ASSAY TEST STRIPS AND READING SAME
An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.
1 - 28 . (canceled)
29 . An assay test strip, comprising:
a flow path for a fluid sample;
a sample receiving zone coupled to the flow path;
a label that specifically binds a target analyte;
a detection zone coupled to the flow path and comprising an immobilized test reagent that specifically binds the target analyte; and
at least one reference feature exposed for optical inspection and having a calibrated amount of the label.
30 - 55 . (canceled)
56 . The assay test strip of claim 29 , wherein the at least one reference feature encodes at least one reference in the detection zone.
57 . The assay test strip of claim 56 , wherein the at least one reference feature produces a series of contrast variations on a surface of the test strip.
58 . The assay test strip of claim 57 , wherein the at least one reference feature has different optical reflection or emission properties than adjacent areas of the surface.
59 . The assay test strip of claim 29 , wherein the reference feature is beside an edge of the detection zone.
60 . The assay test strip of claim 29 , wherein the reference feature is located centrally over the flow path in the detection zone.
61 . The assay test strip of claim 60 , wherein the reference feature is elongated in a direction perpendicular to the flow path.
62 . The assay test strip of claim 29 , wherein the reference feature is calibrated to provide at least one reference optical response to illuminating light within a specified wavelength range.
63 . The assay test strip of claim 62 , wherein the reference feature comprises a calibrated amount of the label.
64 . The assay test strip of claim 63 , further comprising one or more additional labels that specifically bind respective target analytes to form one or more additional labeled target analyte complexes, and the at least one reference feature comprises a respective calibrated amount of each of the additional labels.
65 . The assay test strip of claim 29 , wherein each of the at least one reference feature comprises a respective electrical conductor on a surface of the test strip.
66 . The assay test strip of claim 29 , wherein the at least one reference feature comprises a mechanical feature having a different surface profile on the test strip than adjacent areas of the test strip.
67 . The assay test strip of claim 29 , further comprising an illumination source calibration region exposed for optical inspection on a surface of the detection zone and capable of reflecting or emitting light within a target wavelength range.
68 . The assay test strip of claim 67 , wherein the illumination source calibration region has a reflection or emission greater than adjacent regions of the surface with respect to light within the target wavelength range.
69 . The assay test strip of claim 67 , wherein the illumination source calibration region comprises a metal film.