Internal Medicine and Endocrinology, Worcester, Massachusetts, USA.
Diabetes Technol Ther. 2011 Jan;13(1):1-10. doi: 10.1089/dia.2010.0116. Epub 2010 Dec 13.
a new strip, designed to enhance the ease of use and minimize interference of non-glucose sugars, has been developed to replace the current FreeStyle (Abbott Diabetes Care, Alameda, CA) blood glucose test strip. We evaluated the performance of this new strip.
laboratory evaluation included precision, linearity, dynamic range, effects of operating temperature, humidity, altitude, hematocrit, interferents, and blood reapplication. System accuracy, lay user performance, and ease of use for finger capillary blood testing and accuracy for venous blood testing were evaluated at clinics. Lay users also compared the speed and ease of use between the new strip and the current FreeStyle strip.
for glucose concentrations <75 mg/dL, 73%, 100%, and 100% of the individual capillary blood glucose results obtained by lay users fell within ± 5, 10, and 15 mg/dL, respectively, of the reference. For glucose concentrations ≥75 mg/dL, 68%, 95%, 99%, and 99% of the lay user results fell within ± 5%, 10%, 15%, and 20%, respectively, of the reference. Comparable accuracy was obtained in the venous blood study. Lay users found the new test strip easy to use and faster and easier to use than the current FreeStyle strip. The new strip maintained accuracy under various challenging conditions, including high concentrations of various interferents, sample reapplication up to 60 s, and extremes in hematocrit, altitude, and operating temperature and humidity.
our results demonstrated excellent accuracy of the new FreeStyle test strip and validated the improvements in minimizing interference and enhancing ease of use.
为了提高易用性并最大限度减少非葡萄糖糖的干扰，开发了一种新的试纸条来替代现有的 FreeStyle（Abbott Diabetes Care，加利福尼亚州阿拉米达）血糖测试条。我们评估了这种新试纸条的性能。
实验室评估包括精密度、线性、动态范围、操作温度、湿度、海拔、红细胞压积、干扰物和血液重应用的影响。在诊所评估了系统准确性、非专业用户性能、手指毛细血管血检测的易用性以及静脉血检测的准确性。非专业用户还比较了新试纸条和现有的 FreeStyle 试纸条的速度和易用性。
对于血糖浓度<75mg/dL，非专业用户获得的 73%、100%和 100%的个体毛细血管血糖结果分别有 68%、95%和 99%落在参考值的±5、10 和 15mg/dL 以内。对于血糖浓度≥75mg/dL，非专业用户获得的 68%、95%、99%和 99%的结果分别有 68%、95%、99%和 99%落在参考值的±5%、10%、15%和 20%以内。静脉血研究中也获得了类似的准确性。非专业用户发现新的测试条易于使用，并且比现有的 FreeStyle 测试条更快、更容易使用。新的试纸条在各种具有挑战性的条件下保持准确性，包括各种干扰物的高浓度、样本重应用长达 60 秒以及红细胞压积、海拔和操作温度和湿度的极端情况。
我们的结果表明新的 FreeStyle 测试条具有出色的准确性，并验证了最小化干扰和提高易用性的改进。
