Performance evaluation of the Bio-Rad D-100 system for hemoglobin A1c assay

Background: Recently, the Bio-Rad D-100 system (Bio-Rad Laboratories) for hemoglobin Ale (HbAle) assay was introduced. Methods: We evaluated the precision, linearity, and method comparison of the D-100 system. The results of HbAlc from the D-100 were compared with that of the Variant II Turbo 2.0 (Bio-Rad) and G8 variant mode (Tosoh Bioscience). An additional 17 variant hemoglobin samples were compared to the immunoassay (Integra 800) results. Results: The within-laboratory imprecision coefficient of variation was 1.28-1.58% for the control materials and 1.01-1.03% for the patient samples. The linearity was confirmed ranging from 3.6 to 19.2% in NGSP units. The mean difference (NGSP units) was as follows: D-100 vs. G8, -0.02%; D-100 vs. Variant II Turbo 2.0, 0.07%. There were no clinically significant differences in the HbAlc results in the 17 hemoglobin variants between the D-100 and immunoassay. Conclusions: The analytical performance of the Bio-Rad D-100 system for HbAlc assay is clinically acceptable.