Technical Note: Comparison of Alinity c Hemoglobin A1c Immunoassay with Premier Hb9210 Automated HPLC Assay: A Preliminary Report.

IF 1.1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY Annals of clinical and laboratory science Pub Date : 2024-01-01

Ashton Walton, Jonathan Meador, Kelsey Woodard, Sean Tucker, Susan McIntyre, Amitava Dasgupta

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Abstract

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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技术说明：Alinity c 血红蛋白 A1c 免疫测定与 Premier Hb9210 自动高效液相色谱分析的比较：初步报告。

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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of clinical and laboratory science 医学-医学实验技术

CiteScore

1.60

自引率

0.00%

发文量

112

审稿时长

6-12 weeks

期刊介绍： The Annals of Clinical & Laboratory Science welcomes manuscripts that report research in clinical science, including pathology, clinical chemistry, biotechnology, molecular biology, cytogenetics, microbiology, immunology, hematology, transfusion medicine, organ and tissue transplantation, therapeutics, toxicology, and clinical informatics.