Methods and devices for collecting and storing clinical samples for genetic analysis
First Claim
1. A device for storing and purifying nucleic acids from a biological source other than untreated whole blood, the biological source having naturally occurring nucleic acid amplification inhibitors present, comprising an absorbent material that does not bind irreversibly to nucleic acids, a chaotropic salt impregnated about the absorbent material, nucleic acids from the biological source releasably bound to the absorbent in an amplifiable form, the amplification inhibitors being bound to the adsorbent such that resolubilization does not occur by releasing the nucleic acids from the adsorbent.
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Abstract
The present invention relates to devices and methods for the collection, storage, and purification of nucleic acids, such as DNA or RNA, from fluid samples for subsequent genetic characterization, primarily by conventional amplification methods. The present invention can be used to collect, store, or purify nucleic acids either from a biological source other than untreated whole blood, the biological source having naturally occurring nucleic acid amplification inhibitors present, (including either a buccal swab, cerebrospinal fluid, feces, lymphatic fluid, a plasma sample, a saliva sample, a serum sample, urine, or a suspension of cells or viruses), or from a treated whole blood source that has naturally occurring nucleic acid amplification inhibitors present, as well as added blood stabilization components that also inhibit nucleic acid amplification. More importantly, these nucleic acids can be released after collection or storage in a manner that enables them to be amplified by conventional techniques such as polymerase chain reaction. In particular, an absorbent material that does not bind nucleic acids irreversibly is impregnated with a chaotropic salt. A biological source sample is contacted with the impregnated absorbent material. Any nucleic acids present in the biological source can be either eluted or resolubilized off the absorbent material.
121 Citations
34 Claims
- 1. A device for storing and purifying nucleic acids from a biological source other than untreated whole blood, the biological source having naturally occurring nucleic acid amplification inhibitors present, comprising an absorbent material that does not bind irreversibly to nucleic acids, a chaotropic salt impregnated about the absorbent material, nucleic acids from the biological source releasably bound to the absorbent in an amplifiable form, the amplification inhibitors being bound to the adsorbent such that resolubilization does not occur by releasing the nucleic acids from the adsorbent.
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8. A method for collecting and storing nucleic acids from a biological source other than untreated whole blood, the biological source having naturally occurring nucleic acid amplification inhibitors present comprising:
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a) contacting a biological source with an absorbent material that does not bind to nucleic acids and which has a chaotropic salt impregnated about the absorbent material; and
b) allowing the nucleic acids and the amplification inhibitors of the biological source to be absorbed onto or dried on the absorbent material for storage. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method for collecting, storing, and purifying nucleic acids from a biological source other than untreated whole blood, the biological source having naturally occurring nucleic acid amplification inhibitors present, such that the nucleic acids can be amplified comprising:
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(a) contacting a biological source with an absorbent material that does not bind to nucleic acids and which has a chaotropic salt impregnated about the absorbent material;
(b) allowing the nucleic acids and the amplification inhibitors of the biological source to be absorbed onto or dried on the absorbent material for storage; and
(c) eluting the nucleic acids from the dried biological source into a solution that can be used in a nucleic acid amplification process, whereby the amplification inhibitors remain bound to the adsorbent. - View Dependent Claims (16, 17, 18, 19, 20, 21)
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22. A method for collecting, storing, and purifying nucleic acids from a biological source other than untreated whole blood, the biological source having naturally occurring nucleic acid amplification inhibitors present, such that the nucleic acids can be amplified comprising:
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(a) contacting a biological source with an absorbent material that does not bind to nucleic acids and which has a chaotropic salt impregnated about the absorbent material;
(b) allowing the nucleic acids and the amplification inhibitors of the biological source to be absorbed onto or dried on the absorbent material for storage; and
(c) adding the absorbent material into a nucleic acid re-solubilizing solution, whereby the nucleic acids elute into the solution, but the amplification inhibitors remain bound to the adsorbent. - View Dependent Claims (23, 24, 25, 26, 27, 28)
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- 29. A device for storing and purifying nucleic acids from a treated whole blood source that has naturally occurring nucleic acid amplification inhibitors present, as well as added blood stabilization components that also inhibit nucleic acid amplification, comprising an absorbent material that does not bind irreversibly to nucleic acids, a chaotropic salt impregnated about the absorbent material, nucleic acids from the treated whole blood source releasably bound to the absorbent in an amplifiable form, and the amplification inhibitors from the biological source being bound to the adsorbent such that resolubilization does not occur by releasing the nucleic acids from the adsorbent.
Specification