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US 2016/0257995 A1Published application
Stabilization of nucleic acids in urine
AssigneeStreck, Inc.
InventorsJianbing Qin, Bradford A. Hunsley
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Abstract
A composition and method for preserving a urine sample and a preservative delivery vessel are disclosed wherein treatment of the urine sample aids in preserving circulating cell-free nucleic acids in urine over a wide range of dilution ratios within temperature fluctuations that can occur during urine sample handling, storage and transportation. The urine sample preservation composition and method and preservative delivery vessel provide a method for obtaining high quality stabilized urinary cell-free nucleic acids for clinical diagnostics development and application.
Claims19
1:
- A method for preserving a urine sample comprising the steps of:
- (a) dispensing into a specimen container a predetermined amount of a urine preservative by removing the urine preservative from a sealed vessel;
- (b) contacting the urine preservative with a urine sample;
- (c) sealing the specimen container with the urine sample and the urine preservative contained within it;
- and
- (d) causing the sealed specimen container to be shipped to a clinical laboratory for analysis of the urine sample;
- wherein the urine sample, upon being preserved is capable of analysis after a period at least 168 hours has elapsed.
4 more elements
2:
- The method of claim 1, wherein the urine preservative comprises:
- imidazolidinyl urea (IDU), diazolidinyl urea (DU) or a combination thereof, and glycine.
3:
- The method of claim 2, wherein the urine preservative includes K3EDTA in an amount of at least five times what would be necessary for inhibition of nuclease activity in a blood sample.
4:
- The method of claim 2, wherein the urine preservative is present in an amount of about 1 to about 20 percent by volume of the specimen container.
5:
- The method of claim 2, wherein the sealed vessel is a single unit dose.
6:
- The method of claim 3, wherein the urine preservative is directly contacted with urine sample or the urine sample is directly contacted with the urine preservative.
7:
- The method of claim 2, wherein the contacting step is performed within about two hours of obtaining the specimen.
8:
- The method of claim 1, wherein the shipping temperature of the sealed specimen container is within a range from about 6° C. to about 37° C.
9:
- The method of claim 1, wherein the sample exhibits a stability for at least about 7 days post treatment.
10:
- The method of claim 1, wherein the step of analysis is performed 1, 2, 4, or 7 days after the specimen is obtained.
11:
- The method of claim 10, where the analysis of the urine sample includes nucleic acids from the preserved urine sample and analyzing the isolated nucleic acids to identify a pathological characteristic.
12:
- The method of claim 1, wherein the method is performed in the absence of refrigeration.
13:
- The method of claim 2, wherein the urine includes one or more of cell free nucleic acids, cellular nucleic acids, DNA, circulating tumor DNA (ctDNA), RNA, microRNA (miRNA), or messenger RNA (mRNA).
14:
- The method of claim 2, wherein nucleic acid analysis is performed on one or more of a cell free DNA, circulating tumor DNA (ctDNA), cell free RNA, mRNA, or miRNA from within the urine.
15:
- The method of claim 1, wherein the sealed vessel contains preservative composition present in an amount of about 1 to about 15 ml.
16:
- The method of claim 1, wherein the sealed vessel is packaged in a plurality of vial strips of single unit dosages.
17:
- The method of claim 1, wherein the sealed vessel is formed by injection molding.
18:
- A composition comprising:
- (a) a urine sample;
- (b) a nuclease inhibitor present in a concentration of at least 0.5% of the composition;
- (c) a preservative present in a concentration of from about 0.2% to about 4% of the composition;
- (d) a formaldehyde quencher present in a concentration of at least 0.01%.
2 more elements
19:
- A urine preservative composition for maintaining structural integrity of nucleated blood cells and cell-free nucleic acids in a urine sample comprising:
- (a) a nuclease inhibitor present in an amount of from about 100 to about 300g/L of the composition;
- (b) a preservative present in an amount of from about 300 to about 700 g/L of the composition;
- (c) a formaldehyde quencher present in an amount of at least about 30 g/L of the composition.
1 more element