HRP20170427T1 - Testovi na adrenomedulin i postupci određivanja zrelog adrenomedulina - Google Patents

Testovi na adrenomedulin i postupci određivanja zrelog adrenomedulina Download PDF

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HRP20170427T1
HRP20170427T1 HRP20170427TT HRP20170427T HRP20170427T1 HR P20170427 T1 HRP20170427 T1 HR P20170427T1 HR P20170427T T HRP20170427T T HR P20170427TT HR P20170427 T HRP20170427 T HR P20170427T HR P20170427 T1 HRP20170427 T1 HR P20170427T1
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adrenomedullin
mature
test
gly
adm
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Andreas Bergmann
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Sphingotec Gmbh
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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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    • 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
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Claims (28)

1. Postupak postterapijske kontrole in vitro kod pacijenata za koje se sumnja da imaju sepsu, naznačen time se koncentraciju zrelog adrenomedulina (ADM) (amid 1-52) i/ili zreli ADM 1-52-Gly u uzorku tjelesne tekućine iz navedenog pacijenta sa sepsom se određuje uz pomoć testa koji sadrži dva liganda koje se bira iz skupine koju čine protutijelo protiv adrenomedulina i fragment protutijela protiv ADM koji se veže na ADM, te koji se vežu na dva različita područja unutar područja zrelog adrenomedulina (2amid 1-52) i/ili adrenomedulin-Gly, koji je amid slijeda aminokiselina 21-52 (SEQ ID No. 1) odnosno slijed aminokiselina 21-52-Gly (SEQ ID No. 2), gdje svakoje od navedenih područja sadrži najmanje 4 ili 5 aminokiselina.
2. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s patentnim zahtjevom 1, naznačen time što se jedan od navedenih liganada veže na područje koje se nalazi u sljedećem slijedu zrelog ADM (amid 1-52) i/ili zrelog ADM 1-52-Gly (SEQ ID No. 4), te što se navedeni drugi od tih liganada veže na područje koje se nalazi u sljedećem slijedu zrelog ADM (amid 1-52) i/ili zrelog ADM 1-52-Gly (SEQ ID No. 5).
3. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s patentnim zahtjevom 1 ili 2, naznačen time što se osjetljivost testiranja kod navedenog testa može kvantificirati ADM kod zdravih subjekata i iznosi < 10 pg/ml, po mogućnosti < 40 pg/ml, poželjnije < 70 pg/ml.
4. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što navedeni ligand pokazuje afinitet vezanja na zreli ADM (amid 1-52) i/ili zreli ADM 1-52-Gly od najmanje 107 M–1.
5. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što je takav test sendvič test, po mogućnosti posve automatizirani test.
6. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što je najmanje jedan od navedena dva liganda obilježen kako bi ga se moglo detektirati.
7. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je najmanje jedan od navedena dva liganda vezan na čvrstu fazu.
8. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s patentnim zahtjevom 6, naznačen time što se navedeni biljeg bira iz skupine koju čine kemiluminiscentni biljeg, enzimski biljeg, fluorescentni biljeg, radiojodni biljeg.
9. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što je koncentracija zrelog ADM (amida 1-52) i/ili zrelog ADM 1-52-Gly izmjerena u uzorku u rasponu od 10-500 pg/ml.
10. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što se primjenjuje vrijednost praga, gdje vrijednost iznad praga ukazuje na pacijenta koji bilo ne odgovara ili slabo odgovara na terapiju, dok vrijednost ispod navedenog praga ukazuje na pacijenta koji odgovara na terapiju.
11. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što se primjenjuje vrijednost praga od 60 do 80 pg/ml, po mogućnosti 70 pg/ml.
12. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što se navedeni uzorak bira iz skupine koju čine ljudska plazma obrađena citratom, plazma obrađena heparinom, plazma obrađena s EDTA, puna krv.
13. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s patentnim zahtjevom 12, naznačen time što je navedeni uzeti uzorak izmjeren izravno, bez ikakve dodatne priprave uzorka.
14. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što se navedeni postupak provodi posve automatiziranim uređajem.
15. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 14, naznačen time što se zreli ADM (amid 1-52) i/ili zreli ADM 1-52-Gly određuje u najmanje dva uzorka, gdje su navedeni uzorci uzeti u različitim vremenskim točkama, iz navedenih pacijenata sa sepsom.
16. Postupak postterapijske kontrole in vitro kod pacijenata sa sepsom u skladu s bilo kojim od patentnih zahtjeva 1 do 15, naznačen time što je izmjereni volumen uzorka manji ili jednak 50 µl.
17. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku, naznačen time što sadrži dva liganda koje se bira iz skupine koju čine protutijelo protiv adrenomedulina i fragment protutijela protiv ADM koji se veže na ADM, te koji se vežu na dva različita područja unutar područja zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly, koji je amid slijeda aminokiselina 21-52 sa SEQ ID No. 1 odnosno slijeda aminokiselina 21-52-Gly zrelog adrenomedulina sa SEQ ID No. 2, gdje svakoje od navedenih područja sadrži najmanje 4 ili 5 aminokiselina, te gdje navedeni test nije manualni sendvič test s epruvetama obloženim akridinijevim esterom.
18. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku, naznačen time što sadrži dva liganda koje se bira iz skupine koju čine protutijelo protiv adrenomedulina i fragment protutijela protiv ADM koji se veže na ADM i veže se na dva različita područja unutar područja zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly, koji je amid slijed aminokiselina 21-52 (SEQ ID No. 1) odnosno slijed aminokiselina 21-52-Gly zrelog adrenomedulina (SEQ ID No. 2), gdje svakoje od navedenih područja sadrži najmanje 4 ili 5 aminokiselina, gdje je navedeni test manualni sendvič test s epruvetama obloženim akridinijevim esterom, gdje je jedan od navedenih liganada protutijelo koje se veže na SEQ ID No. 6 CTVQKLAHQIYQ, te gdje je drugi od navedenih liganada protutijelo koje se veže na SEQ ID No. 7 APRSKISPQGY, gdje je karboksilna kiselina zamijenjena amidom skupinom (APRSKISPQGY-CO-NH2).
19. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku u skladu s patentnim zahtjevom 17, naznačen time što se jedan od navedenih liganada veže na područje koje se nalazi u sljedećem slijedu zrelog ADM 1-52-Gly (SEQ ID No. 4), te što se navedeni drugi od tih liganada veže na područje koje se nalazi u sljedećem slijedu zrelog ADM (amid 1-52) i/ili zrelog ADM 1-52-Gly (SEQ ID No. 5).
20. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku u skladu s bilo kojim od patentnih zahtjeva 17 do 19, naznačen time što se osjetljivost testiranja kod navedenog testa može kvantificirati ADM kod zdravih subjekata i iznosi < 10 pg/ml, po mogućnosti < 40 pg/ml, poželjnije < 70 pg/ml.
21. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku u skladu s bilo kojim od patentnih zahtjeva 17 do 20, naznačen time što navedeni ligand pokazuje afinitet vezanja na adrenomedulin od najmanje 107 M–1.
22. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku u skladu s bilo kojim od patentnih zahtjeva 17 do 21, naznačen time što je takav test sendvič test, po mogućnosti posve automatizirani test.
23. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku u skladu s bilo kojim od patentnih zahtjeva 17 do 22, naznačen time što je najmanje jedan od navedena dva liganda obilježen kako bi ga se moglo detektirati.
24. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku u skladu s bilo kojim od patentnih zahtjeva 17 do 23, naznačen time što je najmanje jedan od navedena dva liganda vezan na čvrstu fazu.
25. Test za određivanje zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly u uzorku u skladu s patentnim zahtjevom 23, naznačen time što se navedeni biljeg bira iz skupine koju čine kemiluminiscentni biljeg, enzimski biljeg, fluorescentni biljeg, radiojodni biljeg.
26. Komplet koji sadrži test u skladu s bilo kojim od patentnih zahtjeva 17 do 25, naznačen time što se komponente za navedeni test mogu nalaziti u jednom ili više spremnika.
27. Postupak kalibriranja ispitivanja u skladu s patentnim zahtjevom 17, naznačen time što se upotrebljava ligand koji se veže na područje od najmanje 5 aminokiselina unutar zrelog adrenomedulina (amida 1-52) i/ili aminokiseline 1-16 adrenomedulina-Gly (SEQ ID No. 8), gdje se navedeni ligand bira iz skupine koju čine protutijelo protiv ADM i fragment protutijela protiv ADM.
28. Postupak kalibriranja ispitivanja u skladu s patentnim zahtjevom 27, naznačen time što ligand prepoznaje i veže se na N-terminalni kraj zrelog adrenomedulina (amida 1-52) i/ili adrenomedulina-Gly, gdje se navedeni ligand bira iz skupine koju čine protutijelo protiv ADM i fragment protutijela protiv ADM.
HRP20170427TT 2011-11-16 2017-03-16 Testovi na adrenomedulin i postupci određivanja zrelog adrenomedulina HRP20170427T1 (hr)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
EP11189449 2011-11-16
EP11189447 2011-11-16
EP11189448 2011-11-16
EP11189450 2011-11-16
EP11189452 2011-11-16
EP12160018 2012-03-16
EP12160016 2012-03-16
EP12160017 2012-03-16
EP12160015 2012-03-16
EP12160014 2012-03-16
EP12186449 2012-09-27
EP12791143.6A EP2780717B1 (en) 2011-11-16 2012-11-16 Adrenomedullin assays and methods for determining mature adrenomedullin
PCT/EP2012/072928 WO2013072509A1 (en) 2011-11-16 2012-11-16 Adrenomedullin assays and methods for determining mature adrenomedullin

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