Analysis system for determining an analyte concentration, taking into consideration sample-and analyte-independent light-intensity changes

• US 7,758,812 B2
• Filed: 12/19/2002
• Issued: 07/20/2010
• Est. Priority Date: 12/22/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim, Pachl, Rudolf
• Primary Examiner(s): Hill, Jr.; Robert J
• Assistant Examiner(s): Gerido; Dwan A
• Application Number:
  US10/499,252
• Publication Number:
  US 20050054082A1
• Time in Patent Office: 2,770 Days
• Field of Search: 422/82.05, 422/82.07, 422/82.08, 422/82.09, 436/164, 436/171, 436/172
• US Class Current: 422/82.05
• CPC Class Codes: G01N 21/27 using photo-electric detection G01N21/31 takes precedence; circuits for computing concentration logarithmic circuits G06G7/24; photometric circuits in general G01J
• 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

Abstract

The invention concerns an analytical system and a method for determining an analyte which ensures an exact determination by correcting the measured values based on sample- and analyte-independent light intensity changes. The invention takes into account light intensity changes which are based on changes of measurement conditions in the apparatus. The invention is particularly suitable for use in analytical systems for glucose determination in which light-conducting test elements are used.

Claims

1. Analytical system for determining an analyte in which non-analyte-dependent light intensity changes are taken into account comprising

a test element having an absorption of light in a first wavelength range which is previously known and is not equal to zero,

an illumination unit configured and arranged to emit radiation in the first wavelength range and in a second wavelength range, and configured and arranged within the system to irradiate the test element,

a detector unit which is positioned in such a manner that light transmitted or reflected by the test element is registered,

an evaluation unit configured and arranged within the system to receive signals from the detector when it is irradiated, the evaluation unit being further configured to (i) determine a correction value from an absorption of the test element in the first wavelength range before sample application, (ii) determine a measured value in the second wavelength range wherein the measured value in the second wavelength range is dependent on the analyte concentration after sample application on the test element, and (iii) determine the concentration of the analyte from the measured value taking into account the correction value.

2. System as claimed in claim 1 wherein the evaluation unit is further configured to register at least two correction values in the first wavelength range.

3. System as claimed in claim 1 wherein the test element comprises a light-conducting element in cooperative arrangement with the illumination unit within the system.

4. System as claimed in claim 1 wherein the test element comprises an absorber which does not interact with the sample, the absorber being configured to establish the known absorption of the test element.

5. System as claimed in claim 1, in which the previously known absorption is essentially complete.

6. System as claimed in claim 1, the illumination unit being further configured and arranged to emit radiation in a third wavelength range, the test element further having an absorption of light in the third wavelength range of essentially zero, wherein the evaluation unit is further configured and arranged to determine a white value comprising a light intensity of the test element in the third wavelength range before sample application and to correct the measured value taking into account the white value.

7. System as claimed in claim 1, the test element further having an absorption of light in the second wavelength range of essentially zero, wherein the evaluation unit is further configured and arranged to determine a white value comprising a light intensity of the test element in the second wavelength range before sample application and to correct the measured value taking into account the white value.

8. System as claimed in claim 7 in which the test element has essentially no absorption in the second wavelength range before sample application.

9. Method for analysing and correcting non-analyte-dependent changes in light intensity comprising the steps

(a) irradiating a test element before sample application and detecting the light reflected or transmitted by the test element in a first wavelength range in which an absorption by the test element to which the sample has not been added takes place which is previously known and is not equal to zero and

determining a first correction value based on the detected light,

(b) irradiating the test element after adding the sample and detecting the light reflected or transmitted by the test element in the first wavelength range in which the previously known absorption of the dry test element and an analyte-independent, sample-dependent light intensity change takes place and

determining a second correction value based on the detected light,

subsequently or before method step (b), irradiating the test element and detecting the light reflected or transmitted by the test element in a second wavelength range in which an absorption by an analyte takes place and determining the measured value

computing for the first and second correction value in order to determine the proportion of the light intensity changes that are due to the sample,

determining the amount of light (black value) that is registered by the detector when there is an essentially complete absorption of the dry test element using the first correction value,

calculating the analyte concentration in the second wavelength range with a correction of the measured value taking into account the black value and the sample-dependent change in light intensity.

10. Method as claimed in claim 9 in which the dry test element essentially completely absorbs.

11. Method as claimed in claim 9 in which the sample-dependent change in light intensity in the first wave-length range is set as essentially equal to the sample-dependent change in light intensity in the second wavelength range.

12. Method as claimed in claim 9 in which the sample-dependent change in light intensity in the second wavelength range is determined on the basis of the sample-dependent change in light intensity in the first wavelength range.

13. Method as claimed in claim 9 in which a value is determined using the first and the second correction value and a signal is generated as soon as the value deviates by a predetermined extent from a target value.

14. Method as claimed in claim 9 in which the test element is irradiated in the second or in a third wavelength range in which essentially no absorption by the test element takes place (white value) and the measured value is corrected taking into account the white value.

15. Method as claimed in claim 14 in which the white value is measured in the second wavelength range before sample application.

16. Method for analysing and correcting non-analyte-dependent changes in light intensity comprising the steps

irradiating a test element in a first wavelength range before and after sample application where the test element has an absorption in the first wavelength range before sample application which is previously known and is not equal to zero,

detecting the light reflected or transmitted by the test element in the first wavelength range and determining a first and a second correction value based on the detected light,

irradiating the test element after sample application and detecting the light reflected or transmitted by the test element in a second wavelength range in which an absorption by an analyte takes place and determining the measured value,

determining the analyte concentration with a correction of the measured value taking into account the first or second correction value.

17. Method as claimed in claim 16 in which the dry test element essentially completely absorbs.

18. Method as claimed in claim 16 in which the test element is irradiated in the second or in a third wavelength range in which essentially no absorption by the test element takes place (white value) and correcting the measured value taking into account the white value.

19. Method as claimed in claim 18 in which the white value is measured in the second wavelength range before sample application.