ISSN:
1013-9826
Source:
Scientific.Net: Materials Science & Technology / Trans Tech Publications Archiv 1984-2008
Topics:
Mechanical Engineering, Materials Science, Production Engineering, Mining and Metallurgy, Traffic Engineering, Precision Mechanics
Notes:
To use nanobiosensors as diagnostic devices, they should be evaluated and approved asmedical devices before marketing. This study was performed to establish appropriate evaluationguidelines that provide how to verify the safety and effectiveness of a novel nanobiosensor as amedical device. We prepared an enzymeless glucose sensor with nanoporous platinum electrodeto evaluate performance and stability by comparing it with a commercial enzyme-based glucosesensor. Through these evaluation studies, we developed guidelines, and the guidelines consist offive parts: evaluation of analytical performance, clinical performance, safety, stability, and designand quality control systems. Analytical and clinical performance of nanobiosensors should beevaluated by accuracy, sensitivity, reproducibility, cut-off value, and other specific performancecharacteristics. Also, electric, mechanical, and biological safety should be evaluated. With theperformance and safety, validation of storing conditions and shelf life should be established withevaluation and characterization of nano-structured parts for stability evaluation. Then, design andquality control systems should be evaluated in the aspect of quality requirements, material,manufacturing process, and final product. These guidelines will be helpful for facilitating thecommercialization of the safe, effective, and novel diagnostic nanobiosensors into market place
Type of Medium:
Electronic Resource
URL:
http://www.tib-hannover.de/fulltexts/2011/0528/01/54/transtech_doi~10.4028%252Fwww.scientific.net%252FKEM.342-343.933.pdf
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