Autoantibody enhanced immunoassays and kits

• US 8,304,201 B2
• Filed: 04/19/2012
• Issued: 11/06/2012
• Est. Priority Date: 12/03/2009
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Adamczyk, Maciej, Brashear, Roy Jeffrey, Mattingly, Phillip G.
• Primary Examiner(s): COOK, LISA V
• Application Number:
  US13/450,832
• Publication Number:
  US 20120202217A1
• Time in Patent Office: 201 Days
• Field of Search: None
• US Class Current: 435/7.21
• CPC Class Codes: G01N 33/564 for pre-existing immune complex or autoimmune disease , i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays

Abstract

The present disclosure provides immunoassays and kits for detection or quantification of an analyte of interest in a test sample that potentially contains endogenously produced autoantibodies reactive with the analyte.

Claims

1. A kit for detecting or quantifying an analyte of interest in a test sample, the kit comprising:

a) a solid phase capable of binding autoantibodies present in the test sample;

b) a first antibody that binds to at least one epitope on the analyte of interest, the first antibody bound to the solid phase;

c) a second antibody that binds to at least one epitope on the analyte of interest; and

d) instructions for detecting or quantifying the analyte of interest.

2. The kit of claim 1 further comprising a detectable label conjugated to the second antibody.

3. The kit of claim 2 wherein the detectable label is an enzyme, oligonucleotide, nanoparticle chemiluminophore, fluorophore, fluorescence quencher, chemiluminescence quencher, or biotin.

4. The kit of claim 3 wherein the detectable label is an acridinium compound.

5. The kit of claim 4, wherein the acridinium compound is an acridinium-9-carboxamide having a structure according to formula I:

6. The kit of claim 4 wherein the acridinium compound IS an acridinium-9-carboxylate aryl ester having a structure according to formula II:

7. The kit of claim 4 further comprising a basic solution.

8. The kit of claim 7 wherein the basic solution is a solution having a pH of at least about 10.

9. The kit of claim 4 further comprising a hydrogen peroxide source.

10. The kit of claim 9 wherein the hydrogen peroxide source comprises a buffer or a solution containing hydrogen peroxide.

11. The kit of claim 9 wherein the hydrogen peroxide source comprises a hydrogen peroxide generating enzyme.

12. The kit of claim 11, wherein the hydrogen peroxide generating enzyme is selected from the group consisting of:

(R)-6-hydroxynicotine oxidase, (S)-2-hydroxy acid oxidase, (S)-6-hydroxynicotine oxidase, 3-aci-nitropropanoate oxidase, 3-hydroxyanthranilate oxidase, 4-hydroxymandelate oxidase, 6-hydroxynicotinate dehydrogenase, abscisic-aldehyde oxidase, acyl-CoA oxidase, alcohol oxidase, aldehyde oxidase, amine oxidase, amine oxidase (copper-containing), amine oxidase (flavin-containing), aryl-alcohol oxidase, aryl-aldehyde oxidase, catechol oxidase, cholesterol oxidase, choline oxidase, columbamine oxidase, cyclohexylamine oxidase, cytochrome c oxidase, D-amino-acid oxidase, D-arabinono-1,4-lactone oxidase, D-arabinono-1,4-lactone oxidase, D-aspartate oxidase, D-glutamate oxidase, D-glutamate(D-aspartate) oxidase, dihydrobenzophenanthridine oxidase, dihydroorotate oxidase, dihydrouracil oxidase, dimethylglycine oxidase, D-mannitol oxidase, ecdysone oxidase, ethanolamine oxidase, galactose oxidase, glucose oxidase, glutathione oxidase, glycerol-3-phosphate oxidase, glycine oxidase, glyoxylate oxidase, hexose oxidase, hydroxyphytanate oxidase, indole-3-acetaldehyde oxidase, lactic acid oxidase, L-amino-acid oxidase, L-aspartate oxidase, L-galactonolactone oxidase, L-glutamate oxidase, L-gulonolactone oxidase, L-lysine 6-oxidase, L-lysine oxidase, long-chain-alcohol oxidase, L-pipecolate oxidase, L-sorbose oxidase, malate oxidase, methanethiol oxidase, monoamino acid oxidase, N6-methyl-lysine oxidase, N-acylhexosamine oxidase, NAD(P)H oxidase, nitroalkane oxidase, N-methyl-L-amino-acid oxidase, nucleoside oxidase, oxalate oxidase, polyamine oxidase, polyphenol oxidase, polyvinyl-alcohol oxidase, prenylcysteine oxidase, protein-lysine 6-oxidase, putrescine oxidase, pyranose oxidase, pyridoxal 5′

-phosphate synthase, pyridoxine 4-oxidase, pyrroloquinoline-quinone synthase, pyruvate oxidase, pyruvate oxidase (CoA-acetylating), reticuline oxidase, retinal oxidase, rifamycin-B oxidase, sarcosine oxidase, secondary-alcohol oxidase, sulfite oxidase, superoxide dismutase, superoxide reductase, tetrahydroberberine oxidase, thiamine oxidase, tryptophan a,β

-oxidase, urate oxidase (uricase, uric acid oxidase), vanillyl-alcohol oxidase, xanthine oxidase, xylitol oxidase and combinations thereof.

13. The kit of claim 1, wherein the solid phase is selected from the group consisting of a magnetic particle, a bead, a test tube, a microtiter plate, a cuvette, a membrane, a scaffolding molecule, a quartz crystal, a film, a filter paper, a disc and a chip.

14. The kit of claim 1, wherein the first antibody and the second antibody each bind to an epitope on an analyte of interest selected from the group consisting of cardiac troponin, thyroid stimulating hormone (TSH), beta human chorionic gonadotropin (beta-HCG);

myeloperoxidase (MPO), prostate specific antigen (PSA), human B-type natriuretic peptide (BNP), myosin light chain 2, myosin-6 and myosin-7.