Mycopathologia ( IF 3.6 ) Pub Date : 2023-10-09 , DOI: 10.1007/s11046-023-00798-y
Sutapa Das 1 , Malini R Capoor 1 , Amitabh Singh 1 , Yatish Agarwal 1
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Objective
This study aims to determine the diagnostic utility of galactomannan enzyme immunoassay (GM EIA) in invasive aspergillosis (IA) in children with hematological malignancy (high risk population) in terms of sensitivity, specificity, negative predictive value (NPV) and positive predictive values (PPV) at various cut offs while validating the revised EORTC/MSG 2019 criteria in order to obtain the best cut-off.
Material and Methods
For 100 pediatric patients, serum and respiratory samples were collected. Clinical, mycological workup (potassium-hydroxide mount, fungal culture) and GM EIA was done to classify proven, probable, and possible IA as per EORTC-MSG guidelines,2019. Sensitivity, specificity, PPV and NPV were calculated of GM indices at cut-off 0.5, 0.7 and 1, and validated with revised EORTC -MSG, 2019.
Results
Of 100 patients enrolled, 75 were diagnosed with ALL, 14 with AML, two with Hodgkin's, three had non-Hodgkin lymphoma, and six had undifferentiated leukemia. With routine mycological findings, 51 were classified as probable IA, 11 as possible IA, and 38 as no IA. Aspergillus flavus was the most prevalent on culture (56.9%, 29/51) followed by A. fumigatus (29%, 15/51) A. niger (7.8%, 4/51), A. terreus (3.9%, 2/51) and A. nidulans (2%, 1/51). GM EIA demonstrated sensitivity 82.3%, specificity 97.4%, PPV 98.1%, and NPV 77.1% at cut-off 0.67 when comparing probable/possible IA v/s no IA groups. The GM EIA had the best sensitivity (82.4%), specificity (81.8%), PPV (95.5%), and NPV (50%) at cut off 0.78 when the probable IA group was compared to the possible IA. Seven patients succumbed of whom 5 had GMI ≥ 2.
Conclusion
This study deduces the optimal cut-off for serum GM EIA to be 0.67 obtained by ROC analysis when comparing possible and probable IA versus no IA and reinforces the definition of probable category of EORTC-MSG criteria, 2019. At 0.5 ODI the sensitivity (87.1%) and NPV (80.5%) are high, thus making it the most suitable cut-off for detecting true positive and ruling out IA respectively, in pediatric patients with hematological malignancy. GM EIA when performed adjunctive to clinico-radiological findings can prove to be screening, diagnostic and prognostic test for IA in pediatric hematological malignancy patients.
中文翻译：
半乳甘露聚糖酶免疫分析在儿童血液系统恶性肿瘤患者侵袭性曲霉菌病中的诊断价值
客观的
本研究旨在确定半乳甘露聚糖酶免疫分析（GM EIA）对血液恶性肿瘤儿童（高危人群）侵袭性曲霉病（IA）的诊断效用，包括敏感性、特异性、阴性预测值（NPV）和阳性预测值（NPV）。 PPV）在不同的截止值，同时验证修订后的 EORTC/MSG 2019 标准以获得最佳截止值。
材料与方法
收集了 100 名儿科患者的血清和呼吸道样本。根据 2019 年 EORTC-MSG 指南，进行了临床、真菌学检查（氢氧化钾封片、真菌培养）和 GM EIA，对已证实的、可能的和可能的 IA 进行分类。敏感性、特异性、PPV 和 NPV 是根据截止值 0.5、0.7 和 1 的 GM 指数计算的，并使用修订版 EORTC -MSG, 2019 进行验证。
结果
在纳入的 100 名患者中，75 名被诊断患有 ALL，14 名患有 AML，2 名患有霍奇金氏病，3 名患有非霍奇金淋巴瘤，6 名患有未分化白血病。根据常规真菌学检查结果，51 例被分类为可能 IA，11 例被分类为可能 IA，38 例被分类为无 IA。黄曲霉在培养物中最为普遍 (56.9%, 29/51)，其次是烟曲霉(29%, 15/51)黑曲霉 (7.8%, 4/51) 、黑曲霉(7.8%, 4/51)、黑曲霉 (29%, 15/51) 。terreus (3.9%, 2/51) 和A. nidulans (2%, 1/51)。当比较可能/可能的 IA 组与无 IA 组时，GM EIA 在截止值 0.67 时表现出敏感性 82.3%、特异性 97.4%、PPV 98.1% 和 NPV 77.1%。当将可能的 IA 组与可能的 IA 进行比较时，GM EIA 在截止值 0.78 时具有最佳的敏感性 (82.4%)、特异性 (81.8%)、PPV (95.5%) 和 NPV (50%)。7 名患者死亡，其中 5 名 GMI ≥ 2。
结论
本研究在比较可能和可能的 IA 与无 IA 时，推导出血清 GM EIA 的最佳截止值为 0.67，并强化了 2019 年 EORTC-MSG 标准的可能类别的定义。在 0.5 ODI 时，灵敏度 (87.1 %) 和 NPV (80.5%) 较高，因此使其成为血液恶性肿瘤儿科患者中分别检测真阳性和排除 IA 的最合适的临界点。GM EIA 与临床放射学检查结果一起进行时，可以证明是儿童血液恶性肿瘤患者 IA 的筛查、诊断和预后测试。
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