Diagnostic assay providing blood separation

• US 5,753,497 A
• Filed: 12/22/1995
• Issued: 05/19/1998
• Est. Priority Date: 12/22/1995
• Status: Expired due to Fees

• Current Assignee: Committee Of Unsecured Creditors Of Medical Diagnostic Products, Inc., Wood Gundy Limited
• Original Assignee: Universal Health Watch, Inc.
• Inventors: Bernstein, David, Trainor, William, Childs, Mary Ann
• Primary Examiner(s): Hutzell, Paula K.
• Assistant Examiner(s): Bakalyar, Heather
• Application Number:
  US08/577,105
• Time in Patent Office: 879 Days
• Field of Search: 436/518, 436/541, 436/524, 436/527, 436/528, 436/530, 436/63, 436/169, 436/514, 422/56, 422/60, 422/101, 422/58, 435/7.1, 435/2, 435/4, 435/810, 435/970, 435/287.1, 435/287.2, 430/810, 430/824
• US Class Current: 435/287.1
• CPC Class Codes: B01D 15/3804 Affinity chromatography
• CPC Class Codes: G01N 30/02 Column chromatography
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

This invention provides a device and method for preparing a plasma enriched sample for use in an immunoassay strip. All parts that contact blood or a blood fraction remain in a container and prevent contamination from used blood. In one embodiment a sampling device collects blood and enters the container. A plasma enriched sample fills a plasma receptor which in turn is transferred to an immunoassay strip. Plasma is washed out of the strip by an aqueous solution. In another embodiment the sampling device doubles as a plasma separator. The invention allows sensitive and safe immunoassays to be performed on whole blood samples outside of the normal clinical laboratory setting.

Claims

1. A device comprising:

(a) a container for conducting an assay, the container having an opening for receiving a blood sample, and a transparent portion;

(b) a test strip having a receiving area for receiving a plasma enriched sample, said test strip being positioned within said container such that a visible signal produced on said test strip can be observed through said transparent portion from outside of said container;

(c) a hydrophilic blood collector for receiving a sample of blood, said collector being coupled to said container by a movable support, such that said collector can be moved into position proximate said opening in said container to close said container and deliver said blood sample into said opening;

(d) a red blood cell filter positioned proximate to said opening in said container, such that said blood sample delivered to said opening contacts said filter; and

(e) a plasma receptacle positioned within said container, said plasma receptacle for receiving a plasma enriched sample that passes through said filter, said receptacle being capable of movement within said container so as to be in proximity of said receiving area, said receptacle having a porous area through which a quantity of said plasma enriched sample passes onto said receiving area.

2. The device of claim 1, wherein said blood collector is impregnated with an anticoagulant.

3. The device of claim 2, wherein said anticoagulant is sodium heparin.

4. The device of claim 1, wherein said red blood cell filter is a composite of glass and natural fibers.

5. The device of claim 1, wherein said red blood cell filter separates red blood cells by charge, size or chemical aggregation of said red blood cells.

6. A method for obtaining a plasma enriched sample and transferring it to a test strip, said method comprising the steps of:

(a) providing a blood sample to a hydrophilic blood collector, said collector being coupled to a container by a movable support, such that said collector can be moved into position proximate said opening in said container to deliver said blood sample into an opening in said container and seal said container;

(b) moving said collector into position proximate said opening in said container;

(c) transferring said blood through said opening to a red blood cell filter positioned within said container;

(d) permitting said blood sample to filter through said filter to provide an plasma enriched sample into a plasma receptacle positioned within said container; and

(e) moving said plasma receptacle into contact with a test strip positioned within said container so as to permit transfer of a quantity of said plasma enriched sample onto said test strip.

7. The method of claim 6, wherein said red blood cells are filtered by charge, size, or aggregation of red blood cells by a chemical.

8. The method of claim 7, wherein said chemical is a lectin.

9. The method of claim 6, comprising the further step of:

(f) washing said plasma enriched sample from said receptacle and into said test strip by adding an aqueous solution to said receptacle.

10. The method of claim 6, wherein said strip test is an immunochromatographic strip test.

11. A device comprising:

(a) a container for conducting an assay, said container having an opening for receiving a blood sample, and a transparent portion;

(b) a test strip having a receiving area for receiving a plasma enriched sample, said test strip being positioned within said container such that a visible signal produced on said test strip can be observed through said transparent portion from outside of said container;

(c) a hydrophilic blood collector-separator adapted to receive a sample of blood, said collector-separator comprising a reagent that facilitates separation of plasma from red blood cells, said collector-separator being coupled to said container by a movable support, such that said collector-separator can be moved into position proximate said opening in said container to close said container and deliver a plasma enriched sample into said opening; and

(d) a plasma receptacle positioned within said container, said plasma receptacle being adapted to receive a plasma enriched sample that passes through said opening, said receptacle being capable of movement within said container so as to be in proximity of said receiving area, said receptacle having a porous area through which a quantity of said plasma enriched sample passes onto said receiving area.

12. A device comprising:

(a) a container for conducting an assay, said container having an opening for receiving a blood sample, and a transparent portion;

(b) a test strip having a receiving area for receiving a plasma enriched sample, said test strip being positioned within said container such that a visible signal produced on said test strip can be observed through said transparent portion from outside of said container; and

(c) a hydrophilic blood collector-separator adapted to receive a sample of blood, said collector-separator comprising a reagent that facilitates separation of plasma from red blood cells, said collector-separator being coupled to said container by a movable support, such that said collector-separator can be moved into position proximate said opening in said container to close said container and deliver a plasma enriched sample into said opening;

wherein said receiving area of said test strip is positioned proximate said opening such that a quantity of said plasma enriched sample is received on said receiving area.

13. A device comprising:

(a) a container for conducting an assay, said container having an opening for receiving a blood sample, and a transparent portion;

(b) a test strip having a receiving area for receiving a plasma enriched sample, said test strip being positioned within said container such that a visible signal produced on said test strip can be observed through said transparent portion from outside of said container;

(c) a hydrophilic blood collector for receiving a sample of blood, said collector being coupled to said container by a movable support, such that said collector can be moved into position proximate said opening in said container to close said container and deliver said blood sample into said opening; and

(d) a red blood cell filter positioned proximate to said opening in said container, such that said blood sample delivered to said opening contacts said filter;

wherein said receiving area of said test strip is positioned proximate said opening such that said plasma enriched sample is received on said receiving area.