Biological diagnostic device and method of use

• US 4,906,439 A
• Filed: 12/21/1987
• Issued: 03/06/1990
• Est. Priority Date: 03/25/1986
• Status: Expired due to Fees

• Current Assignee: Behringwerke Aktiengesellschaft (Sanofi )
• Original Assignee: PB Diagnostic Systems, Inc. (Sanofi )
• Inventors: Grenner, Gerd
• Primary Examiner(s): Hill, Jr., Robert J.
• Application Number:
  US07/133,071
• Time in Patent Office: 806 Days
• Field of Search: 422/55, 422/56, 422/57, 422/58, 422/61, 422/100, 422/101, 422/102, 435/805, 436/169, 436/170, 436/165, 436/175, 436/177, 436/178, 436/180, 436/518, 436/524, 436/531
• US Class Current: 422/417
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/552 Glass or silica
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A biological diagnostic device and process for efficiently and accurately analyzing a sample of a biological fluid for in analyte of interest. The device, which is a preferred embodiment utilized for the analysis of whole blood samples, comprises a diagnostic test element and a sample application unit comprising a fluid delivery element and means for providing sample fluid to the fluid delivery element. The fluid delivery element comprises a layer having a plurality of grooves, or channels, in the surface thereof which is adjacent the test element. The fluid which is provided to the grooves is subsequently delivered to the test element.

Claims

1. A biological diagnostic device comprising

a sample application unit including a fluid delivery element with a plurality of grooves in a surface thereof for providing a path for fluids to flow therealong and

means for providing fluid to said grooves arranged in fluid contact with said grooves;

and

at least one diagnostic test element arranged in contact with said grooves to receive fluid admitted to said grooves from said fluid providing means.

2. The diagnostic device as defined in claim 1 wherein said fluid providing means comprises a filter element.

3. The diagnostic device as defined in claim 2 wherein said filter element comprises a layer of fibrous material and is capable of separating cells from plasma or serum.

4. The diagnostic device as defined in claim 3 wherein said diagnostic test element is a multilayer immunoassay element.

5. The diagnostic device as defined in claim 3 wherein said fibrous filter material has been treated with deionized gelatin or albumin.

6. The diagnostic device as defined in claim 3 wherein said fibrous filter material has been treated with a surfactant.

7. The diagnostic device as defined in claim 3 wherein said fibrous filter material has been treated with a protein.

8. The diagnostic device as defined in claim 1 wherein said fluid delivery element includes from about 4 to about 50 grooves per cm, said grooves having a depth of from about 0.05 to about 0.160 mm.

9. The diagnostic device as defined in claim 8 wherein said fluid delivery element comprises a substantially transparent polymeric material.

10. The diagnostic device as defined in claim 9 wherein said fluid delivery element comprises hydrolyzed cellulose acetate butyrate.

11. The diagnostic device as defined in claim 1 wherein the device includes a plurality of diagnostic test elements, each of said diagnostic test elements being arranged in contact with said grooves to receive fluid admitted to said grooves from said fluid providing means.

12. A method for analyzing for an analyte of interest in a biological fluid comprising

applying a sample of a biological fluid to a fluid delivery element having a plurality of grooves in a surface thereof for providing a path for said fluid to flow therealong;

imbibing at least some of said fluid from said grooves into a diagnostic test element arranged in contact with said grooves;

wherein a signal is generated by said test element as a function of an analyte present in said fluid; and

detecting said signal.

13. The diagnostic method as defined in claim 12 wherein said diagnostic test element is a multilayer immunoassay element.

14. The diagnostic method as defined in claim 12 wherein said fluid delivery element comprises a substantially transparent material.