摘要
目的：建立重组乙型肝炎疫苗(CHO细胞)鉴别试验的方法。方法：取重组乙型肝炎疫苗(CHO细胞)以1：10比例加入lmol/L盐酸调节pH值,采用ELISA双抗体夹心法检测,同时设以氢氧化铝、未处理的重组乙型肝炎疫苗、狂犬疫苗、出血热疫苗,以及试剂盒的阴、阳性作为对照。结果：狂犬疫苗、出血热疫苗及氢氧化铝对照为阴性,直接检测重组乙型肝炎疫苗(CHO细胞)呈弱阳性,加入盐酸调节pH值后原倍样品呈弱阳性,10倍稀释后呈强阳性。采用该方法检测5批疫苗均呈强阳性。组内平行试验,组间重复试验。结论：将重组乙型肝炎疫苗(CHO细胞)调节pH值后10倍稀释,用ELISA双抗体夹心法检测呈阳性,而且稳定可靠,该方法可用于该疫苗的鉴别试验。
Objective： To explore a new efficient method of detecting Recombinant CHO hepatitis B vaccine （rHBsAg vaccine）. Methods： rHBsAg （CHO） was mixed by hydrochloric acid of lmol/L with 10：1 to a suitable pH, and detected by ELISA test with aluminium hydroxide, unsettled rHBsAg vaccine, Rabies vaccine, Haemorhagic Fever vaccine and positove and regative control tests in test box as control. Results： Rabies vaccine, Haemorrhagic Fever vaccine and aluminium hydroxide showed negative, unsetlled rHBsAg vaccine（CHO） and HCl mixed one showed slightly positive, HCl adjusted rHBSAg vaccine which was diluted in to a coneentrition of 1/10 of its original one showed stong positive. Also, 5 groups of rHBsAg vaccine got the same result. Control tests carried out in parallel inner group and between groups supported the above. Conclusion： rH- BsAg vaccine adjusted by HC1 and diluted into a concentration of 1/10 of it can make a evident positive result available in ELISA test, which is a stable reaotoin and a good method in rHBsAg vaccine detection.
出处
《生物技术》
CAS
CSCD
2006年第5期38-39,共2页
Biotechnology
