成果報告書詳細
管理番号20130000000206
タイトル*平成22年度中間年報 SBIR技術革新事業 ナノ光学デバイス型バイオセンサーによる検査システムの研究開発
公開日2013/6/22
報告書年度2010 - 2010
委託先名株式会社バイオマーカーサイエンス 国立大学法人大阪大学
プロジェクト番号P08015
部署名技術開発推進部
和文要約
英文要約Title: Technology Innovation Program for Small Business Innovation Research (SBIR)/Reserach and development of a diagnostic system utilizing optical nano-biosensor devices (FY2010-FY2011) FY2010 Annual Report

1.Technological trend research:1-1.Patentability research:A patentability research using database of PTAORIS and USPTO revealed that our key patent (application No. 2006-258045) is patentable. It also revealed that applied patents regarding Cys-TTR are seemed to be patentable. 1-2.Literature research:It is revealed that antigen-antibody reaction is still the main stream principle for biochips to detect proteins. Thus, our systems keep taking advantage of this effectively specific reaction. 2.Comparison to other technologies:It is obviously that the system has at least three crucial advantages compared to other established devices; it requires no secondary antibodies for detections but a small amount of antibodies, and allows multiple analyses within a short time period. 3.Basic examination studies:3-1.Comparing the optical nano-biosensor device and ELIZA:Five marker proteins for the kidney diseases were selected. We successfully detected the maker proteins at the concentration of 100 pg/mL - 1 ng/ mL; within (or superior to) the required limit of detection. The LSPR chip showed the wider range of detection than ELIZA method (log 3 > log 1-2). A good correlation between the wavelength shift of LSPR chip and the corresponding OD value of ELISA (e.g. CRP, R=0.94) was shown. 3-2.Optimization of the antibody immobilization conditions:The previously used method of antibody immobilization was confirmed to be appropriate for the antibodies described above. 3-3.Confirmation of the performance:3-3-1.Sensitivity:The detection ranges of each protein were 100 pg -100 ng/mL or 1 ng-100 ng/mL. Furthermore, the volume of the antibody solution was 20 times smaller than that of ELISA method. 3-3-2.Reproducibility:The coefficient of variation (CV) was 17.6 % (CRP, n=3). It is expected that the CV values will be able to be improved by using the automatic dispensing system. 3-3-3.Detection time:The measurement time for an endpoint assay and a rate assay were 30 minutes and 10 minutes, respectively. 3-3-4.Shortening of the measurement time:It is considered that the integration of our device with blood component removal function such as BBX (Nittobo Medical Co., Ltd.) is useful in order to shorten the measurement time. 4.Market research:Yano Research Institute Ltd. performed a market research to find out that there are various potential needs that could be met with our LSPR biosensor system. 5.Business Planning:In R&D period, we are going to produce a prototype. After R&D period, we will improve the system by taking advices from the actual medical sites. Concurrently, we will establish a production process of antibody tips. Our marketing strategy is divided into three sections including sales to national centers, sales to regional hospitals or clinics, and finally, sales to medical check-up institutes after having marketing approval of diagnostic medicine.
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