摘要
目的对造成生物制品中逆转录酶活性检查假阳性结果的原因进行分析和讨论,并探讨相应的对策。方法查阅生物制品中逆转录酶活性检查方法的相关文献,并结合实际工作中的检定结果进行分析总结。结果多种因素可造成逆转录酶活性检查结果的假阳性,可针对这些原因采取相应的策略。结论逆转录酶活性检查方法的进一步完善,对于生物制品的质量控制具有十分重要的意义。
Objective To analyze and discuss the causes of false positive results in reverse transcriptase assay in biological products.Methods Related literatures were reviewed about reverse transcriptase assay methods for biological products,and relative analyses and summarizations were made with regards to practical results.Results Various factors could lead to false positive results in reverse transcriptase assay,and specific strategies against these factors should be developed and utilized accordingly.Conclusion The improvement of reverse transcriptase assay is important for quality control of biological products.
出处
《中国药事》
CAS
2012年第12期1384-1387,共4页
Chinese Pharmaceutical Affairs
基金
国家高技术研究发展计划(编号SS2012AA020901)
作者简介
通讯作者：李玉华，博士，研究员；Tel：（010）67095986；E—mail：liyuhua@hotmail．com.
