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Background: Recently, the Bio-Rad D-100 system (Bio-Rad Laboratories) for hemoglobin A1c (HbA1c) assay was introduced.
Methods: We evaluated the precision, linearity, and method comparison of the D-100 system. The results of HbA1c 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 HbA1c results in the 17 hemoglobin variants between the D-100 and immunoassay.
Conclusions: The analytical performance of the Bio-Rad D-100 system for HbA1c assay is clinically acceptable.
DOI: 10.7754/Clin.Lab.2017.170524
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