Clozapine Immunoassay
AssigneeSaladax Biomedical Inc.
InventorsSalvatore J. Salamone, Jodi Blake Courtney, Howard Sard, Christopher Spedaliere
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Abstract
Novel conjugates and immunogens derived from clozapine and antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of clozapine in biological fluids.
Claims38
An immunoassay for detecting clozapine in a sample comprising providing a mixture of a) said sample, b) an antibody selectively reactive with clozapine and not substantially cross-reactive with N-desmethylclozapine and clozapine-N-oxide, and c) a conjugate of a carrier having either a reactive thiol or amino group with a compound of the formula:
- wherein B is:
- —(C═O)—, —(C═O)—NH—, —(C═O)—O—, —CH2—;
- Y is an organic spacing group;
- X is a terminal functional group capable of binding to a polyamine polymer;
- and
- p is an integer from 0 to 1;
- or salts thereof;
- causing the clozapine in the sample and said conjugate in said mixture to bind with said antibody and thereafter measuring the amount of said conjugate in said mixture which is bound or unbound to said antibody whereby the presence of clozapine in the sample can be determined.
An antibody which binds selectively to clozapine and does not substantially bind to N-desmethylclozapine and clozapine-N-oxide.
The antibody of claim 13, wherein said antibody is a monoclonal antibody.
A compound of the formula:
- wherein B is:—(C═O)—, —(C═O)—NH—, —(C═O)—O—, —CH2—;
- Y is an organic spacing group;
- X is a terminal functional group capable of binding to a polyamine polymer;
- and
- p is an integer from 0 to 1;
- or salts thereof.
A conjugate of a carrier having a thiol or amine group with a compound of the formula:
- wherein B is:
- —(C═O)—, —(C═O)—NH—, —(C═O)—O—, —CH2—;
- Y is an organic spacing group;
- X is a terminal functional group capable of binding to a polyamine polymer;
- and
- p is an integer from 0 to 1;
- or salts thereof:
A kit for determining the presence of clozapine in a patient sample comprising reagents in separate containers, one of the reagents being a conjugate of a carrier containing a functional amino or thiol group with a compound selected from the groups consisting of compounds of the formula:
- wherein B is:
- —(C═O)—, —(C═O)—NH—, —(C═O)—O—, —CH2—;
- Y is an organic spacing group;
- X is a terminal functional group capable of binding to a polyamine polymer;
- and
- p is an integer from 0 to 1;
- or salts thereof;
- and the second container containing an antibody substantially selectively reactive with clozapine and not substantially cross-reactive to N-desmethylclozapine and clozapine-N-oxide
The kit of claim 37, wherein said carrier has a reactive terminal functional thiol group and X is a terminal functional group capable of binding to said thiol group.
The kit of claim 38, wherein X is
Dependencies are inferred from the claim text.