摘要
目的对甲状腺功能五项进行量值溯源研究,期望建立甲状腺功能五项量值溯源体系,以确保检测系统的检测结果准确可靠,为甲状腺功能五项检测标准化和一致化研究提供参考。方法按照GB/T 21415:2008(ISO 17511:2003)标准文件的规定对总三碘甲腺原氨酸(TT_(3))、总甲状腺素(TT_(4))、游离三碘甲腺原氨酸(FT_(3))、游离甲状腺素(FT_(4))、促甲状腺素(TSH)五项检测系统进行量值溯源,并通过国际参考实验室间质量评价(RELA)评价具有参考方法的TT_(3)和TT_(4)项目,通过国际参考品评价具有参考物质的TSH项目,通过方法学比对评价既无参考方法也无参考物质的FT_(3)和FT_(4)项目。结果迈克TT_(3)和TT_(4)项目溯源到JCTLM推荐的ID-LC/MS/MS参考方法,TSH项目溯源到有证参考物质NIBSC code:81/565,FT_(3)和FT_(4)项目通过方法学比对进行溯源,TT_(3)项目RELA样本A和RELA样本B的偏移分别为3.9%和2.5%,TT_(4)项目RELA样本A和RELA样本B的偏移分别为-0.2%和0.9%,偏移均较小。迈克系统测量TSH国际参考品高中低三个浓度水平的偏移分别是1.7%、0.8%和-3.9%,偏移均小于设定的最大允许误差(±10%)。FT_(3)项目罗氏系统与迈克系统临床比对结果的Passing-Bablok回归方程为Y=-0.403246+1.055337 X;相关系数r_(s)=0.95,可认为两者具有一致性。FT_(4)项目罗氏系统与迈克系统临床比对结果的Passing-Bablok回归方程为Y=-1.604055+1.087905 X;相关系数r_(s)=0.916,可认为两者具有一致性。结论建立了甲状腺功能五项量值溯源体系,量值溯源结果准确可靠。
Objective To conduct a research on the traceability of five analytes of thyroid.It is expected to establish a traceability system of five analytes of thyroid to ensure the accuracy and reliability of the detection system,and to provide a reference for the standardization and harmonization research of five analytes of thyroid.Methods According to GB/T 21415:2008(ISO 17511:2003)standard document,the quantitative traceability of the five-analytes detection systems of total triiodothylamine(TT_(3)),total thyroxine(TT_(4)),free triiodothylamine(FT_(3)),free thyroxine(FT_(4)),and thyrotropin(TSH)was carried out,and the TT_(3) and TT_(4) with reference methods were evaluated through the international reference laboratory quality assessment(RELA).TSH with reference materials were evaluated through international reference materials,FT_(3) and FT_(4) without reference methods or reference substances were evaluated through methodological comparison.Results TT_(3) and TT_(4) projects of Maccura were traced to the ID-LC/MS/MS reference method recommended by JCTLM,and TSH project was traced to the certified reference material NIBSC code:81/565.FT_(3) and FT_(4) projects were traced through methodological comparisons.The deviations of RELA sample A and RELA sample B of TT_(3) were 3.9%and 2.5%,respectively,and the deviations of RELA sample A and RELA sample B of TT_(4) were-0.2%and 0.9%,respectively,both of which were small.The deviations of TSH international reference at high,middle and low concentrations measured by Maccura system were 1.7%,0.8%and-3.9%,respectively,which were all less than the maximum allowable error(±10%)set.Passing-Bablok regression equation of clinical comparison results between Roche system and Maccura system in FT_(3) project was Y=-0.403246+1.055337X with correlation coefficient r_(s)=0.95,which was considered to be consistent.Passing-Bablok regression equation of clinical comparison results between Roche system and Maccura system in FT_(4) project was Y=-1.604055+1.087905X with correlation coefficient r_(s)=0.916,which was considered to be consistent.Conclusion A traceability system for five analytes of thyroid has been established,and the traceability results are accurate and reliable.
作者
鄢中华
顾心如
林晶晶
陆晓琴
杨思诚
孙可其
YAN Zhonghua;GU Xinru;LIN Jingjing;LU Xiaoqin;YANG Sicheng;SUN Keqi(Reference System Department of Maccura, Chengdu 611731, China)
出处
《标记免疫分析与临床》
CAS
2022年第1期170-173,180,共5页
Labeled Immunoassays and Clinical Medicine
基金
国家重点研发计划(编号:2019YFF016500)。
