国产血浆(1-3)-β-D葡聚糖检测试剂对侵袭性真菌病诊断价值评估

Evaluation of domestic plasma(1-3)-β-D-glucan detection reagent in diagnosis of invasive fungal disease

目的观察国产血浆(1-3)-β-D葡聚糖检测试剂对侵袭性真菌病(IFD)的诊断效果。方法筛选2009年4月—2011年6月上海交通大学医学院附属新华医院疑似IFD病例,根据欧洲癌症研究和治疗组织/真菌病研究组(EORTC/MSG)的IFD诊断标准定义,甄选出57例确诊IFD和6例拟诊IFD的真阳性病例为IFD组,100例非IFD真阴性病例为对照组,应用国产血浆(1-3)-β-D葡聚糖检测试剂定量检测血浆中(1-3)-β-D葡聚糖的质量浓度,并进行组间比较。绘制受试者工作特征(ROC)曲线,分析利用血浆(1-3)-β-D葡聚糖水平诊断IFD的最佳临界值。结果两组的血浆(1-3)-β-D葡聚糖水平皆为非正态分布,峰度系数>0、偏度系数>0,呈正偏态分布。对照组和IFD组血浆(1-3)-β-D葡聚糖质量浓度分别为(33.62±5.0)pg/mL和(373.82±125.5)pg/mL,两组比较差异有统计学意义(P<0.001)。ROC曲线分析结果显示:血浆(1-3)-β-D葡聚糖用于诊断IFD的最佳临界值为20.85,曲线下面积最大为0.857(P<0.05),95%CI 0.792～0.923,灵敏度和特异度分别为77.8%和86.0%。结论国产血浆(1-3)-β-D葡聚糖检测试剂对于IFD具有诊断应用价值。

Objective To investigate the value of domestic plasma（1-3）-β-D-glucan detection reagent in the diagnosis of invasive fungal disease（IFD）.Methods Patients suspected of IFD were screened from Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine from April 2009 to June 2011.Based on the diagnostic standard of IFD from the European Organization for Research and Treatment of Cancer/Mycoses Study Group（EORTC/MSG）,63 true positive cases（57 confirmed as IFD and 6 preliminarily diagnosed as IFD） were selected as IFD group,and the other 100 non-IFD true negative cases were served as control group.Plasma mass concentrations of（1-3）-β-D-glucan were measured with domestic plasma（1-3）-β-D-glucan detection reagent,and comparison was made between groups.Receiver operating characteristic（ROC） curve was drafted,and the cutoff value of plasma（1-3）-β-D-glucan in diagnosis of IFD was analysed.Results Plasma levels of（1-3）-β-D-glucan in both groups exhibited non-normal distribution（positive skewness）,with coefficient of kurtosis0 and coefficient of skewness0.The plasma mass concentrations of（1-3）-β-D-glucan of control group and IFD group were（33.62±5.0） pg/mL and（373.82±125.5） pg/mL respectively,and there were significant differences between them（P0.001）.Analysis of ROC curve revealed that the cutoff value of plasma（1-3）-β-D-glucan in diagnosis of IFD was 20.85,maximum area under the curve was 0.857（P0.05）,95% CI was 0.792 to 0.923,and values of sensitivity and specificity were 77.8% and 86.0% respectively.Conclusion Domestic plasma（1-3）-β-D-glucan detection reagent can be used in the diagnosis of IFD.