Department of Hematology, University of Health Sciences, Istanbul Training and Research Hospital, Istanbul, Turkey.
Department of Internal Medicine and Hematology, Istinye University, Liv Hospital ULUS, Istanbul, Turkey.
Mycoses. 2021 Jun;64(6):678-683. doi: 10.1111/myc.13265. Epub 2021 Mar 15.
Aspergillus species meet the most important group of invasive fungal diseases (IFD) in immunosuppressed patients. Galactomannan is a polysaccharide antigen located in the wall structure of Aspergillus. The most commonly used method for antigen detection is enzyme-linked immunoassay (ELISA). Aspergillus galactomannan lateral flow assay (LFA) constitutes one of the new methods in the diagnosis of invasive aspergillosis (IA). The goal of this study was to demonstrate efficacy of LFA in our patients and to compare it to synchronous ELISA results.
Galactomannan antigen was examined using both LFA and ELISA in serum samples taken from patients who were followed up in our haematology clinic. All patients are classified in subgroups as 'proven', 'probable' and 'possible' patients according to the last EORTC / MSG guideline. Patients who met the 'proven' IA criteria were included in the study as the gold standard.
A total of 87 patients were included in the study. Majority of patients had acute myeloid leukaemia (AML) (56.3%). Eleven (12.6%) were in 'proven' IA group. LFA test showed a superior diagnostic performance compared with ELISA (LFA = 0.934 vs ELISA = 0.545; p < .001). The LFA had a sensitivity of 90.9% and a specificity of 90.8% for '0.5 ODI' in predicting IA (PPV = 55.8%; NPV = 98.6%; p < .001).
The most important finding of this study is that the specificity of LFA was found to be higher for cut-off value of 0.5. It is recommended to combine the methods in many studies to provide a better early diagnosis for IA.
曲霉菌属是免疫抑制患者侵袭性真菌感染（IFD）最重要的一组病原体。半乳甘露聚糖是一种位于曲霉菌细胞壁结构中的多糖抗原。最常用的抗原检测方法是酶联免疫吸附试验（ELISA）。曲霉半乳甘露聚糖侧向流检测（LFA）是侵袭性曲霉病（IA）诊断的新方法之一。本研究的目的是证明 LFA 在我们患者中的疗效，并将其与同步 ELISA 结果进行比较。
在我们血液科诊所随访的患者的血清样本中，同时使用 LFA 和 ELISA 检测半乳甘露聚糖抗原。所有患者根据最新的 EORTC / MSG 指南分为“确诊”、“可能”和“疑似”患者亚组。符合“确诊”IA 标准的患者被纳入研究作为金标准。
共有 87 名患者纳入研究。大多数患者患有急性髓细胞白血病（AML）（56.3%）。11 名（12.6%）患者为“确诊”IA 组。LFA 试验的诊断性能优于 ELISA（LFA=0.934 vs ELISA=0.545；p<.001）。LFA 对预测 IA 的“0.5 ODI”具有 90.9%的敏感性和 90.8%的特异性（PPV=55.8%；NPV=98.6%；p<.001）。
本研究的重要发现是，对于 0.5 的截止值，LFA 的特异性较高。建议在许多研究中结合使用这些方法，为 IA 提供更好的早期诊断。
