Clinical Laboratories, The University of Kansas Hospital, Kansas City, KS, USA.
Clinical Laboratories, North Kansas City Hospital, Kansas City, MO, USA.
Ann Clin Lab Sci. 2024 Jan;54(1):118-120.
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.
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.
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).
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.
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.
我们使用 Premier Hb9210 分析仪（HPLC 法；Trinity Biotech，纽约州詹姆斯敦）测量全血中的 HBA1c。由于我们的实验室正在过渡到 Abbott 系统，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 测定法在全血中同时测量总血红蛋白和 HbA1c（酶法），然后计算%HbA1c。该测定法的分析测量范围为 HbA1c 的 4%至 14%。我们通过评估精密度来评估 Alinity c HbA1c 的分析性能，并且还将 77 个临床样本与我们的参考 HPLC 方法进行了比较。
Alinity c HbA1c 和 Premier HB9210 的总精密度均非常出色。在 x 轴上绘制由 Premier Hb9210 分析仪获得的 HbA1c 结果（当前使用的参考方法）和由 Alinity c 测定法获得的相应值，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 分析仪上的 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。
我们得出结论，Alinity c 分析仪上的 HbA1c 测定法是临床实验室测量 HbA1c 的一种可行的 HPLC 替代方法，但在决策点必须谨慎解释这些值，如果有必要，应通过参考 HPLC 方法进行重复测量。
