酶免检测系统检测HBsAg的比对分析

Comparative analyses of the volunteer blood donors' HBsAg detected by ELISA systems

目的对酶免检测系统进行方法学比对和偏差评估,探讨其检测无偿献血者HBs Ag结果的可比性。方法参考NCCLS的EP9-A2文件,以手工加样+洗板机+酶标仪为参比方法,RSP150+FAME24/20,EVO200+FAME24/30为实验方法,用40份献血者新鲜血浆进行HBs Ag双份重复测定,用卡方检验比较不同系统检测结果的差异性;计算相关系数、直线回归方程及预期偏差,以CV%=15%判断酶免系统检测HBs Ag质控结果的可靠性。结果不同检测系统差异无显著性,各检测系统相关系数R>0.975,R2>0.95,检测相关性良好,HBs Ag质控检测结果的预期偏差CV在15%内。结论手工加样+洗板机+酶标仪法,RSP150+FAME24/20,EVO200+FAME24/30测定HBs Ag结果具有可比性。

Objective To study and to evaluate three ELISA systems on their practicability to detect HBsAg from volun- teat blood donors. Methods Using the system of manual sampling and enzyme micro-plate reader as a reference method, the systems RSP150 ＋ FAME24/20 or Eve200 ＋ FAME24/30 were used as testing methods, according to the standards of EP9- A2, Then, the HBsAg in 40 fresh sera from the volunteer blood donors were measured by the analysis systems. After the difference in the three ELISA process systems was evaluated by X2 the correlation coefficient, linear regression equation and expected de,iatiott were obtained. The results of HBsAg from the three Analysis Systems were evaluated according to the val- ue of CV（ 15% ）. The clinical aeeeptability of ELISA process systems was determined by the deviation of QC sample. Results No significant difference was found in the correlation, given by the X2 （ P 〉 0. 05 ）, R = 0. 999 〉 0. 975, R2 = 0. 999 〉 0, 95, The expected deviation met the requirement of 15%. Conclusion The HBsAg detected by three ELISA process sys- tems are comparable.