Test device for detection of an analyte

• US 5,985,675 A
• Filed: 12/31/1997
• Issued: 11/16/1999
• Est. Priority Date: 12/31/1997
• Status: Expired due to Term

• Current Assignee: Charm Sciences, Inc.
• Original Assignee: Charm Sciences, Inc.
• Inventors: Markovsky, Robert J., Charm, Stanley E., Zomer, Eliezer, Skiffington, Richard
• Primary Examiner(s): Chin, Christopher L.
• Assistant Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/001,775
• Time in Patent Office: 685 Days
• Field of Search: 422/56, 422/58, 422/187, 422/188, 422/104, 422/110, 422/278, 435/7.1, 435/7.2, 435/7.8, 435/7.92, 435/7.94, 435/7.95, 435/174, 435/287.1, 435/970, 435/971, 435/7.93, 436/518, 436/524, 436/538, 436/530, 436/535, 436/533, 436/810, 436/807
• US Class Current: 436/514
• CPC Class Codes: G01N 33/537 with separation of immune complex from unbound antigen or antibody
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/971 Capture of complex after antigen-antibody reaction
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A test device, system and method, the device composed of an elongated, toothbrush-shaped, transparent, plastic housing and a lateral-flow test strip for the detection of an analyte, such as a beta-lactam in milk, in the housing, the housing having an expansion cavity to receive expanded, liquid-contacted, absorbing material in the test strip, and to control lateral flow rate and times in the test strip.

Claims

1. An analyte test device for the detection of an analyte or analyte class, which test device comprises:

a) a test device housing having two ends, walls to define an elongated strip cavity, and an expansion cavity at one end of the strip cavity;

b) a lateral, capillary-flow, elongated test strip having two ends located within the strip cavity and designed for the detection of an analyte or analyte class from a liquid sample;

the test strip includes, at a first end, a liquid sample-absorbing material and a reaction-detection material toward a second end;

wherein the liquid sample-absorbing material is located within the expansion cavity;

c) the liquid sample-absorbing material of selected dimensions and moves within the expansion cavity between a dry, nonexpanded state and a wet, expanded state when contacted with the liquid sample;

d) the expansion cavity selected in dimensions to mimic generally the width and length of the liquid sample-absorbing material and to permit expansion of the liquid sample-absorbing material to the wet, expanded state within the expansion cavity, and into contact with at least one wall of the housing to control the volume of the liquid test sample absorbed, and to provide sufficient pressure to drive capillary flow of the absorbed liquid sample, in a selected time period from the first end toward the second end of the test strip;

e) a means to introduce the liquid sample into contact with the liquid sample-absorbing material; and

f) a means for a user to determine the detected analyte or analyte class.

2. The test device of claim 1 wherein the housing includes an aperture in the expansion cavity to reduce absorption time of the liquid sample by the discharge of entrapped air.

3. The test device of claim 1 wherein the aperture is located on a top housing wall of the expansion cavity.

4. The test device of claim 1 wherein the housing comprises a flat-seal strip and a transparent plastic housing secured to the seal strip.

5. The test device of claim 4 wherein the flat seal strip includes, adjacent the expansion cavity, a resealable peel strip to allow the introduction of the liquid sample into contact with the liquid-absorbing material.

6. The test device of claim 5 wherein the resealable peel strip further includes a peel tab at the one end of the flat-seal strip, the peel tab facilitates the movement of the resealable peel strip between a peeled state wherein a liquid sample may be placed in contact with the liquid sample-absorbing material, a sealed state, and a resealed state against the seal strip.

7. The test device of claim 1 wherein the means to determine the detected analyte or analyte class includes a transparent, top housing.

8. The test device of claim 1 wherein the housing comprises a transparent, molded plastic housing.

9. The test device of claim 8 which includes a removable cap to cover an open end of the housing.

10. The test device of claim 1 wherein the housing includes a top wall of selected height in the expansion cavity to prevent the full height expansion of the liquid sample-absorbing material in the wet, expanded state.

11. The test device of claim 1 wherein the liquid sample-absorbing material is designed to receive and retain a liquid sample of about 0.1 to 1.0 ml.

12. The test device of claim 1 wherein the liquid sample-absorbing material is designed to absorb a liquid sample in about 1 to 30 seconds.

13. The test device of claim 1 wherein the liquid sample-absorbing material comprises a dry, compressed cellulosic material.

14. The test device of claim 1 wherein the test strip is selected for the detection of an antibiotic analyte or toxic analyte or analyte class.

15. The test device of claim 1 wherein the reaction-detection material includes a reference line and a control line, and the analyte or analyte class is detected by a change in color of the reference line, or control line, or both lines.

16. The test device of claim 1 wherein the liquid sample-absorbing material comprises a generally rectangular layer and in the wet, expanded state, contacts a housing top wall of the expansion cavity.

17. The test device of claim 1 wherein the test strip comprises:

a) a support strip with a plurality of sequential, contacting, liquid sample-permeable layers extending from the one end to the other end, which layers permit the lateral capillary-flow of the liquid sample from the one end to the other end, and which layers include;

i) a liquid sample-absorbing material layer composed of an expandable, porous, dry, compressed material;

ii) a releasing material layer having a mobile-phase thereon with a receptor for the analyte or analyte class of the liquid sample thereon;

iii) a reaction-detection material layer having at least one analyte reference line and a spaced-apart control line thereon for observation to detect the presence or absence of an analyte or analyte class in the liquid sample, by a change in color; and

iv) optionally, a disposable liquid sample-absorbent material layer for the liquid sample, to induce capillary flow to the second end.

18. The test device of claim 1 wherein the expansion cavity is dimensional to be about 30 to 60 percent less than the wet, expanded state of the liquid-sample absorbing material.

19. The test device of claim 1 wherein the liquid sample-absorbing material has width and height dimensions of about 3 mm by 14 mm, and the expansion cavity has dimensions of about 5 mm by 16 mm in width and length, and about 4 to 6 mm in height.

20. An analyte test device for the detection of an analyte or analyte class, which test device comprises:

a) a housing which comprises a transparent plastic blister secured on a flat seal-backed strip, the housing having two ends, walls to define an elongated strip cavity, and generally is rectangular in width and length, and a selected height expansion cavity with a top housing wall at one end of the strip cavity;

b) a lateral, capillary-flow, elongated test strip having two ends and located within the strip cavity and designed for the detection of an analyte or analyte class from a liquid sample, the test strip includes, at a first end, a liquid sample-absorbing material and a reaction-detection material;

the test strip further includes a reference line and a control line toward a second end to detect an analyte or analyte class;

wherein, the liquid sample-absorbing material is located within the expansion cavity;

c) the liquid sample-absorbing material of selected dimensions and moves within the expansion cavity between a dry, nonexpanded state and a wet, expanded state when contacted with the liquid sample;

d) the expansion cavity is selected to permit expansion of the liquid sample-absorbing material in the wet, expanded state into contact with the top housing wall, and to provide sufficient pressure to drive the capillary-flow of the absorbed liquid sample, at a selected flow rate, from the first end toward the second end of the test strip; and

e) an adhesive peel strip at the one end of the housing, which peel strip moves between a sealed state to seal the expansion cavity, an unsealed state wherein a liquid sample may be introduced into the expansion cavity, and a resealed state to seal the expansion cavity containing the absorbed liquid sample.