Non-precipitating bodily fluid analysis system

• US 8,642,320 B2
• Filed: 10/16/2009
• Issued: 02/04/2014
• Est. Priority Date: 02/03/2004
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Inventors: Lawrence, Gregory M., Knight, Meredith
• Primary Examiner(s): Shen, Bin
• Application Number:
  US12/580,866
• Publication Number:
  US 20100041066A1
• Time in Patent Office: 1,572 Days
• Field of Search: 435/287.7
• US Class Current: 435/287.7
• CPC Class Codes: G01N 2021/8494 Measuring or storing parameters of the band
• CPC Class Codes: G01N 2021/8654 Mechanical support; Mounting of sheet
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: G01N 2800/044 Hyperlipemia or hypolipemia, e.g. dyslipidaemia, obesity
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743

Abstract

A bodily fluid analyzer including a dry test strip impregnated with a reagent providing a non-precipitating reaction to exclude non-desired analytes. The reagent complexes the non-desired analytes so they remain in solution but cannot participate in the test reaction. Red blood cells are removed from the detection area by slowing their vertical movement and stopping flow when the detection membrane is saturated.

Claims

1. A dry test strip for determining a characteristic of a selected analyte in blood, said dry test strip comprising:

a reaction layer including chemicals that will react with said blood to determine a characteristic of a selected analyte in said blood, the reaction layer oriented under the blood separation layer, wherein the red blood cells are slowed or stopped from reaching said reaction layer; and

said dry test strip further containing complexing chemicals that complex one or more non-selected analytes to prevent them from participating in said reaction without precipitating them, wherein said selected analyte is low density lipoprotein, said complexing chemicals including dextran sulphate, a divalent metal, and a destabilizing compound and wherein the complexing chemicals are added prior to the reaction layer.

2. A dry test strip as in claim 1 wherein said destabilizing compound is selected from the group consisting of glycols, polypropylenes, and polyethylenes.

3. A dry test strip as in claim 1 wherein said destabilizing compound is a polyoxyethylene-polyoxypropylene-polyoxyethylene hybrid.

4. A dry test strip as in claim 3 wherein said destabilizing compound has a molecular weight between 2,100 and 6,000.

5. A dry test strip as in claim 3 wherein said destabilizing compound has a preponderance of polyoxyethylene.

6. A dry test strip as in claim 1 wherein said complexing chemicals include a gentle surfactant.

7. A dry test strip as in claim 1 wherein said complexing chemicals include 3-{[3-Cholamidopropyl]dimethylammonio}3-propane-sulfonate.

8. A dry test strip as in claim 1 wherein the complexing chemicals are introduced above the reaction layer, such that as the complexed and non-selected analytes flow through the test strip, they are slowed or retained.

9. A dry test strip as in claim 1 wherein said dextran sulfate has a molecular weight between 50,000 and 8,000.

10. A dry test strip as in claim 1 wherein said dextran sulfate has a molecular weight between 25,000 and 10,000.

11. A dry test strip as in claim 1 wherein said dextran sulfate has a molecular weight between 18,000 and 12,000.