JP2023509681A - 妊娠中毒症診断用バイオマーカー組成物及びその用途 - Google Patents
妊娠中毒症診断用バイオマーカー組成物及びその用途 Download PDFInfo
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Abstract
Description
本発明は、妊娠中毒症診断用バイオマーカー組成物及びその用途に関する。
(b)前記測定されたタンパク質またはその断片の発現レベルを、対照群試料のタンパク質またはその断片の発現レベルと比較する段階と、を含む妊娠中毒症診断のための情報提供方法を提供するのである。
(b)前記測定されたタンパク質またはその断片の発現レベルを、対照群試料のタンパク質またはその断片の発現レベルと比較する段階と、を含むものである妊娠中毒症診断のための情報提供方法を提供する。
(b)前記測定されたタンパク質またはその断片の発現レベルを、対照群試料のタンパク質またはその断片の発現レベルと比較する段階と、を含むものである、妊娠中毒症を診断するための方法を提供する。
患者選定基準は、次の通りである。妊娠中毒症の代表症状である、妊娠20週以後、蛋白尿(≧300mg/day)を伴う高血圧(≧140/90mmHg)症状を示す産婦25名を疾患群として選定し、妊娠全過程において、胎児と産婦とのいずれにも、臨床的特異症状なしに、末期に正常に分娩した産婦29名を正常群として選定した。
バイオマーカー候補の検証は、下記のようになされた。該バイオマーカー候補検証のための候補群のMRMトランジション(transition)を選定した。MRMトランジションの選定は、全てのペプチドにつき、MS基盤の検証データを保有したSRM Atlas(www.srmatlas.org)を利用した。このとき、該選定基準は、次の通りである。
1.メチオニン(M(methionine)及びヒスチジン(H(histidine)含有のペプチド除外
2.誤切断(miscleavage)が含まれたペプチド除外
3.P(protein)前シーケンスが、R(arginine)またはK(lysine)を有するペプチド除外
4.ペプチド長(peptide legnth)5<x<20
1.のような前駆イオン(precursor ion)から派生される3種のフラグメントイオン(fragment ion)が、同一溶出時間を有するか否かということ
2.3回以上の反復実験を介し、同一RT(retention time)を有するか否かということいかん
3.LOQ(limit of quantification)の条件に符合するS/N(signal to noise)>10を満足するか否かということ
Claims (9)
- ANXA3、A2M、APOB、PZP、FETUB、FNl、LCN2、APOM、QSOXl、TGOLN2、FlO、SERPINAll、PRG2、SHBG、TNC、HBD、AGT、CP、HEXB、SERPINA4及びVWFからなる群のうちから選択された1以上のタンパク質またはその断片の発現レベルを測定する製剤を含む、妊娠中毒症診断用組成物。
- 前記タンパク質またはその断片のレベルを測定する製剤は、タンパク質またはその断片に特異的に結合する抗体またはその抗原結合断片である、請求項1に記載の妊娠中毒症診断用組成物。
- 前記妊娠中毒症は、慢性高血圧、妊娠性高血圧、前子癇症、子癇症及び複合子癇前症からなる群のうちから選択された1以上である、請求項1に記載の妊娠中毒症診断用組成物。
- 請求項1に記載の組成物を含む、妊娠中毒症診断用キット。
- 前記キットは、ELISA(enzyme-linked immune sorbent assay)キット、タンパク質チップキット、ラピッド(rapid)キットまたはMRM(multiple reaction monitoring)キットである、請求項4に記載の妊娠中毒症診断用キット。
- (a)個体から分離された生物学的試料において、ANXA3、A2M、APOB、PZP、FETUB、FNl、LCN2、APOM、QSOXl、TGOLN2、FlO、SERPINAll、PRG2、SHBG、TNC、HBD、AGT、CP、HEXB、SERPINA4及びVWFからなる群のうちから選択された1以上のタンパク質またはその断片の発現レベルを測定する段階と、
(b)前記測定されたタンパク質またはその断片の発現レベルを、対照群試料のタンパク質またはその断片の発現レベルと比較する段階と、を含む、妊娠中毒症診断のための情報提供方法。 - 前記(b)段階において、個体から分離された生物学的試料から測定されたANXA3、A2M、APOB、PZP、FETUB、FNl、LCN2、APOM、QSOXl、TGOLN2、FlO、SERPINAll、PRG2、SHBG及びTNCからなる群のうちから選択された1以上のタンパク質またはその断片の発現レベルが、対照群に比べて上昇された場合、妊娠中毒症と判断する段階をさらに含む、請求項6に記載の妊娠中毒症診断のための情報提供方法。
- 前記(b)段階において、個体から分離された生物学的試料から測定されたHBD、AGT、CP、HEXB、SERPINA4及びVWFからなる群のうちから選択された1以上のタンパク質またはその断片の発現レベルが、対照群に比べて低下された場合、妊娠中毒症と判断する段階をさらに含む、請求項6に記載の妊娠中毒症診断のための情報提供方法。
- 前記タンパク質のレベルは、ウェスタンブロット(western blotting)、ELISA(enzyme-linked immuno sorbent assay)、放射線免疫分析(RIA)、放射免疫拡散法(radial immunodiffusion)、オクタロニー免疫拡散法(ouchterlony immunodiffusion)、ロケット免疫電気泳動(rocket immunoelectrophoresis)、免疫組織化学染色法(immunohistochemical staining)、免疫沈澱分析法(immunoprecipitation assay)、補体固定分析法(complement fixation assay)、免疫蛍光法(immunofluorescence)、免疫クロマトグラフィ法(immunochromatography)、FACS分析法(fluorescence activated cell sorter analysis)及びタンパク質チップ分析法(protein chip technology assay)によって構成された群のうちから選択されるいずれか一つを利用して測定される、請求項6に記載の妊娠中毒症診断のための情報提供方法。
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