两种HIV抗体诊断试剂盒检测早期感染比较.doc

两种HIV抗体诊断试剂盒检测早期感染比较[摘要] 目的 比较两种HIV抗体诊断试剂盒检测HIV早期感染的性能。方法 采用两种试剂盒对血液样本进行检测，并对其中5份HIV抗体阳性血浆样品进行稀释，然后用ELISA检测。对检测结果呈阳性反应的稀释样品分别用两种HIV抗体确证试剂盒进行检测以测试其灵敏度，比较两种试剂盒检测结果及灵敏度。结果 两种方法共检出91份阳性，确证68份阳性标本，其余23份确证为阴性。北京万泰试剂盒和英科新创试剂盒检测假阳性率分别为13.92%和15.00%，两种试剂盒假阳性率相似（P＞0.05）；2份质控品英科新创试剂出现漏检；其中有2套系列稀释样品英科新创已显示为阴性，北京万泰仍能检出阳性，且稀释8倍时北京万泰试剂仍检出阳性。结论 北京万泰诊断试剂盒与英科新创诊断试剂盒相比，可以更灵敏地检测出HIV抗体。 [关键词] HIV；抗体；艾滋病血清学诊断；酶联免疫法 [中图分类号] R446.6 [文献标识码] B [文章编号] 1673-9701（2011）26-87-02 Comparison of Two HIV Antibody Diagnostic Reagent Kit in Confirming Early HIV Infection ZHOU Jiaoping GAO Jialiang PAN Tengfei YU Songyi Clinical Laboratory Department，the People’s Hospital of Yinzhou District in Zhejiang Province，Ningbo 315040，China [Abstract] Objective To compare the performance of two HIV antibody diagnostic reagent kit in confirming early HIV infection. Methods All plasma specimens were detected by the two kits，five HIV antibody-positive plasma specimens were diluted and detected by ELISA．The above diluted specimens were detected with the two HIV antibody diagnostic reagent kits to analyze their sensitivity. Results All 91 samples had been diagnosed with the two kits，68 samples were confirmed，the others 23 samples were negative. The FPR of Wantai-RIBA kits and InTec kits were 13.92% and 15.00%. The FPR of two kits were similar（P＞0.05）. Two Samples QC specimens had been not detected by InTec kits，and two samples were diluted to 8 fold still been detected by Wantai-RIBA kits. Conclusion Compared with InTec，Wantai-RIBA diagnostic reagent kit have the better sensitivity of diagnosticing HIV antibody. [Key words] HIV；Antibody；AIDS serodiagnosis diagnosis；ELISA HIV感染的发病率在不断升高，早期的诊断是及时防护和治疗的关键。HIV抗体检测是目前较为普遍的诊断方式，依据2009年修订版《全国艾滋病检测技术规范》制定的常规程序分为筛查试验和确证试验两个步骤，筛查试验呈阳性反应的样品，必须再做确证试验以明确诊断[1]。HIV抗体诊断试剂种类很多，目前普遍采用酶联免疫法（ELISA）检测，具有敏感性高、特异性强特点。本研究选择两种国产人类免疫缺陷病毒HIV（1+2型）抗体诊断试剂盒进行对比试验，观察两者的准确性及灵敏度，现报道如下。 1 材料与方法 1.1 材料 标本收集于2006年1月~2011年6月送检的8349份血液样本。血浆标本的分离、保存和离心等严格按照试验室规范操作，并经宁波市疾病控