Evaluation of the Premier Hb9210 instrument for HbA1c determination

Abstract

Background: Glycated hemoglobin measurements are a valuable tool for long-term blood glucose monitoring and the diagnosis of diabetes. Its widespread use has been made possible due to the development of new analytical methods with improved performances and standardization with reference materials. The aim of the present study was to evaluate the Trinity Biotech Premier Hb9210 analyzer for the measurement of HbA1c.

Methods: The precision was assessed using the CLSI EP-15A3 and EP-10A3 protocols. The latter was also used to investigate linearity, carryover, and linear drift. The comparison study was performed between Premier Hb910 and Tosoh HLC-723 G8 through Passing–Bablok regression and the Bland-Altman plot. The Fleiss Kappa index was used to assess the degree of agreement. The interference of Hb variants was investigated using samples with Hb variants S, C, D, E, J, and Seville.

Results: Within-run and between-run imprecision fell between 0.37% and 1.16%. No statistically significant nonlinearity, carry-over, and/or drift were observed. The resulting regression line of the Passing–Bablok analysis was y = 0.00 + 1.00x. The Pearson correlation coefficient was 0.997. In the Bland–Altman plot, the relative bias was 0.01%. The overall Fleiss Kappa index was 0.9. No interference from hemoglobin variants was observed.

Conclusion: The Premier Hb9210 demonstrated a high degree of automation, reproducibility, good agreement, minimal carry-over effect, and excellent linearity across the wide range of HbA1c levels commonly found in diabetic patients and was not influenced by Hb variants.

HIGHLIGHTS

• Premier Hb9210 can be used as an alternative to monitor glycemic status.

• Premier Hb9210 is not affected by common hemoglobin variants.

• Premier Hb9210 can correctly classify diabetic patients.

Keywords:

• Premier Hb910
• HbA1c
• diabetes mellitus
• hemoglobin variants
• evaluation

Acknowledgements

Not applicable.

Author contributions

PhD David Núñez Jurado ([email protected]): Data curation, formal analysis, methodology, writing - original draft.

Jorge Montenegro Martínez ([email protected]): Data curation, formal analysis, Writing - original draft.

PharmG Ricardo Rubio Sánchez ([email protected]): Data curation, formal analysis, methodology, validation.

PhD Manuel Conde Sánchez ([email protected]): Conceptualization, supervision, writing - review & editing.

PhD Inmaculada Dominguez Pascual ([email protected]): Conceptualization, supervision, writing - review & editing.

Disclosure statement

There is no actual or potential conflict of interest for any author in relation with the results presented in the manuscript.

Financial disclosures

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Geolocation information

Seville, Andalusian, Spain.

Data availability statement

The data underlying this article are available in the article.