Tesija Kuna Andrea, Dukic Kristina, Nikolac Gabaj Nora, Miler Marijana, Vukasovic Ines, Langer Sanja, Simundic Ana-Maria, Vrkic Nada
Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia.
Department for Medical Laboratory Diagnostic, University Hospital Sveti Duh, Zagreb, Croatia.
Lab Med. 2018 Jul 5;49(3):231-238. doi: 10.1093/labmed/lmx090.
To compare the analytical performances of the enzymatic method (EM) and capillary electrophoresis (CE) for hemoglobin A1c (HbA1c) measurement.
Imprecision, carryover, stability, linearity, method comparison, and interferences were evaluated for HbA1c via EM (Abbott Laboratories, Inc) and CE (Sebia).
Both methods have shown overall within-laboratory imprecision of less than 3% for International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) units (<2% National Glycohemoglobin Standardization Program [NGSP] units). Carryover effects were within acceptable criteria. The linearity of both methods has proven to be excellent (R2 = 0.999). Significant proportional and constant difference were found for EM, compared with CE, but were not clinically relevant (<5 mmol/mol; NGSP <0.5%). At the clinically relevant HbA1c concentration, stability observed with both methods was acceptable (bias, <3%). Triglyceride levels of 8.11 mmol per L or greater showed to interfere with EM and fetal hemoglobin (HbF) of 10.6% or greater with CE.
The enzymatic method proved to be comparable to the CE method in analytical performances; however, certain interferences can influence the measurements of each method.
比较酶法（EM）和毛细管电泳法（CE）检测糖化血红蛋白（HbA1c）的分析性能。
通过EM（雅培实验室公司）和CE（赛比公司）对HbA1c的不精密度、携带污染、稳定性、线性、方法比较及干扰情况进行评估。
两种方法在实验室内部的总体不精密度对于国际临床化学和检验医学联合会（IFCC）单位均小于3%（对于美国国家糖化血红蛋白标准化计划[NGSP]单位小于2%）。携带污染效应在可接受标准范围内。两种方法的线性均已证实极佳（R2 = 0.999）。与CE相比，EM存在显著的比例差异和恒定差异，但无临床相关性（<5 mmol/mol；NGSP <0.5%）。在具有临床相关性的HbA1c浓度下，两种方法观察到的稳定性均可接受（偏差<3%）。甘油三酯水平达到或高于8.11 mmol/L时显示会干扰EM，而胎儿血红蛋白（HbF）达到或高于10.6%时会干扰CE。
酶法在分析性能上被证明与CE方法相当；然而，某些干扰会影响每种方法的测量结果。
