JPWO2011105474A1 - 急性腎障害の検査方法 - Google Patents
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/34—Genitourinary disorders
- G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
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Abstract
Description
1.尿中ポドカリキシンを検出することを特徴とする、急性腎障害の検査方法。
2.尿中ポドカリキシン値が基準値よりも高い場合に、急性腎障害であると判定される、前項1に記載の検査方法。
3.基準値が、健常人の尿中ポドカリキシン値の95%信頼区間の上限値である、前項3に記載の検査方法。
4.尿中ポドカリキシン値が、尿中成分値で補正されたものである、前項1〜3のいずれか1項に記載の検査方法。
5.尿中成分が尿中クレアチニンである、前項4に記載の検査方法。
6.急性腎障害が、急性尿細管障害によるものである、前項1〜5のいずれか1に記載の検査方法。
7.尿中ポドカリキシンの検出を、免疫学的手法により行う、前項1〜6のいずれか1に記載の検査方法。
8.尿中ポドカリキシンを検出するための抗ポドカリキシン抗体を含む、前項7に記載の検査方法に用いる、急性腎障害検査用試薬。
9.抗ポドカリキシン抗体を用いた尿中ポドカリキシンを検出するための試薬を含む、前項7に記載の検査方法に用いる、急性腎障害検査用試薬キット。
<式> PCX/Cre:尿中ポドカリキシン排泄量(μg/g)=100×尿中ポドカリキシン濃度(ng/mL)÷尿中クレアチニン濃度(mg/dL)
95%信頼区間=健常人尿中ポドカリキシン値の平均±t×健常人尿中ポドカリキシン値の標準偏差
なお、tは自由度であり、健常人の検体数によって変動するため、t分布表に基づき選択すればよい。一般に95%信頼区間の場合tは1.96である。
一方、健常人の尿中ポドカリキシン値が正規分布していない場合は中央値を含んだ95%を占める範囲を基準範囲とし、その上限値を尿中ポドカリキシン値の基準値とする。
ポドカリキシン濃度の測定には、2種類の抗ヒトポドカリキシンモノクローナル抗体を用いた。これらの2種類の抗体は、ヒトポドカリキシンの異なる2つのエピトープを各々認識し、それぞれ抗ヒトポドカリキシンモノクローナル抗体1(以下単に「抗体1」と称する)と、抗ヒトポドカリキシンモノクローナル抗体2(以下単に「抗体2」と称する)である。本実施例では、抗体1固相化マイクロタイタープレート(分割型マイクロプレートGF8高:Nunc社)と、西洋ワサビPeroxidase(以下「HRP」と略す)により標識化した抗体2を用いた。
<式> 尿中ポドカリキシン排泄量(μg/g)=100×尿中ポドカリキシン濃度(ng/mL)÷尿中クレアチニン濃度(mg/dL)
実施例1の方法により、急性腎障害患者10症例の尿中ポドカリキシン濃度を求め、健常人66例のものと比較した。急性腎障害患者10症例について、急性腎障害に至った背景病状を以下の表1に示す。
尿中ポドカリキシン排泄量に関する結果を図2に示す。急性腎障害患者の尿中ポドカリキシン排泄量は、健常人の値より高値であることがわかった(P<0.01)。健常人から得た尿より求めた尿中ポドカリキシン排泄量「PCX/Cre」の95%信頼区間の上限値を基準値とした場合その基準値は161μg/gとなり、急性腎障害患者の80%がこの基準値より高い値を示した。
Claims (9)
- 尿中ポドカリキシンを検出することを特徴とする、急性腎障害の検査方法。
- 尿中ポドカリキシン値が基準値よりも高い場合に、急性腎障害であると判定される、請求項1に記載の検査方法。
- 基準値が、健常人の尿中ポドカリキシン値の95%信頼区間の上限値である、請求項3に記載の検査方法。
- 尿中ポドカリキシン値が、尿中成分値で補正されたものである、請求項1〜3のいずれか1項に記載の検査方法。
- 尿中成分が尿中クレアチニンである、請求項4に記載の検査方法。
- 急性腎障害が、急性尿細管障害によるものである、請求項1〜5のいずれか1に記載の検査方法。
- 尿中ポドカリキシンの検出を、免疫学的手法により行う、請求項1〜6のいずれか1に記載の検査方法。
- 尿中ポドカリキシンを検出するための抗ポドカリキシン抗体を含む、請求項7に記載の検査方法に用いる、急性腎障害検査用試薬。
- 抗ポドカリキシン抗体を用いた尿中ポドカリキシンを検出するための試薬を含む、請求項7に記載の検査方法に用いる、急性腎障害検査用試薬キット。
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JP2010041748 | 2010-02-26 | ||
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PCT/JP2011/054106 WO2011105474A1 (ja) | 2010-02-26 | 2011-02-24 | 急性腎障害の検査方法 |
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US10801066B2 (en) | 2014-09-05 | 2020-10-13 | American University Of Beirut | Determination of risk for development of cardiovascular disease by measuring urinary levels of podocin and nephrin messenger RNA |
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JP2008122410A (ja) * | 2000-10-27 | 2008-05-29 | Masanori Hara | 腎障害の検査方法 |
WO2010143423A1 (ja) * | 2009-06-10 | 2010-12-16 | 国立大学法人 新潟大学 | 糖尿病性腎症の検査方法 |
WO2010143422A1 (ja) * | 2009-06-10 | 2010-12-16 | 国立大学法人 新潟大学 | 腎疾患の検査方法 |
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JP2008122410A (ja) * | 2000-10-27 | 2008-05-29 | Masanori Hara | 腎障害の検査方法 |
WO2010143423A1 (ja) * | 2009-06-10 | 2010-12-16 | 国立大学法人 新潟大学 | 糖尿病性腎症の検査方法 |
WO2010143422A1 (ja) * | 2009-06-10 | 2010-12-16 | 国立大学法人 新潟大学 | 腎疾患の検査方法 |
Non-Patent Citations (2)
Title |
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JPN6015004616; 関根盛: '腎障害の新しいマーカーについて-尿中ポドサイト,ポドカリキシンと臨床病理学的意義-' Therapeutic Research Vol.29/No.11, 20081120, p.1900-1904, ライフサイエンス出版 * |
JPN7015000343; Kidney International Vol.19/No.1, 198101, p.214, International Society of Nephrology * |
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US20120322087A1 (en) | 2012-12-20 |
US8673577B2 (en) | 2014-03-18 |
EP2541253B1 (en) | 2016-10-12 |
EP2541253A4 (en) | 2013-07-10 |
EP2541253A1 (en) | 2013-01-02 |
WO2011105474A1 (ja) | 2011-09-01 |
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