Integrated buffer dual-path immunoassay device

• US 9,476,875 B2
• Filed: 03/02/2015
• Issued: 10/25/2016
• Est. Priority Date: 03/02/2015
• Status: Active Grant

• Current Assignee: Chembio Diagnostic Systems Incorporated (Chembio Diagnostics, Inc.)
• Original Assignee: Chembio Diagnostic Systems Incorporated (Chembio Diagnostics, Inc.)
• Inventors: Esfandiari, Javanbakhsh
• Primary Examiner(s): TANG, MINH NHUT
• Application Number:
  US14/636,103
• Publication Number:
  US 20160258943A1
• Time in Patent Office: 603 Days
• US Class Current: 1/1
• CPC Class Codes: B01F 31/65 the materials to be mixed being directly submitted to a pulsating movement, e.g. by means of an oscillating piston or air column
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow

Abstract

A test device for use with a liquid solution includes a housing that houses a plurality of sorbent strips. At least one strip has a location for receiving the solution. The housing defines at least an opening in said housing wherein said opening is aligned with the location for receiving the solution. The device includes a sealed reservoir filled with the liquid solution, the sealed reservoir being disposed in alignment with the opening and coupled to the housing. The device includes an opener coupled to the housing. The opener is arranged to rotate from a first position, in which the opener is not in contact with the sealed reservoir, to a second position, in which the opener causes the sealed reservoir to effect a release of the solution from the reservoir and into the opening and onto the sorbent strip housed within the housing.

Claims

1. A test device for use with a liquid solution the test device comprising:

a) a housing that houses a plurality of sorbent strips, at least one strip having a location for receiving the solution, said housing defining at least an opening aligned above said location for receiving the solution;

b) a sealed reservoir filled with the liquid solution, said reservoir being disposed in alignment with said opening and coupled to said housing; and

c) an opener coupled to said housing, said opener arranged to rotate from a first position, in which said opener is not in contact with said sealed reservoir, to a second position, in which said opener causes said sealed reservoir to effect a release of the solution from said reservoir and into said opening and onto said sorbent strip housed within said housing.

2. The test device according to claim 1, wherein:

said opener is pivotally coupled to said housing.

3. The test device according to claim 2, wherein:

said housing includes a hinge and said opener is coupled to said hinge.

4. The test device according to claim 2, wherein:

a living hinge extends from said opener to said housing.

5. The test device according to claim 4, wherein:

said living hinge is integrally formed with said opener and said housing.

6. The test device according to claim 4, wherein:

said living hinge is formed as a separate piece from said housing and is coupled to said housing by a coupler.

7. The test device according to claim 6, wherein:

said coupler includes a mounting ring connected to said living hinge, said mounting ring configured to surround said opening in said housing and couple to said housing by snap fit closure.

8. The test device according to claim 7, wherein:

said mounting ring defines an annular flange that engages an annular flange of said reservoir and retains said annular flange of said reservoir between said mounting ring and said housing.

9. The test device according to claim 1, wherein:

said opener includes a locking feature that is constructed to lock said opener in said second position.

10. The test device according to claim 9, wherein:

said housing includes a locking feature that is constructed to engage said locking feature of said opener to lock said opener in said second position.

11. The test device according to claim 1, wherein:

said opener is formed as a generally disc shaped member and has a plurality of radially spaced arcuate members extending from a first side of said disc shaped member.

12. The test device according to claim 11, wherein:

the housing includes a cylindrical wall surrounding the opening that engages at least one of the arcuate members when the opener is in the second position.

13. The test device according to claim 12, wherein:

an interference fit is formed between said cylindrical wall and a radially outermost arcuate member.

14. The test device according to claim 1, wherein:

said housing defines a generally annular seat surrounding said opening for seating said reservoir over said opening.

15. The test device according to claim 14, wherein:

said housing includes a plurality of tabs radially extending from around said seat, said tabs disposing a flange of said reservoir between said tabs and said seat.

16. The test device according to claim 1, wherein:

said opener is integrally formed with said housing.

17. The test device according to claim 16, wherein:

said opener is integrally formed with said housing and connected via breakaway portions of said housing which, when broken, permanently sever said opener from said housing.

18. The test device according to claim 1, wherein:

said opener is coupled to said housing by a snap fit coupling.

19. The test device according to claim 1, wherein:

said housing includes at least one barb or spike disposed under said sealed reservoir, said barb or spike constructed to pierce and causes said sealed reservoir to drain the solution when said opener is in said second position.

20. A test device for use with a solution and for use with a conjugate having a marker, the test device for determining the presence of a ligand in a liquid sample, the test device comprising:

a) a first sorbent strip having a first location for receiving the solution and defining a first migration path for the solution and the conjugate;

b) a second sorbent strip distinct from said first sorbent strip having a second location for receiving the liquid sample and defining a second migration path for the sample distinct from said first migration path; and

c) a test site located on or in at least one of said first sorbent strip or said second sorbent strip, said test site having an immobilized ligand-binding mechanism, said first and second sorbent strips touching each other at the test site, and said second migration path extending laterally from said second location to at least said test site;

d) a housing that houses said first and second sorbent strips, said housing defining a first opening aligned with said first location, a second opening aligned with said second location, and a window aligned with said test site and through which said test site is viewable;

e) a sealed reservoir filled with the solution, said sealed reservoir disposed in alignment with said first opening and coupled to said housing; and

f) an opener coupled to said housing, said opener arranged to rotate from a first position in which the opener is not in contact with said sealed reservoir and to rotate to a second position in which the opener causes said sealed reservoir to effect a release of the solution from said reservoir and into said first opening and onto said first sorbent strip.

21. A method of using a test device with a liquid solution, the method comprising:

a) providing a test device comprising;

i) a housing that houses a plurality of sorbent strips, at least one strip having a location for receiving the solution, said housing defining at least an opening aligned above said location for receiving the solution,

ii) a sealed reservoir filled with the liquid solution, said reservoir being disposed in alignment with said opening and coupled to said housing, and

iii) an opener coupled to said housing, said opener arranged to rotate from a first position, in which said opener is not in contact with said sealed reservoir, to a second position, in which said opener causes said sealed reservoir to effect a release of the solution from said reservoir and into said opening and onto said sorbent strip housed within said housing; and

b) rotating said opener from said first position to said second position to effect a release of the solution from said reservoir and into said opening and onto said sorbent strip housed within said housing.