1种新型国产超敏HBsAg试剂在血液筛查中的应用研究

Application of a novel domestic hypersensitive HBsAg reagent in blood screening

目的对1种新型国产超敏HBsAg试剂在血液筛查中的应用进行评估。方法用考核试剂WT CLEIA分别检测WHO标准品、HBV阴性的血清、各种HBV亚型及HBsAg突变株标本以及无偿献血者标本,并与参比试剂做比较。结果 WT CLEIA对HBsAg阴性标本的检测特异性为99.81%(95%CI:99.57%～99.93%);对WHO标准品检测的分析灵敏度可达0.012 IU/mL,高于参比试剂Hepanostika HBsAg Ultra的0.05 IU/mL和Abbott Murex V3的0.1 IU/mL;对HBsAg突变株及不同亚型的检出率也高于2种参比试剂;对近5 000份标本的检测结果与参比试剂Abbott Murex V3有高度的符合率(99.60%)。结论该试剂检测性能良好,在血液筛查中有较好的应用前景。

Objective To study the application of a novel domestic hypersensitive HBsAg reagent in blood screening. Methods The reagent for evaluation named WT CLEIA together with reference reagents were used to test WHO standard, HBV negative samples and specimens with various HBV subtypes and HBsAg mutants. Results The specificity of WTCLEIA Was 99.81% （95% CI： 99.57% ~ 99.93%）. The analytical sensitivity of WT CLEIA was 0. 012 IU/ml,which was higher than Hepanostika HBsAg Ultra （0. 05 IU/mL） and Abbott Murex V3（0. 1 IU/mL） ; WT CLEIA also had a higher detection rate of HBsAg mutants and subtypes than these 2 reference reagents. In addition, WT CLEIA had a high accordant rate with Murex V3 in blood donors HBsAg screening. Conclusion WT CLEIA has a good performance in HBsAg screening and would have a good prospect of application in blood screening.