IP Library Granted Patent US 9,329,128
Granted Patent B2
US 9,329,128 · App. 14/054,563 · Granted May 3, 2016

Test element for detecting an analyte in a sample

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Quick Facts
Patent No.
US 9,329,128
App. No.
14/054,563
Granted
May 3, 2016
Kind
B2
Abstract

The invention relates to a test element for detecting at least one analyte in a sample, in particular for detecting at least one metabolite in a bodily fluid. The test element comprises at least one test field with a test field surface. The test field comprises at least one detection reagent that is adapted to undergo a detectable reaction in the presence of the analyte. The test element further comprises at least one distribution element that has at least one distribution surface facing the test field surface. Between the distribution surface and the test field surface is at least one capillary gap, wherein the capillary gap is adapted to allow a layer of the sample with a layer thickness of no more than 50 μm to form within the capillary gap.

Claims (6)

1. A device for detecting at least one metabolite or other analyte in a body fluid or other sample, wherein the device comprises:

at least one test element for detecting the at least one metabolite or other analyte in a body fluid or other sample, the test element comprising at least one test field having a test field surface, wherein the test field comprises at least one detection reagent which is set up to carry out at least one detectable reaction that forms at least one detection substance in the presence of the metabolite or other analyte, wherein the test element is set up such that a stationary state of the detectable reaction is reached within a period of up to 4 seconds from an application of the body fluid or other sample; and

at least one calibration device, wherein the calibration device is set up to determine directly and/or indirectly the detection substance in the sample outside the test field and wherein the device is further set up to carry out the detection of the analyte taking account of said determination of the detection substance in the sample outside the test field.

2. The device of claim 1 , wherein the device is set up to detect the detection substance in the sample outside the test field by means of at least one time-resolved measurement, more particularly by means of at least one time-resolved optical measurement.

3. The device of claim 1 , wherein the test element comprises at least one capillary gap connected to the test field for receiving and distributing the sample on the test field, wherein the calibration device is set up to carry out a calibration of a gap width of the capillary gap by means of the detection of the detection substance in the sample outside the test field.

4. A process for detecting at least one metabolite or other analyte in a body fluid or other sample, using a device of claim 1 , wherein at least one test element is used, wherein the test element comprises at least one test field having a test field surface for applying the sample, wherein the test field comprises at least one detection reagent which is set up to carry out a detectable reaction in the presence of the analyte, wherein the detection reagent is set up such that at least one detection substance is formed in the detectable reaction, wherein the detection substance in the sample outside the test field is determined directly and/or indirectly and wherein the detection of the analyte is carried out taking account of said determination of the detection substance in the sample outside the test field.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2015
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 036008/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 20, 2014
From: PETRICH, WOLFGANG; BEDON-GOMEZ, LUIS DAVID
To: ROCHE DIAGNOSTICS GMBH
Reel/Frame 032257/0798 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 20, 2014
From: ROCHE DIAGNOSTICS GMBH
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 032257/0867 →