Downward or vertical flow diagnostic device and assay

Inventors

Chan, Hermes K. W. • Chan, King Sing • Vats, Neeraj

Assignees

Medmira Inc

Abstract

A downward or vertical flow-through rapid diagnostic device and assay are provided. The device comprises a test area and reagent storage area, which are linked via a channel. The test area further comprises a reaction zone and an absorbent zone. A capture reagent is immobilized on the reaction zone to detect a target analyte in the fluid test sample. The fluid test sample flows downward or vertically through the reaction zone and into the absorbent zone, with the capture reagent and target analyte forming a two-membered complex that is concentrated in the reaction zone. The reagent storage area comprises a breakable cartridge positioned directly and vertically above the test area and a channel. A reagent used in the assay is housed in the breakable cartridge. Once liberated, the reagent passes through the channel and flows to test area for depositing on the reaction zone. The storage of predetermined amounts of reagents in the diagnostic device reduces the number of manual operations required to produce a result.

Core Innovation

A downward or vertical flow through test device determines the presence or absence of at least one target analyte in a fluid test sample. The test device includes a test area with a reaction zone to which the fluid test sample is applied so that the fluid test sample flows downwardly or vertically through the reaction zone, and the reaction zone comprises at least one immobilized capture reagent that binds at least one target analyte in the deposited fluid test sample.

The reaction zone is in vertical communication with an absorbent zone including an absorbent material positioned underneath the reaction zone to facilitate the downward or vertical flow of the fluid test sample through the reaction zone and into the absorbent zone. The device further includes a reagent storage area with at least one breakable cartridge housing a liquid reagent positioned directly and vertically above at least a portion of the test area, and a channel connecting the breakable cartridge to the test area.

Liberating the liquid reagent from the breakable cartridge causes the reagent to flow vertically or downwardly through the channel onto the test area. A matrix is positioned between the breakable cartridge and the test area, and the matrix has dried indicator reagent embedded therein such that the liberated liquid reagent flows through the matrix to reconstitute the indicator reagent. The device also includes liquid permeable members to prevent cartridge solids entering the channel and to manage flow rate, with optional barriers, vents, flexible membranes, and multiple reagent storage cartridges.

Claims Coverage

Two independent claims define the core structure and operation of a downward or vertical flow-through test device, with three inventive features identified across the claims. The claims combine vertical sample flow through a reaction zone and absorbent zone with breakable-cartridge reagent delivery and matrix-based indicator reconstitution, and one claim further adds a liquid permeable member to block cartridge solids from entering the channel.

The claims require a downward or vertical flow test device with a reaction zone containing an immobilized capture reagent and an underlying absorbent zone, together with breakable-cartridge reagent delivery through a channel to a matrix with dried indicator reagent for reconstitution. One independent claim further requires a liquid permeable member that prevents solid cartridge material from entering the channel.

Stated Advantages

Documented Applications