时间分辨荧光分析法检测低值乙型肝炎病毒表面抗原的质量评价

目的评价时间分辨荧光分析法检测低值乙型肝炎病毒表面抗原（HBsAg）的性能。方法使用不同浓度试剂盒标准品、二级标准品进行重复测定,建立相应的数学模型,进行检测低限（lower limit of detection,LLD）、生物检测限（biologic limit of detection,BLD）、功能灵敏度（functional sensitivity,FS）、空白限（limit of blank,LoB）、检出限（limit of detection,LoD）、定量检出限（limit of quantifications,LoQ）的统计计算。结果 LLD为0.044ng/mL、BLD为0.18ng/mL、FS为0.18ng/mL、LoB为0.03ng/mL、LoD为0.108ng/mL,尝试计算低值HBsAg检测结果的不确定度,确定定量检出限（LoQ）约为0.5ng/mL。结论使用灵敏度性能和不确定度2种方法进行评价,该检测系统对低值HBsAg分析能够达到试剂盒规定的性能要求。

The quality assessment on TRFIA detection of low hepatitis B virus surface antigen

Objective To evaluate the performance of time resolved fluorometric immuno assay （TRFIA） detected low hepatitis B surface antigen（HBsAg）. Methods Different concentrations of the two standards were used to repeat measurement. Computation models were then set up. And statistical analysis about the lower limit of detection（LLD）, the biologic limit of detection（BLD）, the functional sensitivity（FS）, the limit of blank（LoB）, the limit of detection（LoD） and the limit of quantifications（LoQ） were conducted. Results The LLD was 0.044 ng/mL, the BLD was 0.18 ng/mL, the FS was 0.18 ng/mL, the LoB was 0.03 ng/mL and the LoD was 0.108 ng/mL. The measurement uncertainty of the low concentrations HbsAg was calculated to determine the LoQ that approximately 0.5 ng/mL. Conclusion The two different methods of using sensitivity and measurement uncertainty to analysis low HBsAg could achieve the performance requirements of provisions kit.