Analytic test unit and test system

• US 10,119,907 B2
• Filed: 02/08/2013
• Issued: 11/06/2018
• Est. Priority Date: 08/11/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Harttig, Herbert, Aigner, Simon
• Primary Examiner(s): Cerioni, Daniel
• Application Number:
  US13/762,877
• Publication Number:
  US 20130150753A1
• Time in Patent Office: 2,097 Days
• Field of Search: 600583
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 21/41 Refractivity; Phase-affecting properties, e.g. optical path length G01N21/21 takes precedence
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

This disclosure relates to an analytic test unit for use in a test device for detecting an analyte in a bodily fluid, having at least one test element with a carrier film and a reagent layer, the latter being affixed on the carrier side of the carrier film and it being possible to apply bodily fluid on said reagent layer, wherein the light-transparent carrier film can be positioned in the beam path of a photometric measuring unit for optically scanning the reagent layer. According to this disclosure, it is proposed that the carrier film has a surface, modified by a raised surface structure, for reducing reflections in the beam path of the measuring unit.

Claims

1. An analytic test unit for use in a test instrument for detecting an analyte in a bodily fluid, comprising:

a test element having a light-transmissive carrier film;

a reagent layer applied to the carrier film and to which bodily fluid can be applied, wherein the reagent layer includes a chemical reagent that changes color when it is wetted by the bodily fluid; and

a spreading layer positioned adjacent the reagent layer and configured to spread the bodily fluid laterally along the regent layer;

wherein the carrier film can be positioned in a beam path of a photometric measuring unit for optically scanning the reagent layer, the photometric measuring unit having an optical waveguide configured to transmit incident light in a direction substantially perpendicular to the carrier film, further wherein the carrier film comprises a raised surface structure configured to reduce reflections in the beam path of the measuring unit.

2. The analytic test unit of claim 1, wherein the optical waveguide is configured to be positioned substantially perpendicular to the carrier film.

3. The analytic test unit of claim 1, wherein the optical waveguide comprises at least two optical waveguides positioned substantially parallel to one another.

4. The analytic test unit of claim 3, wherein at least one the optical waveguides is configured to receive reflected light in a direction substantially perpendicular to the carrier film.

5. The analytic test unit of claim 1, wherein the optical waveguide comprises at least two optical waveguides and at least one of said waveguides is configured to receive reflected light in a direction substantially perpendicular to the carrier film.

6. The analytic test unit of claim 5, wherein each of the at least two optical waveguides is positioned substantially perpendicular to the carrier layer.

7. An analytic test unit for use in a test instrument for detecting an analyte in a bodily fluid, comprising:

a test element having a light-transmissive carrier film;

a reagent layer applied to the carrier film and to which bodily fluid can be applied, wherein the reagent layer includes a chemical reagent that changes color when it is wetted by the bodily fluid; and

a spreading layer positioned adjacent the reagent layer and configured to spread the bodily fluid laterally along the reagent layer;

wherein the carrier film can be positioned in a beam path of a photometric measuring unit for optically scanning the reagent layer, the photometric measuring unit having a plurality of optical waveguides positioned substantially parallel to one another, at least one of the waveguides configured to be positioned substantially perpendicular to the carrier film and to transmit light to the carrier film and at least another one of the waveguides configured to transmit light away from the carrier film, further wherein the carrier film comprises a raised surface structure configured to reduce reflections in the beam path of the measuring unit.

8. The analytic test element of claim 7, wherein the reagent layer is positioned between the carrier film and the spreading layer.

9. The analytic test element of claim 7, wherein the raised surface structure forms a moth'"'"'s eye structure.

10. The analytic test unit of claim 7, wherein at least one of the optical waveguides is configured to transmit incident light in a direction substantially perpendicular to the carrier film.

11. The analytic test unit as claimed in claim 7, wherein the raised surface structure is arranged on a carrier side and/or on a rear side of the carrier film and faces away from the reagent layer and can be directed at the measuring unit.

12. The analytic test unit as claimed in claim 7, wherein the raised surface structure is arranged on a carrier side of the carrier film.

13. The analytic test unit as claimed in claim 7, wherein the raised surface structure has a structure height in the range between 5-times and 0.2-times the wavelength of the measurement light of the measuring unit.

14. The analytic test unit as claimed in claim 7, wherein the raised surface structure has a structure height in the range between 3-times and 0.7-times the wavelength of the measurement light of the measuring unit.

15. The analytic test unit as claimed in claim 7, wherein the raised surface structure has a structure height in the range between 2-times and 1-times the wavelength of the measurement light of the measuring unit.

16. The analytic test unit as claimed in claim 7, wherein the transmission factor of the carrier film is increased compared to an unstructured plane surface as a result of the raised surface structure.

17. The analytic test unit as claimed in claim 7, wherein the raised surface structure is formed by a prism profile on a rear side of the carrier film facing away from a carrier side.

18. The analytic test unit as claimed in claim 17, wherein the prism profile has a profile pitch of less than 100 μ

m from a multiplicity of individual prisms.

19. The analytic test unit as claimed in claim 17, wherein the prism profile has a profile pitch of less than 50 μ

m from a multiplicity of individual prisms.

20. The analytic test unit as claimed in claim 17, wherein the prism profile comprises a triangle profile which extends in a straight line in a longitudinal direction and which is periodic transversely thereto.

21. The analytic test unit as claimed in claim 20, wherein the prism profile comprises a saw-tooth profile.

22. The analytic test unit as claimed in claim 7, wherein the surface structure is stamped.

23. The analytic test unit as claimed in claim 7, wherein the surface structure is cast.

24. The analytic test unit as claimed in claim 7, further comprising a collection structure for bodily fluid which can be brought into fluid connection with the reagent layer arranged on a piercing element for obtaining bodily fluid by piercing the skin.

25. A hand-held analytic test system for detecting an analyte in a bodily fluid, comprising a photometric measuring unit and an analytic test unit according to claim 7.

26. The analytic test system as claimed in claim 25, wherein the measuring unit has a plurality of optical waveguides for transmitting measurement light and the optical waveguides are coupled end-to-end at one end face to a rear side of the carrier film facing away from the reagent layer.

27. The analytic test system as claimed in claim 26, wherein the optical waveguides are arranged parallel to one another in a common plane, with the end sections thereof directed at the carrier film.