Evaluation of VARIANTTM II Hemoglobin A1c Autoanalyzer.
- Author:
Hwa Ryung CHUNG
1
;
Hyang Eun SOHN
Author Information
1. Department of Clinical Pathology, Nowon Eulji Hospital, Eulji Medical College, Seoul, Korea. jhr7301@eulji.or.kr
- Publication Type:Original Article
- Keywords:
Hemoglobin(Hb) A1c;
Ion-exchange HPLC;
Instrument evaluation
- MeSH:
Automatic Data Processing;
Bias (Epidemiology);
Calibration;
Hemoglobin A, Glycosylated;
Reference Values
- From:Korean Journal of Clinical Pathology
2000;20(1):13-17
- CountryRepublic of Korea
- Language:Korean
-
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.
