国产乙型肝炎病毒表面抗原酶联免疫吸附试验试剂盒的检测效果评价

Evaluation and comparison of six domestic made HBsAg ELISA Kits

目的:评价6种国产乙型肝炎病毒表面抗原(HBsAg)酶联免疫吸附试验(ELISA)试剂盒的检测效果。方法:应用AXSYM全自动微粒子酶免疫化学发光分析仪检测测定后余留标本,对相关样品进行稀释,然后选取6种国产HBsAgELISA试剂盒进行检测,评价6种国产试剂盒的灵敏度、精密度、特异度、检测范围和钩状效应(Hook效应),确立临界值(cut-off)对应的浓度范围以及不同孵育时间对检测灵敏度的影响等。结果:6种试剂盒的灵敏度有一定差异,范围在0.40～0.60ng/mL之间。对低浓度标本,6种试剂盒的批内精密度变异系数(CV)分别为6.21%、9.45%、9.42%、13.04%、10.49%和4.84%;批间精密度CV分别为15.76%、19.12%、19.54%、23.89%、24.22%和14.99%。HBsAg质量浓度与临界值指数(COI)呈S型曲线关系。在本实验所分析的HBsAg浓度范围内未发现高剂量Hook效应。6种试剂盒临界值对应的质量浓度在0.3～0.5ng/mL之间。结论:国产HBsAgELISA试剂盒的灵敏度有待进一步提高。

Objective To evaluate the efficiencies of six domestic made HBsAg ELISA kits.Methods Quality control material and patients sera were used to evaluate the sensitivity,precision,specificity,detection range,Hook effect and cut-off concentration value of six domestic made HBsAg ELISA kits.Results were also compared with those obtained by Abbott AXSYM automated immunoassay systems.Results Slight variation in sensitivity was found among these six kits,ranging from 0.40 ng/mL to 0.60 ng/mL.The within-run coefficient of variation （CV） of these 6 kits were 6.21%,9.45%,9.42%,13.04%,10.49%,4.84%,and between-run CV were 15.76%,19.12%,19.54%,23.89%,24.22%,14.99%,respectively.No Hook effect was observed up to a concentration of 5 00 ng/mL.The cut-off concentration levels of these six ELISA kits were ranged from 0.3-0.5 ng/mL.Conclusions More efforts are required to improve the sensitivity of these domestic HBsAg ELISA kits.