Disposable test strip device for analyte detection in a body liquid sample

• US 10,407,710 B2
• Filed: 11/26/2014
• Issued: 09/10/2019
• Est. Priority Date: 12/03/2013
• Status: Active Grant

• Current Assignee: Promilless Oy
• Original Assignee: Goodwiller Oy
• Inventors: Nara, Petteri, Sarkela, Petri, Makiniemi, Teemu
• Primary Examiner(s): Kosar, Aaron J
• Application Number:
  US14/554,398
• Publication Number:
  US 20150152468A1
• Time in Patent Office: 1,749 Days
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/98 involving alcohol, e.g. ethanol in breath

Abstract

A disposable, enzymatic assay based test strip device for colorimetric detection of an analyte compound, such as ethanol, in a body liquid sample, such as saliva, is provided. The test strip device includes at least one reactive test zone configured to develop a visual indication when the concentration of the analyte compound in the body liquid sample exceeds a predetermined limit, and a reactive control zone configured to develop a visual indication upon being supplied with the body liquid sample. The test strip device further includes a compound buffer, preferably selected from non-volatile alcohols and disposed to closely adjoin the reactive control zone such, that the content of the compound buffer admixes with the reagents provided within the reactive control zone, while the control zone is being supplied with the body liquid sample. Deposition of the reactive zones is preferably implemented by conventional printing methods utilizing biological inks.

Claims

1. A disposable, enzymatic assay based test strip device for colorimetric detection of an analyte compound in a body liquid sample, comprising:

a base support;

a substrate material disposed on said base support and defining a number of reactive test zones and a reactive control zone; and

a compound buffer comprising a chemical compound same or equivalent to the analyte compound and bearing a functional group characteristic to the analyte compound,

wherein each reactive test zone is configured to develop a visual indication when the concentration of the analyte compound in the body liquid sample exceeds a predetermined limit and the reactive control zone is configured to develop a visual indication upon being supplied with the body liquid sample,

wherein the substrate material defining each reactive test zone and the reactive control zone is deposited with a biological ink composition comprising at least one enzyme and a chromogen, said biological ink composition being identical in each reactive test zone and the reactive control test zone; and

wherein the substrate material defining the reactive control zone is further disposed with the compound buffer configured to reside within the substrate material defining the reactive control zone such, that the buffer compound is prevented from admixing with the biological ink composition in the reactive control zone until the substrate material, defining said reactive control zone is supplied with the body liquid sample, thereupon the visual indication is developed.

2. The test strip device of claim 1, configured for the detection of an alcohol compound in the body liquid sample.

3. The test strip device of claim 2, configured for the detection of ethanol in the body liquid sample.

4. The test strip device of claim 1, wherein the compound buffer comprises an alcohol compound.

5. The test strip device of claim 1, wherein the compound buffer comprises a mono-, oligo- and/or polysaccharide compound selected from the group of carbohydrate compounds, comprising at least one hydroxyl group bound to carbon backbone.

6. The test strip device of claim 1, in which the reactive control zone and the reactive test zone(s) are each provided on an individual substrate pad fixedly attached to the base support.

7. The test strip device of claim 6, in which the substrate pad defining the reactive control zone contains the biological ink composition and the compound buffer, said biological ink composition and the compound buffer being provided within the substrate material in the form of chemically stable, immiscible substances.

8. The test strip device of claim 6, wherein the compound buffer is provided in the form of a film-like layer disposed in ultimate proximity to the substrate pad defining the reactive control zone, and comprises an alcohol compound-based solid polymer.

9. The test strip device of claim 6, wherein the compound buffer is provided in the form of a film-like layer disposed in ultimate proximity to the substrate pad defining the reactive control zone, and comprises an alcohol compound, selected from the group consisting of:

methanol, ethanol, glycol and glycerol, solidified by admixing thereof into the alcohol compound-based solid polymeric matrix.

10. The test strip device of claim 6, further comprising at least one partition element disposed between the reactive zones such, to prevent the biological ink composition of each reactive zone from mixing with the biological ink composition of the neighboring reactive zone(s) and/or with the compound buffer.

11. The test strip device of claim 6, further comprising a partition element in the form of a protective cover, disposed to cover the exposed surfaces of the reactive zones and to separate said reactive zones from each other, which partition element comprises a number of apertures arranged over each reactive zone covered thereby.

12. The test strip device of claim 6, wherein the reactive test zone is separated from the reactive control zone by means of a slot.

13. The test strip device of claim 1, further comprising a layer of a predetermined color, disposed between the base support and the substrate material defining the reactive zones.

14. The test strip device of claim 1, wherein the reactive test zone and the reactive control zone are deposited on a common substrate, selected from the group consisting of fiber-, paper- or plastic-based materials, which enable capillary forces driven migration of the liquid sample in a lateral direction, and wherein the reactive control zone is disposed on the substrate subsequent to the reactive test zone in a direction of fluid flow.

15. The test strip device of claim 14, wherein the compound buffer is deposited on the substrate within a predetermined region subsequent to the reactive test zone and prior the reactive control zone in a direction of fluid flow.

16. The test strip device of claim 1, wherein the substrate material defining each reactive zone is deposited with a biological ink composition, comprising at least enzymes alcohol oxidase and hydrogen peroxidase and a chromogenic indicator.

17. The test strip device of claim 16, wherein the chromogenic indicator is 3,3′

,5,5′

-tetramethylbenzidine.

18. The test strip device of claim 1, wherein the substrate material defining each reactive zone is deposited with a biological ink composition, comprising at least enzymes alcohol dehydrogenase and NAD(P)H—

dependent oxidoreductase, a phosphopyridine nucleotide cofactor and a chromogenic indicator, selected from the group consisting of reazurin and tetrazolium salts.

19. The test strip device of claim 18, wherein the phosphopyridine nucleotide cofactor is NAD or NADP.

20. The test strip device of claim 1, further comprising a flavoring agent, disposed into the substrate material, wherein said flavoring agent is a compound or a combination of compounds configured to impart a recognizable flavor and/or taste to the substrate material containing thereof, said flavor and/or taste selected from the group consisting of:

citrus, berries, mint, cocoa, caramel, and liquorice.

21. The test strip device of claim 1, further comprising a desiccant, wherein said desiccant is silica gel.

22. The test strip device of claim 1, further comprising at least one lamination layer.