Systems and methods for artificial test strip controls

Patent metadata

Field	Value
Publication number	US-10907192-B2
Application number	US-201615093236-A
Country	US
Kind code	B2
Filing date	Apr 7, 2016
Priority date	Apr 7, 2015
Publication date	Feb 2, 2021
Grant date	Feb 2, 2021

Abstract

A linearity standard includes a plurality of calibration solutions, each calibration solution having a different level of a reactant having a known response in a test strip and meter combination, and an electronic storage medium for storing calibration instructions and known responses for each solution of the plurality of calibration solutions.

First claim

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

1. A method of calibrating a meter and a test strip combination, comprising:
contacting the test strip with a calibration solution;
measuring a detectable property of the test strip with the meter, the meter being an optical meter, wherein the detectable property is a first reflectance; and
adjusting calibration of the meter for lots of test strips associated with the test strip based on the detectable property and an expected detectable property wherein the calibration solution includes potassium ferricyanide and the potassium ferricyanide reacts with a chromophore used in the test strip to produce a color change which is measured as the first reflectance, and the expected detectable property is a second reflectance corresponding to a reflectance expected from a concentration of the potassium ferricyanide in the calibration solution and wherein the potassium ferricyanide only reacts with the chromophore.

2. The method of claim 1 , wherein the meter and the test strip combination tests for total cholesterol.

3. The method of claim 1 , wherein the meter and test strip combination tests for one or more analytes selected from the list consisting of HDL cholesterol, LDL cholesterol, triglycerides, total cholesterol, and glucose.

4. The method of claim 1 , wherein the test strip includes a plurality of separation layers, and the calibration solution does not interact with the plurality of separation layers.

5. The method of claim 1 , wherein the calibration solution includes a plurality of linearity controls, the plurality of linearity controls including solutions containing different levels of potassium ferricyanide, such that generate different responses by the meter.

6. The method of claim 1 , wherein the calibration solution does not include serum.

7. The method of claim 1 , wherein the calibration solution is stable at room temperature.

Assignees

• Polymer Technology Systems Inc

Inventors

• Hughes Gary L
• Patwardhan Aniruddha
• Moskowitz Keith

Classifications

• G01N21/78 Primary

  producing a change of colour · CPC title

• G01N33/96

  involving blood or serum control standard · CPC title

• G01N33/523

  the element being adapted for a specific analyte · CPC title

• G01N21/8483

  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 title

• G01N2021/7759

  Dipstick; Test strip · CPC title