Volume 14, Issue 2 (volume 14, number 2 2022)                   IJDO 2022, 14(2): 95-104 | Back to browse issues page

XML Print

Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:

Rayen G M, Maha C, Jamila B, Fadoua N, Fadhel N M. Capillarys 3 Octa®: Analytical Performance Assessment for HbA1c Quantification. IJDO. 2022; 14 (2) :95-104
URL: http://ijdo.ssu.ac.ir/article-1-706-en.html
Laboratory of Biochemistry and Toxicology University Hospital of Monastir, Tunisia. Faculty of Pharmacy, University of Monastir, Monastir, Tunisia.
Abstract:   (284 Views)
Objective: Determination of HbA1c level is a precious indicator for therapeutic follow-up of patients with type 1 or type 2 diabetes. Our study aimed to evaluate the analytical characteristics of Capillarys 3 Octa® HbA1c measurement by capillary electrophoresis.
Materials and Methods: Our study involved 265 venous whole blood specimens repeatability, intermediate fidelity, accuracy, linearity, and correlation with the Arkray HA-8180 analyzer which uses HPLC as a dosing method. We studied interferences such as hematocrit, triglycerides, total bilirubin, labile fraction, and hemoglobin abnormalities.
Results: The linearity correlation was between 4.4% and 20.3%. There was a strong correlation with HPLC (r > 0.99, P< 0.0001). No interference from hematocrit (20-93%) (P: 0.888), triglycerides (until 25 mmol/L) (P: 0.388), total bilirubin (< 587 µmol/L) (P: 0.993), and labile fraction was observed. No problem related to inter-sample contamination was observed. The sensitivity was zero for homozygous sickle cell disease and S/C composite hemoglobinosis. However, sensitivity was high for heterozygous forms (69% for A/S and 60% for A/C). The analyzer was able to separate and quantify HbA2 fraction, allowing ß-thalassemia accidental detection.
Conclusion: Capillarys 3 Octa® based on capillary electrophoresis proved to be precise and a linear instrument for HbA1c measurement. Several clinical interferences and Hb variants had no effect on the results. The results of this evaluation suggest that this analyzer is suitable for routine use in clinical chemistry laboratories.
Full-Text [PDF 681 kb]   (98 Downloads)    
Type of Study: Research | Subject: Special
Received: 2022/01/8 | Accepted: 2022/03/18 | Published: 2022/05/20

1. Schnell O, Crocker JB, Weng J. Impact of HbA1c testing at point of care on diabetes management. Journal of diabetes science and technology. 2017;11(3):611-7. [DOI:10.1177/1932296816678263]
2. Zimmet P, Alberti KG, Magliano DJ, Bennett PH. Diabetes mellitus statistics on prevalence and mortality: facts and fallacies. Nature Reviews Endocrinology. 2016;12(10):616-22. [DOI:10.1038/nrendo.2016.105]
3. Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes research and clinical practice. 2022;183:109119. [DOI:10.1016/j.diabres.2021.109119]
4. Gillery P. Le dosage de l'hémoglobine A1c en 2013. Médecine des maladies Métaboliques. 2013;7(3):256-61. [DOI:10.1016/S1957-2557(13)70564-9]
5. Hay-Lombardie A, Bigot-Corbel E. Biomarqueurs permettant le suivi de l'équilibre glycémique du patient diabétique. Revue Francophone des Laboratoires. 2018 ;2018(502):33-43. [DOI:10.1016/S1773-035X(18)30146-1]
6. Global report on diabetes [Internet]. [cited 2020 Feb 16]. Available from: https://www.who.int /publications-detail-redirect/9789241565257.
7. guidelines.diabetes.ca. [Internet]; 2018 Oct .[cited 2020 Feb 16]. Available from: http://guidelines. diabetes.ca/CDACPG_resources/cpg_2013_full_fr.pdf
8. 15th EFLM continuous postgraduate course in clinical chemistry and laboratory medicine: How to assess the quality of your method? 24-25 October 2015, Zagreb, Croatia. Clinical Chemistry and Laboratory Medicine (CCLM). 2015;53(11):eA203‑40. [DOI:10.1515/cclm-2015-0870]
9. Kwak SG, Kim JH. Central limit theorem: the cornerstone of modern statistics. Korean journal of anesthesiology. 2017;70(2):144‑56. [DOI:10.4097/kjae.2017.70.2.144]
10. Parikh R, Mathai A, Parikh S, Sekhar GC, Thomas R. Understanding and using sensitivity, specificity and predictive values. Indian journal of ophthalmology. 2008;56(1):45‑50. [DOI:10.4103/0301-4738.37595]
11. Diabetes Prevention Program Research Group. HbA1c as a predictor of diabetes and as an outcome in the diabetes prevention program: a randomized clinical trial. Diabetes care. 2015;38(1):51-8. [DOI:10.2337/dc14-0886]
12. ansm.sante.fr. [Internet]. [cited 2020 Feb 16].Available from: https://archiveansm.integra.fr /afssaps/content/download/1601/15558/version/2/file/hba1c.pdf.
13. Rollborn N, Åkerfeldt T, Nordin G, Xu XY, Mandic-Havelka A, Hansson LO, et al. Analysis of HbA1c on an automated multicapillary zone electrophoresis system. Scandinavian Journal of Clinical and Laboratory Investigation. 2017;77(1):15-8. [DOI:10.1080/00365513.2016.1238507]
14. Herpol M, Lanckmans K, Van Neyghem S, Clement P, Crevits S, De Crem K, et al. Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D-100 systems for the measurement of hemoglobin A1c. American journal of clinical pathology. 2016;146(1):67-77. [DOI:10.1093/ajcp/aqw081]
15. Urrechaga E. High-resolution HbA1c separation and hemoglobinopathy detection with capillary electrophoresis. American journal of clinical pathology. 2012;138(3):448-56. [DOI:10.1309/AJCPVYW9QZ9EVFXI]
16. Park MS, Lee K, Song J, Park HD. Accurate and Rapid Measurement of Glycated Hemoglobin Using HLC-723 G11 Variant Mode. Annals of laboratory medicine. 2019;39(3):237-44. https://doi.org/10.3343/alm.2019.39.3.237 [DOI:10.3343/alm.2019.39.3.243]
17. Wu X, Chao Y, Wan Z, Wang Y, Ma Y, Ke P, et al. A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1c determination. Biochemia medica. 2016;26(3):353-64. [DOI:10.11613/BM.2016.039]
18. Doggui R, Abdelhafidh Sahli C, Aissa WL, Hammami M, Ben Sedrine M, Mahjoub R, et al. Capillarys 2 Flex Piercing: analytical performance assessment according to CLSI protocols for HbA1c quantification. Electrophoresis. 2017 Sep;38(17):2210-8. [DOI:10.1002/elps.201600423]
19. Rohlfing C, Hanson S, Weykamp C, Siebelder C, Higgins T, Molinaro R, et al. Effects of hemoglobin C, D, E and S traits on measurements of hemoglobin A1c by twelve methods. Clinica Chimica Acta. 2016 Apr 1;455:80-3. [DOI:10.1016/j.cca.2016.01.031]

Add your comments about this article : Your username or Email:

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

© 2022 CC BY-NC 4.0 | Iranian Journal of Diabetes and Obesity

Designed & Developed by : Yektaweb