Krouwer Jan S
Krouwer Consulting, Sherborn, MA, USA
J Diabetes Sci Technol. 2014 Mar;8(2):419-421. doi: 10.1177/1932296813518673. Epub 2014 Feb 5.
Glucose meter performance specifications provide limits for 95% of results, which is the same as total error. A popular total error model is that total error equals (average) bias plus 2 times imprecision. This model has been used to specify combinations of average bias and imprecision that satisfy total error goals. But this model is incomplete and its conclusions are suspect. It is shown that when interferences occur in glucose meters as exemplified by hematocrit interference, the total error model proposed by Boyd and Bruns cannot distinguish between meters that differ in performance. The CLSI standard EP21-A, does not have this problem because it directly estimates total error bypassing the need for a model. An example illustrates these points.
血糖仪性能规范规定了95%的结果的限值，这与总误差相同。一种常用的总误差模型是总误差等于（平均）偏差加上2倍不精密度。该模型已被用于确定满足总误差目标的平均偏差和不精密度的组合。但该模型并不完整，其结论值得怀疑。结果表明，当血糖仪出现干扰（如血细胞比容干扰）时，博伊德和布伦斯提出的总误差模型无法区分性能不同的血糖仪。CLSI标准EP21-A没有这个问题，因为它直接估计总误差，无需模型。一个例子说明了这些要点。
