Rohlfing Curt, Hanson Steven, Weykamp Cas, Siebelder Carla, Higgins Trefor, Molinaro Ross, Yip Paul M, Little Randie R
Department of Pathology and Anatomical Sciences, University of Missouri, Columbia, MO, United States.
Department of Pathology and Anatomical Sciences, University of Missouri, Columbia, MO, United States.
Clin Chim Acta. 2016 Apr 1;455:80-3. doi: 10.1016/j.cca.2016.01.031. Epub 2016 Jan 29.
Hemoglobin C, D Punjab, E or S trait can interfere with hemoglobin A1c (HbA1c) results. We assessed whether they affect results obtained with 12 current assay methods.
Hemoglobin AA (HbAA), HbAC, HbAD Punjab, HbAE and HbAS samples were analyzed on one enzymatic, nine ion-exchange HPLC and two Capillary Electrophoresis methods. Trinity ultra(2) 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 >7% difference from HbAA at 6 or 9% HbA1c compared to ultra(2) using Deming regression.
All methods showed statistically significant effects for one or more variants. Clinically significant effects were observed for the Tosoh G8 variant mode and GX (all variants), GX V1.22 (all but HbAE) and G11 variant mode (HbAC). All other methods (Abbott Architect c Enzymatic, Bio-Rad D-100, Variant II NU and Variant II Turbo 2.0, Menarini HA-8180T thalassemia mode and HA-8180V variant mode, Sebia Capillarys 2 and Capillarys 3) showed no clinically significant differences.
Several methods showed clinically significant interference with HbA1c results from one or more variants which could adversely affect patient care.
血红蛋白C、D旁遮普型、E或S性状可能会干扰糖化血红蛋白（HbA1c）检测结果。我们评估了它们是否会影响目前12种检测方法所获得的结果。
采用1种酶法、9种离子交换高效液相色谱法和2种毛细管电泳法对血红蛋白AA（HbAA）、HbAC、HbAD旁遮普型、HbAE和HbAS样本进行分析。以Trinity ultra(2)硼酸亲和高效液相色谱法作为对照方法。进行最小二乘线性回归线的总体一致性检验，以确定HbA1c结果与HbAA样本的结果在统计学上是否有显著差异。使用Deming回归法，将与ultra(2)相比，在HbA1c为6%或9%时与HbAA相差>7%定义为具有临床意义的干扰。
所有方法对一种或多种变体均显示出统计学上的显著影响。在Tosoh G8变体模式和GX（所有变体）、GX V1.22（除HbAE外的所有变体）以及G11变体模式（HbAC）中观察到具有临床意义的影响。所有其他方法（雅培Architect c酶法、伯乐D-100、Variant II NU和Variant II Turbo 2.0、美纳里尼HA-8180T地中海贫血模式和HA-8180V变体模式、Sebia Capillarys 2和Capillarys ）均未显示出具有临床意义的差异。
几种方法对一种或多种变体的HbA1c结果显示出具有临床意义的干扰，这可能会对患者护理产生不利影响。
