CHE-01 : Evaluation of Bio-Rad D-100 HbA1c Analyzer and Comparison of Integra 800

Background: Hemoglobin A1c (HbA1c) is the key indicator for monitoring the regulation of diabetes. We evaluated the D-100 (Bio-Rad, USA) ion exchange high performance liquid chromatography analyzer for HbA1c measurement, and to compare with the Integra 800 (Roche, Germany). Among the various methods of measuring HbA1c, the HPLC (high performance liquid chromatography) method is recognized as a standard method of the Diabetes Control and Complications Trial (DCCT) and is considered to be an important method of the National Glycohemoglobin Standardization Program (NGSP). Methods: We evaluated precision, linearity, correlation, carryover and reference range. HbA1c was reported % as in NGSP unit. Statistical analyses were performed using Excel 2010 (Microsoft Co., USA). All tests were performed according to the manufacturer's instructions. Results: Total precision for control materials (Bio-Rad) were coefficient of variation CV 1.3% and 1.2% in low and high level, respectively. The carryover rate was 0.0%. Linearity evaluation ranged from 3.5% to 19.3% (R2=0.997) and recoveries were 98-106%. The reference range validation was also good. The results obtained by using D-100 showed good correlation (r=0.991) with Integra 800. Conclusion: Many HbA1c analyzer have recently been introduced. The standard method for NGSP and DCCT is HPLC. D-100 using this method showed excellent performance. It also showed good correlation with Integra 800. It could be very useful for the diagnosis of diabetes and follow-up of the patient, and it is very suitable for use in the laboratory.