Solid phase immunoassay device and method of making same

• US 5,223,220 A
• Filed: 07/20/1992
• Issued: 06/29/1993
• Est. Priority Date: 03/27/1990
• Status: Expired due to Term

• Current Assignee: Quidel Corporation
• Original Assignee: Pacific Biotech, Inc. (Quidel Corporation)
• Inventors: Tzeng, Sinfu, Popejoy, Theresa, Wang, Dou-Mei, Fan, Eugene, Huang, Ching, Chen, Fon-Chiu M.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Soderquist, Arlen
• Application Number:
  US07/917,800
• Time in Patent Office: 344 Days
• Field of Search: 422/56-58, 422/101, 435/293, 435/300, 435/301, 435/805, 436/167, 436/169, 206/216, 206/564, 206/570
• US Class Current: 422/412
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/105 using desiccants
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

In response to an express need for an immunoassay device with universal applicability, which further promotes the goals of inventory reduction and simplified, less costly manufacture, a container for holding materials used in conjunction with an immunoassay, having a housing with an inside, an outside, and a top, wherein the top is provided with a plurality of apertures communicating with the inside of the housing, and a thin web of opaque material applied over the top of the housing covering at least one but not all of the apertures.

Claims

1. A method of constructing a plurality of immunoassay devices having a common multi-purpose housing and a different finished appearance, comprising the steps of:

providing at least two identical housings each having an inside, an outside, and a top, said top having a plurality of apertures therein for providing access to the inside of said housing, wherein a first of said plurality of apertures is for receiving a sample;

inserting a web of wicking material in said at least two identical housings extending between second, third, and fourth of said plurality of apertures with said third aperture located between said second and fourth apertures, wherein said second, third, and fourth apertures provide access to said wicking material and said first aperture is in fluid communication with said wicking material;

applying reagents to said wicking material through at least said second and said third apertures, wherein the reagent applied to said wicking material through said third aperture becomes bound to said wicking material and the reagent applied to said wicking material through said second aperture is mobile when liquid is added to said first aperture, and reacts with an analyte in a sample and aid reagent applied to said wicking material through said third aperture to create a signal visible through said third aperture which is indicative of the assay result;

applying a first permanently affixed substantially coextensive web of opaque material having openings therein to the top of a first of said at least two identical housings such that only the first and third apertures are uncovered to form a first immunoassay device; and

applying a second permanently affixed substantially coextensive web of opaque material having openings therein to the top of a second of said at least two identical housings such that the first and third apertures and at least one additional aperture are uncovered to form a second immunoassay device.

2. The method of claim 1, further comprising inserting an absorbent material inside said at least two identical housings wherein the absorbent material is in fluid flow contact with said wicking material and is located at said first aperture.

3. The method of claim 1, further comprising inserting an absorbent material inside said at least two identical housings wherein the absorbent material is in fluid flow contact with said wicking material and is located adjacent said fourth aperture.

4. The method of claim 1, wherein the at least two identical housings have a fifth aperture for receiving a desiccant, further comprising the steps of:

inserting the desiccant into said at least two identical housings through said fifth aperture prior to applying said web of opaque material; and

covering said fifth aperture with said web of opaque material.

5. The method of claim 1, wherein the at least two identical housings have a fifth aperture forming a well for receiving a container.

6. A plurality of immunoassay devices having a common multi-purpose housing and a different finished appearance, comprising:

at least two identical housings each having an inside, an outside, and a top, said top having a plurality of apertures therein for providing access to the inside of said housing, wherein a first of said plurality of apertures is for receiving a sample;

a web of wicking material in said at least two identical housings extending between second, third, and fourth of said plurality of apertures with said third aperture located between said second and fourth apertures, wherein said second, third, and fourth apertures provide access to said wicking material and said first aperture is in fluid communication with said wicking material;

reagents applied to said wicking material at said second and said third apertures, wherein the reagent applied to said wicking material at said third aperture is bound to said wicking material and the reagent applied to said wicking material at said second aperture is mobile when liquid is added to said first aperture, and reacts with an analyte in a sample and said reagent at said third aperture to create a signal visible through said third aperture which is indicative of the assay result;

a first permanently affixed substantially coextensive web of opaque material having openings therein applied to the top of a first of said at least two identical housings such that only the first and third apertures are uncovered to form a first immunoassay device; and

a second permanently affixed substantially coextensive web of opaque material having openings therein applied to the top of a second of said at least two identical housings such that the first and third apertures and at least one additional aperture are uncovered to form a second immunoassay device.

7. The devices of claim 6, further comprising an absorbent material inside said at least two identical housings wherein the absorbent material is in fluid flow contact with said wicking material and is located at said first aperture.

8. The devices of claim 6, further comprising an absorbent material inside said at least two identical housings wherein the absorbent material is in fluid flow contact with said wicking material and is located adjacent said fourth aperture.

9. The devices of claim 6, further comprising:

a fifth aperture in the at least two identical housings and a desiccant inserted inside the at least two identical housings through the fifth aperture, wherein said fifth aperture is covered by said web of opaque material.

10. The devices of claim 6, wherein the at least two identical housings have a fifth aperture that is uncovered by said web of opaque material forming a well for receiving a container.

11. The devices of claim 6, wherein a reagent is applied to the wicking material at said fourth aperture said reagent producing a signal indicative of completion of the assay.

12. The devices of claim 6, wherein the web of opaque material comprises paper.