以IU为单位的乙型肝炎病毒核心抗体国家参考品的建立  

Establishment of national HBcAb reference panel with the unit of IU

作　　者：蓝海云[1] 戴峻英 辜文洁[1] 李克坚[1] 周诚[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]珠海丽珠试剂股份有限公司,广东珠海519060

出　　处：《中国生物制品学杂志》2016年第12期1294-1297,1300,共5页Chinese Journal of Biologicals

摘　　要：目的建立以IU为单位的乙型肝炎病毒核心抗体(hepatitis B core antibody,HBcAb)国家参考品。方法从我国多个省份血液中心和采浆站收集血清、血浆样品300份,应用5家国产和2家进口HBcAb诊断试剂初步筛选,并采用WHO国际HBcAb标准品进行标定,同时验证初步筛选获得的参考品的稳定性及适用性。结果建立了HBcAb国家参考品,包括阴性参考品15份、阳性参考品15份、灵敏度参考品1份、精密性参考品1份。其中灵敏度参考品经WHO国际HBcAb标准品标化后定量为5 IU/ml,19家发光试剂和酶联免疫试剂的最低检出限均值分别为0.67及0.53 IU/ml。参考品经4℃、常温、37℃保存及反复冻融后与置-20℃保存的参考品在阳性参考品符合率、阴性参考品符合率、最低检出限及精密性等方面的结果均一致。5家国产试剂检测阴性参考品符合率均为15/15,阳性参考品符合率均为15/15,其中3家试剂的最低检测限高于1.0 IU/ml,精密性CV均<20%。结论成功建立了以IU为单位的HBcAb国家参考品,且具有良好的稳定性及适用性,为提高HBcAb诊断试剂的质量奠定了基础。Objective To establish the national HBcAb reference panel with the unit of IU. Methods Three hundred serum and plasma samples were collected from various provinces in China, and screened with five domestic and two imported HBcAb diagnostic kits. The obtained HBcAb reference panel was calibrated with WHO international HBcAb standard, and verified for stability and suitability. Results The national reference panel for HBcAb was established,including 15 negative reference samples, 15 positive reference samples, one precision reference sample, and one sensitivity reference sample at a concentration of 5 IU / ml calibrated by WHO HBcAb standard. The mean detection limit by chemiluminescence and ELISA were 0. 67 and 0. 53 IU / ml respectively. The reference panels after storage at 4 ℃,room temperature, 37 ℃ and repeat freeze-thawing were in agreement in the coincidence rates of positive reference,negative reference, minimum detection limit and precision. Both the incidence rates of test results of negative and positive references by five domestic kits were 15 / 15, while the minimum detection limits by three kits were more than 1. 0 IU / ml,and the CVs of precision test results were less than 20%. Conclusion The national reference panel for HBcAb was successfully established, which showed high stability and suitability, and laid a foundation of improvement of the quality of HBcAb diagnostic kit.

关 键 词：乙型肝炎病毒 核心抗体 参考品 

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