| 甲型肝炎灭活疫苗体外相对效力检测方法的研究及应用 |
| 投稿时间：2009-09-14 点此下载全文 |
| 引用本文：谢忠平、龙润乡、李华、陈洪波、宋霞、黄铠、洪超、杨蓉、白惠珠.甲型肝炎灭活疫苗体外相对效力检测方法的研究及应用[J].医学研究杂志,2010,39(1):50-52 |
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| 基金项目:云南省人才基金项目（2002PY11） |
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| 中文摘要:目的建立甲型肝炎灭活疫苗体外相对效力检测方法。方法用双抗体夹心ELISA法检测试剂对甲型肝炎灭活疫苗及效力试验参比进行检测，以检测OD值为反应指标，用生物检定双平行线法的基本原理进行统计分析，计算待检疫苗对应于效力参比品的相对效力（R值）。结果样品HAAg含量与检测OD值之间具有高度的相关性，R2≥0.97，适用于建立双平行线检定方法；通过对3批样品3人次检测结果分析，验证了所建立方法的可靠性，回归、偏离平行、二次曲线、反二次曲线4个指标全部通过了验证；用所建立的体外相对效力试验检测法对32批次甲肝灭活疫苗进行检测，结果与小鼠体内效力检测结果具有良好一致性，均能反映疫苗相对效力，两种方法检测相对效力（R值）之间无明显差别（t=1.0354,P=0.3045）。结论所建立的甲型肝炎灭活疫苗体外相对效力试验是一种灵敏、特异、方便、快捷的效力测定方法，可应用于甲型肝炎灭活疫苗效力检测。 |
| 中文关键词:甲型肝炎病毒、甲型肝炎灭活疫苗、效力、抗原、检测 |
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| The Study of Detection Methods and Application of the Relative Potency in vitro of Inactivated Hepatitis A Vaccine |
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| Abstract:ObjectiveTo establish a new in vitro method to detect the relative potency of inactivated hepatitis A vaccine. MethodsELISA was used to test the potency of hepatitis A vaccines and the reference vaccine. After getting the OD values of ELISA as response indicators, the dual-parallel line bioassays were carried out, and the R values of the vaccines were calculated comparing with the reference vaccine. ResultsThe HAAg level of the samples were consistent well with the OD values obtained by ELISA, with R2≥0.97, indicating that this double parallel line examination method could be established to detect the relative potency of HAV vaccine. The results of 3 lots of HAV vaccine samples tested with this method by 3 different people confirmed the reliability of it because the return, the deviation parallel, the conic section and the counter-conic section all passed the tests. Additional 32 lots of inactivated hepatitis A vaccine were examined with this method too. The results showed a good consistency with those by in vivo method in mice. Both of them could reflect the relative potency of the vaccine with similar R values, between which there was no significant difference (t=1.0354, P=0.3045>0.05). ConclusionThis new in vitro method is so sensitive, specific and fast that can be applied to detect the relative potency of inactivated hepatitis A vaccine. |
| keywords:HAV Inactivated hepatitis A vaccine Test Antigen Potency |
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