HIV抗体检测
HIV感染的诊断1．HIV抗体检测
目前国外用于HIV抗体筛查的方法很多，根据检测原理不同分为酶联免疫吸附法、凝集法和免疫层析法，可对血液、唾液和尿液标本进行常规或快速检测。在实际工作中常用的有酶联免疫吸附试验(ELISA)、明胶凝集试验和各种快速诊断试剂。自1985年第一代ELISA试剂问世以来，随着医学技术的飞速发展，包被抗原已从第一代的全病毒裂解物发展为目前以基因重组与多肽抗原包被和标记的有着良好敏感性和特异性的第三代双抗原夹心试剂，检测亚型包括HIV-1、HIV-2和HIV-1型的O亚型，窗口期由10周缩短至3～4周。为避免窗口期传染，荷兰、法国等国已研制出可同时检测抗原抗体的第四代ELISA筛查试剂，但其临床价值有待评估。按《规范》要求，我国采供血机构进行血液筛查和各医疗卫生机构常规筛查检测宜采用ELISA法，自采自供血的单位必须进行HIV抗体检测，在尚未建立艾滋病筛查实验室的偏远地区或大医院急诊手术前可由经过培训的技术人员在规定的场所用快速检测试剂进行血液筛查。对用ELISA试剂或快速诊断试剂进行的筛查实验如呈阴性反应，即报告HIV抗体阴性；对呈阳性反应的标本，筛查实验室应用原有试剂和另外一种不同原理或不同厂家的试剂进行重复检测，如两种试剂复测均呈阴性反应，则报告HIV抗体阴性；如均呈阳性反应，或一阴一阳，需送艾滋病确认实验室进行确认。筛查试剂必须是HIV-1/2混合型、经国家药品监督管理局(SDA)注册批准、批检合格、临床评估质量优良、在有效期内的试剂。
HIV抗体筛查呈阳性反应的标本由于存在假阳性的可能，必须做确认试验。国际上有3种确认试验方法，包括免疫印迹试验、条带免疫试验及免疫荧光试验，目前以免疫印迹试验最为常用。确认试剂必须经SDA注册批准。免疫印迹试剂有HIV-1/2混合型和单一型，按《规范》要求，一般先用HIV-1/2混合型试剂进行检测，根据《规范》中判定免疫印迹试验结果的基本原则并参照所用试剂说明书综合判定：无HIV抗体特异带出现的报告HIV抗体阴性；出现HIV抗体特异带，符合HIV-1抗体阳性判定标准，则报告HIV-1抗体阳性。如出现HIV-2型的特异性条带，需用HIV-2型免疫印迹试剂再做单一的HIV-2型抗体确认试验，呈阴性反应，报告HIV-2抗体阴性；呈阳性反应的则报告HIV-2抗体血清学阳性，如需鉴别应进行核酸序列分析。如果出现HIV抗体特异带，但带型不足以判定为阳性，则判为HIV抗体不确定。对HIV抗体不确定者应按《规范》要求进行随访，必要时可做HIV-1 P24抗原或核酸测定，但检测结果只能作为辅助诊断依据，确认报告要依据血清学随访结果。由于目前唾液检测试剂的敏感性和尿液检测试剂的特异性明显低于血液检测试剂，故我国SDA已注册批准的HIV抗体筛查和确认试剂只能用于血液标本检测。http://qz.58.com/nanke/15712022044550x.shtmlhttp://qz.58.com/nanke/15712036986626x.shtml
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