A high-throughput test for diabetes care: An evaluation of the next generation Roche Cobas c 513 hemoglobin A(1C) assay

OBJECTIVES: The level of glycated hemoglobin A (HbA(1C)) in blood is the preferred marker for diabetes monitoring and treatment. Here, we evaluate the analytical performance of the Roche Diagnostics Cobas c 513, a stand-alone HbA(1C) immunoassay analyzer. DESIGN AND METHODS: Performance was assessed with regards to imprecision, accuracy, linearity, method comparison against the Roche Cobas Integra 800 CTS, specimen stability, interference from common hemoglobin variants and hemoglobin F, and throughput. RESULTS: Within-run and between-run precisions were 0.5–0.7 and 0.8–1.3%CV, respectively. An average bias of −1.6% to proficiency survey samples was observed. The c 513 correlated well with the Integra (slope = 0.94, y-intercept = 0.50, and correlation coefficient = 0.998). The effect of hemoglobin variants on this assay was negligible while specimens containing ≥10% HbF demonstrated a negative bias. The c 513 instrument can process up to 340 samples per hour. CONCLUSIONS: The c 513 is a precise, accurate, automated high throughput analyzer for measuring HbA(1C) in large laboratories.