Method and device for measuring a target substance in a liquid sample

• US 5,219,762 A
• Filed: 12/20/1989
• Issued: 06/15/1993
• Est. Priority Date: 12/27/1988
• Status: Expired due to Fees

• Current Assignee: Mochida Pharmaceutical Company Limited
• Original Assignee: Mochida Pharmaceutical Company Limited
• Inventors: Sato, Hiroshi, Katamine, Tomoaki, Mochida, Ei
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Pyon, Harold Y.
• Application Number:
  US07/454,018
• Time in Patent Office: 1,273 Days
• Field of Search: 422/58, 422/60, 422/61, 422/68.1, 422/57, 435/6, 435/288, 435/4, 435/805, 435/920, 436/46, 436/177, 436/180, 436/512, 436/514, 436/518, 436/531, 436/807
• US Class Current: 436/518
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/57473 involving carcinoembryonic antigen, i.e. CEA
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• 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 method for measuring target substance contained in a liquid sample is disclosed. The measurement is carried out by using a device having at least one reaction area comprising a solid phase, and the liquid sample is applied onto the reaction area through a porous member to allow for a reaction of predetermined volume of the liquid sample on the reaction area. A device used for such measurement is also disclosed. A device comprises a body having at least one reaction area comprising a solid phase, and a porous member disposed on or above the reaction area. The porous member allows for the liquid sample to be permeated therethrough.

Claims

1. A device for measuring a target substance in a liquid sample comprising:

a first hollow tubular member;

a liquid-impermeable plastic disk arranged on said first member, said disk having an upper surface with a reaction area having an antibody or a fragment thereof which is reactive with said target substance on the upper surface of said disk;

a second hollow tubular member, removably attachable to said first member, said second member having a liquid porous portion located above the reaction area of said first member when said second member is attached to said first member; and

a boundary member which surrounds an edge of the reaction area in order to create a space between said upper surface of said disk and said lower surface of said second member, wherein said space the liquid sample volume is restricted to comprises a predetermined volume of not more than 5 μ

l.

2. The device according to claim 1, wherein a portion of said upper surface of said second member which extends beyond said edge of said reaction area is hydrophobic.

3. A device for measuring a target substance in a liquid sample comprising:

a body having at least one reaction area on a substantially liquid impermeable sheet and an immobilized substance on said reaction area, which is reactive with the target substance in the liquid sample, and

a porous member having at least one porous portion which is permeable to the liquid sample, said porous being disposed above said reaction area so as to contain a predetermined volume of not more than 5 μ

l of said liquid sample on said reaction area, wherein said immobilized substance is an antibody or a fragment thereof which is reactive with a tumor-associated antigen.

4. The device according to claim 3, wherein said porous member is circular and said porous portion is provided on the upper surface of said porous member.

5. The device according to claim 3, wherein said porous member is removably mounted on said body.

6. The device according to claim 3, wherein said liquid-impermeable sheet is made from a material selected from the group consisting of polyester, polypropylene and polyethylene.

7. The device according to claim 3, wherein said porous portion is made of nylon.

8. The device according to claim 3, wherein said tumor-associated antigen is a carcinoembryonic antigen.

9. The device according to claim 3, wherein said body further comprises a second reaction area for comparing a known substance in a second liquid sample.

10. A device for measuring a target substance in a liquid sample comprising:

a body having

at least one reaction area on a substantially liquid impermeable sheet;

an immobilized substance on said reaction area, which is reactive with the target substance in the liquid sample;

a base having a cylindrical form, said porous member being attached to the upper surface of said base; and

a spacer which is attached to the upper surface of said liquid-impermeable sheet; and

a porous member having at least one porous portion which is permeable to the liquid sample, said porous portion being disposed above said reaction area so as to contain a predetermined volume of not more than 5 μ

l of said liquid sample on said reaction area, wherein said immobilized substance is an antibody or a fragment thereof which is reactive with a tumor-associated antigen.

11. The device according to claim 10, wherein said porous member is removably mounted on said body.

12. The device according to claim 10, wherein said liquid-impermeable sheet is made from a material selected from the group consisting of polyester, polypropylene and polyethylene.

13. The device according to claim 10, wherein said porous portion is made of nylon.

14. The device according to claim 10, wherein said tumor-associated antigen is a carcinoembryonic antigen.

15. The device according to claim 10, wherein said body further comprises a second reaction area for comparing a known substance in a second liquid sample.

16. A method for measuring a target substance in a liquid sample by means of a device having:

a body having at least one reaction area on a substantially liquid impermeable sheet and an immobilized substance on said reaction area, which is reactive to the target substance in the liquid sample; and

a porous member having at least one porous portion which is permeable to the liquid sample, said porous being disposed above said reaction area so as to contain a predetermined volume of not more than 5 μ

l of said liquid sample on said reaction area wherein said immobilized substance comprises an antibody or fragment thereof which is reactive with a tumor-associated antigen;

comprising the steps of;

supplying said liquid sample through said porous portion onto said reaction area;

removing the excess volume of the liquid sample by contacting a remover with the excess volume of the liquid sample on said upper surface of said porous portion;

allowing said target substance to react with said immobilized substance;

rinsing unbound liquid from said reaction area;

removing said porous member form the device; and

measuring said target substance on said reaction area.

17. The method according to claim 16, wherein said tumor-associated antigen is carcinoembryonic antigen.

18. The method according to claim 16, wherein said liquid sample is nipple discharge.

19. The method according to claim 18, wherein said breast nipple discharge is supplied to said porous portion of said device by placing said porous portion into direct contact with the outlet of a lactiferous duct of a patient.

20. A method for measuring a target substance in a liquid sample by means of a device comprising:

a body having

at least one reaction area on a substantially liquid impermeable sheet;

an immobilized substance on said reaction area, which is reactive with the target substance in the liquid sample;

a base having a cylindrical form, said porous member being attached to the upper surface of said base;

a spacer which is attached to the upper surface of said liquid-impermeable sheet; and

a porous member having at least one porous portion which is permeable to the liquid sample, said porous portion being disposed above said reaction area so as to contain a predetermined volume of not more than 5 μ

l of said liquid sample on said reaction area, wherein said immobilized substance comprises an antibody or a fragment thereof which is reactive with a tumor-associated antigen;

comprising the steps of;

supplying said liquid sample through said porous portion onto said reaction area;

removing the excess volume of the liquid sample by contacting a remover with the excess volume of the liquid sample on said upper surface of said porous portion;

allowing said target substance to react with said immobilized substance;

rinsing unbound liquid from said reaction area;

removing said porous member from the device; and

measuring said target substance on said reaction area.

21. The method according to claim 20, wherein said tumor-associated antigen is carcinoembryonic antigen.

22. The method according to claim 20, wherein said liquid sample is nipple discharge.

23. The method according to claim 22, wherein said breast nipple discharge is supplied to said porous portion of said device by placing said porous portion into direct contact with the outlet of a lactiferous duct of a patient.