WO2014112318A1 - 検体中のヘモグロビンA1cの免疫測定方法 - Google Patents
検体中のヘモグロビンA1cの免疫測定方法 Download PDFInfo
- Publication number
- WO2014112318A1 WO2014112318A1 PCT/JP2013/084905 JP2013084905W WO2014112318A1 WO 2014112318 A1 WO2014112318 A1 WO 2014112318A1 JP 2013084905 W JP2013084905 W JP 2013084905W WO 2014112318 A1 WO2014112318 A1 WO 2014112318A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- hba1c
- hemoglobin
- whole blood
- sample
- antibody
- Prior art date
Links
Images
Classifications
-
- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
-
- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
-
- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54393—Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
-
- 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
- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
- G01N33/721—Haemoglobin
-
- 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
- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
- G01N33/721—Haemoglobin
- G01N33/723—Glycosylated haemoglobin
Definitions
- the present invention relates to an immunoassay method for hemoglobin A1c in a specimen.
- Hemoglobin A1c is a glycation in which the ⁇ -amino group of the ⁇ -chain N-terminal valine is glycosylated non-enzymatically in hemoglobin (Hb) with a heterotetramer structure consisting of two ⁇ -chains and two ⁇ -chains. Hemoglobin.
- This blood level of HbA1c reflects the relatively long-term glycemic control state of diabetes. Therefore, measuring HbA1c is extremely useful clinically for knowing the glycemic control state, and HbA1c has been measured for monitoring the therapeutic effect of diabetes.
- HbA1c 6.1% or higher JDS level
- Non-patent Document 1 JDS level
- JDS value JDS value
- NGSP value 6.5% or more
- HbA1c adsorbed on the latex particles is brought into contact with the anti-HbA1c antibody, and HbA1c in the specimen is measured by immunoassay.
- the immunoassay technique itself is well known in this field, and any technique may be used in the method of the present invention.
- the immunoassay methods can be classified based on the reaction format: sandwich method, competitive method, aggregation method, immunochromatography method, Western blot method, etc. If classified by label, radioimmunoassay, fluorescent immunoassay, enzyme immunoassay (EIA) Biotin immunoassay and the like are all included in the “immunoassay” referred to in the present invention, and can be employed in the method of the present invention.
- Standard sample 5 HbA1c standard product reconstituted with 100 ⁇ L of R1 buffer containing 2.5 mg / mL ⁇ globulin.
- Standard sample 6 HbA1c standard product reconstituted with 100 ⁇ L of R1 buffer containing 5 mg / mL ⁇ globulin.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
BES [N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid]
MOPS [3-Morpholinopropanesulfonic acid]
TES [N-Tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid]
HEPES [4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]
DIPSO [3-[N,N-Bis(2-hydroxyethyl)amino]-2-hydroxy-1-propanesulfonic acid]
TAPSO [3-(N-tris[Hydroxymethyl]methylamino)-2-hydroxypropanesulfonic acid]
POPSO [Piperazine-1,4-bis(2-hydroxypropanesulfonic acid)]
HEPPSO [N-(Hydroxyethyl)piperazine-N'-2-hydroxypropanesulfonic acid]
EPPS [3-[4-(2-Hydroxyethyl)-1-piperazinyl]propanesulfonic acid]
Tricine [N-[Tris(hydroxymethyl)methyl]glycine]
Bicine [N,N-Bis(2-hydroxyethyl)glycine]
TAPS [N-Tris(hydroxymethyl)methyl-3-aminopropanesulfonic acid]
機器:島津HPLCシステム
移動相:10%アセトニトリル/0.1%トリフルオロ酢酸から60%アセトニトリル/0.1%トリフルオロ酢酸への直線勾配
流 速:0.8mL/min
時間:25min
モニター:吸光度280nm
移動相:10%アセトニトリル/0.1%トリフルオロ酢酸から60%アセトニトリル/0.1%トリフルオロ酢酸への直線勾配
流 速:5mL/min
モニター:吸光度280nm
前処理が施されていない全血検体の測定系では、ラテックス試薬(ラテックス粒子を含む低浸透圧の緩衝液)中に全血を添加して赤血球の溶血及びヘモグロビンのラテックス表面への吸着を完結させる必要がある。そのため、まず、ラテックスを浮遊させる緩衝液自体に赤血球を溶血させる効果があるかどうかを確認した。
下記のサンプルについて、分光光度計Ubest-V530(JASCO)で吸光度を測定した。
No.1:HbA1c標準品(凍乾品、市販)にR1緩衝液2mLを加えて復元したもの
No.2:全血10μLをR1緩衝液2mLに添加して溶血したもの
No.3:血漿10μLをR1緩衝液2mLに溶解したもの
HbA1c標準品(凍乾品、市販)を用いて以下の2通りの標準試料(HbA1c濃度は0.0%~14.9%)を調製し、日立7170自動分析機を用いてラテックス凝集法による測定を行ない、検量線を作成した(図2)。HbA1c特異抗体として、市販のキットにも用いられている公知の抗HbA1cモノクローナル抗体(特許文献1参照)を用いた。
標準試料1:
HbA1c標準品を検体希釈液1mLで復元し、4.8μLをサンプルとした。
標準試料2:
HbA1c標準品を検体希釈液100μLで復元し、12μLをサンプルとした。
全血検体の血球層から血球を採取して溶血させた希釈サンプルと、前処理を施されていない全血サンプルをダイレクトに免疫測定した場合の反応過程の吸光度変化を図3に示した。
HbA1c標準品(凍乾品、市販)を用いて、以下の4通りの標準試料(HbA1c濃度は0.0%~14.9%)を調製し、2μLをサンプルとして日立7170自動分析機を用いてラテックス凝集法による測定を行ない、検量線を作成した。その検量線を図4に示す。
標準試料3:
HbA1c標準品をR1緩衝液 100μLで復元したもの。
標準試料4:
HbA1c標準品を、γグロブリン1.25mg/mL 含むR1緩衝液 100μLで復元したもの。
標準試料5:
HbA1c標準品を、γグロブリン 2.5mg/mL 含むR1緩衝液 100μLで復元したもの。
標準試料6:
HbA1c標準品をγグロブリン 5mg/mL 含むR1緩衝液 100μLで復元したもの。
Claims (3)
- ラテックス粒子と前処理が施されていない全血検体を低張液中で接触させ、次いで、ラテックス粒子上に吸着したヘモグロビンA1cと抗ヘモグロビンA1c抗体を接触させることを含む、検体中のヘモグロビンA1cの免疫測定方法。
- 前記免疫測定が凝集法により行なわれる請求項1記載の方法。
- 前記低張液が、緩衝能が中性からアルカリ側で最大となるグッドバッファーを0.02~0.2mol/Lの濃度で含む緩衝液である請求項1又は2記載の方法。
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2014557383A JP6172163B2 (ja) | 2013-01-16 | 2013-12-26 | 検体中のヘモグロビンA1cの免疫測定方法 |
EP13871622.0A EP2947458A4 (en) | 2013-01-16 | 2013-12-26 | PROCESS FOR THE IMMUNOLOGICAL DETERMINATION OF HEMOGLOBIN-A1C IN SAMPLES |
CN201380070635.2A CN105122060A (zh) | 2013-01-16 | 2013-12-26 | 样本中的血红蛋白A1c的免疫测定方法 |
US14/655,277 US20150316541A1 (en) | 2013-01-16 | 2013-12-26 | Method for immunologically assaying hemoglobin a1c in specimen |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2013-005130 | 2013-01-16 | ||
JP2013005130 | 2013-01-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2014112318A1 true WO2014112318A1 (ja) | 2014-07-24 |
Family
ID=51209420
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2013/084905 WO2014112318A1 (ja) | 2013-01-16 | 2013-12-26 | 検体中のヘモグロビンA1cの免疫測定方法 |
Country Status (6)
Country | Link |
---|---|
US (1) | US20150316541A1 (ja) |
EP (1) | EP2947458A4 (ja) |
JP (1) | JP6172163B2 (ja) |
CN (1) | CN105122060A (ja) |
TW (1) | TW201441621A (ja) |
WO (1) | WO2014112318A1 (ja) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2019207724A1 (ja) * | 2018-04-26 | 2019-10-31 | 株式会社ニコン | 血液成分分離デバイス、血液成分分離方法、及び血液成分分析方法 |
WO2020067396A1 (ja) * | 2018-09-28 | 2020-04-02 | 積水メディカル株式会社 | 糖化ヘモグロビン(%)の測定方法 |
WO2023145915A1 (ja) * | 2022-01-31 | 2023-08-03 | 積水メディカル株式会社 | 肺サーファクタントプロテインの免疫測定方法及び免疫測定試薬 |
WO2023195347A1 (ja) * | 2022-04-04 | 2023-10-12 | デンカ株式会社 | 抗ヒトヘモグロビンβ鎖モノクローナル抗体又はその抗原結合性断片、ヒトヘモグロビン及び/又は糖化ヒトヘモグロビンを検出する方法、ヒトヘモグロビン及び/又は糖化ヒトヘモグロビンの検出キット、並びに、ペプチド |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP6542671B2 (ja) * | 2013-10-25 | 2019-07-10 | キッコーマン株式会社 | ヘモグロビンA1cの測定方法および測定キット |
CN105891519B (zh) * | 2016-07-01 | 2018-03-30 | 安邦(厦门)生物科技有限公司 | 一种用于测定糖化血红蛋白比例的试剂盒及测定方法 |
CN107490677A (zh) * | 2017-07-21 | 2017-12-19 | 王贤俊 | 一种羧基胶乳微球与糖化血红蛋白抗体的交联组合液及其交联方法 |
KR102443804B1 (ko) * | 2018-01-11 | 2022-09-19 | 도요보 가부시키가이샤 | 측정 시료 희석액, 키트 및 측정 방법 |
EP3917398A1 (en) | 2019-01-31 | 2021-12-08 | Aidian Oy | Sampling and assay kit and method for sampling a biological sample |
US20200284807A1 (en) * | 2019-03-05 | 2020-09-10 | Victor Manneh | Saturation binding ratiometric assay |
CN111057150B (zh) * | 2019-12-30 | 2021-10-29 | 深圳开立生物医疗科技股份有限公司 | 一种乳胶微球及其应用以及糖化血红蛋白检测试剂盒 |
CN114280312B (zh) * | 2020-09-27 | 2023-09-15 | 河北特温特生物科技发展有限公司 | 一种用于免疫荧光层析检测的全血分离膜及其制备方法和应用 |
WO2023147522A1 (en) * | 2022-01-28 | 2023-08-03 | GATC Health Corp | Biomarkers for early detection of diabetes |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0735752A (ja) * | 1993-07-22 | 1995-02-07 | S R L:Kk | 凝集イムノアッセイ法 |
JP2001296292A (ja) * | 2001-03-26 | 2001-10-26 | Horiba Ltd | 免疫測定方法 |
JP2004059477A (ja) * | 2002-07-26 | 2004-02-26 | Fujikura Kasei Co Ltd | 非グリコシル化ヘモグロビン、グリコシル化ヘモグロビンに特異的に結合するモノクローナル抗体、その製造方法、並びにそれを用いた非グリコシル化ヘモグロビン及びグリコシル化ヘモグロビンの測定方法 |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ATE438097T1 (de) * | 2000-08-29 | 2009-08-15 | Kyowa Medex Co Ltd | Gut reproduzierbares agglutinations- immunoassayverfahren und reagenzien |
CN101529230A (zh) * | 2006-10-24 | 2009-09-09 | 皇家飞利浦电子股份有限公司 | 糖化血红蛋白的定量测定 |
US8580097B2 (en) * | 2009-04-27 | 2013-11-12 | Wako Pure Chemical Industries, Ltd. | Isotachophoresis of blood-derived samples |
WO2010147251A1 (ko) * | 2009-06-19 | 2010-12-23 | 주식회사 인포피아 | 당화혈색소 측정 방법 |
CN101915849B (zh) * | 2010-06-30 | 2013-06-05 | 深圳市国赛生物技术有限公司 | 一种方便加样的用于测定糖化血红蛋白百分比的检测试剂 |
-
2013
- 2013-12-26 WO PCT/JP2013/084905 patent/WO2014112318A1/ja active Application Filing
- 2013-12-26 JP JP2014557383A patent/JP6172163B2/ja not_active Expired - Fee Related
- 2013-12-26 CN CN201380070635.2A patent/CN105122060A/zh active Pending
- 2013-12-26 EP EP13871622.0A patent/EP2947458A4/en not_active Withdrawn
- 2013-12-26 US US14/655,277 patent/US20150316541A1/en not_active Abandoned
-
2014
- 2014-01-14 TW TW103101248A patent/TW201441621A/zh unknown
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0735752A (ja) * | 1993-07-22 | 1995-02-07 | S R L:Kk | 凝集イムノアッセイ法 |
JP2677753B2 (ja) | 1993-07-22 | 1997-11-17 | 株式会社エスアールエル | 凝集イムノアッセイ法 |
JP2001296292A (ja) * | 2001-03-26 | 2001-10-26 | Horiba Ltd | 免疫測定方法 |
JP2004059477A (ja) * | 2002-07-26 | 2004-02-26 | Fujikura Kasei Co Ltd | 非グリコシル化ヘモグロビン、グリコシル化ヘモグロビンに特異的に結合するモノクローナル抗体、その製造方法、並びにそれを用いた非グリコシル化ヘモグロビン及びグリコシル化ヘモグロビンの測定方法 |
Non-Patent Citations (2)
Title |
---|
JOURNAL OF THE JAPAN DIABETES SOCIETY, vol. 53, no. 6, 2010, pages 450 |
See also references of EP2947458A4 |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2019207724A1 (ja) * | 2018-04-26 | 2019-10-31 | 株式会社ニコン | 血液成分分離デバイス、血液成分分離方法、及び血液成分分析方法 |
JPWO2019207724A1 (ja) * | 2018-04-26 | 2021-01-14 | 株式会社ニコン | 血液成分分離デバイス、血液成分分離方法、及び血液成分分析方法 |
WO2020067396A1 (ja) * | 2018-09-28 | 2020-04-02 | 積水メディカル株式会社 | 糖化ヘモグロビン(%)の測定方法 |
JP7382071B2 (ja) | 2018-09-28 | 2023-11-16 | 積水メディカル株式会社 | 糖化ヘモグロビン(%)の測定方法 |
WO2023145915A1 (ja) * | 2022-01-31 | 2023-08-03 | 積水メディカル株式会社 | 肺サーファクタントプロテインの免疫測定方法及び免疫測定試薬 |
WO2023195347A1 (ja) * | 2022-04-04 | 2023-10-12 | デンカ株式会社 | 抗ヒトヘモグロビンβ鎖モノクローナル抗体又はその抗原結合性断片、ヒトヘモグロビン及び/又は糖化ヒトヘモグロビンを検出する方法、ヒトヘモグロビン及び/又は糖化ヒトヘモグロビンの検出キット、並びに、ペプチド |
Also Published As
Publication number | Publication date |
---|---|
EP2947458A1 (en) | 2015-11-25 |
TW201441621A (zh) | 2014-11-01 |
EP2947458A4 (en) | 2016-08-10 |
US20150316541A1 (en) | 2015-11-05 |
JP6172163B2 (ja) | 2017-08-02 |
CN105122060A (zh) | 2015-12-02 |
JPWO2014112318A1 (ja) | 2017-01-19 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP6172163B2 (ja) | 検体中のヘモグロビンA1cの免疫測定方法 | |
JP5199067B2 (ja) | 免疫凝集反応試薬キット及び抗原の測定方法 | |
EP3264083B1 (en) | L-fabp immunoassay method | |
EP3859332B1 (en) | Glycated hemoglobin (%) assay method | |
JP2677753B2 (ja) | 凝集イムノアッセイ法 | |
JP2008175814A (ja) | 尿中タンパク質分子の検出・定量による糖尿病性腎症の検査方法及びそれに使用するキット | |
JP6304231B2 (ja) | 未感作ラテックス試薬の劣化防止方法 | |
CN101046479B (zh) | 不含目标蛋白质人血清基体物质的制备方法 | |
EP2717054A1 (en) | Method for inhibiting non-specific reaction in pivka-ii measurement reagent | |
EP3264085A1 (en) | Immunoassay method and assay reagent used in said method | |
JP5191291B2 (ja) | 便検体中ヘモグロビンの測定方法及び測定試薬キット | |
JPH06167495A (ja) | 凝集イムノアッセイ法 | |
JPH049262B2 (ja) | ||
JP5294257B2 (ja) | ヘモグロビンの測定方法および測定用キット | |
JP4796893B2 (ja) | ヘモグロビンA1cの測定方法 | |
WO2024053586A1 (ja) | 遊離ヘモグロビン測定試薬、遊離ヘモグロビン測定方法および抗ヘモグロビン抗体 | |
JP2885092B2 (ja) | C反応性タンパク質の測定法及び測定試薬 | |
JP2001228153A (ja) | 免疫学的測定方法 | |
WO2014177701A1 (en) | Process for diagnosing a human subject with diseases affecting the kidneys, or at risk of acquiring diseases affecting the kidneys | |
KR20230074115A (ko) | 페리틴 측정 시약 | |
JPH0783921A (ja) | 糖化蛋白の測定方法 | |
JPH10227793A (ja) | カルバミル化ヘモグロビンの測定方法 | |
JP2018128394A (ja) | 分離材を用いた測定方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 13871622 Country of ref document: EP Kind code of ref document: A1 |
|
ENP | Entry into the national phase |
Ref document number: 2014557383 Country of ref document: JP Kind code of ref document: A |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2013871622 Country of ref document: EP |
|
WWE | Wipo information: entry into national phase |
Ref document number: 14655277 Country of ref document: US |
|
NENP | Non-entry into the national phase |
Ref country code: DE |