Development and verification of quality standard for total thyroxine quantitative labeling immunoassay kit

Objective To develop and verify the quality standard for total thyroxine(TT4)quantitativelabelingimmunoassay kit.Methods Three kinds of TT4 quantitative labeling immunoassay kits(time-resolved fluoroimmunoassay,chemiluminescence method and magnetic particles immune method)manufactured by five manufacturers were inspected on appearance and physical property,and verified for linearity,minimum detection limit,accuracy,precision,quality control measurement,specificity and stability.Results The five kits were qualified in inspection on appearance and physical property,linearity,minimum detection limit,precision and stability,which showed good accuracy,quality control measurement and specificity.The standard reflected the technical points of kits at this stage,and was suitable for the scientific quality evaluation of such kits.Conclusion The quality standard for TT4 quantitative labeling immunoassay kit was developed and verified,which was beneficial to the reasonable quality control of such kit,promoted the improvement of quality and provided a technical basis for the development of similar standards.