文档介绍：AACC September 2009: Volume 35, Number 9
Higher Standards on the Way for Glucose Meters?
FDA Seeking ISO Revision to Is use meters with greater than about 15% total error (Clin Chem 2001 ;47:209 - 214). “If you want 95 percent of insulin doses to be correct, you need a CV that, s 1 percent or 2 percent, and a bias of 1 or 2, ” said Bruns, professor of pathology at University of Virginia in Charlottesville and director of clinical chemistry and toxicology at University of Virginia Health System, "Now, that, s probably not realistic for glucose meters一it' s more the quality of results that come out of a main lab with good equipment. But we think it is realistic to try and avoid very large errors in insulin dose, and that requires meters that do better than plus or minus 20 percent, and more like 15 percent total error."
在2001年的文件，医学博士詹姆斯博伊德和大卫布伦斯，利用计算机 模拟证明，患者使用总误差大于15%的血糖仪用于计算胰岛素的剂量 可能发生非常大的剂量错误
(Clin Chem 2001;47:209 - 214)。 “如果你 想95%胰岛素剂量是正确的，你需要准确度CV在1 %或2%以内，偏 倚Bios在1 %或2%以内。”美国弗吉尼亚大学病理学教授和弗吉尼 亚健康系统大学临床化学主任和毒理学专家布伦斯说。“现在，这可 能对血糖仪来说不切合实际，因为这些精确的结果应该出自配备良好 设备的中心实验室。但我们认为尽量避免在胰岛素的剂量非常大的错 误是很现实的，这要求血糖仪的准确多要比20%的总误差要好，比如 说能够到达15%以内的总误差。"
Balancing Act
Such criticism of the current standard is not unknown to FDA. Considering recent technological advancements, the agency has recommended that the minimum performance requirement in the ISO document be revised, and if not, “wi