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.
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。