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1,3-β-D-葡聚糖血清筛查在接受造血干细胞移植患者中的诊断效能

Diagnostic performance of 1,3-beta-D-glucan serum screening in patients receiving hematopoietic stem cell transplantation.

作者信息

Reischies F M J, Prattes J, Woelfler A, Eigl S, Hoenigl M

机构信息

Section of Infectious Diseases and Tropical Medicine, Medical University of Graz, Graz, Austria.

Center for Biomarker Research in Medicine, Graz, Austria.

出版信息

Transpl Infect Dis. 2016 Jun;18(3):466-70. doi: 10.1111/tid.12527. Epub 2016 May 10.

Abstract

BACKGROUND

The polysaccharide cell wall component, 1,3-beta-D-glucan (BDG), is used as a serum biomarker for invasive fungal infection (IFI). Patients receiving hematopoietic stem cell transplantation (HSCT) are considered a highly vulnerable group for IFI development. We evaluated the diagnostic performance of serum BDG screening in HSCT recipients.

METHODS

HSCT recipients were prospectively enrolled in this study between September 2014 and August 2015. Routine serum BDG screening was performed 2-3 times weekly by using the Fungitell(®) assay. All samples were classified according to the 2008 EORTC/MSG criteria, with serum BDG results not being considered for classification. The diagnostic performance of BDG testing for IFI was calculated. BDG values ≥80 pg/mL were considered positive.

RESULTS

A total of 308 serum samples were collected in 45 patients. The majority of 172 samples (55.8%) were obtained at the early phase (within 30 days) after allogeneic HSCT. BDG levels were significantly higher in 16 possible/probable IFI samples when compared to no evidence for IFI samples (median 170 pg/mL, interquartile range [IQR] 100-274 pg/mL vs. median 15 pg/mL, IQR 15-15 pg/mL; P < 0.001, Mann-Whitney U-test). Diagnostic performance of serum BDG screening for possible IFI/probable invasive pulmonary aspergillosis vs. no evidence for IFI was as follows: sensitivity 81%, specificity 98%, positive predictive value 65%, negative predictive value (NPV) 99%, and diagnostic odds ratio 176 (95% confidence interval 41-761).

CONCLUSIONS

Our data suggest that serum BDG testing in HSCT patients may be highly specific and associated with a very high NPV of >99%. Therefore, serum BDG may be a helpful tool to rule out IFI in HSCT patients.

摘要

背景

多糖细胞壁成分1,3-β-D-葡聚糖(BDG)用作侵袭性真菌感染(IFI)的血清生物标志物。接受造血干细胞移植(HSCT)的患者被认为是发生IFI的高危人群。我们评估了血清BDG筛查在HSCT受者中的诊断性能。

方法

2014年9月至2015年8月前瞻性纳入HSCT受者。每周使用Fungitell(®)检测法进行2 - 3次常规血清BDG筛查。所有样本根据2008年欧洲癌症研究与治疗组织/美国国立医学研究院(EORTC/MSG)标准进行分类,分类时不考虑血清BDG结果。计算BDG检测对IFI的诊断性能。BDG值≥80 pg/mL被视为阳性。

结果

45例患者共采集308份血清样本。172份样本中的大多数(55.8%)是在异基因HSCT后的早期阶段(30天内)获得的。与无IFI证据的样本相比,16份可能/很可能为IFI的样本中的BDG水平显著更高(中位数170 pg/mL,四分位间距[IQR] 100 - 274 pg/mL vs.中位数15 pg/mL,IQR 15 - 15 pg/mL;P < 0.001,曼-惠特尼U检验)。血清BDG筛查对可能的IFI/很可能的侵袭性肺曲霉病与无IFI证据的诊断性能如下:敏感性81%,特异性98%,阳性预测值65%,阴性预测值(NPV)99%,诊断比值比176(95%置信区间41 - 761)。

结论

我们的数据表明,HSCT患者的血清BDG检测可能具有高度特异性,且阴性预测值非常高,>99%。因此,血清BDG可能是排除HSCT患者IFI的有用工具。

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