US 11,988,671 B2
Assays for detecting SARS-CoV-2
Lawrence B. Blyn, Abbott Park, IL (US); Mijung Ji, Seoul (KR); Stephen Kovacs, Abbott Park, IL (US); Anthony S. Muerhoff, Abbott Park, IL (US); Stacey P. Huth, Scarborough, ME (US); Carsten Buenning, Gross-Rohrheim (DE); Tao Xin, Carlsbad, CA (US); Donabel Roberts, Carlsbad, CA (US); Sung Hee Kim, Gyeonggi-do (KR); Sang Yong Park, Gyeonggi-do (KR); and Robert N. Ziemann, Abbott Park, IL (US)
Assigned to Abbott Rapid Diagnostics International Unlimited Company, Dublin (IE)
Filed by Abbott Rapid Diagnostics International Unlimited Company, Dublin (IE)
Filed on Aug. 4, 2021, as Appl. No. 17/394,058.
Claims priority of provisional application 63/126,336, filed on Dec. 16, 2020.
Claims priority of provisional application 63/067,051, filed on Aug. 18, 2020.
Claims priority of provisional application 63/065,898, filed on Aug. 14, 2020.
Claims priority of provisional application 63/060,975, filed on Aug. 4, 2020.
Prior Publication US 2022/0043003 A1, Feb. 10, 2022
Int. Cl. G01N 33/68 (2006.01); G01N 33/543 (2006.01)
CPC G01N 33/6857 (2013.01) [G01N 33/54388 (2021.08); G01N 33/6893 (2013.01)] 15 Claims
 
1. A method of detecting SARS-CoV-2 virus in a sample obtained from a subject, wherein the method is an immunoassay, comprising:
contacting a sample obtained from a subject with a first antibody or antigen-binding fragment thereof which specifically binds to the nucleocapsid (N) protein from the SARS-CoV-2 virus, or a fragment thereof, under conditions which allow binding of the N protein from the SARS-CoV-2 virus, or a fragment thereof, if present in the sample, to the first antibody or antigen-binding fragment thereof, wherein the first antibody or antigen-binding fragment thereof comprises:
(i) a heavy chain variable region comprising a complementarity determining region 1 (CDR) amino acid sequence of SEQ ID NO: 1, a CDR2 amino acid sequence of SEQ ID NO: 2, and a CDR3 amino acid sequence of SEQ ID NO: 3,
(ii) a light chain variable region comprising a CDR1 amino acid sequence of SEQ ID NO: 4, a CDR2 amino acid sequence of SEQ ID NO: 5, and a CDR3 amino acid sequence of SEQ ID NO: 6;
contacting the sample with a conjugate comprising a second antibody which specifically binds to N protein from the SARS-CoV-2 virus, or a fragment thereof, and a detectable label wherein the second antibody or antigen-binding fragment thereof binds to a different epitope than the first antibody, or antigen-binding fragment thereof, and comprises:
(i) a heavy chain variable region comprising a complementarity determining region 1 (CDR) amino acid sequence of SEQ ID NO: 9, a CDR2 amino acid sequence of SEQ ID NO: 10, and a CDR3 amino acid sequence of SEQ ID NO: 11,
(ii) a light chain variable region comprising a CDR1 amino acid sequence of SEQ ID NO: 12, a CDR2 amino acid sequence of SEQ ID NO: 13, and a CDR3 amino acid sequence of SEQ ID NO: 14; and
assessing the presence of a signal from the detectable label, wherein the presence of a signal from the detectable label indicates the presence of the N protein from the SARS-CoV-2 virus, or a fragment thereof in the sample.