Test array for performing assays

• US 5,281,540 A
• Filed: 11/22/1991
• Issued: 01/25/1994
• Est. Priority Date: 08/02/1988
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: Merkh, Carl W., Defreese, James D., Durley deceased, Benton A. III
• Primary Examiner(s): Johnston, Jill A.
• Application Number:
  US07/796,942
• Time in Patent Office: 795 Days
• Field of Search: 422/56-58, 422/101, 436/530, 436/531
• US Class Current: 436/530
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 2021/478 Application in testing analytical test strips
• CPC Class Codes: G01N 2035/00099 Characterised by type of test elements
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/1025 Fluid level sensing
• CPC Class Codes: G01N 2201/0415 Carrusel, sequential
• CPC Class Codes: G01N 2201/0621 Supply
• CPC Class Codes: G01N 2201/1211 for temperature
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/6854 Immunoglobulins
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

A semi-automated biological sample analyzer and subsystems are provided to simultaneously perform a plurality of enzyme immunoassays for human IgE class antibodies specific to a panel of preselected allergens in each of a plurality of biological samples. A carousel is provided to position and hold a plurality of reaction cartridges. Each reaction cartridge includes a plurality of isolated test sites formed in a two dimensional array in a solid phase binding layer contained within a reaction well which is adapted to contain a biological sample to be assayed. The carousel and cartridges contain structures which cooperate to precisely position the cartridges in each of three separate dimensions so that each cartridge is positioned uniformly. An optical reader operating on a principle of diffuse reflectance is provided to read the results of the assays from each test site of each cartridge. Also provided is a subsystem which provides predetermined lot-specific assay calibration data which is useful for normalizing the results of various assays with respect to predetermined common standard values.

Claims

1. An apparatus for supporting a plurality of selected capture reagents, each reactive with a specific assay binding component of interest in a biological sample, for use in simultaneously assaying the sample for said assay binding components, comprising:

a first layer of capture reagent binding material;

a second layer of non-absorbent substrate material below the first layer;

a plurality of test sites formed in said first layer of capture reagent binding material each adapted to bind a selected capture reagent; and

isolation means for isolating each test site from every other test site and for confining capture reagent applied to one of said test sites, wherein said isolation means includes a plurality of isolation moats formed by depressions in said first layer and disposed about said test sites in said first layer, and wherein said depressions of said first layer material are hydrophobic.

2. The apparatus of claim 1 wherein said capture reagent binding material is nitrocellulose or nylon.

3. The apparatus of claim 1 wherein said non-absorbent substrate material is a polyester film.

4. The apparatus of claim 1 wherein said test sites are substantially circular.

5. The apparatus of claim 4 wherein said test sites are approximately 0.1 inches in diameter.

7. The apparatus of claim 5 wherein said capture reagent binding material is nitrocellulose or nylon.

8. The apparatus of claim 5 wherein said hydrophobic material is a hydrophobic adhesive.

9. The apparatus of claim 5 wherein said non-absorbent substrate material is a polyester film.

10. The apparatus of claim 5 wherein said test sites are substantially circular.

11. The apparatus of claim 10 wherein said test sites are approximately 0.1 inches in diameter.

6. An apparatus for supporting a plurality of selected capture reagents, each reactive with a specific assay binding component of interest in a biological sample, for use in simultaneously assaying the sample for said assay binding components, comprising:

a first layer of capture reagent binding material;

a second layer of hydrophobic material below the first layer;

a third layer of non-absorbent substrate material below the second layer;

a plurality of test sites formed in said first layer of capture reagent binding material each adapted to bind a selected capture reagent; and

isolation means for isolating each test site from every other test site and for confining capture reagent applied to one of said test sites, wherein said isolation means includes a plurality of isolation moats formed by depressions in said first layer and disposed about said test sites in said first layer, and wherein said depressions of said first layer material are hydrophobic.