中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2014年
4期
232-234
,共3页
药物滥用%胶体金法%灵敏度
藥物濫用%膠體金法%靈敏度
약물람용%효체금법%령민도
drug abuse%colloidal gold method%sensitivity
通过针对胶体金法药物滥用检测试剂自身特点的分析，对其研发过程中灵敏度研究要点进行了详细解析，从抗原-抗体反应性研究、试剂最低检出限研究、检出限的验证以及相关结构类似物的检出限研究等方面对该类试剂灵敏度研究提出了建议，为该类试剂研发过程中的灵敏度研究提供参考。
通過針對膠體金法藥物濫用檢測試劑自身特點的分析，對其研髮過程中靈敏度研究要點進行瞭詳細解析，從抗原-抗體反應性研究、試劑最低檢齣限研究、檢齣限的驗證以及相關結構類似物的檢齣限研究等方麵對該類試劑靈敏度研究提齣瞭建議，為該類試劑研髮過程中的靈敏度研究提供參攷。
통과침대효체금법약물람용검측시제자신특점적분석，대기연발과정중령민도연구요점진행료상세해석，종항원-항체반응성연구、시제최저검출한연구、검출한적험증이급상관결구유사물적검출한연구등방면대해류시제령민도연구제출료건의，위해류시제연발과정중적령민도연구제공삼고。
The purpose of this article is to discuss the main points of sensitivity study of drug abuse detection reagents. Considering the characteristics of drug abuse detection reagents, recommendations on several aspects of the sensitivity study methods were made including the combination activity of antigen with antibody, the low detection limit establishment and validation, and the low detection limit of structural analogues,providing a reference for the sensitivity study of the reagent's research and development .
