摘要
目的用溶血法研制适合HLC-723G8分析仪的糖化血红蛋白(HbA1c)质控品,并评价其应用效果。方法选择临床标本2份,研制溶血比例,按照制备程序,保存于3种温度,评价自制质控品的稳定性及不同温度下的变化特点。结果自制质控品的溶血比例在80∶1~500∶1,中、高值累积10个月的不精密度分别为1.21%、0.83%,室温颜色变化最快,-20℃保存稳定性>300d。结论自制HbA1c质控品按照溶血比例,可使HbA1c水平在HLC-723G8分析仪上顺利被检测到,质控品的稳定性符合国际对HbA1c室内不精密度<2%的性能要求,值得临床参考使用。
Objective To develop aquality control product of glycosylated hemoglobin(HbA1 c)suitable for HLC-723 G8 analyzer by hemolysis method and evaluate its application effect.Methods Two clinical specimens were selected and stored at three kinds of temperatures according to the preparation procedure.The hemolysis ratio was developed and the stability of the self-made quality control product was evaluated.Results The hemolysis ratio of self-made quality control products was between 80∶1 and 500∶1.The coefficient of variation of the middle and high value accumulated for 10 months were 1.21% and 0.83%respectively.The color change at room temperature was the fastest,and the storage stability at-20℃ was more than 300 days.Conclusion The self-made quality control substance of HbA1 ccan detect the concentration of HbA1 c smoothly on the HLC-723 G8 analyzer according to the hemolysis ratio.The stability of quality control product meets the international performance requirements of indoor imprecision of HbA1 c(less than 2%),which is worthy of clinical reference.
引文
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