Abstract
BackgroundGlycated hemoglobin (HbA1c) results vary by analytical method. Use of same-visit HbA1c testing methodology holds the promise of more efficient patient care, and improved diabetes management. Our objective was to test the feasibility of introducing a same-visit HbA1c methodology into busy family practice centers (FPC) and to calculate the correlation between the same-visit HbA1c test and the laboratory method that the clinical site was currently using for HbA1c testing.MethodsConsecutive diabetic patients 18 years of age and older having blood samples drawn for routine laboratory analysis of HbA1c were asked to provide a capillary blood sample for same-visit testing with the BIO-RAD Micromat II. We compared the results of the same-visit test to three different laboratory methods (one FPC used two different laboratories).Results147 paired samples were available for analysis (73 from one FPC; 74 from the other). The Pearson correlation of Micromat II and ion-exchange HPLC was 0.713 (p < 0.001). The Micromat II mean HbA1c was 6.91%, which was lower than the 7.23% from the ion-exchange HPLC analysis (p < 0.001). The correlation of Micromat II with boronate-affinity HPLC was 0.773 (p < 0.001); Micromat II mean HbA1c 6.44%, boronate-affinity HPLC mean 7.71% (p < 0.001). Correlation coefficient for Micromat II and immuno-turbidimetric analysis was 0.927 (p < 0.001); Micromat II mean HbA1c was 7.15% and mean HbA1c from the immuno-turbidimetric analysis was 7.99% (p = 0.002). Medical staff found the same-visit measurement difficult to perform due to the amount of dedicated time required for the test.ConclusionFor each of the laboratory methods, the correlation coefficient was lower than the 0.96 reported by the manufacturer. This might be due to variability introduced by the multiple users of the Micromat II machine. The mean HbA1c results were also consistently lower than those obtained from laboratory analysis. Additionally, the amount of dedicated time required to perform the assay may limit its usefulness in a busy clinical practice. Before introducing a same-visit HbA1c methodology, clinicians should compare the rapid results to their current method of analysis.
Highlights
Glycated hemoglobin (HbA1c) results vary by analytical method
Considering first the data from the site that used two different laboratories: the boronate-affinity high performance liquid chromatography (HPLC) (n = 63) and the immuno-turbidimetric (n = 11), we found a significant correlation with the Micromat II results for both (Pearson r = 0.773, p < 0.001 and r = 0.927, p < 0.001, respectively) (Figures 1 and 2)
The mean Hemoglobin A1c (HbA1c) result from the laboratory was significantly greater than the mean from the Micromat II (7.23 ± 1.51 vs. 6.91 ± 1.34, p = 0.014)
Summary
Glycated hemoglobin (HbA1c) results vary by analytical method. Use of same-visit HbA1c testing methodology holds the promise of more efficient patient care, and improved diabetes management. The HbA1c level is used for patient education and counseling, for feedback about diabetic control, to improve patient motivation, and to monitor management; its measurement should be optimally accurate and precise [1]. To date, there is no international standard for determining HbA1c [2,3,4], and various methodologies are commercially available. Tran [1] determined the physiological (changes over time between measurements) and analytic variation of two widely used laboratory assays, one a high performance liquid chromatography (HPLC) method, and the other an immunoassay [1]. The 5.1% CV of the immunoassay method exceeded physiologically established limits of 2–3%, and those of the National Glycohemoglobin Standardization Program (3–4%)
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