Immunochemical-based test device with lift and twist specimen full tab

• US 5,747,351 A
• Filed: 06/07/1995
• Issued: 05/05/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Smithkline Diagnostics, Inc. (GSK plc)
• Original Assignee: Smithkline Diagnostics, Inc. (GSK plc)
• Inventors: Hemmati, Goodarz Sahneh
• Primary Examiner(s): Chin, Christopher L.
• Assistant Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US08/480,572
• Time in Patent Office: 1,063 Days
• Field of Search: 422/56, 422/57, 422/58, 422/274, 422/275, 422/276, 422/61, 435/294.1, 435/970, 435/975, 435/7.1, 436/518, 436/809, 436/514, 436/810
• US Class Current: 436/514
• CPC Class Codes: B01L 3/5055 Hinged, e.g. opposable surfaces
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A chromatographic assay test device for use with immunoassays. The test device has a sample collection member pivotally coupled to a test strip receiving member. The sample collection member has a window for applying a test sample to a pad accessible through the window and the pad is repositionable to an inverted position to contact a chromatographic member inserted into the test device. The chromatographic member is then brought into opposition to the sample collection member thus improving test performance by reducing the manipulation of samples. The test device is constructed from five interconnected panels which are die cut from SBS cardboard. The first panel has a window for inserting a test strip and the second panel has a window for viewing the test strip during the test procedure. The third panel has the repositionable pad section. The fourth panel has a window for applying the test sample and the fifth panel covers the test sample window. The first and second panels are coupled to form a first planar member and the third and fourth panels are coupled to form the sample collection member. The fifth panel includes a reusable adhesive for securing the fifth panel over the sample window in the fourth panel.

Claims

1. An immunochemical-based test device for insertion of a chromatographic member, comprising:

a test strip receiving member for inserting a chromatographic test strip therein, the test strip receiving member having an external viewing window to view the inserted chromatographic test strip; and

a sample collection member coupled to the test strip receiving member, the sample collection member having a port for applying a test sample to an accessible pad located in a first position, the pad being repositionable to an inverted position, the pad forming a face section of the sample collection member for contacting the chromatographic test strip as the test strip receiving member is brought into opposition to the sample collection member.

2. The test device of claim 1 further comprising a window cover member for shielding the window of the sample collection member.

3. The test device of claim 1 wherein the pad is coupled to a perforated pull tab, the pull tab being pivoted from the sample collection member to form a pull tab recess area, twisted 180°

and reushered into the recessed area to position the pad for engagement with the test strip member.

4. The test device of claim 1 wherein the pad is coupled to a perforated pull tab having an outside edge and an inside edge, the outside edge of the pull tab being lifted and flipped to the opposite side of the sample collection member to position the pad for engagement with the test strip member.

5. The test device of claim 2 wherein the test strip member, the sample collection member, and the window cover are manufactured from solid bleached sulfite (SBS) cardboard.

6. The test device of claim 5 wherein the SBS cardboard has a thickness of about 0.024 inches.

7. An immunochemical-based test device, comprising:

a two-layer center panel, the two-layer center panel having a window in a first layer, a second layer having a repositionable region, such that the first layer is folded over the second layer, wherein a specimen pad is coupled to the repositionable region of the second layer facing and in alignment with the window and having a membrane disposed between the first and second layer between the window opening in the first layer and the specimen pad in the second layer;

a first cover panel, coupled to the two-layered center panel, for covering the window in the two-layer panel; and

a second cover panel for receiving a chromatographic member, the second cover panel coupled to the two-layered panel, wherein the repositionable region of the second layer having the specimen application pad is repositionable to an inverted position, the specimen pad forming a face section of the repositionable region allowing a chromatographic member inserted into the second cover member to engage the inverted specimen pad as the second cover member and the two-layered panel are brought in opposition.

8. The test device of claim 7 wherein the repositionable region comprises a perforated pull tab, the pull tab being pivoted from the two-layered center panel forming a pull tab recess area, twisted 180°

and reushered into the recessed area to position the pad for engagement with the chromatographic member.

9. The test device of claim 7 wherein the repositionable region comprises a perforated pull tab having an outside edge and an inside edge, the outside edge of the pull tab being lifted and flipped to the opposite side of the two-layer center panel to position the pad in an inverted position for engagement with the chromatographic member.

10. The test device of claim 7 wherein the two-layer center panel, the first cover panel, and the second cover panel are manufactured from solid bleached sulfite (SBS) cardboard.

11. The test device of claim 10 wherein the SBS cardboard has a thickness of about 0.024 inches.

12. An immunochemical-based test device, comprising:

a first panel having a window for insertion of a test strip;

a second panel, coupled to the first panel, the second panel having a window for viewing a test strip inserted into the first panel and the first panel folds over the second panel;

a third panel, coupled to the second panel, the third panel having a repositionable section having a specimen pad coupled to one side, the repositionable section being inverted to expose a collected sample deposited onto the specimen pad to the test strip;

a fourth panel, coupled to the third panel, the fourth panel having a window for applying the test sample to the specimen pad; and

a fifth panel, coupled to the fourth panel, the fifth panel for covering the window, and wherein the fifth panel is folded over the fourth panel, and the fourth is brought toward the third panel, with the fifth panel on the outside of the fourth panel.

13. The test device of claim 12 wherein the repositionable section comprises a perforated pull tab, the pull tab being pivoted away from the third panel forming a pull tab recess area, twisted 180°

and reushered into the recessed area to position the pad for engagement with the test strip.

14. The test device of claim 12 wherein the repositionable section comprises a perforated pull tab having an outside edge and an inside edge, the outside edge of the pull tab being lifted and flipped to the opposite side of the third panel to position the pad for engagement with the test strip.

15. The test device of claim 12 wherein the fourth panel further comprises a notch for facilitating the repositioning of the repositionable section of the third panel.

16. The test device of claim 12 wherein the first and second panels being further coupled to form a first planar member and the third and fourth panels being further coupled to form a second planar member.

17. The test device of claim 12 wherein the fifth panel further comprises a reusable adhesive for securing the fifth panel over the sample window in the fourth panel.

18. The test device of claim 12 wherein panels are die cut from solid bleached sulfite (SBS) cardboard.

19. The test device of claim 18 wherein the SBS cardboard has a thickness of about 0.024 inches.

20. A method of performing immunochemical-based tests with a device having a first planar member and a second planar member, comprising the steps of:

pulling a cover away from a second planar member, the cover being coupled to the second planar member and folded over the second planar member, the second planar member forming a sample collection member of an integrated assay device housing thereby exposing a sample well formed by a sample panel superimposed over a specimen pad,

depositing a sample in the sample well;

closing the cover thereby allowing the integrated assay device housing to be forwarded to a physician or to a laboratory;

lifting a first planar member away from the opposing sample collection member, the first planar member being coupled to the opposing sample collection member and folded over the opposing sample collection member, the first planar member having a test strip insertion well;

installing an immunochromatographic test strip into the test strip insertion well;

repositioning the specimen pad to an inverted position to expose the sample pad to the immunochromatographic test strip;

adding a buffer to the specimen pad to facilitate the interaction between the specimen pad and the immunochromatographic test strip;

bringing the test strip into contact with the specimen pad; and

reading the results of the reaction of the sample the test strip.

21. The method of claim 20 wherein the repositioning of the specimen pad further comprises the steps of lifting the specimen pad away from the sample collection member to form a recess area, twisting the tab 180°

and lowering the tab into the recessed area to position the pad for engagement with the test strip member.

22. The method of claim 20 wherein the specimen pad is attached to a tab, the tab comprises an outside edge and an inside edge, the positioning of the specimen pad further comprises the steps of lifting the outside edge of the tab and flipping the outside edge of the tab to the opposite side of the sample collection member to position the pad for engagement with the test strip member.