DK2535428T3 - Biologisk prøvesamlings- og transportsystem, og fremgangsmåder til anvendelse - Google Patents
Biologisk prøvesamlings- og transportsystem, og fremgangsmåder til anvendelse Download PDFInfo
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- DK2535428T3 DK2535428T3 DK12180376.1T DK12180376T DK2535428T3 DK 2535428 T3 DK2535428 T3 DK 2535428T3 DK 12180376 T DK12180376 T DK 12180376T DK 2535428 T3 DK2535428 T3 DK 2535428T3
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
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- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Sampling And Sample Adjustment (AREA)
Claims (16)
1. En vandholdig sammensætning, der omfatter som komponenter: én chaotrop til stede i en mængde fra 0,5 M til 6 M; ét rengøringsmiddel til stede i en mængde fra 0,1 % til 1 % (wt./vol.), hvor rengøringsmidlet omfatter natriumdodecylsulfat (SDS), lithiumdodecylsulfat (LDS), natrium-taurodeoxycholat (NaTDC), natrium-taurocholat (NaTC), natrium-glycocholat (NaGC), na-trium-deoxycholat (NaDC), natriumcholat, natrium-alkylbenzensulfonat (NaABS), N-lauroylsarcosin (NLS), salte af carboxylsyrer, salte af sulfonsyrer, salte af svovlsyre, phosphor- og polyphosphorsyreestere, alkylphosphater, monoalkylphosphat (MAP), salte af perfluorcarboxylsyrer, anioniske rengøringsmidler og enhver kombination deraf; ét reduktionsmiddel, hvor reduktionsmidlet er β-ΜΕ, DTT, DMSO eller formamid, til stede i en mængde fra 0,05 M til 0,3 M, eller hvor reduktionsmidlet er TCEP til stede i en mængde fra 0,5 mM til 30 mM; én chelatdanner til stede i en mængde fra 0,5 mM til 50 mM; ét overfladeaktivt stof til stede i en mængde fra 0,0001 % til 0,3 % (wt./vol.), hvor det overfladeaktive stof omfatter cocoamidopropyl-hydroxysultain, alkylaminpropionsyrer, imidazolin-carboxylater, betainer, sulfobetainer, sultainer, alkylphenol-ethoxylater, alkohol-ethoxylater, polyoxyethylenerede polyoxypropylenglycoler, polyoxyethylenerede mer-captaner, langkædede carboxylsyreestere, alkonolamider, tertiære acetylenglycoler, polyoxyethylenerede siliconer, N-alkylpyrrolidoner, alkylpolyglycosidaser, siliconepolymerer såsom Antifoam A® eller polysorbater såsom Tween® eller enhver kombination deraf; én kortkædet alkanol til stede i en mængde fra 1 til 25 % (vol./vol.); én buffer, der tilvejebringer sammensætningen en pH-værdi fra 6 til 7; og nuclease-frit vand, hvor komponenterne sammen er til stede i en mængde, der er tilstrækkelig til at denaturere proteiner, inaktivere nucleaser, dræbe patogener og ikke forringe nukleinsyre i en prøve, der er mistænkt for at indeholde patogener, når prøven bringes i kontakt med sammensætningen.
2. Sammensætningen i henhold til krav 1, hvor den ene buffer tilvejebringer sammensætningen en pH-værdi fra 6,4 til 6,8.
3. Sammensætningen i henhold til krav 1 eller krav 2, hvor den ene chaotrop omfatter guanidin-thiocyanat, guanidin-isocyanat eller guanidin-hydrochlorid.
4. Sammensætningen i henhold til krav 1 eller 3, hvor det ene rengøringsmiddel omfatter natriumdodecylsulfat, lithiumdodecylsulfat, natriumtaurodeoxycholat, natriumtauro-cholat, natriumglycocholat, natriumdeoxycholat, natriumcholat, natrium-alkylbenzensulfonat eller /V-lauroylsarcosin.
5. Sammensætningen i henhold til ethvert krav 1 til 4, hvor det ene reduktionsmiddel omfatter 2-mercaptoethanol, tris(2-carboxyethyl)phosphin, dithiothreitol, dimethylsul-foxid eller tris(2-carboxyethyl)phosphin.
6. Sammensætningen i henhold til ethvert krav 1 til 5, hvor den ene chelatdanner omfatter ethylenglycoltetraeddikesyre, hydroxyethylethylendiamintrieddikesyre, diethy-lentriaminpentaeddikesyre, /V//V-bis(carboxymethyl)glycin, ethylendiamintetraeddikesyre, vandfrit citrat, natriumcitrat, calciumcitrat, ammoniumcitrat, ammoniumbicitrat, citronsyre, diammoniumcitrat, ferriammoniumcitrat eller lithiumcitrat.
7. Sammensætningen i henhold til ethvert krav 1 til 6, hvor det ene kortkædede al-kanol omfatter methanol, ethanol, propanol, butanol, pentanol eller hexanol.
8. Sammensætningen i henhold til ethvert krav 1 til 7, hvor den ene buffer omfatter tris(hydroxymethyl)aminomethan, citrat, 2-(/V-morpholino)ethansulfonsyre, N,N- Bis(2-hydroxyethyl)-2 -aminoethansulfonsyre, l,3-bis(tris(hydroxymethyl)methylamino)propan, 4-(2-hydroxyethyl)-l-piperazinethansulfonsyre, 3-(/V-morpholino)propansulfonsyre, bicar-bonat eller phosphat.
9. Sammensætningen i henhold til ethvert krav 1 til 8, hvor patogenerne omfatter influenzavirus, celler inficeret med influenzavirus, tuberkulosebakterier eller celler inficeret med tuberkulosebakterier.
10. Sammensætningen i henhold til ethvert krav 1 til 9, der yderligere omfatter nøgen RNA, DNA eller en kombination deraf; fakultativt hvor den nøgne RNA, DNA eller kombination deraf fungerer som et bærestof eller indeholder en forudbestemt nukleinsyresekvens som en intern positiv kontrol.
11. Sammensætningen i henhold til ethvert krav 1 til 10, hvor den ene chaotrop, det ene rengøringsmiddel, det ene reduktionsmiddel, den ene chelatdanner, det ene overfladeaktive stof, den ene kortkædede alkanol og/eller den ene buffer omfatter en eller flere chaotroper, et eller flere rengøringsmidler, et eller flere reduktionsmidler, en eller flere chelatdannere, et eller flere overfladeaktive stoffer, en eller flere kortkædede al kanoler og/eller en eller flere buffere.
12. Et prøveindsamlingssystem, der omfatter: en indsamlingsanordning til indsamling af prøven og et indsamlingskar, hvori prøven er anbragt, hvor indsamlingskarret indeholder en mængde af sammensætningen i henhold til ethvert krav 1 til 11, hvor sammensætningen effektivt kan opretholde integriteten af den nukleinsyre, der kan være til stede i sammensætningen, for at muliggøre PCR-identifikation af et patogen til stede i prøven, når sammensætningen, der indeholder prøven, opbevares ved en omgivende temperatur eller højere i en periode på 7 dage eller mere.
13. En metode til at påvise en nukleinsyresekvens, der er en indikation på tilstedeværelse af et patogen i prøven, som i ét trin omfatter, at prøven bringes i kontakt med en mængde af den vandholdige sammensætning i henhold til ethvert krav 1 til 11, hvor sammensætningen effektivt kan dræbe alle patogener i prøven uden at forringe eller ændre prøvens nukleinsyre, så patogenets nukleinsyresekvens kan påvises ved PCR-forstærkning.
14. Metoden i henhold til krav 13, hvor patogenet omfatter bakterier, virus eller en fungus; fakultativt hvor bakterierne er tuberkulose, eller virusset er influenza.
15. Metoden i henhold til ethvert krav 13 eller 14, hvor nukleinsyresekvensen er til stede i sammensætningen med en mængde fra 1 pg/mL til 1 pg/mL.
16. En metode til at fremstille den vandholdige sammensætning i henhold til ethvert krav 1 til 11, som omfatter: kombinering af nævnte ene chaotrop og nuclease-frit vand ved en temperatur på 20 °C til 90 °C; kombinering af den ene chaotrop med ét reduktionsmiddel, én chelatdanner, ét overfladeaktivt stof og ét rengøringsmiddel for at danne en mellemsammensætning; fakultativt kombinering af en siliconepolymer med mellemsammensætningen i en mængde, der er tilstrækkelig til at minimere skumdannelse under yderligere fremstilling; kombinering af en tilstrækkelig mængde buffer til mellemsammensætningen for at opnå en pH-værdi på 5 til 7; forøgelse af mellemsammensætningens temperatur til 60 til 95 °C i 1 til 30 minutter og derefter sænkning af temperaturen til omgivende temperatur; kombinering afen Ci-6alkohol med mellemsammensætningen; og justering af formuleringens pH-værdi til mellem 6 og 7 for at danne den vandholdige sammensætning.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US97672807P | 2007-10-01 | 2007-10-01 | |
EP08866356A EP2195466B1 (en) | 2007-10-01 | 2008-10-01 | Method of storing biological specimens |
Publications (1)
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DK2535428T3 true DK2535428T3 (da) | 2015-11-23 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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DK08866356.2T DK2195466T3 (da) | 2007-10-01 | 2008-10-01 | Fremgangsmåde til opbevaring af biologiske prøver |
DK12180376.1T DK2535428T3 (da) | 2007-10-01 | 2008-10-01 | Biologisk prøvesamlings- og transportsystem, og fremgangsmåder til anvendelse |
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DK08866356.2T DK2195466T3 (da) | 2007-10-01 | 2008-10-01 | Fremgangsmåde til opbevaring af biologiske prøver |
Country Status (10)
Country | Link |
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US (5) | US8084443B2 (da) |
EP (3) | EP2535428B1 (da) |
AU (1) | AU2008343745B2 (da) |
CA (2) | CA2701168A1 (da) |
DK (2) | DK2195466T3 (da) |
ES (1) | ES2552858T3 (da) |
IL (1) | IL204756A (da) |
NZ (1) | NZ584308A (da) |
WO (1) | WO2009085355A2 (da) |
ZA (1) | ZA201002174B (da) |
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DK2195466T3 (da) | 2013-01-14 |
EP2535428B1 (en) | 2015-09-09 |
US8084443B2 (en) | 2011-12-27 |
US9212399B2 (en) | 2015-12-15 |
AU2008343745B2 (en) | 2012-05-10 |
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US20120100529A1 (en) | 2012-04-26 |
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US8415330B2 (en) | 2013-04-09 |
US20130040288A1 (en) | 2013-02-14 |
US8669240B2 (en) | 2014-03-11 |
EP2195466A2 (en) | 2010-06-16 |
EP2535428A3 (en) | 2013-03-27 |
US8293467B2 (en) | 2012-10-23 |
WO2009085355A2 (en) | 2009-07-09 |
EP3020832A1 (en) | 2016-05-18 |
CA2701168A1 (en) | 2009-07-09 |
AU2008343745A1 (en) | 2009-07-09 |
CA2861667C (en) | 2017-06-13 |
CA2861667A1 (en) | 2009-07-09 |
US20140193804A1 (en) | 2014-07-10 |
EP2535428A2 (en) | 2012-12-19 |
EP2195466B1 (en) | 2012-10-10 |
ES2552858T3 (es) | 2015-12-02 |
NZ584308A (en) | 2012-04-27 |
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