22个内分泌检验项目允许总误差、允许不精密度和允许偏移的设定  

Establishment of allowable total error,allowable imprecision and allowable bias for 22 endocrine analytes

作　　者：王薇[1] 张志新 张传宝[1] 周伟燕[1] 王治国[1] WANG Wei;ZHANG Zhixin;ZHANG Chuanbao;ZHOU Weiyan;WANG Zhiguo(National Center for Clinical Laboratories,Beijing Engineering Research Center of Laboratory Medicine,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Hospital,National Center of Gerontology,Beijing 100730,China)

机构地区：[1]北京医院、国家老年医学中心、国家卫生健康委临床检验中心、北京市临床检验工程技术研究中心、中国医学科学院老年医学研究院,北京100730

出　　处：《检验医学》2023年第8期707-712,共6页Laboratory Medicine

基　　金：国家自然科学基金项目(81871737)。

摘　　要：目的设定22个内分泌检验项目允许总误差(TEa)、允许不精密度[用变异系数(CV)表示]和允许偏移(Bias),以推荐相关项目的性能规范。方法收集2020—2022年国家卫生健康委临床检验中心内分泌项目室间质量评价(EQA)和室内质量控制(IQC)数据。根据意大利米兰会议最新确定的性能规范设定模式,基于生物学变异(BV)和当前技术水平模式导出性能规范。对于有BV数据的检验项目,将EQA数据的“百分差值”、IQC数据的当月在控“CV”与基于BV导出的3个水平评价标准进行比较,计算所有批号质控品的百分差值通过率和CV通过率,以通过率达到80%为该水平质控品的性能规范满足该项目推荐性能规范要求。对于无BV数据或基于BV导出的3个水平性能规范均无法作为推荐标准的检验项目,基于当前技术水平导出推荐TEa和CV,再导出允许Bias。结果22个内分泌检验项目推荐的TEa/允许CV分别为:游离三碘甲状腺原氨酸18.9%/6.5%,总三碘甲状腺原氨酸17.4%/7.1%,游离甲状腺素25.0%/6.2%,总甲状腺素20.0%/7%,促甲状腺激素24.6%/8.9%,皮质醇26.3%/8.2%,雌二醇26.0%/7.5%,卵泡刺激素21.2%/6.2%,黄体生成素25.0%/6.8%,孕酮26.2%/9.3%,催乳素18.7%/7.4%,睾酮16.5%/6.3%,C-肽20.8%/8.3%,叶酸29.5%/8.9%,胰岛素25.0%/6.4%,甲状腺球蛋白28.2%/8.0%,甲状旁腺激素30.0%/11.8%,醛固酮21.4%/9.2%,硫酸脱氢表雄酮25.0%/7.5%,维生素B1225.0%/7.5%,生长激素25.0%/7.0%,促肾上腺皮质激素27.4%/9.1%。结论设定的22个内分泌检验项目的TEa、允许CV和允许Bias可推荐作为符合中国临床实验室当前技术水平的性能规范。Objective To set the allowable total error(TEa),allowable imprecision[coefficient of variation(CV)]and allowable bias(Bias)for 22 endocrine analytes,and to recommend performance specifications for related items.Methods The data,including external quality assessment(EQA)data and internal quality control(IQC)data,of the National Center for Clinical Laboratories from 2020 to 2022 were collected.According to the performance specification setting mode newly determined at the Milan conference in Italy,the performance specification was derived based on biological variation(BV)and current technology level.For the analytes with BV data,the percentage difference of EQA data and the in-control CV of month IQC data were compared with the 3-level evaluation criteria derived based on BV,and the percentage difference passing rate and CV passing rate of all-batch quality control materials were calculated.When the passing rate reached 80%,the performance specifications of this level met the requirements of the recommended performance specifications of the analyte.For the analytes without BV data or the analytes whose performance specifications at 3-level evaluation criteria derived based on BV could not be used as recommended performance specifications,the recommended TEa and allowable CV may be derived based on the current technology level.Based on the current technology level,the recommended TEa and allowable CV were derived,and then the allowable Bias was derived.Results TEa/allowable CV recommended for 22 endocrine analytes were as follows:free triiodothyronine 18.9%/6.5%,triiodothyronine 17.4%/7.1%,free thyroxine 25.0%/6.2%,thyroxine 20.0%/7.0%,thyroid-stimulating hormone 24.6%/8.9%,cortisol 26.3%/8.2%,estradiol 26.0%/7.5%,follicle-stimulating hormone 21.2%/6.2%,luteinizing hormone 25.0%/6.8%,progesterone 26.2%/9.3%,prolactin 18.7%/7.4%,testosterone 16.5%/6.3%,C-peptide 20.8%/8.3%,folate 29.5%/8.9%,insulin 25.0%/6.4%,thyroglobulin 28.2%/8.0%,parathyroid hormone 30.0%/11.8%,aldosterone 21.4%/9.2%,dehydroepiandrosterone sulfat

关 键 词：生物学变异 允许总误差 允许不精密度 允许偏移 内分泌 性能规范 

分 类 号：R446.7[医药卫生—诊断学]