现代检验医学杂志2012，Vol.27Issue(5)：158-160,3.DOI:10.3969/j.issn.1671-7414.2012.05.056
自制HBV-DNA质控物的稳定性评价
Evaluation of the Stability of Self-made Quality Control Substances of HBV-DNA
摘要
Abstract
Objective To prepare quality control substances of HBV-DNA used in real-time quantitative polymerase chain re-action(real-time PCR) , and observed the stability of it. Methods Collecting HBV-DNA positive and negative fresh serum of specimens. Specimens with positive indexes (HAV-Ab, HCV-Ab, HIV-Ab and syphilis antibody) were removed, then respectively mixed all the serums well. HBV-DNA positive mixed serums were diluted by using HBV-DNA negative mixed serums,then inactivated,subpackage,randomly divided into 5 groups, namely group A,group B, group C,group D and group E. Group A: immediately detecting the serums 20 runs respectively by diagnostic kit for quantification of quantification of HBV-DNA under optimal conditions and routine conditions. Group B: placed the serums in 4℃ refrigerator then detecting in 48 hours. Group C:placed the serums in 4℃ refrigerator for 48 hours,then in —20℃ for 24 hours then thawed. Group D:to meet the conditions of C group,in —20℃ for 24 hours then thawed. Group E:in —20℃ for 12 months then thawed. Each group was detected 20 runs respectively under the routine conditions. Logarithms of mean value of the groups,standards deviation and coefficients of variation were calculated. Results The logarithms of mean value of the five groups were 4. 611, 4. 590,4. 600,4. 638 and 4. 571 respectively. By using analysis of variance, F= 2. 32<F0.05 (4,95)2. 47,P>0. 05,the difference among the logarithms of the mean values had no significance. Standard deviations were 0. 211,0. 198,0. 221,0. 191 and 0. 214 respectively. Coefficients of variability were respectively 4. 5% , 4. 3% , 4. 8% , 4.1% and 4.6%. There was little difference among standard deviations, and coefficients of variability also. Conclusion Quality control substances of HBV-DNA have simple preparation,good stability,and are suitable for external quality assessment (EQA) or spot EQA.关键词
HBV-DNA/质控物/室间质量评价Key words
HBV-DNA/ the stability of quality control substance/ external quality assessment分类
医药卫生引用本文复制引用
邓演超,李全双,沈红艳,徐湛,任思坡..自制HBV-DNA质控物的稳定性评价[J].现代检验医学杂志,2012,27(5):158-160,3.基金项目
徐州市科学技术局科技项目(项目编号XF11C031). （项目编号XF11C031）
