Evaluation of VARIANTTM II Hemoglobin A1c Autoanalyzer

Chung, Hwa Ryung; Sohn, Hyang Eun

Abstract

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.