Krouwer Jan S
1 Krouwer Consulting, Sherborn, MA USA.
J Diabetes Sci Technol. 2017 Nov;11(6):1163-1164. doi: 10.1177/1932296817730084. Epub 2017 Sep 14.
The article titled "Seven Year Surveillance of the Clinical Performance of a Blood Glucose Test-Strip Product" by Setford and coworkers in this issue of Journal of Diabetes Science and Technology is an impressive study showing that over 7 years in three clinics, using multiple reagent lots, a total of 73 600 samples met the ISO 15197 2015 standard with no results in the D or E zones of a Parkes glucose meter error grid. Three requirements are suggested for a clinically acceptable glucose meter. The authors provide strong evidence for meeting two requirements but fail to provide summarized data about the number of nonnumeric results. Finally, the authors overstate some results, called "spin" by some which is not necessary. The superb results should stand on their own.
Setford及其同事在本期《糖尿病科学与技术杂志》上发表的题为《血糖试纸产品临床性能的七年监测》的文章是一项令人印象深刻的研究，表明在三家诊所进行的7年多时间里，使用多个试剂批次，共有73600个样本符合ISO 15197 2015标准，在帕克斯血糖仪误差网格的D区或E区没有出现结果。文章提出了临床可接受血糖仪的三个要求。作者为满足其中两个要求提供了有力证据，但未能提供关于非数字结果数量的汇总数据。最后，作者夸大了一些结果，有些人称之为“夸大”，这是没有必要的。卓越的结果应该靠自身站住脚。
