Evaluation of Hcy assay performance by circulating enzymatic method / 国际检验医学杂志

ABSTRACT

Objective To evaluate analytical performance of homocysteine (Hcy) by circulating enzymatic method .Methods Re‐ferring to CLSI evaluation project and pertinent literature ,and by combining our actual works .we designed a verification procedure and experimental method .By using these above ,the precision ,accuracy ,analytical measurement range ,clinical reportable range of Hcy by circulating enzymatic method were evaluated .Results would be compared with the declaration of the manufacturer (NingBo Medical System Biotechnology Co .,Ltd) or desirable specifications derived from biologic variation .Results The results showed that the within‐run CV were 1 .26% and 0 .84% ,and the total CV were 1 .36% and 1 .32% ,less than 10% of the manufacturer′s statement .The relative bias between the results measured for calibrator at tow levels and target value was 3 .69% and 0 .69% ,less 10% .AMR was 3 .38-51 .81 μmol/L ,and the most suitable dilution rate was 1∶3 ,so the CRR was 3 .38-155 .43 μmol/L .Con‐clusion The analytical performance of Hcy analyzed by circulating enzymatic method is consistent with the standards which manu‐facturers has proclaimed ,so it is conform to the requirements of clinical .