Method for plasma separation and measurement

• US 5,798,272 A
• Filed: 12/09/1996
• Issued: 08/25/1998
• Est. Priority Date: 10/21/1994
• Status: Expired due to Fees

• Current Assignee: First Medical, Inc.
• Original Assignee: First Medical, Inc.
• Inventors: Allen, Michael P., Zuk, Robert F., Ensler, Lawrence M.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/761,909
• Time in Patent Office: 624 Days
• Field of Search: 422/56-58, 422/61, 436/164, 436/169
• US Class Current: 436/169
• CPC Class Codes: G01N 1/2813 Producing thin layers of samples on a substrate, e.g. smearing, spinning-on G01N1/30 takes precedence
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: G01N 35/1095 for supplying the samples to flow-through analysers for a specific analyser see relevant groups, e.g. under G01N15/00, G01N21/00, G01N27/00, G01N30/00, H01J49/00
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

The system for transferring plasma to a test substrate comprises an applicator and the test substrate. The applicator includes a blood reservoir and a filter element which separates cellular components from the blood as plasma is passed to the test substrate. The test substrate includes an absorptive element which receives the plasma from the applicator. In one embodiment, measured amounts of plasma are transferred when the absorptive element becomes saturated, thus stopping the flow of plasma. In another embodiment, excess blood and cellular components are removed from the measured plasma by disengaging the applicator from the test substrate. In another embodiment, plasma transferred to the absorptive element is eluted from the absorptive element by subsequent application of an elution medium.

Claims

1. A method for transferring measured amounts of plasma from unmeasured blood samples to a test substrate, said method comprising

applying a volume of whole blood to an absorptive element through a filter member, said absorptive element on a surface of a test substrate, wherein (a) the filter member permits the passage of plasma and plasma macromolecules but inhibits the passage of blood cells and (b) blood cells are retained on the filter member;

removing the filter member from the absorptive element to separate excess blood and blood cells from the measured amount of plasma absorbed in the absorptive element; and

transferring plasma from the absorptive element to a reaction zone on the surface of the test substrate.

2. A method as in claim 1, wherein the plasma is transferred from the absorptive element to the reaction zone by applying an elution medium to the absorptive element.

3. A method as in claim 1, wherein the plasma is transferred from the absorptive element to the reaction zone by spinning the absorption element zone to cause the plasma to flow radially outward by centrifugal force.

4. A method as in claim 2, wherein the absorptive element has a plasma capacity which is less than the amount of plasma in the whole blood volume and excess blood is retained on the filter member, further comprising removing the filter member from the absorptive element after applying the blood but before applying the elution medium.

5. A method as in claim 1, further comprising removing the filter member from the absorptive element after a time selected to permit the transfer of a preselected amount of plasma to the absorptive element.

6. A method for transferring measured amounts of plasma from unmeasured blood samples to an absorptive element on a test substrate, said method comprising:

applying a volume of whole blood to an absorptive element through a filter member, wherein (a) the absorptive element has a plasma capacity which is less than the amount of plasma in the whole blood volume so that said absorptive element becomes saturated with a predetermined amount of plasma, (b) the filter member permits the passage of plasma and plasma macromolecules but inhibits the passage of blood cells, and (c) excess blood and blood cells are retained on the filter member; and

removing the filter member from the absorptive element to separate excess blood and blood cells from the measured amount of plasma absorbed in the absorptive element.

7. A method as in claim 6, wherein the filter member is removed from the absorptive element after the absorptive element has become saturated with plasma.

8. A method as in claim 7, further comprising applying an elution medium to the absorptive element after the filter member has been removed, wherein plasma absorbed in the absorptive element is transferred to the reaction zone on a fluid-receiving surface of the test substrate.

9. A method as in claim 7, further comprising, spinning the absorptive element after the filter member has been removed, wherein plasma absorbed in the absorptive element flows radially outward to a reaction zone on a fluid-receiving surface of the test substrate.

10. A method for transferring measured amounts of plasma from unmeasured blood samples to an absorptive element on a test substrate, said method comprising:

applying a volume of whole blood to an absorptive element through a filter member, wherein (a) the filter member permits the passage of plasma and plasma macromolecules but inhibits the passage of blood cells, and (b) blood cells are retained on the filter member; and

removing the filter member from the absorptive element to separate excess blood and blood cells from the measured amount of plasma absorbed in the absorptive element.

11. A method as in claim 10, further comprising spinning the absorptive element after the filter member has been removed, wherein plasma absorbed in the absorptive element flows radially outward to a reaction zone on a fluid-receiving surface of the test substrate.

12. A method as in claim 10, wherein the filter member is removed from the absorptive element before the absorptive element has become saturated with plasma.

13. A method as in claim 12, further comprising applying an elution medium to the absorptive element after the filter member has been removed, wherein plasma absorbed in the absorptive element is transferred to a reaction zone on a fluid-receiving surface of the test substrate.

14. A method for transferring measured amounts of plasma from whole blood to a test substrate, said method comprising:

drawing blood through a capillary tube into a reservoir in an applicator;

contacting a filter member extending across a transfer port in the applicator adjacent to the reservoir against a contact surface on an absorptive element on the test substrate, wherein (a) the absorptive element has a plasma capacity which is less than the amount of plasma in the blood, in the reservoir, (b) the filter member permits the passage of plasma and plasma macromolecules but inhibits the passage of blood cells, and (c) excess blood and blood cells are retained on the filter member; and

removing the filter member from the absorptive element to separate excess blood and blood cells from the measured amount of plasma absorbed in the absorptive element.

15. A method as in claim 14, wherein the blood is drawn via a finger prick.

16. A method as in claim 14, wherein the blood is drawn from a vacuum blood collection device.