Assay device, system, method, and kit

Inventors

Rai, Balwant • McAllister, Jeffery Floyd • Smith, Peter Andrew • ZIGNEGO, Jay Colton • O'Donnell, Michael Eugene • Kristal, Leonard • Kwok, Matthew Hon Ming • Kwok, Mark Kin Ming

Assignees

BASELINE BIOSCIENCE, INC.

Abstract

Assay devices, systems, methods, and kits useful for detection of analytes in a bodily fluid sample, such as saliva, are disclosed herein. Assay devices may include a fluid sample collector and an assessment unit to which the fluid sample collector couples. The fluid sample collector may include a cap with a plunger and absorbent member that collects a bodily fluid sample. Insertion of the plunger into the assessment unit during coupling provides pressure-driven fluid flow through a filter rapidly delivering bodily fluid filtrate to one or more test panels which provide the assay result. In embodiments, an on-board light source enables a user to readily detect changes in a test panel indicative of the presence of an analyte thus providing an opportunity for obtaining rapid results with improved confidence.

Core Innovation

The invention relates to an assay device for detection of an analyte in a bodily fluid sample at point-of-care. A fluid sample collector includes a cap, a plunger carried by the cap with a distal end, and an absorbent member supported toward the distal end of the plunger. The collector couples to an assessment unit to process bodily fluid sample into filtrate for subsequent detection.

The assessment unit includes a sample-receiving chamber with a fluid outlet and an opening through which the plunger and absorbent member are received. The plunger and the at least one sidewall are closely sized such that pressure increases within the sample-receiving chamber as the plunger is advanced toward the outlet. A fluid filter across the outlet drives positive-displacement filtration into a well in fluid communication with the outlet, where filtrate is delivered to one or more test panels providing an indication when contacted by an analyte.

The device further includes helical threads on the cap and the assessment unit that removably couple the cap to the assessment unit and convert rotational force to linear force, advancing the plunger axially within the sample-receiving chamber as the cap is rotated. This axial advancement is controlled by the pitch of the threads to create a differential pressure across the filter, thereby driving fluid sample through the filter and into the well. A window allows viewing of the indication, and the device includes an onboard UV/fluorescence light source activated during coupling to enable viewing of indications earlier or at trace analyte/cutoff levels.

Claims Coverage

The independent claim covers an assay device that combines a bodily-fluid collector and an assessment unit that pressurizes a sample-receiving chamber to drive differential-pressure filtration through a fluid filter into a well, then delivers filtrate to lateral-flow style test panels with viewable indications through a window. The claim includes multiple inventive features.

Overall, the independent claim centers on coupling a cap-plunger absorbent collector to an assessment unit that pressurizes a closely sized sample-receiving chamber, then uses thread-converted rotational-to-axial advancement to create differential pressure across a fluid filter and deliver filtrate to test panels whose indications are viewed through a window.

Stated Advantages

Documented Applications

No documented applications found