IP Library Granted Patent US 8,383,058
Granted Patent B2
US 8,383,058 · App. 12/564,696 · Granted Feb 26, 2013

Quantitative analysis of a biological sample of unknown quantity

Inventors: Ilia Vinogradov (Elmhurst, IL); Michael Wandell (Mercer Island, WA); Barbara Godsey (Long Grove, IL)
Assignee: Home Access Health Corporation
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Quick Facts
Patent No.
US 8,383,058
App. No.
12/564,696
Granted
Feb 26, 2013
Kind
B2
Abstract

Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.

Claims (14)

1. A kit comprising: a fluid collector with an absorbent substrate coated with a saccharide, said substrate comprising a mat of glass fibers at least substantially coated with polyvinyl alcohol, said fibers defining a plurality of pores, the pores in said mat having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of serum from red blood cells via differential wicking and a superstrate, said fluid collector being generally fixed with respect to said superstrate, said superstrate having an aperture defining a blood receiving opening and permitting access to said fluid collector, and further comprising a desiccant, said desiccant being present in an amount effective to provide a desiccating protective effect on a blood fluid specimen.

2. A method for collecting a specimen from a patient, comprising: providing a fluid collection device with a fluid collector, said fluid collector comprising an absorbent substrate coated with a saccharide, said substrate comprising a mat of glass fibers at least substantially coated with polyvinyl alcohol, said fibers defining a plurality of pores, the pores in said mat having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of serum from red blood cells via differential wicking; and a superstrate fixed with respect to the fluid collector; and allowing said patient to bleed onto said collector until at least a predetermined adequate amount of blood has been deposited onto said collector, further comprising sending the fluid collection device to a remote location for testing.

3. The method according to claim 2 , comprising sealing the collector in a barrier film pouch.

4. The method according to claim 3 , said barrier film pouch comprising a laminar structure that includes a polyester film and an aluminum foil film.

5. The method according to claim 3 , further comprising adding a desiccant to said barrier film pouch, said desiccant being present in an amount effective to provide a desiccating protective effect on a blood fluid specimen.

6. The method according to claim 5 , said desiccant comprising silica.

7. The method according to claim 2 , further comprising receiving a results reporting form after sending said fluid collection device to a remote location for testing.

8. The method according to claim 2 , further comprising receiving a results reporting form after sending said fluid collection device to a remote location for testing.

9. A method for collecting a specimen from a patient, comprising: providing a fluid collection device with a fluid collector, said fluid collector comprising an absorbent substrate coated with a saccharide, said substrate comprising a mat of glass fibers at least substantially coated with polyvinyl alcohol, said fibers defining a plurality of pores, the pores in said mat having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of serum from red blood cells via differential wicking and a superstrate fixed with respect to the fluid collector; and allowing said patient to bleed onto said collector until at least a predetermined adequate amount of blood has been deposited onto said collector, further comprising indicating a type of test desired on a requisition form.

10. A method for collecting a specimen, comprising: receiving a fluid collection device with a fluid collector, and a superstrate fixed with respect to the fluid collector, said fluid collector comprising a mat of glass fibers at least substantially coated with polyvinyl alcohol, said fibers defining a plurality of pores, the pores in said mat having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of serum from red blood cells via differential wicking; and bleeding onto said collector until at least a predetermined adequate amount of blood has been deposited onto said fluid collection device, further comprising sending the fluid collection device to a remote location for testing, comprising sealing the fluid collection device in a barrier film pouch.

11. The method according to claim 10 , said barrier film pouch comprising a laminar structure that includes a polyester film and an aluminum foil film.

12. The method according to claim 10 , further comprising adding a desiccant to said barrier film pouch, said desiccant said desiccant being present in an amount effective to provide a desiccating protective effect on a blood fluid specimen.

13. The method according to claim 12 , said desiccant comprising silica.

14. A method for providing a test and test results to a patient, comprising: providing a kit, said kit comprising: a fluid collection device comprising; a fluid collector with an absorbent substrate coated with a saccharide, said substrate comprising a mat of glass fibers at least substantially coated with polyvinyl alcohol, said fibers defining a plurality of pores, the pores in said mat having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of serum from red blood cells via differential wicking and a superstrate, said fluid collector being generally fixed with respect to said superstrate, said superstrate having an aperture defining a blood receiving opening and permitting access to said fluid collector; a lancet; a desiccant, said desiccant being present in an amount effective to provide a desiccating protective effect on a blood fluid specimen collected in said device; and a barrier film pouch sized for receiving said fluid collection device and said desiccant; and results from a previous test of the patient.

Assignments (3)
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY AT REEL/FRAME NO. 55879/0989 Recorded May 28, 2025
From: CRG SERVICING LLC, AS ADMINISTRATIVE AGENT
To: PWNHEALTH CHICAGO LLC
Reel/Frame 071454/0320 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2021
From: HOME ACCESS HEALTH CORPORATION
To: PWNHEALTH CHICAGO LLC
Reel/Frame 056408/0695 →
SECURITY INTEREST Recorded Apr 9, 2021
From: PWNHEALTH CHICAGO LLC
To: CRG SERVICING LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 055879/0989 →
Continuity (4)
Division 10706321 · Nov 12, 2003
Continuation In Part 10421086 · Apr 23, 2003
Provisional Application 60374629 · Apr 23, 2002
Related Publication 20100010373A1 · Jan 14, 2010