Antibodies to quetiapine and use thereof
Disclosed is an antibody or a binding fragment thereof which binds to quetiapine, which can be used to detect quetiapine in a sample such as in a competitive immunoassay method. The antibody or the fragment thereof 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.
1. An isolated antibody or a binding fragment thereof, which specifically binds to quetiapine comprising:
a) the isolated antibody or the fragment thereof comprising a light chain variable region having an amino acid sequence consisting of SEQ ID NO:3 and a heavy chain variable region having the amino acid sequence consisting of SEQ ID NO:4;
b) the isolated antibody or the fragment thereof comprising a light chain variable region having an amino acid sequence consisting of SEQ ID NO:8 and a heavy chain variable region having the amino acid sequence consisting of SEQ ID NO:10;
c) the isolated antibody or the fragment thereof comprising a light chain variable region having an amino acid sequence consisting of SEQ ID NO:9 and a heavy chain variable region having the amino acid sequence consisting of SEQ ID NO:10; or
d) the isolated antibody or the a fragment thereof comprising a light chain variable region having an amino acid sequence consisting of SEQ ID NO:17 and a heavy chain variable region having the amino acid sequence consisting of SEQ ID NO:18.
2. The antibody of claim 1 , wherein the antibody or the fragment thereof comprises the light chain variable region having the amino acid sequence SEQ ID NO:3 and the heavy chain variable region having the amino acid sequence SEQ ID NO:4.
3. The antibody of claim 1 , wherein the antibody or the fragment thereof comprises the light chain variable region having the amino acid sequence SEQ ID NO:8 and the heavy chain variable region having the amino acid sequence SEQ ID NO:10.
4. The antibody of claim 1 , wherein the antibody or the fragment thereof comprises the light chain variable region having the amino acid sequence SEQ ID NO:9 and the heavy chain variable region having the amino acid sequence SEQ ID NO:10.
5. The antibody of claim 1 , wherein the antibody comprises the light chain variable region having the amino acid sequence SEQ ID NO:17 and the heavy chain variable region having the amino acid sequence SEQ ID NO:18.
6. The antibody of claim 1 , wherein the antibody or the fragment thereof comprises:
a) a light chain complementarity determining region (CDR) 1 sequence comprising amino acid residues 43 to 58 of SEQ ID NO:3;
b) a light chain CDR2 sequence comprising amino acid residues 74 to 80 of SEQ ID NO:3;
c) a light chain CDR3 sequence comprising amino acid residues 113 to 121 of SEQ ID NO:3;
d) a heavy chain CDR1 sequence comprising amino acid residues 50 to 54 of SEQ ID NO:4;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 84 of SEQ ID NO:4; and
f) a heavy chain CDR3 sequence comprising amino acid residues 117 to 126 of SEQ ID NO:4.
7. The antibody of claim 1 , wherein the antibody or the fragment thereof comprises:
a) a light chain CDR1 sequence comprising amino acid residues 43 to 58 of SEQ ID NO:8;
b) a light chain CDR2 sequence comprising amino acid residues 74 to 80 of SEQ ID NO:8;
c) a light chain CDR3 sequence comprising amino acid residues 113 to 121 of SEQ ID NO:8;
d) a heavy chain CDR1 sequence comprising amino acid residues 49 to 54 of SEQ ID NO:10;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 84 of SEQ ID NO:10; and
f) a heavy chain CDR3 sequence comprising amino acid residues 120 to 130 of SEQ ID NO:10.
8. The antibody or claim 1 , wherein the antibody or the fragment thereof comprises:
a) a light chain CDR1 sequence comprising amino acid residues 46 to 56 of SEQ ID NO:9;
b) a light chain CDR2 sequence comprising amino acid residues 72 to 78 of SEQ ID NO:9;
c) a light chain CDR3 sequence comprising amino acid residues 111 to 119 of SEQ ID NO:9;
d) a heavy chain CDR1 sequence comprising amino acid residues 49 to 54 of SEQ ID NO:10;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 84 of SEQ ID NO:10; and
f) a heavy chain CDR3 sequence comprising amino acid residues 120 to 130 of SEQ ID NO:10.
9. The antibody or claim 1 , wherein the antibody or the fragment thereof comprises:
a) a light chain CDR1 sequence comprising amino acid residues 46 to 55 of SEQ ID NO:17;
b) a light chain CDR2 sequence comprising amino acid residues 71 to 77 of SEQ ID NO:17;
c) a light chain CDR3 sequence comprising amino acid residues 110 to 118 of SEQ ID NO:17;
d) a heavy chain CDR1 sequence comprising amino acid residues 50 to 54 of SEQ ID NO:18;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 85 of SEQ ID NO:18; and
f) a heavy chain CDR3 sequence comprising amino acid residues 118 to 128 of SEQ ID NO:18.
10. The antibody of claim 1 , wherein the antibody binding fragment is selected from the group of fragments consisting of Fv, F(ab′), F(ab′)2, scFv, minibody and diabody fragments.
11. The antibody of claim 1 , wherein the antibody is a monoclonal antibody.
12. An assay kit comprising the antibody of claim 1 .
13. An assay device comprising the antibody of claim 1 .
14. The assay device of claim 13 , wherein the device is a lateral flow assay device.
15. 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.
16. 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.
17. The method of claim 16 , wherein the quetiapine or competitive binding partner thereof is labeled with the detectable marker.
18. The method of claim 16 , wherein the antibody is labeled with a detectable marker.
19. The method of claim 16 , wherein the immunoassay is performed on a lateral flow assay device and the sample is applied to the device.
20. The method of claim 15 , further comprising detecting the presence of one or more analytes in addition to quetiapine.
21. The method of claim 20 , wherein the one or more analytes are anti-psychotic drugs other than quetiapine.
22. The method of claim 21 , wherein the anti-psychotic drugs other than quetiapine are selected from the group consisting of: risperidone, paliperidone, aripiprazole, olanzapine, and metabolites thereof.
23. The method of claim 16 , further comprising detecting the presence of one or more analytes in addition to quetiapine.
24. The method of claim 23 , wherein the one or more analytes are anti-psychotic drugs other than quetiapine.
25. The method of claim 24 , wherein the anti-psychotic drugs other than quetiapine are selected from the group consisting of: risperidone, paliperidone, aripiprazole, olanzapine, and metabolites thereof.