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Comparison of analytical performance of the HbA1c assay on the fine care fluorescence immunochromatographic system.

Bandar Ali Suliman

Background: The Fluorescence Immunochromatographic method is a relatively new technique offering similar advantages to small clinical laboratories with the added value of reagents stability and increased precision. Here we aim to evaluate the Fluorescence Immunochromatographic method in terms of accuracy, precision, and linearity. Also, to compare its performance against the Bronate Affinity method. Methods: Reproducibility between the two methods was assessed by measuring ten prepared HbA1c reference materials with different concentrations. Additionally, the Bland-Altman Plot was also used to determine the comparability of measurements between the two methods within a 1.96 SD limit. Moreover, twenty repeated measurements of two HbA1c reference materials with different concentrations were carried out to assess accuracy and precision. Results: The “best fit values” after comparing ten measurements of the HbA1c reference materials between the two methods for the Slope of the linear regression model was 0.9764 ± 0.05566 with “Y” intercept of 0.5469 ± 0.4657, “X” intercept of -0.5601, and R2 of 0.9747. All ten results were inside the 1.96 limit of the Bland-Altman Plot. Similarly, comparison of two sets of HbA1c references materials, “Control N” and “Control P”, after twenty repeated analysis showed a Coefficient of Variation (CV) of 2.64% and 3.55% respectively. Conclusion: There is no significant difference between the two methods in detecting HbA1c. Method evaluation employing both a liner regression model of analysis as well as the Bland-Altman method showed no significant variance. This shows that the Fluorescent Immunochromatography instrument is suitable for detecting HbA1c in the clinically significant detection range.