Blood plasma test device including a semipermeable membrane made of an expanded hydrophobic material that has been treated with a surfactant

• US 5,130,231 A
• Filed: 06/12/1989
• Issued: 07/14/1992
• Est. Priority Date: 10/18/1985
• Status: Expired due to Fees

• Current Assignee: Chem-Elec Incorporated
• Original Assignee: Chem-Elec Incorporated
• Inventors: Kennedy, Paul R., Woenke, William E., Adams, Ernest C.
• Primary Examiner(s): Hill, Jr., Robert J.
• Application Number:
  US07/364,893
• Time in Patent Office: 1,128 Days
• Field of Search: 422/56, 422/57, 422/58, 422/66, 436/169, 436/170, 436/178, 210/651, 210/500.36, 435/4, 435/10-12, 435/14, 435/28, 435/805
• US Class Current: 435/4
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/28 involving peroxidase
• CPC Class Codes: C12Q 1/58 involving urea or urease
• CPC Class Codes: C12Q 2326/12 3,3',5,5'-Tetramethylbenzidine, i.e. TMB
• CPC Class Codes: G01N 33/5002 Partitioning blood components
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

Single or multiple blood plasma component concentrations are measured by a disposable stick having one or more blood plasma component reactive areas covered by a semipermeable membrane which is permeable by blood plasma or serum components and impermeable by blood cellular and particulate matter. A second overlay may be superposed with the semipermeable membrane over the reactive areas to receive a blood sample and meter and distribute that sample uniformly to the semipermeable membrane which in turn passes the plasma components uniformly to the reactive areas. The overlays are subsequently separable from the reactive area to remove the cellular components and particulate matter and expose the reactive areas for inspection by, for example, color comparison to standardized charts.

Claims

1. A blood component level determination stick comprising a supporting strip, a reactive pad disposed on the supporting strip, and a hydrophobic semipermeable membrane with hydrophilic pores formed of an expanded polytetrafluoroethylene material superposed over the reactive pad.

2. The stick of claim 1 further including an absorbent overlay for receiving, spreading, and metering an applied blood sample to the semipermeable membrane.

3. The stick of claim 1 wherein the reactive pad contains an enzyme for catalyzing a reaction converting a selected blood component and generating hydrogen peroxide as a result of that conversion, a peroxidatively active material, and an indicator material which is oxidized by hydrogen peroxide in the presence of the peroxidatively active material providing a component indicative color change in the indicator material.

4. The stick of claim 1 wherein the reactive pad contains glucose oxidase, peroxidase, and an indicator material.

5. The stick of claim 1 wherein the reactive pad contains cholesterol oxidase, cholesterol esterase, peroxidase, and an indicator material.

6. The stick of claim 1 wherein the reactive pad contains uricase, peroxidase, and an indicator material.

7. The stick of claim 1 wherein the reactive pad contains alcohol oxidase, peroxidase and an indicator material.

8. The stick of claim 1 wherein the reactive pad contains urease, and a pH indicator material.

9. A disposable blood component level measuring arrangement comprising a blood plasma component reactive area, and an overlay formed of a hydrophobic expanded polytetrafluoroethylene containing material which has been treated with a surfactant to make the pores hydrophilic, the overlay being permeable by blood plasma components and impermeable by blood cellular components, the overlay being superposed over the reactive layer to receive a blood sample and subsequently separable therefrom to expose the reactive area for inspection.

10. The measuring arrangement of claim 9 wherein the material is particle size discriminatory having pore sizes ranging from 0.2 to 15 microns.

11. The measuring arrangement of claim 9 wherein the reactive area comprises a plurality of discrete subareas, each having a chemical composition different from the others and reacting with different blood plasma components.

12. A blood cholesterol level determination stick comprising a supporting strip, a reactive pad containing cholesterol oxidase, cholesterol esterase, peroxidase and an indicator material disposed on the supporting strip;

and a semipermeable membrane formed of an expanded porous hydrophobic material which has been treated with a surfactant to make the material hydrophilic superposed over the reactive pad.