Evaluation of a HbA1c point-of-care analyzer

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 (R) was studied to check whether it complied with the quality requirements for this purpose. Design and methods: We evaluated the B-Analyst (R) (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 (R) (Menarini Diagnostics) as a reference method [High Performance Liquid Chromatography (HPLC)]. We assessed the analytical quality of the B-Analyst (R) 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 (R) and B-Analyst (R) 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 (R) with respect to HA-8180 (R) of 0.1872 with a 95% confidence interval. The standard error of the estimate (S-yx) 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 (R) evaluated not only showed good correlation with HA-8180 (R), but also it presented a great accuracy both in the inter-assay and in the intra-assay studies. The 8-Analyst (R) complies with quality specifications required for monitoring of diabetic patients. (C) 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.