Device for sample collection

Abstract

The disclosure relates to devices, solutions and methods for collecting and processing samples of bodily fluids containing cells (as well as embodiments for the collection, and processing and/or analysis of other fluids including toxic and/or hazardous substances/fluids). In addition, the disclosure relates generally to function genomic studies and to the isolation and preservation of cells from saliva and other bodily fluids (e.g., urine), for cellular analysis. With respect to devices for collection of bodily fluids, some embodiments include two mating bodies, a cap and a tube (for example), where, in some embodiments, the cap includes a closed interior space for holding a sample preservative solution and mates with the tube to constitute the (closed) sample collection device. Upon mating, the preservation solution flows into the closed interior space to preserve cells in the bodily fluid. The tube is configured to receive a donor sample of bodily fluid (e.g., saliva, urine), which can then be subjected to processing to extract a plurality of cells. The plurality of cells can be further processed to isolate one and/or another cell type therefrom. The plurality of cells, as well as the isolated cell type(s), can be analyzed for functional genomic and epigenetic studies, as well as biomarker discovery.

1 - 22 . (canceled) 
     
     
         23 . A solution for preserving cells in bodily fluid for further separation into cell types and downstream epigenetic analysis that allows for storage of cells in bodily fluid to retain their antigenicity and cellular architecture, the solution comprising at least one chemical fixing agent and at least one protease inhibitor, buffered at a pH from about 6.4 to about 8.4. 
     
     
         24 . The solution according to  claim 23 , further comprising one or more of at least one antimicrobial agent and serum proteins from human and/or other animal species. 
     
     
         25 . The solution according to  claim 23 , wherein the chemical fixing agent is selected from the group consisting of aldehydes. 
     
     
         26 . The solution according to  claim 25 , wherein the chemical fixing agent is paraformaldehyde. 
     
     
         27 . The solution according to  claim 23 , wherein the chemical fixing agent is present at a concentration of about 1% (v/v). 
     
     
         28 . The solution according to  claim 23 , wherein the antimicrobial agent is selected from the group consisting of antibacterial and antifungal antibiotics. 
     
     
         29 . The solution according to  claim 23 , wherein the protease inhibitor is selected from the group consisting of: Aspartic protease inhibitors, Cysteine protease inhibitors, Metallo protease inhibitors, Serine protease inhibitors, Threonine protease inhibitors, Trypsin inhibitors, Kunitz STI protease inhibitor and a combination of any of the foregoing. 
     
     
         30 . The solution according to  claim 23 , wherein the protease inhibitor is selected from the group consisting of: sodium azide, PMSF, aprotinin, leupeptin, pepstatin, natural or synthetic proteinase inhibitors, mixtures of protease inhibitors both natural and synthetic, and any combination of the foregoing. 
     
     
         31 . The solution according to  claim 23 , wherein the protease inhibitor is sodium azide. 
     
     
         32 . The solution according to  claim 23 , wherein the solution is buffered at a pH of from about 7.2 to about 7.6. 
     
     
         33 . The solution according to  claim 23 , wherein the buffer is selected from the group consisting of: barbital, trisphosphate, citrate, cacodylate, other non-phosphate buffers and any combination of the foregoing. 
     
     
         34 . The solution according to  claim 23 , wherein the buffer is a phosphate buffer. 
     
     
         35 - 55 . (canceled)