Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (4): 232-234.

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Analysis of Sensitivity Study of Drug Abuse Detection by Colloidal Gold Method

LV Yun-feng   

  1. Medical Device Evaluation Center, CFDA, Beijing 100044, China
  • Received:2014-02-07 Revised:2016-02-03 Online:2014-04-08 Published:2016-02-03

Abstract: 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 .

Key words: drug abuse, colloidal gold method, sensitivity

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