【摘要】 目的 对9家血站实验室室内质控数据进行统计分析，提出改进ELISA试验室内质控框架构建方法的参考建议，并进行验证。方法 1)收集9家血站室内质控数据，以某国产HBsAg ELISA检测试剂为例进行分析; 2)比较血站1各批次室内质控值是否存在差异; 3)统计分析9家血站室内质控批次使用情况、使用批次数、使用天数、质控次数、各批次均值和变异系数; 4)采用改进的ELISA试验室内质控框架构建方法，构建血站1和血站9各批次室内质控的临时框架和固定框架，并对离群值进行判定。结果 1) ELISA试验各批次室内质控数据有差异(P<0.01)，宜更换质控品和试剂时均更换质控框架。2) 9家血站之间使用的质控品和试剂批号、每批次质控次数、相同批号质控值差异较大，宜由各实验室单独建立室内质控框架。3)改进ELISA试验室内质控框架构建方法为:使用框架平移，即预实验均值和上一批次累积变异系数构建临时框架，如该批次使用时间≥20 d且质控数据≥20点，则累积20d至少20个点后，汇集计算在控数据累积质控均值和标准差构建固定框架。使用该方法构建的临时框架和固定框架，判定血站1和血站9室内质控26个极端离群值均为失控。218个一般离群值，除10个被临时框架判定为正常外，其余均判定为警告和失控，能够有效监控试验稳定性。结论 根据不同规模血站室内质控情况的统计分析结果，结合ELISA试验的特性、试剂质控品批间的不稳定性，建议在更换质控品或试剂批号时重新构建质控图，以框架平移建立临时框架，以累计数据计算固定框架，适用于不同规模血站实验室，能够对ELISA试验过程稳定性进行有效控制。更多还原

【Abstract】 Objective To propose an improved method for constructing the internal quality control( IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example.2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage,number of batches used,days of use,number of QC points,batch-specific means,and coefficients of variation( CV) across all nine centers. 4) Using the improved construction method for IQC framework,provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9,followed by outlier determination.Results 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1( P< 0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously.2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used,the number of QC runs per batch,and the QC values for identical lots. Therefore,individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting,using the pre-experimental mean and cumulative coefficient of variation( CV)from the preceding batch. For batches used >20 days with >20 QC points,permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers,10 were classified as normal by the provisional frames,while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion Based on the statistical analysis of IQC practices across blood centers of varying scales,combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials,it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.更多还原