AI Article Synopsis
- The Roche Cobas c 513 is evaluated for its effectiveness in measuring glycated hemoglobin A (HbA), which is crucial for diabetes management.
- Performance metrics studied included imprecision, accuracy, consistency with another analyzer, and the impact of hemoglobin variants and stability of specimens.
- Results showed high precision, good correlation with another established system, and the capacity to analyze up to 340 samples per hour, making it suitable for large labs.
Article Abstract
Objectives: The level of glycated hemoglobin A (HbA) 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 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, -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 in large laboratories.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6881683 | PMC |
| http://dx.doi.org/10.1016/j.plabm.2019.e00147 | DOI Listing |
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