论文部分内容阅读
目的探讨伯乐D-10TM糖化血红蛋白(Hb A1c)分析系统测试人份扩展及性能验证效果。方法检测糖化血红蛋白患者的全血1000份为研究对象,于清晨抽取静脉空腹血2 ml置入乙二胺四乙酸(EDTA)管中,分为2份,第一份采用伯乐D-10TM糖化血红蛋白分析系统直接上机检测,将检测结果记录为规格内。第二份标本采用WASH液进行稀释后上机检测,将检测结果作为扩展人份。对规格内分析柱和扩展人份分析柱分别用离子交换高效液相色谱法测定。按照检测糖化血红蛋白水平将标本分为A组(糖化血红蛋白<6.0%)、B组(糖化血红蛋白为6.0%~8.0%)、C组(糖化血红蛋白>8.0%),对三组标本规格内和扩展人份水平进行对比分析。结果经检验后按照糖化血红蛋白分组,得出A组有300例,B组有420例,C组有280例。各组规格内和扩展人份糖化血红蛋白水平比较,差异均无统计学意义(t=1.5418、1.8517、0.8514,P>0.05)。结论伯乐D-10TM糖化血红蛋白分析系统检测糖化血红蛋白水平,试剂检测人份分析柱扩展前后对糖化血红蛋白水平检测无明显影响。
Objective To investigate the effect of population expansion and performance validation of the Bole D-10TM Hb A1c Assay System. Methods A total of 1000 whole blood samples from patients with glycated hemoglobin (HbA1c) were tested. In the early morning, 2 mL of venous fasting blood was drawn into two tubes and divided into two tubes. The first Bovine D-10TM HbA1c Analysis system directly on the machine test, the test results recorded as specifications. The second specimen was diluted with WASH solution on the machine test, the test results as an extension of the people. The analytical column and the expanded analytical column were separately measured by ion exchange high performance liquid chromatography. The samples were divided into group A (glycosylated hemoglobin <6.0%), group B (glycosylated hemoglobin 6.0% -8.0%) and group C (glycated hemoglobin> 8.0%) according to the level of glycosylated hemoglobin. People’s level comparative analysis. The results of the test in accordance with the glycosylated hemoglobin group, draw a group of 300 cases, 420 cases of B group, C group of 280 cases. There was no significant difference in the levels of glycosylated hemoglobin among the groups (t = 1.5418,1.8517,0.8514, P> 0.05). Conclusion The BOHA D-10TM HbA1c system detects the level of HbA1c and the HbA1c level has no significant effect on the HbA1c level before and after the reagent test.