含现症感染条带血清抗体检测幽门螺杆菌现症感染的多中心临床研究

目的 评价应用Genelabs安速TM试剂盒的现症感染条带(CIM)检测诊断幽门螺杆菌(Hp)现症感染的可行性.方法 采用全国性多中心开放性平行对照临床研究,研究对象为未接受过Hp根除治疗的需要接受Hp感染检测患者.共有7个中心参加本项研究,2007年1至12月纳入300例符合入选标准的被检测者,平均年龄(41±16)岁,其中男128例,女172例.对所有患者均采用13C-尿素呼气试验及Genelabs安速TMHp快速检测试剂盒CIM检测Hp感染情况.13C-尿素呼气试验阳性即认为存在Hp现症感染,13C-尿素呼气试验阴性判断为Hp阴性.结果 经13C-尿素呼气试验检测阳性131例,阴性169例.Genelabs安速TM试剂盒血清抗体检测Hp现症感染的敏感度为87.8%(115/131),特异度为89.9%(152/169),阳性预测值为87.1%(115/132),阴性预测值为90.5%(152/168),准确度为89.0%(267/300).结论 Genelabs安速TMHp快速检测试剂盒可以用于Hp现症感染的筛查,对于既往未接受过根除治疗的患者,其检测阳性可以认为存在Hp现症感染.

Abstract：

Objective To evaluate the performance of the ASSURETM Helwobacter pylori (H.pylori)rapid testcurrent infection marker(CIM)kit,Genelabs Diagnostics]in detecting the current infection marker CIM for the diagnosis of H.pylori in adult patients.Methods For this multicenter and controlled clinical trial,a total of 300 patients with an average age of(41±16)years old were recruited from 7 participating hospitals.There were 128 men and 172 women.never received any H.pylori eradication therapy.Each subject received a 13C-urea breath test(13C-UBT)and a CIM test.Such performance parameters as sensitivity,specificity,positive and negative predictive values and accuracy were determined by 13C-UBT for the diagnosis of current H.pylori infection.Results According to the gold standard,there were 131 positive and 169 negative subjects.The accuracy rate,sensitivity,specificity,positive and negative predictive values of CIM test were 89.0%(267/300),87.8%(115/131),89.9%(152/169),87.1%(115/132)and 90.5%(152/168)respectively.Conclusion As a simple,rapid,accurate and affordable assay.CIM test may be useful for a non-invasive diagnosis of H.pylori infection in cases without eradication therapy.

Performance of current infection marker lest for the diagnosis of Helicobacter pylori current infection:a multicenter clinical trial

Objective To evaluate the performance of the ASSURETM Helwobacter pylori (H.pylori)rapid testcurrent infection marker(CIM)kit,Genelabs Diagnostics]in detecting the current infection marker CIM for the diagnosis of H.pylori in adult patients.Methods For this multicenter and controlled clinical trial,a total of 300 patients with an average age of(41±16)years old were recruited from 7 participating hospitals.There were 128 men and 172 women.never received any H.pylori eradication therapy.Each subject received a 13C-urea breath test(13C-UBT)and a CIM test.Such performance parameters as sensitivity,specificity,positive and negative predictive values and accuracy were determined by 13C-UBT for the diagnosis of current H.pylori infection.Results According to the gold standard,there were 131 positive and 169 negative subjects.The accuracy rate,sensitivity,specificity,positive and negative predictive values of CIM test were 89.0%(267/300),87.8%(115/131),89.9%(152/169),87.1%(115/132)and 90.5%(152/168)respectively.Conclusion As a simple,rapid,accurate and affordable assay.CIM test may be useful for a non-invasive diagnosis of H.pylori infection in cases without eradication therapy.