Quantitative antibody test

Inventors

Ball, Andrew • Chang, Lei • Fernandes, Syrena • Johnson, Joe • Lambert, Jeremy • Mattoon, Dawn • Plavina, Tatiana • Wilson, David

Assignees

Quanterix Corp

Abstract

The present disclosure relates to methods and compositions, e.g., kits, for quantitatively detecting an antibody of a subject to an infectious organism. In some embodiments, the present disclosure provides for methods and compositions, e.g., kits, for quantitatively detecting a human antibody to SARS-CoV-2 polypeptide or S (spike) polypeptide. Certain applications and uses of the present methods and compositions, e.g., kits, are also provided.

Core Innovation

The invention relates to a method for quantitatively detecting an antibody of a human to severe acute respiratory syndrome coronavirus 2 by contacting a sample from a human with a SARS-CoV-2 S (spike) polypeptide, or a fragment thereof, to allow binding between the antibody and the SARS-CoV-2 S polypeptide, or fragment. A detectable signal due to binding is assessed, and the method quantifies the antibody amount, concentration, or level by signal comparison rather than qualitative presence/absence.

A calibration data set is generated using a calibrator antibody that specifically binds to the SARS-CoV-2 S polypeptide, or fragment, at multiple concentrations or levels. The method compares the assessed detectable signal to the calibration data set to assess amount, concentration or level of the antibody in the sample. The calibrator antibody is a chimeric antibody, or fragment thereof, comprising a human constant region and a variable region component, or a variable region of a non-human species.

The calibration data set is generated using the calibrator antibody at concentrations or levels ranging from about 0.001 ng/mL to about 10,000 ng/mL. The claim set further constrains the quantitative workflow by defining the binding/label format as involving complex formation and labeled-binder detection, and by specifying that SARS-CoV-2 S polypeptide fragments can include an amino acid sequence specified as SEQ ID NO:1. The assay supports quantitative operation using microtiter plate formats or microwells.

Claims Coverage

One independent claim is provided. The inventive features collectively cover quantitative antibody detection against SARS-CoV-2 S (spike) using a detectable signal that is calibrated against a specifically binding chimeric calibrator antibody prepared to generate a calibration data set at multiple concentrations.

The claim coverage is centered on a quantitative antibody assay for SARS-CoV-2 using SARS-CoV-2 S (spike) binding, detectable signal assessment, and quantitation by comparing the signal to a calibration data set generated with a specifically binding chimeric calibrator antibody across defined concentration levels.

Stated Advantages

Documented Applications

No documented applications found