Reference change values and quality standards for thyroid function assay / 国际检验医学杂志

ABSTRACT

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 varia-tion.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.Individ-uality 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.