乙肝五项自制外部对照质控血清的研究

A Research of Self-made External Quality Control Serum for HBV Serum Mark

目的探讨乙肝五项外部对照质控血清的自制方法,加强实验室工作精密度的监测。方法收集1年量乙肝五项检测全阴的混合血清,稀释试剂厂家提供的高浓度标准品,稀释比由卫生部临床检验中心免疫测定用室内质控血清测定值标定,以5 d量分装、-30℃保存,用全自动酶免疫分析仪连续检测。结果室温复溶自制质控血清后,96 h时24℃下S/CO值较即时测定结果偏低(P<0.05),其余时间点及温度下S/CO值差异无统计学意义(P>0.05)。连续6个月测定冰冻状态自制质控血清,各月S/CO间总体差异无统计学意义(P>0.05)。结论自制外部对照质控血清稳定性较为理想,一定程度可以满足免疫室内质控的要求。

Objective To analyze the self-made external quality control serum for HBV serum mark and improve monitoring the precision of the laboratory. Methods Collect the negative serum of HB, dilute the high concentration standardization which supplied by the man- ufacturers,according to the standard of the Ministry of Health clinical testing centre. Package in 5 day＇s volume and save at -30℃. Results After dissolved the self-made serum at room temperature, we found its basic stability and there is no statistical significance （P 〉0.05 ） except in 96 h under 24 ℃ （P 〈0.05）. By continuous monitoring of the frozen self-made external quality control serum, we found there is no significant difference between the continuous 6 months （P 〉0.05）. Conclusion The self-made external quality control serum has a satisfied stability, and can meet the need of the immunization requirements of internal quality control laboratory in some extent.