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《Journal of Molecular Diagnostics and Therapy》 2018-05
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Quality analysis of human EGFR gene mutation detection kits in 2017

SUN Nan;YU Ting;HUANG Jie;QU Shoufang;The Key Laboratory of Biotechnology Product Test Method and Its Standardization of the Ministry of Health,National Institutes for Food and Drug Control;  
Objective According to the national in vitro diagnostic reagent sampling program,9 batches of"human EGFR gene mutation detection kit"were sampled from 8 companies to evaluate the quality of the kit. Methods The accuracy,specificity,limit of detection and repeatability were verified in accordance with the product technical requirements.Exploratory study was also contacted by using the national reference and referring to the industry standards to be released.Results All of testing reagents met the product technical requirements of each company.According to the industry standard to be implemented,one mutation from one batch was not detected in the accuracy and limit of detection.Conclusion There are differences in technical requirements of each company's products,which affect product quality.It is recommended that the technical requirements of the enterprise be updated in a timely manner according to industry standards,and the national reference products should be used for testing.
【Fund】: 国家高技术研究发展计划(863计划):新型体外诊断试剂质量评价体系和国家参考物质研究项目(2011AA02A115)
【CateGory Index】: R440
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