Distinguishing test types through spectral analysis

• US 20030138356A1
• Filed: 03/04/2003
• Published: 07/24/2003
• Est. Priority Date: 02/28/2001
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Modezelewski, Brent E., Gilmour, Steven B.
• Granted Patent: US 7,390,665 B2
• Time in Patent Office: Days
• US Class Current: 422/82.05
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• 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 2201/062 LED's
• CPC Class Codes: G01N 2201/0621 Supply
• CPC Class Codes: G01N 2201/0624 Compensating variation in output of LED source
• CPC Class Codes: G01N 2201/0625 Modulated LED
• CPC Class Codes: G01N 2201/0694 Microprocessor controlled supply
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G01N 35/00712 Automatic status testing, e.g. at start-up or periodic
• CPC Class Codes: G01N 35/0092 Scheduling
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape

Abstract

A method and apparatus for automatically selecting test types for an analytical meter system based on the insertion into the meter of a test element. The test element can be an analytical element, formed by a test strip with a fluid such as blood applied thereto; a control element, formed by a test strip with control fluid applied thereto; or a standard element, or a standard strip exhibiting known optical properties. By inserting the test element into the analytical meter system, optical properties are measured and the existence of relationships between the measurements are ascertained. Based on the existence or nonexistence of certain relationships, the proper test can be automatically selected by the meter without the need for user interaction. Advantageously, the results of the test can be classified and stored according to test type.

Claims

1. A control solution, comprising:

an analyte in a known concentration; and

a dye, said dye being selected from the group consisting of Bromophenol Blue, Bromophenol Blue sodium salt, and Crystal Violet.

2. The control solution of claim 1, wherein said analyte is glucose.

3. The control solution of claim 1, wherein said dye is Bromophenol Blue sodium salt.

4. The control solution of claim 1, further comprising:

a viscosity enhancer.

5. The control solution of claim 4, wherein said viscosity enhancer is glycerol.

6. The control solution of claim 1, further comprising:

at least one stabilizer.

7. The control solution of claim 1, further comprising:

at least one preservative.

8. A combination for an analytical system, said combination comprising:

a control solution, said control solution including an analyte in a known concentration; and

a reagent, wherein said reagent reacts with a biological fluid that includes said analyte to provide a first spectral curve shape, and said reagent reacts with said control solution to provide a second spectral curve shape, said second spectral curve shape being distinguishably different from said first spectral curve shape.

9. The combination of claim 8, wherein said reagent is contained in a test strip.

10. The combination of claim 9, wherein said test strip includes a viewing port for viewing said optically detectable condition.

11. The combination of claim 8, wherein said control solution includes a dye.

12. The combination of claim 11, wherein said dye is selected from the group consisting of Bromophenol Blue, Bromophenol Blue sodium salt, and Crystal Violet.

13. The combination of claim 8, wherein said analyte is glucose.

14. A analytical system, comprising:

a test strip;

a meter for measuring predetermined optical properties of said test strip; and

a control solution, said control solution including an analyte in a known concentration and a dye, wherein when said control solution is applied to said test strip, said dye alters said predetermined optical properties of said test strip.

15. The analytical system of claim 14, wherein said predetermined optical properties include a first reflectance value, measured at a first wavelength, and a second reflectance value, measured at a second wavelength, wherein said dye alters said predetermined optical properties of said test strip so that said first reflectance value is substantially different from said second reflectance value.

16. The analytical system of claim 15, wherein said dye does not exhibit significant absorbance at said second wavelength.

17. The analytical system of claim 15, wherein said first wavelength is approximately 610 nanometers and said second wavelength is approximately 660 nanometers.

18. The analytical system of claim 14, wherein said analyte is glucose.

19. The analytical system of claim 14, wherein said dye is selected from the group consisting of Bromophenol Blue, Bromophenol Blue sodium salt, and Crystal Violet.

20. The analytical system of claim 19, wherein said dye is Bromophenol Blue sodium salt.