Methodology evaluation and biological variation research of enzymatic colorimetric assay for the determination of serum free fatty acid

doi:10.3969/j.issn.1673-8640.2014.02.013

Abstract

Abstract: Objective To evaluate the precision and trueness of enzymatic colorimetric assay (enzymatic assay) for the determination of serum free fatty acid(FFA), and to study the between-subject and within-subject biological variations of serum FFA. Methods EP5-A2 and EP15-A were employed to evaluate the precision and trueness of serum FFA by enzymatic assay, which were published by the Clinical and Laboratory Standards Institute (CLSI). The serum samples from 13 healthy subjects for biological variation were collected and determined for FFA once every 2 weeks over a period of 6 weeks. The between-subject and within-subject biological variations were calculated by MIXED analysis of SAS9.1 software.Results The overall mean of serum FFA was 0.796 mmol/L, and imprecisions of within-batch, between-batch, inter-day and intra-laboratory were 2.15%, 3.44%, 3.67% and 5.46%, respectively. The deviations for the 3 external quality assessment control samples were 24.20%, －0.90% and －1.50%. The between-subject and within-subject biologicalvariations were 8.43% and 19.36%, respectively. Conclusions The precision and trueness of serum FFA by enzymatic assay could meet the requirements of relevant laboratory quality control. The between-subject and within-subject biological variations have important significations for establishing laboratory accreditation and providing clinical research design′s reference.

Key words: Free fatty acid, Precision, Trueness, Methodology evaluation, Biological variation, Within-subject biological variation

CLC Number:

R446.1

LU Gang, GAO Shejun, JU Yingbo.. Methodology evaluation and biological variation research of enzymatic colorimetric assay for the determination of serum free fatty acid[J]. , 2014, 29(2): 143-147.

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