Disposable diagnostic system

• US 5,104,619 A
• Filed: 12/17/1990
• Issued: 04/14/1992
• Est. Priority Date: 01/24/1990
• Status: Expired due to Term

• Current Assignee: Ameritrust National Bank, Michiana
• Original Assignee: EKF Life Sciences
• Inventors: de Castro, Aurora F., Storvick, David E., Gupta, Surendra K., McLaughlin, William J.
• Primary Examiner(s): Johnston, Jill
• Application Number:
  US07/628,348
• Time in Patent Office: 484 Days
• Field of Search: 422/56-58, 422/101, 422/102, 435/805, 436/169
• US Class Current: 422/422
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing

Abstract

A disposable diagnostic assembly or device for performing diagnostic tests which include test card and strip structures having a generally flat area, containing a well with an interior wall defining a reagent pad pocket to receive a specifically designed chemical reagent pad and which is secured in place by an annular snap-on cover. Additionally, the test card or strip may have a raised rib to contain spilled sample fluid. The diagnostic assembly is used to measure the concentration of an analyte via visualization or in combination with a meter.

Claims

1. A diagnostic testing system for measuring an analyte in a sample, comprising:

a) a semi-rigid structure of a predetermined size configuration;

b) at least one cupped wall integral with and disposed in said structure and being positioned at a predetermined location, said cupped well having a wall of a predetermined depth, a to portion and bottom having means to permit transmission of a signal;

c) a retaining means having an aperture, said retaining structure being for securement at the top portion of said cupped well and defining an interior volume for receiving and retaining a diagnostic element therein; and

d) a raised rib structure integrally formed on the top surface of said structure and extending a predetermined distance thereabove.

2. The diagnostic testing system of claim 1, wherein said structure has a horizontal planar configuration, and wherein said cupped well wall intersects the horizontal plane of said structure.

3. The diagnostic testing system of claim 1, wherein said structure has a horizontal planar configuration, and wherein said cupped well wall is positioned above the horizontal plane of said structure.

4. The diagnostic testing system of claim 1, wherein said structure has a horizontal planar configuration, and wherein said cupped well wall is positioned below the horizontal plane of said structure.

5. The diagnostic testing system of claim 1, wherein said cupped well top portion has a circumferential groove, and wherein said retaining structure is a snap-fit cover and has a configuration to frictionally fit into said circumferential groove.

6. The diagnostic testing system of claim 1, wherein said structure has passive alignment means integrally formed therein, said means comprising at least one notch at a predetermined peripheral area of said structure.

7. The diagnostic testing system of claim 1, wherein said cupped well is constructed and arranged to provide alignment means for said structure for use in a meter.

8. The diagnostic testing system of claim 1, wherein said structure has a rectangular configuration and has the exterior dimensions of a semi-rigid card.

9. The diagnostic testing system of claim 1, wherein said retaining structure further has a grid structure spanning said aperture.

10. The diagnostic testing system of claim 1, wherein said structure is an elongated strip.

11. The diagnostic testing system of claim 1, wherein said structure has a plurality of cupped wells formed therein, each said well having a retaining structure.

12. The diagnostic testing system of claim 11, wherein one of said wells contains a control chemistry reagent.

13. The diagnostic testing system of claim 1, wherein said structure has informational data thereon.

14. The diagnostic testing system of claim 13, wherein said informational data includes data from the group consisting of a bar code, test meter calibration data, patient name, test provider name, and a chemistry lot identifier.

15. The diagnostic testing system of claim 1, wherein said signal is an optical signal, and wherein said means to permit transmission of a signal comprises an aperture in said cupped well bottom.

16. The diagnostic testing system of claim 15, wherein said well bottom has a transparent window covering said aperture.

17. The diagnostic testing system of claim 1, wherein said signal is an optical signal, and wherein said means to permit transmission of a signal comprises a substantially transparent region in said cupped well bottom.

18. The diagnostic testing system of claim 1, wherein said well wall has at least one circumferentially protruding ledge spatially positioned from said well bottom.

19. The diagnostic testing system of claim 18, wherein said well wall has a plurality of spatially parallel circumferential ledges, said retaining structure further having a peripheral edge for placement between adjacent ledges so as to provide an adjustable well depth to receive a range of matrix thicknesses.

20. The diagnostic testing system of claim 19, wherein a plurality of matrices are positioned in said cupped well in a layered configuration.

21. The diagnostic testing system of claim 1, further comprising a diagnostic element, said diagnostic element being for reacting the sample and generating an output signal corresponding to analyte concentration, said diagnostic element comprising at least one matrix which provides an output signal upon contact with an analyte of interest.

22. The diagnostic testing system of claim 21, wherein said matrix comprises at least one chemically impregnated layer.

23. The diagnostic testing system of claim 21, wherein said matrix provides an enzymatic reaction upon contact with the sample for the detection and quantitative measurement of an analyte therein.

24. The diagnostic testing system of claim 21, wherein said matrix provides an immunochemical reaction upon contact with the sample for the detection and quantitative measurement of an analyte therein.

25. The diagnostic testing system of claim 21, wherein said matrix is comprised of at least one filter layer and at least one chemically impregnated layer which is provided between said filter layer and said well bottom.

26. The diagnostic testing system of claim 21, wherein the system further comprises an optical meter having a software algorithm for providing a user-meaningful analyte concentration value via a signal from said reacted diagnostic element, and means for receiving said card structure therein.

27. The diagnostic testing system of claim 21, wherein the system further comprises a color chart having a plurality of color bars or codes corresponding to a range of analyte concentration values, said color chart being visually comparable with said reacted diagnostic element via said means for transmitting a signal.

28. A disposable diagnostic testing system for measuring an analyte in a sample, comprising:

a) a semi-rigid elongated strip of a predetermined size and configuration and having a central axis;

b) at least one cupped well integral with and vertically disposed in said strip and being positioned along said central axis, said cupped well having a predetermined well depth, an upper portion with a circumferential groove therein and a bottom portion with an aperture therethrough;

c) a retaining structure having an aperture for placement in said circumferential groove of said cupped well; and

d) at least one chemically impregnated matrix positioned in said cupped well between said retaining structure and said bottom for reacting a sample and generating an output signal measurable through said well bottom aperture.

29. The disposable diagnostic testing system of claim 28, wherein said elongated strip and retaining structure are constructed of a moldable material.

30. The disposable diagnostic testing system of claim 29, wherein said moldable material is a thermoplastic.

31. The disposable diagnostic testing system of claim 30, wherein said material is polystyrene.

32. A disposable diagnostic test system for detecting and measuring analyte concentration in a sample, comprising:

a) a semi-rigid card structure of a predetermined size and having a substantially planar and rectangular configuration;

b) at least one cupped well integral with and vertically disposed in said card structure, said cupped well having a top portion, a predetermined well depth, an upper circumferential groove in said well, at least one protruding ledge spatially positioned from said well bottom and being below said well top, and a bottom portion with an aperture therethrough;

c) an annular snap-fit cover for placement in said circumferential groove of said cupped well; and

d) at least one chemically impregnated diagnostic matrix layer for reacting a sample and generating an output signal representative of analyte concentration, said matrix being positioned in said cupped well between said annular cover and said well bottom.

33. The disposable diagnostic test system of claim 32, wherein said card and cover structures are constructed of a moldable material.

34. The disposable diagnostic test system of claim 33, wherein said moldable material is a thermoplastic material.

35. The disposable diagnostic test system of claim 34, wherein said material is polystyrene.