评价十五种方法中血红蛋白 C、D、E 和 S 特征对血红蛋白 A1c 测量的干扰。
Evaluation of interference from hemoglobin C, D, E and S traits on measurements of hemoglobin A1c by fifteen methods.
机构信息
Department of Pathology and Anatomical Sciences, University of Missouri, Columbia, MO, USA.
Department of Pathology and Anatomical Sciences, University of Missouri, Columbia, MO, USA.
出版信息
Clin Chim Acta. 2021 Nov;522:31-35. doi: 10.1016/j.cca.2021.07.027. Epub 2021 Aug 2.
BACKGROUND
Hemoglobin C, D Punjab, E or S trait can interfere with hemoglobin A1c (HbA1c) results. We assessed whether they affect results obtained with 15 current assay methods.
METHODS
Hemoglobin AA (HbAA), HbAC, HbAD Punjab, HbAE and HbAS samples were analyzed on 2 enzymatic, 4 ion-exchange HPLC and 9 immunoassay methods. Trinity Premier Hb9210 boronate affinity HPLC was the comparative method. An overall test of coincidence of least-squared linear regression lines was performed to determine if HbA1c results were statistically significantly different from those of HbAA samples. Clinically significant interference was defined as >6% difference from HbAA at 6 or 9% HbA1c compared to Premier Hb9210 using Deming regression.
RESULTS
All methods showed statistically significant effects for one or more variants. Clinically significant effects were observed for the Tosoh G11 variant mode (HbAD), Roche b 101 (HbAC and HbAE) and Siemens DCA Vantage (HbAE and HbAS). All other methods (Beckman Coulter B93009 and B00389 on DxC700AU, and Unicel DxC, Ortho Clinical Vitros 5.1, Roche cobas c 513, Siemens Dimension RxL and Vista, and Enzymatic on Advia and Atellica, Tosoh G8 5.24 and 5.28, and GX) showed no clinically significant differences.
CONCLUSIONS
A few methods showed interference from one or more variants. Laboratories need to be aware of potential HbA1c assay interferences.
背景
血红蛋白 C、D 旁遮普邦、E 或 S 特征可能会干扰血红蛋白 A1c（HbA1c）的结果。我们评估了它们是否会影响 15 种当前检测方法的结果。
方法
分析了血红蛋白 AA（HbAA）、HbAC、HbAD 旁遮普邦、HbAE 和 HbAS 样本，使用了 2 种酶法、4 种离子交换高效液相色谱法和 9 种免疫测定法。Trinity Premier Hb9210 硼酸亲和高效液相色谱法是比较方法。通过最小二乘线性回归线的整体一致性检验来确定 HbA1c 结果是否与 HbAA 样本的结果在统计学上有显著差异。使用 Deming 回归，将与 Premier Hb9210 相比 HbA1c 为 6%或 9%时 HbAA 差异 >6%定义为临床显著干扰。
结果
所有方法均显示出一种或多种变体的统计学显著影响。在 Tosoh G11 变异模式（HbAD）、罗氏 b 101（HbAC 和 HbAE）和西门子 DCA Vantage（HbAE 和 HbAS）中观察到临床显著影响。所有其他方法（贝克曼库尔特 B93009 和 B00389 在 DxC700AU 上，以及 Unicel DxC、Ortho Clinical Vitros 5.1、罗氏 cobas c 513、西门子 Dimension RxL 和 Vista，以及酶法在 Advia 和 Atellica 上，Tosoh G8 5.24 和 5.28，以及 GX）均未显示出临床显著差异。
结论
少数方法显示出一种或多种变体的干扰。实验室需要意识到潜在的 HbA1c 检测干扰。
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