不同生化检测系统结果一致性修正方法的探讨

目的 探讨干、湿化学法两种生化分析系统检测结果的比对和修正方法, 使不同分析系统检测结果具有可比性。 方法 比对方法学参照EP9-A2文件, 并对数据进行偏倚分析, 计算修正参数, 重新设置实验检测系统后再做简单比对, 验证修正方案的可行性。 结果 10个比对项目中, 4个项目的结果比对偏倚超出规定误差范围, 以回归分析所获得的修正参数对干化学检测数据进行调整后, 新获得数据与对比仪器原始数据结果再次比对, 偏差落在规定误差范围内;以此修正系数进行仪器设定后进行简单比对, 结果可接受。 结论 不同原理检测系统参照本方案进行修正后, 仪器间的检测结果获得了可比性, 有利于临床工作中同一项目急诊(多为干化学法)与非急诊(多为湿化学法)检测结果之间变化的直接观察和分析。

Adjusting method for data obtained from different biochemical analyzers

Objective To evaluate and eliminate the potential bias between data obtained from dry and liquid biochemical assays, making data obtained by different assays matchable. Methods Bias estimation was performed based on document EP9-A2. Simple data comparison and methodology validation were performed after the experiment methods were modified with the estimated correction factors and interception. All the collected data were analyzed by EXCEL2007 software. Results The predicted bias of 4 of the 10 compared items exceeded their corresponding acceptable bias. After being adjusted by the coefficient and interception obtained from linear regression analysis, the four bias was improved and was within the acceptable range. The results of simple data comparison further confirmed this comparability. Conclusion Based on EP9-A2, we have established a protocol to obtain a consistency of data from different biochemical analyzers, which makes it possible that the detection results of the same patient from different detection systems can be used directly. The protocol has been approved by the experts during the medicinal laboratory accreditation of ISO15189.