粉尘螨皮肤点刺诊断试剂盒的灵敏性和特异性

Clinical investigation of sensitivity and specificity of dust mite skin prick test kit

目的评估粉尘螨皮肤点刺诊断试剂盒用于诊断粉尘螨引起的过敏性支气管哮喘和变应性鼻炎等过敏性疾病的灵敏性和特异性。方法采用多中心平行分组的研究方法,分别对粉尘螨阳性、阴性各150例受试者采用粉尘螨皮肤点刺诊断试剂盒进行点刺试验,通过测定点刺液与阳性对照液产生丘疹面积的比值来判断患者对粉尘螨的过敏程度,重点评估该试剂盒的灵敏性和特异性。结果粉尘螨皮肤点刺诊断试剂盒对粉尘螨过敏诊断的灵敏性为93.3%,特异性为96.0%。受试者工作特征曲线下的面积为0.950 8。在采用粉尘螨皮肤点刺诊断试剂盒进行皮肤点刺试验的过程中,受试者的依从性良好,没有发生与皮肤点刺试验有关的不良事件。结论粉尘螨皮肤点刺诊断试剂盒具有安全、高灵敏性、高特异性的优点,并且诊断正确率较高,可用于粉尘螨引起过敏性疾病的辅助诊断,也为特异性免疫治疗提供了可靠的客观依据。

Objective To evaluate the sensitivity and specificity of dust mite skin prick test kit in diagnosis of dust mite allergic asthma and rhinitis. Methods A multi-centered parallel trail was performed in 150 dust mite allergic patients and 150 non-dust mite allergic patients using dust mite skin prick test kit. The hypersusceptibility degrees of patients to dust mite were evaluated by comparing the areas caused by mite prick test and positive control solution. The sensitivity and specificity of the skin prick test kit was the major task of evaluation. Results The sensitivity and specificity of the kit for dust mite allergy were 93.3% and 96.0%, respectively. The area under receiver operating characteristic （ROC） curve was 0. 950 8. The patients showed a good compliance to the kit and there was no severe adverse events happened in the trial. Conclusion The dust mite skin prick test kit is safe, highly sensitive, highly specific and accurate; it can be used as assistant diagnosis method for allergic disease and provides reliable evidence for targeted immunotherapy.