Analytical performances of the D-100TM hemoglobin testing system (Bio-Rad) for HbA1c assay
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Stéphane Jaisson
,
Nathalie Leroy
Abstract
Background: Glycated hemoglobin (HbA1c) is widely used for the monitoring of glycemic balance in diabetic patients and has also been proposed as a tool for the diagnostic of diabetes mellitus. Accordingly, HbA1c quantification must be performed using robust, reliable and efficient methods. Here are reported the results of the evaluation of a new high performance liquid chromatography (HPLC) system for HbA1c quantification, the D-100TM system from Bio-Rad Laboratories.
Methods: The analytical performances of the method as well as the influence of the most frequent interferences regarding HbA1c assays (e.g., labile HbA1c, carbamylated hemoglobin, high HbF) have been tested.
Results: Intra- and between-assay CVs were respectively lower than 0.93% and 1.46% (HbA1c results expressed in NGSP units) and lower than 1.67% and 2.27% (HbA1c results expressed in IFCC units). The linearity proved to be excellent from 15 mmol/mol (3.5%) to 184 mmol/mol (19.0%) (r=0.999). The results were well correlated with those obtained by another HPLC method (VARIANTTM II Hemoglobin A1c Program reorder pack 270-2101NU-Bio-Rad): HbA1c[VARIANTTM II, mmol/mol]=1.013×HbA1c[D-100TM, mmol/mol]+0.637 (r=0.993, n=2000). The D-100TM system provided results consistent with IFCC-assigned external quality control samples and the presence of labile HbA1c, carbamylated hemoglobin and HbF did not interfere with HbA1c measurement.
Conclusions: The D-100 TM system proved to be a robust and reliable method for HbA1c measurement suitable for routine practice in clinical chemistry laboratories.
References
1. The International Expert Committe. International Expert Committee report on the role of the A1c assay in the diagnosis of diabetes. Diabetes Care 2009;32:1327–34.10.2337/dc09-9033Suche in Google Scholar
2. Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2011;57:e1–47.10.1373/clinchem.2010.161596Suche in Google Scholar
3. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–86.10.1056/NEJM199309303291401Suche in Google Scholar
4. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837–53.10.1016/S0140-6736(98)07019-6Suche in Google Scholar
5. Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I, et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem 2004;50:166–74.10.1373/clinchem.2003.024802Suche in Google Scholar PubMed
6. Jeppsson JO, Kobold U, Barr J, Finke A, Hoelzel W, Hoshino T, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med 2002;40:78–89.10.1515/CCLM.2002.016Suche in Google Scholar PubMed
7. Little RR, Rohlfing CL, Sacks DB. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem 2011;57:205–14.10.1373/clinchem.2010.148841Suche in Google Scholar PubMed
8. Weykamp CW, Mosca A, Gillery P, Panteghini M. The analytical goals for hemoglobin A1c measurement in IFCC units and National Glycohemoglobin Standardization Program Units are different. Clin Chem 2011;57:1204–6.10.1373/clinchem.2011.162719Suche in Google Scholar PubMed
9. Lin CN, Emery TJ, Little RR, Hanson SE, Rohlfing CL, Jaisson S, et al. Effects of hemoglobin C, D, E, and S traits on measurements of HbA1c by six methods. Clin Chim Acta 2012;413:819–21.10.1016/j.cca.2011.12.019Suche in Google Scholar PubMed PubMed Central
©2015 by De Gruyter
Artikel in diesem Heft
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Artikel in diesem Heft
- Frontmatter
- Editorial
- New trends in the long and puzzling history of HbA1c
- Review
- Thyroglobulin measurement by highly sensitive assays: focus on laboratory challenges
- Opinion Paper
- Possible role of fructosamine 3-kinase genotyping for the management of diabetic patients
- EFLM Original Article
- Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)
- Genetics and Molecular Diagnostics
- Quantitative-fluorescent-PCR versus full karyotyping in prenatal diagnosis of common chromosome aneuploidies in southern Spain
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- General Clinical Chemistry and Laboratory Medicine
- Evidence of Crohn’s disease-related anti-glycoprotein 2 antibodies in patients with celiac disease
- Myocardial interleukin-6 in the setting of left ventricular mechanical assistance: relation with outcome and C-reactive protein
- Different methods to estimate serum free cortisol: a comparison during cortisol tetracosactide testing
- Automated immunoassays for the autoantibodies to carbamylated or citrullinated telopeptides of type I and II collagens
- Relevance of correction for drift and day-to-day variation in cystatin C measurement: a post-hoc analysis of the PREVEND cohort, with independent replication in the ESTHER cohort
- Laboratory utilization improvement through a computer-aided algorithm developed with general practitioners
- Quantitation of 1α,25-dihydroxyvitamin D by LC-MS/MS using solid-phase extraction and fixed-charge derivitization in comparison to immunoextraction
- Reference Values and Biological Variations
- Establishment of trimester-specific thyroid stimulating hormone and free thyroxine reference interval in pregnant Chinese women using the Beckman Coulter UniCel™ DxI 600
- Cancer Diagnostics
- Expression of vascular endothelial factor-A, gelatinases (MMP-2, MMP-9) and TIMP-1 in uterine leiomyomas
- Influence of ABO type on global coagulation assay results: effect of coagulation factor VIII
- Diabetes
- Benchmarking by HbA1c in a national diabetes quality register – does measurement bias matter?
- Comparing HbA1c, fasting and 2-h plasma glucose for screening for abnormal glucose regulation in patients undergoing coronary angiography
- Erroneous HbA1c measurements in the presence of β-thalassemia and common Chinese hemoglobin variants
- Using the likelihood ratio to evaluate allowable total error – an example with glycated hemoglobin (HbA1c)
- Two novel haemoglobin variants that affect haemoglobin A1c measurement by ion-exchange chromatography
- Analytical performances of the D-100TM hemoglobin testing system (Bio-Rad) for HbA1c assay
- Letters to the Editors
- Glycation rate of haemoglobins S, C, D, E, J and G, and analytical interference on the measurement of HbA1c with affinity chromatography and capillary electrophoresis
- Hemoglobin Valme HBB:c.124T>G: a new hemoglobin variant with diminished oxygen affinity causes interference in hemoglobin A1c measurement in an automated ion-exchange HPLC method
- Hemoglobin A1c reported in units and diagnostic cut-offs in relation to the international recommendations
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- Serologic false-positive reactions for syphilis in children of allergic purpura
- Exploration of the pre-analytical stability of β-lactam antibiotics in plasma and blood – implications for therapeutic drug monitoring and pharmacokinetic studies
- Fungal contamination of hyaluronidase solution mimicking fungal joint infection: a preanalytical pitfall in synovial fluid analysis
- Stroke and inherited thrombophilia in a Tunisian girl with sickle cell anemia
- Faecal haemoglobin concentrations do vary across geography as well as with age and sex: ramifications for colorectal cancer screening
