ABSTRACT
BACKGROUND: We evaluated overall performance and analysis time of newly developed HLC-723 G8 (Tosoh corp., Tokyo, Japan) HbA1c autoanalyzerwhich utilizes cation-exchange HPLC method. METHODS: Linearity, precision, correlation with Variant II Turbo (Bio-Rad Laboratories, Hercules, CA, USA), analysis time, labile HbA1c (L-A1c) separation ability and stability of refrigerated sample at 4degrees C were evaluated. RESULTS: HLC-723 G8 showed good linearity between HbA1c 4.9-12.0% range (R2=0.9995). Within-run and total imprecision (CVs) were less than 1.0%. Correlation with Variant II Turbo and L-A1c separation ability were excellent. Analysis time per sample took 1.0 min. Stability of refrigerated sample at 4degrees C for at least 21 days was good. CONCLUSIONS: HLC-723 G8 showed good analytical performance and its rapid analysis time enables us to support outpatient diagnosis of diabetic patients efficiently.
Subject(s)
Humans , Chromatography, High Pressure Liquid , Outpatients , TokyoABSTRACT
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.
Subject(s)
Chromatography, Liquid , Glycated HemoglobinABSTRACT
BACKGROUND: We evaluated newly introduced VARIANTTM II(Bio-Rad Laboratories, CA, USA) hemoglobin(Hb) A1c autoanalyzer, including bar code reading, cap-piercing system and automatic hemolyzing. It utilizes ion-exchange high performance liquid chromatography(HPLC) method. METHODS: Linearity, precision, comparison with Hi-AUTOA1cTM HA-8121(Kyoto Daiichi, Kagaku Co. Ltd, Kyoto, Japan) and analysis time were evaluated. The reference range was determined by VARIANTTM II from 120 healthy subjects. RESULTS: Linearity through the range from 5.8% to 14.7% was good(r2=0.9909). The within-run coefficients of variation(CVs) for groups of low, middle and high level were 3.07%, 1.96% and 2.14% and between-day CVs for each group were 2.35%, 3.09% and 2.10%, respectively. Correlation equation between VARIANTTM II and Hi-AUTOA1cTM HA-8121 was VARIANTTM II = 1.0886(Hi-AUTOA1cTM HA-8121) + 0.4760% Hb A1c(r=0.9906). Two instruments were also compared by Altman and Bland's method and mean bias was 1.20. Analysis time of VARIANTTM II was 15.6 tests per hour compared with 14.8 tests of Hi-AUTOA1cTM HA-8121. The reference range in this study was 2.8-5.9% Hb A1c. CONCLUSIONS: VARIANTTM II showed the acceptable performance and advantage of calibration, and it was suitable for routine use in the clinical laboratory.