HBsAg检测试剂的定量性能分析  

Quantitative performance analysis of detection reagent for HBs Ag

作　　者：肖健[1] 李克坚[2] 喻剑虹[1] 周诚[2] 蓝海云[2] 辜文洁[2] 

机构地区：[1]武汉生物制品研究所有限责任公司,湖北武汉430207 [2]中国食品药品检定研究院,北京100050

出　　处：《中国生物制品学杂志》2015年第12期1285-1288,共4页Chinese Journal of Biologicals

基　　金："十二五"国家科技重大专项(2012ZX10004-702)

摘　　要：目的分析7种HBs Ag定量检测试剂的检测线性范围、定量准确性及对3种HBs Ag亚型的最低检出量性能。方法使用世界卫生组织（World Health Organization,WHO）提供的HBs Ag标准品,应用平行线终点稀释方法进行定量,标定高浓度的HBs Ag样品,评价试剂的有效检测范围;以浓度值在5.9-100 IU/ml范围内的样品,评价试剂的定量准确性;检测3种HBs Ag亚型样品,评价试剂对3种亚型（adr、adw、ay）的最低检出量。结果 S试剂检测浓度为1 600 IU/ml的样品时,其相对偏差为-24%,并且随着样品浓度的升高相对偏差增加;K试剂检测浓度大于3 200 IU/ml的样品时,其相对偏差大于-98%;其余5种试剂在线性范围内的相对偏差均小于20%。6种试剂检测浓度为5.9-100 IU/ml的样品时,平均相对偏差的绝对值均小于15%,其中,K试剂为39%。7种试剂对adr、adw最低检出量均达到0.1 IU/ml,试剂间两两比较差异无统计学意义（P〉0.05）;但L、F、X、K 4种试剂对ay亚型最低检出量高于0.1 IU/ml,对3种亚型最低检出量间的差异有统计学意义（P〈0.01）。结论 S试剂定量检测浓度值上限低于标示值2 500 IU/ml;K试剂检测高浓度样品时,存在HOOK效应,其他6种试剂定量测定相对偏差小于20%;4种试剂对ay亚型检测定量值偏低。Objective To evaluate the linear detection range, accuracy and minimum detection limit of seven reagents for HBs Ag of three subtypes. Methods High concentration HBs Ag samples were quantitatively demarcated by parallel line end dilution method using HBs Ag reference standard provided by World Health Organization（WHO） to evaluate the effective detection range of the reagent. The accuracy of reagent for quantitation was evaluated by using the samples at concentrations of 5. 9 - 100 IU / ml. HBs Ag samples of three subtypes（adr、adw and ay）were determined by the reagent to evaluate the minimum detection limit. Results The relative deviation of reagent S for samples at a concentration of1 600 IU / ml was-24%, which increased with the increasing concentration of samples. The relative deviation of reagent K for samples at concentrations of more than 3 200 IU / ml was more than-98%, while those of the other five reagents within the linear range were less than 20%. The absolute values of mean relative deviations of six reagents for samples at concentrations of 5. 9 - 100 IU / ml were less than 15%, of those that of reagent K was 39%. The minimum detection limits of seven reagents for subtypes adr and adw were 0. 1 IU / ml, which showed no significant difference between various reagents（P〈0. 05）. However, the minimum detection limits of reagents L, F, X and K for subtype ay were more than 0. 1 IU / ml, while those for three subtypes showed significant difference（P〈0. 01）. Conclusion The upper limit of quantitative detection limit of reagent S was lower than stated value（2 500 IU / ml）on label. Hook effect was observed in determination of high concentration samples by reagent K, however, the relative deviation of determination results by the other six reagents were less than 20%. The quantitative determination results of subtype ay by four reagents were relatively low.

关 键 词：乙型肝炎表面抗原 检测 试剂 定量 

分 类 号：R373.21[医药卫生—病原生物学] R392-33[医药卫生—基础医学]