Evaluation of HLC-723 G7 Hemoglobin A1c Autoanalyzer / 임상검사와정도관리

ABSTRACT

BACKGROUND: We evaluated the performance and analysis time of HLC-723 G7 (Tosoh corp. Tokyo, Japan) hemoglobin (Hb) A1c autoanalyzer. It utilizes cation exchange high performance liquid chromatography (HPLC) method and has a reduced analysis time compared with that of an earlier model HLC-723GHb V A1c 2.2(TM) (HLC-723GHb V, Tosoh corp. Tokyo, Japan). METHODS: We evaluated linearity, precision and comparison with HLC-723GHb V following NCCLS guidelines and counted the number of tests per hour to estimate analysis time. RESULTS: Linearity through the range from 5.8% to 13.9% was good (r2=0.9930, relative nonlinearity <2.5%). The within-run coefficients of variation (CVs) for groups of low, middle, and high level were 1.09%, 0.76%, and 0.68% and total CVs for each group were 1.60%, 0.91%, and 1.00%, respectively. Correlation equation between HLC-723 G7 and HLC-723GHb V was HLC-723 G7=1.0308 (HLC-723GHb V)-0.2896 %Hb A1c (r=0.9992, P<0.0001). Analysis time of HLC-723 G7 was 1.2 minutes per test compared with 2.1 minutes of HLC-723GHb V. CONCLUSIONS: HLC-723 G7 showed the acceptable performance and shortening analysis time therefore, it was suitable for reducing turn around time of Hb A1c assay.