HRP20180356T1 - Ispitivanje na protutijela protiv virusa jc - Google Patents
Ispitivanje na protutijela protiv virusa jc Download PDFInfo
- Publication number
- HRP20180356T1 HRP20180356T1 HRP20180356TT HRP20180356T HRP20180356T1 HR P20180356 T1 HRP20180356 T1 HR P20180356T1 HR P20180356T T HRP20180356T T HR P20180356TT HR P20180356 T HRP20180356 T HR P20180356T HR P20180356 T1 HRP20180356 T1 HR P20180356T1
- Authority
- HR
- Croatia
- Prior art keywords
- jcv
- subject
- immunomodulator
- biological sample
- hpvlps
- Prior art date
Links
- 241000700605 Viruses Species 0.000 title 1
- 238000003556 assay Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 20
- 241000701460 JC polyomavirus Species 0.000 claims 17
- 239000012472 biological sample Substances 0.000 claims 13
- 239000002955 immunomodulating agent Substances 0.000 claims 12
- 229940121354 immunomodulator Drugs 0.000 claims 12
- 230000002584 immunomodulator Effects 0.000 claims 12
- 239000000523 sample Substances 0.000 claims 11
- 206010036807 progressive multifocal leukoencephalopathy Diseases 0.000 claims 4
- 238000002560 therapeutic procedure Methods 0.000 claims 3
- 208000011231 Crohn disease Diseases 0.000 claims 2
- 230000002411 adverse Effects 0.000 claims 2
- 238000013101 initial test Methods 0.000 claims 2
- 201000006417 multiple sclerosis Diseases 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 239000000758 substrate Substances 0.000 claims 2
- 208000024891 symptom Diseases 0.000 claims 2
- 108010008212 Integrin alpha4beta1 Proteins 0.000 claims 1
- 238000001514 detection method Methods 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- RTGDFNSFWBGLEC-SYZQJQIISA-N mycophenolate mofetil Chemical compound COC1=C(C)C=2COC(=O)C=2C(O)=C1C\C=C(/C)CCC(=O)OCCN1CCOCC1 RTGDFNSFWBGLEC-SYZQJQIISA-N 0.000 claims 1
- 229960004866 mycophenolate mofetil Drugs 0.000 claims 1
- 229960005027 natalizumab Drugs 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 229920001184 polypeptide Polymers 0.000 claims 1
- 102000004196 processed proteins & peptides Human genes 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 210000002966 serum Anatomy 0.000 claims 1
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
-
- 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
-
- 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
-
- 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
-
- 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)
1. Postupak in vitro, naznačen time što se sastoji u:
(a) stavljanju u kontakt biološkog uzorka dobivenog iz subjekta s visoko pročišćenim česticama sličnim virusima (HPVLP-i), koje se pretežno sastoje od proteina VP1 iz virusa JC (JCV), u otopini u uvjetima pogodnim za vezanje protutijela protiv JCV u uzorku na HPVLP, čime se dobiva predinkubiran uzorak;
(b) stavljanju u kontakt predinkubiranog uzorka s HPVLP-ima, koji se pretežno sastoje od proteina VP1 iz JCV, imobiliziranih na čvrsti supstrat u uvjetima pogodnim za vezanje protutijela protiv JCV u uzorku na HPVLP;
(c) detektiranju razine protutijela protiv JCV u predinkubiranom uzorku koja se vežu na imobilizirane HPVLP-e; i
(d) uspoređivanju detektirane razine protutijela protiv JCV u predinkubiranom biološkom uzorku s razinom protutijela protiv JCV detektiranom u biološkom uzorku dobivenom iz subjekta predinkubiranom u otopini bez HPVLP-a, te stavljenom u kontakt s HPVLP imobiliziranim na čvrsti supstrat u uvjetima pogodnim za vezanje protutijela protiv JCV u uzorku na HPVLP,
gdje se HPVLP-i sastoje od više od 5, najmanje 50, 150 ili 360 polipeptida VP1.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što smanjenje iznad specificiranog postotka za detektiranu razinu protutijela protiv JCV u predinkubiranom biološkom uzorku u usporedbi s biološkim uzorkom dobivenim iz subjekta predinkubiranom u otopini bez HPVLP-a ukazuje da je uzorak pozitivan na protutijelo protiv JCV, a promjena u detektiranoj razini protutijela protiv JCV ispod specificiranog postotka ukazuje da u uzorku nema protutijela specifičnog za JCV.
3. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se biološki uzorak stavlja u kontakt s HPVLP-ima u otopini kroz vremenski period koji se bira između 30 minuta, jedan sat, ili preko noći.
4. Postupak u skladu s patentnim zahtjevom 2, naznačen time što je specificirani postotak 40%.
5. Postupak u skladu s patentnim zahtjevom 2, naznačen time što se specificirani postotak bira tako da se osigura lažno negativna stopa od 3% ili manja radi detektiranja protutijela protiv JCV u uzorku dobivenom iz subjekta.
6. Postupak u skladu s patentnim zahtjevom 2, naznačen time što se specificirani postotak bira tako da se osigura lažno negativna stopa od 1% ili manja radi detektiranja protutijela protiv JCV u uzorku dobivenom iz subjekta.
7. Postupak u skladu s patentnim zahtjevom 2, naznačen time što biološki uzorak dobiven iz subjekta se klasificira kao negativan na protutijelo protiv JCV kada je razina protutijela protiv JCV u predinkubiranom biološkom uzorku koja se vežu na imobilizirane HPVLP-e otprilike ista kao razina protutijela protiv JCV detektirana u biološkom uzorku dobivenom iz subjekta predinkubiranom u otopini bez HPVLP-a.
8. Postupak u skladu s patentnim zahtjevom 1, naznačen time što HPVLP-i sadrže više od 1, najmanje 5, 10, 20, 30, 40, 50, 60, 70 ili 72 pentamera VP1.
9. Postupak u skladu s patentnim zahtjevom 1, naznačen time što:
(i) HPVLP dodatno sadrži najmanje jedan od JCV VP2, ili JCV VP3; ili
(ii) VP1 u HPVLP je rekombinantni VP1; ili
(iii) najmanje jedan VP1 u HPVLP je mutantni VP1.
10. Postupak u skladu s patentnim zahtjevom 1, naznačen time što je biološki uzorak serum.
11. Postupak u skladu s patentnim zahtjevom 1, naznačen time što je uzorak iz subjekta kojem je prepisan imunomodulator, se smatra da subjekt treba uzeti imunomodulator, ili se sumnja da subjekt ima progresivnu multifokalnu leukoencefalopatiju (PML), gdje se imunomodulator bira između terapije protiv VLA-4, terapije protiv CD2, terapije protiv CD11a, ili mikofenolat mofetila.
12. Postupak u skladu s patentnim zahtjevom 11, naznačen time što na subjektu kojem je prepisan imunomodulator, ili se smatra da treba uzeti imunomodulator, nije ranije primijenjen imunomodulator.
13. Postupak u skladu s patentnim zahtjevom 11, naznačen time što je subjekt ranije primao jednu ili više doza imunomodulatora.
14. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što detektiranje protutijela protiv JCV koja se vežu na HPVLP-e ukazuje da subjekt:
(i) je pod povišenim rizikom od PML ako je biološki uzorak pozitivan na protutijelo protiv JCV; ili
(ii) nije kandidat da primi liječenje imunomodulatorom ako je biološki uzorak pozitivan na protutijelo protiv JCV; ili
(iii) je kandidat da primi liječenje imunomodulatorom i pojačani nadzor na nepoželjne simptome prilikom liječenja imunomodulatorom, izborno kada nepoželjni simptomi ukazuju na razvoj PML.
15. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što nemogućnost detektiranja vezanja protutijela protiv JCV na HPVLP-e ukazuje da je subjekt kandidat da primi liječenje imunomodulatorom.
16. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što se subjekt koji ima biološki uzorak za koji je utvrđeno da ne sadrži protutijela protiv JCV kod početnog testiranja ponovno testira najmanje jednom godišnje na prisutnost protutijela protiv JCV nakon početnog testiranja.
17. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što se subjekt kod kojeg je prvog dana utvrđeno postupkom u skladu s patentnim zahtjevom 1 ili 2 da ima protutijela protiv JCV ponovno testira kasnije kako bi se utvrdilo nema li subjekt protutijela protiv JCV.
18. Postupak u skladu s bilo kojim od patentnih zahtjeva 11-15, naznačen time što je imunomodulator natalizumab.
19. Postupak u skladu s patentnim zahtjevom 1, naznačen time što subjekt ima multiplu sklerozu (MS) ili Crohnovu bolest (CD).
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 | |
| PCT/US2011/020832 WO2011085369A1 (en) | 2010-01-11 | 2011-01-11 | Assay for jc virus antibodies |
| EP11732315.4A EP2524060B1 (en) | 2010-01-11 | 2011-01-11 | Assay for jc virus antibodies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180356T1 true HRP20180356T1 (hr) | 2018-04-06 |
Family
ID=44305841
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221390TT HRP20221390T1 (hr) | 2010-01-11 | 2011-01-11 | Analiza za antitijela jc virusa |
| HRP20180356TT HRP20180356T1 (hr) | 2010-01-11 | 2018-02-27 | Ispitivanje na protutijela protiv virusa jc |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221390TT HRP20221390T1 (hr) | 2010-01-11 | 2011-01-11 | Analiza za antitijela jc virusa |
Country Status (27)
| Country | Link |
|---|---|
| US (2) | US9316641B2 (hr) |
| EP (3) | EP4152004A1 (hr) |
| JP (2) | JP5946218B2 (hr) |
| KR (1) | KR101877576B1 (hr) |
| CN (1) | CN102906278A (hr) |
| AU (1) | AU2011203815B2 (hr) |
| BR (1) | BR112012017014B1 (hr) |
| CA (1) | CA2784137A1 (hr) |
| CY (2) | CY1119972T1 (hr) |
| DK (2) | DK3339865T5 (hr) |
| ES (2) | ES2930469T3 (hr) |
| FI (1) | FI3339865T5 (hr) |
| HK (1) | HK1255318A1 (hr) |
| HR (2) | HRP20221390T1 (hr) |
| HU (2) | HUE060312T2 (hr) |
| IN (1) | IN2012DN06139A (hr) |
| LT (2) | LT2524060T (hr) |
| ME (1) | ME03026B (hr) |
| MX (1) | MX341991B (hr) |
| NO (1) | NO2524060T3 (hr) |
| NZ (1) | NZ600681A (hr) |
| PL (2) | PL3339865T3 (hr) |
| PT (2) | PT2524060T (hr) |
| RS (2) | RS63744B1 (hr) |
| SG (2) | SG181653A1 (hr) |
| SI (2) | SI3339865T1 (hr) |
| WO (1) | WO2011085369A1 (hr) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
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| PL3264094T3 (pl) | 2005-04-04 | 2021-04-19 | Biogen Ma Inc. | Sposoby oceniania odpowiedzi immunologicznej na środek leczniczy |
| JP2009528359A (ja) | 2006-02-28 | 2009-08-06 | エラン ファーマシューティカルズ，インコーポレイテッド | ナタリズマブを用いて炎症性疾患および自己免疫性疾患を治療する方法 |
| KR20080104343A (ko) | 2006-03-03 | 2008-12-02 | 엘란 파마슈티칼스, 인크. | 나탈리주마브로 염증 및 자가면역 질환을 치료하는 방법 |
| EP3349010A1 (en) | 2009-10-11 | 2018-07-18 | Biogen MA Inc. | Anti-vla-4 related assays |
| HUE060312T2 (hu) | 2010-01-11 | 2023-02-28 | Biogen Ma Inc | A JC vírus antitestek vizsgálata |
| US11287423B2 (en) | 2010-01-11 | 2022-03-29 | Biogen Ma Inc. | Assay for JC virus antibodies |
| FI3575792T3 (fi) * | 2011-05-31 | 2023-03-17 | Pml-riskin arviointimenetelmä | |
| US20150065367A1 (en) * | 2011-12-12 | 2015-03-05 | Janssen Diagnostics Bvba | Polyomavirus peptide sequences |
| WO2013158674A1 (en) * | 2012-04-16 | 2013-10-24 | Board Of Regents, The University Of Texas System | Detection of extracellular jcv micrornas |
| WO2013192100A1 (en) | 2012-06-18 | 2013-12-27 | The United States Of America, As Represented By The Secretary, Department Of Health & Human Services | Methods and compositions for detecting jc virus |
| EP3517545A1 (en) * | 2012-12-31 | 2019-07-31 | Neurimmune Holding AG | Recombinant human antibodies for therapy and prevention of polyomavirus-related diseases |
| US9949671B2 (en) | 2013-03-13 | 2018-04-24 | Orthoaccel Technologies, Inc. | Diagnostic mouthpieces |
| EP3004334A4 (en) | 2013-05-28 | 2016-12-21 | Biogen Ma Inc | METHODS OF EVALUATION RISK OF DEVELOPMENT OF PML |
| US10955422B2 (en) | 2014-02-27 | 2021-03-23 | Biogen Ma, Inc. | Method of assessing risk of PML |
| MA40985A (fr) | 2014-11-17 | 2017-09-26 | Biogen Ma Inc | Méthodes de traitement de la sclérose en plaques |
| IT201600083859A1 (it) * | 2016-08-09 | 2018-02-09 | Univ Degli Studi Di Ferrara | Immunosaggio per l’identificazione di anticorpi contro il virus Polioma JC (JCPyV) mediante l’uso di peptidi sintetici. |
| WO2019169317A1 (en) * | 2018-03-02 | 2019-09-06 | Stueve Olaf | Methods and compositions for treating natalizumab-associated progressive multifocal encephalopathy |
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