Radial absorption device

• US 5,668,017 A
• Filed: 02/10/1995
• Issued: 09/16/1997
• Est. Priority Date: 02/10/1995
• Status: Expired due to Fees

• Current Assignee: Path
• Original Assignee: Path
• Inventors: Buchanan, Ian Ellis, Tam, Milton Richard
• Primary Examiner(s): Chin, Christopher L.
• Assistant Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US08/386,650
• Time in Patent Office: 949 Days
• Field of Search: 422/56, 422/57, 422/58, 422/60, 422/68.1, 422/99, 422/101, 422/274, 422/275, 422/276, 422/277, 435/7.91, 435/6, 435/7.92, 435/7.93, 435/7.94, 435/970, 435/810, 435/287.1-287.2, 435/287.7, 435/287.9, 435/288.4, 436/518, 436/169, 436/528, 436/807, 436/538, 436/809, 436/534
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays

Abstract

The assay device of this invention provides for very simple assay procedures leading to rapid, sensitive, specific detection of an analyte in a solution. The device is inexpensive and easily manufactured, particularly if automated manufacturing processes are used. The assay device is a test strip having an elongated support sheet of solid non-porous material attached to a similarly shaped sheet of absorbent material. The absorbent sheet has perforations, preferably of circular shape, forming sample receiving wells. Forming the bottom of the sample receiving wells is one surface of the support sheet, and attached to this surface are moieties which specifically bind the analyte (anti-analyte moieties). A liquid sample for assay is placed in the wells, and the liquid is drawn into the absorbent material. As the liquid is absorbed, it flows tangentially across the surface of the support sheet, and across binding moieties specific for the analyte which are attached to the bottom of the wells. If analyte is present in the sample, analyte will form a complex with anti-analyte attached to the support surface, and detection of the complex will demonstrate the presence of the analyte.

Claims

1. A test strip apparatus for use in detection of an analyte in a fluid sample by immunoassay, including:

an upper strip of absorbent material, and

a lower strip of non-porous material, the upper strip being laminated to an upper surface of the lower strip,

the test strip including a plurality of wells for receiving a fluid sample, a well being a transverse hole piercing the absorbent material of the upper strip such that the upper surface of the lower strip forms a base of the well, wherein at least a portion of the base of the well is coated with anti-analyte moieties which specifically bind the analyte, such that a fluid sample placed into the well is in direct contact with the anti-analyte moieties and fluid flows into the absorbent material radially away from the anti-analyte moieties on the base of the well.

2. The test strip of claim 1 wherein the anti-analytes are nucleic acid probes.

3. A test strip apparatus according to claim 1, wherein the analyte and the anti-analyte comprise an antigen-antibody pair.

4. The test strip apparatus of claim 1, wherein the non-porous material is polystyrene plastic sheeting.

5. The test strip apparatus of claim 1, wherein the absorbent material is fiberboard.

6. The test strip apparatus of claim 1, wherein the hole in the upper strip is circular.

7. The test strip apparatus of claim 1, further including score lines placed between adjacent wells to demarcate individual test wells.

8. The test strip apparatus of claim 7, wherein the score lines include perforations which facilitate breaking the test strip between adjacent wells.

9. The test strip apparatus of claim 1, further containing means for controlling flow rate of fluid from the well into the absorbent material.

10. The test strip apparatus of claim 9, wherein the absorbent material is compressed to form a ring of the absorbent material adjacent to the well, said ring having an increased density relative to the remainder of the upper strip, which ring is the means for controlling flow rate.

11. The test strip apparatus of claim 9, wherein the means for controlling flow rate is a ring of absorbent material with additional soluble material dried therein adjacent to the well.

12. The test strip apparatus of claim 9, wherein the means for controlling flow rate is a liner of non-porous material lining the well, the liner forming a ring in contact with the upper strip of absorbent material, the liner containing a plurality of perforations through which fluid may pass from the well into the absorbent material.

13. An assay method for determining the presence of an analyte in a fluid sample, comprising:

placing a fluid sample in a well in a test strip assay device, the well including a transverse hole in an upper layer of absorbent material laminated to an upper surface of a lower layer of non-porous material, the well traversing the absorbent layer to permit the fluid sample to directly contract the upper surface of the non-porous layer, at least a portion of the upper surface of the non-porous layer within the well being coated with anti-analyte moieties which specifically bind the analyte,

allowing the absorbent material of the upper layer to absorb the fluid sample, whereby the fluid sample flows radially over the upper surface of the lower non-porous layer and an analyte/anti-analyte complex forms between the anti-analyte moieties coating the upper surface of the lower non-porous layer and analyte in the fluid,

placing a signal reagent in the well, said reagent having an affinity for the analyte, and

detecting the analyte/anti-analyte complex within the well by detecting a signal generated by the signal reagent, the presence of said signal within the well indicating the presence of the analyte in the fluid sample.

14. The assay method of claim 13, wherein the hole in the upper strip is circular.

15. The assay method of claim 13, wherein the analyte and the anti-analyte comprise an antigen-antibody pair.

16. The assay method of claim 13, wherein the analyte and the anti-analyte comprise a nucleic acid sequence and its complement.