Systems and methods for non-fasting LDL cholesterol assays

Patent metadata

Field	Value
Publication number	US-9470698-B2
Application number	US-201514961634-A
Country	US
Kind code	B2
Filing date	Dec 7, 2015
Priority date	May 4, 2012
Publication date	Oct 18, 2016
Grant date	Oct 18, 2016

Abstract

In one embodiment, a test strip for testing for cholesterol-related blood analytes in whole blood includes a red blood cell separation layer, the red blood cell separation layer separating red blood cells from a blood sample applied to the test strip as the blood sample flows downward through the red blood cell separation layer. The test strip further includes a reaction layer receiving the blood sample from the red blood cell separation layer, the reaction layer including POE-POP-POE block copolymer, a surfactant, and a reflectivity changing reactant, the POE-POP-POE block copolymers solubilizing essentially only non-LDL cholesterol analytes, the non-LDL cholesterol analytes reacting with the reflectivity changing reactant in order to change a reflectivity of the blood sample.

First claim

What is claimed as new and desired to be protected by Letters Patent of the United States is:

1. A method of measuring LDL cholesterol from a human subject providing a blood sample, the blood sample including chylomicrons, the method comprising:
providing a dry test strip;
receiving the blood sample at the dry test strip;
separating red blood cells from the blood sample in a first layer of the dry test strip;
reacting all non-LD cholesterol including chylomicrons in the blood sample in a reaction layer;
producing a color change proportional to the non-LDL cholesterol;
measuring the color change to determine a non-LDL cholesterol amount in the blood sample; and
subtracting the non-LDL cholesterol amount from a total cholesterol amount in the blood sample to yield an LDL cholesterol amount for the blood sample wherein specificity of the reacting non-LDL cholesterol in the blood sample, due to a chemistry that solubilizes all cholesterols, including chylomicrons, other than LDL in the reaction layer, is such that accuracy is not substantially negatively affected by the presence of chylomicrons.

2. The method of claim 1 , wherein the blood sample is from an individual who has not fasted, and the resulting LDL cholesterol amount is more accurate than the Friedwald equation.

3. The method of claim 1 , wherein the reaction layer further includes a surfactant and a reflectivity changing reactant, wherein the reacting includes solubilizing essentially only cholesterol from non-LDL analytes, the cholesterol from non-LDL analytes reacting with the reflectivity changing reactant in order to change a reflectivity of the blood sample.

4. The method of claim 1 , wherein the reaction layer includes a POE-POP-POE block copolymer.

5. The method of claim 4 , wherein the POE-POP-POE block copolymer is selected from the list of copolymers consisting of a copolymer having a MW 3800, and a formula POE 7 -POP 54 -POE 7 ; a copolymer having a MW 4400, and a formula POE 5 -POP 68 -POE 5 ; a copolymer having a MW 5750, and a formula POE 20 -POP 70 -POE 20 ; and a copolymer having a MW 12600; and a formula POE 106 -POP 70 -POE 106 .

6. The method of claim 1 , further comprising:
spreading the blood sample with a spreading layer, oriented on top of the first layer.

7. The method of claim 6 , further comprising:
reacting the blood sample in a total cholesterol reaction layer, the total cholesterol reaction layer oriented to receive a portion of the blood sample from the spreading layer;
producing a color change proportional to the total cholesterol; and
measuring a color change to determine the total cholesterol amount in the blood sample.

8. The method of claim 1 , wherein the test strip includes a secondary blood separation layer adjacent to the red blood cell separation first layer, the secondary blood separation layer separating additional red blood cells from the blood sample, where the secondary blood separation layer further includes dextran sulfate.

9. The method of claim 1 , wherein the first layer includes D-23 borosilicate glass fiber impregnated with Phaselous Vulgaris (PHA-P) Lectins.

10. The method of claim 1 , wherein chemistry that solubilizes all cholesterols other than LDL in the reaction layer includes a surfactant and a POE-POP-POE block copolymer.

11. The method of claim 10 wherein the POE-POP-POE block copolymer is a copolymer having a MW 5750, and a formula POE 20 -POP 70 -POE 20 .

12. The method of claim 11 , further comprising: removing a portion of LDL from the blood sample in an initial incomplete precipitation step.

13. The method of claim 12 , wherein Dextran Sulfate/Mg+2 is added to the test strip to provide for the removing a portion of LDL from the blood sample.

Assignees

• Polymer Technology Systems Inc

Inventors

• Riley Timothy
• Patwardhan Aniruddha
• Laduca Frank

Classifications

• C12Q1/60

  involving cholesterol · CPC title

• G01N2021/7773

  Reflection · CPC title

• G01N21/78 Primary

  producing a change of colour · CPC title

• G01N33/48

  Biological material, e.g. blood, urine (G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence); Haemocytometers (counting blood corpuscules distributed over a surface by scanning the surface G06M11/02) · CPC title

• G01N2021/7759

  Dipstick; Test strip · CPC title