唐山市HIV抗体确证试验的替代策略研究

Alternative strategies of HIV antibody confirmatory testing

目的在几种艾滋病病毒(HIV)抗体筛查试验组合中,找出哪种HIV初筛试验组合做蛋白印迹(WB)试验的必要性。方法以2010-2016年,唐山市HIV初筛试验有反应的1 972份需进一步做WB确证试验的样本为研究对象,包括确证结果为"阳性"、"不确定"、"阴性"样本。两种快检(RT)(+)、两种RT(-)、一种RT(+)或(±),分别与各种酶联免疫吸附试验(ELISA)结果、化学发光结果的各种试验组合与WB结果及不确定带型的比较分析。结果1 972份样本中,两种RT(+)与ELISA、化学发光的试验组合中,WB确证阳性860例,不确定8例,阴性0例;两种RT(-)的试验组合中,WB不确定137例,2例随访后转阳,阴性925例;一种RT(+)或(±)的试验组合中,WB确证阳性7例,阴性20例,不确定15例,其中4例转阳;三种不同RT组合试验的差异有统计学意义(x^2=2 581.367,P=0.001)。在两种RT(+)与ELISA、化学发光的7类试验组合与WB结果的比较无统计学意义(x^2=4.850,P=0.563)。结论两种RT(+)两种ELISA S/C(O值均≥6的试验组合替代WB试验确证HIV感染是完全可行的;两种RT(一)与一种ELISA阴性的试验组合是没必要进行WB确证试验的。这种替代策略可以大量降低HIV抗体确证的费用,也减少WB不确定结果带来的不必要的伤害。

Objective To find alternative strategies by using combinations of human immunodeficiency virus（HIV） antibody screening tests with experimental bands of positive and uncertain results,in order to find the necessity of WB test as confirmation after the combinations of HIV primary screening.Methods There were 1972 serum samples screened positive from 2010 to 2016,including the positive,negative and uncertain results by WB confirmatory test.Comparative analysis was conducted between WB confirmation test with the uncertain experimental bands and combinations of two rapid tests（two RT＋ and two RT-,one RT＋ or RT ±） and all kinds of ELISA and Chemi-luminescence test results.Results In the combination of two RT（＋） with positive results of ELISA and Chemi-luminescence test,860 cases were confirmed as positive by WB confirmation test and 8 cases were uncertain,and none was negative.In the combination of two RT（-）,137 cases were uncertain（2 cases turned to be positive during follow-up test） by WB confirmation test and 925 were negative.In the combination of one kind of RT（＋） or RT（±）,7 cases were positive by WB confirmation test,20 cases were negative and 15 cases were uncertain（4 cases turned to be positive during follow-up test）.There was statistical difference of the results among three different combinations of RT experiment（x^2=2 581.367,P= 0.001〈0.05）.There was no statistical difference between seven different combinations of two RT（＋） with all kinds of ELISA and Chemi-luminescence test results and WB confirmation test（x^2=4.850,P= 0.563〉0.05）.Conclusion The combination of two RT（＋） and two kinds of ELISA＇S/CO≥6 is completely feasible to replace WB test for HIV diagnosis.The combination of two RT（-） and the negative result of one ELISA shows there is no need to take WB test as confirmation.The alternative testing strategies can reduce the costs for HIV diagnosis and avoid the harms which may be caused by the indeterminate results due to WB test.