国产血清半乳甘露聚糖检测试剂对侵袭性肺曲霉菌病的诊断价值评估

目的：评估国产血清半乳甘露聚糖（Galactomannan，GM）检测试剂对侵袭性肺曲霉菌病的诊断价值。方法根据血液病/恶性肿瘤患者侵袭性真菌病的诊断标准与治疗原则（第四次修订版）1]收集临床确诊侵袭性肺曲霉菌病（inva-sive pulmonary aspergillosis，IPA）、临床诊断IPA、拟诊IPA、排除IPA四组病例。采用天津贻诺琦公司酶联免疫吸附法（ELISA）试剂检测纳入的86例患者血清标本的GM浓度，分析其敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）。结果86例病例中，临床诊断27例、拟诊12例、排除47例。在3种不同的阳性判断标准下，敏感性：9444%、9630%、6296%；特异性：5625%、4576%、6441%；PPV：4474%、4483%、4474%；NPV：9643%、9643%、7917%。统计学分析证实标准1（即血清GM值〉095μg/L为阳性，〈075μg/L为阴性，075~095μg/L为灰区，未将灰区加入计算）在3种判断标准中最优，故选择其为最终判断标准。结论该血清GM检测试剂盒诊断性能较好，可以用于侵袭性肺曲霉菌病的辅助诊断。

Evaluation of domestic serum galactomannan detection kit for the diagnosis of invasive pulmonary aspergillosis

Objective To evaluate the performance of domestic serum galactomannan（ GM）test kit for the diagnosis of invasive pulmonary aspergillosis Methods According to the reference standards set by the diagnostic criteria and treatment of invasive pul-monary fungal infection principle1],the serum of confirmed invasive pulmonary aspergillosis（ IPA）,clinical diagnosis of IPA,sus-pected IPA and without IPA were collected Using Tianjin Bio-Enoche reagent kit of ELISA method,86 specimens were analyzed to calculate the sensitivity,specificity,positive predictive value（ PPV）,negative predictive value（ NPV） Results All 86 clinical cases are consisted of 27 clinical proven IPA,12 probable IPA,47 without IPA According to the three different kinds of positive judgment standard,the degree of sensitivity,specificity,PPV,NPV is respectively,sensitivity：94 44%,96 30%,62 96%;Specific-ity：94 44%,96 30%,62 96%;PPV：94 44%,96 30%,62 96%;NPV：94 44%,96 30%,62 96% Statistical analysis con-firmed that standard No 1（ The positive GM test was defined as GM value 〉0 95 μg/L and the negative defined as 〈0 75 μg/L） was the optimal,so standard No 1 was choosed as the final judgment standard Conclusion Performance of the domestic serum GM detection kit is eligible and can be used for the auxiliary diagnosis of invasive pulmonary aspergillosis.