CPC C07K 16/1289 (2013.01) [G01N 33/5302 (2013.01); G01N 33/54388 (2021.08); G01N 33/5695 (2013.01); A61K 2039/505 (2013.01); C07K 2317/56 (2013.01); C07K 2317/565 (2013.01)] | 19 Claims |
1. An assay device for selectively detecting Mycobacterium tuberculosis (Mtb) bacteria or Mtb arabinomannan (AM) in a biological sample, wherein the assay device is a lateral flow assay device or an Enzyme Linked Immunosorbent Assay (ELISA), the assay device comprising:
(a) a first portion comprising a first plurality of anti-Mtb AM antibodies, or Mtb AM-binding fragments thereof, wherein each anti-Mtb AM antibody, or Mtb AM-binding fragment thereof, comprises a heavy chain variable region and a light chain variable region, wherein each of the heavy chain and the light chain variable regions comprises a CDR1, CDR2, and CDR3; and wherein:
(i) the sequence of CDR1 of the heavy chain comprises SEQ ID NO: 1; the sequence of CDR2 of the heavy chain comprises SEQ ID NO:2; the sequence of CDR3 of the heavy chain comprises SEQ ID NO:3; the sequence of CDR1 of the light chain comprises SEQ ID NO:4; the sequence of CDR2 of the light chain comprises SEQ ID NO:5; and the sequence of CDR3 of the light chain comprises SEQ ID NO:6; or
(ii) the sequence of CDR1 of the heavy chain comprises SEQ ID NO: 1; the sequence of CDR2 of the heavy chain comprises SEQ ID NO:2; the sequence of CDR3 of the heavy chain comprises SEQ ID NO:45; the sequence of CDR1 of the light chain comprises SEQ ID NO:4; the sequence of CDR2 of the light chain comprises SEQ ID NO:5; and the sequence of CDR3 of the light chain comprises SEQ ID NO:6,
wherein the anti-Mtb antibodies, or Mtb AM-binding fragments thereof, are each attached to their own reporting entity; and
(b) a second portion comprising a second plurality of anti-Mtb AM antibodies, or Mtb AM-binding fragments thereof.
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