Test carrier for analysis of fluids

• US 5,258,163 A
• Filed: 10/13/1992
• Issued: 11/02/1993
• Est. Priority Date: 04/14/1990
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Klein, Bernd, Schafer, Peter, Schindler, Gerhard, Notzel, Siegfried, Krause, Manfred
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Le, Long V.
• Application Number:
  US07/960,222
• Time in Patent Office: 385 Days
• Field of Search: 422/55, 422/56, 422/58, 422/60, 422/61, 422/102, 422/104, 422/68.1, 436/170, 436/165, 436/66, 436/169, 435/805, 435/970, 206/828, 206/456
• US Class Current: 422/401
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

Test carrier for the analysis of fluids with a frame (2) consisting of at least two parts surrounding a test field opening (6) and with a test field disposed in the test field opening (6). In order to provide such a test carrier with frame with which it is possible to assemble the test field out of several test layers manufactured separately from one another, it is proposed that the test field be designed as a test layer package (7) with test layers (10, 11, 12) resting loosely on one another, the frame (2) comprise two shaped pieces of plastics material, one of which serves as base part (4) and comprises a seat (16) for accommodating the test layers (10, 11, 12), while the other serves as lid part (3) and comprises a bearing surface (17) resting on the topmost layer (10) of the test layer package (7). The lid part (3) and the base part (4) are in addition designed with elastic properties so that the pressure with which the bearing surface (17) presses onto the test layer package (7) is substantially constant in the tolerance range of the thickness of the test field package (7).

Claims

1. A test carrier for analysis of fluids, comprising:

frame means for forming a main body of said test carrier, said frame means comprising two molded pieces of plastic material forming a base part and a lid part of said frame means, each of said base part and said lid part including an aperture forming a test field opening;

seating means disposed on an inner surface of said base part and surrounding said aperture of said base part for seating a plurality of loosely stacked superimposed imperforate test layers therein, said seating means defining a test layer area;

said lid part including attachment means for attaching said lid part to said base part, said lid part having bearing means in said test layer area for resting on a topmost test layer of said superimposed test layers;

said frame means further comprising a plurality of connection means for connecting the lid part and the base part to each other and limiting relative movement thereof in a direction perpendicular to a plane of the superimposed test layers, said connection means including limiting means on each part provided in respective pairs which butt positively against each other, said limiting means for holding said lid part and said base part in a particular position relative to each other, and wherein each of said plurality of connection means is spaced a distance from other connection means which is at least three times as great as a smallest distance between diametrically opposed sides of the apertures;

said frame means having elasticity properties wherein a pressure with which said bearing means presses onto said superimposed test layers to bring said superimposed test layers in uniform fluid contact with each other is substantially constant in a tolerance range of the test layers, wherein uniform fluid contact is ensured between individual test layers and wherein said test layers remain flat and undeformed under said pressure.

2. Test carrier of claim 1, wherein the lid part exerts pressure through the bearing means onto the superimposed test layers, which pressure changes by less than 20% if the thickness of the superimposed test layers changes by 0.01 mm.

3. Test carrier of claim 1, wherein the seating means of the base part is surrounded by a positioning means for positioning the test layers on the seating means, said positioning means being higher than the superimposed test layers.

4. Test carrier of claim 3, wherein the bearing means includes an outer limitation, and the positioning means includes an inner limitation facing toward the superimposed test layers, said outer limitation and said inner limitation defining an annular gap therebetween.

5. A frame type test carrier as recited in claim 1, wherein said frame means has side portions at a periphery of said base part, and said lid part has an outer surface which engages an inner surface of said side portions of said frame means.

6. A frame type test carrier as recited in claim 1, wherein said frame means has side portions at a periphery of said lid part, and said base part has an outer surface which engages an inner surface of said side portions of said frame means.

7. Test carrier of claim 1, wherein the lid part and the base part includes a plurality of connection means for connecting the lid part and the base part to each other and limiting relative movement thereof in a direction perpendicular to a plane of the superimposed test layers.

8. Test carrier of claim 1, wherein the connection means includes limiting means on each part provided in respective pairs which butt positively against each other, said limiting means for holding said lid part and said base part in a particular position relative to each other.

9. Test carrier of claim 1, wherein each pair of limiting means forms a clip connection.

10. Test carrier of claim 9, wherein at least one of the lid part and the base part has an edge portion which protrudes from a surface of that part, said edge portion protruding around a perimeter of that part, wherein the clip connection engages with the edge portion.

11. A test carrier for analysis of fluids, comprising:

frame means for forming a main body of said test carrier, said frame means comprising two molded pieces of plastic material forming a base part and a lid part of said frame means, and each including an aperture, said apertures forming a test field opening;

seating means disposed on an inner surface of said base part and surrounding said aperture of said base part for seating a plurality of loosely stacked superimposed imperforate test layers therein, said seating means defining a test layer area;

said lid part including attachment means for attaching said lid part to said base part, said lid part having bearing means in said test layer area for resting on a topmost test layer of said superimposed test layers;

wherein at least one of said base part and said lid part includes an elasticity region which is thinner than a substantial remainder of the at least one part, a surface area of the elasticity region being at least as great as the apertures and a thickness of the elasticity region being less than 0.3 mm;

said frame means having elasticity properties wherein a pressure with which said bearing means presses onto said superimposed test layers to bring said superimposed test layers in uniform fluid contact with each other is substantially constant in a tolerance range of the test layers, wherein uniform fluid contact is ensured between individual test layers, wherein said test layers remain flat and undeformed under said pressure.

12. Test carrier of claim 11, wherein the lid part and the base part includes a plurality of connection means for connecting the lid part and the base part to each other and limiting relative movement thereof in a direction perpendicular to a plane of the superimposed test layers.

13. Test carrier of claim 12, wherein the connection means includes limiting means on each part provided in respective pairs which butt positively against each other, said limiting means for holding said lid part and said base part in a particular position relative to each other.

14. Test carrier of claim 13, wherein each pair of limiting means forms a clip connection.

15. Test carrier of claim 14, wherein at least one of the lid part and the base part has an edge portion which protrudes from a surface of that part, said edge portion protruding around a perimeter of that part, wherein the clip connection engages with the edge portion.

16. Test carrier of claim 11, wherein the elasticity region thickness is less than 0.2 mm.

17. Test carrier of claim 11, wherein the lid part exerts pressure through the bearing means onto the superimposed test layers, which pressure changes by less than 20% if the thickness of the superimposed test layers changes by 0.01 mm.

18. Test carrier of claim 11, wherein the seating means of the base part is surrounded by a positioning means for positioning the test layers on the seating means, said positioning means being higher than the superimposed test layers.

19. Test carrier of claim 18, wherein the bearing means includes an outer limitation, and the positioning means includes an inner limitation facing toward the superimposed test layers, said outer limitation and said inner limitation defining an annular gap therebetween.

20. A frame type test carrier as recited in claim 11, wherein said frame means has side portions at a periphery of said base part, and said lid part has an outer surface which engages an inner surface of said portions of said frame means.

21. A frame type test carrier as recited in claim 11, wherein said frame means has side portions at a periphery of said lid part, and said base part has an outer surface which engages an inner surface of said side portions of said frame means.

22. A test carrier for analysis of fluids, comprising:

frame means for forming a frame body of the test carrier, said frame means comprising two molded pieces of plastic material forming a base part and a lid part of said frame means, and each including an aperture, said apertures forming a test field opening;

seating means disposed on an inner surface of said base part and surrounding said aperture of said base part for seating a plurality of superimposed test layers therein, said seating means defining a test layer area;

said lid part including attachment means for attaching said lid part to said base part, said lid part further including bearing means in said test layer area for resting on a topmost test layer of said superimposed test layers, the bearing means comprising a plurality of bearing tongues which project into the test field opening, said bearing tongues resting on said topmost layer.

23. A test carrier for analysis of fluids, comprising a test layer package of at least two imperforate superimposed contacting test layers,

a frame having first and second molded plastic pieces, wherein the first plastic piece is a base part which includes a seat for the test layers, and wherein the second plastic piece is a lid part which includes a bearing surface resting on the test layer furthest from the seat,

said frame having flexible means located thereupon for causing the bearing surface to press upon the test layer package with a pressure which is substantially constant over a tolerance range of the thickness of the test layer package, said flexible means being formed by an area of said frame having increased flexibility relative to a substantial remainder of said frame, wherein said bearing surface presses upon said test layer package upon engagement of said base part and said lid part, and wherein said test layers remain flat and undeformed upon said engagement.

24. A test carrier for the analysis of fluids comprising:

a frame consisting of at least two parts, each of said parts having an aperture therein, said apertures forming a test field opening, and,

a test field disposed in the test field opening,

the test field forming at est layer package with at least two imperforate superimposed test layers not connected to one another over their whole area,

said at least two parts each comprising a molded piece of plastic material, wherein

a first molded piece serves as base part and comprises a seat for the test layers, and the second molded piece serves as a lid part and comprises a bearing surface resting on a topmost test layer of the test layer package,

the frame having elastic properties wherein a pressure with which said bearing surface presses onto the test layer package is substantially constant in a tolerance range of the test layer package, and wherein said test layers remain flat and undeformed under said pressure.

25. A test carrier for analysis of fluids comprising:

frame means for forming a main body of said test carrier, said frame means comprising two molded pieces of plastic material forming a base part and a lid part of said frame means, and each including an aperture, said apertures forming a test field opening;

seating means disposed on an inner surface of said base part and surrounding said aperture of said base part for seating a plurality of loosely stacked superimposed imperforate test layers therein, said seating means defining a test layer area;

said lid part including attachment means for attaching said lid part to said base part, said lid part having bearing means in said test layer area for resting on a topmost test layer of said superimposed test layers;

said frame means having elasticity properties wherein a pressure with which said bearing means presses onto said superimposed test layers to bring said superimposed test layers in uniform fluid contact with each other is substantially constant in a tolerance range of the test layers, wherein said fluids can penetrate through an entire horizontal dimension of said test layers, wherein said test layers remain flat and undeformed under said pressure.