Device and method for self contained solid phase immunodiffusion assay

• US 5,169,789 A
• Filed: 12/27/1991
• Issued: 12/08/1992
• Est. Priority Date: 12/03/1986
• Status: Expired due to Fees

• Current Assignee: Aberlyn Capital Management Limited Partnership
• Original Assignee: New Horizons Diagnostics Corp.
• Inventors: Bernstein, David
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): MCMAHON, TIMOTHY M
• Application Number:
  US07/818,439
• Time in Patent Office: 347 Days
• Field of Search: 422/55-58, 422/61, 436/165, 436/166, 436/169, 436/174, 436/177, 436/178, 436/524, 436/528, 436/531, 436/501
• US Class Current: 436/501
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61F 13/38 Swabs having a stick-type handle, e.g. cotton tips ear cleaners other than cotton tips A61F11/006; swabs containing a liquid, e.g. in a rupturable reservoir, A61M35/006
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures

Abstract

A device and method for a self contained solid phase immunodiffusion assay. The device is comprised of a sample collector, and a pre-fabricated laminate which can be used in many different forms. For example, the same collector and laminate can be used with a tube having compartmentalized reagents. The seals can be broken through pressure on the sample collector. The sample collector is pushed through the seals, mixed with reagent, and then pushed into a ligand receptor reaction area which is part of the laminate. The tip of the sample collector contacts diffusable or porous membranes or filters and transfers the reactants to a capture membrane wherein a ligand receptor reaction can be examined by the naked eye or otherwise.

Claims

1. A method of performing a ligand receptor assay in an assay test device wherein a ligand receptor complex is captured on at least one porous capture membrane in the test device, comprising the steps of providing sample collector means, collecting a specimen with said sample collector means and contacting the specimen with one or more reactants as required to perform said assay;

providing at least one porous membrane located in the test device as required to perform said assay to capture any ligand receptor complex formed as a result of the performance of this and the preceding steps;

causing liquid diffusion in the assay test device from the specimen and the reactants on said sample collector means to all of said at least one porous membrane simultaneously to capture said ligand receptor complex while the membrane is a part of the test device; and

examining all of said at least one porous membrane after performance of all of the preceding steps while said at least one porous membrane is a part of the test device;

whereby any change caused by a labelled ligand or a labelled receptor being captured or not being captured on said at least one membrane in accordance with the protocol of said assay can be readily observed.

2. The method of claim 1, and the additional steps of providing two of said porous membranes, and causing the other of said two porous membranes to be a control membrane.

3. The method of claim 1, and the additional step of filtering said specimens and reactants during said liquid diffusion step using filter means having a pore size selected to be large enough to permit said liquid diffusion step and small enough to prevent debris larger than said selected pore size which may be on said sample collector means from contacting any of said at least one porous membrane.

4. The method of claim 1, and performing said liquid diffusion step by including the sub-step of creating physical pressure at least indirectly between said sample collector means and all of said at least one porous membrane simultaneously.

5. The method of claim 1, and performing the method using a pre-fabricated assay device, and constructing said assay device comprising the following steps and providing sequential layers as follows:

(a) said at least one porous membrane;

b) impervious shield means;

c) forming at least one opening in said impervious shield means equal in number to the number of said at least one porous membrane and sizing and clustering said at least one opening so that said liquid diffusion can be performed through all of said at least one opening simultaneously;

d) filter means; and

e) selecting a pore size for said filter means large enough to permit said liquid diffusion and small enough to prevent debris larger than said selected pore size which may be on the sample collector means from contacting any of said at least one porous membrane.

6. The method of claim 5, and the additional steps performed during said construction of said pre-fabricated assay device of providing an absorbent means layer, and locating said absorbent means layer next to said at least one porous membrane on the side thereof opposite said impervious shield means.

7. A pre-fabricated ligand receptor assay device comprising sequential layers of:

a) at least one porous membrane adapted to capture any ligand receptor complex formed during the use of said assay device,

b)

i) impervious shield means formed with at least one opening equal in number to the number of said at least one porous membrane,

ii) means for sizing and clustering said at least one opening so that liquid diffusion between said at least one porous membrane and a reactant brought into contact with said assay device can occur through all of said at least one opening simultaneously,

c) filter means having a pore size large enough to permit said liquid diffusion and small enough to prevent debris larger than said selected pore size from contacting any of said at least one porous membrane,

a sample collection means comprising an elongated shaft and an absorbent tip, and a sandwich device, said sandwich device comprising a pair of plate means, means to hinge said plate means together along one respective side of said pair of plate means, positioning said pre-fabricated assay device between said plate means, and means to apply pressure to said tip when said tip is inserted between said pair of plate means and in contact with said pre-fabricated assay device.

8. The device of claim 7, and means to apply pressure to said tip when said tip is in contact with said assay device, and said means to apply pressure comprising contoured protrusion means adapted to bear on said tip.

9. A kit containing the device of claim 7, said kit including a container containing liquid labelled receptor or labelled ligand reagent for cooperation with said sample collection means and selected in accordance with the protocol of said assay.

10. The device of claim 9, wherein said labelled reagent comprises a chromophore.

11. The device of claim 10, wherein said chromophore comprises a dye.

12. The device of claim 10, wherein said chromophore comprises a dyed particle.

13. The device of claim 10, wherein said chromophore comprises a pigment.

14. The device of claim 10, wherein said chromophore comprises a metal sol particle.

15. The device of claim 10, wherein said chromophore comprises a dye encapsulated liposome.

16. The device of claim 7, and said pre-fabricated assay device including an absorbent layer in contact with said at least one porous membrane on the side thereof opposite said impervious shield.

17. The device in claim 7, said means to apply pressure comprising clamping means.

18. The device of claim 7, and a second porous membrane, said second porous membrane comprising a control membrane.

19. The device of claim 7, and said assay device including an absorbent layer in contact with said at least one porous membrane on the side thereof opposite said impervious shield.

20. The device of claim 19, wherein at least said impervious shield, said at least one membrane and said absorbent layer are prefabricated in the form of a laminate.

21. The device of claim 7, and said means to apply pressure comprising contoured protrusion means adapted to bear on said tip.