Abstract:

Objective To evaluate the performance of 11 commercial cycle enzymatic assay reagents for homocysteine（Hcy） determination. Methods Hcy cycle enzymatic assay reagents from 11 manufacturers were selected,and they were combined with HITACHI 7180 automatic analyzer to set up 11 determination systems respectively. According to the Clinical and Laboratory Standards Institute（CLSI） EP15-A2 and EP6-A documents and the standard of YY/T 1258—2015,the within-laboratory precisionns,truenesses and linearities of 11 determination systems and between-run variations from 9 determination systems were verified. Results The precisions of 11 determination systems met the requirements [<1/3 standard of external quality assessment （EQA） （6.67%）]. Except the between-run variations for middle-level and high-level samples in 1 determination system was out of range （>10.00%,1/2 standard of EQA）,the between-run variations of the other determination systems were <10%. The truenesses of 4 determination systems were not within the verification limit of accuracy,and there were 3 determination systems with nonlinear results through linear range verification. Conclusions For Hcy determination,performance differences exist among the 11 determination systems. Performance evaluation should be performed before Hcy determination in clinical laboratories.

Key words: Homocysteine, Cycle enzymatic assay, Determination system, Performance evaluation