（1→3）-β-D-葡聚糖检测用于辅助人类真菌感染诊断的多中心临床评估

Multicenter clinical evaluation of the (1-->3) beta-D-glucan assay as an aid to diagnosis of fungal infections in humans.

作者信息

Ostrosky-Zeichner Luis, Alexander Barbara D, Kett Daniel H, Vazquez Jose, Pappas Peter G, Saeki Fumihiro, Ketchum Paul A, Wingard John, Schiff Robert, Tamura Hiroshi, Finkelman Malcolm A, Rex John H

机构信息

University of Texas-Houston Medical School, Houston, TX 77030, USA.

出版信息

Clin Infect Dis. 2005 Sep 1;41(5):654-9. doi: 10.1086/432470. Epub 2005 Jul 21.

DOI:10.1086/432470

PMID:16080087

Abstract

BACKGROUND

Measurement of (1-->3)-beta-D-Glucan (BG) has emerged as an adjunct diagnostic strategy for invasive fungal infections (IFI).

METHODS

Subjects at 6 clinical sites in the United States were enrolled as either fungal infection-negative subjects (n = 170) or subjects with proven or probable IFI according to European Organization for the Research and Treatment of Cancer/Mycoses Study Group criteria (n = 163). A central laboratory and 4 sites performed assays. A single sample was obtained per patient and was evaluated using an assay to detect serum BG derived from fungal cell walls (range, 0 to > 7000 pg/mL).

RESULTS

At a cutoff of 60 pg/mL, the sensitivity and specificity of the assay were 69.9% and 87.1%, respectively, with a positive predictive value (PPV) of 83.8% and a negative predictive value (NPV) of 75.1%. At a cutoff value of 80 pg/mL, the sensitivity and specificity were 64.4% and 92.4%, respectively, with a PPV of 89% and an NPV of 73%. Of the 107 patients with proven candidiasis, 81.3% had positive results at a cutoff value of 60 pg/mL, and 77.6% had positive results at a cutoff value of 80 pg/mL. Of the 10 patients with aspergillosis, 80% had positive results at cutoff values of 60 and 80 pg/mL. The 3 subjects diagnosed with Fusarium species had positive results at a cutoff value of 60 pg/mL. Patients infected with Mucor or Rhizopus species (both of which lack BG) had negative results at both cutoff values, and of the 12 patients with Cryptococcus infection, 3 had positive results at a cutoff value of 60 pg/mL, and 2 had positive results at a cutoff value of 80 pg/mL. Of the subjects with proven positive results who were receiving antifungal therapy (n = 118), 72.9% had results positive for BG at a cutoff value of 60 pg/mL, and 69.5% had results positive for BG at a cutoff value of 80 pg/mL. The interlaboratory sample test r2 was 0.93.

CONCLUSION

Reproducible assay results with high specificity and high PPV in a multicenter setting demonstrate that use of an assay to detect serum BG derived from fungal cell walls is a useful diagnostic adjunct for IFI.

摘要

背景

（1→3）-β-D-葡聚糖（BG）检测已成为侵袭性真菌感染（IFI）的辅助诊断策略。

方法

美国6个临床地点的受试者被纳入研究，分为真菌感染阴性受试者（n = 170）或根据欧洲癌症研究与治疗组织/真菌病研究组标准确诊或疑似IFI的受试者（n = 163）。由一个中心实验室和4个地点进行检测。每位患者采集一份样本，使用一种检测方法评估样本，以检测源自真菌细胞壁的血清BG（范围为0至>7000 pg/mL）。

结果

在截断值为60 pg/mL时，该检测方法的灵敏度和特异度分别为69.9%和87.1%，阳性预测值（PPV）为83.8%，阴性预测值（NPV）为75.1%。在截断值为80 pg/mL时，灵敏度和特异度分别为64.4%和92.4%，PPV为89%，NPV为73%。在107例确诊念珠菌病的患者中，81.3%在截断值为60 pg/mL时检测结果为阳性，77.6%在截断值为80 pg/mL时检测结果为阳性。在10例曲霉病患者中，80%在截断值为60和80 pg/mL时检测结果为阳性。3例诊断为镰刀菌属感染的受试者在截断值为60 pg/mL时检测结果为阳性。感染毛霉或根霉属（均缺乏BG）的患者在两个截断值时检测结果均为阴性，在12例隐球菌感染患者中，3例在截断值为60 pg/mL时检测结果为阳性，2例在截断值为80 pg/mL时检测结果为阳性。在接受抗真菌治疗且检测结果证实为阳性的受试者（n = 118）中，72.9%在截断值为60 pg/mL时BG检测结果为阳性，69.5%在截断值为80 pg/mL时BG检测结果为阳性。实验室间样本检测的r2为0.93。