目的对离子交换高效液相色谱法(IE-HPLC)、硼酸盐亲和层析高效液相色谱法(AC-HPLC)和高效毛细管电泳法(HPCE)测定糖化血红蛋白(HbA1c)进行比对分析和偏倚评估,实现不同方法检测结果的可比性。方法以IE-HPLC法为参比方法(该法已通过美国N...目的对离子交换高效液相色谱法(IE-HPLC)、硼酸盐亲和层析高效液相色谱法(AC-HPLC)和高效毛细管电泳法(HPCE)测定糖化血红蛋白(HbA1c)进行比对分析和偏倚评估,实现不同方法检测结果的可比性。方法以IE-HPLC法为参比方法(该法已通过美国NGSPⅠ级实验室认证),HPCE法和AC-HPLC法为实验方法,依据美国临床和实验室标准化协会(CLSI)EP9-A3文件进行方法学比对和偏倚评估,比对前进行参比方法正确度验证和实验方法精密度验证;对不可比的实验方法用经NGSP样本赋值传递的新鲜全血实施校准,校准后进行可比性的验证。结果参比方法对10个定值NGSP样本进行检测,检测结果全部在靶值的±6%内。两个实验方法的批内CV均<1.5%,批间CV均<2.0%。HPCE法在医学决定水平处与参比方法的偏倚分别为-0.06%和-0.07%,小于1/2 CAP TEa,与参比方法具有可比性;AC-HPLC法分别为-0.31%和-0.31%,均大于1/2 CAP TEa,与参比方法不可比;用经NGSP样本赋值传递的两个浓度新鲜全血校准AC-HPLC法,校准后的偏倚分别为0.08%和0.09%,均小于1/2 CAP TEa,与参比方法具有可比性。结论不同方法对HbA1c的测定结果可能存在差异,CLSI EP9-A3是评估这些差异的有效工具,用经NGSP样本赋值传递的新鲜全血对不可比的方法实施校准,可实现检验结果的可比性。展开更多
Nanocrystalline TiO 2 particles film has been considered as an eminent matrix for the immobilization of biomolecules due to its high biocompatiability, high protein loading and special binding ability. The direct elec...Nanocrystalline TiO 2 particles film has been considered as an eminent matrix for the immobilization of biomolecules due to its high biocompatiability, high protein loading and special binding ability. The direct electron transfer process of hemoglobin was achieved at nanosized TiO 2 film electrode, in which a well defined redox peak of hemoglobin could be observed. However, this peak decreased with the presence of NO, indicating the electrochemical activity of hemoglobin was inhibited by the interation between hemoglobin and NO. While the further evidence revealed that such activity could be recovered after releasing NO from hemoglobin with electrochemical oxidation method.展开更多
文摘目的对离子交换高效液相色谱法(IE-HPLC)、硼酸盐亲和层析高效液相色谱法(AC-HPLC)和高效毛细管电泳法(HPCE)测定糖化血红蛋白(HbA1c)进行比对分析和偏倚评估,实现不同方法检测结果的可比性。方法以IE-HPLC法为参比方法(该法已通过美国NGSPⅠ级实验室认证),HPCE法和AC-HPLC法为实验方法,依据美国临床和实验室标准化协会(CLSI)EP9-A3文件进行方法学比对和偏倚评估,比对前进行参比方法正确度验证和实验方法精密度验证;对不可比的实验方法用经NGSP样本赋值传递的新鲜全血实施校准,校准后进行可比性的验证。结果参比方法对10个定值NGSP样本进行检测,检测结果全部在靶值的±6%内。两个实验方法的批内CV均<1.5%,批间CV均<2.0%。HPCE法在医学决定水平处与参比方法的偏倚分别为-0.06%和-0.07%,小于1/2 CAP TEa,与参比方法具有可比性;AC-HPLC法分别为-0.31%和-0.31%,均大于1/2 CAP TEa,与参比方法不可比;用经NGSP样本赋值传递的两个浓度新鲜全血校准AC-HPLC法,校准后的偏倚分别为0.08%和0.09%,均小于1/2 CAP TEa,与参比方法具有可比性。结论不同方法对HbA1c的测定结果可能存在差异,CLSI EP9-A3是评估这些差异的有效工具,用经NGSP样本赋值传递的新鲜全血对不可比的方法实施校准,可实现检验结果的可比性。
文摘Nanocrystalline TiO 2 particles film has been considered as an eminent matrix for the immobilization of biomolecules due to its high biocompatiability, high protein loading and special binding ability. The direct electron transfer process of hemoglobin was achieved at nanosized TiO 2 film electrode, in which a well defined redox peak of hemoglobin could be observed. However, this peak decreased with the presence of NO, indicating the electrochemical activity of hemoglobin was inhibited by the interation between hemoglobin and NO. While the further evidence revealed that such activity could be recovered after releasing NO from hemoglobin with electrochemical oxidation method.
