Patent Document ID: 10067125
Application ID: 14018397
Patent Flag: 1

Claim One:
1. A method for determining the amount of target analyte in a fluid sample, comprising: a) providing the fluid sample; b) providing a set of fluid calibrator samples containing the target analyte at defined levels; c) providing a plurality of assay devices, each assay device comprising a particle region incorporating test particles coated with a target analyte binding reagent and a test area incorporating a capture zone coated with the target analyte binding reagent, each assay device capable of forming, in response to an application of the fluid sample, a collection of measurable assay device compositions comprising an analyte-independent movement of the test particles through the test area and an analyte-dependent immobilization of the test particles in the capture zone, wherein the analyte-independent movement of the test particles correlates with assay parameters that define device-specific assay conditions; d) providing an imaging instrument operatively connected to the plurality of assay devices, wherein the imaging instrument is configured for collecting and recording each collection of measurable assay device compositions as a set of numerical spatiotemporal data points; e) providing a computing device operatively connected to the imaging instrument, wherein the computing device comprises an executable software program configured for analyzing each set of numerical spatiotemporal data points from the imaging instrument so as to calculate the amount of target analyte present in the fluid sample, the program using calibration processes that incorporate correlations between the assay parameters and the immobilization of the test particles in the capture zone; f) applying one of the set of fluid calibrator samples to one of the plurality of assay devices so as to induce the formation of one collection of measurable assay device compositions; g) collecting and recording the one collection of measurable assay device compositions of step f) on the imaging instrument to generate one set of numerical spatiotemporal data points for analysis; h) repeating steps f) and g) for each of the set of fluid calibrator samples to induce the formation of additional collections of measureable assay device compositions, and collecting and recording the additional collections of measurable assay device compositions on the imaging instrument to create a plurality of sets of numerical spatiotemporal data points for the set of fluid calibrator samples; i) repeating steps f), g), and h) for each of the plurality of assay devices; j) using the software program to create a database of the plurality of sets of numerical spatiotemporal data points generated for the set of fluid calibrator samples for each of the plurality of assay devices; k) applying the fluid sample to each of the plurality of assay devices so as to induce the formation of a plurality collection of fluid sample measurable assay device compositions; l) collecting and recording the plurality of collection of fluid sample measurable assay device compositions of step k) on the imaging instrument to generate the fluid sample set of numerical spatiotemporal data points for analysis; m) analyzing the fluid sample set of numerical spatiotemporal data points from step l) with the software program and the database so as to determine the amount of target analyte in the fluid sample, wherein the amount of target analyte is determined based on the amount of test particles coated with the target analyte binding reagent immobilized in the capture zone coated with the target analyte binding reagent together with the assay parameters determined from the analyte-independent movement of the particles in the test area, the assay parameters used to generate device-specific calibration.