Blood plasma test method

• US 4,839,296 A
• Filed: 10/18/1985
• Issued: 06/13/1989
• Est. Priority Date: 10/18/1985
• Status: Expired due to Term

• Current Assignee: Chem-Elec Incorporated
• Original Assignee: Chem-Elec Incorporated
• Inventors: Woenker, William E., Kennedy, Paul R., Adams, Ernest C.
• Primary Examiner(s): Hill, Jr., Robert J.
• Application Number:
  US06/788,793
• Time in Patent Office: 1,334 Days
• Field of Search: 422/56, 422/57, 422/66, 436/169, 436/170, 436/178, 435/805, 210/651, 210/500.36
• US Class Current: 436/170
• 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 inpermeable by blood cellular and particulate matter. A second overlap 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 process of testing whole blood to determine the concentration of certain plasma components thereof comprising the steps of:

treating an expanded hydrophobic polytetrafluoroethylene containing semipermeable membrane with a surfactant to make the membrane hydrophilic and capable of passing plasma components of whole blood while retaining cellular and particulate components of whole blood, the semipermeable membrane having pores which are made hydrophilic by treatment with the surfactant;

superposing the semipermeable membrane over a blood plasma component reactive area;

subjecting the semipermeable membrane to a whole blood sample so that plasma components of the sample pass through the membrane and onto the reactive area while cellular and particulate blood components are blocked by the membrane;

separating the polytetrafluoroethylene containing membrane from the reactive area; and

determining the concentration of plasma components in the sample by measuring the extent of any plasma component induced change in the reactive area.

2. The process of claim 1 wherein the step of measuring includes observing a color change in the reactive area.

3. The process of claim 1 wherein the step of measuring includes at least one of:

visual comparison of the color of the reactive area with a calibrated color chart;

color comparison employing a reflectometer; and

color comparison employing a densitometer.

4. The process of claim 1 wherein the semipermeable membrane has pores ranging in size from 0.2 to 15 microns.

5. The process of claim 1 wherein the surfactant is an anionic surfactant selected from the group consisting of lauryl sulphate, sodium tetradecyl sulfate, and aliphatic polyethyleneoxy phosphate ester.

6. The process of claim 1 wherein the surfactant is para diisobutyl phenoxy ethoxy ethyl dimethyl benzylammonium chloride.

7. The process of claim 1 wherein the surfactant is poly(3-8)tetrafluoroethylene isopropylacetate dimethylammonium acetic acid.

8. The process of claim 1 wherein the surfactant is a nonionic surfactant selected from the group consisting of alkyl polyether alcohol, polysorbate 80, polyoxyethylene 23-lauryl ether, nonyl phenoxy poly(9)ethyleneoxy ethanol, nonyl phenoxy poly(10-11)ethyleneoxy ethanol, decyloxy poly(6)ethyleneoxy ethanol, modified linear aliphatic polyether, nonyl phenoxy poly(9)ethyleneoxy ethanol, isooctyl phenyl poly(9-10)ethoxy ethanol, and isooctyl phenyl poly(5)ethoxy ethanol.

9. The process of claim 1 including the additional step of covering the semipermeable membrane with an absorbent overlay prior to the step of subjecting, the absorbent overlay functioning during the subsequent subjecting step to distribute the same over the semipermeable membrane and therefore also distribute plasma components of the sample over the reactive area.

10. The process of claim 9 wherein the absorbent overlay is treated with a surfactant prior to the step of subjecting.