US 11,686,730 B2
Quantitative antibody test
Andrew Ball, Billerica, MA (US); Lei Chang, Billerica, MA (US); Syrena Fernandes, Billerica, MA (US); Joe Johnson, Billerica, MA (US); Jeremy Lambert, Billerica, MA (US); Dawn Mattoon, Billerica, MA (US); Tatiana Plavina, Billerica, MA (US); and David Wilson, Billerica, MA (US)
Assigned to Quanterix Corporation, Billerica, MA (US)
Filed by Quanterix Corporation, Billerica, MA (US)
Filed on Apr. 28, 2021, as Appl. No. 17/243,502.
Claims priority of provisional application 63/053,364, filed on Jul. 17, 2020.
Claims priority of provisional application 63/018,465, filed on Apr. 30, 2020.
Prior Publication US 2021/0341479 A1, Nov. 4, 2021
Int. Cl. G01N 33/569 (2006.01); G01N 33/567 (2006.01)
CPC G01N 33/56983 (2013.01) [G01N 2333/165 (2013.01); G01N 2469/20 (2013.01)] 21 Claims
 
1. A method for quantitatively detecting an antibody of a human to severe acute respiratory syndrome coronavirus 2 (BARS-Coir-2), which method comprises:
a) contacting a sample from a human with SARS-CoV-2 S (spike) polypeptide, or a fragment thereof, to allow binding between an antibody to said SARS-CoV-2 S polypeptide, or a fragment thereof, if present in said sample, and said SARS-CoV-2 S polypeptide, or a fragment thereof;
b) assessing a detectable signal due to binding between said antibody and said SARS-CoV-2 S polypeptide, or a fragment thereof; and
c) comparing said detectable signal to a calibration data set generated using a calibrator antibody that specifically binds to said SARS-CoV-2 S polypeptide, or a fragment thereof, at multiple concentrations or levels to assess amount, concentration or level of said antibody in said sample, and
wherein said calibrator antibody is a chimeric antibody, or a fragment thereof, that comprises a human constant region and a variable region component or a variable region of a non-human species, and
wherein said calibration data set is generated using said calibrator antibody, or a fragment thereof, at concentrations or levels ranging from about 0.001 ng/mL to about 10,000 ng/mL.