Abstract
Background: HbA1c is a widely used biomarker for the management of diabetes mellitus and can be quantified from blood samples by using various methods, including ion-exchange high-performance liquid chromatography (HPLC), boronate affinity HPLC, and capillary electrophoresis (CE). Here, we evaluated the accuracy of four separation methods for determination of HbA1c values in Chinese patients with different hemoglobin disorders.
Methods: Blood samples from normal patients, patients with β-thalassemia, patients exhibiting heterozygosity, and patients exhibiting homozygosity were analyzed using ion-exchange HPLC (Variant II Turbo, Bio-Rad and Adams A1c HA-8160, Arkray, run in diabetes mode), boronate affinity HPLC (Ultra2, Trinity Biotech), and CE (Capillarys 2 Flex Piercing, Sebia).
Results: Samples from patients with β-thalassemia produced significant positive biases on the Variant II Turbo system compared to the other three systems. For heterozygous βA/βE patients, a good agreement was observed between Capillarys 2 Flex Piercing and Ultra2 systems, while a significant negative bias was observed between HA-8160 and Capillarys 2 Flex Piercing systems and between Variant II Turbo and Capillarys 2 Flex Piercing systems. For homozygous (βE/βE) patients, a clear context without HbA, all systems except the Capillarys 2 Flex Piercing system yielded random HbA1c results. Only the Capillarys 2 Flex Piercing system could detect all hemoglobin variants tested.
Conclusions: β-Thalassemia can cause errors in HbA1c determination using the Variant II Turbo system. HbE heterozygosity or HbE homozygosity also complicated HbA1c measurements. The Capillarys 2 Flex Piercing system detected all Hb variants and HbA1c in patients with β-thalassemia and could provide measurements with high accuracy.
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©2015 by De Gruyter
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
- HIF1A and MIF as potential predictive mRNA biomarkers of pre-eclampsia: a longitudinal prospective study in high risk population
- 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
- Hemoglobin measurements in samples containing hemoglobin-based oxygen carriers
- 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
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
- HIF1A and MIF as potential predictive mRNA biomarkers of pre-eclampsia: a longitudinal prospective study in high risk population
- 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
- Hemoglobin measurements in samples containing hemoglobin-based oxygen carriers
- 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