摘要
目的 对酶联免疫吸附试验（ELISA）室内质控图进行回顾性分析,探讨选择对实验过程变异更敏感的参数作为控制指标对试验过程进行有效控制.方法 ①根据ELISA试剂盒说明书中CO值的确定方式不同将试验数据分为三组：阳性组、阴性组和混合组;②采用统计学方法分析各组内CO和S/CO与S的相关性;③比较分析各组内S,CO和S/CO值的变异情况;④各组内分别以S和S/CO建立质控图并比较其离散趋势.结果 ①阳性组的CO与S、阴性组的S/CO与S、混合组的S/CO与S均在α=0.05水平上显著相关（P＜0.05）;阳性组的S/CO与S、阴性组的CO与S、混合组的CO与S相关性不明显（P＞0.05）.②阳性组S和S/CO各自反应试验过程精密度的能力有显著差异（CVS 23.55%,CVS/CO 10.78%）;阴性组、混合组S和S/CO反应试验过程精密度的能力无明显差异（阴性组：CVS 9.37%,CVS/CO 9.03%;混合组：CVS 15.13%,CVS/CO 15.87%）.③阳性组S和S/CO建立的质控图离散趋势有差异,且离散方向不同;阴性组、混合组S与S/CO建立的质控图离散趋势基本相符.结论 S/CO值作为反应ELISA试验过程变异的控制指标,当CO值来源于阳性对照时对实验过程的有效控制具有局限性.
Objective To investigate for selecting the parameter that could be better response experiment process variation as a control indicator for effective control of the experiment process by retrospectively analyzed （enzyme-linked immunosorbent assay） ELISA internal quality control chart. Method ①According to ELISA kit instructions of the CO value from different sources,the test data was divided into three groups, positive group, negative group and mixed group. ②The correlation a- mong S,CO and S/CO in each group were analyzed by using statistical methods. ③The coefficient of variation of each group S, CO and S/CO value were compared. ④The S/CO and S quality control chart were established within each group, and com-pared discrete trends. Results ①The CO and S of positive group,the S/CO and S of negative group,and the S/CO and S of mixed group were significantly correlated （P〈0. 05） ;the S/CO and S of positive group,the CO and S of negative group,and the CO and S of mixed group were no obvious correlation （P〉 0. 05）. ②The capability of positive group S and S/CO re-flects respectively test precision process had a significant difference （CVs 23.55 %,CVs/co 10.78 %） ;the S and S/CO of neg-ative group, mixed group reflect test precision process capability were no significant difference （negative group：CVs 9. 37%, CVs/co 9.03 % ;mixed group： CVs 15.13%, CVs/co 15.87 % ）. ③The positive group S and S/CO discrete tends of quality con-trol chart were different,and the direction was different discrete; The S and S/CO discrete trends of quality control chart of negative group,mixed group were basically consistent. Conclusion When the CO value was from positive group,the S/CO value as an indicator forreaction ELISA test process variation,had its limitations.
出处
《现代检验医学杂志》
CAS
2013年第5期57-59,共3页
Journal of Modern Laboratory Medicine
关键词
室内质控
S
S
CO
变异能力
差异
internal quality control
S
S/CO
variation capability
differences
