两种质量规范在睾酮、皮质醇检测性能验证中的应用比较  

Application of Two Quality Specifications for Performance Verification of Serum Testosterone and Cortisol

作　　者：廖红娟 张援 宋爱晶 孙娟 官凌菊 LIAO Hongjuan;ZHANG Yuan;SONG Aijing;SUN Juan;GUAN Lingju(Guangdong Provincial Institute of Sports Science,Guangzhou Guangdong,510663)

机构地区：[1]广东省体育科学研究所,广东广州510663

出　　处：《湖北体育科技》2022年第1期59-62,共4页Hubei Sports Science

摘　　要：目的对2种质量规范在睾酮、皮质醇精密度和正确度验证中的应用进行比较,选择适合运动生化实验室中睾酮、皮质醇分析性能验证的评价标准。方法参照WS/T 492-2016、CLSI EP15-A3方案,使用Centaur XP化学发光免疫分析仪对睾酮、皮质醇的精密度、正确度进行验证,用美国临床实验室改进修正法案’88(CLIA’88)质量规范和基于生物学变异的质量规范对验证结果进行评价。结果睾酮、皮质醇的不精密度和正确度能轻松满足CLIA’88质量规范,但该质量规范是基于法规和室间质评而制定的,其评价限过于宽松,不利于运动生化实验室检测质量的提高。以基于生物学变异的质量规范为评价标准时,睾酮的不精密度和正确度能满足适当的质量规范要求,皮质醇的不精密度和正确度能满足最佳的质量规范要求,故推荐“适当的”和“最佳的”质量规范分别作为睾酮和皮质醇分析性能验证的评价标准。结论基于生物学变异的质量规范考虑了分析变异与生物学变异之比值对检验结果变异的影响,其性能优于CLIA’88质量规范,将其作为运动生化实验室检测项目的性能验证评价标准,既能保证实验室的检测水平,又有利于科研人员科学合理地评价检测结果的变异性,从而为运动队提供精准的科技服务。Objective To compare the application of two quality specifications in verification of performance for precision and trueness of serum testosterone and cortisol,and select an appropriate evaluation standard for the verification of performance for laboratory testing methods.Methods According to the standards of WS/T 492-2016 and CLSI EP15-A3,the verification of performance for precision and trueness of serum testosterone and cortisol were carried out,and then using two quality specifications to evaluate the verification results.Results The imprecision and trueness of serum testosterone and cortisol meet CLIA'88,which is formulated on the basis of regulations and external quality assessment.Under the current technical level,the evaluation limits of CLIA'88 are too loose,which is not conducive to improvement of detection quality.Using the quality specifications derived from biological variation as evaluation criteria,the imprecision and trueness of serum testosterone could meet the desired performance of biological variation,the imprecision and trueness of serum cortisol could meet the optimum performance of biological variation.Therefore,the desired performance of biological variation and the optimum performance of biological variation are recommended as evaluation criteria for the performance verification of serum testosterone and cortisol.Conclusion The quality specifications derived from biological variation considers the influence of the ratio of analysis variation to biological variation on test results,it is more objective and reasonable than CLIA’88.Taking it as the evaluation criteria for the performance verification of detection methods in sports biochemical laboratory,which can not only guarantee the testing quality,but also help researchers to evaluate the results variation scientifically and reasonably.

关 键 词：质量规范 精密度 正确度 睾酮 皮质醇 运动生化 

分 类 号：G804.7[文化科学—运动人体科学]