HIV抗体WB确证实验的替代策略研究

Study on replacement strategy of HIV antibody WB confirmatory experiment

目的利用艾滋病病毒(HIV)抗体筛查实验的酶联免疫吸附试验(ELISA)和快诊检测结果与蛋白免疫印迹试验(WB)的组合,对HIV感染与否进行确证,避免单一WB确证实验的"不确定"结果,区别WB实验中"已感染-不确定"和"未感染-不确定"结果,及时精确判定阳性与阴性结果。方法以2007-2013年筛查为"阳性"结果的1190例需进一步进行确证实验的所有血清样本为研究对象,包括确证结果为"阳性"、"不确定"及"阴性"者。三种确证结果及实验条带结果均与两种ELISA(高敏感性和高特异性)和两种快诊(胶体硒和胶体金)的联合检测进行比对分析。结果 1190例HIV抗体待复查标本中,确证试验为阳性的930例样本,两种ELISA和两种快诊试验均为阳性;144例确证试验为阴性的血清样本,两种ELISA和两种快诊试验至少有一种为阴性,其中快诊无一例为强阳性;116例确证试验为"不确定"者,其中"不确定-阳性"样本两种ELISA和两种快诊试验均为阳性(包括强阳性、阳性与弱阳性),"不确定-阴性"样本两种ELISA和两种快诊试验至少有一种为阴性,其中快诊无一例为强阳性。结论两种ELISA与两种快诊的联合运用敏感性、特异性均达到100%(除窗口期),可以有效区分WB结果的"感染-不确定"与"未感染-不确定",建议国家调整艾滋病确证策略,利用HIV抗体筛查试验的联合运用来替代WB的确证试验,既排除了"不确定"结果,又节约了大量资源及减少不必要的伤害还可以满足及时精确判定结果。

Objective Using the HIV antibody screening experiments of ELISA and quick diagnosis test results and Western blot test（WB）combination to confirm HIV infection or not,avoid＂uncertain＂ results by a single WB confirmatory test,distinguish between＂infected-not sure＂ and＂not infected-not sure＂in WB experiment,and timely and accurately identify positive and negative results.Method There were 1190 serum samples screening positive in 2007-2013,and their confirmation test results included＂positive＂,＂uncertainty＂ and＂negative＂.Comparative analysis of three confirmatory results and experimental bands with two ELISA（High sensitivity and high specificity）and two quick diagnosis（colloidal selenium and colloidal gold）tests were performed.Result Of the 1190 cases,930were positive by confirmatory test which were all positive by two ELISA and two quick diagnosis tests.At least one kind of two ELISA and two kinds of quick diagnosis tests was negative and no strong positive occurred in144 negative cases by confirmatory test.Of 116 cases as＂uncertainty＂,＂not sure-positive＂ samples were all positive by two ELISA and two kinds of quick diagnosis tests（including positive,strong positive and weak positive）,while＂ Not sure-negative＂ samples were negative in at lease one of two ELISA and two kinds of quick diagnosis tests,with no strong positive results by quick diagnosis.Conclusion Both sensitivity and specificity reached 100%combining with two quick diagnosis and ELISA（except the window period）,which can effectively distinguish between WB results of＂infection-not sure＂ and＂no infection-not sure＂.It is recommended that the National AIDS detection strategy should be adjusted to replace WB test by using a combination of HIV antibody screening tests,which could remove＂uncertain＂ results of WB confirmatory test,saves a lot of resources and reduce unnecessary damage,and meet the timely and accurate result judgments.