Inspection equipment, assemblies, and methods

Abstract

Apparatus, assemblies, methods, operations, and systems for testing a test substance are shown and described. A lateral flow reader that generates test results from an assay upon contact with a sample includes a camera multiplexer circuit and a host controller. The assembly includes an interface connector and a self-contained optical module having a microcontroller that electrically communicates with the interface connector and the host controller. Typically, the optical imaging device communicates with the interface connector but is independent of the microcontroller.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 452,020, filed Mar. 14, 2023, which is hereby incorporated by reference in its entirety.

[0002] Technical Field The present disclosure generally relates to analytical assays, and more particularly to improved detection of analytes present in testing devices, systems, and assemblies.

Background Art

[0003] Background Reagent strips and films are often useful analytical tools in the fields of clinical chemistry, analytical medicine, and food hygiene diagnostics. For example, it is advantageous to determine or test various matrices such as body fluids such as serum and urine, and foods such as meat products, fruits, vegetables, milk, and honey, by quantitative or qualitative methods. Such matrices can be tested for various chemical substances, biochemicals, and biological molecules within the material or on the surface of the material or any combination thereof, such as antibiotics such as bacteria, sulfonamides, tetracyclines, beta-lactam drugs, toxins such as aflatoxins, zearalenone, ochratoxin, T-2, and vomitoxin, pesticides such as organophosphates and carbamates, and active metabolites, and other analytes.

[0004] Generally, a lateral flow assay is a membrane-based testing device in which a sample suspected to contain a test substance of interest is placed at or near one end of a membrane strip. The sample is carried to the opposite end of the membrane strip by a mobile phase that traverses the membrane strip, for example, by capillary action. The test substance in the test sample, if present, encounters one or more reagents while traversing the membrane strip. The reagents may include a binder for the test substance. The binder may be mobile and therefore flow with the sample, or it may be fixed on the test strip as a capture agent. Depending on the test configuration, either the test substance binder, the test substance itself, or any other reagent in the testing system generates a detectable signal by being captured by the fixed capture agent. The signal may be generated by a label provided within the assay. The detectable signal can be measured by an optical reader or the like.

[0005] The presence and, possibly, the concentration of a test substance on a reagent strip can be determined by measuring the light reflectance from the expression areas on the strip. For example, the expression areas on the strip may be areas of color or image expression. The reflectance percentage can be used to determine the result.

[0006] While testing is generally performed in controlled environments such as laboratories, testing in non-laboratory settings is also common. In some applications, speed and ease of use are particularly important. For example, in food processing, it is advantageous to perform testing in a non-laboratory setting because processors must wait for results. Furthermore, it is also advantageous to perform testing while goods are being transported on a truck. Therefore, accelerating the speed of testing, reducing equipment and testing costs, improving the durability of the equipment, and enhancing ease of use and operation are considered advantageous. In addition, it is advantageous to have confidence that the test results are valid. Accordingly, the systems, methods, and devices described herein also help prevent the misuse of assays known to be negative before execution in place of real samples, or the use of assays pre-marked to produce negative results that do not reflect the true nature of the sample. Furthermore, it is desirable to increase the durability of the assays, systems, and testing procedures.

[0007] Therefore, the applicant of this application desires a system and method for detecting a test substance that does not have the drawbacks of conventional systems and methods. [Overview of the project] [Problems that the invention aims to solve]

[0008] overview This disclosure provides an improved, user-friendly, efficient, and safe test substance detection method, particularly when used to detect the presence or absence of at least one test substance. [Means for solving the problem]

[0009] In one embodiment, the assembly comprises, for example, a multi-channel lateral flow reader system aligned on a carrier substrate, and a microcontroller incorporated in a self-contained optical module that electrically communicates with a host controller configured to match the aforementioned carrier substrate.

[0010] In one example, the optical imager is independent of the microcontroller. The carrier board host controller may include an operating system configured to monitor the individual module installation status. The assembly may include interface connectors that electrically communicate with a self-contained optical module control system. The assembly may include interface connectors that electrically communicate with the microcontroller. The microcontroller may communicate with a constant current driver. The microcontroller may communicate with an incubator. The microcontroller may communicate with an optical interrupter. The microcontroller may communicate with a non-volatile memory configured to store module-specific calibration data.

[0011] In a specific example, a carrier substrate host controller can control multiple optical modules. The assembly may include at least one interchangeable optical module. The carrier substrate may include a module multiplexer circuit. The module multiplexer circuit may include a multiplexer IC configuration. The module multiplexer circuit may include a standard logic multiplexer configuration. The module multiplexer circuit may provide an enable signal configured for subsequent multiplexing. A self-contained optical module assembly may include an incubator configured to incubate an assay. The assembly may include an illumination assembly. The illumination assembly may include a direct dynamic control illumination assembly aligned around the assay. The assembly may include an aperture carrier aligned around a frame and configured to provide multiple optical windows when the assay is in the test position. The assembly may include a stabilizer configured to stabilize the assay accepted in the operating position when generating test results.

[0012] In one embodiment, a lateral flow reader for generating test results from an assay upon contact with a sample comprises an interface connector and a carrier substrate host controller electrically connected to the interface connector, and has a module multiplexer circuit, and a self-contained optical module having a camera that is connected to the interface connector and independent of the microcontroller.

[0013] In certain cases, optical modules may be controlled independently of the host system. A device may include multiple optical modules. A device may include at least one interchangeable optical module. An optical module may include a calibration sequence. A device may include non-volatile memory configured to store module-specific calibration data. A device may include interchangeable, field-replaceable optical modules. Optical modules may be interchangeable, field-installable. The module multiplexer circuit may include a combination of a multiplexer IC configuration and a standard logic multiplexer configuration. The module multiplexer circuit may provide an enable signal configured for subsequent multiplexing. The host system may determine a specific imager from multiple imaging devices. The host system may assert the selection of general-purpose input / output pins. The host system may disable the selection of general-purpose input / output pins. The host system may disable the enable signal and deliver an image capture command.

[0014] In certain examples, the device may include a non-planar optical module configured to align the assay to an offset position, the offset position including an upper part obliquely offset around a lower part. The device may include an upper platform obliquely offset around a lower platform with a pivot point. The device may include an incubator configured to incubate the assay. The device may include an illumination assembly. The illumination assembly may include a direct dynamic control illumination assembly aligned around the assay. The direct dynamic control illumination assembly may include multiple light sources configured to provide illumination around the assay while minimizing specular reflections on at least a portion of the assay. The direct dynamic control illumination assembly may include a dual digital-to-analog converter. The device may include an aperture carrier aligned around a frame and configured to provide multiple optical windows when the assay is in the inspection position and to provide clearance for handling the assay. The optical module may perform at least two image detections of the assay. The device may include a stabilizer configured to stabilize the assay when it is accepted in the working position when producing inspection results. The stabilizer may include a cover. The cover may include a spring-loaded cover. The spring-biased cover may include at least one spring-biased support.

[0015] In one embodiment, the system comprises a device that generates test results from an assay when it comes into contact with a sample, and a module multiplexer circuit that communicates with the device to multiplex images of multiple assays.

[0016] In certain examples, a module multiplexer circuit may be configured to multiplex images from multiple cameras. The device may be configured to image an assay at an offset position. The module multiplexer circuit may include a combination of a multiplexer IC configuration and a standard logic multiplexer configuration. The module multiplexer circuit may provide an enable signal configured for subsequent multiplexing.

[0017] In one embodiment, in an assembly for generating test results from an assay, the optical module may include an offset frame configured to receive an assay and including an upper platform obliquely offset around a lower platform, and an aperture carrier configured to align around the frame and provide multiple optical windows when the assay is in the test position and to provide clearance around the assembly for handling the assay.

[0018] In certain examples, the upper platform may be offset and aligned around the lower platform with respect to a pivot point. The offset frame can receive a portion of the assay at a first substantially flat entry position. The offset frame can align a portion of the assay at a second substantially non-flat inspection position. The optical module may include an elongated optical aperture to enable imaging, such as adjacent to bends around the assay at the inspection position. The aperture carrier may include an assay line expression image region. The aperture carrier may include a reference coding aperture. The aperture carrier may include a reference coding image region. The aperture carrier may include a reference explanatory aperture. The aperture carrier may include an explanatory image region. The explanatory image region may be an optical character recognition image region.

[0019] In certain examples, the aperture carrier may include chamfered edges. The aperture carrier may include clearance channels. The bottom surface of the aperture carrier may include a temperature sensor opening. The bottom surface of the aperture carrier may include at least one mounting opening. The bottom surface of the aperture carrier may include a concave contoured surface. The concave contoured surface may be recessed from the top surface. The device may include a wall that separates the concave contoured surface from the top surface.

[0020] In one embodiment, a device for generating test results from an assay upon contact with a sample includes a non-planar optical module configured to align the assay to an offset position including an upper part that is obliquely angle-offset around a lower part; an incubator configured to incubate the assay; an imaging device configured to image the assay at the offset position; and a direct dynamic control illumination assembly aligned around the assay.

[0021] In certain examples, the optical module includes an overhang grip configured to align at least a portion of the assay protruding around the optical module to the working position. The optical module may include a substantially flat proximal portion and a substantially non-flat distal portion on the opposite side. The proximal and distal portions may define a non-planar flow path around the assay at the test position. The optical module may be removable from the device. The device may include at least one interchangeable optical module. The optical module may include a calibration sequence. The optical module may include a bent portion aligned between the top and bottom.

[0022] In certain examples, the device may include an aperture carrier, such as an aperture carrier thermal block. The aperture carrier thermal block may include an elongated optical aperture. The elongated optical aperture can provide an elongated assay observation area. The device may include an assay line expression image area. The aperture carrier thermal block may include a reference coding aperture. The reference coding aperture can provide an observation area for the reference coding. The reference coding may include a barcode. The device may include a reference coding image area. The aperture carrier thermal block may include a reference explanation aperture. The reference explanation aperture can provide an observation area for the reference explanation. The device may include an explanation image area. The explanation image area may include an optical character recognition image area.

[0023] In certain cases, the opening carrier heat block may include chamfered edges. Chamfered edges can prevent unintended movement, alignment, or blockage around raised portions of the assay. The opening carrier heat block may include clearance channels. Clearance channels can provide clearance for assay operations around the opening carrier heat block. The bottom surface of the opening carrier heat block may include a temperature sensor opening. A temperature sensor opening can thermally couple a corresponding temperature sensor. The bottom surface of the opening carrier heat block may include at least one mounting opening. The bottom surface of the opening carrier heat block may include a concave contoured surface. The concave contoured surface may be recessed from the top surface. The apparatus may include a wall that separates the concave contoured surface from the top surface. The concave contoured surface may include an illumination environment around the assay.

[0024] In certain examples, the optical module can include a proximity switch configured to block the path of a light interrupter to trigger at least one state selected from the group consisting of incubation, detection of light transmission around an assay, and imaging of the assay. The device can perform at least two image detections of the assay. The imaging device can monitor at least one pre-inspection parameter after receiving the assay. The direct dynamic control illumination assembly can include a plurality of light sources. The plurality of light sources are configured to provide illumination around the assay while minimizing specular reflection at at least a portion of the assay. The plurality of light sources can provide illumination around the assay without specular reflection. The plurality of light sources may be aligned along an imaging bracket. The imaging bracket can include an alignment inclined with respect to the surface. The plurality of light sources may be positioned on both sides of the imaging bracket. The plurality of light sources may be positioned substantially opposite the assay at the inspection position. The plurality of light sources can provide an edge of a dispersion angle outside a section of the assay. The edge of the dispersion angle may be outside a section of the assay without specular reflection. The section of the assay may include a sample region of an inspection strip. The plurality of light sources are independently variable.

[0025] In certain examples, the device can include a dual digital-to-analog converter. The dual digital-to-analog converter can include two independently controlled voltage sources. The dual digital-to-analog converter can maintain a constant current. The dual digital-to-analog converter can monitor the voltage in one current limiting resistor to maintain a constant current. The device can monitor a voltage proportional to the light intensity of at least one of the plurality of light sources. The device can include monitoring a low impedance voltage output. The low impedance voltage output may be proportional to the current passing through at least one of the plurality of light sources.

[0026] In one embodiment, the apparatus includes a non-planar optical module configured to align an assay at an offset position, a photodetector configured to image the assay at the offset position, and a direct dynamic control illumination assembly configured to provide illumination around at least a portion of the assay without specular reflection.

[0027] In certain examples, the direct dynamic control illumination assembly can include a plurality of independently variable light sources. The direct dynamic control illumination assembly can include a dual digital-to-analog converter. The dual digital-to-analog converter can include two independently controlled voltage sources. The dual digital-to-analog converter can maintain a constant current.

[0028] In one embodiment, the apparatus includes a non-planar optical module configured to align an assay around an upper tier platform obliquely offset around a lower tier platform, an imaging device configured to image the assay aligned around the upper tier platform and obliquely offset around the lower tier platform, and a direct dynamic control illumination assembly having a plurality of independently variable light sources and a dual digital-to-analog converter.

[0029] In one embodiment, an apparatus for generating an inspection result from an assay when in contact with a sample includes a non-planar optical module configured to align the assay at an offset position, an incubator configured to incubate the assay, and a photodetector configured to image the assay at the offset position.

[0030] In certain examples, the optical module includes an overhang grip that aligns at least a portion of the assay protruding around the optical module to the working position. The optical module may include a substantially flat proximal portion and a non-flat distal portion on the opposite side. The flat proximal portion and the non-flat distal portion can define a non-flat flow path around the assay at the testing position. The flat proximal portion and the non-flat distal portion can define a raised flow path around the assay at the testing position. The non-flat distal portion may be offset from the flat proximal portion by about 10 to 30 degrees. The non-flat distal portion may be offset from the flat proximal portion by about 20 degrees.

[0031] In certain examples, the device may include a pivot point aligned between a flat proximal portion and a non-flat distal portion. The device may include an aperture carrier thermal block. The optical module may include a proximity switch. The proximity switch may interrupt the path of the optical interrupter to trigger at least one state selected from the group consisting of incubation, detection of light transmission around the assay, and imaging of the assay. The device may perform at least two imaging detections of the assay. The photodetector may monitor at least one pre-test parameter after accepting the assay.

[0032] In one embodiment, an assembly for generating test results from an assay includes an offset frame configured to receive the assay and containing an upper platform that is diagonally offset around a lower platform, and an optical aperture aligned around the frame.

[0033] In certain examples, the offset frame aligns the proximal portion of the assay outside the assembly to the working position. The upper platform may be offset and aligned around the lower platform with respect to a pivot point. The offset frame can receive a portion of the assay in a first substantially flat position. The offset frame can align a portion of the assay in a second substantially non-flat position. The optical module can image the assay adjacent to the bends around the assay in the working position.

[0034] In one embodiment, in an apparatus for generating test results from an assay, the module interface includes a housing configured to align the assay to an offset position, a carrier substrate support aligned within the housing, an optical strip detector, a light level detector, an imaging device, a light source, and an integrated incubator.

[0035] In one embodiment, a device for generating test results from an assay upon contact with a sample includes a non-planar optical module for aligning the assay to an offset position, an incubator for incubating the assay, and a photodetector for detecting the transmission of light over the assay, wherein the incubation of the assay and the detection of light transmission over the assay generate the test results.

[0036] In certain examples, the optical module includes a substantially flat proximal portion and an opposite non-flat distal portion. The flat proximal portion and the non-flat distal portion can define a non-planar flow path. The flat proximal portion and the non-planar distal portion can define a raised non-planar flow path. The device may include a pivot point aligned between the flat proximal portion and the non-planar distal portion. The device may include a non-planar cavity. The cavity may include an elongated channel. An aperture carrier may be positioned within the cavity. The optical module may include a lower support. The optical module may include an interface shell. The optical module may include a drip tray. The optical module may include an insulating base. The optical module may include an upper cover. The optical module may include a proximity switch. The proximity switch may interrupt the path of the optical interrupter to trigger incubation. A proximity switch can interrupt the path of the optical interrupter and trigger the detection of light transmission that has passed around the assay, including, but not limited to, bounces. A proximity switch can also interrupt the path of the optical interrupter and trigger the imaging of the assay.

[0037] In certain cases, the device performs continuous image detection of the assay. Furthermore, the incubation environment may include a heating environment. The incubation environment may include a cooling environment. The incubation environment may include a maintained constant temperature environment. The photodetector can monitor at least one pre-test parameter after acquiring at least one image detection in the assay. The image detection may include a light reflectance value. The assay may include a test strip having at least one test line and at least one control line, so that the theoretical reflectance value is a comparison between the reflectance value in the test line and the reflectance value in the control line. The test line and control line may be positioned in the non-planar distal portion at the operating position. The device may include a user interface having a display board.

[0038] In another embodiment of an assembly for generating test results from an assay, the optical module includes an offset frame that is mountable around a base and configured to accept an assay, and which includes an upper platform that is diagonally offset around a lower platform, and an optical aperture aligned within the frame.

[0039] In certain examples, the upper platform is offset and aligned around the lower platform with respect to a pivot point. The offset frame can receive the assay in a first substantially flat position. The offset frame can align the assay in a second substantially non-flat position. The device may include a housing. The assembly may perform continuous imaging detection of the assay to generate test results. The device may include an incubator for incubating the assay. The device may include a photodetector for detecting the transmission of light over the assay. Incubation of the assay and detection of light transmission over the assay generate test results. The device may include an insulating base. The device may include a top cover. The device may include a proximity switch. The proximity switch may trigger incubation by blocking the path of the optical interrupter. The proximity switch may trigger detection of light transmission through the assay by blocking the path of the optical interrupter. The proximity switch device may trigger imaging of the assay by blocking the path of the optical interrupter. The proximity switch device can initiate testing if the incubator is already maintaining the required temperature, or if the incubator is inactive and the device is in read-only mode.

[0040] In another embodiment, a modular interface for generating test results from an assay includes a carrier substrate support and at least one non-planar optical module that can be positioned around the carrier substrate support.

[0041] In a particular example, the device includes at least one inspection unit. In one embodiment, but not limited to, a non-planar inspection and product delivery assembly including an inline component includes a product supply unit having at least one outlet, a sample feed communicating with the product supply unit, a reader, and a delivery line communicating with the supply unit outlet and having a delivery output valve. In a particular embodiment, the reader receives a sample from the sample feed and generates an inspection result from an assay for detecting the presence or absence of a test substance. The reader may include a photodetector for imaging at least a first transmission of light over the assay and an incubator for incubating the assay. In a particular embodiment, detection of the test substance triggers the closure of the delivery output valve, while detection of the absence of the test substance triggers the opening of the delivery output valve to release the feed through the delivery line.

[0042] In certain examples, the reader includes a hood for removably receiving a disposable high-speed assay, the hood having a puncture tip that protrudes to puncture the assay. Furthermore, the hood may include a sample supply line communicating with a sample feed to deliver the sample to the assay. For example, the sample feed may be positioned adjacent to the puncture tip to deliver the sample to the assay at the time of puncture in order to increase the rate of testing.

[0043] In certain examples, the reader includes a slanted cavity with an elongated channel for receiving the assay and holding it in a slanted testing position. The slanted cavity may include a proximal portion and an opposite distal portion, with the distal portion positioned above the proximal portion at an angle of approximately 45 degrees or similar. Further examples include a distal portion positioned above the proximal portion at an angle of less than 45 degrees.

[0044] The reader can provide any test results illustrated and described herein in a timely manner, depending, for example, the specificity of the test, the number of test results, and / or multiple test results. In certain examples, the reader generates the final test results within about 15 seconds to about 1 minute, for example, within about 30 seconds. In other specific examples, the reader generates the final test results within about 10 seconds to about 15 minutes. Furthermore, the assembly may generally include an autosampler communicating with a sample feed. The assembly may include a drip sampler communicating with any of the system elements and embodiments illustrated and described herein. The sample feed may be a closed-loop recirculation system for supplying the product. The assembly may include an autosampler communicating with the closed-loop system at a sample release valve, the recirculation loop communicating with an outlet and having re-entry communication with the product supply. At least a portion of the recirculation loop may be a single-use disposable conduit and / or washable conduit.

[0045] In a specific example, the reader's photodetector detects a first light transmission result on the assay, detects at least a subsequent light transmission result on the assay, and the incubation of the assay and the detection of light transmission on the assay generate a test result. Furthermore, the reader can generate at least one boundary test result.

[0046] In another embodiment, a non-planar inspection and product delivery system includes a product supply unit having at least one outlet, the outlet comprising a product supply unit including at least one valve closure and a delivery line downstream of the valve closure; a recirculation closed loop communicating with the outlet and the supply unit; a reader configured to produce rapid test results from a one-time use assay for detecting the presence or absence of a test substance; and a sampler communicating with the recirculation closed loop for providing a sample to the reader. In a particular example, the reader has a tilting cavity for receiving the assay and holding it in a tilted inspection position, and a puncture tip for puncturing the assay. In a particular embodiment, detection of the test substance triggers the closure of a valve closure upstream of the delivery line, and detection of the absence of the test substance allows for the release of the feed into the delivery line.

[0047] In a specific example of rapid test results, a single-use assay includes an overlap of approximately 3 millimeters in the binder-coated area on the nitrocellulose membrane. Furthermore, a single-use assay may include an absorbent pad approximately 31 millimeters in length.

[0048] In another embodiment, in a non-planar inspection and product delivery system having a supply tank, a sample feed, and a downstream delivery, the leader controls product access between the supply tank and the downstream delivery and includes a tilted cavity for receiving a one-time use assay, a sample portal communicating with the sample feed and aligned with an assay positioned within the cavity, a puncture tip extending into the cavity for puncturing the assay, a photodetector configured to monitor the assay, and an incubator for incubating the assay.

[0049] In a further embodiment, the non-planar inspection and product delivery assembly includes a product supply unit having at least one outlet; a recirculation loop communicating with the outlet and having re-entry communication with the product supply unit; an autosampler receiving a sample from the product supply unit; a reader receiving a sample from the autosampler and configured to generate a test result from an assay for detecting the presence or absence of a test substance; and a delivery line communicating with the product supply unit and having at least one valve closure unit, wherein a positive test result generated by the reader enables valve closure, and a negative test result generated by the reader releases the product to downstream delivery.

[0050] In certain cases, the product supply unit includes a milk tank. The test substance may be a toxin, antibiotic, chemical, biochemical, pesticide, active metabolite, or a combination thereof. For example, the test substance may be mycotoxin, aflatoxin, zeararonone, ochratoxin, T-2, vomitoxin, or a combination thereof. The reader can generate the final test result within approximately 15 seconds to 1 minute, for example, within approximately 30 seconds. In certain cases, the reader generates the final mycotoxin test result within approximately 30 seconds.

[0051] In some examples, the autosampler is aligned to communicate with the recirculation loop. The autosampler may also be a drip sampler. The delivery supply line may also be aligned to communicate with the recirculation loop. The recirculation loop may include shut-off valves. The recirculation loop may include disposable conduits, washable conduits, etc. The recirculation loop may include a pump. The assembly may include multiple auxiliary conduits.

[0052] In certain cases, the reader includes an incubator. The reader can perform diagnostic testing of the assay simultaneously with the incubation of the assay by the incubator. The reader can generate at least one boundary test result. After performing the first read of the diagnostic test, the reader can perform one or more subsequent sequential reads to generate test results. After performing the first read of the diagnostic test, the reader can perform one or more subsequent sequential reads to extend the incubation of the assay and generate a final test result.

[0053] In certain examples, receiving a sample may include automated sampling of the product. The method may include automated sampling from a recirculation loop. The method may include blocking downstream delivery of the product, which may include enabling the closure of a delivery valve. Discharging the product may include enabling the closure of a recirculation valve. Generating test results may include incubating the assay. Generating test results may include reading diagnostic tests of the assay simultaneously with incubation of the assay by an incubator. Generating test results may include generating at least one boundary test result. Generating test results may include performing one or more subsequent sequential readings of diagnostic tests. Generating test results may include extending the incubation of the assay after performing a first reading of a diagnostic test. Generating test results may include extending the incubation of the assay after performing a first reading of a diagnostic test to generate a final test result.

[0054] In certain cases, reading a diagnostic test involves performing a diagnostic reading that takes approximately 30 seconds. Furthermore, generating a test result may involve reading a predetermined difference between the reflectance value on the control line and the reflectance value on the test line. Generating the final test result may involve reading a predetermined difference between the reflectance value on the control line and the reflectance value on the test line, and a predetermined reflectance value on the control line.

[0055] In certain cases, the method may include monitoring the pre-test analysis of the assay and / or decoding the reference coding of the assay. For example, activating the corresponding channels of a multi-channel reader to initiate the incubation of the assay. Furthermore, the method may include monitoring the color development before the start of flow along the assay. The method may include instructing a photodetector to perform continuous image detection of the assay to generate a test result, which is a boundary test result. Furthermore, the method may include triggering subsequent image detection of the boundary test result to generate a final presence or absence test result.

[0056] In yet another embodiment, a method for analyzing boundary checks of an assay includes several image detections of the assay to provide a final presence / absence test result. In a particular example, the method includes incubating the assay in an incubation environment, aligning a photodetector with the assay in the optical path, instructing the photodetector to perform a first image detection, and instructing the photodetector to perform a second image detection. In a particular example, instructing the photodetector to perform a first image detection of the assay generates a boundary check result. Furthermore, the method typically includes instructing the photodetector to perform at least a second subsequent image detection of the assay to generate a final presence / absence test result. Other examples include various subsequent image detections as illustrated and described herein.

[0057] In further embodiments, a method for detecting a test substance from an assay includes aligning a photodetector with the assay and within the optical path, instructing the photodetector to perform continuous imaging detection of the assay to produce a final presence or absence test result, and performing further imaging detection of a diagnostic test for a boundary test result. In some examples, the method may include incubating the assay in an incubation environment simultaneously with performing continuous imaging detection of the assay by the photodetector. In some exemplary embodiments, the method includes instructing the photodetector to perform 1 minute of imaging detection. Typically, detection of a final test result of presence includes stopping the system. Similarly, detection of a final test result of negative includes stopping the system.

[0058] In another embodiment, a method for generating a final test result from an assay to detect the presence or absence of a test substance includes incubating the assay in an incubation environment, reading the diagnostic test of the assay simultaneously with the incubation of the assay by the incubator, performing continuous readings of the diagnostic test, and incubating the assay of the boundary test result to generate a final test result. In a particular example, reading the diagnostic test includes performing a one-minute diagnostic read. Typically, detection of a final positive test includes stopping the system. Similarly, detection of a final negative test includes stopping the system. Generating a final test result may include reading a predetermined difference between the reflectance value on the control line and the reflectance value on the test line. Similarly, generating a final test result may include reading a predetermined difference between the reflectance value on the control line and the reflectance value on the test line, and a predetermined reflectance value on the control line.

[0059] In other examples, the method may include monitoring the pre-test analysis of the assay. Furthermore, the method may include decoding the reference coding on the assay. Furthermore, the method may include activating the corresponding channels of a multi-channel reader and / or activating the incubation of the assay. Furthermore, the method may include monitoring the color development before the start of flow along the assay.

[0060] In another aspect of this disclosure, an assay analyzer for generating diagnostic test results from an assay includes a photodetector and a microprocessor. The photodetector can be aligned with the assay and in the optical path. The photodetector may be configured to acquire image detection on the assay resulting from anomalies in the assay. A microprocessor may communicate with the photodetector. The microprocessor may be configured to signal the photodetector to perform sequential image detection of the assay to generate diagnostic test results.

[0061] The photodetector may include a decoding sensor that is aligned with the assay and configured to decode a reference coding on the assay. In certain examples, the decoding sensor and optical reader are a single device. However, those skilled in the art will understand that other examples may include the decoding sensor and optical reader being separate or separable devices. The reference coding can actuate a corresponding diagnostic test within the photodetector. The apparatus may include a multichannel reader, and the reference coding can actuate a corresponding channel within the multichannel reader. The apparatus may include an incubator, and the reference coding can actuate a corresponding incubation temperature.

[0062] The decoding sensor may be a color sensor. The color sensor may be a photodiode sensitive to wavelengths selected from red, blue, green, and combinations thereof. The decoding sensor may be an RFID reader. The decoding sensor may be a barcode reader.

[0063] Decoding is achieved using character recognition, such as optical character recognition (OCR), or similar algorithmic thresholding assays, which can generate binary labels for analysis of any of the systems and examples illustrated and described herein. Those skilled in the art will benefit from this disclosure to understand further OCR features and methods.

[0064] In certain examples, the apparatus includes a light source. The light source may be an array of discrete light sources. For example, a discrete light source may comprise one and / or more light-emitting diodes. The light-emitting diodes may be colored diodes selected from red, green, blue, and combinations thereof. The light source may have an illumination profile suitable for reflection in the test strip assay. The light source may be positioned at an optical aperture that exposes light from the light source onto the assay. A first mirror may be located below the optical aperture. A focusing lens may receive light from the first mirror. A second mirror may be positioned to guide light from the focusing lens to a photodetector. An illumination processor may be configured to trigger the light source to emit a desired pattern of light. The illumination processor may include data storage for the desired emission patterns.

[0065] In another example, the photodetector does not produce a test result until the decoding sensor decodes the reference coding. The photodetector may be an optical-voltage sensor. The photodetector may include a photodiode in the optical path to the assay coupled to an integrated circuit. The integrated circuit may be a monolithic integrated circuit. The photodetector may include an amplifier. The amplifier may be a transimpedance amplifier or the like.

[0066] The device may include a memory configured to store information corresponding to imaging parameters for image detection. The decoding sensor may be selected from a color sensor, an RFID reader, a barcode reader, and a combination thereof. The photodetector may include an optical window configured to prevent debris from coming into contact with the photodetector. The photodetector may include an optical housing that surrounds the photodetector and is configured to prevent debris from coming into contact with the photodetector. The photodetector can monitor the progress of the diagnostic test. The photodetector can monitor pre-test parameters before generating diagnostic test results. The photodetector can monitor at least one pre-test parameter after the photodetector has acquired at least one image detection of the assay.

[0067] In another embodiment, in an assay measuring device having an imaging detector and a microprocessor, a memory is configured to communicate with the microprocessor and store information corresponding to imaging parameters. The memory may include instructions for monitoring the pre-test analysis of the assay. The memory may also include instructions for generating diagnostic test results of the assay. The pre-test parameters may include theoretical reflectance values.

[0068] In certain examples, the assay may include at least one test line and at least one control line, so that the theoretical reflectance value is a comparison between the reflectance value in the test line and the reflectance value in the control line. A reflectance value on the assay that does not match the theoretical reflectance value may indicate an inappropriate flow on the assay. An inappropriate flow may trigger a detectable signal to produce a no-result response. In certain examples, data for no-result responses are maintained and recorded as in any of the examples and embodiments illustrated and described herein. A reflectance value on the assay that does not match the theoretical reflectance value may indicate a previous test substance expression on the assay. The reflectance value may suggest a previous test substance expression and may trigger a detectable signal to stop the assay measuring device. A reflectance value on the assay that does not match the theoretical reflectance value may indicate contamination of the optical path.

[0069] A contaminated optical path can trigger a detectable signal to produce a no-result response. The command to produce a test result may correspond to image detection on the assay. Image detection may be a light reflectance value or a transmittance value. The assay may include at least one test line and at least one control line, so that the light reflectance value is a comparison between the reflectance value in the test line and the reflectance value in the control line. The apparatus may be configured to perform continuous image detection of the assay. The assay may be a lateral flow assay. The assay may be an elongated test strip of lateral capillary flow.

[0070] The inspection results can be determined within approximately 30 seconds of the photodetector's activation. The inspection results can also be determined within approximately 60 seconds of the photodetector's activation. The device may include a power supply. The power supply may be a vehicle battery. Furthermore, the photodetector can communicate with the vehicle's onboard system.

[0071] In other embodiments, an assay analyzer for generating test results from an assay may include an imaging detector and a microprocessor, the microprocessor having associated memory in communication with the microprocessor. The imaging detector may be configured to decode reference coding on the assay and to obtain image detection on the assay resulting from anomalies on the assay. The microprocessor may be configured to send signals to the imaging detector to generate test results. The memory may be in communication with the microprocessor and may be configured to store information corresponding to a plurality of imaging parameters. The memory may include parameters for monitoring pre-test analysis of the assay. The memory may include parameters for generating diagnostic test results from the assay.

[0072] The reference coding can activate the corresponding diagnostic test within the photodetector. The multichannel reader and reference coding can activate the corresponding channels within the multichannel reader. The apparatus may include an incubator, and the reference coding can activate the corresponding incubation temperature.

[0073] The imaging detector may be configured to decode an inspection reference code and may include a decoding sensor. The decoding sensor may be a color sensor. In certain examples, the decoding sensor may be an OCR sensor or the like. The color sensor may be a photodiode sensitive to wavelengths selected from red, blue, green, and combinations thereof. The decoding sensor may be an RFID reader. The decoding sensor may be a barcode reader.

[0074] Typically, the apparatus includes a light source. The light source may be an array of discrete light sources. The discrete light sources may comprise light-emitting diodes. The light-emitting diodes may be colored diodes selected from red, green, blue, and combinations thereof. The light source may have an illumination profile suitable for reflection in the test strip assay. The light source may be positioned at an optical aperture that exposes the light source to the assay. The light source may include a first mirror below the optical aperture. A focusing lens may receive light from the first mirror. A second mirror may be positioned to direct light from the focusing lens to a photodetector. An illumination processor may be configured to trigger the light source to emit a desired pattern of light. The illumination processor may include data storage for the desired emission patterns. The photodetector does not need to generate test results, or even begin reading the test, until the decoding sensor decodes the reference coding.

[0075] The photodetector may be an optical-voltage sensor. The photodetector may be a camera. The photodetector may comprise a photodiode coupled to an integrated circuit in the optical path to the assay. The integrated circuit may be a monolithic integrated circuit. The photodetector may include an amplifier. The amplifier may be a transimpedance amplifier or the like. The photodetector may include an optical window configured to prevent debris from coming into contact with the photodetector. The photodetector may further include an optical housing that surrounds the photodetector and is configured to prevent debris from coming into contact with the photodetector.

[0076] In some cases, a photodetector can monitor the progress of a diagnostic test. The photodetector can monitor pre-test parameters before generating diagnostic test results. Furthermore, the photodetector can monitor at least one pre-test parameter after the photodetector has acquired at least one image detection of the assay. The pre-test parameter may include a theoretical reflectance value. The assay may include at least one test line and at least one control line, where the theoretical reflectance value is a comparison between the reflectance value in the test line and the reflectance value in the control line. The theoretical reflectance value may be a pre-set parameter value for the control line or the test line. For example, the control line may be the theoretical reflectance value. A reflectance value on the assay that does not match the theoretical reflectance value may indicate an inappropriate flow on the assay. An inappropriate flow may trigger a detectable signal to produce a no-result response. Furthermore, a reflectance value on the assay that does not match the theoretical reflectance value may indicate a previous test substance expression on the assay. A previous test substance expression may trigger a detectable signal to produce a no-result response. Furthermore, reflectance values ​​obtained in the assay that do not match theoretical reflectance values ​​may indicate contamination of the optical path. A contaminated optical path can trigger a detectable signal that results in a response reading with no results and / or causes the assay instrument to shut down.

[0077] The instructions for generating the test results may correspond to image detection on the assay. The image detection may be a light reflectance value. The assay may include at least one test line and at least one control line, so that the light reflectance value is a comparison between the reflectance value on the test line and the reflectance value on the control line. The device may be configured to perform continuous image detection of the assay. The assay may be a lateral flow assay. For example, the assay may be an elongated test strip of lateral capillary flow. Furthermore, the device may include means for power supply.

[0078] In yet another embodiment, a lateral flow assay for detecting a test substance comprises a test zone and a control zone, and a surface having a reflectance profile, and includes at least one flow reference and at least one test result reference. The at least one flow reference region may be configured to allow monitoring of color development before the start of flow along the assay. The at least one test result reference region may be configured to allow monitoring of pre-test detection of the test substance in the assay.

[0079] The reflectance profile may include theoretical light reflectance measurements. The theoretical light reflectance measurements may include theoretical values ​​for expression without flow. The expression value for expression without flow may be a reflectance value of approximately 85. Reflectance values ​​greater than approximately 85 can generate a signal to stop the detection of the test substance. The flow reference region may include at least one downstream flow reference line. The downstream flow reference line may include a theoretical reflectance value after the flow reference line has received a flow of reagent. The flow reference region may include both an intermediate flow reference line and a downstream flow reference line. The intermediate flow reference line may include a theoretical reflectance value after the flow reference line has received a flow of reagent. The theoretical light reflectance measurements may include theoretical values ​​for pre-test expression without test substance. The flow reference may also be a control zone.

[0080] The inspection result reference area may include at least one inspection line having a theoretical reflectance value. The inspection result reference area may include at least one control line having a theoretical reflectance value. The inspection result reference area may include at least one inspection line having a theoretical reflectance value and at least one control line having a theoretical reflectance value. A preset difference between the theoretical reflectance value of at least one inspection line and the theoretical reflectance value of at least one control line can activate the inspection result. Furthermore, a preset difference between the theoretical reflectance value of at least one inspection line and the theoretical reflectance value of at least one control line can trigger an error. An error can cause the inspection result to be suspended.

[0081] In other embodiments, an elongated test strip for lateral capillary flow includes a test zone, a control zone, and a surface having a reflectance profile. The elongated test strip for lateral capillary flow may have at least one reagent for detecting at least one test substance in the sample. The test zone may have a test zone capture agent immobilized thereon, configured to capture at least one reagent. The control zone may include at least one control zone capture agent having different binding affinities for at least one reagent. The reflectance profile may be configured to allow continuous monitoring of the test strip until the test substance is detected. Typically, the test strip generates a detectable signal for the detection of the test substance in the sample. In some examples, improper control line expression, for example, due to reflectance and / or transmittance in the control line, may trigger an error. In these examples, the error may trigger a signal to produce a response with no result.

[0082] The test strip may include a coding system having at least one reference code having a corresponding test sequence. The test sequence may include at least one temperature control parameter. Furthermore, the test sequence may include optical reader test parameters. The optical reader test parameters may include reader channel selection. The reader test parameters may include relevant features selected from standard curves, dose-response curves, and combinations thereof. The reader test parameters may include at least one relevant positive control point and at least one relevant negative control point. The coding system may include a color matrix. The color matrix may include colors selected from red, blue, green, and combinations thereof. The color matrix may be associated with a corresponding diagnostic test. The coding system may include a barcode. The coding system may include an RFID tag.

[0083] The test strip may include a first end having a sample-absorbing material. The test strip may include a release strip for introducing a sample into the sample-absorbing material. The release strip may include a release tab at one end to facilitate movement of the release strip. The sample-absorbing material may be configured to accept about 0.1 to about 1.0 mL of fluid. The sample-absorbing material may include a dry cellulose material. Furthermore, the test strip may include a second end on the opposite side having a reactor detector material. The test strip may include a release region having a mobile phase receptor for at least one test substance. The test strip may be sized and configured to fit into a test strip cavity. Furthermore, the test strip may be sized and configured to fit into a test strip cavity of a removable incubation module. In certain examples, the test strip may be sized and configured to fit into a test strip cavity of a removable incubation and optical module. In a specific example, the test strip is configured to select the detection of a group of diagnostic tests chosen from antibiotic test substances, toxic test substances, test substance classes, combinations thereof, and so on.

[0084] The test zone may include at least one test substance reference line having a theoretical reflectance value. The theoretical reflectance value may be associated with flow parameters on the test strip. The test zone surface may include a first test substance reference line having a first theoretical reflectance value and a second test substance reference line having a second theoretical reflectance value. The control zone surface may include at least one control line having a theoretical reflectance value. For example, the theoretical reflectance value may be a light reflectance value. The control zone may include a first control line having a first theoretical reflectance value and a second control line having a second theoretical reflectance value. In some examples, the reflectance profile is configured to allow monitoring of the test strip before detection of the test substance. Furthermore, the test results can be detected within approximately 30 to 60 seconds.

[0085] In yet another embodiment, an elongated test strip of lateral capillary flow includes a test zone on which a test zone capture agent configured to capture at least one binder is fixed; a control zone including at least one control zone capture agent having different binding affinities for at least one binder; a surface having a reflectance profile configured to allow monitoring of the test strip; and a coding system having at least one coding signal, e.g., a coding corresponding to a test sequence characterizing the test strip. The reflectance profile may include at least one flow reference region configured to allow monitoring of flow expression along the assay and at least one monitoring reference region configured to allow monitoring of detection of the test substance on the assay.

[0086] The test sequence may include at least one temperature control parameter. The test sequence may include optical reader test parameters. The optical reader test parameters may include reader channel selection. The optical reader test parameters may include relevant features selected from standard curves, dose-response curves, and combinations thereof. Furthermore, the optical reader test parameters may include at least one relevant positive control point and at least one relevant negative control point. The coding system may include a color matrix. The color matrix may be associated with the corresponding diagnostic test. The coding system may include barcodes. The coding system may include RFID tags.

[0087] In some examples, the test strip may include a first end having a sample-absorbing material. The test strip may include a peel-off strip for introducing a sample into the sample-absorbing material. The peel-off strip may include a peel-off tab at one end to facilitate the movement of the peel-off strip. The sample-absorbing material may be configured to accept about 0.1 to about 1.0 mL of fluid. The sample-absorbing material may include a dry cellulose material. The test strip may include a second end on the opposite side having a reactor detector material. The test strip may include a release region having a mobile phase receptor for at least one test substance. The test strip may be sized and configured to fit into a test strip cavity. Furthermore, the test strip may be sized and configured to fit into a test strip cavity of a removable incubation and optical module. Typically, the test strip is configured to select a group of diagnostic tests, selected from antibiotic test substances, toxic test substances, test substance classes, combinations thereof, etc., either quantitatively, qualitatively, or both.

[0088] The test zone may include at least one test substance reference line having a theoretical reflectance value. Typically, the theoretical reflectance value is associated with a flow parameter on the test strip. The test zone may include a first test substance reference line having a first theoretical reflectance value and a second test substance reference line having a second theoretical reflectance value. The control zone may include at least one control line having a theoretical reflectance value. The theoretical reflectance value may be a light reflectance value. The control zone may include a first control line having a first theoretical reflectance value and a second control line having a second theoretical reflectance value. The theoretical light reflectance measurement may include a no-flow expression theoretical value. The no-flow expression value may be a reflectance value of about 85. Reflectance values ​​greater than about 85 can generate a signal to stop the detection of the test substance.

[0089] In other examples, the flow reference region may include at least one downstream flow reference line. The downstream flow reference line may include a theoretical reflectance value after the flow reference line has received a reagent flow. The flow reference region may include an intermediate flow reference line and a downstream flow reference line. The intermediate flow reference line may include a theoretical reflectance value after the flow reference line has received a reagent flow. The theoretical light reflectance measurement may include a pre-test expression theoretical value without the test substance. The test result reference region may include at least one test line having a theoretical reflectance value. The test result reference region may include at least one control line having a theoretical reflectance value. The test result reference region may include at least one test line having a theoretical reflectance value and at least one control line having a theoretical reflectance value. A preset difference between the theoretical reflectance value of at least one test line and the theoretical reflectance value of at least one control line can activate the test result. Furthermore, a preset difference between the theoretical reflectance value of at least one test line and the theoretical reflectance value of at least one control line can trigger an error. Typically, errors result in the inspection being unreliable, such as producing a response with no results.

[0090] In yet another embodiment, in an assay system having an incubator and a reader for generating test results from an assay, the sensor may be configured to continuously monitor the assay while the incubator incubates the assay and the reader generates the test results. The sensor may be configured to stop the incubator when the sensor detects an anomaly in the assay. The sensor may be a photodetector. The photodetector may be configured to detect reflectance values. The assay may include at least one test zone and at least one control zone, so that the reflectance value is a comparison between the reflectance value in the test zone and the reflectance value in the control zone. Furthermore, if the reader and / or incubator hood is opened during incubation or reading, the signal may produce a no-response. Furthermore, if the assay is removed before the test results are generated, the signal may produce a no-response.

[0091] In some cases, the assay can be stopped when the sensor detects a reflectance value on the assay that does not match a predetermined theoretical reflectance value on the assay. For example, a reflectance value on the assay that does not match the theoretical reflectance value may indicate an inappropriate flow on the assay. Furthermore, a reflectance value on the assay that does not match the theoretical reflectance value may indicate previous expression of the test substance on the assay. Similarly, a reflectance value on the assay that does not match the theoretical reflectance value may indicate contamination of the optical path.

[0092] In other examples, the sensor may be configured to stop the reader when the sensor detects an anomaly in the assay. The sensor may be a photodetector. The photodetector may be configured to detect reflectance values. The assay may include at least one test zone and at least one control zone, so that the reflectance value is a comparison between the reflectance value in the test zone and the reflectance value in the control zone. When the sensor detects a reflectance value on the assay that does not match a given theoretical reflectance value on the assay, it may produce a no-result response. A reflectance value on the assay that does not match the theoretical reflectance value may indicate an inappropriate flow on the assay. Furthermore, a reflectance value on the assay that does not match the theoretical reflectance value may indicate previous test substance expression on the assay. Similarly, a reflectance value on the assay that does not match the theoretical reflectance value may indicate contamination of the optical path.

[0093] The sensor may be a decoding sensor. Decoding sensors can be selected from color sensors, RFID readers, OCR readers, barcode readers, and combinations thereof. Typically, the sensor is triggered by an actuation element selected from hood sensors, incubator sensors, proximity switches, trigger switches, and combinations thereof.

[0094] The apparatus may include a housing configured to substantially enclose the reader and incubator. The housing may include insulation configured to withstand deformation during incubation. Furthermore, the housing may include a cavity configured to hold the assay in place and receive light from the reader. The cavity may include an optical aperture for receiving light from the reader. The cavity may include an adjustable fastener configured to position the cavity in the optical path to the reader. The cavity may include insulation configured to withstand deformation during the incubation period. The assay may be a lateral capillary flow test strip.

[0095] In certain examples, the system may include a user interface. The user interface may include, for example, an integrated circuit board for supporting a display board. The user interface may be configured to observe flow manifestations. Similarly, the user interface may be configured to observe test results, including responses with no results. The user interface may be configured to observe flow manifestations after a reader has detected at least one flow manifestation on the assay.

[0096] In another embodiment, a lateral flow assay system for generating test results from an assay includes an incubator configured to incubate the assay and a reader configured to read the diagnostic test of the assay. The assay may undergo changes upon contact with a sample and generate a test result.

[0097] In some examples, the system includes a removable assay module. The removable assay module may include an assay cavity configured to align the assay with the reader. The assay may be a lateral flow test strip. Thus, the assay cavity may be sized to accommodate the lateral flow test strip. The removable assay module may include a hood. The hood can enclose the assay in a closed test position and expose the assay in an open access position.

[0098] Furthermore, the removable assay module may include a bottom surface configured to align with at least one optical aperture on the reader. The bottom surface may include an adjustment fastener configured to optically align and secure the assay cavity with the reader. Furthermore, the bottom surface may include an engagement lip for positioning the bottom surface with the reader. The removable assay module may include at least one optical window. The removable assay module may be configured to be removed from the system and cleaned to remove debris.

[0099] In some examples, the incubator includes an adiabatic base. The incubator may also be a temperature-controllable incubator. A temperature-controllable incubator may include at least one temperature control unit. This allows the temperature-controllable incubator to include local temperature fluctuations. For example, the incubator may compensate for local temperature fluctuations. The incubator may compensate for local temperature fluctuations with an analog proportional circuit. In other examples, the incubator may compensate for local temperature fluctuations with a digital control circuit, for example, by utilizing a PID algorithm or PID controller. Furthermore, the temperature-controllable incubator may include a built-in temperature sensor. The temperature-controllable incubator may include a potentiometer. The incubator may include a heater. The heater may be selected from ceramic heaters, resistance heating elements, etc. Similarly, the incubator may include a cooling system. In yet another example, the incubator incubates the assay in means for generating an incubation environment.

[0100] The reader can perform continuous imaging detection of the assay to generate test results. Continuous imaging detection may include monitoring pre-expression along the assay flow, such as monitoring for excessive and inappropriate flow along the assay. The reader may include a light source oriented in a predetermined pattern relative to the assay. The light source may include a first mirror below the light source. The light source may include a focusing lens configured to receive light from the first mirror. Furthermore, the light source may include a second mirror positioned to guide light from the focusing lens to the reader.

[0101] In certain examples, the reader may include a sensor. The sensor may be a photodetector aligned with a light source for detecting the transmission of light through the assay. For example, the transmission embodiment described herein may include the analysis of refracted light from the assay. The sensor may be a decoding sensor. The decoding sensor may be configured to decode at least one reference code having a corresponding test sequence on the assay. Furthermore, the reader may include multiple channels. Each channel may include relevant features selected from standard curves, dose-response curves, positive cutoff values, negative cutoff values, etc.

[0102] In further embodiments, a method for generating test results from an assay includes incubating the assay in an incubation environment and reading the diagnostic test of the assay simultaneously with the incubation of the assay by the incubator. This method may include continuously sensing the assay while the incubator is incubating the assay. This method may include stopping the assay when an abnormality is detected on the assay. This method may include removing a removable assay module, for example, to clean debris from the assay module. This method may include preparing the assay by adding a test sample to a test medium. This method may further include enclosing the test medium within a reader. This method may include positioning the sensor relative to the test medium so that changes on the test medium can be detected by the sensor. This method may include decoding a reference coding on the assay. This may allow the method to select a channel in the reader corresponding to the reference coding on the assay. Furthermore, this method may include incubating the assay in the incubator according to the reference coding on the assay.

[0103] In one embodiment, a method for managing inspection data includes generating inspection results from an inspection device reader, enabling inspection result output communication between the inspection device and a partner device by linking an application on a partner device to the inspection device, subscribing to a first inspection result output from the device to the partner device, and transmitting at least one second result output in relation to the first output, selected from the group consisting of operator identification information, sample identification information, lot number, geographical location, geographical coordinates, sample notes, and inspection result notes.

[0104] In certain examples, the method includes establishing an authorized connection between an instrument and a partner device. Furthermore, the partner device application can scan for valid test instruments. The method may include real-time export of result outputs from the test instruments. In certain examples, the method includes relaying result outputs from the partner device to an external storage configuration. In certain examples, the method may include multiple test instruments.

[0105] In another embodiment, a method for relaying test data generated from a sample in a test instrument includes performing a diagnostic test on the test instrument, interfacing the test instrument with a mobile partner device having a corresponding data communication interface to establish effective data communication with the test instrument, converting the test results into a result output format suitable for transmission, establishing data communication exchange of result output between the test instrument and the partner device, and relaying the result output from the partner device to an external storage configuration. In a particular example, the test instrument may include one or more of the following: a housing, a receiving port for receiving a sample on a sample device, a reading device for generating test results from the sample device, and a data communication interface.

[0106] In certain examples, the method includes establishing data communication between the testing equipment and a partner device, such as linking an application on a partner device to the testing equipment. The partner application can scan for valid testing equipment. The partner application can subscribe to data from the testing equipment. The method may include real-time export of result outputs from the testing equipment to record multiple subsequent sample result outputs. Furthermore, the method may include merging multiple sample result outputs and their associated geographical locations, and mapping multiple result outputs. In certain examples, the method may also include generating a map display showing the toxin occurrence. The method may include establishing an authorized wireless connection between the testing equipment and a partner device, for example, using Bluetooth® Low Energy (BLE), a dongle, or a similar system. The method may include establishing a host IP address connection between the partner device and an external storage configuration.

[0107] In some examples, performing a diagnostic test includes receiving a test strip sample device and imaging the test strip sample device to generate test results. In some examples, performing a diagnostic test includes incubating the sample device. In certain examples, the method includes transmitting at least one sample identifier corresponding to an individual sample test result, selected from the group consisting of operator identification information, device identification information, sample identification information, lot number, geographical location, geographical coordinates, sample note, and test result note. In certain examples, relaying to external storage includes transmission to a remote host website. Furthermore, in certain examples, relaying to external storage includes transmission to a remote host server. In certain examples, the partner device comprises a smartphone having a data processing program as a downloadable application program. The partner device may have an indicator that provides a pairing signal when activated, and the indicator provides a visual indication of pairing with the test instrument. The method may include establishing a secondary messaging data communication exchange between the test instrument and the partner device.

[0108] In yet another embodiment, a testing device and a method for use at a host site configured to support test result data include connecting to a valid testing device having a first operating mode for performing at least one test on a sample and a data communication interface for communicating result output transmissions in a second operating mode, receiving authorized result output transmissions, and converting multiple result outputs into a data display.

[0109] In certain examples, the method includes storing multiple result output data in a first database. Establishing result output communication may include first establishing data communication with a partner device. For example, the partner device may be a mobile phone, tablet, general-purpose computer, PDA, digital media player, digital camera, wireless information device, etc. In some examples, the data can ensure that appropriately inspected food is delivered most efficiently to its assigned destination according to the inspection results. In other examples, the data may be collected from numerous sites and sources and, for illustrative purposes only, combined into a single database using low-cost tools and existing inspection equipment.

[0110] Another embodiment of this disclosure includes a central station external storage configuration, for example, a central station that is an external storage configuration with a web host. In a particular example, the external storage configuration is assigned a public static IP address to which inspection data is transmitted by one of the available deployed devices, if available.

[0111] Another embodiment of this disclosure includes an integrated data processing system that minimizes operator intervention. In some examples, setting up the device requires downloading and installing an app on a smartphone, connecting a Bluetooth adapter to a power source, pairing a device such as a Bluetooth® device with the smartphone, and then launching the app. Real-time display of inspection data on the smartphone can provide the user with confirmation that the inspection data has been properly transmitted to the phone and allows for attaching notes to the inspection data as illustrated and described herein.

[0112] In certain cases, if GPS is enabled on the smartphone, the inspection data may include the latitude and longitude at which the test was performed. In these methods, once the inspection data packets are collected on the phone, the app handles communication with the host central station and attempts to transfer the data when sufficient signal strength is available. The integrated communication protocol ensures that the data remains buffered on the phone until a signal from the host indicates successful collection.

[0113] In one embodiment, a method for preventing the transfer of a product in a delivery system includes performing a diagnostic test, relaying the test results to an external administrator portal, generating substantially continuous operating signals in a protocol converter and transmitting the signals to the administrator portal, receiving trigger conditions from the administrator portal in the protocol converter if such conditions exist, and triggering a relay configured to prevent the product from being transferred downstream. The test equipment may have a receiving port for receiving a sample on a sample device, a reading device for generating test results from the sample device, and a data communication interface.

[0114] In some examples, receiving a trigger condition includes receiving at least one positive test result. Performing a diagnostic test may include receiving a test strip sample device and imaging the test strip sample device to generate a test result.

[0115] Furthermore, performing a diagnostic test may include receiving a plate sample device and imaging the plate sample device to generate test results. Also, performing a diagnostic test may include receiving a swab sample device and analyzing the swab sample device to generate test results.

[0116] In certain cases, interfacing an inspection device with a mobile partner device involves establishing effective data communication with the inspection device. This method may include real-time export of result outputs from the inspection device, recording multiple subsequent sample result outputs. Furthermore, preventing product transfer may include activating relays that trigger events such as audible indicators, visual indicators, access arms, barrier gates, solenoid valves, or combinations thereof.

[0117] In one embodiment, the communication protocol converter includes a data communication interface, a peripheral processor platform that communicates data with an external administrator portal, and at least one relay module that electrically communicates with the processor platform and at least one external peripheral device, wherein the transmission of a trigger condition from the external administrator portal activates the at least one relay module.

[0118] In certain examples, the device includes an enclosure surrounding a peripheral processor platform and relay modules. The enclosure may generally be a metal enclosure positioned within the data communication range of the test equipment. The data communication interface may include a Wi-Fi connection. The data communication interface may also include an Ethernet connection (Ethernet is a registered trademark; the same applies hereafter). The relay module may include a single-pole double-throw relay. The single-pole double-throw relay may include two independently controlled contact relays. The single-pole double-throw relay may include two dry-contact relays. In other examples, the relay module may include a dual single-pole double-throw latch relay. The relay module may include input and output ports configured to trigger the relays. The processor platform can interface with any number of peripheral devices, including sensors, identification devices, etc. The device may include a power supply. Furthermore, the device may include a user interface.

[0119] Another embodiment is a product delivery assembly comprising an inspection device, a host database configured to support inspection result data generated by the inspection device, a communication protocol converter for data communication with the host database, and a product transfer blocking unit, wherein the product transfer blocking unit includes a product delivery assembly that is activated by the protocol converter after receiving a trigger condition.

[0120] In a further alternative embodiment, a method for managing inspection data includes generating inspection results from an inspection instrument, enabling inspection result output communication between the inspection instrument and a partner device by linking an application on a partner device to the inspection instrument, subscribing to a first inspection result output from the instrument to the partner device, and transmitting at least one second result output in relation to the first output, selected from the group consisting of operator identification information, sample identification information, lot number, geographic location, geographic coordinates, sample notes, and inspection result notes.

[0121] In certain cases, this method includes establishing an authorized connection between the instrument and a partner device. Furthermore, the partner device application can scan for valid test instruments. This method may include real-time export of result outputs from the test instruments.

[0122] In certain cases, this method includes relaying the result output from a partner device to an external storage configuration.

[0123] In another embodiment, a method for relaying test data generated from a sample in a test instrument includes performing a diagnostic test on the test instrument, interfacing the test instrument with a mobile partner device having a corresponding data communication interface to establish effective data communication with the test instrument, converting the test results into a result output format suitable for transmission, establishing data communication exchange of result output between the test instrument and the partner device, and relaying the result output from the partner device to an external storage configuration. In a particular example, the test instrument may include one or more of the following: a housing, a receiving port for receiving a sample on a sample device, a reading device for generating test results from the sample device, and a data communication interface.

[0124] In certain examples, the method includes establishing data communication between the testing equipment and a partner device, such as linking an application on a partner device to the testing equipment. The partner application can scan for valid testing equipment. The partner application can subscribe to data from the testing equipment. The method may include real-time export of result outputs from the testing equipment to record multiple subsequent sample result outputs. Furthermore, the method may include merging multiple sample result outputs and their associated geographical locations, and mapping multiple result outputs. In certain examples, the method may also include generating a map display showing toxin mapping occurrences. The method may include establishing an authorized wireless connection between the testing equipment and a partner device, for example, using Bluetooth® Low Energy (BLE), a dongle, or a similar system. The method may include establishing a host IP address connection between the partner device and an external storage configuration.

[0125] In one embodiment, a device that generates a test result from an assay when in contact with a sample comprises a non-planar optical module configured to align the assay to an offset position including an upper part that is angle-offset diagonally around a lower part, and a power over Ethernet (POE) power supply electrically connected to the device and configured to provide data and power connections to the non-planar optical module.

[0126] In certain examples, the device includes an incubator configured to incubate the assay. In certain examples, the device includes an imaging device configured to image the assay at an offset position. In certain examples, the device includes a direct dynamic control illumination assembly aligned around the assay.

[0127] In a particular example, the device includes a PoE power supply with at least one power supply port. The PoE power supply can control the power of the non-planar optical module. The PoE power supply can monitor the power consumption of the non-planar optical module. Multiple PoE controllers can be coupled to their respective physical network elements.

[0128] In one embodiment, in an assembly for generating test results from an assay, the optical module comprises an offset frame configured to receive an assay into which the assay is slid, and which includes an upper platform obliquely offset around a lower platform, and a stabilizer configured to stabilize the assay positioned at the offset position when generating test results.

[0129] In certain examples, the stabilizer includes a cover. The cover may comprise a spring-biased cover. The spring-biased cover may include at least one spring-biased support. Two substantially parallel spring-biased supports can fix the assay in the working position. The two substantially parallel spring-biased supports may be aligned around the assay packaging. The device upper platform may be aligned offset around the lower platform with respect to a pivot point. The offset frame can first receive a portion of the assay at a first substantially flat entry position. The offset frame can then align a portion of the assay at a second substantially non-flat examination position. The optical module may include an elongated optical aperture to enable imaging adjacent to bends around the assay at the examination position. The aperture carrier may include an assay line expression imaging region. The stabilizer can stabilize the assay independently of the examination environment. The stabilizer can stabilize the assay around the optical module during examination in a moving environment. The stabilizer can stabilize the assay during transit through uneven terrain in a moving environment. This moving environment may include collection by dairy supply trucks.

[0130] In certain embodiments, neither the assemblies nor the apparatuses of this specification may include a hood or hood-like feature. For example, in a hoodless assembly for generating test results from an assay, the optical module may include an offset frame comprising an upper platform obliquely offset around a lower platform and configured to receive the assay, and an aperture carrier configured to align around the frame and provide multiple optical windows when the assay is in the test position, and to provide clearance around the assembly for handling the assay.

[0131] The above summary is intended to summarize specific embodiments of the present disclosure. These embodiments are described in further detail in the drawings and the following description of embodiments. However, it will be clear that the description of embodiments is not intended to limit the invention, and the scope of the invention should be appropriately determined by the appended claims.

[0132] Brief explanation of the drawing The embodiments of this disclosure will be better understood by examining the descriptions of the embodiments while reviewing the drawings. [Brief explanation of the drawing]

[0133] [Figure 1] This is a front perspective view of one embodiment of a lateral flow assay system, with some elements omitted for clarity. [Figure 1a] This is a top perspective view of the embodiment shown in Figure 1. [Figure 1b] Figure 1 is a front perspective view of the separated element embodiment, with some elements omitted for clarity. [Figure 1c] This is a side perspective view of the embodiment shown in Figure 1b. [Figure 1d] Figure 1b is a bottom perspective view of the separated element embodiment, with some elements omitted for clarity. [Figure 1e] Figure 1 is a front perspective view of the separated element embodiment, with some elements omitted for clarity. [Figure 1F] This is a top perspective view of the embodiment shown in Figure 1e, in the closed position. [Figure 1g] This is a top perspective view of the embodiment shown in Figure 1e, in the open position. [Figure 1h] This is a rear perspective view of the embodiment shown in Figure 1e. [Figure 1i] This is a top perspective view of an embodiment of a separated element without a display. [Figure 1j]This is a top perspective view of an embodiment of a separated element without a display. [Figure 2] This is a front perspective view of one embodiment of a lateral flow assay assembly. [Figure 3] This is a side view of the embodiment shown in Figure 1. [Figure 3a] This is a top perspective view of an embodiment of a device having multiple integrated modules. [Figure 4] This is an exploded view of one embodiment of a lateral flow assay system. [Figure 5] This is a separated side perspective view of the embodiment shown in Figure 1, which is in operation, with some elements omitted for clarity. [Figure 5a] Figure 1 is a separated perspective view of one embodiment of the stabilizer closure device. [Figure 5b] Figure 5a is an exploded perspective view of the embodiment shown. [Figure 5c] Figure 1 is a separated perspective view of one embodiment of the stabilizer closure device. [Figure 5d] Figure 5c is an exploded perspective view of the embodiment shown. [Figure 5e] Figure 5b is a separated perspective side view of the embodiment of the opening carrier described. [Figure 5f] Figure 5b is a separated perspective rear view of the embodiment of the opening carrier described above. [Figure 5g] Figure 5b is a separated perspective top view of the embodiment of the opening carrier described. [Figure 5h] Figure 5b is a separated perspective side view of the embodiment of the opening carrier described. [Figure 6] This is an isolated side perspective view of one embodiment of a lateral flow assay after testing. [Figure 7] Figure 1 is a separated top perspective view of the embodiment shown, with some elements omitted for clarity. [Figure 7a] This is a side perspective view of the embodiment shown in Figure 7. [Figure 7b] This is a separated perspective view of an embodiment of a circuit board. [Figure 7c] This is an electrical circuit diagram according to one embodiment of the present disclosure. [Figure 7d] This is a comparative diagram showing the improvement of specular reflection according to one embodiment of the present disclosure. [Figure 7e] This is a side perspective view of the alternative embodiment shown in Figure 1. [Figure 7f] Figure 7e is a side perspective view of the alternative embodiment shown. [Figure 7g] Figure 7e is a front perspective view of the alternative embodiment shown. [Figure 8] This is a top view of the embodiment shown in Figure 1, with some elements omitted for clarity. [Figure 9] This is a front perspective view of one embodiment of an assay component useful in any of the present inventions illustrated and described herein. [Figure 10] This is a block diagram outlining the overall system according to the embodiments of this disclosure. [Figure 11] Figure 10 is a schematic diagram of the relay module introduced. [Figure 12] This is an illustrative overview of the main carrier substrate according to an embodiment of the present disclosure. [Figure 12a] This is a schematic diagram of one side of the main carrier substrate according to an embodiment of the present disclosure. [Figure 12b] This is a schematic diagram of one side of the main carrier substrate according to an embodiment of the present disclosure. [Figure 12c] This is a schematic diagram of the main carrier substrate according to an embodiment of the present disclosure. [Figure 12d] This is a schematic diagram of a power-over-Ethernet interface according to an embodiment of the present disclosure. [Figure 12e] This is a schematic diagram of a power-over-Ethernet interface according to an embodiment of the present disclosure. [Figure 13] This is an illustrative overview of an embodiment of the present disclosure. [Figure 13a] This is an illustrative overview of an embodiment of the present disclosure. [Figure 13b] This is an illustrative overview of an embodiment of the present disclosure. [Figure 13c] This is an illustrative overview of an embodiment of the present disclosure. [Figure 14] This is a top perspective view of one embodiment of a lateral flow assay system, with some elements omitted for clarity. [Figure 15] This is a top perspective view of one embodiment of a lateral flow assay assembly, with some elements omitted for clarity. [Figure 15a] This is a top perspective view of one embodiment of a lateral flow assay assembly, with some elements omitted for clarity. [Modes for carrying out the invention]

[0134] Description of the Embodiment In the following description, similar reference numerals indicate similar or corresponding parts in several figures. Again, in the following description, terms such as “forward,” “backward,” “left,” “right,” “upward,” and “downward” are for convenience only and should not be interpreted as limiting terms. It should be understood that the illustrations are for illustrative purposes only and are not intended to limit the disclosure or any invention.

[0135] In some embodiments, the testing apparatus is a lateral flow assay system configured to accept an assay sample device, analyze the assay, and generate a diagnostic test result. Typically, the assay sample device is a lateral flow assay strip. However, any assay device herein may be a non-lateral assay—including, but not limited to, a capillary flow assay strip—and this is within the spirit of the disclosure. Furthermore, any of the readers, incubators, reader / incubator composite devices and systems illustrated and described herein may include any optical analysis reader, which often includes an imaging device, a light source, and an imaging detector, for example, a sensor aligned so that light from the light source is irradiated onto the assay and then imaged / reflected onto the imaging sensor. Examples of useful leader components in embodiments of this specification are described in PCT / US2011 / 49170, filed on 25 August 2011, and U.S. Patent No. 6,124,585 (Apparatus for measuring the reflectance of strips having non-uniform color), issued on 26 September 2000, both of which are incorporated herein by reference in their entirety. Typically, the presence and, possibly concentration, of a test substance on an assay can be determined by measuring, for example, imaging from areas of expression on the assay, light reflectance, etc. In some examples, reflectance percentages can be used to determine the result. In other examples, transmittance can be used to detect the result. For example, the assay may be transparent and may include a surface having a transmittance profile similar to the reflectance profile described below. This structure and function described in these references can be configured by those skilled in the art to obtain a functional unit according to the disclosure herein.

[0136] In many cases, excessive pipetting or other sample delivery to an assay can cause assay overflow, leading to unreliable and inaccurate test results. Figures 1–12e illustrate elements and embodiments of the Optical Module 500, such as offset and non-planar, that are compatible with any of the features of the reader elements illustrated and described herein to minimize or eliminate the uncertainty and undesirable results of sample overflow. The applicant of this application has unexpectedly found that non-planar assay expression and testing mitigate many of these problems.

[0137] As shown in Figures 1, 3, and 5, the non-planar optical module 500 generally includes an upper distal portion 532 positioned adjacent to and substantially offset from the lower proximal portion 530. The proximal portion 530 may include a protruding overhand grip 525 for efficient and convenient access to manipulate any assay illustrated and described herein for the device, for example, during loading and unloading. The overhand grip 525 allows the user to conveniently position at least a portion of the assay so that it extends around the optical module in the operating position, for example, by allowing the proximal portion of the assay to protrude outside the device.

[0138] In certain embodiments, as shown in Figures 1 to 5h, the non-planar optical module 500 may include a power switch 700, a telecommunications port 702, a lower support 502, an interface shell 504, a bracket 506, and a base 508 supporting the positioning of an offset frame 512 for providing non-planar positioning. An aperture carrier 510 for aligning any of the optical systems illustrated and described herein is generally supported within the offset frame 512. The offset frame 512 generally includes a lower floor platform 520 aligned with an upper floor platform 522 on the opposite side, for example at a pivot point 516.

[0139] Any of the devices and assemblies illustrated and described herein may be useful in mobile, transport operations, and similar applications. For example, the applicant has unexpectedly discovered the advantages of improved readers and non-planar optical modules for inspection during transport operations, including, but not limited to, providing immediate test result feedback and bulk collection logistics to truck collectors, external sources, etc., in the collection of batch food supplies. The improved readers and non-planar optical modules enable uninterrupted inspection between multiple collection points, regardless of vibration, shaking, and motion in the vehicle, road conditions, etc., by stabilizing any assay illustrated and described herein in a safe inspection location independent of the transport / inspection environment. One particular advantageous application is to minimize or eliminate combinations of contaminated products with other uncontaminated products that fail the test, by providing accurate and reliable test results for collections at specific locations, such as during mobile batch dairy product collection in transport trucks. For example, if a test result from a certain collection point shows a positive result, the driver is notified to take immediate action. In certain cases, the truck driver is notified on an in-cabin screen communicating with any of the systems and assemblies described herein, but those skilled in the art will be able to understand further notifications by benefiting from this disclosure. Furthermore, emergency actions in response to a positive test result may include initiating further testing, discarding the product, diverting the transport to a designated location, or a combination thereof.

[0140] For example, a stabilizer or similar structure can fix any of the assays illustrated and described herein in a suitable operating position to improve transport inspection. In certain embodiments, the cover 514 is a spring-biased cover for stabilizing and fixing assays, such as lightweight lateral flow assay strips, but is not limited to these. As shown in Figures 5a–5d, the spring-biased cover may include a spring-biased support 534 positioned between the cover 514a and the offset slide frame 512, such as one of the extensions illustrated and described herein, to facilitate access for aligning / removing assays in a fixed / stable position around the device. Other embodiments of the cover include a single cover, such as at least a substantially integrated cover, to provide access for aligning / removing assays around the device in any of the examples illustrated and described herein. As shown in Figures 5c and 5d, an embodiment of the integrated cover includes a cover 514b aligned with an integrated support 534b around an offset slide frame 512 to stabilize the assay, including the assay support material, packaging material, etc. Those skilled in the art will benefit from the present disclosure and will understand further covers, latches, doors, windows, and similar mechanisms to provide improved stabilization, as well as access to and / or concealment, containment, etc., of the assay during operation. An example of a bulk product collection inspection useful in the examples and embodiments of this specification is described in PCT / US2019 / 020535, filed on March 4, 2019, which is incorporated herein by reference in its entirety.

[0141] In certain embodiments, the assay is inserted into the frame and, for example, fed into the test position. At the test position, the flat proximal portion 530 can position the assay elements in a substantially flat position, while the non-flat distal portion 532 positions the assay elements in a substantially non-flat position. For example, as illustrated and described herein, the test line 42, the control line 40, and any combination thereof can be positioned adjacent to a pivot point 516' generated by the positioning of the assay within the cradle module, for example, aligned to such a pivot point, aligned above such a pivot point, or positioned substantially adjacent to such a pivot point. In certain examples, the non-planar distal portion 532 is positioned at an offset of about 10 to about 30 degrees from the planar proximal portion 530. For example, the non-planar distal portion 532 may be positioned at an offset of about 20 degrees from the planar proximal portion 530. Other examples include varying degrees of offset between the distal portion 532 and the proximal portion 530. In certain cases, the optical module can image the assay adjacent to the bending portion of the assay at the operating position at point 516', for example.

[0142] As shown in the illustration, a generally flat assay strip is inserted into the cradle module 500, i.e., along the proximal portion 530, and then bends generally non-flatly as the assay strip protrudes into the non-planar distal portion 532. Unexpectedly, the applicant of this application has found that the wicking and flow advantages and elements allow the sample flow to proceed along the assay strip in the operating position (i.e., within the offset frame), for example against gravity, toward the distal portion 532, while the non-planar alignment with respect to the pivot point, for example, prevents excessive sample flow into the test area of ​​the distal portion 532, while allowing for proper flow. In certain examples, about 40% to about 70% of the assay strip's length, such as about 60%, may be aligned with the non-planar distal portion 532 in the operating position illustrated and described herein. Other examples include, for example, various length ratios between the distal portion 532 and the proximal portion 530, to suit field testing conditions, multiple test and control line expressions, testing of the target substance, etc., as can be understood by those skilled in the art through the benefit of this disclosure.

[0143] As illustrated in Figure 8, useful elements of a lateral flow assay system are shown for application at the test site. The lateral flow assay systems illustrated and described herein typically include a reader, a combination of a reader and an incubator, etc. While the reader may include imaging cameras, devices, detectors, etc., such as sensors, any of the incubator embodiments herein may further include an insulating base, a heat shield, or similar incubation environment components to deliver and maintain a desired test temperature. In some embodiments, the insulating base is a removable assay module. In certain examples, the reader first monitors the assay for one or more monitoring values, such as flow conditions or flow rate, expression of previous test material, and debris. In various examples, if the system detects appropriate monitoring values, the incubator incubates the assay and the reader generates the test results.

[0144] As shown in Figure 8, a lateral flow assay system is configured to accept an assay, analyze the assay, and generate diagnostic test results. Typically, the assay is a lateral flow assay strip. However, any assay described herein may be any other flow assay, and this is within the spirit of the disclosure.

[0145] In one embodiment, an apparatus for generating test results from an assay upon contact with a sample includes a non-planar optical module 500 configured to align the assay to an offset position including an upper part angle-offset around a lower part; an incubator configured to incubate the assay; an imaging device configured to image the assay at the offset position; and a direct dynamic control illumination assembly aligned around the assay. In certain examples, as shown in Figures 1b–1d, the optical module 500 may have an optical system 507 that is removable from the opening 509 of the apparatus, such as a replaceable optical system 507. The optical module may include calibration sequences. Any of the calibration sequences described herein may be housed in the module, for example, to improve support for the removable and replaceable optical module. The optical module may include any bends aligned between the upper and lower parts as illustrated and described herein.

[0146] Certain embodiments include modular systems that provide multiple integrated modules to provide any one or more test results as illustrated and described herein. For example, Figure 3a shows an assembly having multiple modules 500', 500'', 500''', and 500''' that perform any of the operations illustrated and described herein for assays 21', 21'', 21''', and 21'''', respectively. The multiple modules may operate simultaneously or at different time stages to provide any of the associated test results illustrated and described herein. Furthermore, the multiple modules may perform the same type of assay or multiple different assay types to provide any combination of test results. As illustrated, the multiple test results may be integrated into a display as shown in Figure 3a, or communicated to different sources such as a truck driver, an external third-party source, as shown in Figures 3a and 1i / 1j. Those skilled in the art will benefit from this disclosure to understand the various combinations, operations, and orientations of modular systems.

[0147] In certain examples, the apparatus may include an aperture carrier, such as an aperture carrier thermal block 510, as shown in Figures 4–5h. The aperture carrier thermal block may include an elongated optical aperture 511'. The elongated optical aperture 511' can provide an elongated assay observation area for any assay illustrated and described herein. The applicant of this application has unexpectedly discovered the advantage of imaging substantial lengths, such as the entire length of the assay expression area. In certain examples, the apparatus produces an observation expression area that is approximately 150 × approximately 1500 pixels long, while other examples include any combination of expression areas of pixel size.

[0148] The apparatus may include an assay line expression image region 546. The aperture carrier thermal block may include a reference coding aperture 540. The reference coding aperture 540 can provide an observation region for any reference coding as illustrated and described herein. For example, the reference coding may include a barcode. The apparatus may include a reference coding image region 548. The aperture carrier thermal block may include a reference explanation aperture 542. The reference explanation aperture can provide an observation region for any reference explanation as illustrated and described herein. The apparatus may include any corresponding explanation image region. The explanation image region may include an optical character recognition image region 555.

[0149] In certain examples, the opening carrier heat block may include chamfered edges 563 to prevent, for example, unintended movement, misalignment, or blockage around, for example, a raised portion of the assay. The opening carrier heat block may include clearance channels 561 to provide clearance for any assay operation around the opening carrier heat block as illustrated and described herein. In certain examples, the bottom surface of the opening carrier heat block may include a temperature sensor opening 567 for thermal coupling to, for example, any corresponding temperature sensor as illustrated and described herein. Furthermore, the bottom surface of the opening carrier heat block may include at least one mounting opening 565. As also illustrated, the bottom surface of the opening carrier heat block may include a concave contoured surface 569. As illustrated, the concave contoured surface 569 may be recessed from the top surface 571. For example, the apparatus may include a wall 573 that substantially separates the concave contoured surface 569 from the top surface 571 in order to provide any of the illumination environments for the assays illustrated and described herein.

[0150] In certain examples, the optical module may include proximity switches configured to block the path of the optical interrupter to trigger incubation, detection of light transmission around the assay, imaging of the assay, or a combination thereof. The device may perform at least two image detections of the assay. The imaging device may monitor at least one pre-test parameter after accepting the assay. A direct dynamic control illumination assembly may include multiple light sources. Multiple light sources may be configured to provide illumination around the assay while minimizing specular reflection at least a portion of the assay. Multiple light sources may provide illumination around the assay without specular reflection. Multiple light sources may be aligned along an imaging bracket. The imaging bracket may include inclined alignment with respect to a surface. Light sources may be positioned on both sides of the imaging bracket to provide any of the illuminations illustrated and described herein, as shown through various figures, such as Figures 7–7g, but not limited to these. For example, multiple light sources may be positioned substantially opposite the assay at the test location. Multiple light sources may provide a periphery of dispersion outside the section of the assay. The edges of the dispersion angle may be outside the assay section without specular reflection.

[0151] Any of the light sources illustrated and described herein may be independently variable for supply, control, or cooperation with similar systems. For example, the device may include a dual digital-to-analog converter. The dual digital-to-analog converter may include two independently controlled voltage sources. The dual digital-to-analog converter may maintain a constant current. Also, as shown in Figure 7c, the dual digital-to-analog converter may monitor the voltage at one current-limiting resistor to maintain a constant current. The device may monitor a voltage proportional to the light intensity of at least one of the multiple light sources. The device may include monitoring a low-impedance voltage output. The low-impedance voltage output may be proportional to the current flowing through at least one of the multiple light sources.

[0152] Various housings may enclose the optical module 500, reader, and / or incubator as an integrated diagnostic unit. Other embodiments include housings that partially enclose components of the lateral flow assay system. In certain examples, the cavity is enclosed with an insulating material, such as a plastic material, a thermoplastic resin such as polyoxymethylene known as Delrin (DELRIN is a registered trademark of DuPont), to insulate the cavity so as not to deform when heated to the temperature required to produce the test results.

[0153] The applicant of this application has unexpectedly discovered the advantages of the non-planar systems and assemblies of this specification when operating a test strip having multiple line expressions in various regions on the test strip, as described below and shown in Figure 9, for example, along a multi-test substance detection test strip. For example, a multi-test substance detection test strip that tests multiple drug families, etc., can support variable binder strength with the speed of binding limitation, which is affected by excessive pipetting, sample pooling, improper flow, etc.

[0154] Any of the readers illustrated and described herein may include a variety of light sources, such as a light bar aligned along the tilt pitch of the device, an incandescent bulb, a fluorescent tube, or a light-emitting diode. In some examples, the light source may be a discrete light source, such as an array of colored light-emitting diodes selected from red, green, blue, and combinations thereof. In yet another example, the light source may be an individual light source, such as a single diode. Typically, the light source is driven by an electric current and is configured to emit an illumination pattern suitable for reflection onto the assay, for example, along an elongated inspection strip. In certain examples, the light may be directed onto the assay, for example, through the cavity and aperture 511. In certain examples, the light may be reflected from the assay and directed onto a photodetector, again through the cavity aperture.

[0155] In certain examples, the optical circuit board may have multiple light-emitting diodes (LEDs) mounted in a predetermined pattern around a light-emitting aperture, for example. The LEDs may be mounted on one side of the optical circuit board. The photodetector array may be mounted on the back side of the same optical circuit board. Furthermore, a first mirror may be positioned below the light-emitting aperture at a predetermined angle with respect to the circuit board, for example, about 315 degrees. A second mirror may be positioned below the photodetector at an angle of about 220 degrees with respect to the circuit board, for example, such that there is a substantially 90-degree angle between the first and second mirrors. A focusing lens may be positioned between the first and second mirrors. This allows light emitted from the LED array to illuminate the assay, and then the light is reflected from there, passes through the light-emitting aperture to, for example, the first mirror, from the first mirror through the focusing lens to the second mirror, and from the second mirror to the photodetector. In this respect, the light striking the photodetector allows the photodetector to generate a measurable voltage. In a further example, an optical processor may be coupled to a light source to operate the light source and supply the appropriate current to each light to generate a desired emission pattern. The optical processor may also be used to read and store data from a photodetector. Furthermore, the optical processor may be used to adjust the output of an array of discrete light sources so that the emission pattern hitting the photodetector array has a uniform intensity. The illumination processor may include data storage for the desired emission pattern.

[0156] Furthermore, the light source may be an LED light source containing red, green, and blue LED devices within a single package. For example, an LED light source for a color sensor could be three separate LEDs. Similarly, a single white LED and three separate photodiodes with narrow bandwidth responses at red, green, and blue wavelengths can be used as a detector front end.

[0157] In yet another example, a single LED is used in conjunction with a voluntary feedback loop. The feedback loop can use a photodiode to sense fluctuations in the light output from the single LED. When the light output changes, a signal is sent to allow for appropriate adjustments, such as increasing or decreasing the current to the LED. Changes in reflectivity may result from the coupling of labels containing colored particles, such as gold beads. Alternatively, changes in reflectivity may result from contaminants and interference in the optical path.

[0158] Some embodiments include a plurality of readers that can be positioned around a modular interface 600 (e.g., shown in Figure 2), and / or the readers may be programmed with a plurality of channels, each having distinct parameters relating to the relevant diagnostic test. Each channel selection parameter may include a standard curve, a dose-response curve, and so on. A particular example includes any various offset alignment cradles 500 positioned around a carrier substrate, e.g., slot 552, to support a plurality of optical units useful for multiple tests simultaneously. For example, a particular module may provide a plurality of test strips having identical specifications, or specific test parameters for test strips having unique incubation temperatures, incubation timeframes, test emergence specifications, and monitoring specifications. The modular interface can further accommodate any various test elements, including drip trays 556, strip holders 554, lens mechanisms, and so on, as can be understood by those skilled in the art through the benefit of this disclosure.

[0159] Embodiments include, but are not limited to, various user interfaces, modular interfaces, or tangential electronic devices on the reader, such as handheld devices, telephones, computers, in-vehicle analysis during batch pickup, and vehicle displays. In certain examples, the user interface includes an integrated circuit board supporting a display board. In certain examples, the user interface allows the user to observe flow expressions. Furthermore, the user interface may allow the user to monitor subsequent flow expressions after the reader has already detected at least one flow expression on the assay. Similarly, the user interface may display final test results, including responses with no results.

[0160] Figure 9 shows one embodiment of an assay element for a specific diagnostic test having components useful in the embodiments of this specification, including those described in U.S. Patent No. 7,410,808 issued on 12 August 2008, No. 7,097,983 issued on 29 August 2006, No. 6,475,805 issued on 5 November 2002, No. 6,319,466 issued on 20 November 2001, and No. 5,985,675 issued on 16 November 1999, as well as U.S. Patent Application No. 11 / 883,784 filed on 6 August 2007, all of which are incorporated herein by reference.

[0161] In certain embodiments, any of the inventions herein can be triggered, for example by a positive test result, to prevent contaminated and / or low-quality products from being transferred to a mixture with good products, such as products with a negative test result. Specific examples of indicators triggered by the examples herein include, for example, audible and / or visual indicators placed in the receiving bay or along various points in the processing line to warn of the detection of products with a positive test result. Further blocking mechanisms may include preventing tank trucks from accessing the receiving bay by gate access control arms or barrier gates, or blocking the flow of products by solenoid valves. Those skilled in the art will benefit from this disclosure and understand further blocking mechanisms that operate by any of the examples and embodiments illustrated and described herein.

[0162] For example, various embodiments include a communication protocol converter that communicates data with an administrator portal, database, software, etc., and provides data exchange and trigger events to any of the product movement blocking units illustrated and described herein. Figure 10 shows the components of one communication platform embodiment having a display, a peripheral processor platform 14, multiple data communication interfaces including, but not limited to, a WiFi interface 20, an Ethernet interface 22, and channel connection units 28, 28' for accepting relay modules 18, 18'.

[0163] In certain examples, plug-in modules 18, 18' may be single-pole double-throw relays. A single-pole double-throw relay may have two independently controlled dry-contact relays. In certain examples, a single-pole double-throw relay may activate any of the indicators illustrated and described herein. In other examples, plug-in modules 18, 18' may be dual single-pole double-throw latching relays, where the relays latch to reduce or minimize current for prolonged operation. Furthermore, the relays may be rated to 250V AC with a current of 16 amps, although other examples may include additional loads and currents to meet specific field demands.

[0164] In certain examples, the system includes onboard diagnostics to determine overall health in order to generate any of the operational signals illustrated and described herein. Programmable trigger conditions from the portal, such as a "positive" test result, can initiate transmission to perform blocking actions. Furthermore, an administrator portal, etc., may allow IP address entries for devices. Each channel may have independent control, and the administrator portal can catalog / operate any variety of devices and systems.

[0165] In a particular module, the test equipment establishes valid, i.e., approved, authorized, and / or available data communication between the test equipment and a mobile partner device having a corresponding data communication interface, including one of the data communication systems illustrated and described herein. A particular example of a partner device receives the test result data communication before relaying the test result output to an external storage configuration. In a particular example, the module may include linking an application on the partner device, such as a downloadable program application, to the test equipment. Furthermore, the module may include establishing a data communication exchange of result output between the test equipment and the partner device. Also, the module may include establishing secondary messaging data communication between the test equipment and the partner device, including, but not limited to, email and text messages.

[0166] Any of the testing equipment described herein can interface with a partner device to relay test results to an external storage configuration, or the testing equipment can directly interface with an external storage configuration to provide any of the benefits illustrated and described herein. In certain examples, the partner device is a smartphone, but other partner devices include tablets, general-purpose computers, PDAs, digital media players, digital cameras, wireless information devices, and the like.

[0167] Those skilled in the art will be able to understand, by benefiting from this disclosure and the incorporated testing and sampling devices, further interface configurations between partner devices and testing devices, communication exchanges between partner devices and external storage configurations, direct exchanges between testing devices and external storage configurations, and other data communication and storage functions within the spirit of these inventions.

[0168] In certain embodiments, the devices and assemblies of this specification may operate via a power-over-Ethernet power scheme, for example. For instance, as shown in Figures 12–12e, the main carrier board 800 may support a power-over-Ethernet interface 804 to provide power to one or more of the elements illustrated and described herein. As shown in Figures 12–12e, the main carrier board 800 / power-over-Ethernet interface 804 may transmit power along with data to any reader, incubator, and communication element illustrated and described herein via an Ethernet cable or the like. Those skilled in the art will benefit from this disclosure and understand the useful elements and explanations of PoE found in https: / / wikipedia.org / Power_over_Ethernet, etc., whose teachings are incorporated herein by reference. In a particular example, the main carrier board 800 provides data communication to any display interface illustrated and described herein, such as a unit display, track display, external display, or touch panel interface. In a particular example, as shown in Figures 12–12e, the power over Ethernet interface 804 may include a DC power decoupler, a transceiver, and a Bobsmith plane 810 communicating with the chassis 820.

[0169] Generally, a lateral flow assay 21 is a generally flat membrane-based assay device prior to operation / testing in any of the examples illustrated and described herein, in which a sample suspected to contain the test substance of interest is placed at or near one end of a membrane strip. The sample is carried to the opposite end of the membrane strip by a mobile phase that traverses the membrane strip, for example by capillary action. The test substance in the assay sample, if present, encounters one or more reagents while traversing the membrane strip. The reagents may include a binder for the test substance. The binder may be mobile and therefore flow with the sample, or it may be fixed on the assay strip as a capture agent. Depending on the assay configuration, either the test substance binder, the test substance itself, or any other reagent in the assay system generates a detectable signal by being captured by the fixed capture agent. The signal may be generated by a label provided within the assay. The detectable signal can be measured by an optical reader or the like. As illustrated and described herein, the applicant of this application unexpectedly discovered the advantage of aligning the assay or a portion thereof to a non-planar position, which minimizes the impact of in-line sample delivery, including dropping, while the mobile phase moves along the assay.

[0170] Assay 21 may include at least one test line 40 in the test zone and at least one control line 42 in the control zone. The theoretical reflectance value may be a comparison between the reflectance value in test line 42 and the reflectance value in control line 40. A preset difference between the theoretical reflectance value in test line 42 and the theoretical reflectance value in control line 40 can activate a lateral flow assay system including a reader and generate test results. Furthermore, another preset difference between the theoretical reflectance value in test line 40 and the theoretical reflectance value in control line 42 can trigger an error. An error trigger can cause the microprocessor to withhold test results, such as by generating a no-result response or stopping the reader and / or incubator. Other embodiments include a comparison between the transmittance value in test line 40 and the reflectance value in control line 42.

[0171] A rapid results assay is beneficial for any of the non-planar testing examples and embodiments illustrated and described herein. For example, the rapid results assay provides final test results within approximately 15 seconds to 1 minute, such as final test results within approximately 30 seconds. In other examples, the reader generates test results within approximately 10 seconds to 15 minutes. To increase the speed of test results, the applicant unexpectedly discovered that optimizing the overlap of the binder-coated areas on the nitrocellulose membrane in the assay enables final test results beneficial for any of the non-planar testing processes and embodiments illustrated and described herein. In a particular example, a 3 mm overlap of the binder-coated areas on the nitrocellulose membrane optimizes the contact surface area between the binder-coated areas and the nitrocellulose membrane, increasing sample flow and release to meet the 30-second test of this specification. In a particular embodiment, the binder-coated areas may be, for example, POREX® (POREX is a registered trademark of Porex Technologies Corp. of Georgia, USA) mounted on a solid support. Furthermore, in certain embodiments, the nitrocellulose membrane can be optimized to meet the 30-second rapid test requirements of this specification, for example, ensuring that the sample is efficiently, rapidly, and appropriately absorbed across the membrane to produce the rapid test result analysis illustrated and described herein. However, those skilled in the art will benefit from this disclosure and understand the spacing of further binder-coated areas and / or binder-coated areas around the nitrocellulose membrane.

[0172] Furthermore, the applicant of this application unexpectedly discovered that by optimizing the length of the absorbent pad in the distal portion of the assay, capillary action can be enhanced, thereby adjusting the rate of sample flow to meet the requirements of non-planar tests, such as the 30-second rapid test described herein. In a particular example, an absorbent pad 31 millimeters in length optimizes the sample flow along the assay.

[0173] In certain embodiments, reflectance values ​​on the assay that do not match theoretical reflectance values ​​may indicate improper flow of the mobile phase on the assay. For example, assay 21 may have a flow line 44 with corresponding theoretical light reflectance measurements. An expression value without flow may be a reflectance value of about 85 on the reflectance scale. Such improper flow may trigger a detectable signal to produce a response without results. Further examples include stopping the lateral flow assay system 1, such as by stopping the reader and / or incubator. In other examples, the flow reference region may include both an intermediate flow reference line 46 and a flow reference line 44, both having corresponding theoretical reflectance values.

[0174] Similarly, reflectance values ​​on an assay that do not match theoretical reflectance values ​​may also indicate previous test substance expression on the assay. Such previous test substance expression can trigger a detectable signal that produces a no-response. Furthermore, if the assay is removed before it produces a test result, the system may produce a no-response result.

[0175] In some embodiments, the packing and / or support material of assay 21 includes a coding reference component having a corresponding inspection sequence for a lateral flow assay system. The coding may be, for example, alphanumeric coding, color coding, barcodes, RFID tags, etc., and may be positioned at any location along the assay on the surface of the assay packing, support, etc., so that a decoder sensor can decode the reference code. For example, in some examples, the coding reference is positioned along the distal end of assay 21. Depending on the type of coding on the inspection strip, the reader may require an integrated decoding sensor, such as a barcode reader, RFID decoder, or color sensor.

[0176] In a particular example, the test sequence is at least one temperature control parameter within the incubator and / or channel selection for the reader. Furthermore, the reader test parameter may include relevant features selected from standard curves, dose-response curves, etc. Other embodiments include various test sequence parameters for relevant diagnostic tests performed in the assay.

[0177] In some examples, one or more color matrix reference codes, including colors selected from red, blue, green, and combinations thereof, can be associated with corresponding diagnostic test parameters. When color coding is used in assay 21, the colors can be read by a reader, either by a separate optical reading system or by the same system that reads the test results. That is, the assay may include colored portions that are placed in the system and, after the test has started, are read by a color sensor to determine the reader channel and / or appropriate incubator temperature. For example, a photodiode with a wide dynamic range sensitive to red, green, and blue wavelengths can be used as a detector. Red, green, and blue LEDs can be used as light sources. Each LED can be turned on sequentially, and the detector is used to determine the reflectance of each color. A black surface (completely absorptive as it contains no color) does not produce reflectance for a given LED wavelength, and therefore the detector produces a low output reading. A white surface produces the maximum reflectance for all three LEDs. Different colors (depending on their content on the surface being measured) produce output from the detector at different levels.

[0178] Such color sensor components may be configured as separate sensing components within the system, or as a single component that detects both expression and color coding on the test strip, depending on the sensor used to read the test strip results. In various examples, the assay may be coded with a color that defines the test being performed. For example, red may indicate a test strip used to detect beta-lactam antibiotics. Different matrices can also be distinguished by the color system. In the red example, after the system detects red on the test strip, the reader and / or incubator may be automatically configured to suit that particular assay 21, for example, by adjusting the temperature of the incubator and selecting appropriate reflectivity test parameters in the reader. Thus, in some embodiments, the system may provide an integrated diagnostic test unit triggered by a specific reference coding on the assay.

[0179] In other examples, the coding reference may include a radio frequency identification (RFID) tag. Such an RFID signal is transmitted from the tag to a decoding RFID sensor module. This signal can be used to initiate analytical testing sequences, events, channels, temperatures, etc., in a reader and / or incubator. Similarly, the reference coding may be a barcode, which is placed on the assay and a barcode reader decodes the reference coding and associated testing sequence information.

[0180] In certain examples of closed testing locations, heating elements, incubators, etc., can incubate assay 21 in an incubation environment. For example, the incubator may heat and / or cool assay 21 to provide a suitable incubation environment for the corresponding assay and diagnostic test. Typically, the incubator can contact the cavity and maintain a constant temperature within the cavity by either heating or cooling at a predetermined rate. In some examples, the incubator includes an insulating base. In other examples, the incubator incubates a removable assay module, as described below. The incubator may be a temperature-controllable incubator. In these examples, the temperature-controllable incubator may include temperature control. In a further embodiment, the temperature-controllable incubator may allow for localized temperature changes.

[0181] An incubator may include a heater. The heater may be a ceramic heater, a resistive heating element, etc. In certain examples, the cavity is designed to be small so that the heater only needs to draw a minimal current. In this way, power requirements are minimized by heating only essential areas and providing insulation around those areas. The use of various heating algorithms may be useful. For example, proportional-integral-derivative (PID) algorithms can be used. In other examples, the incubator may compensate for local temperature fluctuations from a selected target temperature, such as a target temperature determined by a corresponding inspection sequence. The incubator may compensate for local temperature fluctuations with an analog proportional control circuit. In other examples, the incubator may compensate for local temperature fluctuations with a digital control circuit, for example by utilizing a PID algorithm or PID controller. Furthermore, those skilled in the art will understand that PI, PD, P or I controllers and / or algorithms do not preclude any of the inventions herein. For example, a temperature-adjustable incubator may include a digitally controlled potentiometer that allows a microprocessor to select the temperature. In other examples, the algorithm is particularly useful when test results are affected by small temperature fluctuations. Embodiments include an incubator control system that eliminates the need for manual adjustment by using a built-in digital temperature sensor and digital potentiometer that provides both accurate temperature reporting and a mechanism that allows adjustment by a microcontroller of a standalone analog incubator control circuit. In one particular embodiment shown in Figure 7a, for example, an integrated heater 708 with a thermal fuse and a temperature sensor can incubate an assay in any of the incubation environments illustrated and described herein.

[0182] In a further embodiment, cooling may be advantageous to lower the incubation environment temperature, for example, to stabilize the environment of the test medium and / or sample prior to incubation.

[0183] In certain examples, the inspection strip 21 may include a first end having a sample-absorbing material, such as a sample-absorbing material that can be exposed by manipulating a component. For example, the inspection strip 21 may have a release strip 50 for introducing a sample into the sample-absorbing material. The release strip 50 may include a release tab at one end to facilitate the movement of the release strip 50. The sample-absorbing material 50 may be sized and configured to accept about 0.1 to about 1.0 mL of fluid. Furthermore, the sample-absorbing material may be composed of a dry cellulose material. The sample-absorbing material may be flat or non-flat. Other embodiments include other materials for the sample-absorbing material.

[0184] In certain embodiments, assay 21 also includes a second end on the opposite side having a reactor detector material. Assay 21 may support a release region having a mobile phase receptor for at least one test substance. Typically, assay 21 is configured to select a group of diagnostic tests selected from antibiotic test substances, toxic test substances, test substance classes, combinations thereof, etc.

[0185] In certain embodiments, a photodetector is aligned with the assay and in the optical path and configured to acquire image detection on the assay, performing continuous image detection acquisition of the assay. In one particular embodiment shown in Figure 7a, the housing 508 can support a camera 706 supported on, for example, a camera ribbon from a substrate. Furthermore, any illumination arrangement can improve the imaging of the assay, such as, for example, a light bar 710 shown in Figure 7a. The light level detector 706 can detect the internal illumination level during operation to trigger the maintenance of consistent illumination with respect to the assay, i.e., feedback, etc., to improve imaging and / or minimize the occurrence of undesirable shadows. Unexpectedly, the applicant of this application has found that the addition of a wall foundation adjacent to the imaging device and white reflective material further minimizes the occurrence of undesirable shadows and improves any of the examinations illustrated and described herein.

[0186] The sensor may be a single camera, multiple cameras, a single photodiode, multiple photodiodes, a linear photodiode array, a charge-coupled element, a complementary metal-oxide-semiconductor, or a combination thereof. Therefore, simultaneously with incubation and flow, or before or after the completion of incubation and flow, the optical sensor can monitor the assay and compare optical readings, such as reflectance and / or transmittance readings, to determine various aspects such as sample flow, interference with the optical path due to debris in the optical path, line expression, and the test results. Once the assay and line expression fall within the range of pre-set parameters, the test can continue to completion and provide the final results. Checking the assay with the optical sensor before completion can provide the user with additional confidence that the test has been properly handled.

[0187] In certain embodiments, the output may be a voltage, current, or digital output proportional to the light intensity determined by a signal conditioning circuit. Some examples of readers include the TSL12T and TSL13T sensors available from TAOS (Texas Advanced Optolectronic Solutions). The TSL12T and TSL13T sensors are cost-optimized, highly integrated optical-voltage sensors, each combining a photodiode and a transimpedance amplifier (feedback resistances = 80 MΩ and 20 MΩ, respectively) on a single monolithic integrated circuit. The active area of ​​the photodiode is 0.5 mm × 0.5 mm, and the sensor responds to light in the range of 320 nm to 1050 nm. The output voltage is linear with respect to the light intensity (irradiance) incident on the sensor over a wide dynamic range.

[0188] In some examples, the microprocessor can communicate with a photodetector, particularly a sensor. In other examples, the photodetector outputs to other logic means. Furthermore, the microprocessor may be configured to signal the photodetector to perform sequential image detection of the assay to generate diagnostic test results. The microprocessor may include, or be associated with, memory for storing information corresponding to imaging parameters. The memory may include instructions for monitoring pre-test analysis of the assay and generating diagnostic test results of the assay.

[0189] In some embodiments having assays with coding references, as discussed herein, the photodetector may have the capability to decode the reference code on the assay. Thereafter, the decoding sensor can activate the corresponding diagnostic test in the reader. For example, the decoding sensor can activate the corresponding channel in a multi-channel reader and / or the corresponding incubation temperature profile in an incubator.

[0190] The decoding sensor may also be a color sensor. For example, the color sensor may be a photodiode sensitive to wavelengths selected from red, blue, green, and combinations thereof. In such an example, a color sensor is used to read an array of photodiodes, each having a specific color filter, and a white LED (providing light with a broad spectrum across three bands (red, green, and blue)) is used as the light source. When the LED is turned on, the output from each photodiode is obtained to determine the reflectance of that particular color. The decoding sensor may also be an RFID reader or a barcode reader.

[0191] While this specification frequently refers to light reflectance and light reflectance readers, a variety of readers, including, for example, transmittance readers, fluorophotometers, luminescence meters, barcode readers, radiation detectors (such as scintillation counters), UV detectors, infrared detectors, electrochemical detectors, or optical readers such as spectrophotometers, charge-coupled devices (CCDs), or complementary metal-oxide-semiconductor (CMOS) readers, can be usefully used and used as image sensors. A light reflectance reader can be programmed to analyze an inspection strip by two-dimensional reading rather than a one-dimensional 1x128 reading, for example, a 5x128 or 512x492 matrix of "pixels". Such two-dimensional reading expands the reflectance capture area to directly capture reflectance from the sides of the inspection strip.

[0192] In other embodiments, transmittance readers, such as UV-Vis-NIR spectroscopy, can provide characterization of the absorption, transmission, and / or reflectance of an assay. For example, such analytical techniques can measure the amount of light absorbed in an assay at a given wavelength. Those skilled in the art will understand that a molecule or part of a molecule can be excited by absorption. Typically, organic chromophores that strongly absorb in the UV or visible portion of the spectrum almost always contain multiple bonds such as C=C, C=O, or C=N. This molecular excitation energy can be dissipated as heat, or kinetic energy, when the excited molecule returns to its ground state by colliding with another molecule, such as a solvent molecule. In other embodiments, the excitation energy can be dissipated by the emission of light via fluorescence. Regardless of the process, an excited molecule may have any one of a set of discrete energy quantities, as described, for example, by the laws of quantum mechanics. In the examples herein, the primary energy level is determined primarily by the possible spatial distribution of electrons, and to a lesser extent by the vibrational energy levels arising from the various vibrational modes of the molecule.

[0193] Therefore, in certain examples herein, absorbance measurements may be determined by the concentration of the solute in the assay. For example, the progress of such a chemical reaction can be tracked using a spectrophotometer in the reader to measure the concentration of either the reactants or products over time. In other examples, transmission spectroscopy can be used for sampling solids, liquids, and gases. Typically, light that passes through the assay is compared to light that does not. The resulting spectrum may depend on the path length or sample thickness, the absorption coefficient of the sample, the reflectance of the sample, the angle of incidence, the polarization of the incident radiation, and, for particulate matter, the particle size and orientation.

[0194] Furthermore, the sensor can monitor the flow development along assay 21 to assess whether the amount of sample applied to assay 21 is insufficient or excessive. For example, before determining the test result, the sensor can monitor the progress of the flow on assay 21 along flow line 44. In other examples, the sensor monitors the progress of the flow both at flow line 44 and along the assay, for example, at intermediate flow line 46. The sensor may be configured to sense whether a proper flow of reagent occurred on assay 21 while assay 21 was in the cavity, and / or whether one or more lines, i.e., reflectance or transmittance values, were present on assay 21 before assay 21 came into contact with the sample under test.

[0195] Certain embodiments involve configuring a lateral flow assay system to allow simultaneous incubation and reading of assay 21. This combination allows sensors to be used not only to detect test results but also to check parameters indicating whether flow has occurred on the assay and whether such flow has produced appropriate test results. That is, a sample containing one or more test substances of interest that may be present is flowing over assay 21, and the assay is incubated while binding occurs on assay 21 in the mobile phase. By combining the reader and incubator into such an integrated diagnostic unit, results can be achieved more quickly than when the assay, such as a test strip or other test medium, is incubated in one device and then moved to a separate device for reading. For example, the speed to results can be improved to, for example, less than about 60 seconds, or even less than about 30 seconds. In general, such a combined system can be dynamic and can sense changes in the assay as they occur by looking for areas where reflectivity and / or transmittance have decreased somewhere in the assay that is unused or not fully expressed.

[0196] To prevent pre-execution assays from being read (for example, the reader determining whether line expression in, for example, flow line 44, intermediate flow line 44, test line 40, and / or control line 42 occurred before the sample flow could reach such lines), a certain level of protection is provided to prevent erroneous readings caused by debris or similar interference with the system optics.

[0197] Various triggers can initiate assay analysis of any of the systems and assemblies described herein. For example, a test strip package can be inserted into holder 500, and a sample can be pipetted into the sample well (or delivered by another method). Insertion into holder 500 can trigger the activation of incubation time or readings, for example, as illustrated and described herein, by tripping a proximity switch that blocks the path of the optical interrupter. Furthermore, as introduced herein, if the reader does not detect a suitable flow, the reader can trigger an interruption of the test sequence and, in certain cases, deliver an error message.

[0198] If assay 21 is properly detected, any reading sequence illustrated and described herein may be initiated. For example, optical measurements, such as the detection of light reflected from assay 21, may utilize values ​​such as the average reflectance value in a particular region of assay 21. First, the system can analyze the assay to determine whether there is any interference in the optical path from debris, etc. Debris can be at any number of positions in the optical path, including on assay 21 or the assay container. Simultaneously with, or following, the analysis of the optical path for debris, the system can analyze the assay to determine whether line expression has already occurred; that is, whether the appropriate assay has been inserted into the cavity. For example, a test strip configured to express in specific regions, such as a test line and a control line, should not express in those regions until the test substance and mobile phase have had sufficient time to reach them.

[0199] In some cases, lines configured to exhibit changes in reflectance and / or transmittance upon contact with reagents and samples should not exhibit any expression until the sample and reagent flow reaches them and binding occurs. This flow has not yet reached them during the initial readings, for example, around 3 seconds. Therefore, if line expression is detected in the initial assay analysis, an error message is delivered to the user, allowing them to stop further readings, e.g., further optical measurements. In this way, this mechanism can detect the use of an assay that has not yet been performed (known to be negative) or a pre-marked assay. Generally, when reflectance decreases in an unused assay, either due to the presence of line expression or other darkening of the assay away from baseline, the decrease in reflectance can inform the user that something is happening in either the assay or the optical path and therefore the results should not be accepted.

[0200] After the initial optical readings are satisfactory and appropriate reader parameters and incubator temperature have been selected manually or automatically, further optical readings, for example, approximately 15 seconds after sample application, can be used to determine whether proper flow has occurred. For example, the optical readings can be used to determine whether the reagent has flowed between the sample application area and a downstream line such as a test line.

[0201] The presence of colored particles flowing through the mobile phase, such as gold sol beads or other labels, and the resulting change in reflectivity on the assay between the sample application area and the first test line, can inform the user that flow is occurring, and an error message can be returned if no flow is detected. An assay lacking the expected change in reflectivity may indicate that there was no sample flow or that the sample flow was insufficient. Furthermore, certain measurements may indicate whether excessive flow occurred, such as when an excessively large amount of sample is applied to the test strip and the change in reflectivity that may be caused by the reagent is overwhelmed by the excessive sample volume. Changes in reflectivity between the sample application area and result detection areas such as the test line and control line are temporary and may disappear as the mobile phase flows. If optical measurements are performed, such temporary / non-permanent changes can be detected.

[0202] If an assay, including a test strip or other assay type, passes a preliminary reading, the system can begin reading to generate test results. For example, analysis of the test line and control line can begin after approximately 30 seconds. Results can be provided if there is a sufficient difference between the test and the control, e.g., a percentage reflectance difference. Typically, negative results and more extreme results can be provided more quickly, while results close to the threshold level take longer. For example, in a test where the reflectance value on the test line is inversely proportional to the amount of the test substance, a negative result can be determined when the reflectance of the test line drops to a certain level. In some cases, if hood 2 is opened while the reader is reading the assay, the signal may produce a response without results.

[0203] The reader and / or incubator can be powered by a power source. For example, in some cases for field analysis in harsh environments, the power source may be a vehicle battery. Furthermore, the reader's footprint is smaller than many conventional systems, for example, for enhanced and efficient inspection during batch pickup or delivery, and to improve use and communication with on-board vehicle systems.

[0204] In certain embodiments, software applications, instrumentation, systems, and assemblies can provide real-time data acquisition of test data, including, but not limited to, field data, using data communication exchanges, including adapters and widely used telephones and similar personal devices, technologies such as Bluetooth® Interface. For example, an embodiment of a single instrument relay may include generating test results in any one or more of the test instrument readers illustrated and described herein, communicating the test results to a partner device module, and relaying the test result output to an external host module. Furthermore, any of the test instrument readers herein may interface directly with an external storage configuration. In certain examples, the partner device is a smartphone, but other partner devices may include tablets, general-purpose computers, PDAs, digital media players, digital cameras, wireless information devices, and the like.

[0205] The partner device can be connected to the external storage configuration in various modes. In remote access mode, the partner device links to available test equipment, allowing the system to deliver test data to the external storage configuration. The partner device may have an indicator that provides a pairing signal when activated, and the indicator provides a visual indication of pairing to the test equipment reader.

[0206] In certain embodiments, the partner device communicates locally with one or more test devices, such as via wireless Bluetooth® transmission / reception. Furthermore, the partner device communicates with an external host via host-switched communication, such as via Wi-Fi, 3G / 4G / 5G connectivity, or any other mobile telecommunications communication technology. In certain modules, the test device establishes valid, i.e., approved, authorized, and / or available data communication with the test device by interfacing with a mobile partner device having a corresponding data communication interface. In certain examples, the module may include linking an application on the partner device, such as a downloadable program application, to the test device. Furthermore, the module may include establishing a data communication exchange of result outputs between the test device and the partner device. Also, the module may include establishing secondary messaging data communication between the test device and the partner device, including, but not limited to, email, text, or other secondary message exchanges.

[0207] Typically, a partner device relays the output results to an external storage configuration. In certain examples, relaying to an external storage configuration includes sending to a remote host website. In other examples, relaying to external storage includes sending to a remote host server. In yet another example, relaying to external storage includes sending to two or more host providers for data storage and management.

[0208] In certain embodiments, the test equipment establishes valid, i.e., authorized, licensed, and / or available data communication with the test equipment by interfacing with a mobile partner device having a corresponding data communication interface. In certain examples, the module may include linking an application on the partner device, such as a downloadable program application, to the test equipment. Furthermore, the module may include establishing a data communication exchange of result output between the test equipment and the partner device. Also, the module may include establishing secondary messaging data communication, including secondary message exchange between the test equipment and the partner device, but not limited to email, text, etc. The partner device may relay the result output to an external storage configuration. In certain examples, relaying to an external storage configuration includes transmission to a remote host website. In other examples, relaying to external storage includes transmission to a remote host server. In yet another example, relaying to external storage includes transmission to two or more host providers for data storage and management.

[0209] A specific method for analyzing a test substance includes, for example, incubating an assay, such as in any of the embodiments previously illustrated or described, and reading the assay to generate a test result, such as in any of the embodiments previously illustrated or described. In a particular example, a diagnostic test method for detecting a test substance in a test sample includes creating an assay by adding the test sample to a test medium, such as a lateral flow test strip, configured to produce a detectable test result after incubation with the test sample; surrounding the test medium in a hood configured to surround a cavity, which is configured to accept the test medium and connected to a temperature-controlled source that can maintain a constant temperature; positioning a sensor, such as an optical sensor capable of reading the reflectance from the test medium, relative to the test medium so that the sensor can detect changes on the test medium; and activating the sensor, such as by closing the hood, which causes the sensor to compare the test medium with preset parameters. If the test medium is not within the preset parameters, no test result is provided; if the test medium is within the preset parameters, the test result is determined from the test medium, and the test result indicates whether the test substance was detected in the test sample.

[0210] In another embodiment of this method, preset parameters can be used to determine, either or both, whether a suitable reagent flow occurred on the test strip while it was in the cavity, and whether one or more test lines were present on the test strip before contact with the test sample. To do this, the sensor can be configured to continuously analyze changes on the test medium until a test result is obtained. The test result can be determined by comparing changes, such as changes in reflectivity, between a first line on the test strip, e.g., a test line, and a second line, e.g., a control line.

[0211] In a particular embodiment, the apparatus for generating a test result from an assay upon contact with a sample comprises an incubator configured to incubate the assay and a photodetector configured to detect a first light transmission result on the assay and at least subsequent light transmission results on the assay, wherein the incubation of the assay and the detection of light transmission on the assay generate the test result.

[0212] In a particular embodiment, in an incubated apparatus for generating test results from an assay upon contact with a sample, the reader includes a photodetector configured to image a first light transmission on the assay and a plurality of subsequent light transmissions on the assay, wherein the incubation of the assay and the imaging of light transmissions on the assay generate the test results.

[0213] In a particular embodiment, an in-vehicle system for generating test results from an antibiotic test substance assay includes a photodetector reader that communicates with a vehicle microprocessor assembly to synchronize the light transmission on the test substance assay, upon contact with the sample, with the expression of the test result in the in-vehicle inspection environment.

[0214] In a particular embodiment, an on-board vehicle system for generating antibiotic test results from an antibiotic test substance assay includes a photodetector reader that communicates the test results with a vehicle assembly to generate antibiotic test results by detecting light transmission on the antibiotic test substance assay when in contact with a sample.

[0215] In a particular embodiment, an on-board vehicle system for generating antibiotic test results from an antibiotic test substance assay includes a photodetector reader that communicates the test results with a vehicle assembly to synchronize the progression of antibiotic test result development with optical detection when in contact with a sample in an on-board vehicle inspection environment.

[0216] None of the devices and assemblies illustrated and described herein are required to include a hood or hood-like feature. For example, the applicant of this application unexpectedly discovered the advantages of the improved reader and non-planar optical module of this specification that do not include a hood or hood-like feature.

[0217] A further example of this method involves comparing a test strip before sample application, including before sample application, to an actual strip in use, using pre-set parameters. For example, a blank strip before reagent flow or before sample coating has occurred should have a theoretical reflectance profile within a predictable range. If areas of reduced reflectance are detected that are not caused by sample / reagent flow on the strip, it may indicate not only that something is wrong with the test strip, but also that the optical path is contaminated and may require cleaning. Such contamination could be on the strip or within the reader. Generally, an unused test strip should not have areas of reduced reflectance. Any such areas may indicate problems from dirt / debris, use of a test strip that has already been run, or other factors. In any case, the test results may be invalid.

[0218] Numerous features and advantages, along with structural and functional details, are described above. Many of the novel features are pointed out in the attached claims. However, this disclosure is illustrative only, and modifications are possible within the scope of the principles of this disclosure, to the maximum extent indicated by the broad general meaning of the terms used to express the general claims, particularly with respect to the shape, size, and arrangement of each part. It should be further noted that, as used in this application, the singular forms "a," "an," and "the" refer to multiple subjects unless explicitly and clearly limited to a single subject.

Claims

1. a. Interface connector and b. A microcontroller electrically connected to the interface connector, c. Optical imaging devices and It is equipped with, The optical imaging device is a self-contained optical module that communicates with the interface connector but is independent of the microcontroller.

2. The device according to claim 1, wherein the optical module is controlled independently of the host system.

3. The device according to claim 1, wherein the optical module comprises a calibration sequence.

4. The device according to claim 3, comprising a non-volatile memory configured to store module-specific calibration data.

5. The device according to claim 1, wherein the optical module is replaceable on-site.

6. The device according to claim 1, wherein the optical module is replaceable and can be installed on-site.

7. The device according to claim 2, wherein the host system is configured to assert the selection of general-purpose input and output pins.

8. The device according to claim 2, wherein the host system is configured to disable the selection of general-purpose input and output pins.

9. The device according to claim 2, wherein the host system is configured to disable the enable signal and deliver an image capture command.

10. The device according to claim 1, comprising a non-planar optical module configured to align the assay to an offset position, wherein the offset position includes an upper part that is obliquely offset around a lower part.

11. The device according to claim 10, comprising an upper platform that is diagonally offset around a lower platform with respect to a pivot point.

12. The device according to claim 1, comprising an incubator configured to incubate the assay.

13. The device according to claim 1, comprising a lighting assembly.

14. The device according to claim 13, wherein the lighting assembly includes a directly dynamically controlled lighting assembly aligned around the assay.

15. The device according to claim 14, wherein the direct dynamic control illumination assembly includes a plurality of light sources configured to provide illumination around the assay with minimal specular reflection in at least a portion of the assay.

16. The device according to claim 14, wherein the direct dynamic control lighting assembly includes a dual digital-to-analog converter.

17. An aperture carrier is configured to be aligned around a frame, provide multiple optical windows when the assay is in the testing position, and provide clearance for operating the assay. The device according to claim 1, including the following:

18. The device according to claim 1, wherein the optical module is configured to perform at least two image detections of the assay.

19. The device according to claim 1, comprising a stabilizer configured to stabilize the assay received at the operating position when generating the test results.

20. The device according to claim 19, wherein the stabilizer includes a cover.

21. The device according to claim 20, wherein the cover comprises a spring-biased cover.

22. The device according to claim 21, wherein the spring-biased cover includes at least one spring-biased support.

23. A lateral flow reader that generates test results when it comes into contact with a sample, The device described above, a. Interface connector and b. A module multiplexer circuit connected to the interface connector, c. A host controller electrically connected to the module multiplexer circuit and A lateral flow leader equipped with [a specific feature].

24. The device according to claim 23, comprising a plurality of self-contained optical modules.

25. The device according to claim 23, comprising at least one interchangeable optical module.

26. The device according to claim 23, wherein the module multiplexer circuit includes a combination of a multiplexer IC configuration and a standard logic multiplexer configuration.

27. The device according to claim 23, wherein the module multiplexer circuit provides an enable signal configured in accordance with subsequent multiplexing.

28. The host system determines a specific imager from a plurality of imaging devices, as described in claim 23.

29. The device according to claim 23, wherein the host system determines a specific module from a plurality of self-contained optical modules.

30. a. A device that generates test results from an assay when it comes into contact with a sample, b. A camera multiplexer circuit that communicates with the aforementioned device and multiplexes the imaging of the assay. A system equipped with these features.

31. The system according to claim 30, wherein the camera multiplexer circuit is configured to multiplex images from multiple cameras.

32. The system according to claim 31, wherein the apparatus is configured to image the assay at the offset position.

33. The system according to claim 31, wherein the camera multiplexer circuit includes a combination of a multiplexer IC configuration and a standard logic multiplexer configuration.

34. The system according to claim 30, wherein the camera multiplexer circuit provides an enable signal configured in accordance with subsequent multiplexing.

35. a. Multi-channel lateral flow reader host system and b. A self-contained optical module control system consisting of a microcontroller electrically connected to the host system and An assembly comprising:

36. The assembly according to claim 35, comprising an operating system configured to monitor the installation status of individual modules.

37. The assembly according to claim 35, comprising an interface connector electrically connected to the self-contained optical module control system.

38. The assembly according to claim 35, comprising an interface connector electrically connected to the microcontroller.

39. The assembly according to claim 35, wherein the microcontroller communicates with a constant current driver.

40. The assembly according to claim 35, wherein the microcontroller communicates with an incubator.

41. The assembly according to claim 35, wherein the microcontroller is in communication with an optical interrupter.

42. The assembly according to claim 35, wherein the microcontroller communicates with a non-volatile memory configured to store module-specific calibration data.

43. The assembly according to claim 35, wherein the self-contained optical module control system controls a plurality of optical modules.

44. The assembly according to claim 35, comprising at least one interchangeable optical module.

45. The assembly according to claim 35, wherein the multi-channel lateral flow reader has a camera multiplexer circuit.

46. The assembly according to claim 45, wherein the camera circuit includes a multiplexer IC configuration.

47. The assembly according to claim 45, wherein the camera multiplexer circuit includes a standard logic multiplexer configuration.

48. The assembly according to claim 45, wherein the camera multiplexer circuit provides an enable signal configured in accordance with subsequent multiplexing.

49. The assembly according to claim 35, comprising an incubator configured to incubate an assay.

50. The assembly according to claim 35, including a lighting assembly.

51. The assembly according to claim 50, wherein the lighting assembly includes a direct dynamic control lighting assembly aligned around the assay.

52. An aperture carrier that is aligned around the frame and configured to provide multiple optical windows when the assay is in the testing position. The assembly according to claim 35, including the assembly described in claim 35.

53. The assembly according to claim 35, comprising a stabilizer configured to stabilize the assay received in the operating position when generating the aforementioned test results.

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