自制糖化血红蛋白质控品及其性能评价

目的探讨自制溶血液作为乳胶增强免疫比浊法室内质控品的可行性。方法选择糖化血红蛋白(HbAlc)值分别为低值和高值的两个水平肝素抗凝血各1份,按试剂说明书,配制成测定用溶血液,分装、-20℃保存。使用Roche公司质控品做好室内质控,对溶血液进行性能评价。结果两个水平的溶血液的批内不精密度均小于2.5%,批内天间不精密度均小于5%;-20℃保存稳定期可达3个月(P>0.05),瓶间差异无统计学意义(P>0.05)。结论自制两个水平值的糖化血红蛋白质控品是可行的,能够满足实验室室内质控的要求。

Performance of quality control product in self-made for measuring glucosylated hemoglobin

Objective To evaluate the feasibility of the hemolysis fluid as internal quality control product. Methods According to operation manual,two levels value of heparin anticoagulant bloods were selected,their HbAlc values were low and high,hemolysis fluid was made, packed, preserved at --20℃. Quality control products of Roche were tested for good quality control, the performance of the hemolysis fluid was evaluated. Results The term stabili- ty of hemolysis fluid in self-made was more than 3 months（P〉0.01） ,and the value of variation coefficient was less than 2. 5%. The difference among bottles was no significant. Conclusion Two levels value of hemolysis fluid can meet the requirements of internal quality control, it is feasible.