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.

doi:https://doi.org/10.17116/labs20231204131

Stavitskaya S.V.

Vorokhobov City Clinical Hospital No. 67

ORCID: 0009-0002-7710-4177

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)

Authors:

Stavitskaya S.V.

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

DOI: 10.17116/labs20231204131

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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

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Abstract:

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

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References:

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