Assaying device and method for in field urinalysis

• US 6,805,837 B2
• Filed: 10/04/2002
• Issued: 10/19/2004
• Est. Priority Date: 11/16/1998
• Status: Expired due to Fees

• Current Assignee: Zyon Int'l Inc
• Original Assignee: Zyon Int'l Inc
• Inventors: Tydings, Barry M.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US10/264,605
• Publication Number:
  US 20030165405A1
• Time in Patent Office: 746 Days
• Field of Search: 422/58, 422/50, 422/60, 422/56, 422/61, 422/102, 422/55, 422/57, 422/68.1, 422/99, 422/100, 436/164, 436/169
• US Class Current: 422/412
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

An assay device for in field urine analysis including a container having an opening for collecting a urine sample, a cover for sealing the opening of the container and an assay assembly provided in the container for chemically analyzing the urine sample. The assay assembly comprises a liquid impermeable backing, a wicking material provided on a rear surface of the backing, at least one assay strip provided on a front surface of the backing and adjacent a top edge of the backing in contact with the wicking material, a front cover provided on the front surface of the backing for sealing the assay strip to the backing at a bottom and two sides of the assay strip and a rear cover provided on the rear surface of the backing for together with the front cover sealing said wicking material and the assay strip adjacent the top edge and two sides of said wicking material.

Claims

1. An assaying device for in field urine analysis comprising:

a container having an opening for collecting a urine sample, a base for the container, and a wall for the container,

a cover for sealing the opening of the container;

an assay assembly with the container for chemically analyzing the urine sample, the assay assembly having at least one assay strip provided for the assembly and being in liquid transmittable contact with wicking, the wicking having a lower portion proximal to the base of the container and being for communication with urine in the container such that, in use, when there is urine in the container and the container is in an upright position with the opening above the base, the urine wicks up the wicking to the assay strip thereby to permit a flow of urine in the container to the assay strip; and

the assay strip being directed adjacent to the wall of the container thereby to be readable through the container wall.

4. An assaying device as claimed in claim 1, including a series of assay strips in parallel relationship on the assay assembly.

5. An assaying device as claimed in claim 1, wherein the wicking material acts to draw urine upwardly to the assay strip.

6. An assaying device as claimed in claim 1, wherein the assay assembly is substantially the same height as the height of the container.

7. An assaying device as claimed in claim 1, wherein the assay assembly conforms to the inner wall of the container.

8. An assaying device as claimed in claim 1, wherein the container includes and an essentially circular portion for receiving a screw-on cap to close the circular portion.

21. A device as claimed in claim 1 wherein the assay is performed without inverting the container.

2. A device as claimed in 1, wherein the layer includes slots spaced apart in the front face of the layer, the slots being directed longitudinally and being for accommodating sides of an assay strip in adjacency with a front surface of the layer and in adjacency to a wall of the container.

3. A device as claimed in claim 2 including a transverse slot extending between the longitudinal slots and being in communication between slots for accommodating an end of the assay strips.

9. An assay assembly for chemically analyzing a urine sample in a container, the assay assembly comprising:

a backing;

at least one assay strip provided on a front surface of the backing so that, in use, it is arranged for being in liquid transmittable contact with urine in the container so that urine in the container travels to the assay strip;

a front cover provided on the front surface of the backing to facilitate locating the assay strip between the backing and the front cover;

the backing together with the front cover and the assay strip being locatable adjacent a wall of a container and extendable from a position proximal to the bottom of the container to a position proximal to the top of the container; and

a wicking element extending from the front of the backing to the back of the backing to facilitate urine flow from the container to the assay strip.

10. An assembly according to claim 9, including a rear cover for supporting the backing, assay strip and front cover, the rear cover conforming at least in part to the container wall.

11. An assaying assembly as claimed in claim 9, wherein the wicking material acts to draw urine upwardly.

12. An assaying device as claimed in claim 9, wherein the container has a curved wall profile.

13. An assaying device as claimed in claim 9 wherein the container has a curved wall profile, and the assay assembly is for adjacency with the curved wall.

22. An assembly as claimed in claim 9 wherein the assay is performed without inverting the container.

14. An assay assembly for chemically analyzing a urine sample, the assay assembly comprising:

a container with an opening and a base;

a liquid impermeable backing;

at least one assay strip provided on a front surface of the liquid impermeable backing;

a wicking provided with one portion of the wicking being in fluid connection to the assay strip with another portion of the wicking being for contact with a urine sample in the container for receiving the assembly and having a lower portion proximal to the base of the container so that, in use, when urine is in the container and the container is in an upright position with the opening above the base, urine wicks up to the assay strip and thereby permits a flow of urine in the container to the assay strip;

a front cover provided on the front surface of the liquid impermeable backing for locating the assay strip between the front cover and the liquid impermeable backing; and

the assembly being for mounting against a wall of a container thereby to be visible through the container wall.

23. An assembly as claimed in claim 14 wherein the assay is performed without inverting the container.

15. An assaying device for in field urinalysis comprising:

a substantially transparent container having an opening for collecting a urine sample and a base for the container;

a cover for sealing the opening of the container;

an assay assembly provided in the container for chemically analyzing the urine sample, the assay assembly comprising a liquid impermeable layer, at least one assay strip provided on a front surface of the liquid impermeable layer facing outwardly and being viewable through the container;

at least one wicking, the wicking having a lower portion proximal to the base of the container and being an intermediate element extending to the assay strip and being arranged with one portion of the intermediate wicking extending to communicate with the assay strip to permit urine to pass from the wicking to the assay strip; and

an element provided to the assay assembly for inhibiting the assay strip from liquid contact with the urine sample except through the wicking so that, in use, urine wicks through the wicking to the strip, and up the strip when the container is located with the opening above the base.

24. An assembly as claimed in claim 15 wherein the assay is performed without inverting the container.

16. An assaying device for in field urine analysis, comprising:

a substantially transparent container having an opening for collecting a urine sample, and a base for the container;

a cover for sealing the opening of the container and the container being operable when in an upright position to effect the assaying;

an assembly including a rear surface for supporting a liquid impermeable backing for mounting a liquid impermeable backing for an assay assembly in the container, the rear surface being shaped to conform generally to the container wall, and to extend at least partly in adjacency with the periphery of the container,

the assay assembly having the liquid impermeable layer, at least one assay strip provided on a front surface of the liquid impermeable layer facing outwardly and viewable through the container; and

at least one wicking for contacting the assay strip at one end of the wicking and for contacting the urine at the other end of the wicking, and having a lower portion proximal to the base of the container, and for causing urine to wick to the assay strip, and up the strip when the container is located with the opening above the base.

17. A device according to claim 16, wherein the rear surface of the assembly is injection molded and made from a flexible resilient material, and includes a pair of slots spaced apart in the front face of the support, the slots being directed longitudinally and being for accommodating the sides of the assay strip in adjacency with a surface of the support and in adjacency to a wall of the container, and including a transverse slot extending between the longitudinal slots and being in communication between the slots for accommodating the assay strip.

25. A device as claimed in claim 16 wherein the assay is performed without inverting the container.

18. A method for in field urine analysis in an assay device, the device comprising:

a substantially transparent container having an opening for collecting a urine sample, and a base for the container;

a cover for sealing the opening of the container; and

an assay assembly provided for the container for chemically analyzing the urine sample, the assay assembly comprising a liquid impermeable backing, at least one assay strip provided on a front surface of the backing to face outwardly and be viewable through the container, a front cover provided on the front surface of the backing, and the front cover locating be assay strip between the front cover and the backing; and

the method including the steps of;

introducing a urine sample into the container;

locating the container with the opening above the base, and the wicking having a portion extending for connection with a urine sample in the container and a portion for adjacency with the assay strip;

allowing urine to wick up a wicking to the assay strip; and

analyzing the urine on the assay strip.

19. A method as claimed in claim 18 wherein the urine wicks solely up the wicking until it reaches the assay strip thereby to provide for continuous flow of the urine to the assay strip.

20. A method as claimed in claim 18 including extending the wicking from the front end of the backing to the rear end of the backing, and wherein the urine wicks both down and up the wicking in traveling from the container to the assay strip thereby to provide for continuous flow of urine to the assay strip.

26. A method as claimed in claim 18 wherein the assay is performed without inverting the container.

27. An assaying device comprising:

a container having a base, an opening and a top for closing the opening;

a wicking having a lower portion proximal to the base of the container and an upper portion removed from the base in the direction of the opening of the container;

at least one assay strip contacting the wicking in proximity of the removed portion of the wicking, and the wicking having a lower portion proximal to the base of the container, to allow analysis of a urine sample through contact of the urine with the one assay strip; and

wherein, in use the urine contacts the assay strip during transmission of the urine from the lower portion of the wicking to the upper portion of the wicking.

28. An assaying device comprising:

a container having a base, an opening end a top for closing the opening;

a wicking having a lower portion proximal to the base and an upper portion proximal to the opening of the container;

at least one assay strip contacting the wicking in proximity of the upper position of the wicking, and the wicking having a lower portion proximal to the base of the container, to allow analysis of a urine sample through contact of the urine with the assay strip; and

wherein, a path of the urine to the strip has a first portion where the urine moves, along the wicking, in a direction from the base towards the opening of the container, and a second portion where the urine reaches the assay strip and moves along the assay strip in the direction from the base towards the opening of the container.

29. An assaying device comprising:

a container having a base, an opening and a top for closing the opening;

a wicking having a lower portion proximal to the base of the container and an upper portion proximal to the opening of the container;

at least one assay snip contacting the wicking in proximity of the upper portion of the wicking, and the wicking having a lower portion proximal to the base of the container, to allow analysis of a urine sample through contact of the urine with the assay strip; and

wherein, in use, the urine contacts the assay strip while moving along the wicking in an upward direction, the upward direction being defined by a direction from the base towards the opening.

30. An assaying device comprising:

a container having a base, an opening and a top for closing the opening;

a wicking having a lower portion proximal to the base of the contain and an upper portion proximal to the opening of the container;

at least one assay strip contacting the wicking in proximity of the upper portion of the wicking, to allow analysis of a urine sample through contact of the urine with di assay strip; and

wherein the urine wicks on the wicking solely in a direction from the base towards the opening of the container before contacting the assay strip.