摘要
目的：用灭活法研制乙肝表面抗原（HBsAg）室内质控血清。方法：筛选HBsAg阳性血清,60℃加热1h进行灭活,同时与卫生部临床检验中心提供的HBsAg质控品比较,选取合适浓度的阳性血清作为ELISA法检测HBsAg的室内质控品。结果：该质控品定值为2 IU/ml和10 IU/ml。其稳定性实验表明：2-8℃3个月及-20℃保存6个月的含量无明显变化。均一性检测结果：瓶间不精密度为7.15%和8.97%。结论：60℃加热1h灭活法制备的质控品可以作为用于ELISA法检测HBsAg的室内质控。
Objective： To assess the efficiency of inactivated method to manufacture internal quality control serum of hepatitis B type virus surface antigen （ HBsAg ）. Method： The HBsAg positive serum samples with good quality were collected and inactivated by bathing at 60℃ for 1 hour, then mixed and diluted to proper concentration with the reference of control serum provided by the national center for clinical laboratory （ NCCL）, fractional packed in eppendolf tube and preserved in 2 -8℃ refrigerator for assessment detection by enzyme linked immunosorbent assay （ ELISA ）. Result： The target titer value of the self - manufacture control serum was set to 2 IU/ml and 10 IU/ml respectively. Stability of these control serum was confirmed to preserving at 2 to 8℃ for 3 months and -20℃ for 6 months. Homogeneity test showed that the vail -to -vail imprecision was 5.53% and 8.97% respectively. Conclusion： These samples could be used as the internal quality control for HBsAg test with ELISA assay.
出处
《河北医学》
CAS
2009年第4期402-405,共4页
Hebei Medicine
基金
汕头市重点科技计划项目:汕府科[2006]82号
关键词
乙肝表面抗原(HBsAg)
室内质控
Hepatitis B virus surface antigen（HBsAg）
Internal quality control
