Comparison of the high-performance HPLC glycated hemoglobin analyzer H9 (Lifotronic, China) with HPLC glycated hemoglobin analyzers Variant II Turbo (Bio-Rad, USA) and Capillarys 2 (Sebia, France)

Stavitskaya S.V.

Vorokhobov City Clinical Hospital No. 67

ORCID: 0009-0002-7710-4177

Authors:

Stavitskaya S.V.

More about the authors

Journal: Laboratory Service. 2023;12(4): 31‑36

DOI: 10.17116/labs20231204131

Downloaded: 26

Download PDF (RU)

Contact the author

Table of contents

To cite this article:

Stavitskaya SV. Comparison of the high-performance HPLC glycated hemoglobin analyzer H9 (Lifotronic, China) with HPLC glycated hemoglobin analyzers Variant II Turbo (Bio-Rad, USA) and Capillarys 2 (Sebia, France). Laboratory Service. 2023;12(4):31‑36. (In Russ.)
https://doi.org/10.17116/labs20231204131

Close metadata

In context of radically changing situation in the world, manufacturers of new medical equipment are entering the Russian market. The article presents comparisons of the new HPLC analyzer H9 (Lifotronic, China) with analyzers of glycated hemoglobin Variant II Turbo (BioRad, USA) and Capillarys 2 (Sebia, France). Research was carried out to assess the inter-instrument convergence of the results from HPLC analyzer H9 (Lifotronic, China) with the results from HPLC analyzers of glycated hemoglobin that are available in the laboratory: Variant II Turbo (Bio-Rad, USA) and Capillarys 2 (Sebia, France). Statistical processing of the comparative method was carried out using the Bland-Altman method, as well as linear regression and Pearson correlation analysis. Quality control and evaluation of the Federal system of external quality assessment was performed in accordance with the order dated May 26, 2003 No. 220 of the Ministry of Health of the Russian Feveration. The data demonstrate a very high degree of correlation. Taking into account the results of this study, we can conclude that the experimental analytical system H9 (Lifotronic, China) is of high quality.

Keywords:

glycated hemoglobin

comparison of analyzers

Authors:

Stavitskaya S.V.

Vorokhobov City Clinical Hospital No. 67

ORCID: 0009-0002-7710-4177

Received:

11.09.2023

Accepted:

28.11.2023

List of references:

Emanuel AV, Ivanov GA, Emanuel YuV. The analytic quality in laboratory medicine: problems and perspectives (a lecture). Klinicheskaya laboratornaya diagnostika. 2014;59(3):29-36. (In Russ.).
Yis ÖM. Evaluation of the Analytical Performance of Lifotronic H9 Glycated Hemoglobin Analyzer and its Effect on Clinical Decision Making. Clinical Laboratory. 2020;66:1835-1841. Accessed September 08, 2023. https://www.clin-lab-publications.com/issue/163
Xu Yan, Yao Tiantian, Hu Wenyong, Zhang Bo, Guo Xingming. A New Interference-Free High Performance Liquid Chromatographic Method — Haemoglobin Analysis System. Journal of Biomedical Engineering. 2021;38(5):940-950. (In Russ.).
Bondarev AM, Verovskiy VE, Ostrovskiy OV, Murzina NP, Nokhashkieva IA, Trifonova AN, Fomina TA. The advantages of dynamic evaluation of measurement quality in clinical diagnostic laboratory. Klinicheskaya laboratornaya diagnostika. 2014;59(1): 62-65. (In Russ.).
Menshikov VV. The clinical safety of patient and reliability of laboratory information. Klinicheskaya laboratornaya diagnostika. 2013;6:29-36. (In Russ.).
Westgard JO, Barry PL. Basic QC practices: training in statistical quality control for medical laboratories. Madison: Westgard Quality Corporation; 2001.
Order of the Health Ministry of Russian Federation of 26.05.2003 No. 220 “On approval of State Standard Rules for intra-laboratory quality control of quantitative methods of clinical laboratory tests using control materials”. (In Russ.). Accessed September 08, 2023. https://www.webapteka.ru/phdocs/doc5212.html

Close metadata