Comparison of enzymatic assay for HbA1c measurement (Abbott Architect) with capillary electrophoresis (Sebia Minicap Flex piercing analyser) (CROSBI ID 125422)
Prilog u časopisu | izvorni znanstveni rad | međunarodna recenzija
Podaci o odgovornosti
Tešija Kuna, Andrea ; Dukić, Kristina ; Nikolac Gabaj, Nora ; Miler, Marijana ; Vukasović, Ines ; Langer, Sanja ; Šimundić, Ana-Maria ; Vrkić, Nada
engleski
Comparison of enzymatic assay for HbA1c measurement (Abbott Architect) with capillary electrophoresis (Sebia Minicap Flex piercing analyser)
Objective: The HbA1c assays are required to have high analytical precision and low variability between different assays. We aimed to compare the analytical performances of enzymatic method and capillary electrophoresis (CE) for HbA1c measurement. Methods: Imprecision, carryover, stability, linearity, method comparison and interferences were evaluated for HbA1c enzymatic method (Abbott, USA) and CE (Sebia, France). Results: Both methods have shown overall within-laboratory imprecision <3% for IFCC units (<2% NGSP units), with %CV <2 for medium and high HbA1c concentration. Carryover effects were within acceptable criteria. The linearity of both methods has proven to be excellent (R2 = 0.999). Significant proportional and constant difference were found for enzymatic method in comparison to CE, but not clinically relevant (<5 mmol/mol ; NGSP < 0.5%). At the clinically relevant HbA1c concentration stability observed with CE and enzymatic method were acceptable (bias <3%). Enzymatic method showed to be subjected to interference of triglyceride 8.11 mmol/L and CE to interference of HbF 10.6%. Conclusion: Enzymatic method proved to be comparable to CE method in analytical performances but one should be aware that certain interferences can influence the measurements of each method.
glycated hemoglobin ; electrophoresis ; enzymatic methods ; imprecison ; lipemia ; fetal hemoglobin
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Podaci o izdanju
Povezanost rada
Kliničke medicinske znanosti, Farmacija