三种试剂检测血清幽门螺杆菌抗体的比较研究

目的　对三种用于检测血清中的幽门螺杆菌（ Helicobacter pylori，Hp）抗体的试剂进行比较研究。方法　于 2017年 4月采集未经抗 Hp治疗并接受快速尿素酶试验（ rapid urease test，RUT）和尿素 13C呼气试验（ 13C urease breath test， 13C-UBT）的 80例患者血清样本，用三种不同试剂—— A试剂:胶体金法幽门螺杆菌尿素酶抗体检测试剂盒， B试剂:胶乳增强免疫比浊法幽门螺杆菌检测试剂盒， C试剂抗幽门螺杆菌 IgG ELISA试剂盒检测血清 Hp抗体。以 RUT和 13C-UBT任何一项阳性为 Hp感染诊断标准，评估 A, B和 C三种试剂的检测性能，包括敏感度、特异度、准确度以及与诊断的一致性。结果　敏感度由高到低依次是 C（92.50%），B（78.57%）和 A（57.14%）；特异度由高到低依次是 A（100.00%），C（75.00%）和 B（70.83%）；准确度由高到低依次是 C（88.75%），B（76.25%）和 A（70.00%）；三种试剂检测结果之间存在差异。经 Kappa检验，C试剂与 RUT和 13C-UBT检测结果一致性最高（κ =0.722, P<0.001）。结论　三种血清 Hp抗体试剂检测结果与 RUT和 13C-UBT检测结果存在相关性，其中 C试剂一致性最高，可用于检测未经抗 Hp治疗患者的 Hp感染。

Comparative Study on Three Reagents for Detecting Helicobacter Pylori Infection

Objective To evaluate three kinds of erological tests for diagnosis of Hp infection.Methods Three reagents were used to detecting Hp antibody from serum specimens obtained in April 2017 from 80 patients who never treated for Hp and examined with both rapid urease test(RUT)and 13C urease breath test(13C-UBT).The three reagents were Hp urease antibody detection kit by colloidal gold method(Reagent A),Hp detection kit by latex-enhanced immunoturbidimetry(Reagent B)and serum anti-Hp IgG ELISA kit(Reagent C).Any one of RUT and 13C-UBT positive as the diagnostic criteria for Hp infection,evaluate the performance of the three reagents A,B and C,including sensitivity,specificity,accuracy and consistency,respectively.Results The sensitivity,spcecificity and accuracy of reagent A was 57.14%,100%and 70.00%respectively,reagent B was 78.57%,70.83%and 76.25%respectively,reagent C was 92.50%,75.00%and 88.75%,respectively.Test results of reagent C and those of RUT and 13C-UBT had the highest consistency(κ=0.722,P<0.001).Conclusion The Hp antibody detection results of the three reagents were correlated with the RUT and 13C-UBT test results.The C reagent had the highest coincidence rate and can be used to detect Hp infection in patients without anti-Hp treatment..