WO2013071055A1 - Dosage pour autoanticorps associés au diabète - Google Patents

Dosage pour autoanticorps associés au diabète Download PDF

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Publication number
WO2013071055A1
WO2013071055A1 PCT/US2012/064373 US2012064373W WO2013071055A1 WO 2013071055 A1 WO2013071055 A1 WO 2013071055A1 US 2012064373 W US2012064373 W US 2012064373W WO 2013071055 A1 WO2013071055 A1 WO 2013071055A1
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WO
WIPO (PCT)
Prior art keywords
autoantibodies
sample
diabetes
antibody
binding
Prior art date
Application number
PCT/US2012/064373
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English (en)
Inventor
Michael Lenardo
Amy CONNOLLY
Lawrence F. JEROME
Bernice LO
Kimberly SHAFER-WEAVER
Austin SWAFFORD
Original Assignee
Wellstat Diagnostics, Llc
The Government Of The Usa, As Represented By The Secretary, Department Of Health And Human Services Office Of Technology Transfer
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Wellstat Diagnostics, Llc, The Government Of The Usa, As Represented By The Secretary, Department Of Health And Human Services Office Of Technology Transfer filed Critical Wellstat Diagnostics, Llc
Publication of WO2013071055A1 publication Critical patent/WO2013071055A1/fr

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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
    • G01N33/6854—Immunoglobulins
    • 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
    • G01N33/54306—Solid-phase reaction mechanisms
    • 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
    • G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • G01N2333/62—Insulins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/04—Endocrine or metabolic disorders
    • G01N2800/042—Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/50—Determining the risk of developing a disease

Definitions

  • the present disclosure further provides methods for detecting diabetes-associated autoantibodies against at least one antigen in a sample, wherein the at least one diabetes-associated autoantibody is selected from the group consisting of insulin autoantibodies, GAD65 autoantibodies, IA-2 (ICA51 2) autoantibodies, ZnT8 autoantibodies, CPE (CPH) autoantibodies, DNA Topi I autoantibodies, GAD67 autoantibodies, Glima38 autoantibodies, GLUT2 autoantibodies, GM2-1 autoantibodies, GT3 autoantibodies, HIP/PAP autoantibodies, HSP-60 autoantibodies, HSP-70 autoantibodies, HSP-90 autoantibodies, ⁇ -2 ⁇ (phogrin) autoantibodies, IAPP (amylin) autoantibodies, ICA69 autoantibodies, IGRP autoantibodies, lmogen38 autoantibodies, Jun-B autoantibodies, peripherin autoantibodies, S1003
  • the present disclosure further provides methods for detecting diabetes-associated autoantibodies against at least one antigen in a sample, wherein the first and second binding partners are selected from the following binding partner pairs: biotin/streptavidin; Antibody/antigen; Antibody/Fc receptor; an antibody of a first species and an antibody of a second species against first species antibodies; Fc/Fc receptor; PolyA/oligodT; 6-His/Ni 2+; 6-His/ cobalt; 6- His/divalent cation resin; complementary DNA strands; Lymphotoxin-alpha (LT- alpha)/LT-alpha receptor; Lymphotoxin-beta (LT-beta)/LT-beta receptor; T cell antigen gp39 (CD40L)/CD40; CD30L/CD30; FASL/FAS; 4-1 BBL/4-1 BBL receptor; OX40L/OX40L receptor; and TNF-related apoptosis inducing ligand (
  • the present disclosure further provides methods for detecting diabetes-associated autoantibodies against at least one antigen in a sample, the methods further comprising treating the untreated sample or treated sampl from step (a) with acid to disrupt immune complexes followed by neutralizing t acid, and performing step (b) on the acid-treated/neutralized sample.
  • kits wherein the electrochemiluminescent label is a ruthenium-containing reagent.
  • the present disclosure further provides methods of determining whether a mammalian subject is at risk for developing autoimmune diabetes, further comprising treating the subject to delay or lessen the risk of developing autoimmune diabetes or the severity of autoimmune diabetes in the subject.
  • FIG. 8A is a graphical representation of an evaluation of specificity and stability of the electrochemiluminescence (ECL)-based assay for insulin autoantibodies (lAA) where results from samples from five IAA+ and one lAA- donors-incubated with an increasing percentage of non-biotinylated insulin prior to addition of biotinylated insulin are plotted;
  • ECL electrochemiluminescence
  • reagent/antibody complex is captured through antigen bound to a tag, because both of those interactions depend on the avidity of the autoantibody within the subject which is variable.
  • the method can include a step (a) optionally treating the sample under nonspecific protein-binding conditions with a first material that does not bind specifically to the autoantibodies.
  • the first material has a first binding partner on its surface. After treating the sample, then the first-binding-partner-surfaced material and any bound proteins are separated from the sample.
  • the method can further include a step (b) contacting the untreated sample or treated sample from step (a) with a capture reagent that is capable of binding specifically to the diabetes-associated autoantibodies in the sample.
  • step (b) can be performed simultaneously for each antigen detected by contacting the sample with at least two capture reagents each of which specifically binds to a different first binding partner.
  • step (b) can be performed sequentially, that is, repeated in sequence for each antigen detected.
  • the contacting of the sample to at least two capture reagents in each iteration is with a different capture reagent that specifically binds its respective first binding partner and in which step (c) is then performed on each sample from the at least two iterations of step (b).
  • each set of pelleted beads can be resuspended with a secondary antibody that is tagged with a Ruthenium reagent (TAG) to detect antibody-bound to each islet antigen of interest. It is further contemplated that the method can be performed in a hybrid
  • the second material of the method can be any material that has the first binding partner on its surface and that can be separated from the sample.
  • Suitable magnetic beads are commercially available, such as, for example, Dynabeads ® by Invitrogen, or alternatively, beads can be prepared using techniques known to those of skill in the art.
  • the magnetic beads are pulled down to a magnet during detection such as, for example, with detection by electrochemiluminescence (ECL).
  • IAA may be one of the earliest markers of ⁇ -cell autoimmunity that can be detected for the diagnosis or prediction of disease.
  • the ability to identify individuals prior to diabetes onset will aid in research and clinical trials for preventive therapies.
  • This sensitive ECL technology could also be applied to the other known islet-associated autoantibodies, such as those antibodies to GAD65, IA-2, and ZnT8, to augment the power of diabetes prediction (Verge 1996; Wenzlau 2007;
  • LEITER EH. "The NOD Mouse: A Model for Insulin-Dependent Diabetes Mellitus," Curr Protoc Immunol, Chapter 15: Unit 15(9) (2001 ).
  • VERGE, CF, et al. "Prediction of Type I Diabetes in First-Degree Relatives Using a Combination of Insulin, GAD, and ICA512bdc/IA-2

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  • 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)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Pathology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La présente invention concerne des procédés consistant à détecter des autoanticorps associés au diabète contre au moins un antigène dans un échantillon. L'invention porte en outre sur des procédés pouvant être utilisés pour déterminer si un sujet mammifère présente une insulite autoimmune et/ou s'il risque de développer un diabète insulinodépendant. Une fois ces pathologies identifiées, il est possible de recourir à des interventions thérapeutiques pour traiter l'insulite et prévenir, retarder ou diminuer la gravité du diabète insulinodépendant. La présente invention concerne en outre un kit permettant de mettre en œuvre les procédés susmentionnés.
PCT/US2012/064373 2011-11-10 2012-11-09 Dosage pour autoanticorps associés au diabète WO2013071055A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161558193P 2011-11-10 2011-11-10
US61/558,193 2011-11-10

Publications (1)

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WO2013071055A1 true WO2013071055A1 (fr) 2013-05-16

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016536587A (ja) * 2013-10-31 2016-11-24 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 中和抗体を検出するための競合リガンド結合アッセイ
WO2017087634A1 (fr) * 2015-11-17 2017-05-26 The Regents Of The University Of Colorado, A Body Corporate Évaluations multiplexes innovantes pour diagnostiquer ou évaluer des maladies ou des désordres chez les mammifères
CN108440666A (zh) * 2018-03-07 2018-08-24 深圳市伯劳特生物制品有限公司 一种生物素化的insulin抗原及其生物素化工艺
WO2019014044A1 (fr) * 2017-07-12 2019-01-17 The Johns Hopkins University Auto-antigène znt8 à base de protéoliposomes pour le diagnostic du diabète de type 1
WO2019169798A1 (fr) * 2018-03-07 2019-09-12 深圳市伯劳特生物制品有限公司 Composition pour nécessaire de dosage immuno-adsorbant lié à une enzyme, nécessaire de détection de répertoire d'anticorps de diabète et procédé de préparation associé
WO2020047026A1 (fr) * 2018-08-30 2020-03-05 Essen Instruments, Inc. D/B/A Essen Bioscience, Inc. Procédés de détermination de la concentration de protéines à concentration faible et élevée dans un échantillon unique
CN111175518A (zh) * 2020-01-08 2020-05-19 杭州北角医学检验所有限公司 一种用于ⅰ型糖尿病联合抗体检测试剂盒及其制备方法
CN111505268A (zh) * 2020-04-29 2020-08-07 四川携光生物技术有限公司 一种自身免疫抗体检测方法
WO2020247920A1 (fr) * 2019-06-06 2020-12-10 The Johns Hopkins University Compositions et procédés de détection d'auto-anticorps
CN113930435A (zh) * 2021-09-16 2022-01-14 江苏省人民医院（南京医科大学第一附属医院） 一种放射配体法检测c肽抗体的试剂盒
WO2023103464A1 (fr) * 2021-12-09 2023-06-15 深圳市亚辉龙生物科技股份有限公司 Kit de dosage immunologique par chimiluminescence d'anticorps anti-transporteur-8 de zinc et son procédé de préparation
US11841363B2 (en) 2016-04-25 2023-12-12 The Johns Hopkins University ZnT8 assays for drug development and pharmaceutical compositions

Citations (4)

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US4459359A (en) * 1981-11-19 1984-07-10 New York Blood Center, Inc. Sensitive immunoassays of antigens or antibodies sequestered within immune complexes
US20070041973A1 (en) * 2002-04-09 2007-02-22 Habib Zaghouani Compositions and methods for treating, preventing and/or reversing type-1 diabetes
US20090131267A1 (en) * 2006-01-03 2009-05-21 Peter Porschewski Use of polymers for increasing the signal intensity when carrying out detection reactions
WO2010107433A1 (fr) * 2009-03-18 2010-09-23 Prometheus Laboratories Inc. Réseaux d'anticorps adressables et procédés d'utilisation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4459359A (en) * 1981-11-19 1984-07-10 New York Blood Center, Inc. Sensitive immunoassays of antigens or antibodies sequestered within immune complexes
US20070041973A1 (en) * 2002-04-09 2007-02-22 Habib Zaghouani Compositions and methods for treating, preventing and/or reversing type-1 diabetes
US20090131267A1 (en) * 2006-01-03 2009-05-21 Peter Porschewski Use of polymers for increasing the signal intensity when carrying out detection reactions
WO2010107433A1 (fr) * 2009-03-18 2010-09-23 Prometheus Laboratories Inc. Réseaux d'anticorps adressables et procédés d'utilisation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
GOLLA ET AL.: "A Sensitive, Robust High-Throughput Electrochemiluminescence Assay for Rat Insulin", JOUMAL OF BIOMOLECULAR SCREENING, vol. 9, no. 1, 1 February 2004 (2004-02-01), pages 62 - 70 *

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10261094B2 (en) 2013-10-31 2019-04-16 Regeneron Pharmaceuticals, Inc. Competitive ligand binding assay for detecting neutralizing antibodies
JP2016536587A (ja) * 2013-10-31 2016-11-24 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 中和抗体を検出するための競合リガンド結合アッセイ
WO2017087634A1 (fr) * 2015-11-17 2017-05-26 The Regents Of The University Of Colorado, A Body Corporate Évaluations multiplexes innovantes pour diagnostiquer ou évaluer des maladies ou des désordres chez les mammifères
CN108603885A (zh) * 2015-11-17 2018-09-28 科罗拉多大学评议会公司 诊断或评估哺乳动物中的疾病或紊乱的新型多重分析
US11841363B2 (en) 2016-04-25 2023-12-12 The Johns Hopkins University ZnT8 assays for drug development and pharmaceutical compositions
CN111316099A (zh) * 2017-07-12 2020-06-19 约翰霍普金斯大学 用于1型糖尿病诊断的基于脂蛋白体的znt8自身抗原
US11892457B2 (en) 2017-07-12 2024-02-06 The Johns Hopkins University Proteoliposome-based ZnT8 self-antigen for type 1 diabetes diagnosis
WO2019014044A1 (fr) * 2017-07-12 2019-01-17 The Johns Hopkins University Auto-antigène znt8 à base de protéoliposomes pour le diagnostic du diabète de type 1
CN108440666B (zh) * 2018-03-07 2021-03-23 深圳市伯劳特生物制品有限公司 一种生物素化的insulin抗原及其生物素化工艺
WO2019169798A1 (fr) * 2018-03-07 2019-09-12 深圳市伯劳特生物制品有限公司 Composition pour nécessaire de dosage immuno-adsorbant lié à une enzyme, nécessaire de détection de répertoire d'anticorps de diabète et procédé de préparation associé
CN108440666A (zh) * 2018-03-07 2018-08-24 深圳市伯劳特生物制品有限公司 一种生物素化的insulin抗原及其生物素化工艺
WO2020047026A1 (fr) * 2018-08-30 2020-03-05 Essen Instruments, Inc. D/B/A Essen Bioscience, Inc. Procédés de détermination de la concentration de protéines à concentration faible et élevée dans un échantillon unique
WO2020247920A1 (fr) * 2019-06-06 2020-12-10 The Johns Hopkins University Compositions et procédés de détection d'auto-anticorps
CN111175518A (zh) * 2020-01-08 2020-05-19 杭州北角医学检验所有限公司 一种用于ⅰ型糖尿病联合抗体检测试剂盒及其制备方法
CN111505268A (zh) * 2020-04-29 2020-08-07 四川携光生物技术有限公司 一种自身免疫抗体检测方法
CN113930435A (zh) * 2021-09-16 2022-01-14 江苏省人民医院（南京医科大学第一附属医院） 一种放射配体法检测c肽抗体的试剂盒
WO2023103464A1 (fr) * 2021-12-09 2023-06-15 深圳市亚辉龙生物科技股份有限公司 Kit de dosage immunologique par chimiluminescence d'anticorps anti-transporteur-8 de zinc et son procédé de préparation

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