Boronate Affinity Chromatography Accurately Measures HbA1c also in Patients with End-Stage Renal Disease - Performance Evaluation of the A1c HPLC Analyzer.

Background: Boronate affinity chromatography is widely used, and the method has lately been improved and designed for HbA1c measurements. We report performance evaluation of the affinity chromatography HbA1c HPLC analyzer.
Methods: Within- and between-run imprecision was assessed based on the results of a series of measurements in three different EDTA blood samples and in control materials. HbA1c levels were measured and compared in 349 EDTA blood samples and 50 samples from patients with end-stage renal disease (ESRD) using the Premier Hb9210 analyzer (affinity chromatography) and the D-10 Hemoglobin Testing System (ion-exchange chromatography).
Results: The within- and between-run imprecision CVs ranged from 0.72% to 2.01%. Median HbA1c level measured by the Premier Hb9210 was significantly lower (6.4% [46 mmol/mol] vs. 6.6% [49 mmol/mol], p < 0.001). The Passing-Bablok agreement test yielded a slope of 1.0 (95% CI: 1.0 to 1.0) and intercept of -0.1 (95% CI: -0.1 to -0.1). Correlation coefficient and the mean difference amounted to 0.992 and -0.13% (95% CI: -0.11 to -0.15), respectively. Similar results were obtained for HbA1c levels < 7% [< 53 mmol/mol] and ≥ 7% [≥ 53 mmol/mol]. In ESRD patients, median HbA1c level measured by the Premier Hb9210 was also significantly lower (6.0% [42 mmol/mol] vs. 6.5 [48 mmol/mol], p < 0.001) with the mean difference equal to -0.52% (95% CI: -0.59 to -0.46).
Conclusions: Although the Premier Hb9210 gave lower HbA1c levels, good results agreement with the D-10 Hemoglobin Testing System was found. Analytical performance found for HbA1c measurements in ESRD patients was similar. The Premier Hb9210 analyzer is suitable for routine HbA1c testing in clinical practice.