4种HIV筛查试剂与免疫印迹试验结果对比  

Comparation of the results of four HIV screening kits and Western Blot test

作　　者：韩思媛[1] 杨植 汤旭[1] 陈玉[1] 郝春芬 HAN Si-yuan;YANG Zhi;TANG Xu;CHEN Yu;HAO Chun-fen(Beijing Haidian District Center for Disease Control and Prevention,Beijing 100094,China)

机构地区：[1]北京市海淀区疾病预防控制中心,北京100094

出　　处：《中国国境卫生检疫杂志》2022年第6期496-500,共5页Chinese Journal of Frontier Health and Quarantine

摘　　要：目的对比分析4种人类免疫缺陷病毒(HIV)的抗体/抗原筛查试剂与免疫印迹试验的检测结果,评估筛查试剂的检测性能。方法用1种酶联免疫吸附试验(ELISA)试剂和3种快速检测试剂,同时检测1085例HIV感染者的血清样本的HIV抗原/抗体,用免疫印迹试验确证。结果在1085例感染者中,经免疫印迹试验确认为HIV-1抗体阳性的387例(35.67%),抗体不确定247例(22.76%),阴性451例(41.57%)。4种筛查试剂分别与免疫印迹试验比较,均具有一致性。在876例随访病例的检测结果中,万泰第三代(胶体金法)的特异性最好(99.38%),与其他3种试剂的差异有统计学意义(P=0.004);使用双试剂联合检测,万泰四代ELISA法+万泰三代胶体金法的结果与随访结果差异无统计学意义(P=0.481),且一致性最好(Kappa=0.959)。结论4种HIV筛查试剂具有较好的灵敏度和特异性,均可用于HIV筛查。用第四代抗原抗体检测试剂筛查,再用第三代抗体检测试剂进行复检并联合免疫印迹试验,可以缩短检测窗口期,防止漏检。Objective To evaluate the performance of four kits for HIV antibody/antigen screening by comparative analysis of the HIV screening and Western Blot test results.Methods A total of 1085 HIV positive serum samples for HIV antibody/antigen screening were tested by one ELISA kit and three rapid test kits.All tests were confirmed by Western Blot.Results In the 1085 cases,387 cases(35.67%)were HIV-1 positive,247 cases(22.76%)were uncertain,and 451(41.57%)were negative.The data showed that the test result of four screening kits were consistent with that of Western Blot.The performance of four screening kits was compared among 876 follow-up cases,the specificity of third-generation colloidal gold method(Wantai)was the best(99.38%),which was statistically different from the other three screening kits(P=0.004).Comparing the results of combined screening by two kits,there was no significant difference between the test results of fourth-generation ELISA kit(Wantai)combined with thirdgeneration colloidal gold method(Wantai)and the follow-up results(P=0.481),and the consistency between them was the best(Kappa=0.959).Conclusion The good sensitivity and specificity of all the four screening kits could meet the detection requirements for HIV screening.Screening by the fourth-genetation antigen/antibody test kit followed by the reexamination of the third-generation antibody test kit,and combinding with Western Blot test could shorten the detection window period and avoid undetectod case the missed detection.

关 键 词：人类免疫缺陷病毒 艾滋病 筛查 血清学方法 免疫印迹试验 

分 类 号：R183.9[医药卫生—流行病学]