Ashton Walton, Jonathan Meador, Kelsey Woodard, Sean Tucker, Susan McIntyre, Amitava Dasgupta
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We evaluated the analytical performance of Alinity c HbA1c by evaluating precision and also comparing 77 clinical samples with our reference HPLC method.</p><p><strong>Results: </strong>Both Alinity c HbA1c and Premier HB9210 have excellent total precision. Plotting HbA1c results obtained by the Premier Hb9210 analyzer in the x-axis (currently used reference method) and the corresponding values obtained by the Alinity c assay, we observed the following regression equation: y=0.9473x+0.1548 ( n=77, r=0.99).</p><p><strong>Discussion: </strong>Our result indicates that HbA1c enzymatic assay on the Alinity c analyzer showed values comparable to HPLC method. 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引用次数: 0
摘要
目的我们使用 Premier Hb9210 分析仪（HPLC 法；Trinity Biotech，Jamestown，NY）测量全血中的 HBA1c。由于我们的实验室正在向雅培系统过渡，因此我们比较了 Alinity c 和 Premier Hb9210 获得的 HbA1c 值：Premier Hb9210 分析仪基于硼酸盐亲和高效液相色谱法，分析测量范围为 3.8%至 18.5%。Alinity c 血红蛋白 A1c 分析仪测量全血中的总血红蛋白和 HbA1c（酶法测定），然后计算 %HbA1c。该测定法的分析测量范围为 HbA1c 的 4% 至 14%。我们通过评估精确度评估了 Alinity c HbA1c 的分析性能，并将 77 份临床样本与我们的 HPLC 参考方法进行了比较：结果：Alinity c HbA1c 和 Premier HB9210 的总精密度都非常好。将 Premier Hb9210 分析仪获得的 HbA1c 结果（目前使用的参考方法）与 Alinity c 分析法获得的相应值绘制成 x 轴，我们观察到以下回归方程：y=0.9473x+0.1548 ( n=77, r=0.99)：我们的结果表明，Alinity c 分析仪的 HbA1c 酶法测定值与 HPLC 方法相当。然而，在决策点（>6.4% 时平均负偏差为 2.8%，7% 时平均负偏差为 3.3%），Alinity c 分析仪获得的 HbA1c 值低于参考方法：我们得出的结论是：在临床实验室测量 HbA1c 时，用 Alinity c 分析仪进行 HbA1c 分析是 HPLC 的可行替代方法，但必须谨慎解释决策点的数值，必要时应使用 HPLC 参考方法进行复测。
Technical Note: Comparison of Alinity c Hemoglobin A1c Immunoassay with Premier Hb9210 Automated HPLC Assay: A Preliminary Report.
Objective: We utilized Premier Hb9210 analyzer (HPLC method; Trinity Biotech, Jamestown, NY) for measuring HBA1c in whole blood. As our laboratory is transitioning to Abbott system, we compared HbA1c values obtained by Alinity c and Premier Hb9210.
Methods: The Premier Hb9210 analyzer is based on boronate affinity high performance liquid chromatography with analytical measurement range of 3.8 to 18.5%. The Alinity c Hemoglobin A1c assay measured both total hemoglobin and HbA1c (enzymatic assay) in whole blood and then calculated %HbA1c. The analytical measurement range of this assay is 4 to 14% of HbA1c. We evaluated the analytical performance of Alinity c HbA1c by evaluating precision and also comparing 77 clinical samples with our reference HPLC method.
Results: Both Alinity c HbA1c and Premier HB9210 have excellent total precision. Plotting HbA1c results obtained by the Premier Hb9210 analyzer in the x-axis (currently used reference method) and the corresponding values obtained by the Alinity c assay, we observed the following regression equation: y=0.9473x+0.1548 ( n=77, r=0.99).
Discussion: Our result indicates that HbA1c enzymatic assay on the Alinity c analyzer showed values comparable to HPLC method. However, at the decision points (2.8% average negative bias at >6.4% and 3.3% average negative bias at 7%), HbA1c values obtained by the Alinity c analyzer were lower than the reference method.
Conclusions: We conclude that HbA1c assay on the Alinity c analyzer is a viable alternative to HPLC for measuring HbA1c in clinical laboratories but values at the decision points must be interpreted with caution and if necessary should be repeated by a reference HPLC method.
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The Annals of Clinical & Laboratory Science
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