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目的运用六西格玛(σ)理论评估实验室乙肝病毒核酸(HBV DNA)检测系统的分析性能,并根据现有性能建立合适的质控方案。方法收集2014年的室内质控数据和参加卫生部临床检验中心的室间质评数据,计算不精密度和偏倚(bias)。允许总误差(TEa)根据文献报道的医学决定水平假定的最低水平1 log IU/ml和合适水平0.5 log IU/ml。根据变异系数(CV)、bias和TEa计算σ值,同时绘制标准化σ性能评价图,并整合质量目标指数(QGI),σ<3为不可接受性能,查找导致性能不佳的主要原因,以判断优先改进精密度或准确度。绘制标准化操作过程图(OPS图),选择合适的质控规则。结果假定TEa为0.5 log IU/ml,HBV DNA高水平、低水平质控的σ值分别为3.79、2.25;假定TEa为1 log IU/ml,则HBV DNA高水平、低水平质控的σ值分别为8.64、5.14。结论实验室目前的HBV DNA检测性能还无法达到TEa为0.5 log IU/ml的水平,需优先改进精密度。假定TEa为1 log IU/ml,则设定13s/22s/R4s,N=2的室内质控方案是合适的。
Objective To evaluate the analytical performance of laboratory HBV DNA detection system using Six Sigma (σ) theory and establish a suitable quality control program based on the existing performance. Methods We collected indoor quality control data from 2014 and laboratory quality assessment data from the Clinical Laboratory Center of the Ministry of Health to calculate the imprecision and bias. The total allowable error (TEa) is assumed to be 1 log IU / ml and 0.5 log IU / ml, respectively, based on the level of medical decision reported in the literature. Calculate the value of σ based on the CV, bias, and TEa, plot the standardized σ performance map, and integrate the QGI, where σ <3 is unacceptable and find the main cause of poor performance to determine Prioritize precision or accuracy. Draw a standardized process map (OPS chart), select the appropriate quality control rules. The results showed that the TEa was 0.5 log IU / ml. The values of high and low HBV DNA control were 3.79 and 2.25, respectively. Assuming TEa was 1 log IU / ml, the value of high and low HBV DNA control sigma Respectively 8.64,5.14. Conclusion The current HBV DNA detection performance in the laboratory still can not reach the level of 0.5 log IU / ml of TEa, and the precision should be prioritized. Assuming TEa is 1 log IU / ml, an indoor QC scheme with 13s / 22s / R4s, N = 2 is suitable.