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目的建立兔抗戊型肝炎病毒(hepatitis E virus,HEV)抗体定量线性标准品并对其应用效果进行评价。方法利用抗-HEV抗体检测试剂盒筛选出本实验室的抗-HEV抗体阳性兔血清S26。用世界卫生组织(World Health Organization,WHO)抗-HEV Ig标准品对其进行标定并检测其稳定性。将S26血清稀释至其线性范围,再倍比系列稀释5个稀释度作为定量线性标准,进行多次实验考评其重复性和应用效果。结果经3次标定,S26血清抗-HEV水平为39.54IU/ml,95%CI为39.47~39.62IU/ml,变异系数<0.1%,稳定性好。从3.95IU/ml开始的5个倍比系列稀释度可作为兔抗-HEV抗体定量线性标准品,其重复性好且可有效地反映兔血清抗体水平变化趋势。结论本研究建立的兔抗-HEV抗体定量线性标准品,稳定性、重复性好,可用于兔HEV的疫苗原性评价及流行病学调查。
Objective To establish a quantitative linear standard of rabbit anti-hepatitis E virus (HEV) antibody and evaluate its application effect. Methods The anti-HEV antibody positive rabbit serum S26 was screened by anti-HEV antibody test kit. It was calibrated with the anti-HEV Ig standard of the World Health Organization (WHO) and its stability was tested. S26 serum diluted to its linear range, and then than the serial dilution of 5 dilutions as a quantitative linear standard, repeated experiments to evaluate its repeatability and application results. Results After 3 times of calibration, the level of anti-HEV of S26 was 39.54IU / ml, the 95% CI was 39.47-39.62IU / ml, the coefficient of variation was <0.1%, and the stability was good. The 5-fold serial dilutions from 3.95 IU / ml can be used as a quantitative linear standard for rabbit anti-HEV antibodies, which shows good reproducibility and can effectively reflect the trend of rabbit serum antibody levels. Conclusion The quantitative linear standard of rabbit anti-HEV antibody established in this study has good stability and repeatability and can be used for the evaluation of vaccineicity and epidemiological investigation of rabbit HEV.