Single-use test device for imaging assay beads

A test device for imaging assay beads, comprising:

• a housing comprising a sample entry port for receiving a biological sample;
• an imager chip formed in the housing and comprising an array of pixels, wherein each pixel of the array has an area of less than about two μm2;
• a sample testing conduit fluidically connected to the sample entry port and comprising a first wall and a second wall, wherein at least a portion of the imager chip forms the first wall;
• a plurality of wells abutting the portion of the imager chip, wherein each of the plurality of wells has a width from about 2 μm to about 20 μm;
• and
• a conformable transparent material layer contacting the plurality of wells and forming the second wall of the sample testing conduit,
• wherein each of the plurality of wells is aligned vertically with one or more pixels in the array of pixels and each of the plurality of wells comprise at least one assay bead.

A system for imaging assay beads, comprising:

• an analyzer comprising:
• a port, a multi-terminal connector, a processor connected to the multi-terminal connector, and memory coupled to the processor;
• and
• a test cartridge comprising:
• a plurality of discrete connector contacts,
• a sample receiving chamber configured to receive a biological sample,
• a sample testing conduit fluidically connected to the sample receiving chamber, the sample testing conduit comprising:
• (i) a first wall, (ii) a second wall, and (iii) a plurality of wells having an average well height and disposed between the first wall and the second wall, and
• an analyte assay region comprising:
• a portion of the sample testing conduit and an imager chip, wherein the imager chip is electrically connected to at least one of the plurality of discrete connector contacts, and at least a portion of the imager chip forms a portion of the first wall of the sample receiving chamber,
• wherein each of the plurality of wells is aligned vertically with one or more pixels of the imager chip and each of the plurality of wells comprise at least one assay bead,
• wherein the test cartridge is insertable into the port such that the multi-terminal connector is in electrical contact with the plurality of discrete connector contacts,
• wherein the memory is encoded with a set of instructions configured to perform an analytical test on the biological sample, and
• wherein to perform the analytical test, (i) the processor is electrically connected to a light emitter, (ii) the processor is electrically connected to the imager chip via at least one of the plurality of discrete connector contacts and the multi-terminal connector, (iii) the processor is configured to drive the light emitter to generate light projected into the portion of the sample testing conduit, (iv) the imager chip is configured to convert light received from the portion of the sample testing conduit to an output signal, and (v) the processor is configured to convert the output signal of the imager chip to a value indicative of a reaction of the biological sample with the at least one assay bead in each of the plurality of wells.