毛发中吗啡定量检测关键试剂的质量评价方法构建及分析
Construction and analysis of quality evaluation methods of key reagents for quantitative detection of morphine in hair
张婧 1李学洋 1刘姗姗 1李晶 1于智睿 1田恺 1张寅豹1
作者信息
- 1. 天津海关工业产品安全技术中心,天津 300457
- 折叠
摘要
目的 构建毛发中吗啡定量检测关键试剂的质量评价方法,筛选出结果稳定可靠的关键试剂,为开展涉毒试剂盒筛选工作提供技术支持.方法 基于吗啡检测试剂盒基本性能及盲样考核指标,运用层次分析法分析得出各指标权重,量化打分.结果 经综合评定影响试剂盒质量标准的因素,考核基本性能指标和盲样考核指标两项六类指标,覆盖最低检出限、重复性、线性、敏感性、特异性和功效率,筛选出关键指标最低检出限、功效率为关键指标.结论 影响质量评价的功效率测评权重最高,综合权重最高,占比45％,评分差距较大,建议相关机构开展试剂测评时将功效率纳入关键考核评价指标,亦可作为企业内控重点指标.
Abstract
Objective To establish a quality evaluation method for the key reagents for quantitative detection of morphine in hair,and to screen out the key reagents with stable and reliable results,so as to provide technical support for drug screening.Methods Based on the basic performance of morphine detection kit and blind test index,the weights of each index were obtained by AHP,and the comprehensive evaluation score was calculated.Results The factors affecting the quality standard of the kit included basic performance index and blind test index,which contributed 25％and 75％to the evaluation results,respectively.The basic performance index included the lowest detection limit,repeatability and linearity,and the lowest detection limit was the key index.Blind sample assessment indexes include sensitivity,specificity and work efficiency,and work efficiency is the key index.Conclusion The weight of work efficiency evaluation affecting quality evaluation is the highest,accounting for 45％,and the score gap is large.It is suggested that relevant institutions should include work efficiency in assessment and evaluation and the key indicators of enterprise internal control.
关键词
毛发/吗啡/定量检测/关键试剂/质量评价Key words
hair/morphine/quantitative detection/key reagent/quality evaluation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据