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US 10,294,513 B2Granted
Preservation of cell-free nucleic acids
AssigneeStreck, Inc.
InventorM. Rohan Fernando
Life of this patent
Estimating the term…
Abstract
A method for preserving and processing cell-free nucleic acids located within a blood sample is disclosed, wherein a blood sample containing cell-free nucleic acids is treated to reduce both blood cell lysis and nuclease activity within the blood sample. The treatment of the sample aids in increasing the amount of cell-free nucleic acids that can be identified and tested while maintaining the structure and integrity of the nucleic acids.
Claims27
A direct blood draw tube comprising:
- a composition formulated for stabilizing a direct drawn blood sample having cell-free nucleic acids within plasma of the blood sample while the blood sample is in the tube including:
- a) at least two formaldehyde releaser preservative agents;
- b) ethylenediaminetetraacetic acid (EDTA);
- c) one or more solvents;
- d) less than, or about, 1% formaldehyde as a result of the at least two formaldehyde releaser preservative agents;
- wherein an amount of the at least two formaldehyde releaser preservative agents within the direct blood draw tube prior to blood draw is an amount of about 50 to about 500 grams per liter;
- wherein an amount of the composition is in an amount so that any consequential dilution of the blood sample is substantially avoided, and cell-free nucleic acids in the blood sample are not materially diluted;
- and
- wherein at least, or about, 7 days elapses between a time of blood draw and a time of any testing or screening of a drawn blood sample, and or isolation of the cell-free nucleic acids.
6 more elements
A direct blood draw tube comprising:
- a composition formulated for stabilizing a direct drawn blood sample having cell-free nucleic acids within the blood sample while the blood sample is within the tube including:
- a) a formaldehyde releaser preservative agent selected from one or both of 2-bromo-2-nitropropane-1,3-diol and imidazolidinyl urea (IDU);
- b) ethylenediaminetetraacetic acid (EDTA);
- c) water;
- d) formaldehyde as a result of the formaldehyde releaser preservative agent;
- and
- wherein an amount of the formaldehyde releaser preservative agent within the direct blood draw tube prior to blood draw is an amount of about 50 to about 500 grams per liter;
- wherein an amount of the composition is in an amount so that any consequential dilution of the blood sample is substantially avoided, and cell-free nucleic acids in the blood sample are not materially diluted;
- and
- wherein at least, or about, 7 days elapses between a time of blood draw and a time of any testing or screening of a drawn blood sample, and or isolation of the cell-free nucleic acids.
7 more elements
A direct blood draw tube comprising:
- a composition formulated for stabilizing a direct drawn blood sample having cell-free nucleic acids within the blood sample while the blood sample is within the tube including:
- a) 2-bromo-2-nitropropane-1,3-diol;
- b) imidazolidinyl urea (IDU);
- c) one or more protease inhibitors;
- d) one or more metabolic inhibitors;
- e) beta-mercaptoethanol;
- f) water;
- wherein the composition includes some formaldehyde but less than 2000 parts per million of formaldehyde;
- wherein an amount of the composition is in an amount so that any consequential dilution of the blood sample is substantially avoided, and cell-free nucleic acids in the sample are not materially diluted;
- wherein at least, or about, 7 days elapses between a time of blood draw and a time of any testing or screening of a drawn blood sample, and or isolation of the cell-free nucleic acids contained.
7 more elements
A direct blood draw tube comprising:
- a composition formulated for stabilizing a direct drawn blood sample having cell-free nucleic acids within the blood sample while the blood sample is within the tube including:
- a) about 1 part by weight of a formaldehyde releaser preservative agent selected from one or both of 2-bromo-2-nitropropane-1,3-diol and imidazolidinyl urea (IDU);
- b) about 2 parts by weight of ethylenediaminetetraacetic acid (EDTA);
- c) water;
- d) formaldehyde as a result of the formaldehyde releaser preservative agent;
- and
- wherein a fill volume of the direct blood draw tube is such that an amount of the formaldehyde releaser preservative agent is less than, or about, 10 g/l of the blood sample;
- wherein an amount of the composition is in an amount so that any consequential dilution of the blood sample is substantially avoided, and cell-free nucleic acids in the blood sample are not materially diluted;
- and
- wherein at least, or about, 7 days elapses between a time of blood draw and a time of any testing or screening of a drawn blood sample, and or isolation of the cell-free nucleic acids.
7 more elements
Dependencies are inferred from the claim text.