Cardiac biomarker assay cartridge or card

Inventors

Brenk, Victor Reed • Klein, Todd Michael • Wang, Wei

Assignees

Zepto Life Technology Inc

Abstract

An assay cartridge for mixing a test sample and reagent for diagnostic purposes, and method of using the same. The assay cartridge includes a housing, an injection port for receiving the test sample (whole blood), a filtration membrane for separating plasma from the sample, a section for receipt of reagent, and one or more sets of valves provided in the housing. Each valve is configured for movement between an open position and a closed position. Metering chambers are provided in the housing for receiving separated plasma and the reagent therein. A port is fluidly connected to each metering chamber and uses to draw air from or deliver pressurized fluid into the housing. Mixing channels are provided in the housing and selectively connected to the metering chambers for mixing the separated plasma and reagent into a substantially homogeneous mixture. The homogeneous mixture is delivered out of the housing through output ports.

Core Innovation

The invention provides an assay cartridge for mixing a test sample and reagent for diagnostic purposes. The cartridge includes a housing with an injection port for receiving the test sample and a filtration membrane positioned between the top surface and the bottom surface of the housing to filter the test sample after injection, producing a filtered test sample received in a receiving area within the housing.

The cartridge further includes a reagent injection section, a sample delivery channel extending between the receiving area and a first set of valves, and a reagent delivery channel extending between the reagent injection section and the first set of valves. At least one metering chamber receives the filtered test sample and reagent via connections to the sample delivery channel and the reagent delivery channel, and the metering chamber extends a length along the longitudinal direction of the housing. At least one pump port is fluidly connected to the metering chamber via a communication channel and is configured to selectively draw and deliver pressurized fluid into the housing when connected to a pump.

A gas permeable membrane is provided in the housing relatively below both the top surface of the housing and the metering chamber. The gas permeable membrane is configured to receive and deliver atmospheric air into the metering chamber while preventing the filtered test sample and the reagent from entering into the communication channel. Mixing is achieved using at least one mixing channel connected to the metering chamber via a connecting channel, where fluid communication through the connecting channel is selectively limited based on positioning of elastomeric deflection portions of first and second valves.

The cartridge delivers a substantially homogeneous mixture through at least one output port connected to the mixing channel, and the mixing channel comprises a stepped configuration between a first end connected to the connecting channel and a second end connected to the at least one output port, with alternating first portions extending longitudinally and second portions extending laterally relative to the longitudinal axis. With the first valve in the first position and the second valve in the second position, fluid communication is established between the sample delivery channel and the reagent delivery channel and the metering chamber while communication into the connecting channel and mixing channel is blocked via the second valve. With the first valve in the second position and the second valve in the first position, communication is established between the metering chamber, the connecting channel, and into the mixing channel while communication with the sample delivery channel and reagent delivery channel is blocked via the first valve.

Claims Coverage

The independent claim covers a disposable diagnostic assay cartridge that filters a test sample, meters filtered sample and reagent into longitudinal metering chambers under pump-controlled pressurized fluid, uses a gas-permeable membrane to deliver atmospheric air while preventing sample and reagent ingress into a communication channel, and produces a substantially homogeneous mixture through valve-selectively limited connecting and mixing channels with a stepped mixing configuration to an output port. Inventive features are organized around the filter-to-meter-to-valve-switch-to-mix-to-output architecture, including atmospheric-air metering control.

Across the independent claim and its dependents provided in the partial material, the inventive focus is on a cartridge that integrates filtration, longitudinal metering chambers, atmospheric-air delivery via a gas permeable membrane, pressurized-fluid pump connection, and valve-selectively limited connecting and mixing channels with a stepped mixing geometry to deliver a substantially homogeneous mixture from output ports.

Stated Advantages

Documented Applications