Distinguishing test types through spectral analysis

• US 6,562,625 B2
• Filed: 02/28/2001
• Issued: 05/13/2003
• Est. Priority Date: 02/28/2001
• Status: Expired due to Term

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Modzelewski, Brent E., Gilmour, Steven B.
• Primary Examiner(s): Snay, Jeffrey
• Application Number:
  US09/794,044
• Publication Number:
  US 20020160517A1
• Time in Patent Office: 804 Days
• Field of Search: 422/82.05, 422/82.08, 422/82.09, 436/63, 436/67, 436/164, 436/165, 436/169, 436/170, 436/172, 356/448
• US Class Current: 436/44
• 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 method for automatically selecting test types in an analytical meter system, comprising:

providing a test element, said test element belonging to one of a plurality of test element types, said test element including a reaction site, said reaction site having an optically detectable condition formed by a reaction between a reagent and an analyte of a sample;

inserting said test element into an analytical meter system;

measuring a first optical property of the test element at said reaction site;

measuring a second optical property of the test element at said reaction site;

distinguishing said test element by identifying a predetermined relationship between said first and second optical properties; and

selecting a test type based at least in part upon the results of said distinguishing step.

2. The method of claim 1, wherein said plurality of test element types include analytical elements.

3. The method of claim 1, wherein said plurality of test element types include control elements.

4. The method of claim 1, wherein said plurality of test element types include standard elements.

5. The method of claim 1, wherein said first and second optical properties are absorbance at predetermined wavelengths.

6. The method of claim 5, wherein each of said absorbances are measured by taking at least one reflectance measurement.

7. The method of claim 6, wherein said predetermined relationship comprises a relative difference in percent reflectance which is substantially constant over a range of measured percent reflectance values.

8. The method of claim 1, wherein said sample comprises a biological fluid.

9. The method of claim 8, wherein said biological fluid comprises a fluid selected from the set consisting of:

whole blood, blood serum, and blood plasma.

10. The method of claim 1, wherein said sample comprises a control solution, said control solution containing a substance for modifying at least one of said first or second optical properties.

11. The method of claim 10, wherein said substance for altering at least one of said first or second optical properties is a dye.

12. The method of claim 11, wherein said dye is selected from the group consisting of:

Bromophenol Blue and Crystal Violet.

13. The method of claim 3, wherein said standard element comprises an element having known first and second optical properties.

14. The method of claim 1, wherein the step of inserting said test element further comprises the step of automatically either positively or negatively activating a switch based on the configuration of the test element.

15. The method of claim 14, wherein said selecting step is based at least in part upon the activation state of said switch.

16. The method of claim 1, further comprising the step of performing the test selected in said selecting step.

17. The method of claim 16, further comprising the step of displaying the results of said test performed in said performing step.

18. The method of claim 16 further comprising the step of storing data based at least in part according to the results of said selecting step.

19. The method of claim 18, where said storing step further comprises storing data classified according to test type.

20. A meter system for performing one of a plurality of test types on a test element, where the test element is inserted into the meter system and belongs to one of a plurality of test element types, said meter system comprising:

a first light emitting diode selectively discharging light at a first wavelength;

a second light emitting diode selectively discharging light at a second wavelength;

at least one light detector for measuring light emitted from the first and second light emitting diodes and reflected from a reaction site on a test element, said reaction site having an optically detectable condition formed by a reaction between a reagent and an analyte of a sample; and

a processor for distinguishing said test element by identifying a predetermined relationship between said first and second optical properties, and further for selecting a test type based at least in part upon the results of said distinguishing.

21. The meter system of claim 20, wherein said test type performed by the meter system comprises a glucose test, and wherein said sample comprises whole blood.

22. The meter system of claim 20, wherein the processor distinguishes at least an analytical element from a control element.

23. The meter system of claim 20, said meter further comprising a memory for separately storing results of each test type.

24. The meter system of claim 20, wherein the light discharged from the first and second light emitting diode has a wavelength within the range of 600 nm to 700 nm.

25. The meter system of claim 24, wherein the wavelength emitted from the first light emitting diode has a wavelength of approximately 660 nm.

26. The meter system of claim 24, wherein the wavelength emitted from the second light emitting diode has a wavelength of approximately 610 nm.

27. A method for distinguishing a control element from an analytical element in a meter system, comprising:

programming said meter with control element reflectance characteristics;

inserting a test element into said meter, said test element being either a control element or an analytical element, said test element including a reaction site, said reaction site having an optically detectable condition formed by a reaction between a reagent and an analyte of a sample;

measuring at two predetermined wavelengths a set of reflectance values reflected from said reaction site on said test element; and

distinguishing whether said test element is a control element or an analytical element based on the conformity of said reflectance values obtained by said measuring step with said control element reflectance characteristics programmed in said meter.