Devices, solutions and methods for sample collection related applications, analysis and diagnosis
A solution is described for preserving cells and/or extra-cellular components in naturally expressed bodily fluids (e.g. saliva, sputum, urine) for further downstream analysis and/or for diagnosis of a medical condition. The solution may be hypertonic with respect to blood. Techniques are described for enriching cells from a sample of a naturally expressed bodily fluid, and/or for analysis, e.g. to diagnose medical conditions such as cancer, obesity, infections, autism, Alzheimer disease, hetotological disorders, cardiovascular disease or disorders, diabetes, vulnerable plack, LTBI, HIV infection, COPD, ACQS.
1. A method of diagnosing and/or monitoring cancer in a subject, comprising:
obtaining a saliva sample from the subject;
stabilizing cells, proteins, free-floating DNA, and free-floating RNA in the saliva sample by contacting the saliva sample with a preservation solution to form a mixture, wherein the proteins, free-floating DNA, and free-floating RNA are extracellular components of the saliva sample,
wherein the preservation solution includes paraformaldehyde, at least one serum protein from human and/or other animal species, and sodium azide, and wherein the preservation solution is buffered at a pH from 6.4 to 8.4;
storing the mixture at room temperature;
subsequently separating the proteins, free-floating DNA, and free-floating RNA from the cells; and
analyzing two or more analytes selected from the proteins, free-floating DNA, and free-floating RNA to diagnose and/or monitor the cancer, wherein the step of analyzing comprises molecular analysis.
2. The method of claim 1 , wherein the cancer is lung cancer, lung carcinoma, leukemia, or non-small cell lung carcinoma.
3. The method of claim 1 , wherein the at least one serum protein from human and/or other animal species comprises fetal bovine serum.
4. The method of claim 3 , wherein the preservation solution comprises 1% (v/v) paraformaldehyde, 1% (v/v) fetal bovine serum, and 0.01% (w/v) sodium azide, and the preservation solution is buffered at a pH of 7.4.
5. The method of claim 1 , wherein the saliva sample and the preservation solution are contacted at a 1:1 ratio by volume.
6. The method of claim 1 , wherein the proteins, free-floating DNA, and/or free-floating RNA are separated from the cells by centrifugation.
7. The method of claim 1 , wherein the step of analyzing comprises sequencing.
8. The method of claim 7 , wherein the step of analyzing comprises whole genome sequencing.
9. The method of claim 7 , wherein the step of analyzing comprises RNA sequencing.
10. The method of claim 7 , wherein the step of analyzing comprises DNA sequencing.
11. The method of claim 7 , wherein the step of analyzing comprises epigenetic sequencing.
12. The method of claim 1 , further comprising determining a drug treatment for the subject.
13. The method of claim 1 , further comprising analyzing the cells.
14. The method of claim 1 , wherein the cancer is lung cancer.
15. The method of claim 1 , wherein the two or more analytes are selected from free-floating DNA and free-floating RNA.
16. A method of diagnosing and/or monitoring, and treating cancer in a subject, comprising:
obtaining a saliva sample from the subject;
stabilizing cells, proteins, free-floating DNA, and free-floating RNA in the saliva sample by contacting the saliva sample with a preservation solution to form a mixture, wherein the proteins, free-floating DNA, and free-floating RNA are extracellular components of the saliva sample,
wherein the preservation solution includes paraformaldehyde, at least one serum protein from human and/or other animal species, and sodium azide, and wherein the preservation solution is buffered at a pH from 6.4 to 8.4;
storing the mixture at room temperature;
subsequently separating the proteins, free-floating DNA, and free-floating RNA from the cells;
analyzing two or more analytes selected from the proteins, free-floating DNA, and free-floating RNA to diagnose and/or monitor the cancer, wherein the step of analyzing comprises molecular analysis;
determining a drug treatment for the subject; and
administering the drug treatment to the subject.
17. The method of claim 16 , wherein the two or more analytes are selected from free-floating DNA and free-floating RNA.
18. A method of diagnosing and/or monitoring cancer in a subject, comprising:
obtaining a saliva sample from the subject;
stabilizing cells, proteins, free-floating DNA, and free-floating RNA in the saliva sample by contacting the saliva sample with a preservation solution to form a mixture, wherein the proteins, free-floating DNA, and free-floating RNA are extracellular components of the saliva sample,
wherein the preservation solution includes paraformaldehyde, at least one serum protein from human and/or other animal species, and sodium azide, and wherein the preservation solution is buffered at a pH from 6.4 to 8.4;
storing the mixture at room temperature;
subsequently separating the proteins, free-floating DNA, and free-floating RNA from the cells; and
analyzing two or more analytes selected from the proteins, free-floating DNA, and free-floating RNA to diagnose and/or monitor the cancer;
wherein the cancer is lung cancer.