摘要目的 评价胶乳免疫比浊法检测幽门螺杆菌抗体的性能及对幽门螺杆菌(Hp)感染诊断的有效性.方法 采用胶乳免疫比浊法检测人血清中Hp抗体,并与C13呼气测试进行比较实验,以评价该方法对Hp感染的诊断效果,同时对试剂的线性范围、稳定性、抗干扰性等各项性能指标进行评价.结果 胶乳免疫比浊法测定Hp抗体与C13呼气法试验比较,两者的阳性及阴性符合率分别为93.3%和90.0%,总符合率达91.7%;此外,该Hp抗体检测试剂具有良好的线性、准确度和特异性,抗干扰能力强等特点.结论 胶乳免疫比浊法测定Hp抗体的试剂各性能指标均满足测定要求,适用于临床Hp的诊断与筛查.

abstractsObjective To evaluate the performance of helicobacter pylori antibody test kit and its effectiveness in the diagnosis of helicobacter pylori( Hp) infection. Methods Helicobacter pylori antibody in human serum was detected by latex immunoturbidimetry assay. The results were compared with C13-Urea Breath Test to evaluate the diagnostic effect of this method on Hp infection. Meanwhile,other experiments were performed to evaluate the kit performance such as linearity, stability and anti-interference and etc. Results Helicobacter pylori samples in human serum were detected by latex immunoturbidimetry assay by comparing with C13-Urea Breath Test. The positive and negative coincidence rates of these two methods were 93. 3% and 90. 0%,respectively,and the total coincidence rate was 91. 7%. In addition,the experiments showed that Hp antibody kit had good linearity, accuracy, specificity, anti-interference ability and so on. Conclusion The performance of the Hp antibody kit for diagnosis on Hp infection can meet the clinical testing requirement,and can be applied to clinical diagnosis and screening of Hp.