Evaluation of performance of homocysteine test kit / 国际检验医学杂志

ABSTRACT

Objective To evaluate the performance of homocysteine(Hcy)test kit produced by a domestic company and to inves-tigate its feasibility in clinical application.Methods A series of methodological evaluation experiments including the accuracy,re-peatability,stability and linear range of the Hcy reagent kit were carried out on the Olympus Au640 biochemistry analyzer.Results The experiments showed that the relative biases of detection results of normal value quality control serum and pathological value quality control serum were 0.2% and 4.9%,respectively,which were far less than 15% of the reagent instruction.The intra-assay coefficients of variation(CV)of normal and pathological quality control serum were 2.6% and 2.3% respectively,which were less than 5% of the reagent instruction.While the inter-assay CV of normal and pathological quality control serum were 4.4% and 4.1% respectively,which were less than 10% of the reagent instruction.The experiments for the linear range evaluation showed that R 2 was 0.997 in the concentration range of 0 -66 μmol/L,which suggested that the correlation between expected value and measured value was very well.Otherwise,the slope rate b1 of 0.979 9 and the intercept b0 of 0.151 8 were both showed that the de-tection results of Hcy reagent were linear in the concentration of 0-66 μmol/L.Conclusion The performance of Hcy kit produced by a domestic company is very good in the performance indexes of accuracy,repeatability,stability,and linear range and suitable for the clinical application.