Antibodies to olanzapine and use thereof
Disclosed is an antibody which binds to olanzapine, which can be used to detect olanzapine 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 olanzapine, including multiplex detection of aripiprazole, olanzapine, quetiapine, and risperidone in a single lateral flow assay device.
1. An isolated antibody or a binding fragment thereof, which binds to olanzapine, comprising:
a) a light chain variable region consisting of SEQ ID NO:11 and a heavy chain variable region consisting of SEQ ID NO:12;
b) a light chain variable region consisting of SEQ ID NO:15 and a heavy chain variable region consisting of SEQ ID NO:16.;
c) a light chain variable region consisting of SEQ ID NO:31 and a heavy chain variable region consisting of SEQ ID NO:32;
d) a light chain variable region consisting of SEQ ID NO:35 and a heavy chain variable region consisting of SEQ ID NO:36; or
e) a light chain variable region consisting of SEQ ID NO:39 and a heavy chain variable region consisting of SEQ ID NO:40.
2. The isolated antibody of claim 1 , comprising the light chain variable region consisting of SEQ ID NO:11 and the heavy chain variable region consisting of SEQ ID NO:12.
3. The isolated antibody of claim 1 , comprising the light chain variable region consisting of SEQ ID NO:15 and the heavy chain variable region consisting of SEQ ID NO:16.
4. The isolated antibody of claim 1 , comprising the light chain variable region consisting of SEQ ID NO:31 and the heavy chain variable region consisting of SEQ ID NO:32.
5. The isolated antibody of claim 1 , comprising the light chain variable region consisting of SEQ ID NO:35 and the heavy chain variable region consisting of SEQ ID NO:36.
6. The isolated antibody of claim 1 , comprising the light chain variable region consisting of SEQ ID NO:39 and the heavy chain variable region consisting of SEQ ID NO:40.
7. The isolated antibody of claim 1 , comprising:
a) a light chain CDR1 sequence comprising amino acid residues 44 to 54 of SEQ ID NO:11;
b) a light chain CDR2 sequence comprising amino acid residues 70 to 76 of SEQ ID NO:11;
c) a light chain CDR3 sequence comprising amino acid residues 109 to 117 of SEQ ID NO:11;
d) a heavy chain CDR1 sequence comprising amino acid residues 45 to 54 of SEQ ID NO:12;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 85 of SEQ ID NO:12; and f) a heavy chain CDR3 sequence comprising amino acid residues 118 to 122 of SEQ ID NO:12.
8. The isolated antibody of claim 1 , comprising:
a) a light chain CDR1 sequence comprising amino acid residues 44 to 54 of SEQ ID NO:15;
b) a light chain CDR2 sequence comprising amino acid residues 70 to 76 of SEQ ID NO:15;
c) a light chain CDR3 sequence comprising amino acid residues 109 to 117 of SEQ ID NO:15;
d) a heavy chain CDR1 sequence comprising amino acid residues 45 to 54 of SEQ ID NO:16;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 85 of SEQ ID NO:16; and
f) a heavy chain CDR3 sequence comprising amino acid residues 118 to 122 of SEQ ID NO:16.
9. The isolated antibody of claim 1 , comprising:
a) a light chain CDR1 sequence comprising amino acid residues 44 to 54 of SEQ ID NO:31;
b) a light chain CDR2 sequence comprising amino acid residues 70 to 76 of SEQ ID NO:31;
c) a light chain CDR3 sequence comprising amino acid residues 109 to 117 of SEQ ID NO:31;
d) a heavy chain CDR1 sequence comprising amino acid residues 44 to 54 of SEQ ID NO:32;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 84 of SEQ ID NO:32; and
f) a heavy chain CDR3 sequence comprising amino acid residues 119 to 127 of SEQ ID NO:32.
10. The antibody of claim 1 , comprising:
a) a light chain CDR1 sequence comprising amino acid residues 44 to 54 of SEQ ID
NO:35;
b) a light chain CDR2 sequence comprising amino acid residues 70 to 76 of SEQ ID NO:35;
c) a light chain CDR3 sequence comprising amino acid residues 109 to 117 of SEQ ID NO:35;
d) a heavy chain CDR1 sequence comprising amino acid residues 45 to 54 of SEQ ID NO:36;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 87 of SEQ ID NO:36; and
f) a heavy chain CDR3 sequence comprising amino acid residues 120 to 127 of SEQ ID NO:36.
11. The isolated antibody of claim 1 , comprising:
a) a light chain CDR1 sequence comprising amino acid residues 44 to 54 of SEQ ID
NO:39;
b) a light chain CDR2 sequence comprising amino acid residues 70 to 76 of SEQ ID NO:39;
c) a light chain CDR3 sequence comprising amino acid residues 109 to 117 of SEQ ID NO:39;
d) a heavy chain CDR1 sequence comprising amino acid residues 44 to 54 of SEQ ID NO:40;
e) a heavy chain CDR2 sequence comprising amino acid residues 69 to 84 of SEQ ID NO:40; and
f) a heavy chain CDR3 sequence comprising amino acid residues 120 to 127 of SEQ ID NO:40.
12. The isolated 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.
13. The antibody of claim 1 , wherein the antibody is a monoclonal antibody.
14. An assay kit comprising the antibody of claim 1 .
15. An assay device comprising a lateral flow assay device and the antibody of claim 1 , wherein the antibody is disposed on the lateral flow assay device.
16. The assay device of claim 15 , wherein the assay device is a porous lateral flow assay device.
17. The assay device of claim 15 , wherein the assay device is a non-porous lateral flow assay device.
18. A method of detecting olanzapine in a sample, the method comprising:
(i) contacting the sample with the antibody of claim 1 labeled with a detectable marker, wherein the labeled antibody and olanzapine present in the sample form a labeled complex; and
(ii) detecting the labeled complex, thereby detecting olanzapine in the sample.
19. A competitive immunoassay method for detecting olanzapine in a sample, the method comprising:
(i) contacting the sample with the antibody of claim 1 , and with olanzapine or a competitive binding partner of olanzapine, wherein one of the antibody and the olanzapine or competitive binding partner thereof is labeled with a detectable marker, wherein sample olanzapine competes with the olanzapine for binding to the antibody to form a complex;
(ii) detecting the amount of the detectable marker bound to the complex; and
(iii) determining the amount of sample olanzapine based on the amount of bound detectable marker.
20. The method of claim 18 or 19 , further comprising detecting the presence of one or more analytes in addition to olanzapine.
21. The method of claim 20 , wherein the one or more analytes are anti-psychotic drugs other than olanzapine.
22. The method of claim 21 , wherein the anti-psychotic drugs other than olanzapine are selected from the group consisting of: risperidone, paliperidone, quetiapine, aripiprazole, and metabolites thereof.
23. The method of claim 19 , wherein the olanzapine or competitive binding partner thereof is labeled with the detectable marker.
24. The method of claim 19 , wherein the antibody is labeled with a detectable marker.
25. The method of claim 16 , wherein the immunoassay is performed on a lateral flow assay device and the sample is applied to the device.