Evaluation of a HbA1c point-of-care analyzer

Abstract

Objectives: A better glycemic monitoring of diabetic patients and avoiding complications of poorly controlled diabetes could be possible with point-of-care testing technology (POCT) for HbA1c determination. B-Analyst® was studied to check whether it complied with the quality requirements for this purpose.

Design and methods: We evaluated the B-Analyst® (Menarini Diagnostics), which is based in the principle of latex agglutination immunoturbidimetry, to assess the validity of the technique of HbA1c. We carried out the method comparison with the HA-8180® (Menarini Diagnostics) as a reference method [High Performance Liquid Chromatography (HPLC)]. We assessed the analytical quality of the B-Analyst® studying the accuracy: inter-assay variability and intra-assay study. Furthermore, possible interferences by hemoglobinopathies were studied.

Results: Regression analysis of the data for the method comparison between HA-8180® and B-Analyst® showed a slope of 1.0085 and an intercept of 0.1208. The Pearson's correlation coefficient was 0.9958 (p<0.0001). Bias study showed a mean difference from B-Analyst® with respect to HA-8180® of 0.1872 with a 95% confidence interval. The standard error of the estimate (Syx) was 0.2091. The concordance correlation coefficient to assess accuracy was 0.9922 (0.9891-0.9945). The CV for the inter-assay study was 1.4%. For the intra-assay study we analyzed 3 samples with different HbA1c % whose CV were 1.03% [4.7% HbA1c (28 mmol/mol)], 0.46% [6.4% HbA1c (46 mmol/mol)] and 0.78% [8.1% HbA1c (65 mmol/mol)].

Conclusion: The B-Analyst® evaluated not only showed good correlation with HA-8180®, but also it presented a great accuracy both in the inter-assay and in the intra-assay studies. The B-Analyst® complies with quality specifications required for monitoring of diabetic patients.

Keywords: Diabetes; Evaluation; HbA1c; POCT.