SI2524060T1 - Preiskava za protitelesa virusa JC - Google Patents
Preiskava za protitelesa virusa JC Download PDFInfo
- Publication number
- SI2524060T1 SI2524060T1 SI201131438T SI201131438T SI2524060T1 SI 2524060 T1 SI2524060 T1 SI 2524060T1 SI 201131438 T SI201131438 T SI 201131438T SI 201131438 T SI201131438 T SI 201131438T SI 2524060 T1 SI2524060 T1 SI 2524060T1
- Authority
- SI
- Slovenia
- Prior art keywords
- virus
- subject
- antibody
- highly purified
- particles
- Prior art date
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Classifications
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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
- G01N33/6854—Immunoglobulins
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
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- 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
- G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
- G01N2333/01—DNA viruses
- G01N2333/025—Papovaviridae, e.g. papillomavirus, polyomavirus, SV40, BK virus, JC virus
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2469/00—Immunoassays for the detection of microorganisms
- G01N2469/20—Detection of antibodies in sample from host which are directed against antigens from microorganisms
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/50—Determining the risk of developing a disease
Claims (19)
- PREISKAVA ZA PROTITELESA VIRUSA JC Patentni zahtevki1. Metoda in vitro, ki zajema: (a) stik biološkega vzorca, pridobljenega iz subjekta, z visoko prečiščenimi virusu podobnimi delci, večinoma sestavljenimi iz proteina VP1 virusa JC, v raztopini pod pogoji, primernimi za vezavo protitelesa virusa JC v vzorcu z visoko prečiščenim virusu podobnim delcem, s čimer se zagotovi predhodno inkubiran vzorec; (b) stik predhodno inkubiranega vzorca z visoko prečiščenimi virusu podobnimi delci, večinoma sestavljenimi iz proteina VP1 virusa JC, imobiliziranimi na trdnem substratu pod pogoji, primernimi za vezavo protitelesa virusa JC v vzorcu z visoko prečiščenim virusu podobnim delcem; (c) zaznavanje ravni protitelesa virusa JC v predhodno inkubiranem vzorcu, ki se veže na imobilizirane visoko prečiščene virusu podobne delce; in (d) primerjavo zaznane ravni protitelesa virusa JC v predhodno inkubiranem biološkem vzorcu z ravnjo protitelesa virusa JC, zaznanega v biološkem vzorcu, pridobljenem iz subjekta, ki je bil predhodno inkubiran v raztopini brez visoko prečiščenih virusu podobnih delcev in je prišel stik z visoko prečiščenim virusu podobnim delcem, imobiliziranim na trdnem substratu pod pogoji, primernimi za vezavo protitelesa virusa JC v vzorcu z visoko prečiščenim virusu podobnim delcem, pri čemer so visoko prečiščeni virusu podobni delci sestavljeni iz najmanj 5, 50, 150 ali 360 polipeptidov VP1.
- 2. Metoda iz patentnega zahtevka 1, pri čemer znižanje nad določenim odstotkom za zaznano raven protitelesa virusa JC v predhodno inkubiranem biološkem vzorcu v primerjavi z biološkim vzorcem, pridobljenim iz subjekta, ki je bil predhodno inkubiran v raztopini brez visoko prečiščenih virusu podobnih delcev, pomeni, da je vzorec s protitelesom virusa JC pozitiven, sprememba zaznane ravni protitelesa virusa JC pod določenim odstotkom pa pomeni, da v vzorcu ni protitelesa, značilnega za virus JC.
- 3. Metoda iz patentnega zahtevka 1, pri čemer se stik biološkega vzorca z visoko prečiščenimi virusu podobnimi delci v raztopini izvede v časovnem obdobju, ki izbirno traja 30 minut, eno uro ali eno noč.
- 4. Metoda iz patentnega zahtevka 2, pri čemer je vrednost določenega odstotka 40 %.
- 5. Metoda iz patentnega zahtevka 2, pri čemer se za zaznavanje protiteles virusa JC v vzorcu, pridobljenem iz subjekta, izbere določeni odstotek, ki zagotavlja največ 3-odstotni delež lažno negativnih rezultatov.
- 6. Metoda iz patentnega zahtevka 2, pri čemer se za zaznavanje protiteles virusa JC v vzorcu, pridobljenem iz subjekta, izbere določeni odstotek, ki zagotavlja največ 1-odstotni delež lažno negativnih rezultatov.
- 7. Metoda iz patentnega zahtevka 2, pri čemer je biološki vzorec, pridobljen iz subjekta, s protitelesom virusa JC razvrščen kot negativen, če je raven protitelesa virusa JC v predhodno inkubiranem biološkem vzorcu, ki se veže na imobilizirane visoko prečiščene virusu podobne delce, približno enaka ravni protitelesa virusa JC, zaznani v biološkem vzorcu, pridobljenem iz subjekta, ki je bil predhodno inkubiran v raztopini brez visoko prečiščenih virusu podobnih delcev.
- 8. Metoda iz patentnega zahtevka 1, pri čemer visoko prečiščeni virusu podobni delci vsebujejo najmanj 1, 5, 10, 20, 30, 40, 50, 60, 70 ali 72 pentamerov VP1.
- 9. Metoda iz patentnega zahtevka 1, pri čemer velja naslednje: (i) visoko prečiščeni virusu podobni delec dodatno zajema najmanj en VP2 ali VP3 virusa JC; ali (ii) VP1 v visoko prečiščenem virusu podobnem delcu je rekombinantni VP1; ali (iii) najmanj en VP1 v visoko prečiščenem virusu podobnem delcu je mutirani VP1.
- 10. Metoda iz patentnega zahtevka 1, pri čemer je biološki vzorec serum.
- 11. Metoda iz patentnega zahtevka 1, pri čemer je vzorec pridobljen iz subjekta, ki mu je bil predpisan imunomodulator, subjekta, ki namerava jemati imunomodulator, ali subjekta, za katerega se domneva, da ima progresivno multifokalno levkoencefalopatijo, pri čemer je imunomodulator izbran med zdravljenjem proti VLA-4, zdravljenjem proti CD2, zdravljenjem proti CD11a ali mofetilmikofenolatom.
- 12. Metoda iz patentnega zahtevka 11, pri čemer subjektu, ki mu je bil predpisan imunomodulator ali ga namerava jemati, ta predhodno ni bil odmerjen.
- 13. Metoda iz patentnega zahtevka 11, pri čemer je subjekt predhodno prejel enega ali več odmerkov imunomodulatorja.
- 14. Metoda iz patentnega zahtevka 1 ali 2, pri čemer zaznavanje protitelesa virusa JC, ki se veže na visoko prečiščene virusu podobne delce, pomeni naslednje: (i) če je biološki vzorec s protitelesom virusa JC pozitiven, za subjekt obstaja povečano tveganje progresivne multifokalne levkoencefalopatije; ali (ii) če je biološki vzorec s protitelesom virusa JC pozitiven, subjekt ni primeren za zdravljenje z imunomodulatorjem; ali (iii) subjekt je primeren za zdravljenje z imunomodulatorjem in povečano spremljanje neželenih simptomov pri zdravljenju z imunomodulatorjem, pri čemer neželeni učinki po možnosti pomenijo razvoj progresivne multifokalne levkoencefalopatije.
- 15. Metoda iz patentnega zahtevka 1 ali 2, pri čemer nezmožnost zaznavanja protitelesa virusa JC, ki se veže na visoko prečiščene virusu podobne delce, pomeni, da je subjekt primeren za zdravljenje z imunomodulatorjem.
- 16. Metoda iz patentnega zahtevka 1 ali 2, pri čemer se za subjekt z biološkim vzorcem, za katerega je bilo pri prvem preizkusu ugotovljeno, da nima protiteles virusa JC, opravi ponoven preizkus prisotnosti protiteles virusa JC najmanj enkrat letno po prvem preizkusu.
- 17. Metoda iz patentnega zahtevka 1 ali 2, pri Čemer se za subjekt, za katerega je bilo sprva z metodo iz patentnega zahtevka 1 ali 2 ugotovljeno, da ima protitelesa virusa JC, pozneje izvede ponoven preizkus, da se ugotovi, ali so v subjektu še vedno prisotna protitelesa virusa JC.
- 18. Metoda iz katerega koli patentnega zahtevka 11-15, pri čemer je imunomodulator natalizumab.
- 19. Metoda iz patentnega zahtevka 1, pri čemer ima subjekt multiplo sklerozo ali Crohnovo bolezen.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US29404810P | 2010-01-11 | 2010-01-11 | |
US31619310P | 2010-03-22 | 2010-03-22 | |
EP11732315.4A EP2524060B1 (en) | 2010-01-11 | 2011-01-11 | Assay for jc virus antibodies |
PCT/US2011/020832 WO2011085369A1 (en) | 2010-01-11 | 2011-01-11 | Assay for jc virus antibodies |
Publications (1)
Publication Number | Publication Date |
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SI2524060T1 true SI2524060T1 (sl) | 2018-05-31 |
Family
ID=44305841
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SI201131438T SI2524060T1 (sl) | 2010-01-11 | 2011-01-11 | Preiskava za protitelesa virusa JC |
SI201132069T SI3339865T1 (sl) | 2010-01-11 | 2011-01-11 | Preiskava za protitelesa virusa JC |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SI201132069T SI3339865T1 (sl) | 2010-01-11 | 2011-01-11 | Preiskava za protitelesa virusa JC |
Country Status (27)
Country | Link |
---|---|
US (2) | US9316641B2 (sl) |
EP (3) | EP2524060B1 (sl) |
JP (2) | JP5946218B2 (sl) |
KR (1) | KR101877576B1 (sl) |
CN (1) | CN102906278A (sl) |
AU (1) | AU2011203815B2 (sl) |
BR (1) | BR112012017014B1 (sl) |
CA (1) | CA2784137A1 (sl) |
CY (2) | CY1119972T1 (sl) |
DK (2) | DK2524060T3 (sl) |
ES (2) | ES2664173T3 (sl) |
FI (1) | FI3339865T5 (sl) |
HK (1) | HK1255318A1 (sl) |
HR (2) | HRP20221390T1 (sl) |
HU (2) | HUE060312T2 (sl) |
IN (1) | IN2012DN06139A (sl) |
LT (2) | LT2524060T (sl) |
ME (1) | ME03026B (sl) |
MX (1) | MX341991B (sl) |
NO (1) | NO2524060T3 (sl) |
NZ (1) | NZ600681A (sl) |
PL (2) | PL2524060T3 (sl) |
PT (2) | PT3339865T (sl) |
RS (2) | RS63744B1 (sl) |
SG (2) | SG181653A1 (sl) |
SI (2) | SI2524060T1 (sl) |
WO (1) | WO2011085369A1 (sl) |
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HRP20221390T1 (hr) | 2010-01-11 | 2023-01-06 | Biogen Ma Inc. | Analiza za antitijela jc virusa |
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