甲状腺功能检测参考变化值及质量规范的应用

Reference change values and quality standards for thyroid function assay

目的评估TSH、T4、T3、FT4和FT3的参考变化值(RCV)和个体指数;分析其以人群为基础的参考范围的局限性;确定基于生物学变异的质量规范。方法通过TSH、T4、T3、FT4和FT3的个体内生物学变异、个体间生物学变异和实验室的分析变异得出RCV和个体指数,并计算基于生物学变异质量规范要求的分析变异。结果 TSH、T4、T3、FT4和FT3的RCV分别为54.0%、16.8%、22.4%、42.8%、23.8%,个体指数分别为0.78、0.45、0.56、0.47、0.45,达到基于生物学变异质量规范中满意的分析变异应分别小于9.6%、2.5%、4.4%、2.9%、4.0%。结论评判个体甲状腺结果的改变时应认识到参考范围的局限性,重视RCV,实验室进行分析变异设置时还应满足基于生物学变异的质量规范要求。

Objective To evaluate the reference change values（RCV）,individual indexes of TSH,T4,T3,FT3,and FT4 and the limitations of population-based reference ranges.Furthermore,to determine the quality standards based on the biological variation.Methods Acorrding to intra-and inter-individual biological variations,and analytical variations,RCV and individual indexes of TSH,T4,T3,free T3,and free T4 were calculated,and analytical variations of quality standards based on biological variation were induced.Results RCV of TSH,T4,T3,FT3,and FT4 is 54.0%,16.8%,26.8%,42.8%,23.8%,respectively.Individuality index is 0.78,0.45,0.49,0.47,0.45,respectively,and satisfied analytical variation based on biological variation is less than 9.6%,2.5%,4.4%,2.9%,4.0%,respectively.Conclusion When monitoring thyroid functions,the RCV values should be considered.It is important to recognize population-based reference ranges limitations for use in individuals.Quality standards based on biological variation should be meeted when laboratory analysis of variance is determined.