JP6517933B2 - 検査システム、検査装置、及び検査方法 - Google Patents
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Description
また、第二試験試料調製103で調製される試験試料は精密なバイオマーカー検出に供試する試料であるため、試験手法適合性の判定基準に基づいて、実施される検査技術に応じた望ましい試料状態が定義される。図2に例示した試料固定手法2004、試料保管温度2005、試験試料サイズ2006等はバイオマーカー検査の結果に大きな影響を与える項目であり、これら検査値に影響する項目の適合性を試料適合基準データベースに格納された指標と比較、判定することが重要である。試験試料間の適合性判定に用いた検査の結果とバイオマーカー検出技術によって定義される試験試料の状態および本システムによって成された適合性判定結果の一部あるいは全体が比較閲覧可能な状態で、判定結果表示部609によって本システム使用者に対して処理継続判断の指標として提示される。
Claims (7)
- 腫瘍組織検体よりがん組織診のために調製された第一試験試料から得られた、がん細胞数、がん細胞割合及びがん進行度のうちの少なくとも何れか一つを含む検査情報を格納するデータベースと、
同一腫瘍組織検体よりバイオマーカー検出のために調製された第二試験試料を単一細胞解析して、がん細胞数、がん細胞割合及びがん進行度のうちの少なくとも何れか一つである特徴量を光学的に抽出する顕微鏡観察部と、
前記特徴量と前記検査情報とを比較して、前記比較結果に基づいて、前記第二試験試料のバイオマーカー遺伝子分析への処理継続か、前記検体からの試料再調製か、の何れを行うかを判定する指標を提示する検査装置と、を備える、
ことを特徴とする検査システム。 - 請求項1に記載の検査システムであって、
前記データベースは、前記第二試験試料に関する試料固定手法、試料保管温度、試験試料サイズのうちの少なくとも何れか一つの試験手法情報の基準値をさらに格納する、ことを特徴とする検査システム。 - 請求項1に記載の検査システムであって、
前記バイオマーカー遺伝子分析への処理には、細胞分離工程と個別DNAライブラリ作成工程とが含まれる、ことを特徴とする検査システム。 - 請求項3に記載の検査システムであって、
前記データベースがさらに回収細胞数、細胞個別化率及び標的細胞率のうちの少なくとも何れか1つの基準値を格納し、
前記検査装置は、前記細胞分離が行われた際に、分離された個別細胞の回収細胞数、細胞個別化率及び標的細胞率のうちの少なくとも何れか1つと、上記基準値との比較に基づいて個別DNAライブラリ作成か、個別細胞の再調製か、の何れを行うかを判定する指標を提示する、ことを特徴とする検査システム。 - 請求項3に記載の検査システムであって、
前記データベースがさらにDNA量、DNA濃度及びDNA断片長のうちの少なくとも何れか一つの基準値を格納し、
前記検査装置は、前記個別DNAライブラリ作成が行われた際に、作成された個別DNAライブラリのDNA量、DNA濃度及びDNA断片長のうちの少なくとも何れか一つと、上記基準値との比較に基づいて遺伝子分析か、検体試料の再調製か、の何れを行うかを判定する指標を提示する、ことを特徴とする検査システム。 - 腫瘍組織検体よりがん組織診のために調製された第一試験試料から得られた、がん細胞数、がん細胞割合及びがん進行度のうちの少なくとも何れか一つを含む検査情報と、
同一腫瘍組織検体よりバイオマーカー検出のために調製された第二試験試料を単一細胞解析して、がん細胞数、がん細胞割合及びがん進行度のうちの少なくとも何れか一つである特徴量と
を比較して、前記比較結果に基づいて、前記第二試験試料のバイオマーカー遺伝子分析への処理継続か、前記検体からの試料再調製か、の何れを行うかを判定する指標を算出する演算部と、
前記指標をユーザに提示する表示部と、を備える、
ことを特徴とする検査装置。 - 腫瘍組織検体よりバイオマーカー検出のために調製された第二試験試料を単一細胞解析して、がん細胞数、がん細胞割合及びがん進行度のうちの少なくとも何れか一つである特徴量を光学的に取得し、
前記特徴量を同一腫瘍組織検体よりがん組織診のために調製された第一試験試料から得られた、がん細胞数、がん細胞割合及びがん進行度のうちの少なくとも何れか一つを含む事前の検査情報と比較し、
前記比較結果に基づいて、前記第二試験試料のバイオマーカー遺伝子分析への処理継続か、前記検体からの試料再調製か、の何れを行うかを判定する、
ことを特徴とする検査方法。
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