US20090093445A1 - Release reagent for vitamin d compounds - Google Patents

Release reagent for vitamin d compounds Download PDF

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Publication number
US20090093445A1
US20090093445A1 US12/053,655 US5365508A US2009093445A1 US 20090093445 A1 US20090093445 A1 US 20090093445A1 US 5365508 A US5365508 A US 5365508A US 2009093445 A1 US2009093445 A1 US 2009093445A1
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United States
Prior art keywords
vitamin
hydroxyvitamin
reagent
compound
reagent composition
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Abandoned
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US12/053,655
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English (en)
Inventor
Apostolos Kyriatsoulis
Susanne Feldmann
Eramus Huber
Nicole Horn
Leopold von Proff
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Roche Diagnostics Operations Inc
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Individual
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35427234&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20090093445(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Assigned to ROCHE DIAGNOSTICS GMBH reassignment ROCHE DIAGNOSTICS GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KOBOLD, UWE, PUHLMANN, ANGELA, VON PROFF, LEOPOLD, HUBER, ERAMUS, HORN, NICOLE, FELDMANN, SUSANNE, KYRIATSOULIS, APOSTOLOS
Assigned to ROCHE DIAGNOSTICS OPERATIONS, INC. reassignment ROCHE DIAGNOSTICS OPERATIONS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ROCHE DIAGNOSTICS GMBH
Publication of US20090093445A1 publication Critical patent/US20090093445A1/en
Assigned to ROCHE DIAGNOSTICS OPERATIONS, INC. reassignment ROCHE DIAGNOSTICS OPERATIONS, INC. CORRECTIVE ASSIGNMENT TO CORRECT THE SERIAL NUMBER 12/056655 PREVIOUSLY RECORDED ON REEL 021937 FRAME 0542. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: ROCHE DIAGNOSTICS GMBH
Priority to US14/575,423 priority Critical patent/US9341552B2/en
Abandoned legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/34—Purifying; Cleaning
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/44—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • 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
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • 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
    • G01N33/82—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving vitamins or their receptors
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Definitions

  • vitamin D An adequate supply of vitamin D is vital as the term “vitamin” already suggests.
  • a deficiency of vitamin D leads to severe diseases such as rickets or osteoporosis.
  • vitamin D was still regarded as a single substance at the beginning of the last century, the vitamin D system has changed in the course of the last three decades into a complex and manifold network of vitamin D metabolites.
  • more than 40 different vitamin D metabolic products are known (Zerwekh, J. E., Ann. Clin. Biochem. 41 (2004) 272-281).
  • ⁇ DMSO combined liquid chromatography and mass spectroscopy
  • IA immunoassay
  • FIG. 3 Method comparison: Immunoassay ( ⁇ DMSO) and LC-MS-MS. 25-Hydroxyvitamin D was determined by means of LC-MS-MS as well as by means of IA, where buffer without DMSO was used for the incubation in the IA. 31 Samples from persons of African descent were used as samples. The results in ng/ml for a total of 78 samples arc plotted on the X axis for the LC-MS-MS and on the Y axis for the IA.
  • FIG. 7 Method comparison: Immunoassay (+N-MP) and LC-MS-MS.
  • 81 samples from persons of African descent were used as the samples.
  • the results in ng/ml for a total of 135 samples are plotted on the X axis for the LC-MS-MS and on the Y axis for the IA.
  • mixtures of several of the amphiphilic reagents specified above, e.g., consisting of several liquid amides, can be present in a reagent composition according to the invention.
  • Short-chain alcohols within the sense of the present invention are methanol, ethanol, propanol and isopropanol. Ethanol has especially proven to be suitable as the short-chain alcohol, and it is therefore more preferred.
  • vitamin D With the exception of vitamin D itself, other known compounds from vitamin D metabolism bind to the vitamin D-binding protein.
  • the gene coding for the vitamin D-binding protein occurs in the human population in the form of different alleles. It is known that the polypeptides coded by these alleles differ biochemically, i.e., they lead to different phenotypes. These biochemical differences also influence the binding and release of vitamin D compounds.
  • the reagent composition according to the invention is suitable for releasing vitamin D compounds independently of the phenotype of the vitamin D-binding protein.
  • a preferred embodiment of the present invention is the use of a reagent composition according to the invention to release vitamin D compounds from vitamin D-binding protein or, as explained above, to release vitamin D compounds from complexes of vitamin D-binding protein and vitamin D compound.
  • the reagent composition according to the invention is mixed with the sample (preferably serum or plasma).
  • the mixing ratio of release reagent to sample is preferably between 10:1 and 1:10.
  • 1,25-Dihydroxyvitamin D refers to the active forms of vitamin D (the so-called D hormones) that have a hydroxylation at position 1 as well as at position 25 of the structural Formulas I and II.
  • 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 are particularly relevant forms of vitamin D for diagnostics.
  • the detection of 25-hydroxyvitamin D 2 and/or 25-hydroxyvitamin D 3 is preferred.
  • EAH SEPHAROSE (Amersham Biosciences, No.17-0569-03) was washed with 200 ml 0.5 M sodium chloride solution on a G3 glass frit and equilibrated with 200 ml 0.03 M potassium phosphate buffer pH 7.1. After excess liquid has drained off through the frit, the suspension was taken up in 200 ml of the same buffer, and 1.7 mg (2.3 ⁇ mol) N-hydroxysuccinimide ester in 10 ml DMSO was added. The reaction mixture was agitated overnight at room temperature on a shaker.
  • Absolute values from the immunological test were determined in this example as well as in the previous example based on preliminary reference values and thus have no informative value.
  • a reference standardization to determine reliable absolute values by means of LC-MS-MS still has to be carried out.
  • the relative values show the significant test improvements achieved with reagent compositions according to the invention.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Steroid Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
US12/053,655 2005-09-29 2008-03-24 Release reagent for vitamin d compounds Abandoned US20090093445A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/575,423 US9341552B2 (en) 2005-09-29 2014-12-18 Release reagent for vitamin D compounds

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP05021246.3 2005-09-29
EP05021246 2005-09-29
PCT/EP2006/009361 WO2007039194A1 (en) 2005-09-29 2006-09-27 Release reagent for vitamin d compounds

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/009361 Continuation WO2007039194A1 (en) 2005-09-29 2006-09-27 Release reagent for vitamin d compounds

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/575,423 Division US9341552B2 (en) 2005-09-29 2014-12-18 Release reagent for vitamin D compounds

Publications (1)

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US20090093445A1 true US20090093445A1 (en) 2009-04-09

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US12/053,655 Abandoned US20090093445A1 (en) 2005-09-29 2008-03-24 Release reagent for vitamin d compounds
US14/575,423 Expired - Fee Related US9341552B2 (en) 2005-09-29 2014-12-18 Release reagent for vitamin D compounds

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Country Status (10)

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US (2) US20090093445A1 (da)
EP (1) EP1931999B1 (da)
JP (1) JP4852614B2 (da)
CN (1) CN101273272B (da)
AT (1) ATE530915T1 (da)
CA (1) CA2624129C (da)
DK (1) DK1931999T3 (da)
ES (1) ES2374942T3 (da)
PL (1) PL1931999T3 (da)
WO (1) WO2007039194A1 (da)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014083427A3 (en) * 2012-11-30 2014-07-24 Siemens Healthcare Diagnostics Inc. Compositions and methods for detecting vitamin d
US20160018390A1 (en) * 2013-03-14 2016-01-21 Enzo Life Science, Inc. Vitamin d assays
US9863963B2 (en) 2013-03-21 2018-01-09 Orgentec Diagnostika Gmbh Method and reagent for determining vitamin D metabolites
US10571479B2 (en) 2013-02-06 2020-02-25 Fujirebio Inc. Vitamin D measurement method and measurement kit
US11435367B2 (en) 2016-07-29 2022-09-06 Diazyme Laboratories, Inc. Methods and kits for assaying a vitamin D moiety
CN115774111A (zh) * 2022-12-20 2023-03-10 江苏拜明生物技术有限公司 一种25-羟基维生素d的检测方法及试剂盒
CN119716094A (zh) * 2024-12-25 2025-03-28 珠海丽珠试剂股份有限公司 一种用于25-羟基维生素d检测的磁珠稀释液和试剂盒

Families Citing this family (24)

* Cited by examiner, † Cited by third party
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ATE452343T1 (de) * 2006-06-06 2010-01-15 Hoffmann La Roche Verbesserte vitamin-d-messung
GB0709322D0 (en) * 2007-05-15 2007-06-20 Nordic Bioscience As Exposure agent for detection of vitamin d
US20110097733A1 (en) 2009-10-27 2011-04-28 Michel Anciaux Process for the production of a hybridoma and antibody obtained therefrom, able to recognize more than one vitamin d metabolite
EP2572204B1 (en) 2010-05-20 2017-12-27 Roche Diagnostics GmbH Release reagent for vitamin d compounds
CA2821415C (en) * 2010-12-28 2017-08-01 Future Diagnostics B.V. Release reagent for vitamin d
US9052308B2 (en) 2011-01-07 2015-06-09 The General Hospital Corporation Assays and methods of treatment relating to vitamin D insufficiency
WO2014179737A2 (en) 2013-05-03 2014-11-06 The General Hospital Corporation Assays and methods of treatment relating to vitamin d insufficiency
JP5918784B2 (ja) * 2011-01-07 2016-05-18 ザ ジェネラル ホスピタル コーポレイション ビタミンｄ欠乏症に関連するアッセイおよび治療方法
TW201250248A (en) * 2011-04-25 2012-12-16 Kyowa Medex Co Ltd Prognostication method of renal failure
US8785603B2 (en) 2011-05-20 2014-07-22 Siemens Healthcare Diagnostics Inc. Antibodies to 25-hydroxyvitamin D2 and D3 and uses thereof
EP3467510B1 (en) 2011-11-18 2022-10-26 F. Hoffmann-La Roche AG Release reagent for vitamin d compounds
CN103163306B (zh) * 2013-02-05 2015-06-17 北京九强生物技术股份有限公司 25羟维生素d检测试剂盒及其制备方法
WO2014122974A1 (ja) * 2013-02-06 2014-08-14 富士レビオ株式会社 カオトロピック剤を利用するビタミンｄの測定方法
US9618523B2 (en) 2013-02-28 2017-04-11 Siemens Healthcare Diagnostics Inc. Methods and reagents for determining isomeric analytes
CN105556313B (zh) 2013-09-17 2018-08-24 生物梅里埃公司 用于从维生素d结合蛋白解离维生素d的溶液、相关的检测方法及用途
KR102425339B1 (ko) * 2014-12-08 2022-07-25 에프. 호프만-라 로슈 아게 비타민 d 의 측정을 위한 방법
WO2017039574A1 (en) * 2015-08-28 2017-03-09 Enzo Life Sciences, Inc. Vitamin d assays
JP2019507890A (ja) 2016-01-22 2019-03-22 アフィメディックス， インコーポレイテッド ビタミンｄ代謝産物の検出のためのデバイス
ES2942490T3 (es) * 2017-05-11 2023-06-01 Boditechmed Inc Procedimiento para el ensayo de cuantificación rápida de la vitamina D basado en la medición de fluorescencia utilizando un cartucho de flujo lateral
KR102042609B1 (ko) * 2017-05-11 2019-11-08 바디텍메드(주) 측방유동 카트리지에서 형광측정법을 이용한 비타민 d의 신속 정량 검사법
CN108089015B (zh) * 2017-12-18 2020-07-24 郑州安图生物工程股份有限公司 用于检测人血清样品中25羟基维生素d含量的释放剂及其检测方法
CN110058028B (zh) * 2019-05-05 2021-03-02 苏州长光华医生物医学工程有限公司 一种24,25-双羟基维生素d免疫检测试剂盒及其应用
CN113495159A (zh) * 2020-03-20 2021-10-12 郑州达诺生物技术有限公司 一种系统反应液、一种25羟基维生素d定量检测试剂盒及其使用方法
CN113884687B (zh) * 2021-12-08 2022-02-11 南京岚轩生物科技有限公司 用于检测25-羟基维生素d含量的解离剂及其制备方法

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US5714586A (en) * 1995-06-07 1998-02-03 American Cyanamid Company Methods for the preparation of monomeric calicheamicin derivative/carrier conjugates

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104937422B (zh) * 2012-11-30 2017-06-20 西门子医疗保健诊断公司 用于检测维生素d的组合物和方法
CN104937422A (zh) * 2012-11-30 2015-09-23 西门子医疗保健诊断公司 用于检测维生素d的组合物和方法
WO2014083427A3 (en) * 2012-11-30 2014-07-24 Siemens Healthcare Diagnostics Inc. Compositions and methods for detecting vitamin d
US9244083B2 (en) 2012-11-30 2016-01-26 Siemens Healthcare Diagnostics Inc. Compositions and methods for detecting vitamin D
US10203344B2 (en) 2012-11-30 2019-02-12 Siemens Healthcare Diagnostics Inc. Compositions and methods for detecting vitamin D
US10571479B2 (en) 2013-02-06 2020-02-25 Fujirebio Inc. Vitamin D measurement method and measurement kit
US10197581B2 (en) 2013-03-14 2019-02-05 Enzo Life Sciences, Inc. Vitamin D assays
US9476873B2 (en) * 2013-03-14 2016-10-25 Enzo Life Sciences, Inc. Vitamin D assays
US20160018390A1 (en) * 2013-03-14 2016-01-21 Enzo Life Science, Inc. Vitamin d assays
US9863963B2 (en) 2013-03-21 2018-01-09 Orgentec Diagnostika Gmbh Method and reagent for determining vitamin D metabolites
US11435367B2 (en) 2016-07-29 2022-09-06 Diazyme Laboratories, Inc. Methods and kits for assaying a vitamin D moiety
CN115774111A (zh) * 2022-12-20 2023-03-10 江苏拜明生物技术有限公司 一种25-羟基维生素d的检测方法及试剂盒
CN119716094A (zh) * 2024-12-25 2025-03-28 珠海丽珠试剂股份有限公司 一种用于25-羟基维生素d检测的磁珠稀释液和试剂盒

Also Published As

Publication number Publication date
EP1931999A1 (en) 2008-06-18
DK1931999T3 (da) 2012-01-30
US9341552B2 (en) 2016-05-17
CA2624129A1 (en) 2007-04-12
EP1931999B1 (en) 2011-10-26
CN101273272A (zh) 2008-09-24
JP2009510415A (ja) 2009-03-12
ES2374942T3 (es) 2012-02-23
ATE530915T1 (de) 2011-11-15
HK1124919A1 (en) 2009-07-24
CA2624129C (en) 2011-03-29
CN101273272B (zh) 2012-11-07
WO2007039194A1 (en) 2007-04-12
US20150104876A1 (en) 2015-04-16
PL1931999T3 (pl) 2012-03-30
JP4852614B2 (ja) 2012-01-11

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Owner name: ROCHE DIAGNOSTICS OPERATIONS, INC., INDIANA

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