用西格玛性能验证图评价中国血糖检测项目

Application of sigma performance verification for blood glucose test in China

目的探讨用西格玛性能验证图评价全国血糖检测项目。方法将参加实验室的室内质控在控变异系数作为不精密度的估计值,用实验室正确度验证计划中检测结果的平均值与参考方法得到的靶值之间的百分差值作为实验室检测的偏倚估计值,用国家标准GB/T 20470-2006和卫生行业标准WS/T 403-2012中血糖项目的允许总误差(10%、7%)作为质量规范,计算所有参加实验室的西格玛(σ)值,并绘制西格玛性能验证图。结果当使用国家标准作为允许总误差时,σ值的中位数(四分位数间距)为4.92(3.93);西格玛性能验证图中位于左下区域也就是σ≥6(世界一流水平)的实验室数量较多,为52家(38.2%),检测性能可接受(σ≥3)的实验室数量为109家(80.1%)。当用卫生行业标准作为允许总误差时,σ值的中位数(四分位数间距)为3.04(2.89),西格玛性能验证图中位于右上区域也就是σ<2(不可接受)的实验室数量较多,为44家(32.4%),检测性能可接受(σ≥3)的实验室数量为70家(51.5%)。结论西格玛性能验证图可直观地展示多个实验室的检测性能水平。

Objective To evaluate blood glucose test in China by using sigma performance verification. Methods The coefficient of variability in internal quality control of participant laboratories was regarded as the estimated value of imprecision. The percentage difference between mean in accuracy verification scheme and target value of refernce method was used as the estimated bias. The total allowable errors of blood glucose test in national standard GB / T 20470-2006（ 10%） and health professional standard WS / T 403-2012（ 7%） were adopted as the quality specification when the sigma（ σ） values of all participants were calculated. Sigma performance verification diagrams were plotted using professional software. Results When the national standard was used as the total allowable error,the median（ interquartile range） of σ value was 4. 92（ 3. 93）. In 52 laboratories（ 38. 25%） the medium located in the left bottom area of sigma performance verification diagram indicating σ value greater than or equal to 6（ world class level）,and the amount of laboratories with acceptable performance（ σ≥3） was 109（ 80. 1%）. When the health professional standard was used as the total allowable error,the median（ interquartile range） of σ value was 3. 04（ 2. 89）. In 44 laboratories（ 32. 4%） the medium located in the right top area of sigma performance verification diagram indicating σ 〈2（ unacceptable）,while the amount of laboratories with acceptable performance（ σ≥3） was 70（ 51. 5%）. Conclusion Sigma performance verification may intuitively show the level of test performance in multiple laboratories.