US 12,455,247 B2
Devices and method for measuring an analyte concentration in a sample of bodily fluid
Bernd Limburg, Soergenloch (DE); Max Berg, Mannheim (DE); Daniel Sieffert, Mannheim (DE); Fredrik Hailer, Mannheim (DE); and Christian Hoertz, Worms (DE)
Assigned to ROCHE DIABETES CARE, INC., Indianapolis, IN (US)
Appl. No. 17/290,343
Filed by Roche Diabetes Care, Inc., Indianapolis, IN (US)
PCT Filed Oct. 29, 2019, PCT No. PCT/EP2019/079445
§ 371(c)(1), (2) Date Apr. 30, 2021,
PCT Pub. No. WO2020/089188, PCT Pub. Date May 7, 2020.
Claims priority of application No. 18203789 (EP), filed on Oct. 31, 2018.
Prior Publication US 2022/0003683 A1, Jan. 6, 2022
Int. Cl. G01N 21/78 (2006.01); G01N 21/77 (2006.01); G06T 7/00 (2017.01)
CPC G01N 21/78 (2013.01) [G06T 7/0014 (2013.01); G01N 2021/7759 (2013.01); G06T 2207/30024 (2013.01)] 28 Claims
OG exemplary drawing
 
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.