Systems and methods for hematocrit correction in analyte test strips

Patent metadata

Field	Value
Publication number	US-9989542-B2
Application number	US-201514952015-A
Country	US
Kind code	B2
Filing date	Nov 25, 2015
Priority date	Nov 25, 2014
Publication date	Jun 5, 2018
Grant date	Jun 5, 2018

Abstract

A system for determining a level of a lipid analyte corrected for hematocrit includes a test strip configured to receive a sample and a meter configured to receive the test strip. The system further includes circuitry and a microprocessor, the circuitry and microprocessor configured to read the test strip and the sample and determine a level of a lipid analyte and correct the level of the lipid analyte based on a hematocrit level of the sample.

First claim

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

1. A system for determining a level of a lipid analyte corrected for hematocrit, comprising:
a test strip configured to receive a sample;
a meter configured to receive the test strip; and
further including circuitry and a microprocessor located in the meter, the circuitry and microprocessor configured to read the test strip and the sample when the test strip interfaces with the meter and determine a level of a lipid analyte, determine a hematocrit level of the sample, and correct the level of the lipid analyte based on the hematocrit level of the sample, wherein the correction of the level of the lipid analyte is based on correcting the level of the lipid analyte according to an angle of deflection of a line formed by a range of lipid analyte concentrations provided by the hematocrit level compared to said line provided by a normal hematocrit level.

2. The system of claim 1 , wherein the test strip is a hybrid strip.

3. The system of claim 2 , wherein the test strip has a first sample window and a second sample window configured to receive the sample, the first sample window is configured to enable a measurement of the level of lipid analyte, and the second sample window is configured to enable a measurement of hematocrit level.

4. The system of claim 3 , wherein the first sample window is an optical sample window.

5. The system of claim 4 , wherein the second sample window is an electrochemical sample window.

6. The system of claim 5 , wherein the first sample window includes a spreading layer and is configured to allow for testing of multiple analytes.

7. The system of claim 4 , wherein the lipid analyte is selected from the group consisting of HDL, LDL, triglycerides, and total cholesterol.

8. The system of claim 1 , wherein the meter is configured to receive the test strip and an additional test strip.

9. The system of claim 8 , wherein the additional test strip is configured to test for hematocrit.

10. The system of claim 1 , wherein the Law of Sines is used to determine an amount of correction.

11. A method for determining a level of a lipid analyte corrected for hematocrit, comprising:
providing a system, the system including:
a test strip configured to receive a sample;
a meter configured to receive the test strip; and
further including circuitry and a microprocessor located in the meter, the circuitry and microprocessor configured to read the test strip and the sample when the test strip interfaces with the meter, determine a hematocrit level of the sample, and determine a level of a lipid analyte and correct the level of the lipid analyte based on the hematocrit level of the sample;
receiving a sample at the test strip and inserting the test strip into the meter;
determining the level of the lipid analyte and the hematocrit level using the circuitry and microprocessor;
calculating a corrected level of the lipid analyte by correcting for the hematocrit level; and
providing an output of corrected level of the lipid analyte to a user, wherein the calculating is based on correcting the level of the lipid analyte according to an angle of deflection of a line formed by a range of lipid analyte concentrations provided by the hematocrit level compared to said line provided by a normal hematocrit level.

12. The method of claim 11 , wherein the level of hematocrit is based on an electrochemical test.

13. The method of claim 12 , wherein the test strip is a hybrid strip.

14. The method of claim 13 , wherein the test strip has a first sample window and a second sample window configured to receive the sample, the first sample window is configured to enable a measurement of the level of lipid analyte, and the second sample window is configured to enable a measurement of hematocrit level.

15. The method of claim 14 , wherein the first sample window is an optical sample window.

16. The method of claim 11 , wherein the level of the lipid analyte is based on an optical test.

17. The method of claim 11 , wherein the Law of Sines is used to determine an amount of correction.

Assignees

• Polymer Technology Systems Inc

Inventors

• Hughes Gary L
• Huffstodt Robert
• Moskowitz Keith

Classifications

• G01N33/92 Primary

  involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)} · CPC title

• G01N33/80

  involving blood groups or blood types {or red blood cells (white blood cells G01N33/56972)} · CPC title

• G01N27/27

  Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter · CPC title

• G01N27/3274

  Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771) · CPC title

• G01N33/96

  involving blood or serum control standard · CPC title