JP5871228B2 - 慢性副鼻腔炎の検出方法 - Google Patents
慢性副鼻腔炎の検出方法 Download PDFInfo
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- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5308—Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
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- 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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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
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Description
[1]被験者より採取した血液又は鼻腔分泌液におけるペリオスチンタンパク質濃度を測定することを含む、慢性副鼻腔炎の検出又は診断方法。
[2]測定したタンパク質濃度が、血清中濃度で95ng/mL以上であるときに、慢性副鼻腔炎を発症していると疑われると判断することを含む、上記[1]に記載の方法。
[3]測定したタンパク質濃度が、鼻腔洗浄液中の濃度で0.8 ng/mL以上であるときに、慢性副鼻腔炎を発症していると疑われると判断することを含む、上記[1]に記載の方法。
[4](i)被験者より採取した血液又は鼻腔分泌液におけるペリオスチンタンパク質濃度と、(ii)正常試料におけるペリオスチンタンパク質濃度との比較を行うことを含む、上記[1]に記載の方法。
[5](i)被験者より採取した血液又は鼻腔分泌液におけるペリオスチンタンパク質濃度が(ii)正常試料におけるペリオスチンタンパク質濃度よりも高いときに、慢性副鼻腔炎を発症していると疑われると判断することを含む、上記[1]に記載の方法。
[6]正常試料が、アレルギー性鼻炎患者から採取した血液又は鼻腔分泌液である、上記[4]又は[5]記載の方法。
[7]測定が免疫測定法によるものである、上記[1]〜[6]のいずれか1項に記載の方法。
[8]ペリオスチンを認識する抗体を含有し、血液又は鼻腔分泌液中のペリオスチンタンパク質濃度を測定して慢性副鼻腔炎を検出するために用いられる、慢性副鼻腔炎の検出又は診断薬。
[9]上記[8]に記載の検出薬を含有し、血液又は鼻腔分泌液中のペリオスチンタンパク質濃度を測定して慢性副鼻腔炎を検出するために用いられる、慢性副鼻腔炎の検出又は診断用キット。
[10]採取した鼻腔分泌液の分析方法において、鼻腔分泌液のペリオスチンタンパク質濃度を測定することを含む、鼻腔分泌液の分析方法。
[11]ペリオスチンタンパク質濃度の測定が免疫測定法により行われることを特徴とする上記[10]に記載の鼻腔分泌液の分析方法。
なお、本明細書において引用された全ての刊行物、例えば先行技術文献、及び公開公報、特許公報その他の特許文献は、参照として本明細書に組み込まれる。
ここで、ROC曲線から、「所定タンパク質濃度」としての至適閾値(cut−off値)を求める方法としては、Youden index(感度 + 特異度 −1)を用いる方法が一般的である(Akobeng, AK. et al. Acta Paediatrica 96:644-647, 2007)。この方法では、Youden index(感度 + 特異度 −1)が最大となりうる点が感度及び特異度ともにバランスのとれた値を示す点であることから、この診断成績を示す値をcut-off値とし、「所定タンパク質濃度」として採用することが好ましい。
なお、従来知られる他の診断手法により慢性副鼻腔炎を発症していないと判断される被験者においても、例えば、他のアレルギー疾患などで血液又は鼻腔分泌液中のペリオスチンタンパク質の濃度が上昇する可能性があることから、上記の統計処理において、特に慢性副鼻腔炎を発症していない群について、特異なペリオスチンタンパク質濃度を示す例は統計処理から除外することが望ましい。
この場合において、より好ましくは、慢性副鼻腔炎を発症していると疑われると判断するための基準を提供する手法として、以下のような手法を採用する。先ず、従来知られる他の診断手法により、慢性副鼻腔炎を発症していると判断される複数の被験者と、慢性副鼻腔炎を発症していないと判断される複数の被験者について、それぞれに由来する生体試料(血液又は鼻腔分泌液)におけるペリオスチンタンパク質濃度を測定し、それぞれの被験者群毎に測定されたペリオスチンタンパク質濃度の平均値を求める。そして、慢性副鼻腔炎を発症している被験者における平均値をA、慢性副鼻腔炎を発症していない被験者における平均値をBとしたとき、C=[(A−B)/B]x 100(%)を求める。ここで求められるC値は、慢性副鼻腔炎を発症していないと判断される被験者由来の生体試料に対して慢性副鼻腔炎の患者由来の生体試料において増加するペリオスチンタンパク質濃度の平均値であり、この値を基準として慢性副鼻腔炎の発症の有無を判断することができる。
事前にインフォームド・コンセントを得た被験者より採取した血液における血清中ペリオスチン濃度の分析は、抗ペリオスチン抗体を用いるELISA法により以下のように行った。
本実施例においては、鼻腔分泌液として、特に事前にインフォームド・コンセントを得た被験者より採取した鼻腔洗浄液を用いて、当該鼻腔洗浄液中のペリオスチン濃度を分析した。
Claims (11)
- 被験者より採取した血液又は鼻腔分泌液におけるペリオスチンタンパク質濃度を測定することを含む、慢性副鼻腔炎の検出方法。
- 測定したタンパク質濃度が、血清中濃度で95ng/mL以上であるときに、慢性副鼻腔炎を発症していると疑われると判断することを含む、請求項1に記載の方法。
- 測定したタンパク質濃度が、鼻腔洗浄液中の濃度で0.8 ng/mL以上であるときに、慢性副鼻腔炎を発症していると疑われると判断することを含む、請求項1に記載の方法。
- (i)被験者より採取した血液又は鼻腔分泌液におけるペリオスチンタンパク質濃度と、(ii)正常試料におけるペリオスチンタンパク質濃度との比較を行うことを含む、請求項1に記載の方法。
- (i)被験者より採取した血液又は鼻腔分泌液におけるペリオスチンタンパク質濃度が(ii)正常試料におけるペリオスチンタンパク質濃よりも高いときに、慢性副鼻腔炎を発症していると疑われると判断することを含む、請求項1に記載の方法。
- 正常試料が、アレルギー性鼻炎患者から採取した血液又は鼻腔分泌液である、請求項4又は5記載の方法。
- 測定が免疫測定法によるものである、請求項1〜6のいずれか1項に記載の方法。
- ペリオスチンを認識する抗体を含有し、請求項1〜7のいずれか1項に記載の方法で用いられる、慢性副鼻腔炎の検出薬。
- 請求項8に記載の検出薬を含有し、請求項1〜7のいずれか1項に記載の方法で用いられる、慢性副鼻腔炎の検出用キット。
- ペリオスチンを認識する抗体を含有する、鼻腔分泌液のペリオスチンタンパク質濃度の測定用検出薬。
- 請求項10に記載の検出薬を含有する、鼻腔分泌液のペリオスチンタンパク質濃度の測定用キット。
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