3种幽门螺杆菌抗体检测试剂盒的临床应用价值  

The Clinical Application Value of Three Helicobacter pylori Antibody Detection Kits

作　　者：黄倩妮 梁荣良 石文[1] 王会敏[1] 何敏[1] 林馥嘉[1] 刘冬冬[1] 李邑华 林海标[1] Huang Qianni;Liang Rongliang;Shi Wen;Wang Huimin;He Min;Lin Fujia;Liu Dongdong;Li Yihua;Lin Haibiao(Department of Laboratory Medicine,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou Guangdong 510105,China;KingMed School of Laboratory Medicine,Guangzhou Medical University,Guangzhou Guangdong 511436,China)

机构地区：[1]广东省中医院检验医学部,广东广州510105 [2]广州医科大学金域检验学院,广东广州511436

出　　处：《医疗装备》2021年第23期66-68,共3页Medical Equipment

摘　　要：目的评价3种幽门螺杆菌抗体检测试剂盒的临床应用价值。方法选取2020年6—8月在广东省中医院二沙岛医院消化内科进行尿素13C呼气试验人群的血清样本100例(阴性、阳性各50例),分别用幽门螺杆菌抗体检测试剂盒1(康美天虹胶体金法)、2(惠安生物胶体金法)和3(万泰德瑞胶乳免疫比浊法)对血清样本进行检测,以尿素13C呼气试验的结果为幽门螺杆菌现症感染的金标准,对3种幽门螺杆菌抗体检测试剂盒检测结果进行比较分析,并参照EP12-A2文件推荐方法,比较3种幽门螺杆菌抗体检测试剂盒检测指标。结果 3种幽门螺杆菌抗体检测试剂盒的灵敏度比较,差异均无统计学意义(P>0.05);幽门螺杆菌抗体检测试剂盒1和试剂盒2的特异度比较,差异无统计学意义(P>0.05);幽门螺杆菌抗体检测试剂盒3的特异度高于试剂盒1,差异有统计学意义(P<0.05)。幽门螺杆菌抗体检测试剂盒1和试剂盒2的灵敏度和特异度差值的95%可信区间为[-1.81%,25.29%]和[-19.14%,7.40%];幽门螺杆菌抗体检测试剂盒2和试剂盒3的灵敏度和特异度差值的95%可信区间为[-13.80%,1.74%]和[-24.72%,0.77%];幽门螺杆菌抗体检测试剂盒1和试剂盒3的灵敏度和特异度差值的95%可信区间为[-5.64%,21.47%]和[-32.39%,-2.81%]。结论 3种幽门螺杆菌抗体检测试剂盒的灵敏度和特异度均较为良好,可用于幽门螺杆菌感染的筛查,且幽门螺杆菌抗体检测试剂盒3(胶乳免疫比浊法)的特异度更好,是一种更为可靠的筛查方法。Objective The clinical application value of three Helicobacter pylori antibody detection kits were evaluated. Methods 100 serum samples of people who performed 13C-Urea Breath Test in the Department of Gastroenterology in Ersha Island Hospital of Guangdong Provincial Hospital of Chinese Medicine, including 50 cases of negative and 50 cases of positive, were detected by three detection kits, that is, Kit 1(colloidal gold method of Kangmei Tianhong), Kit 2(colloidal gold method of Hui’an Biology) and Kit 3(latex immunoturbidimetry method of WANTAI DRD). Taking the results of 13C-Urea Breath Test as the gold standard for current Helicobacter pylori infection, the detection results of the three Helicobacter pylori antibody detection kits were compared and analyzed. Referring to the recommended method in the EP12-A2 document, the detection indexes of the three kits were compared. Results There were no statistically significant differences in the sensitivity of the three kits(P>0.05);There was no statistically significant difference in the specificity of Kit1 and Kit2(P>0.05);The specificity of Kit3 was higher than that of Kit1, with statistically significant difference(P<0.05). The results showed that the 95% confidence intervals of the differences of sensitivities and specificities between Kit1 and Kit2 were [-1.81%,25.29%] and [-19.14%,-7.40%];The 95% confidence intervals for the differences of sensitivities and specificities between Kit2 and Kit3 were [-13.80%,1.74%] and [-24.72%,0.77%];The 95% confidence intervals for the differences of sensitivities and specificities between Kit1 and Kit3 were [-5.64%,21.47%] and [-32.39%,-2.81%]. Conclusion The sensitivities and specificities of the three kits are satisfactory, proved to be adaptable to screen Helicobacter pylori infection. And with the highest specificity among them, Helicobacter pylori antibody detection Kit3 turned out to be a more reliable method for screening.

关 键 词：幽门螺杆菌 幽门螺杆菌抗体检测 免疫胶体金法 胶乳免疫比浊法 

分 类 号：R446.11[医药卫生—诊断学]