Devices and method for measuring an analyte concentration in a sample of bodily fluid

Patent metadata

Field	Value
Publication number	US-12455247-B2
Application number	US-201917290343-A
Country	US
Kind code	B2
Filing date	Oct 29, 2019
Priority date	Oct 31, 2018
Publication date	Oct 28, 2025
Grant date	Oct 28, 2025

Abstract

An optical test strip ( 118 ) for measuring an analyte concentration in a sample of bodily fluid is disclosed. The optical test strip ( 118 ) comprises:
a) a bottom layer ( 116 ) having a first end ( 130 ); b) a top layer ( 110 ) having a first end ( 132 ) essentially aligned with the first end ( 130 ) of the bottom layer ( 116 ); c) at least one spacer layer ( 114 ) interposed between the bottom layer ( 116 ) and the top layer ( 110 ), the spacer layer ( 114 ) having a length shorter than the bottom layer ( 116 ) and shorter than the top layer ( 110 ) such that the top layer ( 110 ) and the bottom layer ( 116 ) protrude over the spacer layer ( 114 ), wherein the first end ( 130 ) of the bottom layer ( 116 ), the first end ( 132 ) of the top layer ( 110 ), and the spacer layer ( 114 ) form a sample receiving area ( 140 ) which at least partially has capillary properties for receiving the sample of bodily fluid; and d) at least one test field ( 112 ), wherein the test field ( 112 ) comprises a test chemical being configured for performing an optically detectable detection reaction with the analyte, wherein the test field ( 112 ) comprises at least one first region ( 126 ) and at least one second region ( 128 ), wherein the first region ( 126 ) faces the sample receiving area ( 140 ), wherein the first region ( 126 ) is configured to be at least partly wetted by the sample of bodily fluid upon sample application, wherein the second region ( 128 ) is covered by the spacer layer ( 114 ) such that the second region ( 128 ) is essentially inaccessible for the sample of bodily fluid.

First claim

The invention claimed is:

1 . An optical test strip for measuring an analyte concentration in a sample of bodily fluid, comprising:
a) a bottom layer having a first end and an upper surface; b) a top layer having a first end essentially aligned with the first end of the bottom layer and having a lower surface facing the upper surface of the bottom layer; c) at least one spacer layer interposed between the upper surface of the bottom layer and the lower surface of the top layer, the at least one spacer layer having a length shorter than the bottom layer and shorter than the top layer such that the top layer and the bottom layer protrude over the first ends of the at least one spacer layer, wherein the first end of the bottom layer, the first end of the top layer, and the at least one spacer layer form a sample receiving area which at least partially has capillary properties for receiving the sample of bodily fluid; and d) at least one test field comprising a test chemical which reacts with the analyte to provide an optically detectable detection reaction,
wherein the at least one test field having a first surface and an opposed second surface, wherein the first surface of the at least one test field faces the top layer, and the opposed second surface faces the bottom layer,
the at least one test field comprising at least one first region and at least one second region,
wherein the at least one first region comprises a surface which faces the sample receiving area, wherein the surface of the at least one first region is uncovered by the at least one spacer layer and is exposed to the sample of bodily fluid upon sample application,
wherein the at least one second region comprises a surface which faces in the same direction as the surface of the at least one first region,
wherein the surface of the at least one second region is covered by the at least one spacer layer to essentially prevent exposure to the sample of bodily fluid upon sample application, the covering of the at least one second region by the at least one spacer layer essentially preventing a detectable reaction taking place in the at least one second region, and
the surface of the at least one first region and the surface of the at least one second region are visible in a top view of the optical test strip.

2 . The optical test strip according to claim 1 , wherein the at least one first region and the at least one second region of the at least one test field are located in close proximity.

3 . The optical test strip according to claim 1 , wherein the at least one first region and the at least one second region have essentially the same spectral and/or spectroscopic characteristics and/or reflective and/or absorption properties.

4 . The optical test strip according to claim 1 , wherein the top layer comprises at least one top foil, wherein the at least one top foil is transparent and has low reflective properties.

5 . The optical test strip according to claim 4 , wherein the at least one top foil comprises at least one material selected from the group consisting of: Polyesters, Polymethacrylates, Polyolefins, Polycarbonates, Polyamides, Cellulose or derivatives thereof, Polyvinylchloride, Polystyrene, or combinations thereof, or flexible glass, and/or wherein the at least one spacer layer comprises Polyesters, Polymethacrylates, Polyolefins, Polycarbonates, Polyamides, Cellulose or derivatives thereof, Polyvinylchloride, Polystyrene, or combinations thereof.

6 . The optical test strip according to claim 1 , wherein the optical test strip comprises at least one capillary element, wherein a height of the at least one capillary element is defined by a thickness of the at least one spacer layer, wherein the at least one capillary element is open at three sides.

7 . The optical test strip according to claim 1 , wherein the bottom layer comprises at least one bottom foil, wherein the at least one bottom foil is opaque.

8 . The optical test strip according to claim 1 , wherein the length of the bottom layer extends beyond the length of the top layer or wherein the length of the top layer extends beyond the length of the bottom layer.

9 . The optical test strip according to claim 1 , wherein the optical test strip comprises at least one supporting spacer which is arranged between the top layer and the at least one spacer layer.

10 . The optical test strip of claim 1 wherein the surface of the at least one first region is uncovered by the at least one spacer layer and is available for the sample of bodily fluid.

11 . The optical test strip of claim 10 , wherein the surface of the at least one second region is covered by the at least one spacer layer and essentially prevents exposure of the surface of the at least one second portion to bodily fluid.

12 . The optical test strip of claim 1 wherein the at least one second region is underneath the at least one spacer layer.

13 . The optical test strip of claim 1 wherein the surface of the at least one first region and the surface of the at least one second region are coplanar.

14 . The optical test strip of claim 13 wherein the surface of the at least one first region is in close proximity to the surface of the at least one second region.

15 . The optical test strip of claim 14 wherein the surface of the at least one first region is contiguous with the at least one second region.

16 . The optical test strip of claim 15 wherein the surface of the at least one first region is adjacent to the surface of the at least one second region.

17 . The optical test strip of claim 13 wherein the at least one first region and the at least one second region comprise the same test chemical.

18 . The optical test strip of claim 17 wherein the surface of the at least one second region is covered by the at least one spacer layer and the surface of the at least one first region is uncovered by the at least one spacer layer.

19 . The optical test strip of claim 1 , wherein the at least one spacer layer covering the at least one second region is transparent.

20 . The optical test strip of claim 1 , wherein the top layer does not cover the at least one second region.

21 . The optical test strip of claim 1 , wherein the top layer covering the at least one second region is transparent.

22 . The optical test strip of claim 21 , wherein the at least one spacer layer covering the at least one second region is transparent.

23 . The optical test strip according to claim 1 , wherein the top layer is transparent adjacent the at least one first region of the at least one test field.

24 . The optical test strip according to claim 1 , wherein the top layer includes a hole adjacent the at least one first region of the at least one test field.

25 . The optical test strip according to claim 1 , wherein further comprising a transparent adhesive layer between the first region of the at least one test field and the spacer layer.

26 . An optical test strip for measuring an analyte concentration in a sample of bodily fluid, comprising:
a) a bottom layer having a first end; b) a top layer having a first end essentially aligned with the first end of the bottom layer; c) at least one spacer layer interposed between the bottom layer and the top layer, the at least one spacer layer having a length shorter than the bottom layer and shorter than the top layer such that the top layer and

Assignees

• Roche Diabetes Care Inc

Inventors

• Limburg Bernd
• Berg Max
• Sieffert Daniel
• Hailer Fredrik
• Hoertz Christian

Classifications

• G06T2207/30024

  Cell structures in vitro; Tissue sections in vitro · CPC title

• G06T7/0014

  using an image reference approach · CPC title

• G01N2021/7759

  Dipstick; Test strip · CPC title

• G01N33/4875

  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) · CPC title

• G01N21/27

  using photo-electric detection (G01N21/31 takes precedence){; circuits for computing concentration (logarithmic circuits G06G7/24; photometric circuits in general G01J)} · CPC title