DK2780717T3 - Adrenomedullinassays og fremgangsmåder til bestemmelse af modent adrenomedullin - Google Patents

Adrenomedullinassays og fremgangsmåder til bestemmelse af modent adrenomedullin Download PDF

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DK2780717T3
DK2780717T3 DK12791143.6T DK12791143T DK2780717T3 DK 2780717 T3 DK2780717 T3 DK 2780717T3 DK 12791143 T DK12791143 T DK 12791143T DK 2780717 T3 DK2780717 T3 DK 2780717T3
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adrenomedullin
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gly
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Andreas Bergmann
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Sphingotec Gmbh
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Claims (28)

1. In-vitro-fremgangsmåde til efterbehandlingsterapi hos patienter der er mistænkt for at have sepsis hvor koncentrationen af modent adrenomedullin (ADM) (1-52-amid) og/eller modent ADM 1-52-Gly i en legemsvæskeprøve fra patienten med sepsis bestemmes under anvendelse af et assay omfattende to bindemidler der er valgt fra gruppen omfattende et anti-adrenomedullinantistof og et anti-ADM-antistoffragment der binder til ADM og som binder til to forskellige regioner indenfor regionen af modent adrenomedullin (21-52-amid) og/eller adrenomedullin-Gly, der er henholdsvis et aminosyre-21-52-amid (SEQ ID No. 1) eller aminosyre 21-52-Gly (SEQ ID No. 2), hvor hver af disse regioner omfatter mindst 4 eller 5 aminosyrer.
2. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge krav 1 hvor ét af disse bindemidler binder til en region omfattet i den følgende sekvens af modent ADM (1-52-amid) og/eller modent ADM 1-52-Gly (SEQ ID No. 4) og hvor det andet af disse bindemidler binder til en region omfattet i den følgende sekvens af modent ADM (1-52-amid) og/eller modent ADM 1-52-Gly (SEQ ID No. 5).
3. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge krav 1 eller 2, hvor assaysensitiviteten af assayet er i stand til at kvantificere ADM af raske individer og er <10 pg/ml, fortrinsvis <40 pg/ml og mere fortrinsvis <70 pg/ml.
4. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 3, hvor bindemidlet udviser bindingsaffinitet overfor modent ADM (1-52-amid) og/eller modent ADM 1-52-Gly på mindst 107 M1.
5. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 4, hvor et sådant assay er et sandwichassay, fortrinsvis et fuldautomatisk assay.
6. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 5, hvor mindst ét af de to bindemidler er mærket med henblik at blive påvist.
7. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 6 hvor mindst ét af de to bindemidler er bundet til en fast fase.
8. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge krav 6, hvor markøren er valgt fra gruppen omfattende kemiluminescerende markør, enzymmarkør, fluorescerende markør, radioiod-markør.
9. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 8, hvor koncentrationen af modent ADM (1-52-amid) og/eller modent ADM 1-52-Gly målt i prøven er i området mellem 10-500 pg/ml.
10. /n-w'fro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 9, hvor en tærskelværdi påføres hvorved en værdi over tærskelværdien er indikation for en patient der ikke eller dårligt responderer på terapi og hvorimod en værdi under tærskelværdien er indikation for en patient der responderer på terapi.
11. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 10, hvor en tærskelværdi på 60 til 80 pg/ml, fortrinsvis 70 pg/ml påføres.
12. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 11, hvor prøven er valgt fra gruppen omfattende human citratplasma, heparin plasma, EDTA plasma, helblod.
13. /n-w'fro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge krav 12, hvor den tagne prøve måles direkte uden nogen yderligere prøveforberedelse.
14. /n-v/fro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 13, hvor fremgangsmåden udføres på en fuldautomatisk indretning.
15. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 14, hvor modent ADM (1-52-amid) og/eller modent ADM 1-52-Gly bestemmes i mindst to prøver, hvor prøverne er taget på forskellige tidspunkter fra sepsis-patienterne.
16. In-vitro-fremgangsmåde til efterbehandlingsterapi i sepsis-patienter ifølge et hvilket som helst af kravene 1 til 15, hvor det målte prøvevolumen er mindre end eller lig med 50pl.
17. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve omfattende to bindemidler der er valgt fra gruppen omfattende et anti-adrenomedullinantistof og et anti-ADM-antistoffragment der binder til ADM og som binder til forskellige regioner indenfor regionen af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly, der er henholdsvis en aminosyre-21-52-amid SEQ ID No. 1 eller aminosyre 21-52-Gly af modent adrenomedullin SEQ ID No. 2, hvor hver af disse regioner omfatter mindst 4 eller 5 aminosyrer og hvor assayet ikke er et manuelt coatet-rør-Akridiniumester sandwich-assay.
18. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve omfattende to bindemidler der er valgt fra gruppen omfattende et anti-adrenomedullinantistof og et anti-ADM-antistoffragment der binder til ADM og binder til to forskellige regioner indenfor regionen af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly, der er henholdsvis et aminosyre-21-52-amid (SEQ ID No. 1) eller aminosyre 21-52-Gly af modent adrenomedullin (SEQ ID No. 2), hvor hver af disse regioner omfatter mindst 4 eller 5 aminosyrer og hvor assayet er et manuelt coatet-rør-Akridiniumester sandwichassay og hvor ét af disse bindemidler er et antistof der binder til SEQ ID No. 6 CTVQKLAHQIYQ og hvor det andet af bindemidlerne er et antistof der binder til SEQ ID No. 7 APRSKISPQGY i hvilket carboxylsyren er erstattet af en amidgruppe (APRSKISPQGY-CO-NH2).
19. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve ifølge krav 17, hvor ét af disse bindemidler binder til en region omfattet i den følgende sekvens af modent ADM 1-52-Gly (SEQ ID No. 4) og hvor det andet af disse bindemidler binder til en region omfattet i den følgende sekvens af modent ADM (1-52-amid) og/eller modent ADM 1-52-Gly (SEQ ID No. 5).
20. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve ifølge et hvilket som helst af kravene 17 til 19 hvor assaysensitiviteten af assayet er i stand til at kvantificere ADM fra raske individer og er <10 pg/ml, fortrinsvis <40 pg/ml og mere fortrinsvis <70 pg/ml.
21. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve ifølge et hvilket som helst af kravene 17 til 20, hvor bindemidlet udviser en bindingsaffinitet til adrenomedullin på mindst 107 M'1.
22. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve ifølge et hvilket som helst af kravene 17 til 21 hvor sådant assay er et sandwichassay, fortrinsvis et fuldautomatisk assay.
23. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve ifølge et hvilket som helst af kravene 17 til 22 hvor mindst ét af de to bindemidler er mærket med henblik at blive påvist.
24. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve ifølge et hvilket som helst af kravene 17 til 23, hvor mindst ét af de to bindemidler er er bundet til en fast fase.
25. Assay til bestemmelse af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly i en prøve ifølge krav 23, hvor markøren er valgt fra gruppen omfattende en kemiluminescerende markør, en enzymmarkør, en fluorescerende markør, en radioiodmarkør.
26. Kit comprising et assay ifølge et hvilket som helst af kravene 17 til 25, hvor komponenterne af dette assay kan være omfattet i én eller flere beholdere.
27. Fremgangsmåde til kalibrering af et assay ifølge krav 17, hvor et bindemiddel anvendes der binder til en region på mindst 5 aminosyrer indenfor modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly aminosyrer 1-15 (SEQ ID No. 8), hvor bindemidlet er valgt fra gruppen omfattende et anti-ADM-antistof og et anti-ADM-antistoffragment.
28. Fremgangsmåde til kalibrering af et assay ifølge krav 27, hvor bindemidlet genkender og binder til den N-terminale ende af modent adrenomedullin (1-52-amid) og/eller adrenomedullin-Gly, hvor bindemidlet er valgt fra gruppen omfattende et anti-ADM-antistof og et anti-ADM-antistoffragment.
DK12791143.6T 2011-11-16 2012-11-16 Adrenomedullinassays og fremgangsmåder til bestemmelse af modent adrenomedullin DK2780717T3 (da)

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EP11189449 2011-11-16
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PCT/EP2012/072928 WO2013072509A1 (en) 2011-11-16 2012-11-16 Adrenomedullin assays and methods for determining mature adrenomedullin

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