Analysis system for determining an analyte in a body fluid

• US 8,280,642 B2
• Filed: 09/19/2008
• Issued: 10/02/2012
• Est. Priority Date: 09/22/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Haar, Hans-Peter
• Primary Examiner(s): Huynh, Phuong
• Application Number:
  US12/233,889
• Publication Number:
  US 20090082973A1
• Time in Patent Office: 1,474 Days
• Field of Search: 702/19, 702 30- 32, 702117-126, 702187-190
• US Class Current: 702/19
• 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 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

An analysis system for determining an analyte of a body fluid comprises a test element and an analysis instrument having a measurement and evaluation unit. The test element has a sample application zone and two analysis zones and a reagent system, whose reaction with the analyte results in a detectable change characteristic for the desired analytical result. The measurement and evaluation unit comprises two analog measuring units, in each of which an analog measurement signal corresponding to one of the analysis zones is generated, two analog-digital converters for digitizing the analog measurement signal, a comparator unit for comparing control data values based on the digitized measurement signals, and a final processing unit, in which, if the determined deviation between the control data values of the digitized measurement signals is less than a predefined value, at least one of the control data values is allowed to pass for further processing into the desired analytical result.

Claims

1. An analysis system for determining an analyte in a body fluid, comprising:

a test element with a reagent system, whose reaction with the analyte results in a detectable change which is characteristic for the desired analytical result, with a sample application zone and with two analysis zones, and

an analysis instrument with a measurement and evaluation unit, which comprises;

two analog measuring units, in each of which an analog measurement signal corresponding to one of the analysis zones is generated,

two analog-digital converters for digitizing the analog measurement signal,

a comparator unit for comparing control data values based on the digitized measurement signals, and

a final processing unit, in which, if a determined deviation between the control data values of the digitized measurement signals is less than a predefined value, at least one of the control data values is allowed to pass for further processing into the desired analytical result.

2. The analysis system according to claim 1, wherein the control data values are concentration values and the predefined value is a reference concentration value.

3. The analysis system according to claim 2, wherein the measurement and evaluation unit comprises an evaluation unit in which concentration values are determined from the control data values using an evaluation algorithm and the evaluation algorithm comprises an assignment between the control data values and concentration values, the evaluation unit being positioned between the comparator unit and the final processing unit.

4. The analysis system according to claim 3, wherein the assignment of the evaluation algorithm is performed by a calibration wherein digitized reference measurement signals are generated for reference concentration values.

5. The analysis system according to claim 2, wherein the measurement and evaluation unit comprises two evaluation units in which concentration values are determined from the digitized measurement signals each using an evaluation algorithm, which comprises an assignment between values of the digitized measured signals and concentration values, the evaluation units being positioned in the processing chain before the comparator unit.

6. The analysis system according to claim 5, wherein the assignment of the evaluation algorithm is performed by a calibration wherein digitized reference measurement signals are generated for reference concentration values.

7. The analysis system of claim 1, wherein:

the analysis instrument has an optical transmitter for emitting light onto the analysis zones, and

the measurement and evaluation unit has two optical receivers each for receiving light from one analysis zone, and

an analog measurement signal is generated in each of the two analog measuring units, which analog signals are proportional to the light reflected from each of the analysis zones.

8. The analysis system of claim 7, wherein an optical fiber is positioned between the optical transmitter and an analysis zone and configured so that at least one of the analysis zones is irradiated with light, and an optical fiber is positioned between each optical receiver and each analysis zone and configured so that reflected light from the analysis zone is transmitted to the optical receivers.

9. The analysis system according to claim 1, wherein the measurement and evaluation unit comprises a first electrical conductor which is contacted with at least one of the analysis zones, and a second electrical conductor, which is contacted with an analysis zone and an analog measuring unit and configured so that a current flow through the first electrical conductor, the at least one analysis zone, and the second electrical conductor is measurable by the one analog measuring unit.

10. The analysis system according to claim 1, wherein a capillary channel is positioned between the sample application zone and the analysis zones, whereby the body fluid is transferred onto the analysis zones.

11. The analysis system according to claim 1, wherein the two analysis zones have analysis volumes different from one another.

12. The analysis system according to claim 1, wherein if the deviation between two control data values in less than the predefined value, both control data values are enabled in the final processing unit and the further processing into the desired analytical result is performed on the basis of both control data values.

13. The analysis system according to claim 12, wherein the analytical result is determined from the mean value of the two control data values.

14. The analysis system according to claim 1, wherein if the deviation between two control data values in less than the predefined value, only one of the control data values are enabled in the final processing unit and the further processing into the desired analytical result is performed on the basis of the lower or higher of the two control data values.

15. The analysis system according to claim 1, wherein if the determined deviation between the control data values of the digitized measurement signals is more than the predefined value, the control data values are not allowed to pass and an error signal is generated.

16. The analysis system according to claim 1, wherein the analysis instrument comprises an output unit, at which the analytical result or an error signal is outputted.

17. The system according to claim 1, wherein the measurement signals from each of the two analog measuring units are digitized by a corresponding one of the two analog-digital converters for digitizing the analog measurement signal in parallel to one another.

18. The system according to claim 17, wherein the measurement signals from each of the two analog measuring units are digitized simultaneously by the two analog-digital converters.