Analysis system with coding recognition

• US 8,293,539 B2
• Filed: 02/04/2011
• Issued: 10/23/2012
• Est. Priority Date: 08/04/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Petrich, Wolfgang, Kalveram, Stefan, Serr, Markus
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US13/021,356
• Publication Number:
  US 20120045842A1
• Time in Patent Office: 627 Days
• Field of Search: 436/14, 436/44, 436/46, 436/63, 436/95, 436/164, 436/169, 422/420, 422/430, 422/66, 422/68.1, 422/82.05, 422/82.09, 422/421, 435/14, 435/287.7, 435/288.7
• US Class Current: 436/169
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: G01N 35/00663 of consumables
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

An analysis system for detecting at least one analyte in a sample is proposed, in particular for detecting glucose in a bodily fluid. The analysis system is designed to detect the analyte using at least one test element. The test element has at least one analysis zone for detecting the analyte. The test element includes at least one coding with at least one test element specific item of information and/or at least one position specific item of information. The analysis system includes a detector and furthermore at least one transfer device which is designed to afford the detector the possibility of acquiring the analysis zone in at least a first position and to afford the detector the possibility of acquiring the coding in at least a second position which differs from the first position.

Claims

1. An analysis system for detecting at least one analyte in a sample, the analysis system being configured to detect the analyte using at least one test element including one of a test strip and a test tape having at least one analysis zone for detecting the analyte and at least one coding encoded with one or both of at least one test element specific item of information and at least one position specific item of information, the analysis system comprising:

a detector;

at least one transfer device configured to enable the detector to acquire the analysis zone in at least a first position and to enable the detector to acquire the coding in at least a second position which differs from the first position;

wherein the analysis system is configured to acquire at least the test element specific item of information of the coding with the detector when the test element is the test strip; and

wherein the analysis system is configured to acquire at least the position specific item of information with the detector when the test element is the test tape; and

wherein in the second position the analysis system is configured to perform a histogram analysis of a gray-scale coding encoded by the coding on the test element to evaluate the test element specific item of information.

2. The analysis system according to claim 1, wherein the analysis system furthermore comprises an evaluation unit operatively connected to the detector and configured to carry out the detection of the analyte using the test element specific item of information.

3. The analysis system according to claim 1, wherein the detector comprises an optical detector.

4. The analysis system according to claim 3, wherein the detector comprises a spatially resolving detector.

5. The analysis system according to claim 1, wherein the transfer device comprises a guide configured for lateral movement of the test element, wherein the at least one coding is configured for moving past the detector during the lateral movement.

6. The analysis system according to claim 1, wherein the transfer device comprises at least one drive apparatus, the drive apparatus being designed to move the test element.

7. The analysis system according to claim 1, furthermore comprising a test element with at least one analysis zone for detecting the analyte and at least one coding with at least one test element specific item of information.

8. The analysis system according to claim 7, wherein the test element comprises a planar test element configured such that the analysis zone and the coding are arranged so as to be acquired by the detector from the same side of the planar test element.

9. The analysis system according to claim 7, wherein the test element comprises a plurality of analysis zones or a plurality of groups of analysis zones, with at least one said coding being assigned to each analysis zone or group of analysis zones.

10. The analysis system according to claim 9, wherein the analysis zones or the groups of analysis zones and the respective codings are arranged alternately on the test element.

11. The analysis system according to claim 7, wherein the coding comprises at least one two-dimensional optical information component.

12. The analysis system according to claim 7, wherein the coding comprises at least one positioning marker provided for encoding the position specific item of information.

13. The analysis system according to claim 1, wherein the histogram analysis comprises a histogram analysis of a fill factor of individual gray-scale values for a number of fields of the coding.

14. The analysis system according to claim 1, wherein the detector is configured to perform the histogram analysis at least in part.

15. The analysis system according to claim 1, wherein the analysis system is furthermore configured to use the gray-scale coding for scaling, the gray-scale coding comprising at least one of a black item of information and a white item of information.

16. The analysis system according to claim 1, wherein the acquisition of the coding by the detector generates at least one item of start information and at least one item of stop information, with the test element comprising a test tape, the analysis system being configured to spool the test tape in accordance with the item of start information and the item of stop information.

17. A method for detecting at least one analyte in a sample comprising the steps of:

(a) providing an analysis system comprising a test element having at least one analysis zone and at least one coding encoded with one or both of at least one test element specific item of information and at least one position specific item of information, the coding comprising at least one gray-scale coding, a detector, and at least one transfer device configured to enable the detector to acquire the analysis zone in at least a first position and to enable the detector to acquire the coding in at least a second position which differs from the first position, the analysis system being configured to detect the analyte using the test element;

(b) acquiring the analysis zone in the first position with the detector;

(c) acquiring the coding in the second position with the detector;

(d) evaluating the test element specific item of information with a histogram analysis of the gray-scale coding; and

wherein for an analysis system in which the test element comprises a test strip, the coding is encoded with at least the test element specific item of information; and

wherein for an analysis system in which the test element comprises a test tape, the coding is encoded with at least the position specific item of information.

18. An apparatus, comprising:

test element for receiving a sample having at least one analyte in the sample, the test element including a plurality of analysis zones or a plurality of groups of analysis zones for detecting the analyte, the test element furthermore comprising at least one individual coding assigned to each analysis zone or group of analysis zones, wherein the coding comprises at least one gray-scale coding encoded with at least one test element specific item of information and the analysis zone and gray-scale coding are configured so that a detector of an analysis system acquires the analysis zone in at least a first position and acquires the gray-scale coding in a second position that is different from the first position and in the second position a histogram analysis of the gray-scale coding can be performed by the analysis system to evaluate the test element specific item of information.

19. The apparatus according to claim 18, wherein the at least one individual coding comprises an individual fill factor of individual gray-scale values.