广东中山地区糖化血红蛋白检测现状调查

Investigation of glycohemoglobin A1c detection status in Zhongshan,Guangdong

目的对广东中山地区糖化血红蛋白的检测现状进行调查。方法以Bio—RadVARIANTⅡTURBO糖化血红蛋白分析仪作为比对系统，以通过NGSP认证的Bio—RadD-10糖化血红蛋白分析仪作为参比系统，用20份不同浓度的新鲜全血进行比对；再以通过比对系统对两份新鲜全血进行赋值，两份赋值的新鲜全血与另外3个定值的Bio—Rad全球室间糖化血红蛋白调查物作为调查品派发给参与调查的17家实验室，对回报结果进行统计分析。结果比对系统与参比系统具有可比性；17家实验室使用12套检测系统，分析方法包括3种，分别是离子交换高效液相层析法、免疫比浊法和微粒色谱法。糖化血红蛋白检测的百分偏倚范围和变异系数（CⅥ范围分别为0．00％～32．29％、2．30％～14．59％，其中离子交换高效液相层析法的平均百分偏倚和CV均最小，新鲜全血和室间调查物的平均百分偏倚和CV分别为1．79％、2．30％和4．35％、6．28％。结论Bio—RadVARIANTIITURBO和Bio—RadD-10糖化血红蛋白分析检测系统检测结果相关性良好。中山地区糖化血红蛋白检测使用多个检测系统和检测方法，不同检测系统、检测方法间糖化血红蛋白检测结果一致性有待进一步提高。

Objective To investigate the status of glycohemoglobin Alc detection in Zhongshan area. Methods Bio-Rad VARI- ANT 11 TURBO glycohemoglobin analyzer was chosen as a comparison system, Bio-Rad D-10 glycohemoglobin analyzer which through the NGSP certification was chosen as a reference system. 20 different concentrations of fresh whole blood was collected for comparison. Then through comparison system on two fresh whole blood assignment, the two assignment of fresh whole blood and the other three valued Bio-Rad global chamber investigation were surveyed to 17 laboratories. The results were statistically ana- lyzed. Results The comparison system and reference system were comparable. In 17 laboratories used 12 sets of detection system, and the analysis methods included ion exchange high performance liquid chromatography（IE-HPLC） ,immunoturbidimetry and par- ticulate chromatography. Detection of glycohemoglobin Alc percentage bias range and coefficient of variation （CV） range were 0.00 %- 32.29% and 2.30 %-14.59% respectively. The average percentage bias of IE-HPLC was minimum. The average percent bias and CV of fresh whole blood and global chamber investigation were 1.79%, 2.30% and 4.35%, 6.28 % respectively. Conclu- sion Bio-Rad VARIANT II TURBO and Bio-Rad D-10 glycohemoglobin detection system for detecting results correlated well. De- tection of glycohemoglobin Alc in Zhongshan used multiple detection systems and detection methods. Glycohemoglobin Alc test re- sults consistency between different detection systems and detection methods need to be further improved.