Objective To evaluate the significance of several Dermatophagoides pteronyssinus allergen extracts for skin prick test(SPT) in patients allergic to Dermatophagoides pteronyssinus.Methods Two hundred and nineteen patie...Objective To evaluate the significance of several Dermatophagoides pteronyssinus allergen extracts for skin prick test(SPT) in patients allergic to Dermatophagoides pteronyssinus.Methods Two hundred and nineteen patients enrolled in Peking Union Medical College Hospital underwent SPT and serum specific IgE assay to detect the Dermatophagoides pteronyssinus allergen.Three kinds of house dust mite allergen extracts were used for SPT,including the Dermatophagoides pteronyssinus extract prepared by our laboratory(group A),standardized Dermatophagoides pteronyssinus extract(group B),and mixed extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae(group C).Human serum specific IgE result was regarded as the reference standard for diagnosis of Dermatophagoides pteronyssinus allergy.The receiver operating characteristic(ROC) curve was used to evaluate the diagnostic performance of SPT with the extracts of three groups.Results SPT results showed that the median wheal diameter of group A,group B,and group C was 0.43,0.35,and 0.28 cm,respectively,with significant difference among three groups(P<0.05).The difference was significant between group A and B(P<0.01) as well as group A and C(P<0.01),but not between group B and C(P>0.05).There was no local urticaria or systemic allergic reactions following the procedure of SPT.Local reaction was observed in 5 patients and delayed reaction was in 2 patients of group A.As for group B and C,local reaction occurred in 3 cases and delayed reaction in 2 cases in each group.The area under ROC curve of SPT with extract in group A,group B,and group C was 0.765,0.801,and 0.782,respectively.Based on the detection results of serum specific IgE,the sensitivity of SPT in diagnosis of Dermato-phagoides pteronyssinus allergy with extract of group A,group B,and group C was 92.4%,87.0%,and 81.5%,and the specificity was 60.6%,73.2%,and 74.8%,respectively.Conclusion The Dermatophagoides pteronyssinus extract for SPT prepared by our laboratory offers good sensitivity and specificity comparable to commercially available allergen extracts,and it may be an appropriate candidate for clinical screening and diagnosis of Dermatophagoides pteronyssinus allergy.展开更多
Background:Dermatophagoides pteronyssinus is a common allergen causing allergic diseases in China.The aim of this study was to evaluate the efficacy and safety of D.pteronyssinus extracts produced by Peking Union Medi...Background:Dermatophagoides pteronyssinus is a common allergen causing allergic diseases in China.The aim of this study was to evaluate the efficacy and safety of D.pteronyssinus extracts produced by Peking Union Medical College Hospital(PUMCH)for the skin prick test(SPT)in the diagnosis of D.pteronyssinus allergy.Methods:A total of 910 subjects with allergic diseases were prescribed D.pteronyssinus SPT and specific sIgE(sIgE)test among the Outpatients of Department of Allergy,PUMCH from August 10,2015 to August 30,2017.Receiver operating characteristic curve(ROC)analysis was performed according to the results of D.pteronyssinus-sIgE detection.The accuracy of D.pteronyssinus extracts used for SPT in the diagnosis of D.pteronyssinus allergy was evaluated under different cutoff values.Adverse events after SPT were recorded to evaluate safety.Results:There were 796 and 618 subjects in the full analysis set(FAS)and the per protocol set(PPS),respectively.The areas under the curve of FAS and PPS were 0.871 and 0.873,respectively.According to the ROC of PPS,the optimal and 95%specificity diagnostic cutoff values of D.pteronyssinus SPT mean wheal diameter were 3.25 and 3.75 mm,respectively.No adverse events occurred.Conclusion:The extracts of D.pteronyssinus for SPT were simple,highly accurate,and safe and should be considered for recommendation in the clinical diagnosis of D.pteronyssinus allergy.展开更多
基金Supported by the National Natural Science Foundation of China (30671943)the National Scientific Supporting Foundation of China (2008BAI59B04)the National High Technology Research and Development Program of China (863 Program) (2003AA2Z3502)
文摘Objective To evaluate the significance of several Dermatophagoides pteronyssinus allergen extracts for skin prick test(SPT) in patients allergic to Dermatophagoides pteronyssinus.Methods Two hundred and nineteen patients enrolled in Peking Union Medical College Hospital underwent SPT and serum specific IgE assay to detect the Dermatophagoides pteronyssinus allergen.Three kinds of house dust mite allergen extracts were used for SPT,including the Dermatophagoides pteronyssinus extract prepared by our laboratory(group A),standardized Dermatophagoides pteronyssinus extract(group B),and mixed extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae(group C).Human serum specific IgE result was regarded as the reference standard for diagnosis of Dermatophagoides pteronyssinus allergy.The receiver operating characteristic(ROC) curve was used to evaluate the diagnostic performance of SPT with the extracts of three groups.Results SPT results showed that the median wheal diameter of group A,group B,and group C was 0.43,0.35,and 0.28 cm,respectively,with significant difference among three groups(P<0.05).The difference was significant between group A and B(P<0.01) as well as group A and C(P<0.01),but not between group B and C(P>0.05).There was no local urticaria or systemic allergic reactions following the procedure of SPT.Local reaction was observed in 5 patients and delayed reaction was in 2 patients of group A.As for group B and C,local reaction occurred in 3 cases and delayed reaction in 2 cases in each group.The area under ROC curve of SPT with extract in group A,group B,and group C was 0.765,0.801,and 0.782,respectively.Based on the detection results of serum specific IgE,the sensitivity of SPT in diagnosis of Dermato-phagoides pteronyssinus allergy with extract of group A,group B,and group C was 92.4%,87.0%,and 81.5%,and the specificity was 60.6%,73.2%,and 74.8%,respectively.Conclusion The Dermatophagoides pteronyssinus extract for SPT prepared by our laboratory offers good sensitivity and specificity comparable to commercially available allergen extracts,and it may be an appropriate candidate for clinical screening and diagnosis of Dermatophagoides pteronyssinus allergy.
基金National Science and Technology Major Projects(No. 2014ZX09102041-008)Beijing Science and technology plan(No. Z131100006813047)CAMS Innovation Fund for Medical Sciences(No. 2016-I2M-1-003)
文摘Background:Dermatophagoides pteronyssinus is a common allergen causing allergic diseases in China.The aim of this study was to evaluate the efficacy and safety of D.pteronyssinus extracts produced by Peking Union Medical College Hospital(PUMCH)for the skin prick test(SPT)in the diagnosis of D.pteronyssinus allergy.Methods:A total of 910 subjects with allergic diseases were prescribed D.pteronyssinus SPT and specific sIgE(sIgE)test among the Outpatients of Department of Allergy,PUMCH from August 10,2015 to August 30,2017.Receiver operating characteristic curve(ROC)analysis was performed according to the results of D.pteronyssinus-sIgE detection.The accuracy of D.pteronyssinus extracts used for SPT in the diagnosis of D.pteronyssinus allergy was evaluated under different cutoff values.Adverse events after SPT were recorded to evaluate safety.Results:There were 796 and 618 subjects in the full analysis set(FAS)and the per protocol set(PPS),respectively.The areas under the curve of FAS and PPS were 0.871 and 0.873,respectively.According to the ROC of PPS,the optimal and 95%specificity diagnostic cutoff values of D.pteronyssinus SPT mean wheal diameter were 3.25 and 3.75 mm,respectively.No adverse events occurred.Conclusion:The extracts of D.pteronyssinus for SPT were simple,highly accurate,and safe and should be considered for recommendation in the clinical diagnosis of D.pteronyssinus allergy.
