Patent ID: 11891439
Assignee: ASTUTE MEDICAL, INC.
Field: Measurement (Instruments)
Classification: CPC C  G | IPC C  G

Claim 7:
8. The kit of claim 6, wherein
(a) the first monoclonal antibody or antigen binding fragment thereof is immobilized to a surface within the disposable test device, and the second monoclonal antibody or antigen binding fragment thereof is conjugated to a detectable label;
(b) the first monoclonal antibody or antigen binding fragment thereof is immobilized to a surface within the disposable test device, and the second monoclonal antibody or antigen binding fragment thereof is conjugated to a detectable label and is provided in a separate container from the disposable test device;
(c) the kit is configured to perform an assay method which provides a signal related to the presence or amount of human CCL14 in a biological sample, and wherein the minimum detectable concentration of CCL14 in the assay method is 10 ng/mL or less;
(d) one or both of the first or second monoclonal antibodies or antigen binding fragment thereof is an F(ab) or F(ab′)2 fragment;
(e) one or both of the first or second monoclonal antibodies or antigen binding fragment thereof is a rabbit antibody or an antigen binding fragment thereof; or
the first and second monoclonal antibodies or antigen binding fragments thereof in the kit are a pair selected from the group consisting of a 10H3/10K1-2H3/2K1 pair, and a 10H3/10K1-31H1/31K1 pair, or in each case a corresponding antigen binding fragment thereof,
wherein 2H3/2K1 comprises three CDRs of a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 1, and three CDRs of a light chain variable region comprising the amino acid sequence of SEQ ID NO: 2, and
wherein 31H1/31K1 comprises three CDRs of a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 19, and three C s of a light chain variable region comprising the amino acid sequence of SEQ ID NO: 20.