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常温での保存・輸送が可能な蛍光LAMP用試薬の開発について

2019年05月13日

国立大学法人 長崎大学 (以下、長崎大学) とキヤノンメディカルシステムズ株式会社(本社:栃木県大田原市 社長:瀧口登志夫 以下、キヤノンメディカル)は、国立研究開発法人 日本医療研究開発機構(以下、AMED)の「新興・再興感染症に対する革新的医薬品等開発推進研究事業」(研究開発代表者:安田二朗(長崎大学 感染症共同研究拠点))において、常温での保存や輸送が可能な蛍光LAMP用(注1)常温保存試薬を開発しました。

長崎大学とキヤノンメディカルが2015年に共同開発したエボラ出血熱ウイルス検出試薬は、その迅速性と簡便性が高く評価されてきました(注2)が、試薬の運搬は冷凍で行うことから、常温での輸送・保管ができる試薬が求められてきました。
そこで長崎大学とキヤノンメディカルは、エボラ出血熱ウイルス専用の常温保存試薬(注3)の製造法の開発、品質の検証を進め、本年3月に3ヶ月保存の検証が終了しました。

昨年9月、長崎大学感染症共同研究拠点の安田教授が内閣官房のミッションでコンゴ民主共和国に派遣された際に、本試薬の試作品を持参し、エボラウイルス実検体を用いたテストを行い、期待する成果が得られました。
安田教授は「世界でアウトブレイクが発生した際、本試薬は活用可能と思われ、当該成果は今後海外の感染症対策支援などに大いに役立つ」と述べています。これにより実用に際しての大きな課題であった冷凍輸送問題が解決します。

本成果に加え、使用現場でプライマー等を添加し検査に使用する汎用プラットフォーム試薬(注4)を開発し、3ヶ月保存の検証が終了しました。3年目となるAMEDの同研究において最終年度である今年度の研究では、逆転写酵素を含むRNA用汎用プラットフォーム試薬の開発・検証を行い、長崎大学やブラジルのFederal University of Pernambuco Laboratory of Immunopathology Keizo Asami (UFPE/LIKA) などの研究機関にサンプル品の提供、評価を進め、年度内の上市を目指します。さらに、熱帯地域等での活用を目指し、高温環境下での保存試験を進めていく計画です。長崎大学とキヤノンメディカルは、引き続き共同開発を進めることで研究成果の実用化、普及を推進します。

詳しくは以下のWEBを併せてご覧ください。
https://jp.medical.canon/products/dnachip

注1:当社の等温増幅蛍光測定装置GenelyzerFシリーズ、及び蛍光LAMP試薬により、迅速・簡便に遺伝子検出が可能です。

注2:長崎大学とキヤノンメディカルは、2015年に判定時間が約11.2分と従来システムに比べて1/6程度に短縮でき
る「エボラ出血熱迅速検査システム」を実用化し、ギニア政府に供与しました。

概要は、西アフリカ諸国におけるエボラ出血熱流行に対する我が国の支援(ギニアへのエボラ迅速検査キット供与)(外務省) https://www.mofa.go.jp/mofaj/press/release/press3_000088.html をご覧ください。
(株式会社東芝で行っていた関連事業は、2015年12月1日付けで当社分子検査ソリューション事業へ、吸収分割により承継致しました。)

注3:専用プライマー、逆転写酵素などの試薬を全て含んでおり、検体から抽出された核酸を添加するだけで検査を実現するもの。25℃で保存可能。

注4:ユーザーが、検体、プライマー、逆転写酵素などを添加して使用する常温試薬

 

◎本資料に関するお問い合わせ

国立大学法人 長崎大学 広報戦略本部 
TEL:095-819-2007
E-mail:kouhou@ml.nagasaki-u.ac.jp

キヤノンメディカルシステムズ株式会社   
広報室  江野        
TEL:0287-26-5100
E-mail:hiroko.eno@medical.canon

 
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