EP0460102A1 - Procede et kit de test de diagnostic pour la detection d'anticorps autoimmun - Google Patents

Procede et kit de test de diagnostic pour la detection d'anticorps autoimmun

Info

Publication number
EP0460102A1
EP0460102A1 EP90904577A EP90904577A EP0460102A1 EP 0460102 A1 EP0460102 A1 EP 0460102A1 EP 90904577 A EP90904577 A EP 90904577A EP 90904577 A EP90904577 A EP 90904577A EP 0460102 A1 EP0460102 A1 EP 0460102A1
Authority
EP
European Patent Office
Prior art keywords
coating
antigen
rnp
antibody
sera
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP90904577A
Other languages
German (de)
English (en)
Other versions
EP0460102A4 (en
Inventor
Luis R. Lopez
Marcia Sterhan
Tammy PETERSON-BUCKNER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Reaads Medical Products Inc
Original Assignee
Biostar Medical Products Inc
Reaads Medical Products Inc
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.)
Filing date
Publication date
Application filed by Biostar Medical Products Inc, Reaads Medical Products Inc filed Critical Biostar Medical Products Inc
Publication of EP0460102A1 publication Critical patent/EP0460102A1/fr
Publication of EP0460102A4 publication Critical patent/EP0460102A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • 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
    • G01N33/5308—Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
    • 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
    • G01N33/53—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
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/24—Immunology or allergic disorders

Definitions

  • kits claim a low level of cross reactivity with ssDNA which should render good sensitivity to low, medium, and high levels of anti- dsDNA; however, as evidenced by the kit instructions, there is a lack of sensitivity in the sera sample which are borderline positives. As a consequence, these kits cannot be used to accurately monitor patients who are borderline positives. In fact, most kits require that low positives must be retested to assure confidence in the results, thereby increasing the cost to the patient. Development of an assay which is sensitive to all levels of anti-dsDNA can only be achieved by reducing non-specific binding by such components as ssDNA.
  • compositions, methods, articles, and a diagnostic test kit for the selective adsorption, or affixing of dsDNA, Sm antigen, or Sm/RNP antigen, or any of the various antigens to the autoimmune antibodies previously listed, to a pre-coated plate for the effective detection of the specific autoimmune antibodies present in sera or plasma. It is a further objective of this invention to overcome the aforementioned sensitivity, subjectivity, stability, and shelf life disadvantages inherent in many of the previously described assays. It is, moreover, also an objective of this invention to provide in the form of a kit a novel, readily utilizable means for quantitative and qualitative detection of anti-dsDNA, anti-Sm or anti-Sm/RNP.
  • Figure 5 This graph depicts a standardized curve based on arbitrary READS ⁇ units/ml. This curve was generated by using the ELISA format of this invention.
  • the Center for Disease Control (CDC) ANA Human Reference Lot #82-001 #5 Serum (for Sm antigen) and the ANA Human Reference Lot #82-011 #4 Serum (for RNP antigen) was run on an immunodiffusion assay with median titer of 1 :64.
  • An equal volume of reference sera #4 and #5 are combined to form the standard.
  • This standard was serially diluted with normal sera and graphed. The 1:1 or neat dilution was assigned arbitrarily a value of 1400 READS units.
  • Step 3 Assay for the Anti-dsDNA Affixed to the Wells: Standard enzyme-linked immunoassay techniques, previously described, are used forthis assay, although any suitable means of detection such as radioactive labeling, fluorescence, or the like can be employed.
  • anti-human IgG and anti-human IgM induced in goats were used to ascertain whether anti-dsDNA IgG and IgM antibodies were present. Please note that other species of animal can be used to produce anti-human antibodies..
  • These antisera were linked to horseradish peroxidase, an enzyme which yields a colored product whenever one of its substrates is present together with hydrogen peroxide.
  • the substrate should be chosen to be consistent with the enzyme conjugated to the antibody.
  • the substrate was (3,3',5,5') Tetramethylbenzidine and hydrogen peroxide.
  • TMB Substrate Solution A - contains 3,3',5,5' Tetramethylbenzidine.
  • Casein blocker solution (pH 7.3) was dispensed in 200 microliter increments into each well.
  • the casein blocker solution consists of 2 ml glycerol, 10 g sucrose, 15 mg casein and sufficient TEN buffer to bring the volume to 100 ml.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Organic Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

On a mis au point un procédé et un appareil optimisés se présentant sous la forme d'un kit de test d'analyse en sandwich, de diagnostic autoimmun, capable d'immobiliser un antigène sur des puits de support pré-enduits, permettant la détection d'anticorps autoimmuns spécifiques auxdits composés, à l'aide de techniques soit ELISA (analyse d'immunosorbant à liaison enzymatique) soit FIA (immunoanalyse fluorescente).
EP19900904577 1989-02-27 1990-02-26 Method and diagnostic test kit for detection of autoimmune antibody Withdrawn EP0460102A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US315567 1981-10-27
US31556789A 1989-02-27 1989-02-27

Publications (2)

Publication Number Publication Date
EP0460102A1 true EP0460102A1 (fr) 1991-12-11
EP0460102A4 EP0460102A4 (en) 1992-01-15

Family

ID=23225031

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19900904577 Withdrawn EP0460102A4 (en) 1989-02-27 1990-02-26 Method and diagnostic test kit for detection of autoimmune antibody

Country Status (4)

Country Link
EP (1) EP0460102A4 (fr)
AU (1) AU5186890A (fr)
CA (1) CA2050340A1 (fr)
WO (1) WO1990010229A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103575907A (zh) * 2013-10-30 2014-02-12 浙江理工大学 一种古代胶结剂文物材料中卵蛋白的检测方法

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69204157T2 (de) * 1991-01-22 1996-03-21 Akzo Nobel N.V., Arnheim/Arnhem Verfahren zur bestimmung von anti-rns-antikörpern.
US6030773A (en) * 1992-07-08 2000-02-29 Agnello; Vincent Chemiluminescent assay for DSDNA antibodies
US5681700A (en) * 1994-05-25 1997-10-28 Oklahoma Medical Research Foundation Assay for pathogenicity of anti-DNA antibodies
US6280944B1 (en) 1994-05-25 2001-08-28 Oklahoma Medical Research Foundation Assay for pathogenicity of anti-DNA antibodies
CA2339030A1 (fr) 2000-03-02 2001-09-02 Ortho-Clinical Diagnostics, Inc. Elements analytiques
EP3712618B1 (fr) * 2019-03-18 2023-10-04 Euroimmun Medizinische Labordiagnostika AG Procédé de détection d'une liaison d'anticorps d'un échantillon de patient à l'adn double brin à l'aide des cellules de crithidia luciliae et microscopie par fluorescence
CN113917136A (zh) * 2021-10-18 2022-01-11 北京和杰创新生物医学科技有限公司 抗双链脱氧核糖核酸抗体免疫球蛋白g的检测方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4564597A (en) * 1981-03-18 1986-01-14 Research Corporation Anti-Sm hybridoma
US4784942A (en) * 1984-11-05 1988-11-15 The Board Of Regents For The University Of Oklahoma Monoclonal antibodies against autoimmune RNA proteins
US4738932A (en) * 1985-12-03 1988-04-19 Advanced Polymer Systems, Inc. Reaginic test for syphilis
EP0460097A4 (en) * 1989-02-27 1992-03-11 Biostar Med Prod Method and diagnostic test kit for detection of anti-cardiolipin

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103575907A (zh) * 2013-10-30 2014-02-12 浙江理工大学 一种古代胶结剂文物材料中卵蛋白的检测方法

Also Published As

Publication number Publication date
WO1990010229A1 (fr) 1990-09-07
AU5186890A (en) 1990-09-26
EP0460102A4 (en) 1992-01-15
CA2050340A1 (fr) 1990-08-28

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