Screening arrangment for screening immunoassay tests and agglutination tests

• US 7,070,920 B2
• Filed: 01/12/2001
• Issued: 07/04/2006
• Est. Priority Date: 07/14/1998
• Status: Expired due to Term

• Current Assignee: Cozart Bioscience Limited (Abbott Laboratories)
• Original Assignee: Cozart Bioscience Limited (Abbott Laboratories)
• Inventors: Baldwin, Dene, Hand, Christopher William, Jones, Osborn Pierce, Spivey, Robin James
• Primary Examiner(s): DIRAMIO, JACQUELINE A
• Assistant Examiner(s): DIRAMIO, JACQUELINE A
• Application Number:
  US09/760,374
• Publication Number:
  US 20010034068A1
• Time in Patent Office: 1,999 Days
• Field of Search: 435/4, 435/6, 435/7.1, 435/7.9, 435/7.92, 4352871-2873, 435/805, 435/810, 435/970, 436/164, 436/172, 436/518, 436/524, 436/528, 436/532, 436/805, 436/810, 422/68.1, 422/82.01, 356/73, 356/318, 356/445, 356/446, 356/246, 356/317, 356/338, 356/343, 356/417
• US Class Current: 435/4
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/805 Test papers
• 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 436/805 Optical property

Abstract

A screening device for performing an immunoassay test to detect the presence of a compound in a body fluid. The device includes a holder for removably receiving a membrane to which the fluid has been applied. A light is directed to the membrane. A photodetector measures the concentration of the light reflected back from the membrane. Specifically, the concentrations of reflected light from a control zone and a test zone are measured. Signals representative of the measured light concentrations are applied to a processor. If a specified concentration of predetermined light from a control zone on the membrane is detected, the processor considers the test to be successful. In the test is successful, the processor, based upon the measured concentration of reflected light from the test zone, generates data representative of the presence of the compound.

Claims

1. A screening arrangement to test for presence of a compound in a fluid specimen, comprising:

a support cartridge having at least one elongate immunoassay test strip mounted thereon to which a fluid specimen is applied, the test strip including a test membrane having at least one test zone that changes reflectivity as a function of the amount of the compound in the specimen, at least one control zone that changes reflectivity upon contact with the specimen, and a background zone between the test and control zones;

a screening device for mounting thereon the support cartridge and the test strip associated therewith to test for the presence of the compound when the fluid specimen is applied to the test strip;

said screening device being portable, and including;

a receiving bracket removably mounting the support cartridge and the test strip carried thereon in a predefined stationary testing position so that an exposed surface of the membrane faces generally upwardly,

a photosensitive detector assembly stationarily interconnected to and positioned adjacent said receiving bracket and directed toward a region directly above the upper surface of the test strip for receiving light reflected by the test membrane, said photosensitive detector assembly generating output signals representative of the concentration of light reflected by the test, control and background zones of the test membrane,

a mirror arrangement interconnected to and positioned adjacent said receiving bracket and oriented for receiving light reflected from the test membrane and redirecting it to the photosensitive detector assembly,

a processor to receive the output signals from the photosensitive detector assembly and configured (1) to evaluate the concentration of light reflected from the control zone to determine if the assay test has been successfully run and (2) to evaluate the concentration of light reflected from the test zone and to generate output data representative of the presence of the compound in the specimen,

a visual display disposed adjacent one side of the screening device and connected to the processor for receiving the output data, and

means for supplying d.c. voltage to the portable screening device for supplying power for operation thereof;

whereby said portable screening device, in conjunction with the support cartridge bearing the test strip thereon, is utilized for testing the fluid specimen while providing flexibility with respect to its handling and location of use.

2. The screening arrangement according to claim 1, wherein:

said processor is connected to said display and is configured to control the display so that if the test is not successful, said processor causes said display to generate a message indicating the test is not successful, and if the test is successful said processor causes said display to generate a message indicating the presence/absence of the compound in the specimen.

3. The screening arrangement according to claim 1, wherein the screening device mounts therein a visual indicator light for indicating when a test is in process and has been completed.

4. The screening arrangement according to claim 1, wherein the support cartridge has a swab-receiving structure fixedly associated with one end thereof and providing fluid communication with the test strip so that, when a swab having the fluid specimen thereon is inserted into the swab-receiving structure, the specimen is placed in fluid communication with the test strip;

and

said swab-supporting structure and the swab engaged therewith being positioned sidewardly from the upper exposed surface of the test membrane so as to not interfere with the test strip when the support cartridge is mounted on the receiving bracket.

5. The screening arrangement according to claim 1, wherein said screening device includes a position detector positioned adjacent the receiving bracket for sensing when the support cartridge is properly supported and positioned on the receiving bracket for permitting initiating of a test.

6. The screening arrangement according to claim 1, wherein the means for supplying d.c. voltage to the screening device includes a battery arrangement carried therewith.

7. The screening arrangement according to claim 6, wherein the display is oriented vertically adjacent an opposite side of the screening device, and wherein the photosensitive detector assembly, the processor and the battery arrangement are all positioned generally between the display arid the receiving bracket.

8. The screening arrangement according to claim 1, wherein the receiving bracket defines a generally horizontally open guide track which cooperates with the support cartridge so as to enable the support cartridge to be horizontally slidably inserted into the guide track for disposition in said predetermined position.

9. The screening arrangement according to claim 1, wherein the screening device has a maximum weight of approximately 300 grams.

10. The screening arrangement according to claim 1, wherein the screening device includes a plurality of lights disposed above the receiving bracket to individually emit light downwardly toward the exposed upper surface of the test membrane, each said light emitting a different light frequency.

11. The screening arrangement according to claim 1, wherein the processor is configured to evaluate the concentration of light reflected from the control zone relative to the concentration of light reflected from the adjacent background zone to determine if the assay test has been successfully run, and to evaluate the concentration of light reflected from the test zone relative to the concentration of light reflected from the adjacent background zone to generate data representative of the compound in the specimen.

12. The screening arrangement according to claim 1, wherein the screening device is a portable unitized assembly.

13. The screening arrangement according to claim 1, wherein the screening arrangement includes a light arrangement disposed above the receiving bracket to emit light downwardly toward the exposed upper surface of the test membrane.