Automated Microfluidic Sample Analyzer Platforms for Point of Care

摘要

An automated assay platform for determining the presence and/or amount of analytes of interest in a sample at point of care integrates microfluidic enhanced assay sites, disposable cartridge designs, a sensitive low-volume detection module, together with selected pumping and valving modules, customized control board and user friendly graphical user interface (GUI). Comparing to traditional assay platform like 96-well ELISA, the platform is capable of reducing reagent consumption, increasing assay speed, and enhancing assay performance with a sample-in-answer-out automated process. This platform also features flexibility of adapting different assay schemes for different analytes.

主权项

1. A microfluidic sample analysis apparatus, said apparatus comprising:
a. a housing; b. a multi-layer assay cartridge, comprising:
i. a rigid layer, comprising:
1. at least one microfluidic assay site having a cross-sectional dimension less than 1 mm for receiving a fluid assay;2. a fluid receptacle; and3. a microfluidic interface fluidically connected the fluid receptacle and the microfluidic assay site of the rigid layer, andii. a barrier layer comprising a barrier material that seals said ridged layer comprising the microfluidic assay site to prevent fluid from leaking out and prevent air from leaking into the microfluidic assay site; c. a door attached to the housing, wherein the door is sized to receive the assay cartridge within the housing; d. a rigid chassis located within the housing, wherein the chassis comprises:
i. a platform to receive the multi-layer assay cartridge assembly;ii. a microfluidic interface to establish fluidic communication with the assay cartridge;iii. a pump to deliver a fluid into the assay cartridge at a rate of between 1 μL and 1000 μL per minute; andiv. a detector subsystem, comprising at least one of either an optical detector to detect an optical signal from a sample analyte within a fluid located within the assay cartridge, or an optical source to measure an optical signal from a sample analyte within a fluid located within the assay cartridge or an optical signal from a downstream microfluidic flow cell from the assay cartridge, with a defined path length of at least 1 mm, or an electrochemical-sensing electrode to receive a signal from the fluid located within the assay cartridge and generate an electrical signal in response; e. an electronic controller in electrical communication with the detector subsystem and the pump to control a rate of flow of the pump and receive and record a reading from the detector subsystem; and f. a user interface in electrical communication with the electronic controller to provide bi-directional communications with the electronic controller.