Quality Control and Evaluation of Colloidal Gold Immunochromatography Qualitative Detection Reagents
Objective:To discuss the key requirements of quality control technology for colloidal gold immunochromatography qualitative detection reagents,aiming to provide reference for quality control and evaluation of production enterprises and inspection institutions,and effectively promote the quality level of such in vitro diagnostic reagents.Method:Based on the quality standard requirements and classification management of colloidal gold immunochromatography qualitative detection reagents,analyze the key performance elements of this type of reagent quality,put forward corresponding suggestions,improve reagent quality.Results and Conclusion:Quality control and evaluation are the core elements that run through the entire product process.Membrane width,liquid migration speed,negative compliance rate,positive compliance rate,detection limit and repeatability are the key performance indicators for quality control and evaluation of colloidal gold immunochromatography qualitative detection reagents,which are crucial for the quality of reagents.Relevant production and R&D enterprises should reasonably design performance requirements and improve quality management systems,inspection agencies should conduct quality evaluations based on the key product performance points,regulatory authorities should accelerate the revision of standards and strengthen post listing supervision based on industry and regulatory needs.Control these key performance indicators from various aspects of production,inspection,and supervision to improve the quality standards of reagents,so as to meet the clinical and regulatory needs.
NETL
NSTL
万方数据
维普
