Systems and methods for an e-gating feature in an electrochemical test strip

Inventors

Joyce, Joseph P. • Musho, Matthew

Assignees

Polymer Technology System Inc • Polymer Technology Systems Inc

Abstract

A system for testing for an analyte includes a test strip. The test strip includes a first flow path. The test strip further includes a heating element in communication with a heating area of the first flow path, for heating a sample in the first flow path. The test strip further includes an e-gate, the e-gate in the first flow path, the e-gate separating the heating area from a detection area of the first flow path.

Core Innovation

The invention provides an electrochemical point-of-care test system using a test strip having a first flow path. The test strip includes a time dependent area in the first flow path and an e-gate positioned in the first flow path, separating the time dependent area from a detection area so the detection area is electrically isolated from the upstream time dependent portion.

The e-gate is defined as a hydrophobic glass bead dielectric. The hydrophobic e-gate separates a time dependent region, including a reaction holding area with reaction reagents and optional reagents, a heating area with a heating element, and/or a temperature change element, from a downstream electrochemical detection area.

The e-gate is electrically released by a meter, for example by applied current or voltage, under conditions such as reaching necessary temperature, necessary digestion, or after a preset period of time. The disclosure further includes dual-channel electrochemical testing, including hemoglobin and HbA1c using interdigitated electrodes, and an integrated consumable assay strip embodiment with an e-gate activation at a finger/lead interface and a piercing port.

Claims Coverage

The independent claim is directed to an analyte testing system with a test strip architecture that includes an e-gate separating a time dependent area from an electrochemical detection area, where the e-gate is a hydrophobic glass bead dielectric. The claim set includes 6 inventive features, with dependent claims refining the time dependent function, the detection electrode structure and/or analyte targets, and the meter-controlled e-gate opening conditions.

Overall, the claim set centers on a hydrophobic glass bead dielectric e-gate that separates a time dependent region from an electrochemical detection area, with refinements that specify heating in the time dependent region, interdigitated-electrode A1C detection, HbA1c targeting, and meter-controlled e-gate release tied to digestion completion or a preset time.

Stated Advantages

Documented Applications