Device and method for detection of analytes

Inventors

BOONE, JAMES H. • Lyerly, David M. • Wilkins, Tracy D.

Assignees

Techlab Inc

Abstract

The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.

Core Innovation

The invention provides assays and devices for detecting the presence or amount of a substance of interest in a liquid sample. The devices include a sample receiving zone present on a porous material, and an integral sample filtering zone also present on the porous material, so the liquid sample is received and filtered before reaching a detection zone associated with a porous membrane bearing a specific binding pair member.

A porous membrane is provided as a separate element from the porous material, and the porous material and the porous membrane are placed in physical contact over at least an area comprising a portion of the detection zone. This configuration permits liquid present in the liquid sample to diffuse in, out, through, and about the porous membrane in a substantially random, non-directional manner in an area comprising at least a portion of the detection zone.

The detection zone includes the porous membrane carrying a specific binding pair member that specifically binds to the substance of interest or to a substance bound to the substance of interest. Binding complexes formed at the detection zone can be detected directly or indirectly using labeled binding complexes, including labels such as enzymes, fluorescent compounds, and colloidal gold.

The described approach is directed toward fast and sensitive detection that can be used with complex samples, including samples that may clog or are difficult to assay using conventional approaches. The document also provides examples, including detection of C. difficile toxins A and B and use of glutamate dehydrogenase, with comparisons to tissue culture assay and ELISA.

Claims Coverage

The partial content provides one independent claim and dependent claims that refine the device by adding structural components and narrowing the nature of the specific binding pair member. Across these claims, the coverage focuses on an integral porous sample receiving and filtering structure combined with a separate porous membrane in physical contact to enable substantially random, non-directional diffusion to a detection zone.

Overall, the independent claim covers a detection device that combines an integral porous sample receiving and filtering structure with a separate porous membrane carrying a specific binding pair member, where physical contact and substantially random, non-directional diffusion govern access to the detection zone. Dependent claims add a container and a wash-solution receiving zone and narrow the binding member to biological binding pairs, including proteins such as antibodies and other enumerated biological components.

Stated Advantages

Documented Applications