改良幽门螺杆菌抗原检测试剂盒检测粪便幽门螺杆菌抗原的临床评价

Detection of Helicobacterpyloriantigen by using modified H. pylori antigen test kit:A clinical evaluation

目的评估改良幽门螺杆菌抗原检测试剂盒检测粪便幽门螺杆菌抗原(Helicobacter pylori stool antigen,HpSA)的准确性以及临床应用价值。方法采用随机、双盲、双验证和与^(13) C呼气试验(^(13) C-UBT)对比的方法,对门诊175例接受^(13) C-UBT检测的患者,采用最新研制出的一种改良幽门螺杆菌抗原检测试剂盒(胶体金法)检测粪便幽门螺杆菌抗原,以^(13) C-UBT检测结果为诊断H.pylori感染的"金标准",并将两者进行对比研究,所有检测结果均拍照存档,采用随机、双盲和双验证法,以期客观真实地评价改良幽门螺杆菌抗原检测试剂盒检测粪便幽门螺杆菌的效果。结果改良幽门螺杆菌抗原检测试剂盒检测HpSA敏感度为90.48%,特异度为90.00%,Youden指数为80.48%,Kappa值为0.799;HpSA检测ROC曲线下面积为0.902±0.027,与完全无诊断价值的机会线下面积0.50相比,差异有统计学意义(P=0.000);Spearman相关系数r=0.800,P=0.000。结论改良幽门螺杆菌抗原检测试剂盒能准确检测H.pylori感染,其操作简便,可作为非侵入性诊断H.pylori感染筛查以及流行病调查的一种方法,将来有望成为患者家庭自查幽门螺杆菌的一种方法。

Objective To evaluate the accuracy and clinical value of the modified Helicobacter pylori antigen test kit for detection of H.pylori stool antigen (HpSA).Methods A randomized,double-blind,doublevalidated method and ^13C-breath test (^13C-UBT)were used.175patients receiving ^13C-UBT in the clinic were included and underwent HpSA detection by using modified Helicobacter pylori antigen test kit (colloidal gold method)which was recently developed;the results were compared with those of the ^13C-UBT test which was used as the gold standard for the diagnosis of H.pylori infection.All the results were photographed and archived.Randomized,double-blind and double-validated methods were used to objectively and truthfully evaluate the efficacy of the modified Helicobacter pylori antigen test kit for detecting HpSA. Results The sensitivity and specificity of modified Helicobacter pylori antigen test kit were 90.48%and 90.00%respectively,with the Youden index being 80.48%and Kappa value being 0.799.The area under the ROC curve of HpSA detection was 0.902±0.027,which was significantly different (P=0.000)from the absolute under-estimated opportunity-line area of 0.50;Spearmanls correlation coefficient was 0.800(P=0.000). Conclusion The modified Helicobacter pylori antigen test kit can accurately detect H.pylori infection,and the operation is simple.It can be used as a noninvasive method for the diagnosis of H.pylori refection and epidemiological investigation.It is expected to be a family self-examination of H.pylori in the future.