Antibodies to quetiapine and use thereof

Abstract

Disclosed is an antibody which binds to quetiapine, which can be used to detect quetiapine in a sample such as in a competitive immunoassay method. The antibody can be used in a lateral flow assay device for point-of-care detection of quetiapine, including multiplex detection of aripiprazole, quetiapine, olanzapine, and risperidone in a single lateral flow assay device.

What is claimed is: 
     
         1 . An isolated antibody or a binding fragment thereof, which specifically binds to quetiapine and which said isolated antibody or binding fragment thereof comprises an amino acid sequence selected from the group consisting of:
 a) the isolated antibody or the binding fragment thereof comprising a light chain variable region comprising an amino acid sequence having at least 90% sequence identity with the amino acid sequence of SEQ ID NO:19, SEQ ID NO:23 or SEQ ID NO:27, and a heavy chain variable region;   b) the isolated antibody or the binding fragment thereof comprising a light chain variable region, and a heavy chain variable region comprising an amino acid sequence having at least 90% sequence identity with the amino acid of SEQ ID NO:20, SEQ ID NO:24 or SEQ ID NO:28;   c) the isolated antibody or the binding fragment thereof comprising a light chain variable region having at least 90% sequence identity with the amino acid sequence of SEQ ID NO:19 and a heavy chain variable region having at least 90% sequence identity with the amino acid sequence of SEQ ID NO:20;   d) the isolated antibody or the binding fragment thereof comprising a light chain variable region having at least 90% sequence identity with the amino acid sequence of SEQ ID NO:23 and a heavy chain variable region having at least 90% sequence identity with the amino acid sequence of SEQ ID NO:24; and   e) the isolated antibody or the binding fragment thereof comprising a light chain variable region having at least 90% sequence identity with the amino acid sequence of SEQ ID NO:27 and a heavy chain variable region having at least 90% sequence identity with the amino acid sequence of SEQ ID NO:28.   
     
     
         2 . The antibody of  claim 1 , wherein the antibody comprises the light chain variable region having the amino acid sequence SEQ ID NO:19 and the heavy chain variable region having the amino acid sequence SEQ ID NO:20. 
     
     
         3 . The antibody of  claim 1 , wherein the antibody comprises a light chain variable region having at least 95% sequence identity with the amino acid sequence SEQ ID NO:23 and a heavy chain variable region having at least 95% sequence identity the amino acid sequence SEQ ID NO:24. 
     
     
         4 . The antibody of  claim 1 , wherein the antibody comprises a light chain variable region having at least 95% sequence identity the amino acid sequence SEQ ID NO:27 and a heavy chain variable region having at least 95% sequence identity the amino acid sequence SEQ ID NO:28. 
     
     
         5 . The antibody of  claim 1 , wherein the antibody comprises: a) a light chain CDR1 sequence comprising amino acid residues 43 to 58 of SEQ ID NO:19; b) a light chain CDR2 sequence comprising amino acid residues 74 to 80 of SEQ ID NO:19; c) a light chain CDR3 sequence comprising amino acid residues 113 to 121 of SEQ ID NO:19; d) a heavy chain CDR1 sequence comprising amino acid residues 45 to 54 of SEQ ID NO:20; e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 85 of SEQ ID NO:20; and f) a heavy chain CDR3 sequence comprising amino acid residues 118 to 129 of SEQ ID NO:20. 
     
     
         6 . The antibody of  claim 1 , wherein the antibody comprises: a) a light chain CDR1 sequence comprising amino acid residues 43 to 58 of SEQ ID NO:23; b) a light chain CDR2 sequence comprising amino acid residues 74 to 80 of SEQ ID NO:23; c) a light chain CDR3 sequence comprising amino acid residues 113 to 121 of SEQ ID NO:23; d) a heavy chain CDR1 sequence comprising amino acid residues 45 to 54 of SEQ ID NO:24; e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 85 of SEQ ID NO:24; and f) a heavy chain CDR3 sequence comprising amino acid residues 123 to 129 of SEQ ID NO:24. 
     
     
         7 . The antibody of  claim 1 , wherein the antibody comprises: a) a light chain CDR1 sequence comprising amino acid residues 43 to 58 of SEQ ID NO:27; b) a light chain CDR2 sequence comprising amino acid residues 74 to 80 of SEQ ID NO:27; c) a light chain CDR3 sequence comprising amino acid residues 113 to 121 of SEQ ID NO:27; d) a heavy chain CDR1 sequence comprising amino acid residues 45 to 54 of SEQ ID NO:28; e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 85 of SEQ ID NO:28; and f) a heavy chain CDR3 sequence comprising amino acid residues 123 to 129 of SEQ ID NO:28. 
     
     
         8 . The antibody of  claim 1 , wherein the antibody fragment is selected from the group of fragments consisting of Fv, F(ab′), F(ab′)2, scFv, minibody and diabody fragments. 
     
     
         9 . The antibody of  claim 1 , wherein the antibody is a monoclonal antibody. 
     
     
         10 . An assay kit comprising the antibody of  claim 1 . 
     
     
         11 . An assay device comprising the antibody of  claim 1 . 
     
     
         12 . The assay device of  claim 11 , wherein the device is a lateral flow assay device. 
     
     
         13 . A method of detecting quetiapine in a sample, the method comprising:
 (i) contacting a sample with the antibody of  claim 1  labeled with a detectable marker, wherein the labeled antibody and quetiapine present in the sample form a labeled complex; and   (ii) detecting the labeled complex so as to detect quetiapine in the sample.   
     
     
         14 . A competitive immunoassay method for detecting quetiapine in a sample, the method comprising:
 (i) contacting a sample with the antibody of  claim 1 , and with quetiapine or a competitive binding partner of quetiapine, wherein one of the antibody and the quetiapine or competitive binding partner thereof is labeled with a detectable marker, and wherein sample quetiapine competes with the quetiapine or competitive binding partner thereof for binding to the antibody; and   (ii) detecting the label so as to detect sample quetiapine.   
     
     
         15 . The method of  claim 14  wherein the quetiapine or competitive binding partner thereof is labeled with the detectable marker. 
     
     
         16 . The method of  claim 14  wherein the antibody is labeled with a detectable marker. 
     
     
         17 . The method of  claim 14  wherein the immunoassay is performed on a lateral flow assay device and the sample is applied to the device. 
     
     
         18 . The method of  claim 13  or  14 , further comprising detecting the presence of one or more analytes in addition to quetiapine. 
     
     
         19 . The method of  claim 18  wherein the one or more analytes are antipsychotic drugs other than quetiapine. 
     
     
         20 . The method of  claim 19  wherein the anti-psychotic drugs other than quetiapine are selected from the group consisting of: risperidone, paliperidone, aripiprazole, olanzapine, and metabolites thereof.