DK1616184T4 - Fremgangsmåde og kit til at påvise tidlig begyndelse af renal tubulær cellebeskadigelse - Google Patents

Fremgangsmåde og kit til at påvise tidlig begyndelse af renal tubulær cellebeskadigelse Download PDF

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DK1616184T4
DK1616184T4 DK04758356.2T DK04758356T DK1616184T4 DK 1616184 T4 DK1616184 T4 DK 1616184T4 DK 04758356 T DK04758356 T DK 04758356T DK 1616184 T4 DK1616184 T4 DK 1616184T4
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ngal
antibody
renal
urine
complex
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DK1616184T3 (da
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Prased Devarajan
Jonathan M Barasch
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Childrens Hospital Med Ct
Univ Columbia
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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
    • G01N33/6893—Chemical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • 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
    • C12Q1/37—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving peptidase or proteinase
    • 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
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/118—Prognosis of disease development
    • 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/16—Primer sets for multiplex assays
    • 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
    • G01N2333/475—Assays involving growth factors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/34—Genitourinary disorders
    • G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/56—Staging of a disease; Further complications associated with the disease

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  • Life Sciences & Earth Sciences (AREA)
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Claims (24)

1. Fremgangsmåde til påvisning af en renal tubulær cellebeskadigelse, som er en iskæmisk renal beskadigelse i en human patient, omfattende trinnene: 1) at bringe en urinprøve opnået fra en human patient i kontakt med et antistof for en biomarkør bestående af NGAL, som fremkommer inden for de første 24 timer efter starten af den iskæmiske renale beskadigelse, for at tillade dannelse af et kompleks af antistoffet og NGAL, og 2) at påvise antistof-NGAL-komplekset.
2. Fremgangsmåde ifølge krav 1, hvor flere urinprøver for patienten opnås med mellemrum.
3. Fremgangsmåde ifølge krav 2, hvor urinprøverne opnås kontinuert.
4. Fremgangsmåde ifølge krav 1, hvor trinnet med at påvise antistof-NGAL-komplekset omfatter at bringe komplekset i kontakt med et andet antistof til at påvise NGAL.
5. Fremgangsmåde ifølge krav 1 til yderligere at overvåge effektiviteten afen behandling af den renale tubulære cellebeskadigelse omfattende de yderligere trin: 3) at bringe mindst én urinprøve efter behandling fra den humane patient, som lider af renal tubulær cellebeskadigelse og får behandling derfor, i kontakt med et indfangningsantistof for NGAL for at tillade dannelse af et kompleks af antistoffet og NGAL, og 4) at påvise tilstedeværelsen af NGAL i urinprøven efter behandling ved påvisning af antistof-NGAL-komplekset.
6. Fremgangsmåde ifølge krav 5, hvor trin 4) med at påvise antistof-NGAL-komplekset omfatter trinnene: (4i) at adskille eventuelt ubundet materiale fra urinprøven fra indfangningsantistoffet-NGAL-komplekset, (4ii) at bringe ind-fangningsantistof-NGAL-komplekset i kontakt med et andet antistof til at påvise NGAL, for at tillade dannelse af et kompleks mellem NGAL og det andet antistof, (4iii) at adskille eventuelt ubundet andet antistof fra NGAL-andet antistofkomplekset, og (4iv) at påvise det andet antistof fra NGAL-andet antistofkomplekset.
7. Fremgangsmåde ifølge krav 5, hvor trin 3) omfatter trinnet at bringe urinprøven i kontakt med et medie, hvortil er fastgjort det første antistof.
8. Anvendelse af et kit omfattende: 1) midler til at opnå en kvantitet af en urinprøve fra den humane patient, 2) et medie hvorpå er fastgjort et indfangningsantistof i stand til at kompleksdanne med NGAL, 3) et assay til påvisning af et kompleks af NGAL og indfangningsantistoffet ved en fremgangsmåde ifølge krav 1.
9. Anvendelse ifølge krav 8, hvor midlerne til at opnå urinprøven er konstrueret til en mængde af urinprøven på mindre end 1 ml, mere typisk mindre end 10 μΙ.
10. Anvendelse ifølge krav 8, hvor opnåelsesmidlerne omfatter et redskab omfattende en overflade, hvor overfladen omfatter mediet.
11. Anvendelse ifølge krav 8, hvor opnåelsesmidlerne omfatter en beholder til at modtage urinprøven, hvor den urinkontaktende overflade af beholderen omfatter mediet.
12. Anvendelse ifølge krav 8, hvor assayet omfatter ELISA.
13. Anvendelse ifølge krav 8, hvor opnåelsesmidlerne omfatter et apparat omfattende en kassette indeholdende mediet.
14. Anvendelse ifølge krav 8, hvor kittet er et kit til tæt på patienten (point-of-care).
15. Anvendelse af point-of-care kit ifølge krav 14, hvor midlerne til at opnå urinprøven er konstrueret til en mængde af urinprøven på mindre end 1 ml, mere typisk mindre end 10 μΙ.
16. Anvendelse af point-of-care kit ifølge krav 15, hvor opnåelsesmidlerne omfatter et redskab omfattende en dyppepind, hvor dyppepindens overflade omfatter mediet.
17. Anvendelse af point-of-care kit ifølge krav 15, hvor assayet omfatter et kolo-rimetrisk dyppepinds-assay.
18. Anvendelse af et kit til konkurrerende enzymforbundet immunosorbentassay (ELISA) omfattende et antistof specifikt for NGAL, for at påvise dets tilstedeværelse i en urinprøve fra patienten ved en fremgangsmåde ifølge krav 1.
19. Anvendelse ifølge krav 18 beregnet til at assaye en urinprøve, som kan omfatte en væskemængde på ca. 1 ml eller mindre.
20. Fremgangsmåde til at identificere graden afen renal tubulær cellebeskadigelse, som er en iskæmisk renal beskadigelse forårsaget af en hændelse, omfattende trinnene: 1) at påvise i mindst én urinprøve opnået fra en human patient tilstedeværelsen afen biomarkør bestående af NGAL, som fremkommer inden for de første 24 timer efter starten af den iskæmiske renale beskadigelse, og 2) at bestemme graden af den renale tubulære cellebeskadigelse baseret på tidspunktet for starten af tilstedeværelsen af NGAL i urinprøven i forhold til tidspunktet for hændelsen.
21. Fremgangsmåde ifølge krav 1 omfattende trinnene: 1) at bringe en urinprøve omfattende op til 1 ml af den første urin fra patienten i kontakt med antistoffet for NGAL for at tillade dannelse af et kompleks af antistoffet og NGAL, og 2) at påvise antistof-NGAL-komplekset.
22. Fremgangsmåde ifølge krav 1 til påvisning af iskæmisk renal beskadigelse, hvor det urinale NGAL, målt inden for to timer efter nyretransplantation, er forudsigende for akut nyresvigt.
23. Fremgangsmåde ifølge krav 1 til påvisning af post-operativ akut nyresvigt hos humane patienter efter åben hjertekirurgi, hvor den urinale NGAL målt inden for to timer efter kirurgien er forudsigende for akut nyresvigt.
24. Fremgangsmåde ifølge krav 1, hvor urinprøven er en urinprøve inden for to timer efter den renale tubulære cellebeskadigelse.
DK04758356.2T 2003-03-27 2004-03-26 Fremgangsmåde og kit til at påvise tidlig begyndelse af renal tubulær cellebeskadigelse DK1616184T4 (da)

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Application Number Priority Date Filing Date Title
US45814303P 2003-03-27 2003-03-27
US48159603P 2003-11-04 2003-11-04
PCT/US2004/009191 WO2004088276A2 (en) 2003-03-27 2004-03-26 A method and kit for detecting the early onset of renal tubular cell injury

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DK1616184T3 DK1616184T3 (da) 2009-10-19
DK1616184T4 true DK1616184T4 (da) 2018-08-13

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US (11) US20040219603A1 (da)
EP (3) EP2083270B1 (da)
JP (2) JP5392980B2 (da)
CN (1) CN102183656B (da)
AT (1) ATE437371T1 (da)
AU (1) AU2004225472B2 (da)
BR (1) BRPI0408802B8 (da)
CA (1) CA2520658A1 (da)
DE (1) DE602004022150D1 (da)
DK (2) DK2360475T3 (da)
ES (3) ES2330005T5 (da)
MX (1) MXPA05010385A (da)
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