市售HBsAg检测ELISA免疫逃逸变异检测能力的再评价

目的考核现行市售ELISA试剂对野生及免疫逃逸变异HBsAg的检测能力。方法采用一组市售ELISA试剂对本室既往研制的高浓度与定值基因重组G145R变异HBsAg质控物，部颁血清HBsAgELISA检测质控物，多种乙肝病毒免疫逃逸变异重组S蛋白表达产物（细胞培养上清），以及一组经特殊选择的临床血清进行检测，并与既往有关检测资料进行比较。结果自制G145R变异HBsAg质控物与抗HBsG6mAb的结合能力较一年前降低40．7％，但仍保持留较为完好的免疫反应性。以此及部颁质控血清进行考核，10份市售试剂中6份对IEMHBsAg的检测能力与野生HBsAg相当（比较显色强度大于90．0％，相对应敏感指数大于0．5），3份试剂出现不同程度的降低（比较显色强度介于83．5％～50．7％，相对应敏感指数介于0．25～0．125），1份试剂仅表现出极弱的检测现象（比较显色强度为11．20％，相对应敏感指数0．0039）。采用ELISAI、J及L等试剂对一组临床标本进行检测，阳性率分别为6．23％、14．89％、19．21％，前者HBsAg检出率较后两者显著为低（P〈0．05及0．01），后两者阳性率间亦表现出显著的差异（P〈0．05）。结论现行国产试剂对IEMHBsAg检测能力较既往已大幅度提高，采用以单一G145R变异HBsAg制备的质控物仅能部分评价它们对IEMHBsAg的检测能力。

Re-estimate of the detection ability of marketed HBsAg ELISA kits for immune escape mutant

Objective To estimate the detection ability of the marketed HBsAg ELISA kits for wild and immune escape mutant HBsAg.MethodsUsed a group of marketed HBsAg ELISA kits to detect the high concentration and fixed value quality controller of gene recombine G145R mutang HBsAg made by self,the HBsAg quality controller made by National Center for Clinical Laboratory(NCCL),kinds of recombine protein S of immune escape mutant HBV(cell culture supernatant)and a group of clinical serum sample by special selection,and compared with the related detection data as before.ResultsThe result show that the combination ability of G145R mutant HBsAg and anti-HBsAg G6 mAb had reduced 59.3%than that one year before.6 of 10 marketed kits' detection ability for this controller and for wild HBsAg were equal(relative color intension>90.0%,relaitive sensitivety index>0.5,and the same as the followed).3 of 10 had reduced in some degree(83.5%~50.7%,0.25~0.125),1 kit only show weakly detection ability.(11.20%,0.003 9).Use ELISA I,J and L detected 177 clinical samples for HBsAg,the positive rate were 6.23%,14.89%and 19.21%respectively.ELISA I(very poor dectetion ablity for IEM HBsAg)was marked lower than the other two(P<0.05,P<0.01).The detection ability for IEM HBsAg of ELISA J and ELISA L were equal,but the positive rate of the two kits for HBsAg show markedly difference(P<0.05).ConclusionThe detection ability for IEM HBsAg of our present marketed HBsAg kits have greatly improved.Used the single G145R mutant HBsAg quality controller can only partly estimate the kits' detection ability for IEM HBsAg.