HRP20170427T1 - Testovi na adrenomedulin i postupci određivanja zrelog adrenomedulina - Google Patents
Testovi na adrenomedulin i postupci određivanja zrelog adrenomedulina Download PDFInfo
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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
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- gly
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- 102000004379 Adrenomedullin Human genes 0.000 title claims 46
- 101800004616 Adrenomedullin Proteins 0.000 title claims 46
- ULCUCJFASIJEOE-NPECTJMMSA-N adrenomedullin Chemical compound C([C@@H](C(=O)N[C@@H](CCC(N)=O)C(=O)NCC(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)NCC(=O)N[C@@H]1C(N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)NCC(=O)N[C@H](C(=O)N[C@@H](CSSC1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CO)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCC(N)=O)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(N)=O)[C@@H](C)O)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](N)CC=1C=CC(O)=CC=1)C1=CC=CC=C1 ULCUCJFASIJEOE-NPECTJMMSA-N 0.000 title claims 46
- 238000000034 method Methods 0.000 title claims 20
- 238000003556 assay Methods 0.000 title 1
- 150000001408 amides Chemical class 0.000 claims 23
- 239000003446 ligand Substances 0.000 claims 19
- 206010040047 Sepsis Diseases 0.000 claims 18
- 238000000338 in vitro Methods 0.000 claims 16
- 150000001413 amino acids Chemical group 0.000 claims 11
- 239000003550 marker Substances 0.000 claims 10
- 239000012634 fragment Substances 0.000 claims 3
- 102000004190 Enzymes Human genes 0.000 claims 2
- 108090000790 Enzymes Proteins 0.000 claims 2
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 2
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 2
- XMBWDFGMSWQBCA-RNFDNDRNSA-M iodine-131(1-) Chemical compound [131I-] XMBWDFGMSWQBCA-RNFDNDRNSA-M 0.000 claims 2
- RXNXLAHQOVLMIE-UHFFFAOYSA-N phenyl 10-methylacridin-10-ium-9-carboxylate Chemical compound C12=CC=CC=C2[N+](C)=C2C=CC=CC2=C1C(=O)OC1=CC=CC=C1 RXNXLAHQOVLMIE-UHFFFAOYSA-N 0.000 claims 2
- 230000035945 sensitivity Effects 0.000 claims 2
- 239000007790 solid phase Substances 0.000 claims 2
- 238000002560 therapeutic procedure Methods 0.000 claims 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 1
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims 1
- 125000003368 amide group Chemical group 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 210000001124 body fluid Anatomy 0.000 claims 1
- 239000010839 body fluid Substances 0.000 claims 1
- 150000001735 carboxylic acids Chemical class 0.000 claims 1
- 229960002897 heparin Drugs 0.000 claims 1
- 229920000669 heparin Polymers 0.000 claims 1
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- 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
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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.
Applications Claiming Priority (13)
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EP11189449 | 2011-11-16 | ||
EP11189448 | 2011-11-16 | ||
EP11189447 | 2011-11-16 | ||
EP11189450 | 2011-11-16 | ||
EP11189452 | 2011-11-16 | ||
EP12160014 | 2012-03-16 | ||
EP12160016 | 2012-03-16 | ||
EP12160017 | 2012-03-16 | ||
EP12160018 | 2012-03-16 | ||
EP12160015 | 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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US (3) | US9304127B2 (hr) |
EP (1) | EP2780717B1 (hr) |
JP (1) | JP6336911B2 (hr) |
CN (1) | CN104067130B (hr) |
DK (1) | DK2780717T3 (hr) |
ES (1) | ES2617211T3 (hr) |
HK (1) | HK1202624A1 (hr) |
HR (1) | HRP20170427T1 (hr) |
HU (1) | HUE032648T2 (hr) |
MY (5) | MY175997A (hr) |
PL (1) | PL2780717T3 (hr) |
PT (1) | PT2780717T (hr) |
RS (1) | RS55804B1 (hr) |
RU (1) | RU2657517C2 (hr) |
SI (1) | SI2780717T1 (hr) |
WO (1) | WO2013072509A1 (hr) |
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DK2780717T3 (en) | 2017-02-13 |
EP2780717B1 (en) | 2016-12-21 |
PL2780717T3 (pl) | 2017-06-30 |
CN104067130B (zh) | 2017-02-22 |
MY175997A (en) | 2020-07-20 |
JP2014533827A (ja) | 2014-12-15 |
JP6336911B2 (ja) | 2018-06-06 |
PT2780717T (pt) | 2017-02-16 |
MY174894A (en) | 2020-05-20 |
US20130195875A1 (en) | 2013-08-01 |
MY178654A (en) | 2020-10-20 |
US20140322824A1 (en) | 2014-10-30 |
CN104067130A (zh) | 2014-09-24 |
MY174877A (en) | 2020-05-20 |
WO2013072509A1 (en) | 2013-05-23 |
US9535060B2 (en) | 2017-01-03 |
ES2617211T3 (es) | 2017-06-15 |
MY192113A (en) | 2022-07-28 |
RS55804B1 (sr) | 2017-08-31 |
SI2780717T1 (sl) | 2017-05-31 |
US20130195874A1 (en) | 2013-08-01 |
RU2657517C2 (ru) | 2018-06-14 |
EP2780717A1 (en) | 2014-09-24 |
HK1202624A1 (en) | 2015-10-02 |
HUE032648T2 (en) | 2017-10-30 |
US9140696B2 (en) | 2015-09-22 |
US9304127B2 (en) | 2016-04-05 |
RU2014123987A (ru) | 2015-12-27 |
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