Abstract: A diagnostic assay reader includes a detector configured to read a diagnostic assay result and develop a result signal that is indicative of the result, a processor configured to process the result signal, and an external power interface connected to the detector and to the processor, the external power interface configured to receive external power for the diagnostic assay reader.

Abstract: Systems and methods for end-of-life disabling of a diagnostic test system are described. In one aspect, a diagnostic test system that includes a test unit and a disabling unit. The test unit performs at least one diagnostic test on a diagnostic assay to determine whether at least one analyte is present within a sample. The disabling unit determines a measure of current lifetime of the test unit and disables the test unit in response to a determination that the current lifetime measure meets an end-of-life threshold. In a diagnostic test method, at least one diagnostic test is performed on a diagnostic assay to determine whether at least one analyte is present within a sample. A measure of current lifetime of the test unit is determined. The test unit is disabled in response to a determination that the current lifetime measure meets an end-of-life threshold.

Abstract: In one aspect, an assay test strip includes a test label that specifically binds a target analyte and a control label that is free of any specific binding affinity for the target analyte and has a different optical characteristic than the test label. In another aspect, an assay test strip includes a test label that specifically binds a target analyte and at least one non-specific-binding label that is free of any specific binding affinity for the target analyte. Systems and methods of reading assay test strips also are described.

Abstract: A diagnostic test reader including a test unit and a disabling unit. The test unit is configured to perform one or more tests. Each of the one or more tests employs a diagnostic assay to analyze whether an analyte is present within a sample. The disabling unit is coupled with the test unit and is configured to disable the test unit based on a selected threshold number of tests.

Abstract: 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.

Abstract: In one aspect, a diagnostic test system includes a housing, a reader, and a data analyzer. The housing includes a port for receiving a test strip. The reader obtains separable light intensity measurements from localized regions of an area of the detection zone exposed for optical inspection, wherein each of the localized regions is characterized by at least one surface dimension smaller than the first dimension. The data analyzer identifies ones of the light intensity measurements obtained from the at least one test region and computes at least one parameter from the identified ones of the light intensity measurements. In another aspect, the reader obtains a respective set of light intensity measurements from each of multiple corresponding regions of the exposed surface area of the detection zone, and the data analyzer computes at least one parameter from at least one of the sets of light intensity measurements.

Abstract: A rapid diagnostic test system or process uses a gated measurement of the fluorescent light from quantum dots after shutting off an illuminating light source. A delay between shutting off the illumination and measuring allows background fluorescence from substances other than the quantum dots to drop significantly when compared to the intensity of the fluorescence from the quantum dots. Using quantum dots permits high measurement repetition rates and good extinction of background fluorescence.

Abstract: A read-write assay system includes providing an assay device; and writing assay device information to the assay device for subsequent reading of the assay device information from the assay device; or performing an assay with the assay device and subsequent writing of the assay related information to the assay device or reading of assay related information from the assay device.

Abstract: A rapid diagnostic test system or process uses a single-use module that includes a photodetector. The photodetector generates an electrical signal representing a measurement of light from a test region on a medium such as a lateral-flow strip for a binding assay. For light measurement, the test medium can contain a labeling substance that attaches a persistent fluorescent structure such as a quantum dot to a target analyte, so that the photodetector measures fluorescent light. Multiple photodetectors and an optical system that separates or filters light of wavelengths corresponding to different fluorescent labeling substances allow simultaneous testing for multiple analytes. The single-use module can include a display or LED for visual indication of test results, or the electrical signal can be output for processing in a reusable module.

Abstract: A rapid diagnostic test system or process uses a single-use module that includes a photodetector. The photodetector generates an electrical signal representing a measurement of light from a test region on a medium such as a lateral-flow strip for a binding assay. For light measurement, the test medium can contain a labeling substance that attaches a persistent fluorescent structure such as a quantum dot to a target analyte, so that the photodetector measures fluorescent light. Multiple photodetectors and an optical system that separates or filters light of wavelengths corresponding to different fluorescent labeling substances allow simultaneous testing for multiple analytes. The single-use module can include a display or LED for visual indication of test results, or the electrical signal can be output for processing in a reusable module.

Abstract: A method of encoding data for transmission over a communication link. A cumulative polarity of previously-transmitted frames is maintained. A frame is prepared for transmission by combining a data word with a plurality of additional bits. The additional bits provide a master transition. A phantom bit is encoded in the additional bits. If the polarity of the frame is the same as the cumulative polarity, the data bits or in some instances all the bits are inverted so as to maintain balance. Control words and fill words are provided and are distinguished from data words by encoding the additional bits. Control words carry additional data or control instructions and are distinguished from fill words by the number of transitions. The phantom bit either conveys additional data or is used for such purposes as error checking.