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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 evaluate the methodological bias and the methodological comparison of enzyme-free detection system, and to explore the comparability of HBsAg test in unpaid blood donors. Methods Reference NCCLS EP9-A2 file to manual plus + plate washer + microplate reader as the reference method, RSP150 + FAME24 / 20, EVO200 + FAME24 / 30 as experimental methods, 40 donors fresh plasma HBs Ag double-replicate determination, the chi-square test was used to compare the differences of the test results of different systems; the correlation coefficient, the linear regression equation and the expected deviation were calculated, and the reliability of the enzyme-free system for detecting HBsAg quality was judged by CV% = 15%. Results There was no significant difference between the two detection systems. The correlation coefficient of each detection system was R> 0.975, R2> 0.95. The detection correlation was good. The expected CV of HBs Ag quality control test was within 15%. Conclusion The results of hand-adding + plate washer + microplate reader, RSP150 + FAME24 / 20 and EVO200 + FAME24 / 30 were comparable.