Immunoassays empolying generic anti-hapten antibodies and materials for use therein
First Claim
1. An immunoassay method for detecting the presence or measuring the amount of an analyte (A) in a test sample comprising:
- a) exposing the test sample to a particle-analyte (P-A) and a common antibody pool to form a reaction mixture, wherein said particle-analyte (P-A) comprises a particle (P) attached to analyte (A) and said common antibody pool comprises (1) at least two antisera, one of said at least two antisera containing an antibody α
A, the other of said at least two antisera containing an antibody α
B, or (2) at least one antisera and at least one monoclonal antibody, said at least one antisera containing an antibody α
A and said monoclonal antibody being antibody α
B, or (3) at least two monoclonal antibodies, one of said at least two monoclonal antibodies being antibody α
A, the other of said at least two monoclonal antibodies being antibody α
B, wherein antibody α
A and antibody α
B have different binding specificities for analyte (A), one of which antibodies α
A or α
B is also able to cross-react with other substances that are structurally related to analyte (A), while the other antibody cannot cross-react with said substances;
b) allowing the formation of complexes including (P-A)(α
A), or (P-A)(α
B), or (P-A)(α
B)(α
A), or combinations of the three; and
c) detecting the presence or measuring the amount of any of (P-A)(α
A), or (P-A)(α
B), or (P-A)(α
B)(α
A), or combinations of the three in the absence of analyte (A);
or the absence of (P-A)(α
A), or (P-A)(α
B), and (P-A)(α
B)(α
A) in the presence of analyte (A).
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Accused Products
Abstract
The present invention relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of generic anti-hapten antibodies. Also disclosed are multi-analyte immunoassay methods. Reagents, devices, and kits using the anti-hapten antibodies are also disclosed. The present invention also relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of a dual antibody format.
The present invention also relates to dyed erythrocytes, preferably fixed, which are coated with antibodies. Also disclosed is the use of these dyed erythrocytes in agglutination assays to detect and measure the presence of an analyte in a sample. The analyte can be a hapten, an antigen, or an antibody. Also included are agglutination assays, compositions and kits using these dyed and coated erythrocytes.
82 Citations
18 Claims
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1. An immunoassay method for detecting the presence or measuring the amount of an analyte (A) in a test sample comprising:
-
a) exposing the test sample to a particle-analyte (P-A) and a common antibody pool to form a reaction mixture, wherein said particle-analyte (P-A) comprises a particle (P) attached to analyte (A) and said common antibody pool comprises (1) at least two antisera, one of said at least two antisera containing an antibody α
A, the other of said at least two antisera containing an antibody α
B, or (2) at least one antisera and at least one monoclonal antibody, said at least one antisera containing an antibody α
A and said monoclonal antibody being antibody α
B, or (3) at least two monoclonal antibodies, one of said at least two monoclonal antibodies being antibody α
A, the other of said at least two monoclonal antibodies being antibody α
B, wherein antibody α
A and antibody α
B have different binding specificities for analyte (A), one of which antibodies α
A or α
B is also able to cross-react with other substances that are structurally related to analyte (A), while the other antibody cannot cross-react with said substances;b) allowing the formation of complexes including (P-A)(α
A), or (P-A)(α
B), or (P-A)(α
B)(α
A), or combinations of the three; andc) detecting the presence or measuring the amount of any of (P-A)(α
A), or (P-A)(α
B), or (P-A)(α
B)(α
A), or combinations of the three in the absence of analyte (A);
or the absence of (P-A)(α
A), or (P-A)(α
B), and (P-A)(α
B)(α
A) in the presence of analyte (A). - View Dependent Claims (2, 3, 4)
-
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5. An immunoassay method for detecting the presence or measuring the amount of an analyte (A) in a test sample comprising:
-
a) exposing the test sample to a hapten-analyte (H-A) conjugate, an anti-hapten antibody, and a common antibody pool to form a reaction mixture, wherein said common antibody pool comprises (1) at least two antisera, one of said at least two antisera containing an antibody α
A, the other of said at least two antisera containing an antibody α
B, or (2) at least one antisera and at least one monoclonal antibody, said at least one antisera containing an antibody α
A and said monoclonal antibody being antibody α
B, or (3) at least two monoclonal antibodies, one of said at least two monoclonal antibodies being antibody α
A, the other of said at least two monoclonal antibodies being antibody α
B, wherein antibody α
A and antibody α
B have different binding specificities for analyte (A), one of which antibodies α
A or α
B is also able to cross-react with other substances that are structurally related to analyte (A), while the other antibody cannot cross-react with said substances;b) allowing the formation of complexes including (α
H)(H-A)(α
A), or (α
H)(H-A)(α
B), or (α
H)(H-A)(α
B)(α
A), or combinations of the three; andc) detecting the presence or measuring the amount of any of (α
H)(H-A)(α
A), or (α
H)(H-A)(α
B) or (α
H)(H-A)(α
B)(α
A), or combinations of the three in the absence or analyte (A);
or the absence of (α
H)(H-A)(α
A), or (α
H)(H-A)(α
B), and (α
H)(H-A)(α
B)(α
A) in the presence of analyte (A). - View Dependent Claims (6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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Specification