DEVICES FOR COLLECTION AND STABILIZATION OF BIOMARKERS IN LIQUID SAMPLES

• US 20110192239A1
• Filed: 10/18/2010
• Published: 08/11/2011
• Est. Priority Date: 02/10/2010
• Status: Abandoned Application

• Current Assignee: Companion Diagnostics, Inc.
• Original Assignee: Companion Diagnostics, Inc.
• Inventors: Vig, Rakesh, Gill, Richard P., Selinfreund, Richard H.
• Application Number:
  US12/906,173
• Publication Number:
  US 20110192239A1
• Time in Patent Office: Days
• US Class Current: 73/864.51
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: C12Q 1/40 involving amylase
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

Device for collection and stabilization of biomarkers in liquid samples. In at least one embodiment of a fluid collection device, the device comprises a housing having a top end, a bottom end, and a tubular compartment therethrough, a swab connected to bottom end of the housing and in fluid communication with the tubular compartment, the swab designed to collect a body fluid, and a stabilizing agent contained within the fluid collection device, the stabilizing agent capable of completely or substantially preventing the degradation or inactivation of a diagnostic agent in a bodily fluid upon receipt of the bodily fluid into the fluid collection device. Optionally, the stabilizing agent may be coupled to the swab, and/or contained within the tubular compartment of the housing.

Claims

1. A fluid collection device comprising:

a housing having a top end, a bottom end, and a tubular compartment therethrough;

a swab connected to bottom end of the housing and in fluid communication with the tubular compartment, the swab designed to collect a body fluid; and

a stabilizing agent contained within the fluid collection device, the stabilizing agent capable of completely or substantially preventing the degradation or inactivation of a diagnostic agent in a bodily fluid upon receipt of the bodily fluid into the fluid collection device.

2. The device of claim 1, wherein the stabilizing agent is coupled to the swab.

3. The device of claim 1, wherein the stabilizing agent is contained within the tubular compartment of the housing.

4. The device of claim 3, wherein the tubular compartment comprises a stabilizer compartment containing the stabilizing agent and a sample compartment capable of receiving a body fluid from the swab.

5. The device of claim 4, wherein the stabilizer compartment and sample compartment are connected by a channel having a barrier preventing fluid movement between the stabilizer compartment and the sample compartment.

6. The device of claim 5, further comprising a release mechanism capable of disrupting the barrier and allowing fluid movement between the stabilizer compartment and sample compartment.

7. The device of claim 1, wherein the housing further comprises a sealing mechanism capable of fluidly sealing the tubular compartment.

8. The device of claim 1, wherein the stabilizing agent is selected from the group consisting of Fixanal®

Buffer 6.0 (Sigma-Aldrich Co.), acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, aluminum potassium sulfate dodecahydrate, benzoic acid, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof.

9. The device of claim 1, wherein the stabilizing agent comprises a plurality of stabilizing agents each present in approximately the same concentration.

10. The device of claim 1, wherein the stabilizing agent is selected from the group consisting of a protease inhibitor, a DNase inhibitor, and a RNase inhibitor.

11. The device of claim 1, wherein the diagnostic marker is selected from the group consisting of a protein, a glycoprotein, a nucleic acid, an enzyme, an enzyme inhibitor, and a metabolite.

12. The device of claim 1, wherein the stabilizing agent is useful to completely or substantially inactivate an enzyme selected from the group consisting of an amylase, a lysozyme, a peroxidase, a glycosidase, an esterase, a protease, and a peptidase.

13. The device of claim 1, wherein the body fluid is selected from the group consisting of saliva, a mucous secretion, tears, sweat, semen, urine, a vaginal secretion, exhalate, blood, serum, and an anal secretion.