Patent ID: 9575076
Date: 2017-02-21
CPC Classifications: B01L,C07K,G01N

Claim:
1. A method of performing a single-wash step sandwich immunoassay for detecting thyroid stimulating hormone (TSH) comprising: a) contacting a whole-blood sample with at least one signal antibody and at least one capture antibody to form a sandwich complex, wherein the at least one capture antibody is immobilized on an immunosensor; (b) washing the whole-blood sample and uncomplexed signal antibody from the immunosensor with a wash fluid in no more than one washing step, wherein the wash fluid comprises a substrate; and (c) detecting an electrochemical signal on the immunosensor generated from a reaction of the sandwich complex with the substrate as indicative of a level of the TSH in the whole-blood sample, wherein a dissociation constant (Kd) of the at least one signal antibody and the at least one capture antibody for TSH is between 0.08 and 0.1 nM, wherein a Kd of the at least one capture antibody for follicle stimulating hormone (FSH), luteinizing hormone (LH) and chorionic gonadotropin (CG) is substantially 1000 nM, 1000 nM, and 500 nM, respectively, and wherein the at least one capture antibody is mouse monoclonal anti-TSH antibody 5409 and the at least one signal antibody is mouse monoclonal anti-TSH antibody M94206.