论文部分内容阅读
在提高乙型肝炎表面抗原(HBsAg)酶联免疫诊断盒灵敏度的研究中对包被抗体、酶标记用抗体作了大量的筛选、对比实验。结果表明,包被单克隆抗体配伍酶标记山羊或豚鼠多克隆抗体可使乙肝表面抗原检测灵敏度达到0.2ng,超过中国药品生物制品检定所要求的1ng批批检合格标准,同时,特异性及变异系数均合乎要求,从而提高了试剂盒的质量。这一研究结果对提高其它以夹心法为原理的检测灵敏度有重要意义。
In the study of improving the sensitivity of HBsAg ELISA kit, a large number of screening and comparison experiments were carried out on the antibodies coated on the coated antibody and the enzyme labeled antibody. The results showed that the coated monoclonal antibody with enzyme-labeled goat or guinea pig polyclonal antibody can make HBsAg detection sensitivity of 0.2ng, exceeding the requirements of the Chinese pharmaceutical and biological products 1ng batch inspection standards, at the same time, specificity and variation Coefficient are in line with the requirements, thus improving the quality of the kit. The results of this study to improve the other to sandwich the principle of detection sensitivity is of great significance.