Assay device

• US 7,241,417 B2
• Filed: 07/26/2005
• Issued: 07/10/2007
• Est. Priority Date: 07/29/2004
• Status: Active Grant

• Current Assignee: Savyon Diagnostics Limited
• Original Assignee: Savyon Diagnostics Limited
• Inventors: Rogel, Eitan, Greenberg, Zvi, Lee, Martin Jerome
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): DiRamio; Jacqueline A.
• Application Number:
  US11/188,799
• Publication Number:
  US 20060024843A1
• Time in Patent Office: 714 Days
• Field of Search: 422/50, 422/55, 422/56, 422/58, 422/68.1, 422/101, 422/103, 422/104, 435/4, 435/7.1, 435/283.1, 435/287.1, 435/287.2, 435/287.6, 435/288.7, 436/180
• US Class Current: 422/408
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A device for carrying out a lateral flow assay on a sample comprising: (a) a sample containing unit comprising a sample container, said sample container being closed off at one end by a bottom wall, said bottom wall having a hole sealed by a plug; and (b) a housing located under said sample container and capable of holding a test strip, said sample containing unit and said housing being coupled so as to allow rotation one relative to the other, said housing comprising a cutting arrangement capable of cutting said plug; wherein rotation of said sample containing unit and said housing one relative to the other results in said cutting arrangement cutting said plug, thereby unplugging the hole in said bottom wall. Also disclosed is a method for determining the presence or absence of an analyte in a sample, using the device.

Claims

1. A device for carrying out a lateral flow assay on a sample comprising:

(a) a sample containing unit comprising a sample container, said sample container being closed off at one end by a bottom wall, said bottom wall having a hole therein sealed by a plug; and

(b) a housing located under said sample container and capable of holding a test strip, said sample containing unit and said housing being coupled so as to allow rotation one relative to the other, said housing comprising a slicing arrangement capable of slicing said plug, wherein said housing comprises an upper part which comprises a bore to receive the sample container, said bore having a bottom wall with an aperture therein, through which the sample reaches the test strip when the hole in the bottom wall of said sample containing unit is in alignment with the aperture in the bottom wall of the bore of the upper part of said housing;

wherein rotation of said sample containing unit and said housing one relative to the other results in (1) said slicing arrangement slicing said plug, thereby unplugging the hole in said bottom wall, and (2) the hole becoming aligned with the aperture in the bottom of the bore.

2. The device according to claim 1 wherein said housing further comprises a bottom part which comprises a base support for receiving the test strip.

3. The device according to claim 2 wherein said slicing arrangement is located in the bottom of the bore in the upper part of the housing.

4. The device according to claim 3 wherein said test strip comprises a sample application pad and said aperture in the bottom of the bore is positioned over the sample application pad.

5. The device according to claim 1 wherein the dimensions of the hole in the bottom of the sample container and the aperture in the bottom of the bore are determined by one or more of the following parameters:

(a) the volume of the sample;

(b) the viscosity of the sample;

(c) the dimensions of the test strip; and

(d) the fluid capacity of the test strip.

6. The device according to claim 2 wherein said upper part of the housing further comprises pressing members which apply pressure to pre-determined locations on the test strip when said strip is placed in the base support of said bottom part of the housing.

7. The device according to claim 2 wherein said upper part of said housing further comprises a limiting groove and one or more limiting protrusions for limiting rotation of the sample containing unit, and said sample containing unit comprises a corresponding limiting protrusion which is received within the limiting groove when the sample container is installed in the housing.

8. The device according to claim 2 wherein said housing comprises a plurality of base supports for receiving a plurality of test strips.

9. The device according to claim 8 comprising a plurality of sample containers for delivering a sample to each of said test strips.

10. The device according to claim 1 wherein the test strip is capable of detecting a plurality of analytes.

11. The device according to claim 1 wherein said sample container comprises a filtering member to filter the sample prior to its reaching the test strip.

12. The device according to claim 1 wherein an interior wall of the sample container comprises ribs capable of enhancing the mixing efficiency of the sample in the sample container.

13. An apparatus for carrying out a lateral flow assay on one or more samples comprising two or more devices according to claim 1.

14. A device for carrying out a lateral flow assay on a sample comprising:

(a) a sample containing unit comprising a sample container, the sample container being closed off at one end by a bottom wall, and the bottom wall having a hole therein sealed by a plug; and

(b) a housing located under the sample container adapted to hold a test strip, the sample containing unit and said housing being coupled so as to allow relative rotation of one to the other, the housing comprising a slicing arrangement capable of slicing off the plug to open the hole, wherein said housing comprises an upper part which comprises a bore to receive the sample container, and said bore has an aperture in the bottom thereof, through which the sample reaches the test strip when the hole in the bottom wall of said sample containing unit is in alignment with the aperture in the bottom wall of the bore of the upper part of said housing;

wherein rotation of the sample containing unit and the housing one relative to the other results in (1) the slicing arrangement slicing off the plug, thereby opening the hole in the bottom wall, and (2) the hole becoming aligned with the aperture in the bottom of the bore.

15. The device of claim 14, wherein said bore is of frustroconical shape to receive the sample container and said bottom part further comprises a base support for receiving the test strip, and

wherein said slicing arrangement is located at the bottom of the bore in the upper part of the housing.