Method of diagnosis and kit therefor
Inventors
Anderson, David Andrew • Howard, Teresa Sylvia • Healy, Anne • Anders, Katherine • Garcia, Mary Louise
Assignees
Hepgenics Pty Ltd • Burnet Institute • NANJING BIOPOINT DIAGNOSTIC TECHNOLOGY Co Ltd
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Publication Number
US-7785773-B1
Publication Date
2010-08-31
Expiration Date
Abstract
This invention is directed to diagnostic methods detecting the presence of an antibody to a virus in a sample from a subject and kits for using the methods.
Core Innovation
The invention provides a kit for diagnosing or monitoring an infection with a virus by detecting the presence of an IgM antibody to the virus in a test sample from a subject. The kit includes an immunographic device comprising a porous membrane operably connected to a sample portion and a test portion that includes an IgM antibody binding agent, and the device can optionally include a control portion.
The immunographic device further comprises a sucker portion, a virus portion and a conjugate portion. The kit also includes instructions for using the immunographic device to detect the presence of the antibody to the virus in the test sample. In embodiments, the immunographic device is implemented in reverse-flow immunochromatography or lateral flow immunochromatography formats.
The disclosed embodiments include an IgM antibody binding agent that binds substantially only target IgM on an antibody-binding agent, and a detection-marker–viral particle complex that binds epitopes on the viral particles. The complex is then captured by immobilized captured antibody to provide a visual test/control readout on the device, with visually detectable reporters such as colloidal gold and other detection marker options.
Claims Coverage
The independent claim is clm-00001. It requires a diagnostic/monitoring kit for virus infection based on detecting an IgM antibody to the virus in a subject test sample, using an immunographic device with defined portions including an IgM antibody binding agent and optionally a control portion.
Kit for diagnosing or monitoring viral infection by detecting IgM antibody
A kit for diagnosing or monitoring an infection with a virus by detecting the presence of an IgM antibody to the virus in a test sample from a subject.
Immunographic device with porous membrane and IgM antibody binding agent
An immunographic device comprising a porous membrane operably connected to a sample portion and a test portion comprising an IgM antibody binding agent, optionally including a control portion.
Immunographic device portions including sucker, virus, and conjugate portions
The immunographic device further comprising a sucker portion, a virus portion and a conjugate portion.
Instructions for detecting the IgM antibody in the test sample
Instructions for using the immunographic device to detect the presence of the antibody to the virus in the test sample.
Overall, the independent claim centers on a virus IgM antibody diagnostic/monitoring kit using a porous-membrane immunographic device with an IgM antibody binding agent and specific device portions, together with instructions for detecting IgM antibody in a subject sample.
Stated Advantages
Provides a rapid detection/monitoring approach using an immunographic device with visual readout.
Includes detection marker options using visually detectable reporter molecules (e.g., colloidal gold).
Improved binding of macromolecules to solid substrates using the adhesive peptide (reported as an approximately 5-fold increase).
Documented Applications
Diagnosing or monitoring an infection with a virus by detecting IgM antibody in a test sample from a subject.
Rapid testing for hepatitis A virus (HAV) IgM using a disclosed HAV IgM rapid test format.
Applying the kit for infections with hepatitis viruses including HAV, HBV, HCV, HDV, and HEV (as viral particles).
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