A high-throughput test for diabetes care: An evaluation of the next generation Roche Cobas c 513 hemoglobin A
| Autor: | Jessica L, Gifford, Trefor, Higgins, S M Hossein, Sadrzadeh |
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| Rok vydání: | 2019 |
| Předmět: |
Immunoassay
Automated analyzer HbA1C glycated hemoglobin A1C TE total error Method evaluation HbA adult hemoglobin CV coefficient of variation Article CI confidence interval LoD Limit of Detection NGSP National Glycohemoglobin Standardization Program Diabetes mellitus LoB Limit of Blank Hemoglobin A1C CLSI Clinical Laboratory Standards Institute HPLC high-performance liquid chromatography High through-put CAP College of American Pathologists IFCC International Federation of Clinical Chemistry and Laboratory Medicine Hb hemoglobin |
| Zdroj: | Practical Laboratory Medicine |
| ISSN: | 2352-5517 |
| Popis: | Objectives The level of glycated hemoglobin A (HbA1C) 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 HbA1C 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 HbA1C in large laboratories. |
| Databáze: | OpenAIRE |
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