Test element analysis system for the analytical examination of a sample

• US 10,328,429 B2
• Filed: 10/03/2017
• Issued: 06/25/2019
• Est. Priority Date: 10/14/2016
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Stein, Reiner, Fischheiter, Lars, Mertens, Martin
• Primary Examiner(s): Wecker, Jennifer
• Application Number:
  US15/723,252
• Publication Number:
  US 20180104683A1
• Time in Patent Office: 630 Days
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/14 Process control and prevention of errors
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/416 Systems G01N27/27 takes precedence
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B

Abstract

A test element analysis system for the analytical examination of a sample, a method for positioning a test element in a measuring device and a method for an analytical examination of a sample are disclosed. The test element analysis system comprises: a measurement device comprising a test element receptacle for receiving a test element at least partially, wherein the receptacle comprises a first part and a second part, the first part comprises a support surface for placement of the test element, the second part comprises an alignment pin for engagement with an alignment hole of the test element, the second part is movable relative to the first part in a direction essentially perpendicular to the support surface, the receptacle is configured to position the second part in at least three distinct positions relative to the first part comprising an intermediate position, a closed position, and an open position.

Claims

1. A test element analysis system for the analytical examination of a sample, comprising a measurement device, the measurement device comprising a test element receptacle for receiving at least one test element at least partially, wherein the test element receptacle comprises at least one first part and at least one second part, wherein the first part comprises at least one support surface for placement of the test element, wherein the second part comprises at least one alignment pin for engagement with at least one alignment hole of the test element, wherein the second part is movable relative to the first part in a direction essentially perpendicular to the support surface, wherein the test element receptacle is configured to position the second part in at least three distinct positions relative to the first part, the at least three distinct positions comprising an intermediate position for inserting the test element into the test element receptacle, a closed position for performing a measurement and an open position for removing the test element from the test element receptacle,

wherein in the closed position the alignment pin protrudes through the alignment hole,

wherein in the open position the first part and the second part are spaced apart such that the test element may freely be removed from the test element receptacle, and

wherein in the intermediate position the first part and the second part are spaced apart such that the test element may be inserted into the test element receptacle, whereas the alignment pin is positioned such that the test element is resiliently deformed by the alignment pin during the insertion, until the alignment pin snaps into the alignment hole.

2. The test element analysis system according to claim 1, wherein the test element analysis system further comprises at least one test element having the at least one alignment hole.

3. The test element analysis system according to claim 1, wherein in the closed position the test element is supported by the first part, and the second part rests on the test element.

4. The test element analysis system according to claim 1, wherein in the open position the alignment pin is pulled out of the alignment hole completely.

5. The test element analysis system according to claim 1, wherein the test element receptacle further comprises a lateral guiding for the test element, wherein the lateral guiding prevents at least to a large extent a rotation of the test element within the test element receptacle when the alignment hole is engaged by the alignment pin.

6. The test element analysis system according to claim 1, wherein the second part comprises a block that is linearly movable in the direction essentially perpendicular to the support surface, and the alignment pin is at least partially integrated into the block.

7. The test element analysis system according to claim 1, wherein the measurement device comprises at least one detector for detecting at least one detection reaction between the sample or at least one component thereof, and at least one constituent of the test element.

8. The test element analysis system according to claim 7, wherein the at least one detector is fully or partially comprised in the second part.

9. The test element analysis system according to claim 7, wherein the alignment pin is configured to position the test element relative to the at least one detector.

10. The test element analysis system according to claim 1, wherein the second part comprises at least one abutment surface interacting with the support surface in the closed position, and wherein, in the closed position, the abutment surface rests on the test element.

11. The test element analysis system according to claim 1, wherein a tip of the alignment pin, in the intermediate position, penetrates a plane through the support surface, and wherein, in the open position, the alignment pin does not penetrate the plane through the support surface.

12. The test element analysis system according to claim 1, wherein the test element receptacle contains at least one guiding element for guiding a relative movement of the second part and the first part.

13. The test element analysis system according to claim 1, wherein the test element analysis system further comprises at least one actuator for driving a relative movement of the first part and the second part.

14. A method for positioning a test element in a measuring device for performing an analytical examination of a sample, the method comprising:

a) providing a measurement device having a test element receptacle for receiving at least one test element at least partially, wherein the test element receptacle comprises at least one first part and at least one second part, wherein the first part comprises at least one support surface for placement of the test element, wherein the second part comprises at least one alignment pin for engagement with at least one alignment hole of the test element, and wherein the second part is movable relative to the first part in a direction essentially perpendicular to the support surface,

b) positioning the second part in an intermediate position, wherein in the intermediate position the first part and the second part are spaced apart such that the test element may freely be inserted into the test element receptacle,

c) inserting at least one test element having at least one alignment hole into the test element receptacle, wherein the test element is temporarily and resiliently deformed by the alignment pin during the insertion, until the alignment pin snaps into the alignment hole,

d) positioning the second part in a closed position, wherein in the closed position the alignment pin protrudes through the alignment hole,

e) positioning the second part in an open position, wherein in the open position the first part and the second part are spaced apart, and

f) removing the test element from the test element receptacle.

15. The method according to claim 14, wherein the sample is a sample of a body fluid.

16. A method for an analytical examination of a sample, wherein the method comprises the method steps according to claim 14, and wherein the method further comprises at least one measurement step for detecting at least one analyte in the sample.