Schwartz Kendra L, Monsur Joseph C, Bartoces Monina G, West Patricia A, Neale Anne Victoria
Department of Family Medicine, Wayne State University School of Medicine, 101 E. Alexandrine, Detroit, MI 48201, USA.
BMC Fam Pract. 2005 Jul 13;6:28. doi: 10.1186/1471-2296-6-28.
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. 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.
Consecutive 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).
147 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.
For 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.
糖化血红蛋白（HbA1c）检测结果因分析方法而异。采用同次就诊时的HbA1c检测方法有望提高患者护理效率并改善糖尿病管理。我们的目标是测试在繁忙的家庭医疗中心（FPC）引入同次就诊时的HbA1c检测方法的可行性，并计算同次就诊时的HbA1c检测结果与临床机构当前用于HbA1c检测的实验室方法之间的相关性。
要求年龄在18岁及以上、因HbA1c常规实验室分析而采集血样的连续糖尿病患者提供一份毛细血管血样，以便使用伯乐Micromat II进行同次就诊检测。我们将同次就诊检测结果与三种不同的实验室方法进行了比较（一个FPC使用了两个不同的实验室）。
共有147对样本可供分析（其中73对来自一个FPC；74对来自另一个FPC）。Micromat II与离子交换高效液相色谱法的Pearson相关性为0.713（p < 0.001）。Micromat II测得的HbA1c平均值为6.91%，低于离子交换高效液相色谱法分析得出的7.23%（p < 0.001）。Micromat II与硼酸亲和高效液相色谱法的相关性为0.773（p < 0.001）；Micromat II测得的HbA1c平均值为6.44%，硼酸亲和高效液相色谱法测得的平均值为7.71%（p < 0.001）。Micromat II与免疫比浊法的相关系数为0.927（p < 0.001）；Micromat II测得的HbA1c平均值为7.15%，免疫比浊法测得的HbA1c平均值为7.99%（p = 0.002）。医务人员发现由于该检测所需的专用时间量，同次就诊测量难以实施。
对于每种实验室方法，相关系数均低于制造商报告的值0.96。这可能是由于Micromat II机器的多个用户引入的变异性所致。HbAic的平均结果也始终低于实验室分析得出的结果。此外，进行该检测所需的专用时间量可能会限制其在繁忙临床实践中的实用性。在引入同次就诊的HbA1c检测方法之前，临床医生应将快速检测结果与其当前的分析方法进行比较。
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