Universal assay reader

A method to detect the negative, positive, or invalid status of one or more indicator lines on a test strip by analyzing at least one electronic image of the test strip, the electronic image comprising a Cartesian arrangement of pixels, in an assay system having at least one processor to perform assays of the test strips, the method comprising:

• (a) receiving in an interior of a housing at least one lateral flow test strip comprising at least one sample, the housing having an interior to receive at least a portion of the at least one of said test strip;
• (b) capturing using an imaging unit at least one electronic image of at least a portion of said test strip as a read window comprising at least one of said indicator lines, the imaging unit operable to capture electronic images of one or more of the test strips received in the interior of the housing;
• (c) computationally identifying, by a processor, individual test strips in the captured electronic image of the test strip, the image comprising high and low intensity pixels, where the low intensity pixels are lighter in color or grayscale and the high intensity pixels are darker in color or grayscale the communicatively coupled to the imaging unit to receive image information representative of the images captured by the imaging unit, the processor configured to:
• (i) identify individual test strips, in the image from the image information;
• (ii) analyze whether said pixels within the region belongs to a subset as a local intensity optimum of high pixel intensity corresponding to an indicator line, by electronically determining on a processor, sets of pixels in the electronic image within the regions in a vertical or horizontal orientation, provide a sufficient number of contiguous selected pixel sets to identify an indicator line, by determining, electronically on a process, whether the average pixel set intensity above background and relative to adjacent rows of pixels of lower intensity, provides said local intensity optimum corresponding to an indicator line;
• (iii) counting, positioning, or orienting each of the distinct local intensity optimums corresponding to one or more distinct indicator lines found within each of the regions;
• (d) computationally performing, using at least one processor, a negative, positive, or invalid assay evaluation for each of the identified indicator lines in each of the individual test strips that appear in one or more of the captured electronic images based at least in part on a representation of at least one indicator line of each of the test strips in the captured electronic image;
• the at least one processor further configured to perform said negative, positive, or invalid assay evaluation based at least in part on at least one indicator line on each of the test strips and based at least in part on at least one configurable criteria to provide one or more of a negative, positive, or invalid assay result for each test strip.

An assay reader system, comprising:

• an assay device having a plurality assay test strips;
• and
• an assay reader unit, the assay reader unit including:
• a processor;
• an imaging unit for imaging a portion of the assay device, the imaging unit communicatively coupled to the processor;
• a user interface for receiving input from a user of the assay reader unit, the imaging unit communicatively coupled to the processor;
• a memory storing image data associated with the assay device, the memory communicatively coupled to the processor;
• wherein the processor is configured to:
• identify the assay device;
• cause the imaging unit to expose the assay device to light emitted by the imaging unit;
• cause the imaging unit to capture and store an image of a portion of the assay device and a portion of a background of the assay device, the background of the assay device comprising a shroud of the assay reader unit, the image defined by a set of pixel data;
• perform a registration process to determine an angle of rotation of the assay device within the assay reader device;
• and
• determine an image offset based on the angle of rotation, and use the image offset to determine a subset of pixel data to analyze for the presence or absence of an indicator line.