评估国产（1,3）-β-D-葡聚糖检测试剂的诊断价值

目的比较国产与进口（1,3）-β-D-葡聚糖（BG）检测试验并对国产试剂在侵袭性真菌感染中的诊断价值进行评估。方法回顾性调查2008年4月～2009年5月我院203例（342份样本）怀疑侵袭性真菌感染的住院患者,根据诊断标准分为感染组和非感染组,对其中同时进行国产与日本试剂检测的100份样本进行配对t检验比较;在不同的判断标准下计算国产试剂的灵敏度、特异度、阳性预测值和阴性预测值等,采用McNemar配对χ2检验对不同方法进行比较。结果国产和日本试剂在感染组和非感染组配对t检验结果分别为P=0.235,P=0.076;国产试剂以单次≥20pg/mL和≥50pg/mL为界值的灵敏度、特异度分别为78.3%,67.2%和56.5%,85.0%,双次≥20pg/mL和≥50pg/mL为界值的灵敏度、特异度分别为25.0%,64.9%和25.0%,87.7%。结论国产与日本试剂检测值无统计学差异;国产试剂单次≥50pg/mL为界值较20pg/mL可以明显提高特异度,降低假阳性率,而不影响灵敏度。连续双份血清阴性（BG〈50pg/mL）具有较高的特异度和阴性预测值。

Diagnostic value of Chinese assay of(1,3)-β-D-glucan in invasive fungal infections

Objective To evaluate the diagnostic value of Chinese assay of （1,3）-β-D-glucan in invasive fungal infections （IFI） and compare with Japenese assay.Methods A retrospective study was performed on 203 patients at risk of IFI （totally 342 sanmples） in our hospital from April,2008 to May,2009.Paired-sample t test was analyzed in 100 samples which were detected by both Chinese and Japanese assay.Sensitivity,specificity,positive predictive value （PPV） and negative predictive value （NPV） were calculated under different criterion,which was compared by McNemar paired χ2 test.Results The significance values of t test between the two assays were 0.235 for IFI samples and 0.076 for non-IFI samples,respectively.For Chinese assay ,the sensitivity （78.3%,56.5%,25.0%,25.0%） and specificity （67.2%,85.0%,64.9%,87.7%） were obtained by single cutoff values or double cutoff values of 20 pg/mL,50 pg/mL respectively.Conclusions There is no statistical significance between Chinese and Japanese assays.The specificity with single cutoff value of 50 pg/mL was significantly elevated without evident influence on sensitivity compared with that with 20 pg/mL.The NPV and specificity were elevated with double cutoff values.