酶免检测系统检测HBsAg的比对分析

发布时间：2018-04-09 17:16

本文选题：NCCLS-EP-A　切入点：HBsAg　出处：《中国输血杂志》2016年02期

【摘要】：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R0.975,R20.95,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。
[Abstract]:Objective to compare and evaluate the methodology and deviation of enzyme immunoassay system (Elisa), and to explore the comparability of the results of detecting HBs Ag in blood donors.Methods referring to the EP9-A2 document of NCCLS, the double repeated determination of HBs Ag was performed with 40 fresh plasma samples of blood donors, using a manual plate washing machine enzyme marker as a reference method and RSP150 FAME24 / 20 EVO200 FAME24/30 as the experimental method.The differences of test results of different systems were compared by chi-square test, the correlation coefficient, linear regression equation and expected deviation were calculated, and the reliability of HBs Ag quality control results was judged by CV15%.Results there was no significant difference among different detection systems. The correlation coefficient of each detection system was R 0.975N R 20.95, and the expected deviation CV of quality control test results of HBs Ag was within 15%.Conclusion the determination of HBs Ag by RSP150 FAME24 / 20 EVO200 FAME24/30 is comparable.
【作者单位】：衡阳市中心血站检验科;
【分类号】：R446.6

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