用现行国产HBsAg EIA检测乙肝S基因突变体问题的研究

Preliminary study on the capability of HBsAg EIA kits to detect HBsAg mutants

目的探讨乙型肝炎表面抗原（ＨＢｓＡｇ）突变体对抗体结合能力的影响，寻找鉴别变异株的办法和规律，并为改进试剂质量进行基础研究。方法用２３家国产ＨＢｓＡｇＥＩＡ检测１０株重组表达ＨＢｓＡｇ突变体和１株原型ＨＢｓＡｇ。结果２３家国产试剂均能检测出原型、重组表达ＨＢｓＡｇ。表达的１０株突变体，１号试剂可全部检出，其它试剂的检出率分别为：对突变体抗原１４５精氨酸、１３３亮氨酸、１２６天冬酰胺的检出率为９１％，１４２丝氨酸为８６％，１４２亮氨酸为８２％，１２９组氨酸为７８％，１４１谷氨酸为３４％，１２６丝氨酸为３０％，１４４丙氨酸为２６％，１４５精氨酸＋１２６丝氨酸为１７％。结论乙肝Ｓ基因不同位点变异可导致与某些单抗的结合力降低，为进一步发展检测鉴别ＨＢｓＡｇ突变体的诊断试剂提供了理论基础。

The HBsAg EIA kits from 23 different companies were used to detect the recombinant wild type HBsAg and the mutants including 145R,144A,142S,142L,141E,133L,129H,126S,126N and 145R+126S.The results showed that all the HBsAg EIA kits could detect the wild type HBsAg, 90% of kits could detect 145R,133L,126N mutants,and 86%,82%,78%,34%,30%,26% and 17% of kits could detect 142S,142L,129H,126S,141E,144A and 145R+126S mutants,respectively.It showed that the capabilities for detecting the HBsAg mutants among HBsAg EIA kits from different companies were quite different. So it is necessary to improve the quality of HBsAg EIA kits in order to find out the mutants.