Development of a guideline for protein chip evaluation as medical devices

• Published in: Current applied physics pp. 261 - 265
• Main Authors: H.W. Roh, N.R. Lee, Y.H. Cho, J.B. Jung, H.N. Chung, W.S. Yang, W.K. Lee, H.K. Lee, G.H. Ryu
• Format: Journal Article
• Language: Korean
• Published: 한국물리학회 01-08-2006
• Subjects: 물리학
• ISSN: 1567-1739; 1878-1675

Protein chip technology can be applied to diagnosis of disease, prognosis, drug discovery, tailored drug therapy, screening of drugcandidates and so on. A protein chip should be evaluated and approved as a medical device to be used as a diagnostic device beforemarketing. In this study, we prepared a cancer protein chip and evaluated it. From the results of this evaluation study, we developedthe requirements and standards for protein chip evaluation as medical devices to guide how to prepare technical documents and whatestablished with three areas; evaluation of quality control system, analytical, and clinical performance. First, quality control systemshould be evaluated in the aspect of material, manufacturing process, and nal product. In addition, validation of expiration dateand storing condition is needed to conrm the quality control system. Second, evaluation of analytical performance includes the valida-tion of analytical sensitivity, reproducibility, specicity, and eectiveness of signal detecting instruments with related software. Third,and reviewing of diagnostic protein chip submission as medical devices and facilitating the commercialization of protein chips. KCI Citation Count: 2