Biological specimen collection and transport system and method of use
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-031/66
A61K-031/19
C12Q-001/70
C12Q-001/68
C12M-003/08
출원번호
US-0847202
(2013-03-19)
등록번호
US-8669240
(2014-03-11)
발명자
/ 주소
Fischer, Gerald W.
Daum, Luke T.
출원인 / 주소
Longhorn Vaccines & Diagnostics, LLC
대리인 / 주소
Remenick PLLC
인용정보
피인용 횟수 :
4인용 특허 :
147
초록▼
Disclosed are compositions for isolating populations of nucleic acids from biological, forensic, and environmental samples. Also disclosed are methods for using these compositions as one-step formulations for killing pathogens, inactivating nucleases, and releasing polynucleotides from other cellula
Disclosed are compositions for isolating populations of nucleic acids from biological, forensic, and environmental samples. Also disclosed are methods for using these compositions as one-step formulations for killing pathogens, inactivating nucleases, and releasing polynucleotides from other cellular components within the sample, and stabilizing the nucleic acids prior to further processing or assay. The disclosed compositions safely facilitate rapid sample collection, and provide extended storage and transport of the samples at ambient or elevated temperature without contamination of the sample or degradation of the nucleic acids contained therein. This process particularly facilitates the collection of specimens from remote locations, and under conditions previously considered hostile for presenting the integrity of nucleic acids released from lysed biological samples without the need of refrigeration or freezing prior to molecular analysis.
대표청구항▼
1. A aqueous composition comprising: a) one or more chaotropes; b) one or more detergents; c) one or more reducing agents; d) one or more chelators; and e) one or more buffers, each present in an amount sufficient to denature one or more proteins, inactivate one or more nucleases, kill one or more p
1. A aqueous composition comprising: a) one or more chaotropes; b) one or more detergents; c) one or more reducing agents; d) one or more chelators; and e) one or more buffers, each present in an amount sufficient to denature one or more proteins, inactivate one or more nucleases, kill one or more pathogens, or prevent one or more nucleic acids from degrading in a sample suspected of containing nucleic acids, when the sample is contacted with the composition. 2. The composition of claim 1, wherein the one or more reducing agents comprise 2-mercaptoethanol, tris(2-carboxyethyl)phosphine, dithiothreitol, dimethylsulfoxide, or any combination thereof. 3. The composition of claim 2, wherein the one or more reducing agents comprise tris(2-carboxyethyl)phosphine. 4. The composition of claim 1, comprising: a) one or more chaotropes, each present in an amount from about 0.5 M to about 6 M; b) one or more detergents, each present in an amount from about 0.1% to about 1% (wt./vol.); c) one or more reducing agents, each present in an amount from about 0.05 M to about 0.3 M; d) one or more chelators, each present in an amount from about 0.01 mM to about 1 mM; and e) one or more buffers, each present in an amount from about 0.0001% to about 0.3% (wt./vol.). 5. The composition of claim 1, wherein the one or more chaotropes comprise guanidine thiocyanate, guanidine isocyanate, guanidine hydrochloride, or any combination thereof. 6. The composition of claim 1, wherein the one or more detergents comprise sodium dodecyl sulfate, lithium dodecyl sulfate, sodium taurodeoxycholate, sodium taurocholate, sodium glycocholate, sodium deoxycholate, sodium cholate, sodium alkylbenzene sulfonate, N-lauroyl sarcosine, or any combination thereof. 7. The composition of claim 1, wherein a) the one or more chelators comprise ethylene glycol tetraacetic acid, hydroxyethylethylenediaminetriacetic acid, diethylene triamine pentaacetic acid, N,N-bis(carboxymethyl)glycine, ethylenediaminetetraacetic, citrate anhydrous, sodium citrate, calcium citrate, ammonium citrate, ammonium bicitrate, citric acid, diammonium citrate, ferric ammonium citrate, lithium citrate, or any combination thereof; or b) the one or more surfactants comprise a silicone polymer, a polysorbate, or any combination thereof. 8. The composition of claim 1, wherein the at least one or more buffers comprise tris(hydroxymethyl)aminomethane, citrate, 2-(N-morpholino)ethanesulfonic acid, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid, 1,3-bis(tris(hydroxymethyl)methyl amino)propane, 4-(2-hydroxyethyl)-1-piperazine ethanesulfonic 3-(N-morpholino)propanesulfonic acid, bicarbonate, phosphate, or any combination thereof. 9. The composition of claim 8, wherein each of the buffers is present it the composition in an amount from about 1 mM to about 1 M. 10. The composition of claim 1, further comprising one or more short-chain alkanols. 11. The composition of claim 10, wherein said short-chain alkanols comprise methanol, ethanol, propanol, butanol, pentanol, or hexanol, or any combination thereof. 12. The composition of claim 11, wherein each of the short-chain alkanols is present in an amount from about 1 to about 25% (vol./vol.). 13. The composition of claim 1, buffered to a pH of about 6.4 to 6.8. 14. The composition of claim 1, at least substantially free of RNAse or DNAse activity. 15. The composition of claim 1, further comprising a defoaming agent that comprises a silicone polymer or a polysorbate. 16. The composition of claim 1, further comprising a population of isolated polynucleotides that comprises RNA, DNA, or a combination thereof. 17. The composition of claim 1, comprising: a) about 4 M guanidine thiocyanate; b) about 30 mM sodium citrate; c) about 0.25% (wt./vol.) sodium dodecyl sulfate; d) about 0.25% (wt./vol.) N-lauroyl sarcosine, sodium salt; e) about 0.1 M 2-mercaptoethanol; and f) about 0.1% silicone polymer (wt./vol.). 18. The composition of claim 1, comprising: a) about 3 M guanidine thiocyanate; b) about 1 mM TCEP; c) about 10 mM sodium citrate; d) about 0.5% N-lauroyl sarcosine; e) about 0.0002% silicone polymer; f) about 100 mM 2-amino-2-hydroxymethyl-propane-1,3-diol (TRIS); and 2) about 0.1 mM EDTA. 19. The composition of claim 1, comprising: a) about 1 M to about 4 M guanidine thiocyanate; b) about 0.5 mM to 10 mM TCP, about 1 mM to 100 mM sodium citrate; c) about 0.1% to about 1% SDS or NLS; d) about 0.001% to about 0.0001% of a silicone polymer, e) about 10 mM to about 500 mM TRIS, f) about 0.1 mM to about 1 mM APCA, EDTA, EGTA, HEDTA, DTPA, NTA, or citrate; and g) about 10% to about 25% ethanol (vol./vol.). 20. The composition of claim 1, comprising: a) about 3 M guanidine thiocyanate; b) 1 mM TCEP; about 10 mM sodium citrate; c) about 0.5% N-lauroyl sarcosine, sodium salt; d) about 0.0002% of a silicone polymer; e) about 100 mM TRIS; f) about 0.1 mM EDTA; and g) about 10% to about 25% ethanol (vol./vol.). 21. A method for obtaining a population of polynucleotides from a sample suspected of containing nucleic acids, comprising contacting the sample with an amount of a composition in accordance with claim 1, under conditions effective to obtain a population of polynucleotides from the sample. 22. The method of claim 21, wherein the sample is of clinical, veterinary, epidemiological, environmental, forensic, or pathological origin; or wherein the sample comprises one or more vital, bacterial, fungal, animal, or plant cells or is suspected of containing a population of nucleic acids. 23. The method of claim 21, wherein the sample is contacted with the composition at a temperature of from about −20° C. to about 40° C. for a period of from about 24 to about 96 hrs. 24. The method of claim 21, wherein the integrity of a population of polynucleotides in the sample is at least substantially maintained when the composition comprising the sample is stored at a temperature of from about −20° C. to about 40° C. for a period of from about 7 to about 14 days. 25. The method of claim 21, wherein the integrity of a population of polynucleotides in the sample is at least substantially maintained when the composition comprising the sample is stored at a temperature of from about −20′C to about 40° C. for a period of from about 14 to about 30 days. 26. The method of claim 21, wherein the sample further comprises one or more nucleases, at least a portion of which is at least substantially inactivated by the composition. 27. The method of claim 21, wherein the sample further comprises one or more pathogens, at least a portion of which is killed or at least substantially inactivated by the composition. 28. The method of claim 21, wherein one or more biological cells in the sample is at least substantially lysed to release a population of polynucleotides into the composition. 29. The method of claim 21, wherein the composition comprising the sample is stored substantially at ambient temperature from the time of collection to the time of analyzing a population of polynucleotides therein. 30. The method of claim 21, wherein the composition comprising the sample is stored at a temperature of from about 10° C. to about 40° C. substantially from the time of collection to the time of isolating, purifying, or characterizing a population of polynucleotides therein. 31. The method of claim 21, wherein less than about 5% of the population of polynucleotides contained in the sample is degraded after the composition comprising the sample has been stored at a temperature of from about 10° C. to about 40° C. for a period of about 7 to about 30 days. 32. A sample collection system that comprises: a) a collection device; and b) a collection vessel comprising the composition of claim 1. 33. The sample collection system of claim 32, wherein the collection device comprises a swab, curette, or culture loop, or any combination thereof; and the collection vessel comprises a vial, tube or specimen cup, or any combination thereof. 34. A method of preparing a one-step aqueous formulation of claim 1, which comprises: combining one or more chaotropes and nuclease-free water at a temperature of about 20° C. to 90° C. in a reaction zone;then combining the dissolved one or more chaotropes with one or more reducing agents, one or more chelators, and one or more detergents in the reaction zone to form an intermediate composition;optionally combining a silicone polymer with the intermediate composition in an amount sufficient to minimize foaming during further preparation of the one-step aqueous formulation;combining a sufficient amount of buffer to the intermediate composition to maintain a pH of about 6 to 6.9;optionally combining a second chelating agent to the reaction zone;then increasing the temperature of the second intermediate composition to about 60 to 95° C. for about 1 to 30 minutes and lowering the temperature to ambient conditions;optionally then combining a C1-6alcohol with the contents of the reaction zone; andoptionally adjusting the pH to be about 6.4 to 6.9. 35. A method for preparing one-step aqueous formulation adapted to obtain a population of polynucleotides from a biological sample suspected of containing nucleic acids, comprising contacting the sample with an amount of the one-step aqueous formulation effective to: at least substantially kill or inactivate potentially-infectious pathogens in the sample;lyse a portion of cells to release RNAs and/or DNAs from the sample; andsubstantially inhibit or prevent the released polynucleotides in the sample from further hydrolysis or enzymatic degradation, modification, or inactivation, so as to obtain the population of polynucleotides from the sample.
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이 특허에 인용된 특허 (147)
Liav Avraham ; Hansjergen Joyce Anne ; Shimasaki Craig David, 4,7-dialkoxy N-acetylneuraminic acid derivatives and methods for detection of influenza type A and B viruses in clinic.
Bridgham John (Palo Alto CA) Geiser Timothy G. (La Honda CA) Hunkapiller Michael W. (San Carlos CA) Kent Stephen B. H. (Pasadena CA) Marriott Mark P. (Los Altos CA) Ramstad Paul O. (Oakland CA) Nordm, Automated polypeptide synthesis apparatus.
Bridgham John (Palo Alto CA) Geiser Timothy G. (La Honda CA) Hunkapiller Michael W. (San Carlos CA) Kent Stephen B. H. (Pasadena CA) Marriott Mark P. (Los Altos CA) Ramstad Paul O. (Oakland CA) Nordm, Automated polypeptide synthesis apparatus.
Bridgham John (Palo Alto CA) Geiser Timothy G. (La Honda CA) Hunkapiller Michael W. (San Carlos CA) Kent Stephen B. H. (Pasadena CA) Marriott Mark P. (Los Altos CA) Ramstad Paul O. (Oakland CA) Nordm, Automated polypeptide synthesis process.
Gayral, Jean Pierre; Picard, Francois; Boissinot, Maurice; Bastien, Martine, Biological reagents and methods to verify the efficiency of sample preparation and nucleic acid amplification and/or detection.
Monthony James F. (Baltimore MD) Stitt David T. (Parkton MD) Gosnell C. Michael (Fallston MD) Stewart Shannon D. (Stewartstown PA), Biological sample collection and transport device.
Bair, Jr., Robert Jackson; Heath, Ellen M.; Meehan, Heather; Paulsen, Kim Elayne; Wages, Jr., John M., Compositions and methods for using a solid support to purify RNA.
Cerutti Peter A. (Poly/Lausanne CHX) Bressoud Albric (Lausanne CHX), Detection of influenza a virus by polymerase chain reaction (PCR) preceded by reverse transcription of a region of the v.
Whiteley Norman M. (San Carlos CA) Hunkapiller Michael W. (San Carlos CA) Glazer Alexander N. (Orinda CA), Detection of specific sequences in nucleic acids.
Doyle Michael V. (Oakland CA) Newell Arthur D. (Orinda CA) Nunberg Jack H. (Oakland CA) White Thomas J. (Oakland CA), Human IL-2 as a vaccine adjuvant.
Hunter Kenneth W. (4401 Dresden St. Kensington MD 20895) Fischer Gerald W. (10748 Wayridge Dr. Gaithersburg MD 20879), Human monoclonal antibody reactive with polyribosylribitol phosphate.
Heller Michael J. (Encinitas CA), Hybridization of polynucleotides conjugated with chromophores and fluorophores to generate donor-to donor energy transfe.
Sette, Alessandro; Sidney, John; Southwood, Scott; Vitiello, Maria A.; Livingston, Brian D.; Celis, Esteban; Kubo, Ralph T.; Grey, Howard M.; Chesnut, Robert W., Inducing cellular immune responses to hepatitis B virus using peptide and nucleic acid compositions.
Liav Avraham ; Shimasaki Craig D. ; Maher James F. ; Clinkscales C. Worth ; Roark Michael D., Kit for visually detecting the presence of a clinical specimen.
Yagi Kunio (Aichi-ken JPX) Noda Hitoshi (Aichi-ken JPX) Ohishi Nobuko (Gifu JPX) Kurono Masayasu (Mie-ken JPX), Liposome for entrapping gene, liposomal preparation and process for the manufacture of the preparation.
Liav Avraham (Denver CO) Maher James F. (Broken Arrow OK) Shimasaki Craig D. (Tulsa OK) Clinkscales C. Worth (Tulsa OK) Roark Michael D. (Owasso OK), Method for visually detecting the presence of a virus in a clinical specimen.
Reece Phillip A.,AUX ; Wu Wen-Yang,AUX ; Jin Betty,AUX ; Krippner Guy Y.,AUX ; Watson Keith Geoffrey,AUX, Method of detection of influenza virus and compounds for use therein.
Turner Gregory A. (Independence MO) Maher James F. (Broken Arrow OK) Clinkscales C. Worth (Tulsa OK) Roark Michael D. (Owasso OK), Methods for diagnosing human influenza and 4-position modified chromogenic N-acetylneuraminic acid substrated for use th.
Fischer, Gerald W.; Schuman, Richard F.; Wong, Hing; Stinson, Jeffrey R., Opsonic and protective monoclonal and chimeric antibodies specific for lipoteichoic acid of gram positive bacteria.
Fischer, Gerald W.; Schuman, Richard F.; Wong, Hing; Stinson, Jeffrey R., Opsonic and protective monoclonal and chimeric antibodies specific for lipoteichoic acid of gram positive bacteria.
Monthony James F. (Baltimore MD) Stitt David T. (Parkton MD) Gosnell C. Michael (Fallston MD) Stewart Shannon D. (Stewartstown PA), Polyurethane biological sample collection and transport device and its use.
Mullis Kary B. (La Jolla CA) Erlich Henry A. (Oakland CA) Arnheim Norman (Woodland Hills CA) Horn Glenn T. (Emeryville CA) Saiki Randall K. (Richmond CA) Scharf Stephen J. (Berkeley CA), Process for amplifying, detecting, and/or cloning nucleic acid sequences.
Mullis Kary B. (Kensington CA) Erlich Henry A. (Oakland CA) Arnheim Norman (Woodland Hills CA) Horn Glenn T. (Emeryville CA) Saiki Randall K. (Richmond CA) Scharf Stephen J. (Berkeley CA), Process for amplifying, detecting, and/or-cloning nucleic acid sequences.
Boom Willem R. (Amsterdam NLX) Adriaanse Henritte M. A. (Arnhem NLX) Kievits Tim (The Hague NLX) Lens Peter F. (Amsterdam NLX), Process for isolating nucleic acid.
Fell ; Jr. H. Perry (Redmond WA) Folger-Bruce Kim R. (Seattle WA) Yarnold Susan M. (Seattle WA), Production of chimeric antibodies by homologous recombination.
Crawford Jack T. (Atlanta GA) Eisenach Kathleen D. (Little Rock AR) Cave M. Donald (Little Rock AR) Bates Joseph H. (Little Rock AR), Repetitive DNA sequence specific for mycobacterium tuberculosis to be used for the diagnosis of tuberculosis.
Liversidge Gary G. (West Chester PA) Cundy Kenneth C. (Pottstown PA) Bishop John F. (Rochester NY) Czekai David A. (Honeoye Falls NY), Surface modified drug nanoparticles.
Judd Amrit K. (Belmont CA) Bucher Doris J. (New York NY) Popple Steven W. (Brooklyn NY), Synthetic peptides for diagnosis and prevention of influenza virus infection and their use.
Picard,Francois J.; Menard,Christian, Universal method and composition for the rapid lysis of cells for the release of nucleic acids and their detection.
van Scharrenburg, Gustaaf J. M.; Brands, Rudi; de Haan, Lolke; Verweij, Willem Ronald; Wilschut, Jan C.; Agsteribbe, Etienne, Vaccines with an LTB adjuvant.
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