ES2822295T1 - Métodos y reactivos para el diagnóstico de la infección por SARS-CoV-2 - Google Patents

Métodos y reactivos para el diagnóstico de la infección por SARS-CoV-2 Download PDF

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Publication number
ES2822295T1
ES2822295T1 ES21158065T ES21158065T ES2822295T1 ES 2822295 T1 ES2822295 T1 ES 2822295T1 ES 21158065 T ES21158065 T ES 21158065T ES 21158065 T ES21158065 T ES 21158065T ES 2822295 T1 ES2822295 T1 ES 2822295T1
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ES
Spain
Prior art keywords
antibody
infection
sars
cov
iga
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Pending
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ES21158065T
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English (en)
Inventor
Katja Steinhagen
Claudia Messing
Erik Lattwein
Konstanze Stiba
Fabian Lindhorst
Eva Neugebauer
Marcel Müller
Victor Corman
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Charite Universitaetsmedizin Berlin
Euroimmun Medizinische Labordiagnostika AG
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Charite Universitaetsmedizin Berlin
Euroimmun Medizinische Labordiagnostika AG
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Priority claimed from EP20158626.0A external-priority patent/EP3715847A1/en
Application filed by Charite Universitaetsmedizin Berlin, Euroimmun Medizinische Labordiagnostika AG filed Critical Charite Universitaetsmedizin Berlin
Publication of ES2822295T1 publication Critical patent/ES2822295T1/es
Pending legal-status Critical Current

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • G01N33/6857Antibody fragments
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983Viruses
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326Magnetic particles
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/20Fusion polypeptide containing a tag with affinity for a non-protein ligand
    • C07K2319/21Fusion polypeptide containing a tag with affinity for a non-protein ligand containing a His-tag
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08RNA viruses
    • G01N2333/165Coronaviridae, e.g. avian infectious bronchitis virus
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2469/00Immunoassays for the detection of microorganisms
    • G01N2469/20Detection of antibodies in sample from host which are directed against antigens from microorganisms
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/12Pulmonary diseases

Abstract

Un método para diagnosticar una infección por SARS-CoV-2 que comprende la etapa de detectar la presencia o ausencia de un anticuerpo contra SEQ ID NO1, preferentemente anticuerpo de clase IgA, en una muestra de un sujeto.

Claims (15)

REIVINDICACIONES
1. Un método para diagnosticar una infección por SARS-CoV-2 que comprende la etapa de detectar la presencia o ausencia de un anticuerpo contra SEQ ID NO1, preferentemente anticuerpo de clase IgA, en una muestra de un sujeto.
2. Un método para el diagnóstico diferencial de una infección por coronavirus, preferentemente para distinguir entre una infección por SARS-CoV; preferentemente por SARS-CoV-2; MERS, NL63, 229E, OC43 y HKU1, que comprende la etapa de detectar la presencia o ausencia de un anticuerpo contra SEQ ID NO1 en una muestra de un sujeto, preferentemente un anticuerpo de clase IgA y/o IgG, más preferentemente un anticuerpo de clase IgA.
3. El método según cualquiera de las reivindicaciones 1 o 2, en el que se detecta la presencia de un anticuerpo de clase IgG y/o IgM contra SEQ ID NO1 además de un anticuerpo de clase IgA contra SEQ ID NO1.
4. El método según cualquiera de las reivindicaciones 1 a 3, en el que la muestra es una muestra de sangre, preferentemente seleccionada del grupo que comprende sangre completa, suero o plasma.
5. El método según cualquiera de las reivindicaciones 1 a 4, en el que se detecta un anticuerpo de clase IgA contra SEQ ID NO1 usando un anticuerpo secundario marcado, preferentemente que se une a anticuerpos de clase IgA.
6. El método según cualquiera de las reivindicaciones 1 a 5, en el que el anticuerpo IgA se detecta usando un método seleccionado del grupo que comprende colorimetría, inmunofluorescencia, detección de actividad enzimática, quimioluminiscencia y radiactividad.
7. El método según cualquiera de las reivindicaciones 1 a 6, en el que la infección se detecta en una etapa temprana.
8. Un uso de un anticuerpo contra SEQ ID NO1, preferentemente anticuerpo de clase IgA, para diagnosticar una infección por SARS-CoV-2 o para el diagnóstico diferencial de una infección por coronavirus, preferentemente para distinguir entre una infección por SARS-CoV, preferentemente por SARS-CoV-2, MERS y NL63, 229E, OC43 y h Ku 1.
9. El uso según la reivindicación 8, en el que el uso es para el diagnóstico temprano de una infección por SARS-CoV-2.
10. Un kit que comprende un polipéptido que comprende SEQ ID NO1 o una variante del mismo, preferentemente recubierto con un vehículo útil para el diagnóstico y uno o más, preferentemente todos los reactivos del grupo que comprende un anticuerpo contra SEQ ID NO1, un tampón de lavado, un medio para detectar la presencia de anticuerpo contra SEQ ID NO1, preferentemente un anticuerpo de clase IgA, preferentemente un anticuerpo secundario que se une específicamente a anticuerpos de clase IgA, que comprende preferentemente un marcador detectable y un tampón de dilución.
11. El kit según la reivindicación 10, en el que el vehículo útil para el diagnóstico se selecciona del grupo que comprende una perla, preferentemente una perla paramagnética, una tira reactiva, una placa de microtitulación, una membrana, preferentemente del grupo que comprende transferencia western, transferencia de línea y transferencia de punto, un dispositivo de flujo lateral, una superficie de vidrio, un portaobjetos, una micromatriz y un biochip, y es preferentemente una placa de microtitulación.
12. El kit según la reivindicación 10 u 11, en el que el kit comprende dos o más, preferentemente tres o más calibradores.
13. El kit según la reivindicación 12, en el que cada calibrador es un anticuerpo recombinante que se une a SEQ ID NO1, que preferentemente es reconocido por un anticuerpo secundario que se une a anticuerpos de clase IgA.
14. Un uso de un polipéptido que comprende SEQ ID NO1 o una variante del mismo o un anticuerpo contra SEQ ID NO1, preferentemente un anticuerpo de clase IgA, para la fabricación de un kit de diagnóstico.
15. Un uso de un anticuerpo recombinante que se une a SEQ ID NO1 que preferentemente es reconocido por un anticuerpo secundario que se une a anticuerpos de clase IgA como calibrador para el diagnóstico temprano de una infección por SARS-CoV-2.
ES21158065T 2020-02-19 2021-02-19 Métodos y reactivos para el diagnóstico de la infección por SARS-CoV-2 Pending ES2822295T1 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP20158348 2020-02-19
EP20158626.0A EP3715847A1 (en) 2020-02-20 2020-02-20 A method and reagents for the diagnosis of sars-cov-2
EP20158821 2020-02-21
DE202020003564 2020-08-20
DE202020104982 2020-08-28

Publications (1)

Publication Number Publication Date
ES2822295T1 true ES2822295T1 (es) 2021-04-30

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US (1) US20210190797A1 (es)
EP (2) EP3978927A3 (es)
JP (1) JP7022969B2 (es)
KR (1) KR102570713B1 (es)
CN (1) CN113557431A (es)
AU (1) AU2021223701B2 (es)
BR (1) BR102021003012A2 (es)
CA (1) CA3109607C (es)
DE (2) DE202021100842U1 (es)
ES (1) ES2822295T1 (es)
MX (1) MX2022010234A (es)
RU (1) RU2021134819A (es)
SG (1) SG11202112544XA (es)
WO (1) WO2021165448A1 (es)

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SG11202112544XA (en) 2021-12-30
MX2022010234A (es) 2022-11-16
JP7022969B2 (ja) 2022-02-21
EP3978927A3 (en) 2022-06-22
WO2021165448A1 (en) 2021-08-26
US20210190797A1 (en) 2021-06-24
AU2021223701A1 (en) 2022-01-06
EP3809137A1 (en) 2021-04-21
RU2021134819A (ru) 2022-02-17
BR102021003012A2 (pt) 2021-11-30
DE202021100842U1 (de) 2021-08-17
CA3109607C (en) 2023-04-04
EP3978927A2 (en) 2022-04-06
AU2021223701B2 (en) 2022-05-19
KR20220006125A (ko) 2022-01-14
CA3109607A1 (en) 2021-05-20
KR102570713B1 (ko) 2023-08-25
JP2021167805A (ja) 2021-10-21
DE21158065T1 (de) 2021-06-10
CN113557431A (zh) 2021-10-26
RU2021134819A3 (es) 2022-04-29

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