Faster HbA1c Turnaround Times Using a Dedicated Analyzer Based on Turbidimetric Inhibition Immunoassay Technology

Abstract

Abstract Introduction The Roche Cobas c513 (c513) is a dedicated stand-alone high throughput HbA1c analyzer. We evaluated the performance and the difference in turnaround times (TAT) of the c513 against our Cobas 8000 c502 (c502). Methods We assessed the linearity and precision of the c513, and its agreement (Deming regression and Bland–Altman analysis) with the c502 assay. We compared TAT for these analyzers for a single run of 50 samples and for all samples run over 2 comparable time periods. Results The c513 assay was linear from 4.4–18.3% HbA1c. Interassay precision (CV%) was 1.2 and 0.8 at HbA1c levels of 5.7 and 10.5%, respectively. The c513 assay showed excellent concordance with the c502 assay (r = 0.997) with no significant difference between methods by Bland–Altman analysis (mean difference = 0.021% HbA1c, P = 0.1422). The c513 took 17 min to analyze 50 samples, compared to 40 min on the c502. Over comparable 2-month periods, 90% of samples requiring HbA1c tests only were completed under 25 min (c513) vs 30–35 min (c502). For tubes sharing complete blood count (CBC) testing with HbA1c, the 90th percentile TAT was 35–40 min (c513) compared to 45–50 min (c502). Conclusion The c513 assay performs well with excellent correlation to the c502 assay. The improved TAT of the c513 is suitable when there are demands for rapid HbA1c results and it may forestall requests for point-of-care testing. It is also attractive to sites with heavy workloads with a claimed throughput of 400 tests / h.