公开(公告)号：US20180088111A1

公开(公告)日：2018-03-29

申请号：US15565525

申请日：2016-04-12

Applicant: BRISTOL-MYERS SQUIBB COMPANY

Inventor： Yan G. Ni ,  Xiling Yuan ,  Steven P. Piccoli

IPC: G01N33/566 ,  G01N33/74

CPC classification number: G01N33/566 ,  G01N33/74

Abstract: This disclosure provides a method for quantifying total soluble Programmed Death-1 (sPD-1) in a sample solution comprising the steps of performing a “sandwich” immunoassay on the sample solution and a series of reference solutions containing known quantities of sPD-1, wherein the immunoassay is performed using (a) a sPD-1 reference antigen in monomeric form; (b) a capture antibody that is capable of binding to sPD-1 in both monomeric and dimeric forms, which binding is essentially unaffected by the presence of the PD-1 ligands, PDL-1, PDL-2, and/or a therapeutic anti-PD-1 antibody; and (c) an electrochemiluminescent-labeled detection antibody that is capable of binding to sPD-1 in both monomeric and dimeric forms, which binding is to a different epitope on sPD-1 than the epitope bound by the capture Ab and is essentially unaffected by the presence of PDL-1, PDL-2 and/or a therapeutic anti-PD-1 Ab.