KITS AND METHODS FOR SEPARATING A TARGET ANALYTE FROM A SUSPENSION

• US 20140309553A1
• Filed: 04/09/2014
• Published: 10/16/2014
• Est. Priority Date: 04/11/2013
• Status: Abandoned Application

• Current Assignee: RareCyte, Incorporated
• Original Assignee: RareCyte, Incorporated
• Inventors: Spatafore, Paul, Quarre, Steve, Lundt, Jonathan
• Application Number:
  US14/248,890
• Publication Number:
  US 20140309553A1
• Time in Patent Office: Days
• US Class Current: 600/579
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

This disclosure is directed to kits and methods for extracting a target analyte from a biological fluid in real time. The biological fluid, therefore, does not need to be stored or shipped/delivered. Isolating the target analyte in real-time allows for on-the-spot processing with minimal, if any, down time between collection and testing. Furthermore, isolating in real time may also allow for the biological fluid to be extracted, processed, and returned—similar to that of dialysis—to permit for more volume to be processed and tested. In one aspect, an inner surface of a conduit may include a coating having a high affinity for the target analyte. The conduit may also include features which create turbulent flow to permit all portions of the biological fluid to come into contact with the coating. In another aspect, a capture chip is used to isolate the target analyte from the biological fluid.

Claims

1. A kit for separating a target analyte from a sample, comprising:

a conduit including a first end and a second end;

a coating with a high affinity for the target analyte deposited on an inner surface of the conduit,

a first needle to connect to the first end of the conduit to permit continuous fluid flow of the sample.

2. The kit of claim 1, wherein the inner surface further comprises at least one protrusion.

3. The kit of claim 1, wherein the inner surface further comprises a rough surface to effect turbulent flow of the sample within the conduit.

4. The kit of claim 1, wherein the coating comprises a capture molecule to capture the target analyte

5. The kit of claim 4, wherein the capture molecule is a primary antibody that binds to a biomarker on the target analyte, a chemo-attractant, or an adhesive.

6. The kit of claim 1, further comprising a collection vessel including a cavity for holding a sample and a pressure regulator to reduce a pressure differential between a blood vessel and the cavity, the collection vessel to connect to the second end of the conduit.

7. The kit of claim 6, wherein the pressure regulator is a valve or a vacuum pump.

8. The kit of claim 1, further comprising a second needle to connect the second end of the conduit to a collection vessel or a place from where the sample originated.

9. The kit of claim 1, wherein the conduit further comprises a flow control to regulate flow of the sample through the conduit.

10. The kit of claim 1, wherein the conduit further comprises a pressure control to regulate the pressure differential between a collection vessel and the first needle.

11. A kit for separating a target analyte from a sample, comprising:

a first needle;

a capture chip including an inner surface;

a conduit to connect the first needle to the inner surface of the capture chip; and

a coating with a high affinity for the target analyte deposited on at least a portion of the inner surface,

the conduit to permit continuous fluid flow between the first needle and the inner surface of the capture chip.

12. The kit of claim 11, wherein the inner surface further comprises at least chip protrusion.

13. The kit of claim 11, wherein the coating comprises a capture molecule to capture the target analyte

14. The kit of claim 13, wherein the capture molecule is a primary antibody that binds to a biomarker on the target analyte, a chemo-attractant, or an adhesive.

15. The kit of claim 11, the conduit further comprising a first conduit segment and a second conduit segment, the first conduit segment to fluidly connect the first needle to the first end of the capture chip and the second conduit segment to fluidly connect the second end of the capture chip to a second needle.

16. The kit of claim 15, the second needle to be inserted into a collection vessel to collect any remaining sample or into a place from where the sample originated.

17. The kit of claim 11, further comprising a collection vessel including a cavity for holding a sample and a pressure regulator to reduce a pressure differential between a blood vessel and the cavity, the collection vessel to connect to the second end of the conduit.

18. The kit of claim 17, wherein the pressure regulator is a valve or a vacuum pump.

19. The kit of claim 11, wherein the conduit further comprises a flow control to regulate flow of the sample through the conduit.

20. The kit of claim 11, wherein the conduit further comprises a pressure control to regulate the pressure differential between a collection vessel and the first needle.