High-sensitivity Assay for Serum Neurofilament Light Chain
AssigneeSiemens Healthcare Diagnostics Inc.
InventorsEddine Merabet, James Freeman, Sarmistha Ray, Arejas James Uzgiris
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Abstract
The present disclosure provides methods and kits for identifying and treating individuals at risk of or suffering from disease such as a neurological condition or disease. In general, detection or measurement of one or more biomarkers, such as neurofilament light chain (NfL), and combinations thereof with assays of the present disclosure, assists in the identification of disease such as neurological disease. The present disclosure also provides methods for selecting patients for treatment of neurological disease.
Claims20
A method for the detection or quantification of an analyte in a sample (e.g., a biological sample such as blood, saliva, serum, a sample derived from a biological sample such as a diluted biological sample) comprising:
- (a) mixing the sample with a composition comprising a chemiluminescent label conjugated to a first antibody or antibody fragment that binds to the analyte, wherein the chemiluminescent label is bound to a carrier protein comprising a linker, and the linker is bound to the antibody or antibody fragment;
- (b) adding, to the mixture, a particle having a second antibody or antibody fragment that binds to the analyte attached to the surface of the particle;
- (c) preparing the mixture to measure chemiluminescence (e.g., by separation of the particle having chemiluminescent acridiniums conjugated to the surface);
- (d) triggering chemiluminescence from the preparation;
- and
- (e) detecting the presence or calculating the concentration of said at least one analyte by comparing the amount of chemiluminescence with a standard dose response curve which relates the amount of light emitted to a known concentration of the at least one of the multiple analytes.
An immunoassay composition comprising a chemiluminescent label conjugated to a first antibody fragment that binds to nerofilament, wherein the chemiluminescent label is bound to a carrier protein comprising a polyethylene glycol linker (e.g., PEG2-PEG15 such as PEG4), and the linker is bound to the antibody fragment;
- and
- a carrier or excipient.
A solid particle coated with streptavidin conjugated to biotinylated mouse anti neurofilament antibody optionally through a linker (e.g., PEG, Iodo-PEG), wherein the anti neurofilament antibody is bound neurofilament, and
- the bound neurofilament is further bound to a monoclonal mouse antibody fragment linked to a carrier protein conjugated to one or more chemiluminescent acridiniums.
Dependencies are inferred from the claim text.