[Evaluation of the new kit HbA(1c) Analyzer 2.0 Variant II Turbo (Bio-Rad)].
The evaluation of glycated hemoglobin (HbA(1c)) is used in daily practice for monitoring the diabetes mellitus. HbA(1c) may be assayed by different methods, among which high-pressure liquid chromatography (HPLC). We have evaluated a new kit 2.0 available on HPLC Variant II(®) Turbo analyzer (Bio-Rad), which is characterized by an elution buffer containing sodium perchlorate. The correlation with the routine method used in our laboratory (HPLC Variant II(®) analyzer equipped with the NU kit) is good (r² = 0.997). Intra- and inter-assay coefficients of variation are respectively lower than 0.6 and 1.6%. Linearity is excellent from 3.2% (11 mmol/mol) to 18.3% (177  mmol/mol). There is no inter-sample contamination. This method provides a result quickly (96  seconds), but does not allow separating labile HbA(1c) from carbamylated hemoglobin, contrary to the NU kit. As the control of analytical quality is a major concern for validation and clinical use of HbA(1c) results, the characteristics of this new kit make it a well-suited tool for daily laboratory practice.
CHU de Reims, Laboratoire de Biologie et Recherche Pédiatriques, 45 rue Cognacq-jay 51092 Reims Cedex, France.
Julie
J
Meurice
Emmanuelle
E
Guillard
Stéphane
S
Jaisson
Nathalie
N
Leroy
Philippe
P
Gillery
D000925:Anticoagulants / Q000009:adverse effects / Q000494:pharmacology; D001331:Automation; D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000379:methods* / Q000639:trends; D002648:Child; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis; D004340:Drug Contamination / Q000706:statistics & numerical data; D004526:Efficiency; D006442:Glycated Hemoglobin / Q000032:analysis*; D006776:Hospitals, Pediatric; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000639:trends; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors; D054928:Validation Studies as Topic
D000925:Anticoagulants; D006442:Glycated Hemoglobin; D011933:Reagent Kits, Diagnostic; C517652:hemoglobin A1c protein, human