FI3339865T3 - - Google Patents
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- Publication number
- FI3339865T3 FI3339865T3 FI17203178T FI17203178T FI3339865T3 FI 3339865 T3 FI3339865 T3 FI 3339865T3 FI 17203178 T FI17203178 T FI 17203178T FI 17203178 T FI17203178 T FI 17203178T FI 3339865 T3 FI3339865 T3 FI 3339865T3
- Authority
- FI
- Finland
- Prior art keywords
- jcv
- sample
- subject
- amount
- hpvlp
- Prior art date
Links
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
- G01N33/53—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
- 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
- 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
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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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Urology & Nephrology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Virology (AREA)
- Medicinal Chemistry (AREA)
- Pathology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Food Science & Technology (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Tropical Medicine & Parasitology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Peptides Or Proteins (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Claims (13)
1. In vitro -menetelmä tutkittavan tunnistamiseksi sellaiseksi, jolla on kohonnut progressiivisen multifokaalisen leukoenkefalopatian (PML) riski, jolloin tutkittavalla tunnistetaan olevan kohonnut PML-riski, jos tutkittavalta saatu biologinen näyte on positiivinen JCV-vasta-aineen suhteen, jolloin JCV-vasta-aineen määrä määritetään seuraavalla tavalla: (a) tutkittavalta saatu biologinen näyte saatetaan yhteen sellaisten erittäin puhtaaksi puhdistettujen viruksen kaltaisten partikkelien (HPVLP) kanssa, jotka koostuvat pääasiassa JC-viruksen (JCV) VP1-proteiinista, liuoksessa näytteessä olevan JCV-vasta-aineen HPVLP:hen sitomiseen soveltuvissa olosuhteissa, jolloin saadaan esi-inkuboitu näyte (b) esi-inkuboitu näyte saatetaan yhteen sellaisten HPVLP:eiden kanssa, jotka koostuvat pääasiassa JCV:n VP1-proteiinista ja jotka on immobilisoitu kiinteään substraattiin näytteessä olevan JCV-vasta-aineen HPVLP:hen sitomiseen soveltuvissa olosuhteissa (c) havaitaan JCV-vasta-aineen immobilisoituihin HPVLP:eihin sitoutunut määrä esi-inkuboidusta näytteestä (d) saatetaan osa biologisesta näytteestä, jota inkuboitiin HPVLP:eitä sisältämättömässä liuoksessa, yhteen samoissa olosuhteissa kuin vaiheessa (b) käytettiin ja havaitaan JCV-vasta-aineen immobilisoituun HPVLP:hen sitoutunut määrä ja (e) verrataan vaiheiden (a)—(c) esi-inkuboidusta näytteestä havaittua JCV-vasta- aineen määrää JCV-vasta-aineen määrään, joka havaittiin tutkittavalta vaiheen (d) näytteestä; jolloin havaitun JCV-vasta-aineen määrän laskeminen esi-inkuboidussa näytteessä verrattuna tutkittavalta saatuun näytteeseen, jota inkuboitiin HPVLP:eitä sisältämättömässä liuoksessa, viittaa siihen, että näyte on positiivinen JCV-vasta-aineen suhteen, ja JCV-vasta-aineen havaitun määrän muuttuminen määritettyä prosenttiosuutta vähemmän viittaa siihen, ettei näytteessä ole JCV- spesifistä vasta-ainetta, jolloin HPVLP:t koostuvat useammasta kuin 5:stä, vähintään 50:stä, 150:stä tai 360:stä VP1-polypeptidistä; jolloin menetelmä sisältää lisäksi anti-JCV-vasta-aineiden määrän määrittämisen tutkittavalta näytteestä, joka on myöhemmältä päivämäärältä kuin alkuperäinen näyte, myöhemmän päivämäärän näytteen sisältämien anti-JCV-vasta- aineiden määrän vertaamisen alkuperäisessä näytteessä olevaan määrään ja sen määrittämisen, onko tutkittavan PML-riski koholla myöhempänä päivämääränä verrattuna — alkuperäisen näytteen ajankohtaan.
2. Patenttivaatimuksen 1 mukainen menetelmä, jossa biologinen näyte saatetaan yhteen HPVLP:eiden kanssa liuokseen sellaisen ajanjakson ajaksi, joka valitaan 30 minuutin, yhden tunnin tai yön ajan joukosta, 4 *C:n lämpötilaan.
3. Jommankumman patenttivaatimuksen 1 tai 2 mukainen menetelmä, jossa määritetty prosenttiosuus on 40 %.
4. Jonkin patenttivaatimuksista 1-3 mukainen menetelmä, jossa määritys antaa enintään 3 %:n virheellisten negatiivisten tulosten määrän JCV-vasta-aineiden havaitsemisessa tutkittavalta saadusta biologisesta näytteestä.
5. Jonkin patenttivaatimuksista 1-4 mukainen menetelmä, jossa määritys antaa enintään 1 %:n virheellisten negatiivisten tulosten määrän JCV-vasta-aineiden havaitsemisessa — tutkittavalta saadusta biologisesta näytteestä.
6. Jonkin patenttivaatimuksista 1-5 mukainen menetelmä, jossa HPVLP:t sisältävät useamman kuin 1 VP1-pentameerin, vähintään 5, 10, 20, 30, 40, 50, 60, 70 tai 72 VP1- pentameeriä.
7. Jonkin patenttivaatimuksista 1-6 mukainen menetelmä, jossa
(i) HPVLP käsittää lisäksi vähintään toisen JCV VP2:n ja JCV VP3:n joukosta tai (i) HPVLP:n VP1 on rekombinantti VP1 tai (iii) vähintään yksi HPVLP:n VP1 on mutantti VP1.
8. Jonkin patenttivaatimuksista 1-7 mukainen menetelmä, jossa biologinen näyte on seerumi.
9. Jonkin patenttivaatimuksista 1-8 mukainen menetelmä, jossa biologinen näyte on — tutkittavalta, jolle on määrätty immunomodulaattoria, tai tutkittavalta, joka harkitsee immunomodulaattorin aloittamista, jolloin immunomodulaattori valitaan anti-VLA-4- hoidon ja anti-CD20-hoidon, anti-CD11a-hoidon ja mykofenolaattimofetiilin joukosta.
10. Patenttivaatimuksen 9 mukainen menetelmä, jossa tutkittava (a) ei ole saanut aiemmin kyseistä immunomodulaattoria tai (b) on saanut aiemmin yhden tai useamman annoksen kyseistä immunomodulaattoria.
11. Jonkin patenttivaatimuksista 1-10 mukainen menetelmä, jossa tutkittava, jonka biologisesta näytteestä on määritetty alkutestauksessa, ettei se sisällä JC V-vasta-aineita, testataan uudelleen vähintään vuosittain JCV-vasta-aineiden läsnäolon suhteen alkutestauksen jälkeen.
12. Jommankumman patenttivaatimuksen 9 tai 10 mukainen menetelmä, jossa immunomodulaattori on natalitsumabi.
13. Jonkin patenttivaatimuksista 1-12 mukainen menetelmä, jossa tutkittavalla on multippeliskleroosi (MS) tai Crohnin tauti (CD).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US29404810P | 2010-01-11 | 2010-01-11 | |
| US31619310P | 2010-03-22 | 2010-03-22 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| FI3339865T3 true FI3339865T3 (fi) | 2022-11-30 |
| FI3339865T5 FI3339865T5 (fi) | 2023-04-15 |
Family
ID=44305841
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FIEP17203178.3T FI3339865T5 (fi) | 2010-01-11 | 2011-01-11 | Jc-viruksen vasta-aineiden määritys |
Country Status (27)
| Country | Link |
|---|---|
| US (2) | US9316641B2 (fi) |
| EP (3) | EP4152004A1 (fi) |
| JP (2) | JP5946218B2 (fi) |
| KR (1) | KR101877576B1 (fi) |
| CN (1) | CN102906278A (fi) |
| AU (1) | AU2011203815B2 (fi) |
| BR (1) | BR112012017014B1 (fi) |
| CA (1) | CA2784137A1 (fi) |
| CY (2) | CY1119972T1 (fi) |
| DK (2) | DK3339865T5 (fi) |
| ES (2) | ES2664173T3 (fi) |
| FI (1) | FI3339865T5 (fi) |
| HK (1) | HK1255318A1 (fi) |
| HR (2) | HRP20221390T1 (fi) |
| HU (2) | HUE060312T2 (fi) |
| IN (1) | IN2012DN06139A (fi) |
| LT (2) | LT3339865T (fi) |
| ME (1) | ME03026B (fi) |
| MX (1) | MX341991B (fi) |
| NO (1) | NO2524060T3 (fi) |
| NZ (1) | NZ600681A (fi) |
| PL (2) | PL2524060T3 (fi) |
| PT (2) | PT2524060T (fi) |
| RS (2) | RS63744B1 (fi) |
| SG (2) | SG181653A1 (fi) |
| SI (2) | SI3339865T1 (fi) |
| WO (1) | WO2011085369A1 (fi) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1872136B9 (en) | 2005-04-04 | 2023-02-08 | Biogen MA Inc. | Methods and products for evaluating an immune response to a therapeutic protein |
| LT2676967T (lt) | 2006-02-28 | 2019-09-10 | Biogen Ma Inc. | Uždegiminių ir autoimuninių ligų gydymo būdai su natalizumabu |
| KR20080104343A (ko) | 2006-03-03 | 2008-12-02 | 엘란 파마슈티칼스, 인크. | 나탈리주마브로 염증 및 자가면역 질환을 치료하는 방법 |
| CA2776756A1 (en) | 2009-10-11 | 2011-04-14 | Biogen Idec Ma Inc. | Anti-vla-4 related assays |
| LT3339865T (lt) | 2010-01-11 | 2022-12-12 | Biogen Ma Inc. | Tyrimas, skirtas antikūnams prieš jc virusą nustatyti |
| US11287423B2 (en) * | 2010-01-11 | 2022-03-29 | Biogen Ma Inc. | Assay for JC virus antibodies |
| JP6243838B2 (ja) * | 2011-05-31 | 2017-12-06 | バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． | Ｐｍｌの危険性を査定する方法 |
| EP2791162A2 (en) * | 2011-12-12 | 2014-10-22 | Janssen Diagnostics BVBA | Polyomavirus peptide sequences |
| US20130273549A1 (en) * | 2012-04-16 | 2013-10-17 | Board Of Regents, The University Of Texas System | Detection of extracellular jcv micrornas |
| US9631243B2 (en) | 2012-06-18 | 2017-04-25 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Methods and compositions for identifying JC virus |
| EP2938631B1 (en) * | 2012-12-31 | 2018-12-19 | Neurimmune Holding AG | Recombinant human antibodies for therapy and prevention of polyomavirus-related diseases |
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| EP3004334A4 (en) | 2013-05-28 | 2016-12-21 | Biogen Ma Inc | METHODS OF EVALUATION RISK OF DEVELOPMENT OF PML |
| EP3757224A3 (en) | 2014-02-27 | 2021-03-17 | 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. |
| US20210002372A1 (en) * | 2018-03-02 | 2021-01-07 | United States Government As Represented By The Department Of Veterans Affairs | Methods and compositions for treating natalizumab-associated progressive multifocal encephalopathy |
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