可视化即刻法质控判断标准的研究

Study on the judicial standards of instant visual technique in quality control

目的 在可视化即刻法用于免疫学实验的室内质控中 ,探讨更加准确有效的判断标准。方法 制作标准Levey Jennings质控图并收集同批次的用可视化即刻法进行质控的数据 ,采用Shapiro Wilk拟合优度检验和方差分析进行比较。结果 用Shapiro Wilk检验后认为累积数据呈正态分布且方差分析无显著性差异时 (P >0 .0 5 ) ,即时累积得到的 x± 2s、 x± 3s值可作为判断标准 ;当累积数据不呈正态分布时 (P <0 .0 5 ) ,即时累积得到的 x± 2s、 x± 3s值仅作为参照标准。结论 Shapiro Wilk进行正态性检验可以强化可视化即刻法质控中即时累积的 x± 2s、 x± 3s值作为判断标准的能力 ,而分析质控结果应联合即刻法离散指数 (SI)界值表和即时累积的质控图进行 。

Objective To explore more accurate and effectual judicial standards during application of instant visual technique in quality control of the immunology experiments. Methods To make standard Levey-Jennings quality control maps and collect quality control data of the same group by instant visual technique, then analyze them by Shapiro-Wilk goodness of fit test and ANOVA. Results If the cumulative data were considered as belonging to Gauss distribution by Shapiro-Wilk test and non-obvious discriminations by ANOVA(P>0.05), ±2s,±3s by instant cumulation can become a judicial standards;if the cumulative data were not considered as belonging to Gauss distribution(P< 0.05), it was only regarded as a relative standards.Conclusions Shapiro-Wilk test can strengthen the ability of judicial standards by ±2s,±3s from instant cumulation in instant visual technique in quality control, and analyzing the results of quality control must combine Separation Index value table with instant cumulative map in order to enlarge accuracy in quality control of the immunology experiments.