Multicenter clinical evaluation of the (1→3) β-D-glucan assay as an aid to diagnosis of fungal infections in humans
Multicenter clinical evaluation of the (1→3) β-D-glucan assay as an aid to diagnosis of fungal infections in humans
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DOI：
10.1086/432470
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发表时间：
2005-09-01
影响因子：
11.8
通讯作者：
Rex, JH
中科院分区：
文献类型：
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作者：
Ostrosky-Zeichner, L;Alexander, BD;Rex, JH
背景。测量(1 - bbbb3)- β - d -葡聚糖（BG）已成为侵袭性真菌感染（IFI）的辅助诊断策略。美国6个临床站点的受试者被招募为真菌感染阴性受试者（n = 170）或根据欧洲癌症研究和治疗组织/真菌病研究组标准（n = 163）证实或可能患有IFI的受试者。一个中心实验室和4个地点进行了化验。每位患者获得单个样本，并使用检测真菌细胞壁衍生的血清BG（范围为0至17000 pg/mL）的方法进行评估。在60 pg/mL的临界值下，该方法的敏感性和特异性分别为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，敏感性和特异性分别为64.4%和92.4%，PPV为89%，NPV为73%。在107例确诊念珠菌病患者中，81.3%的患者在60 pg/mL的临界值下呈阳性，77.6%的患者在80 pg/mL的临界值下呈阳性。在10例曲霉病患者中，80%在60和80 pg/mL的临界值下呈阳性结果。诊断为镰刀菌的3名受试者在临界值为60 pg/mL时结果呈阳性。感染毛霉或根霉（均缺乏BG）的患者在两个临界值均为阴性，而感染隐球菌的12例患者中，3例在临界值为60 pg/mL时呈阳性，2例在临界值为80 pg/mL时呈阳性。在接受抗真菌治疗的确诊阳性受试者（118例）中，BG阳性（60 pg/ mL）的检出率为72.9%，BG阳性（80 pg/ mL）的检出率为69.5%，实验室间样品检验r(2)为0.93。在多中心环境下具有高特异性和高PPV的重复性分析结果表明，使用检测真菌细胞壁衍生的血清BG的方法是IFI的有用诊断辅助手段。
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 17000 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 r(2) 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.