏度分别为83.1％和55.1％（GM-Monotest）和86.4％和71.4％（GM-LFA）。
结论：如果需要两个连续的阳性样本来检测阳性，两种检测方法均显示出相当的诊断性能，对GM-LFA具有更高的灵敏度。然而,由于重现性差，GM-LFA阳性结果应始终得到确认。
目的：比较GM-Monotest和GM-LFA诊断IA的性能。
方法：分析了两个患者队列：接受异基因造血干细胞移植的成人（alloHSCT队列）和5年后证实/可能患有IA的患者（横断面IA队列）。在alloHSCT队列中，每周检测血清样本，而在横截面IA队列中，分析了血清和支气管肺泡灌洗液。使用两个阳性定义计算诊断性能:(1)单个阳性GM结果和(2)来自连续样品的至少两个阳性GM结果。IA分类遵循EORTC/MSG2019。
结果：alloHSCT队列包括101例患者。四个已经证明/可能的IA，26个可能的IA和71个没有IA。一种阳性血清和两种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）。alloHSCT队列中ROC曲线的比较没有显着差异。横断面IA队列包括59例确诊/可能的IA患者。一个阳性样本和两个连续阳性样本的灵敏度分别为83.1％和55.1％（GM-Monotest）和86.4％和71.4％（GM-LFA）。
结论：如果需要两个连续的阳性样本来检测阳性，两种检测方法均显示出相当的诊断性能，对GM-LFA具有更高的灵敏度。然而,由于重现性差，GM-LFA阳性结果应始终得到确认。
