Biosensor

• US 7,575,915 B2
• Filed: 05/25/2001
• Issued: 08/18/2009
• Est. Priority Date: 05/26/2000
• Status: Expired due to Fees

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Tanaka, Hirotaka, Kitawaki, Fumihisa, Takahashi, Mie, Nadaoka, Masataka
• Primary Examiner(s): Chin; Christopher L
• Application Number:
  US10/031,988
• Publication Number:
  US 20020137230A1
• Time in Patent Office: 3,007 Days
• Field of Search: 435/7.1, 435180-182, 4352871-2872, 435/287.7, 435/287.8, 435/805, 435970-971, 436/514, 436/518, 436/522, 436/535, 436169-170, 436/810, 422 56- 57, 422/61, 422/68.1, 422/255
• US Class Current: 435/287.2
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

A biosensor is provided with a development layer for developing an inspection target solution, that has a reagent immobilization part where an antibody for a measurement target in the inspection target solution is immobilized and a reagent holding part which marks in a dry state and holds an antibody which can be eluted by development of the inspection target solution in parts of the development layer. The biosensor measures a bonding amount of the marker reagent bonded to the reagent immobilization part, thereby qualitatively or quantitatively measuring components to be measured in the inspection target solution, and is further provided with a space forming material that forms a cavity part, which is a space into which the inspection target solution flows, between the development layer for developing the inspection target solution and the space forming material.

Claims

1. A biosensor comprising:

a development layer for developing an inspection target solution as a specimen by making the inspection target solution permeate inwards,

wherein said development layer includes a reagent immobilization part immobilized therein and a marker reagent holding part where a marker reagent which can be eluted by the development of the inspection target solution is held,

wherein said biosensor measures a bonding amount of the marker reagent in said reagent immobilization part, thereby qualitatively or quantitatively measuring components to be measured in the inspection target solution, and

wherein said biosensor further comprises;

a space forming part which forms a cavity part, wherein said cavity part is a space into which the inspection target solution flows by a capillary phenomenon,

wherein said space forming part is located only at a part upstream of said reagent immobilization part in a permeating direction of the inspection target solution,

wherein an amount of inspection target solution which flows into said cavity part is regulated by a volume of said cavity part, and

wherein, by permeating the inspection target solution of the amount regulated by the volume of said cavity part into said development layer, B/F separation of the marker reagent in said reagent immobilization part is implemented.

2. The biosensor as defined in claim 1, wherein

said cavity part temporarily holds the inspection target solution.

3. The biosensor as defined in claim 1, further including

a cell component destruction reagent part for destroying cell components in said cavity part.

4. The biosensor as defined in claim 1, further including

a cell component shrinkage reagent part for shrinking cell components in said cavity part.

5. The biosensor as defined in claim 1, further including

a bleaching reagent part in said cavity part.

6. The biosensor as defined in claim 1, wherein

said cavity part has a volume of 20 μ

l or less.

7. The biosensor as defined in claim 1, wherein

said cavity part has a means for externally checking whether the inspection target solution flowed inwards or not.

8. The biosensor as defined in claim 1, wherein

said space forming part is partially or entirely light permeable.

9. The biosensor as defined in claim 1, further including a separation part for separating concrete components unnecessary for a measurement in said cavity part.

10. The biosensor as defined in claim 1, wherein

said space forming part includes an air vent for assisting the inspection target solution in flowing into said cavity part.

11. The biosensor as defined in claim 1, further including

a porous material which can be permeated by permeation of the inspection target solution in said cavity part.

12. The biosensor as defined in claim 1, wherein

the reagent in said reagent immobilization part and the marker reagent are in a dry state.

13. The biosensor as defined in claim 1, wherein

the biosensor is employed for an immuno-chromatography.

14. The biosensor as defined in claim 1, wherein

the biosensor is employed for a one-step immuno-chromatography.

15. The biosensor as defined in claim 1, wherein a portion of said development layer, other than a portion of said development layer facing said cavity party, is adherently covered by a liquid-impermeable material.

16. The biosensor as defined in claim 1, wherein said development layer is disposed so that only a portion of said development layer is able to contact an externally located inspection target solution, the portion of said development layer which is able to contact the externally located inspection target solution facing said cavity part.

17. A biosensor comprising:

a development layer for developing an inspection target solution as a specimen by making the inspection target solution permeate inwards; and

a reagent immobilization part immobilized in a part of said development layer for developing the inspection target solution,

wherein said biosensor measures a bonding amount of the marker reagent in the reagent immobilization part, thereby qualitatively or quantitatively measuring components to be measured in the inspection target solution, and

wherein said biosensor further comprises;

a space forming part which forms a cavity part, wherein said cavity part is a space into which the inspection target solution flows by a capillary phenomenon; and

a marker reagent holding part for holding a marker reagent which can be eluted by flowing-in of the inspection target solution, in said cavity part,

wherein said space forming part is located only at a part upstream of said reagent immobilization part in a permeating direction of the inspection target solution,

wherein an amount of inspection target solution which flows into said cavity part is regulated by a volume of said cavity part, and

wherein, by permeating the inspection target solution of the amount regulated by the volume of said cavity part into said development layer, B/F separation of the marker reagent in said reagent immobilization part is implemented.

18. The biosensor as defined in claim 17, wherein

said cavity part temporarily holds the inspection target solution.

19. The biosensor as defined in claim 17, further including

a cell component destruction reagent part for destroying cell components in said cavity part.

20. The biosensor as defined in claim 17, further including

a cell component shrinkage reagent part for shrinking cell components in said cavity part.

21. The biosensor as defined in claim 17, further including

a bleaching reagent part in said cavity part.

22. The biosensor as defined in claim 17, wherein

said cavity part has a volume of 20 μ

l or less.

23. The biosensor as defined in claim 17, wherein

said cavity part has a means for externally checking whether the inspection target solution flowed inwards or not.

24. The biosensor as defined in claim 17, wherein

said space forming part is partially or entirely light permeable.

25. The biosensor as defined in claim 17, further including

a separation part for separating concrete components unnecessary for a measurement in said cavity part.

26. The biosensor as defined in claim 17, wherein

said space forming part includes an air vent for assisting the inspection target solution in flowing into said cavity part.

27. The biosensor as defined in claim 17, further including

a porous material which can be permeated by permeation of the inspection target solution in said cavity part.

28. The biosensor as defined in claim 17, wherein

the reagent in said reagent immobilization part and the marker reagent are in a dry state.

29. The biosensor as defined in claim 17, wherein

the biosensor is employed for an immuno-chromatography.

30. The biosensor as defined in claim 17, wherein

the biosensor is employed for a one-step immuno-chromatography.

31. The biosensor as defined in claim 17, wherein a portion of said development layer, other than a portion of said development layer facing said cavity party, is adherently covered by a liquid-impermeable material.

32. The biosensor as defined in claim 17 wherein said development layer is disposed so that only a portion of said development layer is able to contact an externally located inspection target solution, the portion of said development layer which is able to contact the externally located inspection target solution facing said cavity part.