Home Evaluation of a new Sebia kit for analysis of hemoglobin fractions and variants on the Capillarys® system
Article
Licensed
Unlicensed Requires Authentication

Evaluation of a new Sebia kit for analysis of hemoglobin fractions and variants on the Capillarys® system

  • Amal Louahabi , Marianne Philippe , Salah Lali , Pierre Wallemacq and Diane Maisin
Published/Copyright: September 21, 2011

Abstract

We evaluated the analytical performances of the new Sebia kit for quantification of hemoglobin fractions (HbA, HbF and HbA2) and structural hemoglobin variants on the Capillarys® system. This automated capillary zone electrophoresis method uses an alkaline buffer with silica capillaries and spectrophotometric detection. Specimen stability was evaluated during 1 month. The reproducibility of migration and the imprecision of quantification were also investigated. Comparison with the Beckman P/ACE® system was performed on 202 samples. A total of 131 subjects without any hematological abnormality were analyzed to establish the HbA2 reference ranges based on our local population. Quantification of the Hb fractions and variants exhibited excellent stability for 4weeks of storage at 4°C, with CVs <0.3%. The imprecision of the migration normalized to that of HbA2 for all hemoglobins tested (fractions and variants) was low, with a CV of <2.5%. At physiological and pathological levels, total imprecision ranged from 1.9% to 4.6% for HbA2, from 0.6% to 9.7% for HbF, and from 0.6% to 1% for HbS. Statistical analysis revealed a small proportional negative bias for HbA2 (−8.6%). Small systematic bias (−0.2%) and proportional bias (−28%) were observed for HbF. No statistically significant difference was found for HbS. The reference range for HbA2 was 2.1–3.2%. The Capillarys® system is a fully automated and accurate system that gives high-resolution performance and displays appropriate characteristics for use as a routine method for the diagnosis of thalassemias and hemoglobinopathies.


Corresponding author: Diane Maisin, Department of Clinical Chemistry, University Hospital St Luc, 10 Hippocrate Ave, 1200 Brussels, Belgium Phone: +32-27646715,

References

1. US Preventive Services Task Force. Screening for hemoglobinopathies. Guide to clinical preventive services, 2nd ed. In: Congenital disorders. Washington, DC: US Department of Health and Human Services, Office of Disease Prevention and Health Promotion, 1996 (http://cpmcnet.columbia.edu/texts/gcps/gcps0053.html#top).Search in Google Scholar

2. Clarke GM, Higgins TN. Laboratory investigation of hemoglobinopathies and thalassemias: review and update. Clin Chem 2000; 46:1284–90.10.1093/clinchem/46.8.1284Search in Google Scholar

3. Hedlund B. Hemoglobins of human embryos, fetuses, and neonates. In: Fairbanks VF, editor. Hemoglobinopathies and thalassemias. New York: Brian C. Decker, 1980:14–27.Search in Google Scholar

4. Steinberg MH, Forget BG, Higgs DR, Nagel RL. Disorders of hemoglobin: genetics, pathophysiology, and clinical management. Cambridge, UK: Cambridge University Press 2001:174–230, 910–40.Search in Google Scholar

5. Globin Chain Disorder Working Party of the BCSH General Haematology Task Force. Guidelines for the fetal diagnosis of globin genes disorders. J Clin Pathol 1994;47:199–204.10.1136/jcp.47.3.199Search in Google Scholar

6. Vaysal E, Huisman TH. Detection of common deletional α-thalassemia-2 determinants by PCR. Am J Hematol 1994; 46:208–13.10.1002/ajh.2830460309Search in Google Scholar

7. Reddy PL, Bowie LJ. Sequence-based diagnosis of hemoglobinopathies in the clinical laboratory. Clin Lab Med 1997; 17:85–96.10.1016/S0272-2712(18)30233-6Search in Google Scholar

8. Mario N, Baudin B, Bruneel A, Janssens J, Vaubourdolle M. Capillary zone electrophoresis for the diagnosis of congenital hemoglobinopathies. Clin Chem 1999; 45:285–8.10.1093/clinchem/45.2.285Search in Google Scholar

9. Kim HC, Atwater J, Schwartz E. Separation of hemoglobins. In: Williams WJ, Beutler E, Erslev AJ, Lichtman MA, editors. Hematology. New York: McGraw-Hill, 1990:1611–9.Search in Google Scholar

10. Schneider RG, Barwick RC. Hemoglobin mobility in citrate agar electrophoresis – its relationship to anion binding. Hemoglobin 1982; 6:199–208.10.3109/03630268209002296Search in Google Scholar

11. Lehmann R, Voelter W, Liebich H. Capillary electrophoresis in clinical chemistry. J Chromatogr B Biomed Sci Appl 1997; 697:3–35.10.1016/S0378-4347(97)00183-7Search in Google Scholar

12. Mario N, Baudin B, Aussel C, Giboudeau J. Capillary isoelectric focusing and high performance cation-exchange chromatography compared for the qualitative and quantitative analysis of hemoglobin variants. Clin Chem 1997; 43:2137–42.10.1093/clinchem/43.11.2137Search in Google Scholar

13. Joutovsky A, Hadzi-Nesic J, Nardi MA. HPLC retention time as a diagnostic tool for hemoglobin variants and hemoglobinopathies: a study of 6000 samples in a clinical diagnostic laboratory. Clin Chem 2004; 50:1736–47.10.1373/clinchem.2004.034991Search in Google Scholar PubMed

14. Jenkins M, Ratnaike S. Capillary electrophoresis of hemoglobin. Clin Chem Lab Med 2003; 41:747–54.10.1515/CCLM.2003.114Search in Google Scholar PubMed

15. Burtis CA, Ashwood ER. Chemometrics. In: Tietz textbook of clinical chemistry, 3rd ed. Philadelphia, PA: Saunders, 1999:265–356.Search in Google Scholar

16. Cotton F, Lin C, Fontaine B, Gulbis B, Janssens J, Vertongen F. Evaluation of a capillary electrophoresis method for routine determination of hemoglobins A2 and F. Clin Chem 1999; 45:237–43.10.1093/clinchem/45.2.237Search in Google Scholar

17. Hollis S. Analysis of method comparison studies. Ann Clin Biochem 1996; 33:1–4.10.1177/000456329603300101Search in Google Scholar

18. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of agreement. Lancet 1986;307–10.10.1016/S0140-6736(86)90837-8Search in Google Scholar

Received: 2005-10-25
Accepted: 2005-12-16
Published Online: 2011-9-21
Published in Print: 2006-3-1

©2006 by Walter de Gruyter Berlin New York

Articles in the same Issue

  1. Recent advances in physiological calcium homeostasis
  2. Associations of apolipoprotein E exon 4 and lipoprotein lipase S447X polymorphisms with acute ischemic stroke and myocardial infarction
  3. Association of angiotensin II type 1 receptor gene polymorphism with carotid atherosclerosis
  4. Comparison of the TaqMan and LightCycler systems in pharmacogenetic testing: evaluation of CYP2C9*2/*3 polymorphisms
  5. Urinary cystatin C as a specific marker of tubular dysfunction
  6. Time-resolved fluorimetric immunoassay of calprotectin: technical and clinical aspects in diagnosis of inflammatory bowel diseases
  7. Direct and fast determination of antiretroviral drugs by automated online solid-phase extraction-liquid chromatography-tandem mass spectrometry in human plasma
  8. Markers of oxidative stress in children with Down syndrome
  9. Influence of hemolysis on routine clinical chemistry testing
  10. C-Reactive protein and neopterin levels in healthy non-obese adults
  11. Comparison of the lipid profile and lipoprotein(a) between sedentary and highly trained subjects
  12. Clinical outcome estimates based on treatment target limits of laboratory tests: proposal for a plot visualizing effects and differences of medical target setting exemplified by glycemic control in diabetes
  13. Metrological traceability of values for catalytic concentration of enzymes assigned to a calibration material
  14. Evaluation of a new Sebia kit for analysis of hemoglobin fractions and variants on the Capillarys® system
  15. Recommendation for measuring and reporting chloride by ISEs in undiluted serum, plasma or blood: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): IFCC Scientific Division, Committee on Point of Care Testing and Working Group on Selective Electrodes
  16. Diluent Multiassay for the MODULAR ANALYTICS E170 does not improve TSH dilutions compared to Diluent Universal
Downloaded on 14.9.2025 from https://www.degruyterbrill.com/document/doi/10.1515/CCLM.2006.059/html
Scroll to top button