Analytical performances of a new enzymatic assay for hemoglobin A1c.
BACKGROUND
HbA1c is considered the gold standard for the follow-up of diabetic patients and a new diagnostic tool for diabetes mellitus, which implies the availability of reliable assay methods. We have evaluated a new assay developed by Abbott Laboratories, based on the enzymatic quantification of HbA1c by a fructosyl dipeptide oxidase using Architect analyzers.


METHODS
Precision, linearity, correlation with a HPLC method, accuracy and potential impact interferences on HbA1c measurement have been evaluated.


RESULTS
Intra-day and between-day CVs were lower than 1.2% and linearity was excellent from 19 mmol/mol (3.9%) to 163 mmol/mol (17.1%). The results were well correlated with those obtained by the HPLC (Variant II device, kit NU - BioRad): HbA1c [Architect, mmol/mol]=0.986×HbA1c [Variant II, mmol/mol]+0.713 (r=0.998, n=109). This method provided consistent results with IFCC titrated quality control samples. Classical interferences in HbA1c assays (i.e. labile HbA1c, carbamylated hemoglobin, triglycerides or bilirubin) did not have an impact on HbA1c quantification by this method.


CONCLUSIONS
This new enzymatic assay proved to be a robust and reliable method for HbA1c measurement suitable for routine practice in clinical chemistry laboratories.
Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, France. Electronic address: sjaisson@chu-reims.fr.
Stéphane
S
Jaisson
Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, France.
Aurore
A
Desmons
Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, France.
Benoît
B
Renard
Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, France.
Benjamin
B
Chevelle
Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, France.
Nathalie
N
Leroy
Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, France.
Philippe
P
Gillery
D003920:Diabetes Mellitus / Q000097:blood; D057075:Enzyme Assays / Q000379:methods*; D006442:Glycated Hemoglobin / Q000737:chemistry*; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
Diabetes; Enzymatic assay; Evaluation; HbA(1c)