کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10554 | 690 | 2007 | 17 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: In vitro, in vivo and post explantation testing of glucose-detecting biosensors: Current methods and recommendations In vitro, in vivo and post explantation testing of glucose-detecting biosensors: Current methods and recommendations](/preview/png/10554.png)
To date, there have been a number of cases where glucose sensors have performed well over long periods of implantation; however, it remains difficult to predict whether a given sensor will perform reliably, will exhibit gradual degradation of performance, or will fail outright soon after implantation. Typically, the literature emphasizes the sensor that performed well, while only briefly (if at all) mentioning the failed devices. This leaves open the question of whether current sensor designs are adequate for the hostile in vivo environment, and whether these sensors have been assessed by the proper regimen of testing protocols. This paper reviews the current in vitro and in vivo testing procedures used to evaluate the functionality and biocompatibility of implantable glucose sensors. An overview of the standards and regulatory bodies that govern biomaterials and end product device testing precedes a discussion of up-to-date invasive and non-invasive technologies for diabetes management. Analysis of current in vitro, in vivo, and then post explantation testing is presented. Given the underlying assumption that the success of the sensor in vitro foreshadows the long-term reliability of the sensor in the human body, the relative merits of these testing methods are evaluated with respect to how representative they are of human models.
Journal: Biomaterials - Volume 28, Issue 25, September 2007, Pages 3687–3703