Compositions and methods for obtaining nucleic acids from sputum

Abstract

The present invention relates to compositions and methods for preserving and extracting nucleic acids from saliva. The compositions include a chelating agent, a denaturing agent, buffers to maintain the pH of the composition within ranges desirable for DNA and/or RNA. The compositions may also include a reducing agent and/or antimicrobial agent. The invention extends to methods of using the compositions of the invention to preserve and isolate nucleic acids from saliva as well as to containers for the compositions of the invention.

What is claimed is: 
     
         1 . A device for storage of nucleic acid from a biological sample, said device comprising:
 (a) a container having a barrier capable of disestablishment, said barrier separating a reagent compartment from a sample receiving compartment; and   (b) a nucleic acid storage composition within said reagent compartment, wherein upon disestablishment of said barrier there is fluid communication between said sample receiving compartment and said reagent compartment to facilitate mixing of said biological sample with said nucleic acid storage composition.   
     
     
         2 . The device according to  claim 1 , which additionally comprises means for closing said container, means for disestablishment of the barrier, or both. 
     
     
         3 . The device according to  claim 1 , wherein the storage composition comprises a denaturing agent, a chelator and has a pH of greater than 5.0. 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . The device according to  claim 1 , wherein the nucleic acid is DNA. 
     
     
         7 . (canceled) 
     
     
         8 . The device according to  claim 1 , wherein the biological sample is tissue or a bodily fluid. 
     
     
         9 . The device according to  claim 8 , wherein the bodily fluid is sputum. 
     
     
         10 . The device according to  claim 2 , wherein the displaceable barrier is a pivoting disk. 
     
     
         11 . The device of  claim 2 , wherein the means for closing said container includes means for disestablishment of said barrier. 
     
     
         12 . The device of  claim 2 , wherein the means for closing said container is an airtight lid. 
     
     
         13 . A method of preserving a nucleic acid from a biological sample comprising:
 (a) placing a nucleic acid storage composition into a reagent compartment of a storage container;   (b) placing a biological sample into a sample receiving compartment of said storage device, said sample receiving compartment separated from said reagent compartment by a barrier;   (c) closing said storage container; and   (d) disestablishing said barrier such that said composition contacts said biological sample to form a mixture thereby preserving the nucleic acid from said biological sample.   
     
     
         14 . The method according to  claim 13 , wherein the storage composition comprises a denaturing agent, a chelator and has a pH of greater than 5.0. 
     
     
         15 . The method according to  claim 14 , additionally comprising the step of storing said mixture for at least one day at room temperature. 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . The method according to  claim 13 , wherein the nucleic acid is DNA. 
     
     
         19 . (canceled) 
     
     
         20 . The method according to  claim 13 , wherein the biological sample is tissue or a bodily fluid. 
     
     
         21 . The method according to  claim 20 , wherein the bodily fluid is sputum. 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 13 , wherein the closing of said container is coupled to the disestablishing of said barrier. 
     
     
         24 . A sample receiving container comprising:
 (a) a sample receiving compartment;   (b) a reagent storage compartment;   (c) a barrier separating said sample receiving compartment from said reagent storage compartment and capable of disestablishment; and   (d) means for closing said container that comprises means for disestablishing said barrier to allow fluid communication between said sample receiving compartment and said reagent storage compartment.   
     
     
         25 . The container of  claim 24 , which additionally comprises a nucleic acid storage composition within said reagent storage compartment. 
     
     
         26 . The container of  claim 25 , wherein the storage composition comprises a denaturing agent, a chelator and has a pH of greater than 5.0. 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . The container of  claim 24 , wherein said barrier is a disc pivotable about a pivot axis from a closed position to an open position, such that when said barrier is in the open position there is fluid communication between sample receiving compartment from said reagent storage compartment.