三种试剂检测血清幽门螺杆菌抗体的比较研究

Comparative Study on Three Reagents for Detecting Helicobacter Pylori Infection

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。

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..