不同HBsAg酶联免疫检测试剂的血清型灵敏度  

Serotype-sensitivities of Various EIA Kits for HBsAg

作　　者：辜文洁[1] 黄维金[1] 于洋[1] 吴星[1] 周诚[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院病毒二室,北京100050

出　　处：《中国生物制品学杂志》2011年第7期832-834,共3页Chinese Journal of Biologicals

摘　　要：目的比较不同HBsAg酶联免疫检测试剂(国产试剂:1号～4号,进口试剂:5号和6号)的分析灵敏度差异。方法收集乙型肝炎病毒(Hepatitis B virus,HBV)感染者血清,提取病毒核酸,PCR扩增HBV的S基因,测序后,根据其氨基酸序列确定血清型。应用雅培HBsAg检测试剂对各血清型样品进行定量检测,根据定量结果稀释至1～4 IU/ml,将各样品以1∶2系列稀释至4个稀释度,分别利用6种HBsAg酶联免疫检测试剂双孔检测。将各试剂的cut-off值代入各样品,检测A值和浓度值的双对数曲线,计算各血清型样品的分析灵敏度,比较各试剂间与各血清型间的分析灵敏度差异。结果不同血清型间的分析灵敏度差异无统计学意义(P>0.05),不同试剂间的检测结果差异均有统计学意义(P<0.01)。国产4号试剂与进口5号和6号试剂间的分析灵敏度差异无统计学意义(P>0.05),国产4号、进口5号和6号试剂的分析灵敏度高于国产1号和3号试剂,低于国产2号试剂。各试剂对不同血清型样品的分析灵敏度差异无统计学意义(P>0.05)。结论各血清型间HBsAg检测的分析灵敏度无差别,但不同试剂间的分析灵敏度有差别,应对其临床意义进一步研究。Objective To compare the analytical sensitivities of various EIA kits（domestic kits 1 ～ 4,imported kits 5 and 6）.Methods Sera of patients infected with hepatitis B virus（HBV） were collected,from which viral nucleic acid was extracted for amplification of S gene by PCR.The amplified gene was sequenced and determined for serotype by its amino acid sequence.The serotype samples were analyzed quantitatively by Abbott detection kit for HBsAg,and diluted to a concentration of 1 ～ 4 IU/ml according to the detection result,then further diluted 2-fold serially to four dilutions and determined by 4 domestic and 2 imported kits,in duplicate.The cut-off values of detection results by various kits were inserted into the double logarithmic curve plotted by the A value against concentration of each sample to calculate the analytical sensitivities of samples of various serotypes,based on which the sensitivities of various kits and samples of various serotypes were compared.Results The analytical sensitivities of showed no significant difference in samples of various serotypes（P 〉 0.05）,while showed significant difference in the detection results by various kits（P 〈 0.01）.The analytical sensitivity of domestic kit 4 showed no significant difference with those of imported kits 5 and 6（P 〉 0.05）.However,the analytical sensitivities of domestic kit 4 as well as imported kits 5 and 6 were significantly higher than those of domestic kits 1 and 3,while lower than that of domestic kit 2.The analytical sensitivities of various kits for the samples of various serotypes showed no significant difference（P 〉 0.05）.Conclusion The analytical sensitivities of HBsAg of various serotypes showed no significant difference,while those of detection results by various kits showed significant difference,of which the significance in clinic should be further studied.

关 键 词：肝炎表面抗原 乙型 酶联免疫吸附测定 灵敏度 血清型 

分 类 号：R392-33[医药卫生—免疫学]