SYSTEMS, COMPOSITIONS AND METHODS OF DETERMINING VIABILITY OF EMBRYOS USING THE SAME
The present disclosure relates generally to compositions and methods of detecting viable embryos for implantation based upon detection and/or quantification of levels or concentrations of the preimplantation factor (PIF) in an embryo culture medium sample.
1 . A monoclonal antibody, or an antigen-binding fragment thereof, comprising a variable region comprising:
a) a complementarity-determining region (CDR) comprising at least about 70% sequence identity to one or a combination of: amino acid sequence of SEQ ID NO: 3, SEQ ID NO: 4 or SEQ ID NO: 5; or
b) a CDR comprising at least about 70% sequence identity to the amino acid sequence of SEQ ID NO: 8, SEQ ID NO: 9 or SEQ ID NO: 10.
2 . The monoclonal antibody of claim 1 , comprising:
a) a heavy chain variable region comprising a CDR comprising at least about 70% sequence identity to the amino acid sequence of SEQ ID NO: 3, SEQ ID NO: 4 or SEQ ID NO: 5; and
b) a light chain variable region comprising a CDR comprising at least about 70% sequence identity to the amino acid sequence of SEQ ID NO: 8, SEQ ID NO: 9 or SEQ ID NO: 10.
3 . The monoclonal antibody of claim 1 , comprising:
a1) a heavy chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 3 and a second CDR comprising the amino acid sequence of SEQ ID NO: 4;
a2) a heavy chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 3 and a second CDR comprising the amino acid sequence of SEQ ID NO: 5; or
a3) a heavy chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 4 and a second CDR comprising the amino acid sequence of SEQ ID NO: 5.
4 . The monoclonal antibody of claim 1 , comprising:
b1) a light chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 8 and a second CDR comprising the amino acid sequence of SEQ ID NO: 9;
b2) a light chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 8 and a second CDR comprising the amino acid sequence of SEQ ID NO: 10; or
b3) a light chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 9 and a second CDR comprising the amino acid sequence of SEQ ID NO: 10.
5 . The monoclonal antibody of claim 1 , comprising a heavy chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 3, a second CDR comprising the amino acid sequence of SEQ ID NO: 4, and a third CDR comprising the amino acid sequence of SEQ ID NO: 5.
6 . The monoclonal antibody of claim 1 , comprising a light chain variable region comprising a first CDR comprising the amino acid sequence of SEQ ID NO: 8, a second CDR comprising the amino acid sequence of SEQ ID NO: 9, and a third CDR comprising the amino acid sequence of SEQ ID NO: 10.
7 . The monoclonal antibody of claim 1 , comprising a heavy chain variable region comprising at least about 70% sequence identity to SEQ ID NO: 2.
8 . The monoclonal antibody of claim 1 , comprising a light chain variable region comprising at least about 70% sequence identity to SEQ ID NO: 7.
9 . The monoclonal antibody of claim 1 , comprising a heavy chain variable region comprising at least about 90% sequence identity to SEQ ID NO: 2, and a light chain variable region comprising at least about 90% sequence identity to SEQ ID NO: 7.
10 . The monoclonal antibody of claim 1 , comprising a heavy chain variable region comprising SEQ ID NO: 2, and a light chain variable region comprising SEQ ID NO: 7.
11 . The monoclonal antibody of claim 1 , further comprising a heavy chain constant region and a light chain constant region.
12 . (canceled)
13 . The monoclonal antibody of claim 1 , wherein the monoclonal antibody is a rabbit monoclonal antibody, wherein the monoclonal antibody is capable of binding to a preimplantation factor (PIF), or an immunogenic fragment or epitope thereof, and wherein the monoclonal antibody is specific to the PIF comprising the amino acid sequence of SEQ ID NO: 11.
14 . (canceled)
15 . (canceled)
16 . A system comprising:
a) one or a plurality of monoclonal antibodies of claim 1 ;
b) a solid support onto which the one or plurality of monoclonal antibodies are immobilized; and
c) at least one substrate.
17 . The system of claim 16 , further comprising a fluorimeter or spectrophotometer.
18 . The system of claim 16 , wherein the at least one substrate is capable of binding to the one or plurality of monoclonal antibodies; wherein the at least one substrate is fluorogenic, fluorescent, or chemiluminescent fluorescently labeled; and wherein the at least one substrate is a preimplantation factor (PIF), or an immunogenic fragment or epitope thereof.
19 - 76 . (canceled)