Device for self contained solid phase immunodiffusion assay

• US 4,770,853 A
• Filed: 12/03/1986
• Issued: 09/13/1988
• Est. Priority Date: 12/03/1986
• Status: Expired due to Term

• Current Assignee: Aberlyn Capital Management Limited Partnership
• Original Assignee: New Horizons Diagnostics Corp.
• Inventors: Bernstein, David
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): McMahon, Timothy M.
• Application Number:
  US06/938,003
• Time in Patent Office: 650 Days
• Field of Search: 422/58, 422/61, 422/102, 435/294, 435/295, 206/209, 206/210, 206/15.2, 206/361, 206/438
• US Class Current: 422/413
• 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: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• CPC Class Codes: B01L 3/527 for a plurality of reagents
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures

Abstract

A device for a self contained solid phase immunodiffusion assay. The device is comprised of a sample collector, a tube with compartmentalized reagents and a ligand receptor capture membrane filter area. 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 wherein the tip of the sample collector contacts diffusable membranes or filters and transfers the reactants to a capture membrane wherein a ligand receptor reaction can be visualized by the naked eye.

Claims

1. A self-contained ligand receptor assay device, the combination comprising;

(a) collection means having an elongated shaft with an absorbent tip for collecting a specimen;

(b) a tube, cooperative with said collection means, said tube having an interior, an open end and a distal end;

(c) at least one sealed chamber in said tube;

(d) a number of reagents equal to the number of said at least one chamber located one reagent in each of said at least one chamber;

(e) means to seal each said reagent in a respective one of said at least one chamber;

(f) said seal means comprising frangible seals;

(g) ligand receptor reaction means including at least one porous membrane;

(h) means forming a hole in said tube in predetermined spaced relation to said distal end thereof;

(i) means fixing said ligand receptor reaction means to said tube covering said hole with said least one porous membrane exposed to said interior of said tube; and

(j) the length of said shaft being such as to permit said absorbent tip to reach through all of said at least one chamber to mix all of said at least one reagent and to permit fluid diffusion between said tip and said at least one membrane;

whereby

(k) a labelled ligand or a labelled receptor is immobilized on said ligand receptor reaction means and the result of said assay can be examined.

2. The device of claim 1, further comprises a guiding mechanism for said collection means, said guiding mechanism comprising guide and stop means, nodule means on said tube, and said guide and stop means and said nodule means cooperating with each other causing sequential breaking of said at least one frangible seal and moving said absorbent tip completely through and out of said at least one chamber when said absorbent tip passes through all of said at least one chamber.

3. The device of claim 1, wherein said absorbent tip for collecting a specimen is sterile.

4. The device of claim 1, wherein said at least one porous membrane comprises a plurality of porous membranes at least one membrane of which is coated with different ligands or receptors.

5. The device of claim 1, wherein said at least one reagent comprises a labelled ligand or a labelled receptor.

6. The device of claim 5, wherein said labelled ligand or labelled receptor reagent is lyophilized.

7. The device of claim 5, further comprising at least one other chamber, and microbiological growth media in said other chamber.

8. The device of claim 5, further comprising at least one other chamber, and an extraction reagent for exposing antigenic determinants or hidden epitopes of an antigen, in said other chamber.

9. The device of claim 5, further comprising at least one other chamber, adsorption particles in said other chamber, said absorption particles comprising binders to remove inhibiting or cross reative substances from said assay;

and at least one other porous membrane, and

(a) said adsorption particles being larger than said labelled ligands or labelled receptors, and

(b) said at least one other porous membrane having an effective pore size smaller than said adsorption particles and larger than said labelled ligands or labelled receptors.

10. The device of claim 5, wherein one said at least one chamber contains ligand or receptor coated particles which are larger in mean particle size diameter than said labelled ligand or labelled receptor and the effective pore size of said at least one porous membrane.

11. The device of claim 5 wherein said labelled ligand or labelled receptor reagent comprised a chromophore.

12. The device of claim 11 wherein said chromophore is selected from the group consisting of dyes, dyed particles, pigments, metal sol particles, or dye encapsulated liposomes.

13. The device of claim 12, wherein said chromophore is a metal sol particle selected from the group consisting of gold, silver, or the combination of gold and silver.