DISPOSITIVO, CONJUNTO E MÉTODO DE TESTE

Abstract

Analyte testing devices, assemblies, methods, operations, and systems are shown and described. In a lateral flow reader to generate a test result from an assay when contacted with a sample and having a camera multiplexer circuit and a host controller. An assembly includes an interface connector; a self-contained optics module having a microcontroller in electrical communication with the interface connector and a host controller. Typically, an optical imaging device being in communication with an interface connector but independent of a microcontroller.

Description

[001] This application claims the benefit of provisional application no. US 63 / 452020, filed March 14, 2023, is incorporated herein by reference in its entirety. FIELD OF TECHNOLOGY

[002] The present invention generally relates to analytical testing, and more particularly to the enhanced detection of an analyte, when present, in a device, system and test set. BACKGROUND

[003] Reagent strips and films are often a useful analytical tool in the fields of clinical chemistry, analytical medicine, and food hygiene diagnostics. For example, it is advantageous to determine or test, through quantitative or qualitative methods, various matrices, including body fluids such as serum and urine, and food, such as meat products, fruits, vegetables, milk, honey, and the like. Such matrices can be tested for a variety of analytes including a variety of chemicals, biochemicals, and biological molecules, such as bacteria, antibiotics, for example, sulfa drugs, tetracyclines, beta-lactam drugs; toxins, such as aflatoxin, zearalonone, ochratoxin, T-2 and vomitoxin, pesticides such as organophosphates and carbamates, and active metabolites, either in materials or on the surface of materials or a combination thereof.

[004] Generally, lateral flow assays are membrane-based test devices in which a sample suspected of containing the analyte of interest is placed at or near one end of the membrane strip. The sample is carried to the opposite end of the membrane strip by a mobile phase that travels along the membrane strip, for example, by capillary action. As it travels along the membrane strip, the analyte in the test sample, if present, encounters one or more reagents. The reagents may include ligands. Petition 870250082244, dated 12 / 09 / 2025, page 8 / 156 2 / 97 for the analyte. The ligands can be mobile and therefore flow with the sample, or they can be immobilized on the test strip as a capture agent. Depending on the test configuration, the analyte ligand, the analyte itself, or some other reagent in the test system will be captured by the immobilized capture agent and thus produce a detectable signal. The signal may be generated by a label supplied within the assay. The detectable signal can be measured, such as by means of an optical reader.

[005] The presence and, in some cases, the concentration of an analyte on a reagent strip can be determined by measuring the optical reflectance of a development area on the strip. For example, the development area on the strip can be a color or image development area. The percentage reflectance can be used to determine the result.

[006] Testing commonly takes place in a controlled environment, such as a laboratory, but 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 would be advantageous for tests to be performed in non-laboratory settings because processors must wait for the results. Furthermore, it would also be advantageous for tests to be performed in trucks during the transport of items. For this reason, it would be advantageous to accelerate the speed of testing, reduce the cost of equipment and testing, improve the robustness of the device, and enhance ease of use and simplicity of operation. In addition, it is advantageous to have confidence that the test results are valid.Therefore, systems, methods, and devices in this document also assist in preventing fraudulent use of pre-run tests, known negative assays in place of true samples, or the use of pre-labeled assays to provide a negative result that is not true. Petition 870250082244, dated 12 / 09 / 2025, page 9 / 156 3 / 97 reflects the true nature of the sample. It is also desirable to increase the robustness of the assays, systems, and test procedures.

[007] Therefore, systems and methods for analyte detection without the disadvantages presented by traditional systems and methods are desired. SUMMARY

[008] This invention provides enhanced analyte detection that is convenient, efficient and safe for the user, particularly when used to detect the presence or absence of at least one analyte.

[009] In one embodiment, an assembly comprises a multi-channel lateral flow reader system, for example, aligned on a carrier board; and a microcontroller embedded in an independent optical module in electrical communication with a host controller adapted for the aforementioned carrier board.

[0010] In one example, the optical imager is independent of the microcontroller. The carrier board host controller may include an operating system adapted to monitor an individual module installation situation. The assembly may include an interface connector in electrical communication with the independent optical module control system. The assembly may include an interface connector in electrical communication with the microcontroller. The microcontroller may be in communication with a constant current driver. The microcontroller may be in communication with an incubator. The microcontroller may be in communication with an optical switch. The microcontroller may be in communication with a non-volatile memory adapted to store module-specific calibration data.

[0011] In certain examples, the board host controller Petition 870250082244, dated 12 / 09 / 2025, page 10 / 156 The 4 / 97 carrier can control a plurality of optical modules. The assembly may include at least one interchangeable optical module. The carrier board 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 enabled signal adapted for subsequent multiplexing. The standalone optical module assembly may include an incubator adapted for incubating the assay. The assembly may include an illumination assembly. The illumination assembly may include a dynamically controlled direct illumination assembly aligned around the assay. The assembly may include an aperture carrier aligned around a frame and adapted to provide a plurality of optical windows with the assay in a test position.The assembly may include a stabilizer adapted to stabilize the incoming test specimen in an operational position while generating the test result.

[0012] In one embodiment, a lateral flow reader for generating a test result from an assay upon contact with a sample comprises an interface connector; a carrier board host controller in electrical communication with the interface connector; which has a module multiplexer circuit, wherein an independent optical module that is in communication with the interface connector and has a camera that is independent of the microcontroller.

[0013] In certain examples, the optics module may be under independent control of a host system. The device may include a plurality of optics modules. The device may include at least one interchangeable optics module. The optics module may include a calibration sequence. The device may include Petition 870250082244, dated 12 / 09 / 2025, page 11 / 156 5 / 97 a non-volatile memory adapted to store module-specific calibration data. The device may include an optical module that is interchangeably replaceable in place. The optical module may be interchangeably installable in place. The module multiplexer circuit may include a combination of multiplexer IC configuration and a standard logic multiplexer configuration. The module multiplexer circuit may provide an enabled signal adapted for subsequent multiplexing. The host system may determine a specific imager from a plurality of imaging devices. The host system may ensure selection of a general-purpose input and output pin. The host system may deny selection of a general-purpose input and output pin. The host system may deny an enabled signal and deliver an image capture command.

[0014] In certain examples, the device may include a non-planar optical module adapted to align the assay in an offset position, wherein the offset position includes an angled upper portion offset around a lower portion. The device may include an aligned upper-level platform offset around an inner-level platform around a pivot point. The device may include an incubator adapted to incubate the assay. The device may include a lighting assembly. The lighting assembly may include a dynamically controlled direct lighting assembly aligned around the assay. The dynamically controlled direct lighting assembly may include a plurality of light sources adapted to provide illumination around the assay with minimal specular reflection in at least a portion of the assay.The dynamically controlled direct lighting assembly may include a dual digital-to-analog converter. The device may include an aperture carrier aligned around it. Petition 870250082244, dated 12 / 09 / 2025, page 12 / 156 6 / 97 a frame and adapted to provide a plurality of optical windows with the test in a test position and provide clearance for handling the test. The optical module may perform at least two image detections of the test. The device may include a stabilizer adapted to stabilize the incoming test in an operating position while generating the test result. The stabilizer may include a cover. The cover may include a spring-loaded cover. The spring-loaded cover may include at least one spring-loaded support.

[0015] In one embodiment, a system comprises an apparatus for generating a test result from an assay upon contact with a sample; and a module multiplexer circuit in communication with the apparatus for multiplexing images from multiple assays.

[0016] In certain examples, the module multiplexer circuit can be adapted to multiplex images from a plurality of cameras. The apparatus can be adapted to image the test in a shift position. The module multiplexer circuit may include a combination of multiplexer IC configuration and a standard logic multiplexer configuration. The module multiplexer circuit may provide an enabled signal adapted for subsequent multiplexing.

[0017] In one embodiment, in an assembly for generating a test result from a test, an optical module comprises an offset frame adapted to receive the test, wherein the frame includes an angled top-level platform offset around an inner-level platform; and an aperture carrier aligned around the frame and adapted to provide a plurality of optical windows with the test in a test position and provide clearance for handling the test around the assembly. Petition 870250082244, dated 12 / 09 / 2025, p. 13 / 156 7 / 97

[0018] In certain examples, the upper-level platform may be aligned offset around the lower-level platform around a pivot point. The offset frame may receive a portion of the test in a first substantially flat entry position. The offset frame may align a portion of the test in a second substantially non-flat test position. The optics module may include an elongated optics aperture to allow adjacent, or similar, imaging of a bend around the test in a test position. The aperture carrier may include a test line development imaging area. The aperture carrier may include a reference encoding aperture. The aperture carrier may include a reference encoding imaging area. The aperture carrier may include a reference writing aperture. The aperture carrier may include a writing imaging area.The writing image area can be an optical character recognition image area.

[0019] In certain examples, the aperture carrier may include a chamfered edge. The aperture carrier may include a clearance channel. One bottom side of the aperture carrier may include a slot for a temperature sensor. The bottom side of the aperture carrier may include at least one mounting opening. The bottom side of the aperture carrier may include a recessed, contoured surface. The recessed, contoured surface may be recessed from an upper surface. The device may include a wall spacing the recessed, contoured surface from the upper surface.

[0020] In one embodiment, an apparatus for generating a test result from an assay upon contact with a sample comprises a non-planar optical module adapted to align the assay in a displacement position, wherein the displacement position includes an angled upper portion displaced around Petition 870250082244, dated 12 / 09 / 2025, page 14 / 156 8 / 97 a lower portion; an incubator adapted for incubating the assay; an imaging device adapted for imaging the assay in the displacement position; and a dynamically controlled direct lighting assembly aligned around the assay.

[0021] In certain examples, the optics module includes a suspended rim adapted to align at least one portion of the assay projecting around the optics module in an operating position. The optics module may include a substantially flat proximal portion and an opposing substantially non-flat distal portion. The proximal and distal portions may define a non-flat flow path around the assay in a test position. The optics module may be removable from the apparatus. The apparatus may include at least one interchangeable optics module. The optics module may include a calibration sequence. The optics module may include an aligned bend between the upper and lower portions.

[0022] In certain examples, the apparatus may include an aperture carrier, for example, a thermal aperture carrier block. The thermal aperture carrier block may include an elongated optical aperture. The elongated optical aperture may provide an elongated test viewing area. The apparatus may include a test line development imaging area. The thermal aperture carrier block may include a reference coding aperture. The reference coding aperture may provide a viewing area for a reference coding. The reference coding may include a barcode. The apparatus may include a reference coding imaging area. The thermal aperture carrier block may include a reference writing aperture. The reference writing aperture may provide a viewing area for a reference writing. The apparatus may include Petition 870250082244, dated 12 / 09 / 2025, page 15 / 156 9 / 97 a writing image area. The writing image area may include an optical character recognition image area.

[0023] In certain examples, the thermal opening carrier block may include a chamfered edge. The chamfered edge may prevent unintentional movement, misalignment, blocking, and / or the like around a raised, or similar, portion of the test. The thermal opening carrier block may include a clearance channel. The clearance channel may provide clearance for test handling around the thermal opening carrier block. The bottom side of the thermal opening carrier block may include a temperature sensor slot. The temperature sensor slot may thermally couple a corresponding temperature sensor. The bottom side of the thermal opening carrier block may include at least one mounting opening. The bottom side of the thermal opening carrier block may include a recessed, contoured surface. The recessed, contoured surface may be recessed from an upper surface.The apparatus may include a wall spacing the recessed, contoured surface from the upper surface. The recessed, contoured surface may include a lighting environment around the test area.

[0024] In certain examples, the optics module may include a proximity switch adapted to break the path of an optical switch to trigger at least one condition chosen from the group consisting of an incubation, a detection of a light transmission around the assay, and an imaging of the assay. The apparatus may perform at least two imaging detections of the assay. The imaging device may monitor at least one pre-test parameter after receiving the assay. The dynamically controlled direct illumination assembly may include a plurality of light sources. The plurality of light sources is adapted Petition 870250082244, dated 12 / 09 / 2025, page 16 / 156 10 / 97 to provide illumination around the test with minimal specular reflection in at least a portion of the test. The plurality of light sources can provide illumination around the test free of specular reflection. The plurality of light sources can be aligned along an imaging clamp. The imaging clamp can include an angled alignment relative to a surface. The plurality of light sources can be positioned on opposite sides of the imaging clamp. The plurality of light sources can be positioned substantially facing the test in a test position. The plurality of light sources can provide an edge of a scattering angle outside a section of the test. The edge of a scattering angle can be outside a section of the test free of specular reflection. The test section can include a sample area of ​​a test strip. The plurality of light sources is independently variable.

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

[0026] In one embodiment, an apparatus comprises a non-planar optical module adapted for aligning the test in a displacement position; an optical detector adapted for imaging the test. Petition 870250082244, dated 12 / 09 / 2025, page 17 / 156 11 / 97 in the displacement position; and a dynamically controlled direct lighting system adapted to provide illumination around at least a portion of the test free from specular reflection.

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

[0028] In one embodiment, an apparatus comprises a non-planar optical module adapted for aligning the test around an offset-aligned upper-level platform around an inner-level platform; an imaging device adapted for imaging the test aligned around the upper-level platform and offset-aligned around the inner-level platform; and a dynamically controlled direct 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 a test result from an assay upon contact with a sample includes a non-planar optical module adapted to align the assay in a displacement position; an incubator adapted to incubate the assay; and an optical detector adapted to image the assay in the displacement position.

[0030] In certain examples, the optics module includes a suspended rim to align at least a portion of the assay that projects around the optics module in an operating position. The optics module may include a substantially flat proximal portion and an opposing non-flat distal portion. The flat proximal portion and the Petition 870250082244, dated 12 / 09 / 2025, p. 18 / 156 12 / 97 The non-planar distal portion can define a non-planar flow path around the assay in a test position. The proximal planar portion and the non-planar distal portion can define an elevated flow path around the assay in a test position. The non-planar distal portion can have approximately ten to thirty degrees of displacement from the proximal planar portion. The non-planar distal portion can have approximately twenty degrees of displacement from the proximal planar portion.

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

[0032] In one embodiment, an assembly for generating a test result from a test includes an offset frame adapted to receive the test, wherein the frame includes an aligned upper-level platform offset around an inner-level platform; and an optical aperture aligned around the frame.

[0033] In certain examples, the offset frame aligns a portion of the test near the outer assembly in an operational position. The upper level platform may be aligned offset around the inner level platform around a pivot point. The offset frame may receive a portion of the test in a first substantially flat position. The offset frame may align a portion of the test in a second substantially flat position. Petition 870250082244, dated 12 / 09 / 2025, p. 19 / 156 13 / 97 non-planar. The optical module can image the test adjacent to a bend around the test in an operating position.

[0034] In one embodiment, in an apparatus for generating a test result from an assay, a modular interface includes a housing adapted for aligning the assay in a displacement position; a carrier plate holder aligned in the housing; an optical strip detector; a light level detector; an imaging device; a light source; and an integrated incubator.

[0035] In one embodiment, an apparatus for generating a test result from an assay upon contact with a sample includes a non-planar optical module that aligns the assay in an offset position; an incubator that incubates the assay; and an optical detector that detects a light transmission in the assay, wherein the incubation of the assay and detection of the light transmission in the assay generates the test result.

[0036] In specific examples, the optical module includes a substantially flat proximal portion and an opposing non-flat distal portion. The flat proximal portion and the non-flat distal portion may define a non-flat flow path. The flat proximal portion and the non-flat distal portion may define an elevated non-flat flow path. The apparatus may include a pivot point aligned between the flat proximal portion and the non-flat distal portion. The apparatus may include a non-flat cavity. The cavity may include an elongated channel. The aperture carrier may be positioned within the cavity. The optical module may include a bottom support. The optical module may include an interface housing. The optical module may include a collection tray. The optical module may include an insulated base. The optical module may include a top cover. The optical module may include a proximity switch. The proximity switch may break a path of an inter Petition 870250082244, dated 12 / 09 / 2025, p. 20 / 156 14 / 97 Optical interrupter to trigger incubation. The proximity switch can break the path of an optical switch to trigger the detection of a light transmission passed around, including, but not limited to, reverberation, in the assay. The proximity switch can break the path of an optical switch to trigger imaging in the assay.

[0037] In certain examples, the apparatus performs continuous image detection of the assay. Furthermore, the incubation environment may include a heated environment. The incubation environment may include a cooled environment. The incubation environment may include a consistently maintained temperature environment. The optical detector may monitor at least one pre-test parameter after acquiring at least one image detection in the assay. The image detection may include an optical reflectance value. The assay may include a test strip that has at least one test line and at least one control line, and wherein a theoretical reflectance value is a comparison between a reflectance value on the test line and a reflectance value on the control line. The test line and the control line may be positioned on a non-flat distal portion in an operating position. The apparatus may include a user interface that has a display plate.

[0038] In another embodiment, in an assembly for generating a test result from a test, an optics module includes an offset frame mountable around a base and adapted to receive the test, wherein the frame includes an angled top-level platform offset around an inner-level platform; and an optical aperture aligned within the frame.

[0039] In certain examples, the upper-level platform is aligned offset around the inner-level platform around a pivot point. The offset frame can receive the test in a Petition 870250082244, dated 12 / 09 / 2025, p. 21 / 156 15 / 97 first substantially flat position. The displaced frame may align the assay in a second substantially non-flat position. The device may include a housing. The assembly may perform continuous image detection of the assay to generate the test result. The device may include an incubator to incubate the assay. The device may include an optical detector to detect light transmission in the assay. Incubation of the assay and detection of light transmission in the assay generates the test result. The device may include an insulated base. The device may include a top cover. The device may include a proximity switch. The proximity switch may break a path of an optical switch to trigger incubation. The proximity switch may break a path of an optical switch to trigger detection of light transmission that has traversed the assay.The proximity switching device can bypass the path of an optical switch to trigger imaging in the assay. The proximity switching device can initiate a test where the incubator is already maintaining a required temperature or where the incubator is inactive and the device is in a read-only mode.

[0040] In another embodiment, a modular interface for generating a test result from an assay includes a carrier board support; and at least one non-planar optical module positionable around the carrier board support.

[0041] In certain examples, the device includes at least one test unit.

[0042] In one embodiment, a non-planar product distribution and test set, including but not limited to, online, includes a product supply that has at least one output; a sample feed in fluid communication with the supply of Petition 870250082244, dated 12 / 09 / 2025, page 22 / 156 16 / 97 product; a reader; and a distribution line in fluid communication with the supply outlet and having a distribution outlet valve. In specific embodiments, the reader receives a sample from the sample feed and generates a test result from an assay to detect the presence or absence of an analyte. The reader may have an optical detector to image at least one first light transmission in the assay and an incubator to incubate the assay. In specific embodiments, detection of the analyte triggers closure of the distribution outlet valve, while detection of an absence of the analyte triggers opening of the distribution outlet valve to release the supply through the distribution line.

[0043] In certain examples, the reader includes a hood for removable receipt of a single-use rapid assay, wherein the hood comprises a piercing tip that projects to pierce the assay. Furthermore, the hood may include a sample supply line in fluid communication with the sample feed for dispensing the sample into the assay. For example, the sample feed may be aligned adjacent to the piercing tip for dispensing the sample into the assay at the piercing point to enhance the rapid test.

[0044] In certain examples, the reader includes a slanted cavity that has an elongated channel to receive and hold the assay in a slanted test position. The slanted cavity may include a proximal portion and an opposing distal portion, wherein the distal portion is positioned above the proximal portion at approximately forty-five degrees, or similar, slanting. Additional examples include the distal portion being positioned above the proximal portion at a slope of less than forty-five degrees.

[0045] The reader can provide any test result shown. Petition 870250082244, dated 12 / 09 / 2025, page 23 / 156 17 / 97 and described in this document in a timely manner, for example, depending on the specificity of the test, number and / or plurality of test results, and the like. In specific examples, the reader generates a definitive test result within approximately fifteen seconds to approximately one minute, for example, the reader generates a definitive test result within approximately thirty seconds. In other specific examples, the reader generates a definitive test result within approximately ten seconds to approximately fifteen minutes. Furthermore, the assembly may include an autosampler that is generally in fluid communication with the sample feed. The assembly may include a collection sampler in fluid communication with any of the system elements or modalities shown and described in this document. The sample feed may be a closed-loop recirculation system around the product supply.The assembly may include an autosampler in fluid communication with the closed-loop system at a sample release valve, wherein the recirculation circuit is in fluid communication with the outlet and has fluid re-entry communication with the product supply. At least a portion of the recirculation circuit may be a single-use disposable conduit and / or a cleanable conduit.

[0046] In certain examples, the reader's optical detector detects a first light transmission in the assay and detects at least one subsequent light transmission in the assay, and wherein the incubation of the assay and detection of the light transmissions in the assay generate the test result. In addition, the reader may generate at least one limit test result.

[0047] In another embodiment, a non-planar product distribution and testing system includes a product supply that has at least one outlet, wherein the outlet includes at least one valve closure and a distribution line downstream of the closure. Petition 870250082244, dated 12 / 09 / 2025, page 24 / 156 18 / 97 valve; a closed recirculation loop in fluid communication with the outlet and supply; a reader adapted to generate a rapid test result from a single-use assay for detecting the presence or absence of an analyte, and a sampler in fluid communication with the closed recirculation loop to supply a sample to the reader. In specific examples, the reader has an angled cavity to receive and hold the assay in an angled test position and a piercing tip to pierce the assay. In specific embodiments, detection of the analyte triggers a valve closure upstream of the distribution line, and detection of an absence of the analyte enables the release of the supply to the distribution line.

[0048] In certain examples of rapid test results, the single-use assay includes an overlap of approximately three millimeters of a binder application area along a nitrocellulose membrane. Furthermore, the single-use assay may include an absorbent pad approximately thirty-one millimeters long.

[0049] In another embodiment, in a non-flat product and test distribution that has a supply tank, a sample feed and a downstream distribution, a reader controls the access of a product between the supply tank and the downstream distribution and includes an inclined cavity to receive a single-use assay; a sample portal in fluid communication with the sample feed and in alignment with the assay lined up in the cavity; a piercing tip that extends into the cavity to pierce the assay; an adapted optical detector to monitor the assay; and an incubator to incubate the assay.

[0050] In an additional embodiment, a non-planar product distribution and testing set includes a product supply that has at least one output; a recirculation circuit in communication Petition 870250082244, dated 12 / 09 / 2025, page 25 / 156 19 / 97 fluid communication with the output and having fluid re-entry communication with the product supply; an autosampler to receive a sample from the product supply; a reader that receives the sample from the autosampler and is adapted to generate a test result from an assay to detect the presence or absence of an analyte; and a distribution line in fluid communication with the product supply and having at least one valve closure, wherein a positive test result generated by the reader enables valve closure and a negative test result generated by the reader releases the product for downstream distribution.

[0051] In specific examples, the product supply includes a milk tank. The analyte may be toxins, antibiotics, chemicals, biochemicals, pesticides, active metabolites, and a combination thereof. For example, the analyte may be mycotoxin, aflatoxin, zearalonone, ochratoxin, T-2, vomitoxin, and a combination thereof. The reader may generate a definitive test result within approximately fifteen seconds to approximately one minute, for example, within approximately thirty seconds. In specific examples, the reader generates a definitive mycotoxin test result within approximately thirty seconds.

[0052] In some examples, the autosampler is aligned in fluid communication with the recirculation circuit. The autosampler may be a collection sampler. The distribution supply line may be aligned in fluid communication with the recirculation circuit. The recirculation circuit may include a shut-off valve. The recirculation circuit is a disposable conduit, a cleanable conduit, or similar. The recirculation circuit may include a pump. The assembly may include a plurality of complementary conduits.

[0053] In certain examples, the reader includes an incubator. The reader Petition 870250082244, dated 12 / 09 / 2025, page 26 / 156 The 20 / 97 can perform a diagnostic test on the assay concurrently while the incubator incubates the assay. The reader can generate at least one endpoint test result. The reader can perform one or more subsequent continuous readings to generate the test result after performing the first diagnostic test reading. The reader can perform one or more subsequent continuous readings and extend the assay incubation to generate a definitive test result after performing the first diagnostic test reading.

[0054] In specific examples, sample receipt includes self-sampling the product. The method may include self-sampling from the recirculation circuit. The method may include blocking downstream product distribution, which includes enabling a distribution valve closure. Product release may include enabling a recirculation valve closure. Test result generation may include incubating the assay. Test result generation may include reading a diagnostic test on the assay concurrently while an incubator incubates the assay. Test result generation may include generating at least one limit test result. Test result generation may include performing one or more subsequent continuous readings of the diagnostic test. Test result generation may include extending the assay incubation after performing the first diagnostic test reading.Generating a test result may involve extending the assay incubation period to generate a definitive test result after performing the first reading of the diagnostic test.

[0055] In certain examples, the diagnostic test reading includes performing the diagnostic reading in approximately thirty seconds. Furthermore, generating the test result may include reading a predetermined difference between a reflectance value on a control line and a reflectance value on a test line. Generating a re Petition 870250082244, dated 12 / 09 / 2025, page 27 / 156 21 / 97 The definitive test result may include reading a predetermined difference between a reflectance value of a control line and a reflectance value of the test line, and a predetermined reflectance value on the control line.

[0056] In specific examples, the method may include monitoring a pre-test analysis in the assay and / or decoding a reference encoding in the assay. For example, to activate a corresponding channel in a multichannel reader and activate an assay incubation. Furthermore, the method may include monitoring a pre-flow development throughout the assay. The method may include signaling an optical detector to perform the continuation of assay image detection to generate a test result, wherein the test result is a limit test result. Additionally, the method may include developing a subsequent image detection of the limit test result to generate a test result with definite presence or absence.

[0057] In yet another embodiment, a method for analyzing a limit test of an assay includes multiple image detections of the assay to provide a definitive presence or absence test result. In certain examples, the method includes incubating the assay in an incubation environment, aligning an optical detector in an optical path with the assay, signaling the optical detector to perform a first image detection, and signaling the optical detector to perform a second image detection. In specific examples, signaling the optical detector to perform a first image detection of the assay generates a limit test result. Furthermore, the method typically includes signaling the optical detector to perform at least one subsequent second image detection of the assay to generate a definitive presence or absence test result. Other examples include a variety of subsequent image detections, as shown and described in this document. Petition 870250082244, dated 12 / 09 / 2025, p. 28 / 156 22 / 97

[0058] In still other embodiments, a method of detecting an analyte from an assay includes aligning an optical detector in an optical path with the assay; signaling the optical detector to perform continued imaging of the assay to generate a test result with definite presence or absence; and developing additional imaging of the diagnostic test for a threshold test result. In some examples, the method may include incubating the assay in an incubation environment concurrently while the optical detector performs continued imaging of the assay. In some exemplary embodiments, the method includes signaling the optical detector to perform a one-minute imaging detection. Typically, detecting a test result with definite presence involves disabling the system. Similarly, detecting a test result with definite negative involves disabling the system.

[0059] In another embodiment, a method of generating a definitive test result from an assay to detect the presence or absence of an analyte includes incubating the assay in an incubation environment; reading a diagnostic test on the assay concurrently while an incubator incubates the assay; and performing continuous reading of the diagnostic test and assay incubation of a limit test result to generate the definitive test result. In certain examples, reading the diagnostic test includes performing a one-minute diagnostic reading. Typically, detecting a definitive positive test includes turning off the system. Similarly, detecting a definitive negative test includes turning off the system. Generating a definitive test result may include reading a predetermined difference between a reflectance value on a control line and a reflectance value on a test line.Similarly, generating a definitive test result might involve reading a predetermined difference between a reflectance value of a control line and a reflectance value. Petition 870250082244, dated 12 / 09 / 2025, page 29 / 156 23 / 97 of the test line, and a predetermined reflectance value on the control line.

[0060] In other examples, the method includes monitoring a pre-test analysis in the assay. Furthermore, the method may include decoding a reference coding in the assay. Additionally, the method may include activating a channel in a multichannel reader and / or activating an assay incubation. The method may also include monitoring a pre-flow development throughout the assay.

[0061] In another aspect of the invention, a test measuring apparatus for generating a diagnostic test result from a test includes an optical detector and a microprocessor. The optical detector can be aligned in an optical path with the test. The optical detector can be adapted to acquire an image detection in the test due to an aberration in the test. The microprocessor can be in communication with the optical detector. The microprocessor can be adapted to signal the optical detector to perform continuous image detection of the test to generate the test result.

[0062] The optical detector may comprise a decoding sensor that is adapted to align with the assay and decodes a reference coding in the assay. In specific examples, the decoding sensor and the optical reader are a single device. However, those skilled in the art who have the benefit of this invention will recognize that other examples include the decoding sensor and the optical reader being separate or separable devices. The reference coding may activate a corresponding diagnostic test in the optical detector. The apparatus may include a multichannel reader, and the reference coding may activate a corresponding channel in the multichannel reader. The apparatus may include an incubator, and the reference coding may activate an incubation temperature. Petition 870250082244, dated 12 / 09 / 2025, page 30 / 156 24 / 97 corresponding.

[0063] The decoding sensor can be a color sensor. The color sensor can be a photodiode with sensitivity to wavelengths chosen from red, blue, green, and combinations thereof. The decoding sensor can be an RFID reader. The decoding sensor can be a barcode reader.

[0064] Decoding can be accompanied by character recognition, for example, OCR, or similar algorithms that limit the assays to generate binary labeling for analysis of any of the systems and examples shown and described in this document. Those skilled in the art who have the benefit of this invention will recognize additional OCR and methodological features.

[0065] In certain examples, the device includes a light source. The light source may be an arrangement of discrete light sources. For example, discrete light sources may comprise a single light-emitting diode and / or multiple light-emitting diodes. The light-emitting diodes may be colored diodes chosen from red, green, blue, and a combination thereof. The light source may comprise a lighting profile suitable for reflecting onto a test strip assay. The light source may be aligned with a light aperture, exposing the light from the light source onto the assay. A first mirror may be below the light aperture. A focusing lens may receive light from the first mirror. A second mirror may be positioned to direct the light from the focusing lens to the optical detector. A lighting processor may be adapted to trigger light emission from the light source to a desired pattern.The lighting processor may include data storage for the desired light emission pattern.

[0066] In another example, the optical detector will not generate a Petition 870250082244, dated 12 / 09 / 2025, p. 31 / 156 25 / 97 test result until the decoding sensor decodes the reference encoding. The optical detector may be a light-to-voltage sensor. The optical detector may comprise a photodiode in the optical path with the test coupled to an integrated circuit. The integrated circuit may be a monolithic integrated circuit. The optical detector may include an amplifier. The amplifier may be a transimpedance amplifier or similar.

[0067] The device may include a memory adapted to store information corresponding to an imaging parameter for image detection. The decoding sensor may be chosen from a color sensor, an RFID reader, a barcode reader, or a combination thereof. The optical detector may include an optical window that is adapted to block debris contact with the optical detector. The optical detector may include an optical housing to confine the optical detector and that is adapted to block debris contact with the optical detector. The optical detector may monitor diagnostic test progress. The optical detector may monitor a pre-test parameter before generating a diagnostic test result. The optical detector may monitor at least one pre-test parameter after the optical detector has acquired at least one image detection in the assay.

[0068] In another embodiment, in a test measuring apparatus that has an imaging detector and a microprocessor, a memory that is in communication with the microprocessor and is adapted to store information that corresponds to an imaging parameter. The memory may include an instruction to monitor a pre-test analysis in the test. The memory may include an instruction to generate a diagnostic test result in the test. The pre-test parameter may include a theoretical reflectance value. Petition 870250082244, dated 12 / 09 / 2025, page 32 / 156 26 / 97

[0069] In certain examples, the assay may include at least one test line and at least one control line, whereby the theoretical reflectance value is a comparison between a reflectance value on the test line and a reflectance value on the control line. A reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate inadequate flow in the assay. Inadequate flow may trigger a detectable signal to generate a no-result response. In specific examples, the no-result response data are retained and recorded as in any of the examples and embodiments shown and described in this document. A reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate prior analyte development in the assay. Reflectance values ​​may suggest prior analyte development and may trigger a detectable signal to disable the assay measuring apparatus.A reflectance value in the test that is inconsistent with the theoretical reflectance value may indicate a contaminated optical path.

[0070] A contaminated optical path may trigger a detectable signal to generate a no-result response. The instruction to generate a test result may correspond to an image detection in the assay. The image detection may be an optical reflectance value or a transmission value. The assay may include at least one test line and at least one control line, whereby the optical reflectance value is a comparison between a reflectance value on the test line and a reflectance value on the control line. The apparatus may be adapted to perform continuous image detection of the assay. The assay may be a lateral flow assay. The assay may also be an elongated, capillary, lateral flow test strip.

[0071] The test result can be determined within approximately Petition 870250082244, dated 12 / 09 / 2025, p. 33 / 156 27 / 97 thirty seconds activation time of the optical detector. The test result can be determined within approximately sixty seconds of optical detector activation. The device may include a power supply. The power supply may be a vehicle battery. Additionally, the optical detector may be in communication with an onboard vehicle system.

[0072] In other embodiments, a test measuring apparatus for generating a test result from a test may include an imaging detector and a microprocessor with an associated memory in communication with the microprocessor. The imaging detector may be adapted to decode a reference encoding in the test and to acquire an image detection in the test due to an aberration in the test. The microprocessor may be adapted to signal the imaging detector to generate the test result. The memory may be in communication with the microprocessor and may be adapted to store information corresponding to a plurality of imaging parameters. The memory may include a parameter to monitor a pre-test analysis in the test. The memory may include a parameter to generate the diagnostic test result of the test.

[0073] A reference code can activate a corresponding diagnostic test on the optical detector. A multichannel reader and the reference code can activate a corresponding channel on the multichannel reader. The device may include an incubator and the reference code can activate a corresponding incubation temperature.

[0074] The imaging detector can be adapted to decode the test reference encoding and comprise a decoding sensor. The decoding sensor can be a color sensor. In specific examples, the decoding sensor can be a Petition 870250082244, dated 12 / 09 / 2025, page 34 / 156 28 / 97 OCR sensor or similar. The color sensor can be a photodiode with sensitivity to wavelengths chosen from red, blue, green, and combinations thereof. The decoding sensor can be an RFID reader. The decoding sensor can also be a barcode reader.

[0075] Typically, the apparatus includes a light source. The light source may be an arrangement of discrete light sources. The discrete light sources may comprise light-emitting diodes. The light-emitting diodes may be colored diodes chosen from red, green, blue, and a combination thereof. The light source may comprise a lighting profile suitable for reflecting in a test strip assay. The light source may be aligned with a light aperture exposing the light source in the assay. The light source may include a first mirror below the light aperture. A focusing lens may receive light from the first mirror. A second mirror may be positioned to direct the light from the focusing lens to the optical detector. A light processor may be fitted to trigger light emission from the light source to a desired pattern. The light processor may include data storage for the desired light emission pattern.The optical detector may not generate a test result, or even initiate a test reading, until the decoding sensor decodes the reference encoding.

[0076] The optical detector may be a light-to-voltage sensor. The optical detector may be a camera. The optical detector may comprise a photodiode coupled to an integrated circuit in the optical path with the test. The integrated circuit may be a monolithic integrated circuit. The optical detector may include an amplifier. The amplifier may be a transimpedance amplifier or similar. The optical detector may include an optical window that is adapted to block Petition 870250082244, dated 12 / 09 / 2025, p. 35 / 156 29 / 97 the contact of debris with the optical detector. The optical detector may also include an optical housing to confine the optical detector and which is adapted to block contact of debris with the optical detector.

[0077] In some examples, the optical detector may monitor a diagnostic test progress. The optical detector may monitor a pre-test parameter before generating a diagnostic test result. Furthermore, the optical detector may monitor at least one pre-test parameter after the optical detector has acquired at least one image detection in 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, whereby the theoretical reflectance value is a comparison between a reflectance value on the test line and a reflectance value on the control line.Theoretical reflectance values ​​can also be a predefined parameter value for the control line or the test line. For example, the control line could be the theoretical reflectance value. A reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate inadequate flow in the assay. Inadequate flow can trigger a detectable signal to generate a no-result response. Furthermore, a reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate prior analyte development in the assay. Prior analyte development can trigger a detectable signal to generate a no-result response. Additionally, a reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate a contaminated optical path.A contaminated optical path can trigger a detectable signal, resulting in a meaningless response reading and / or disabling the test measuring device.

[0078] An instruction to generate a test result can cor Petition 870250082244, dated 12 / 09 / 2025, p. 36 / 156 30 / 97 respond to an image detection in the assay. The image detection may be an optical reflectance value. The assay may include at least one test line and at least one control line, whereby the optical reflectance value is a comparison between a reflectance value on the test line and a reflectance value on the control line. The apparatus may be adapted to perform continuous image detection of the assay. The assay may be a lateral flow assay. For example, the assay may be an elongated, capillary, lateral flow test strip. Furthermore, the device may include a means for a power supply.

[0079] In yet another embodiment, a lateral flow assay for the detection of an analyte having a test zone and a control zone, a surface having a reflectance profile includes at least one flow reference and at least one test result reference. At least one flow reference area may be adapted to enable monitoring of pre-flow development throughout the assay. At least one test result reference area may be adapted to enable monitoring of pre-test detection of the analyte in the assay.

[0080] The reflectance profile may include a theoretical light reflectance measurement. The theoretical light reflectance measurement may comprise a theoretical no-flow development value. The no-flow development value may be a reflectance value of approximately 85. A reflectance value greater than approximately 85 may generate a signal to disable analyte detection. The flow reference area 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 receives reagent flow into it. The flow reference area may include both an intermediate flow reference line and a reference line. Petition 870250082244, dated 12 / 09 / 2025, page 37 / 156 31 / 97 downstream flow reference line. The intermediate flow reference line may include a theoretical reflectance value after the flow reference line receives reagent flow at it. The theoretical light reflectance measurement may comprise a theoretical pre-test development value without analyte. The flow reference may also be the control zone.

[0081] The test result reference area may include at least one test line that has a theoretical reflectance value. The test result reference area may include at least one control line that has a theoretical reflectance value. The test result reference area may include at least one test line that has a theoretical reflectance value and at least one control line that has a theoretical reflectance value. A predefined difference between at least one theoretical reflectance value of the test line and at least one theoretical reflectance value of the control line may activate a test result. Furthermore, a predefined difference between at least one theoretical reflectance value of the test line and at least one theoretical reflectance value of the control line may trigger an error. The error may support a test result.

[0082] In other embodiments, an elongated, capillary-flow, lateral test strip includes a test zone, a control zone, and a surface that has a reflectance profile. The elongated, capillary-flow, lateral test strip may have at least one reagent for the detection of at least one analyte in a sample. The test zone may include, immobilized on it, a test zone capture agent that is adapted to capture at least one reagent. The control zone may include at least one control zone capture agent that has a different binding affinity for at least one reagent. The reflectance profile may be adapted to enable Petition 870250082244, dated 12 / 09 / 2025, page 38 / 156 32 / 97 monitoring of the test strip continuously until analyte detection. Typically, the test strip generates a detectable signal to detect the analyte in the sample. In some instances, inadequate control line development, for example, due to reflectance and / or transmission issues in the control line, can trigger an error. In these instances, the error can trigger a signal that generates a response without a result.

[0083] The test strip may comprise a coding system that has at least one reference code with a corresponding test sequence. The test sequence may include at least one temperature adjustment parameter. In addition, the test sequence may include an optical reader test parameter. The optical reader test parameter may include a reader channel selection. The reader test parameter may include an associated feature chosen from a standard curve, a dose-response curve, and a combination thereof. The reader test parameter may include at least one associated positive control point and at least one associated negative control point. The coding system may include a color matrix. The color matrices may include a color chosen from red, blue, green, and combinations thereof. The color matrices may be associated with a corresponding diagnostic test.The encoding system may include a barcode. The encoding system may include an RFID tag.

[0084] The test strip may include a first end that has a sample absorption material. The test strip may include a peel-off strip for introducing the sample into the sample absorption material. The peel-off strip may include a peel-off tab at one end of the peel-off strip to facilitate movement of the peel-off strip. The sample absorption material may be adapted to receive approximately 0.1 to approximately 1.0 ml of a Petition 870250082244, dated 12 / 09 / 2025, page 39 / 156 33 / 97 fluid. The sample absorption material may comprise a dry cellulosic material. Furthermore, the test strip may include a second opposite end that has a reactor detector material. The test strip may include a release area that has a mobile phase receptor for at least one analyte. The test strip may be sized and adapted to be confined within a test strip cavity. Furthermore, the test strip may be sized and adapted to be confined within a test strip cavity of a removable incubation module. In specific examples, the test strip may be sized and adapted to be confined within a test strip cavity of a removable optical and incubation module. In specific examples, the test strip is adapted to select the detection of a diagnostic test group chosen from an antibiotic analyte, toxic analyte, analyte class, a combination thereof, and similar analytes.

[0085] The test zone may include at least one analyte reference line that has a theoretical reflectance value. The theoretical reflectance value may be associated with a flow parameter on the test strip. The surface test zone may include a first analyte reference line that has a first theoretical reflectance value and a second analyte reference line that has a second theoretical reflectance value. The surface control zone may include at least one control line that has a theoretical reflectance value. For example, the theoretical reflectance value may be an optical reflectance value. The control zone may include a first control line that has a first theoretical reflectance value and a second control line that has a second theoretical reflectance value. In some examples, the reflectance profile is adapted to enable monitoring of the test strip prior to analyte detection.Furthermore, the test result can be detected within approximately... Petition 870250082244, dated 12 / 09 / 2025, p. 40 / 156 34 / 97 thirty to about sixty seconds.

[0086] In yet another embodiment, an elongated, capillary-flow, lateral test strip includes a test zone that includes, immobilized thereon, a test zone capture agent adapted to capture at least one ligand, a control zone that includes at least one control zone capture agent that has a different binding affinity for at least one ligand, a surface that has a reflectance profile adapted to enable monitoring of the test strip, and a coding system that has at least one coding signal, for example, a coding that corresponds to a test sequence to characterize the test strip. The reflectance profile may include at least one flow reference area adapted to enable monitoring of flow development throughout the assay, and at least one monitoring reference area adapted to enable monitoring of analyte detection in the assay.

[0087] The test sequence may include at least one temperature adjustment parameter. The test sequence may include an optical reader test parameter. The optical reader test parameter may include a reader channel selection. The optical reader test parameter may include an associated feature chosen from a standard curve, a dose-response curve, and a combination thereof. Furthermore, the optical reader test parameter may include at least one associated positive control point and at least one associated negative control point. The coding system may include a color matrix. Color matrices may be associated with a corresponding diagnostic test. The coding system may include a barcode. The coding system may include an RFID tag.

[0088] In some examples, the test strip may include a pri Petition 870250082244, dated 12 / 09 / 2025, page 41 / 156 35 / 97 first end that has a sample absorption material. The test strip may include a take-off strip for introducing the sample into the sample absorption material. The take-off strip may include a take-off tab at one end of the take-off strip to facilitate movement of the take-off strip. The sample absorption material may be adapted to receive about 0.1 to about 1.0 ml of a fluid. The sample absorption material may comprise a dry cellulosic material. The test strip may include a second opposite end that has a reactor detector material. The test strip may include a release area that has a mobile phase receptor for at least one analyte. The test strip may be sized and adapted to be confined within a test strip cavity.Furthermore, the test strip can be sized and adapted to be confined within a test strip cavity of a removable optical and incubation module. Typically, the test strip is adapted to select for the detection of a diagnostic test group chosen from an antibiotic analyte, toxic analyte, analyte class, a combination thereof, and similar analytes, whether quantitatively, qualitatively, or both.

[0089] The test zone may include at least one analyte reference line that has 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 analyte reference line that has a first theoretical reflectance value and a second analyte reference line that has a second theoretical reflectance value. The control zone may include at least one control line that has a theoretical reflectance value. The theoretical reflectance value may be an optical reflectance value. A control zone may include a first control line that has a first theoretical reflectance value and a second control line. Petition 870250082244, dated 12 / 09 / 2025, page 42 / 156 36 / 97 which has a second theoretical reflectance value. The theoretical light reflectance measurement may comprise a theoretical no-flow development value. The no-flow development value may be a reflectance value of approximately 85. A reflectance value greater than approximately 85 may generate a signal to disable analyte detection.

[0090] In other examples, the flow reference area 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 receives reagent flow on it. The flow reference area 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 receives reagent flow on it.Theoretical light reflectance measurement may include a pre-test development theoretical value without analyte. The test result reference area may include at least one test line that has a theoretical reflectance value. The test result reference area may include at least one control line that has a theoretical reflectance value. The test result reference area may include at least one test line that has a theoretical reflectance value and at least one control line that has a theoretical reflectance value. A predefined difference between at least one theoretical reflectance value of the test line and at least one theoretical reflectance value of the control line may trigger a test result. Furthermore, a predefined difference between at least one theoretical reflectance value of the test line and at least one theoretical reflectance value of the control line may trigger an error.Typically, the error supports a test result, including generating a response with no result.

[0091] In yet another form, in a test system Petition 870250082244, dated 12 / 09 / 2025, page 43 / 156 37 / 97 which has an incubator and a reader to generate a test result from an assay, a sensor can be adapted to continuously monitor the assay while the incubator incubates the assay and the reader generates the test result. The sensor can be adapted to disable the incubator when the sensor detects an aberration in the assay. The sensor can be an optical detector. The optical detector can be adapted to detect a reflectance value. The assay can include at least one test zone and at least one control zone, whereby the reflectance value is a comparison between a reflectance value in the test zone and a reflectance value in the control zone. Furthermore, if the reader and / or the incubator hood is opened during incubation or reading, a signal may generate a no-result response. Additionally, if the assay is removed before a test result is generated, a signal may generate a no-result response.

[0092] In some instances, the assay may be deactivated when the sensor detects a reflectance value in the assay that is inconsistent with a predetermined theoretical reflectance value in the assay. For example, a reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate inadequate flow in the assay. Furthermore, a reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate prior analyte development in the assay. Similarly, a reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate a contaminated optical path.

[0093] In other examples, the sensor may be adapted to disable the reader when the sensor detects an aberration in the test. The sensor may be an optical detector. The optical detector may be adapted to detect a reflectance value. The test may include at least one test zone and at least one control zone, and by Petition 870250082244, dated 12 / 09 / 2025, page 44 / 156 38 / 97 whereby the reflectance value is a comparison between a reflectance value in the test zone and a reflectance value in the control zone. A no-result response may be generated when the sensor detects a reflectance value in the test that is inconsistent with a predetermined theoretical reflectance value in the test. A reflectance value in the test that is inconsistent with the theoretical reflectance value may indicate inadequate flow in the test. Furthermore, a reflectance value in the test that is inconsistent with the theoretical reflectance value may indicate prior analyte development in the test. Similarly, a reflectance value in the test that is inconsistent with the theoretical reflectance value may indicate a contaminated optical path.

[0094] The sensor can be a decoding sensor. The decoding sensor can be chosen from a color sensor, an RFID reader, an OCR reader, a barcode reader, and a combination thereof. Typically, the sensor is triggered with an activation element chosen from a hood sensor, an incubator sensor, a proximity switch, a trigger switch, and a combination thereof.

[0095] The apparatus may include a housing that is adapted to substantially confine the reader and the incubator. The housing may include insulation adapted to withstand deformation during incubation. The housing may also include a cavity adapted to secure the assay and receive light from the reader. The cavity may include an optical aperture to receive light from the reader. The cavity may include an adjustable clamp adapted to position the cavity in an optical path with the reader. The cavity may include insulation adapted to withstand deformation during an incubation period. The assay may be a capillary flow test strip, lateral.

[0096] In specific examples, the system may include an inter Petition 870250082244, dated 12 / 09 / 2025, page 45 / 156 39 / 97 User interface. The user interface may include an integrated circuit board, for example, to support a display board. The user interface may also be adapted to visualize flow development. Similarly, the user interface may be adapted to visualize the test result, including a no-result response. The user interface may also be adapted to visualize flow development after the reader has detected at least one flow development in the test.

[0097] In another embodiment, a lateral flow assay system for generating a test result from an assay includes an incubator that is adapted to incubate the assay and a reader that is adapted to read a diagnostic test in the assay. The assay may undergo a change upon contact with a sample to generate the test result.

[0098] In some examples, the system includes a removable test module. The removable test module may include a test cavity adapted to align the test with the reader. The test may be a lateral flow test strip. Through the same, the test cavity may be sized to receive the lateral flow test strip. The removable test module may include a hood. The hood may confine the test in a closed test position and expose the test in an open access position.

[0099] Furthermore, the removable test module may include a bottom face adapted to align with at least one light opening in the reader. The bottom face may include an adjustment fastener adapted to secure the test cavity in optical alignment with the reader. The bottom face may also include an engagement rim to position the bottom face with the reader. The removable test module may include at least one optical window. The removable test module may be adapted to be removed from the system. Petition 870250082244, dated 12 / 09 / 2025, page 46 / 156 40 / 97 and have the debris cleaned up.

[00100] In some examples, the incubator includes an insulated base. The incubator may be a temperature-adjustable incubator. The temperature-adjustable incubator may include at least one temperature control. Through the same, the temperature-adjustable incubator may include localized temperature variations. For example, the incubator may compensate for localized temperature variations. The incubator may compensate for localized temperature variations with a proportional analog circuit. In other examples, the incubator may compensate for localized temperature variations with a digital control circuit, for example, using a PID algorithm or PID controller. Furthermore, the temperature-adjustable incubator may include a built-in temperature sensor. The temperature-adjustable incubator may include a potentiometer. The incubator may include a heater.The heater can be chosen from a ceramic heater, a resistive heating element, and similar options. Similarly, the incubator may include a cooling system. In still other examples, the incubator incubates the assay in a medium to create an incubation environment.

[00101] The reader can perform continuous image detection of the assay to generate the test result. Continuous image detection may include monitoring pre-flow development throughout the assay, including monitoring overflow throughout 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 adapted to receive light from the first mirror. Additionally, the light source may include a second mirror positioned to direct the light from the focusing lens to the reader. Petition 870250082244, dated 12 / 09 / 2025, p. 47 / 156 41 / 97

[00102] In specific examples, the reader may include a sensor. The sensor may be an optical detector that is aligned with a light source to detect light transmission through the assay. For example, transmission modes in this document may include refracted light analysis of the assay. The sensor may be a decoding sensor. The decoding sensor may be adapted to decode at least one reference code having a corresponding test sequence in the assay. Additionally, the player may include multiple channels. Each of the channels may include an associated feature chosen from a standard curve, a dose-response curve, a positive cutoff value, a negative cutoff value, and the like.

[00103] In further embodiments, a method of generating a test result from an assay includes incubating the assay in an incubation environment and reading a diagnostic test on the assay concurrently while the incubator incubates the assay. The method may include continuously capturing the assay while the incubator is incubating the assay. The method may include disabling the assay upon capturing an aberration in the assay. The method may include removing the removable assay module, for example, to clean debris, or similar, from the assay module. The method may include adding a test sample to a test medium to create the assay. The method may also include confining the test medium within the reader. The method may include positioning a sensor relative to the test medium so that a change in the test medium is detectable by the sensor. The method may include decoding a reference coding in the assay.Through the same method, it may include selecting a channel on the reader that corresponds to the reference coding in the assay. Furthermore, the method may include incubating the assay within the incubator, according to the reference coding in the assay.

[00104] In one modality, a method for managing the data Petition 870250082244, dated 12 / 09 / 2025, page 48 / 156 42 / 97 testing includes generating a test result from a test instrument reader; linking an application on a partner device to the test instrument, thereby enabling test result output communication between the test instrument and the partner device; subscribing to a first test result output from the instrument on the partner device; and transmitting at least one second result output associated with the first output and selected from the group consisting of an operator ID, a sample ID, a batch number, a geographic location, a geographic coordinate, a sample note, and a test result note.

[00105] In specific examples, the method includes establishing the authorized connection between the instrument and the partner device. Additionally, the partner device application can scan an enabled test instrument. The method may include exporting the test instrument's result outputs in real time. In certain examples, the method includes relaying the partner device's result outputs to an external storage configuration. In certain examples, the method may involve a plurality of test instruments.

[00106] In another embodiment, a method for retransmitting test data generated from a sample on a test instrument includes performing a diagnostic test on the test instrument; interfacing the test instrument with a mobile partner device that has a corresponding data communication interface to establish data communication enabled with the test instrument; transforming the test result into a suitable result output format for transmission, and establishing the data communication exchange of the result output between the test instrument and the partner device; and retransmitting the result output from the device. Petition 870250082244, dated 12 / 09 / 2025, page 49 / 156 43 / 97 partner for an external storage configuration. In certain examples, the test instrument may include one or more of the following: a housing, a receiving port to receive the sample in a sample apparatus, a reading device to generate a test result from the sample apparatus, and a data communication interface.

[00107] In specific examples, the method includes establishing data communication between the test instrument and the partner device, for example, linking an application on the partner device to the test instrument. The partner application can scan an enabled test instrument. The partner application can subscribe to data from the test instrument. The method may include real-time export of the test instrument's result output to record a plurality of subsequent sample result outputs. Furthermore, the method may include merging the plurality of sample result outputs and associated geographic locations and mapping the plurality of result outputs. And, in specific examples, the method may include generating a map display indicative of a toxin mapping incidence.The method may include establishing an authorized wireless connection between the test instrument and the partner device, for example, with a Bluetooth® Low Energy (BLE) system, dongle, or similar system. The method may also include establishing a host IP address connection between the partner device and the external storage configuration.

[00108] In some examples, performing the diagnostic test includes receiving a test strip sample device and imaging the test strip sample device to generate the test result. In some examples, performing the diagnostic test includes incubating the sample device. In certain examples, the method includes transmitting at least one sample identifier that corresponds to Petition 870250082244, dated 12 / 09 / 2025, page 50 / 156 44 / 97 an individual sample test result selected from the group consisting of an operator ID, a device ID, a sample ID, a batch number, a geographic location, a geographic coordinate, a sample score, and a test result score. In specific examples, relaying to external storage includes transmitting to a remote host web site. Furthermore, in specific examples, relaying to external storage includes transmitting 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, and when activated, provides a pairing signal, wherein the indicator provides a visual indication of pairing to the test instrument.The method may also include establishing a secondary message data communication exchange between the test instrument and the partner device.

[00109] In yet another embodiment, a method for use with a test instrument and a host site adapted to support test result data includes connecting to an enabled test instrument that has a first mode of operation to perform at least one test on a sample, and in a second mode, the instrument that has a data communication interface, communicate a result output transmission; receive authorized result output transmissions; and transform a plurality of the result outputs into a data display.

[00110] In certain examples, the method includes storing the plurality of output data in a first database. Establishing output communication may include first establishing data communication with a device. Petition 870250082244, dated 12 / 09 / 2025, p. 51 / 156 45 / 97 partner. For example, the partner device could be a mobile phone, a tablet, a general-purpose computer, a PDA, a digital media player, a digital camera, a wireless information device, and the like. In some examples, the data might ensure that properly tested food products are distributed with maximum efficiency to an assigned destination depending on the test results. In other examples, the data might be collected from a multitude of websites and sources and combined, for illustrative purposes only, into a single database using low-cost tools and existing testing instruments.

[00111] Yet another embodiment of the present invention includes a central station external storage configuration, for example, a central station being a web-hosted external storage configuration. In specific examples, the external storage configuration is assigned a static, public IP address to which any of the deployed and available developed instruments transmit test data when available.

[00112] Another embodiment of the invention includes an integrated data system that handles minimal operator intervention. In some examples, setting up the instrument requires downloading and installing the app on the smartphone, connecting the Bluetooth adapter to a power source, pairing the Bluetooth® device or similar device with the smartphone, and then launching the app. Real-time display of test data on the smartphone can provide the user with confirmation that test data has been properly transmitted to the phone and allows notes to be attached to the test data as shown and described herein.

[00113] In certain examples, with GPS enabled on the smart phone Petition 870250082244, dated 12 / 09 / 2025, page 52 / 156 46 / 97 folks, the test data may contain the latitude and longitude where the test was performed. In these methods, once the test data packet has been collected to the phone, the app handles communication with the host central station, which attempts to transfer it when adequate signal strength is available. The integrated communication protocol ensures that the data remains temporarily stored on the phone until a signal from the host indicates successful collection.

[00114] In one embodiment, a method of inhibiting the transfer of a product in a distribution system includes performing a diagnostic test; retransmitting the test result to an external administrator portal; generating a substantially continuous operational signal in a protocol converter and transmitting the signal to the administrator portal; receiving in the protocol converter a triggering condition, when present, from the administrator portal; and triggering a tailored retransmission to inhibit downstream product transfer. The test instrument may have a receiving port to receive a sample in a sample apparatus, a reading device that generates a test result from the sample apparatus, and a data communication interface.

[00115] In some examples, receiving the triggering condition includes receiving at least one positive test result. Performing the diagnostic test may include receiving a test strip sample device and imaging the test strip sample device to generate the test result. Furthermore, performing the diagnostic test may include receiving a sample plate device and imaging the sample plate device to generate the test result. Additionally, performing the diagnostic test may include receiving a swab sample device and analyzing the swab sample device to generate the... Petition 870250082244, dated 12 / 09 / 2025, page 53 / 156 47 / 97 test result.

[00116] In certain examples, the interface of the test instrument with a mobile partner device includes establishing data communication enabled with the test instrument. The method may include real-time export of a test instrument result output by recording a plurality of subsequent sample result outputs. Furthermore, product transfer inhibition may include activating a relay trigger event, for example, an audible indicator, visual indicator, access arm, barrier gate, solenoid valve, a combination thereof, and similar events.

[00117] In one embodiment, a communication protocol converter includes a data communication interface; a peripheral processor platform in data communication with an external administrator portal; and at least one relay module in electrical communication with the processor platform and at least one external peripheral, wherein a trigger condition transmission from the external administrator portal activates at least one relay module.

[00118] In certain examples, the device includes an enclosure that confines the peripheral processor platform and the relay module. The enclosure may have a metallic enclosure that is generally positioned within a data communication range of a test instrument. The data communication interface may include a Wi-Fi connection. The data communication interface may include an Ethernet connection. The relay module may include a single-pole dual-projection relay. The single-pole dual-projection relay may include two independently controlled contact relays. The single-pole dual-projection relay may include two relays Petition 870250082244, dated 12 / 09 / 2025, page 54 / 156 48 / 97 dry contact connections. In other examples, the relay module includes dual single-pole dual engagement relay. The relay module may include an input / output port adapted to trigger the relay. The processor platform may interface any number of peripherals, including a sensor, identification device, and the like. The device may include a power supply. Furthermore, the device may include a user interface.

[00119] Another embodiment includes a product distribution set that has a test instrument; a host database adapted to support the test result data generated by the test instrument; a communication protocol converter for data communication with the host database; and a product transfer inhibitor, wherein the product transfer inhibitor is activated by the protocol converter after receiving a trigger condition.

[00120] In additional alternative embodiments, a method for managing test data includes generating a test result from a test instrument; linking an application on a partner device to the test instrument, thereby enabling test result output communication between the test instrument and the partner device; subscribing to a first test result output from the instrument on the partner device; and transmitting at least one second result output associated with the first output and selected from the group consisting of an operator ID, a sample ID, a batch number, a geographic location, a geographic coordinate, a sample note, and a test result note.

[00121] In specific examples, the method includes establishing the authorized connection between the instrument and the partner device. Ade Petition 870250082244, dated 12 / 09 / 2025, page 55 / 156 49 / 97 plus, the partner device application can scan an enabled test instrument. The method may include exporting the test instrument result outputs in real time.

[00122] In certain examples, the method includes relaying the result outputs from the partner device to an external storage configuration.

[00123] In another embodiment, a method for retransmitting test data generated from a sample on a test instrument includes performing a diagnostic test on the test instrument; interfacing the test instrument with a mobile partner device that has a corresponding data communication interface to establish data communication enabled with the test instrument; transforming the test result into a result output format suitable for transmission, and establishing the data communication exchange of the result output between the test instrument and the partner device; and retransmitting the result output from the partner device to an external storage configuration.In certain examples, the test instrument may include one or more of the following: a housing, a receiving port to receive the sample in a sampling apparatus, a reading device to generate a test result from the sampling apparatus, and a data communication interface.

[00124] In specific examples, the method includes establishing data communication between the test instrument and the partner device, for example, connecting an application on the partner device to the test instrument. The partner application can scan an enabled test instrument. The partner application can subscribe to data from the test instrument. The method may include real-time export of the test instrument's result output to record a plurality of subsequent sample result outputs. Ade Petition 870250082244, dated 12 / 09 / 2025, page 56 / 156 50 / 97 plus, the method may include merging the plurality of sample result outputs and associated geographic locations and mapping the plurality of result outputs. And, in specific examples, the method may include generating a map display indicative of a toxin mapping incidence. The method may include establishing an authorized wireless connection between the test instrument and the partner device, for example, with a Bluetooth® Low Energy (BLE) system, dongle, or similar system. The method may include establishing a host IP address connection between the partner device and the external storage configuration.

[00125] In one embodiment, an apparatus for generating a test result from an assay by contacting a sample comprises a non-planar optical module adapted to align the assay in an offset position, wherein the offset position includes an angled upper portion offset around a lower portion; and a power supply via Ethernet (POE) electrically connected to the apparatus and adapted to provide a data connection and a power connection to the non-planar optical module.

[00126] In certain examples, the apparatus includes an incubator adapted for incubating the assay. In certain examples, the apparatus includes an imaging device adapted for imaging the assay in the displacement position. In certain examples, the apparatus includes a dynamically controlled direct illumination assembly aligned around the assay.

[00127] In certain examples, the device includes a PoE-enabled power supply that includes at least one power supply port. The PoE-enabled power supply can control the power to the non-planar optics module. The PoE-enabled power supply can monitor the power consumed by the non-planar optics module. The plurality of Petition 870250082244, dated 12 / 09 / 2025, p. 57 / 156 51 / 97 controllers with PoE can be coupled to the respective physical network elements.

[00128] In one embodiment, in an assembly for generating a test result from a test, an optics module comprises an offset frame adapted to receive the test that is slid into the optics module, wherein the offset frame includes an angled upper level platform offset around an inner level platform; and a stabilizer adapted to stabilize the test positioned in an offset position when generating the test result.

[00129] In certain examples, the stabilizer includes a cover. The cover may comprise a spring-loaded cover. The spring-loaded cover may include at least one spring-loaded support. The two substantially parallel spring-loaded supports may secure the test in an operating position. The two substantially parallel spring-loaded supports may align around the test pack. The upper level platform of the device may be aligned offset around the lower level platform around a pivot point. The offset frame may first receive a portion of the test in a first substantially flat entry position. The offset frame may substantially align the portion of the test in a second substantially non-flat test position. The optics module may include an elongated optics aperture to allow imaging adjacent to a bend around the test in a test position.The aperture carrier may include an area of ​​developing test line imaging. The stabilizer can stabilize the test independently of a test environment. The stabilizer can stabilize the test around the optical module during testing in a mobile environment. The stabilizer can stabilize the test to... Petition 870250082244, dated 12 / 09 / 2025, page 58 / 156 52 / 97 along a non-uniform transmission path during the mobile environment. The mobile environment may include a fleet of dairy supply trucks.

[00130] In certain embodiments, any of the assemblies and devices in this document may not include a hood or hood-like feature. For example, in an assembly free of a hood to generate a test result from a test, an optics module comprises an offset frame adapted to receive the test, wherein the frame includes an angled top-level platform offset around an inner-level platform; and an aperture carrier aligned around the frame and adapted to provide a plurality of optical windows with the test in a test position and provide clearance for handling the test around the assembly.

[00131] The above summary is intended to summarize certain embodiments of the present invention. The embodiments will be set forth in more detail in the figures and description below. It will be evident, however, that the description of the embodiments is not intended to limit the present invention, the scope of which should be properly determined by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[00132] The embodiments of the invention will be better understood by reading the Description of Embodiments together with a review of the drawings, in which:

[00133] Figure 1 is a front perspective view of one embodiment of a lateral flow test system, with elements removed for clarity;

[00134] Figure 1a is a top perspective view of the embodiment introduced in Figure 1;

[00135] Figure 1b is a front perspective view of a mo Petition 870250082244, dated 12 / 09 / 2025, page 59 / 156 53 / 97 faction of isolated elements introduced in Figure 1, with elements removed for clarity;

[00136] Figure 1c is a side perspective view of the modality introduced in Figure 1b;

[00137] Figure 1d is a background perspective view of a range of isolated elements introduced in Figure 1b, with elements removed for clarity;

[00138] Figure 1e is a front perspective view of a range of isolated elements introduced in Figure 1, with elements removed for clarity;

[00139] Figure 1F is a top perspective view of the embodiment introduced in Figure 1e in a closed position;

[00140] Figure 1g is a top perspective view of the embodiment introduced in Figure 1e in an open position;

[00141] Figure 1h is a rear perspective view of the embodiment introduced in Figure 1e;

[00142] Figure 1i is a top perspective view of a configuration of isolated elements without a display;

[00143] Figure 1j is a top perspective view of a configuration of isolated elements without a display;

[00144] Figure 2 is a front perspective view of one embodiment of a lateral flow test set;

[00145] Figure 3 is a side view of the embodiment introduced in Figure 1;

[00146] Figure 3a is a top perspective view of an embodiment of a device that has multiple integrated modules;

[00147] Figure 4 is an exploded view of one embodiment of a lateral flow test system;

[00148] Figure 5 is an isolated side perspective view of the modality introduced in Figure 1 in an operational position, with Petition 870250082244, dated 12 / 09 / 2025, page 60 / 156 54 / 97 elements removed for clarity;

[00149] Figure 5a is an isolated perspective view of a stabilizer closure embodiment introduced in Figure 1;

[00150] Figure 5b is an exploded perspective view of the embodiment shown in Figure 5a;

[00151] Figure 5c is an isolated perspective view of a stabilizer closure embodiment introduced in Figure 1;

[00152] Figure 5d is an exploded perspective view of the mode shown in Figure 5c;

[00153] Figure 5e is an isolated side perspective view of an aperture carrier embodiment introduced in Figure 5b;

[00154] Figure 5f is an isolated rear perspective view of an aperture carrier embodiment introduced in Figure 5b;

[00155] Figure 5g is an isolated top perspective view of an aperture carrier embodiment introduced in Figure 5b;

[00156] Figure 5h is an isolated side perspective view of an aperture carrier embodiment introduced in Figure 5b;

[00157] Figure 6 is an isolated side perspective view of a post-tested lateral flow test arrangement;

[00158] Figure 7 is an isolated top perspective view of a modality introduced in Figure 1, with elements removed for clarity;

[00159] Figure 7a is a side perspective view of an embodiment shown in Figure 7;

[00160] Figure 7b is an isolated perspective view of a circuit board embodiment;

[00161] Figure 7c is an electrical schematic, according to an embodiment of the present invention;

[00162] Figure 7d is a comparison view of specular reflection enhancements, according to an embodiment of the present Petition 870250082244, dated 12 / 09 / 2025, page 61 / 156 55 / 97 invention;

[00163] Figure 7e is a side perspective view of an alternative embodiment introduced in Figure 1;

[00164] Figure 7f is a side perspective view of the alternative modality introduced in Figure 7e;

[00165] Figure 7g is a front perspective view of the alternative embodiment introduced in Figure 7e;

[00166] Figure 8 is a top view of a modality introduced in Figure 1, with elements removed for clarity;

[00167] Figure 9 is a front perspective view of an embodiment of test components useful for any of the inventions shown and described herein;

[00168] Figure 10 is an overview of the overall system in block diagram form, according to one embodiment of the invention;

[00169] Figure 11 is an overview of the diagram of a relay module introduced in Figure 10;

[00170] Figure 12 is a schematic overview of a main carrier plate, according to one embodiment of the invention;

[00171] Figure 12a is a schematic of a side of the main carrier plate, according to one embodiment of the invention;

[00172] Figure 12b is a schematic of a side of the main carrier plate, according to one embodiment of the invention;

[00173] Figure 12c is a schematic of a main carrier plate, according to one embodiment of the invention;

[00174] Figure 12d is a schematic of a power interface via Ethernet, according to one embodiment of the invention;

[00175] Figure 12e is a schematic of a power interface via Ethernet, according to one embodiment of the invention;

[00176] Figure 13 is a schematic overview according to Petition 870250082244, dated 12 / 09 / 2025, p. 62 / 156 56 / 97 an embodiment of the invention;

[00177] Figure 13a is a schematic overview according to an embodiment of the invention;

[00178] Figure 13b is a schematic overview according to an embodiment of the invention;

[00179] Figure 13c is a schematic overview according to an embodiment of the invention;

[00180] Figure 14 is a top perspective view of one embodiment of a lateral flow test system, with elements removed for clarity;

[00181] Figure 15 is a top perspective view of one embodiment of a lateral flow test set, with elements removed for clarity; and

[00182] Figure 15a is a top perspective view of one embodiment of a lateral flow test set, with elements removed for clarity. DESCRIPTION OF MODALITIES

[00183] In the following description, characters with similar reference designate similar or corresponding parts from all different views. Also in the following description, it should be understood that terms such as forward, backward, left, right, up, down, and the like are words of convenience and should not be interpreted as limiting terms. It will be understood that the illustrations are for the purpose of describing embodiments of the invention and are not intended to limit the invention or any invention thereof.

[00184] In some embodiments, the test instrument is a lateral flow test system configured to receive a test sample apparatus and analyze the sample to generate a diagnostic test result. Typically, the test sample apparatus is Petition 870250082244, dated 12 / 09 / 2025, p. 63 / 156 57 / 97 a lateral flow test strip. However, it is within the spirit of this invention for any of the test apparatus in the present document to be assays other than, but not limited to, lateral capillary flow test strips. Furthermore, any of the reader, incubator, combined reader / incubator devices and systems shown and described in the present document may include any optical analysis readers, which often include an imaging device, a light source and an imaging detector, including a sensor aligned so that the light from the light source shines on the assay and is then imaged / reflected on the imaging sensor. An example of reader components useful in embodiments in the present document is described in document PCT / US2011 / 49170 filed August 25, 2011 and US Patent No. 6,124.585 (Apparatus for measuring the reflectance of strips having non-uniform color), issued on September 26, 2000, and both are incorporated herein by reference in their entirety. Typically, the presence and, in some cases, the concentration of an analyte in an assay can be determined by measuring, for example, the imaging, optical reflectance, and the like of a development area in the assay. In some examples, percentage reflectance can be used to determine the result. In other examples, transmission can be used to detect the result. For example, the assay may be transparent and include a surface that has a transmission profile similar to the reflectance profile discussed below. This structure and function described in these references can be adapted by one skilled in the art, according to the invention in the present document, to obtain a working unit.

[00185] Frequently, excessive pipetting or other sample distribution for an assay can create an assay flood and Petition 870250082244, dated 12 / 09 / 2025, page 64 / 156 58 / 97 generate unreliable and inaccurate test results. Figures 1 to 12e introduce elements and embodiments of an offset, non-planar optical module 500, similar to any of the reader element features shown and described in this document, to minimize or eliminate uncertainties and undesirable sample flooding results. It was unexpectedly found that the development and testing of non-planar tests alleviates many of these problems.

[00186] As introduced in Figures 1, 3, and 5, the non-planar optical module 500 generally includes an upper distal portion 532 aligned adjacent to and substantially offset from a lower proximal portion 530. The proximal portion 530 may include a protruding suspended rim 525 for efficient and convenient access to manipulate any assay shown and described in this document around the device, for example, during loading and unloading. The suspended rim 525 allows a user to conveniently align at least a portion of the assay to extend around the optical module in an operating position, for example, the proximal portion of the assay may project outward from the device or similar.

[00187] In specific embodiments, as shown in Figures 1 to 5h, the non-planar optics module 500 may include a power switch 700, electrical communication port 702, bottom support 502, interface housing 504, clamp 506, and base 508 that supports the positioning of the offset frame 512 to provide non-planar positioning. The aperture carrier 510 that aligns any of the optics shown and described in this document is generally supported within the offset frame 512. The offset frame 512 generally includes an inner level platform 520 aligned with the opposite upper level platform 522, for example, in Petition 870250082244, dated 12 / 09 / 2025, p. 65 / 156 59 / 97 pivot point 516.

[00188] Any of the devices and assemblies shown and described herein may be useful for mobile, transit operation, and similar applications. For example, advantages of the enhanced non-flat optical reader and module have been unexpectedly found for testing during transit operation, including, but not limited to, during batch food supply collection, to provide immediate test result feedback and mass collection logistics for a truck fleet operator, an external source, and the like. The enhanced non-flat optical reader and module can stabilize any test shown and described herein in a safe test position independent of the transit / test environment, thus allowing any uninterrupted testing between multiple collection points, regardless of vibrations, sway and movement in a vehicle, road conditions, or the like.A specific advantageous application is the accurate and reliable provision of test results from a specific location collection during mobile collections of dairy batches in a transit truck or similar, to minimize or eliminate the combination of contaminated product that fails a test result with other uncontaminated product. For example, if a test result from a collection location indicates a positive result, the driver is notified to act immediately. In certain examples, the truck driver is notified on a screen in the cab that is in communication with any system and assembly present, while those skilled in the art who have the benefit of this invention will recognize additional notifications. Furthermore, immediate action following a positive test result may include triggering a subsequent test, discarding the product, rerouting the transit to a specified location, a combination thereof, and similar actions. Petition 870250082244, dated 12 / 09 / 2025, p. 66 / 156 60 / 97

[00189] For example, a stabilizer or similar structure may secure any of the tests shown and described herein in an operating position suitable for intensifying the test in transit. In certain embodiments, the cover 514 is a spring-loaded cover for stabilizing and securing a test, including, but not limited to, a light lateral flow test strip. As introduced in Figures 5a to 5d, a spring-loaded cover may include spring-loaded supports 534, for example, any of the extensions shown and described herein, aligned between the cover 514a and offset sliding frame 512 to allow ease of access for aligning / removing a test around the device in a secure / stabilized position.Although other embodiments of the cover include a unit, including at least one substantially integral cover(s) to provide access for aligning / removing a test around the device in any of the examples shown and described herein. As introduced in Figures 5c and 5d, the integral cover embodiments include the cover 514b aligned with integrated supports 534b around the offset sliding frame 512 to stabilize the test, including support material, packing material or similar of the test. Those skilled in the art who have the benefit of this invention will recognize the additional cover, latch, door, window and similar features to provide enhanced stabilization, as well as access to and / or sealing, housing, etc. of the test during operation.An example of a useful mass product collection test with examples and embodiments in the present document is described in document PCT / US2019 / 020535 filed on March 4, 2019, which is incorporated herein by reference in its entirety.

[00190] In certain modalities, the essay is inserted, for example, Petition 870250082244, dated 12 / 09 / 2025, p. 67 / 156 61 / 97 fed to, in the frame in a test position. In the test position, the near-flat portion 530 can align the test elements in an overall flat position, while the distal non-flat portion 532 aligns test elements in an overall non-flat position. For example, as shown and described in this document, any of the test lines 42, control lines 40, and combinations thereof can be aligned adjacent to, including at, above, or substantially adjacent to, a pivot point 516' created by positioning the test within the docking module. In specific examples, the distal non-flat portion 532 is aligned approximately ten degrees to approximately thirty degrees offset from the near-flat portion 530. For example, the distal non-flat portion 532 can be aligned approximately twenty degrees offset from the near-flat portion 530. Other examples include a variety of degrees offset between the distal portion 532 and the near portion 530.In specific examples, the optics module can image the test adjacent to a bend in the test in an operational position, for example, at point 516'.

[00191] As illustrated, a generally flat test strip is inserted into the fitting module 500, i.e., along the proximal portion 530, and then generally flexes non-flat as the test strip projects to the non-flat distal portion 532. Unexpectedly, capillary and flow advantages and elements were found that allow sample flow to proceed along the test strip while in the operating position (i.e., within the displaced frame) to the distal portion 532, for example, against the pull of gravity, while non-flat alignment, for example, against the pivot point, prevents excess sample flow to the test areas of the distal portion 532 while allowing adequate flow. In specific examples, about forty percent to about seventy percent, including about sixty percent, Petition 870250082244, dated 12 / 09 / 2025, page 68 / 156 62 / 97 of the length of the test strip can be aligned on the non-flat distal portion 532 in the operating positions shown and described in this document. Other examples include a variety of length ratios between the distal portion 532 and the proximal portion 530, for example, to suit site testing conditions, multiple control and test line developments, analyte testing of interest, and the like, as recognized by those skilled in the art who have the benefit of this invention.

[00192] As introduced in Figure 8, useful elements of a lateral flow assay system are shown for application in the test positions. The lateral flow assay system shown and described in this document typically includes a reader, a combined reader and incubator, and the like. Readers may include a camera, device, imaging detector, or similar, such as a sensor, while any of the incubator embodiments in this document may additionally include an insulated base, thermal shielding, or similar incubation environment component to deliver and maintain a desired test temperature. In some embodiments, the insulated base is a removable assay module. In certain examples, the reader first monitors an assay for one or more monitoring valves, including status or flow rate, prior analyte development, and debris.In several examples, if an adequate monitoring value is detected by the system, the incubator incubates the assay and the reader generates a test result.

[00193] As shown in Figure 8, the lateral flow test system is configured to receive a test and analyze the test to generate a diagnostic test result. Typically, the test is a lateral flow test strip. However, it is within the spirit of this invention that any of the tests in the present document may be within other flow tests. Petition 870250082244, dated 12 / 09 / 2025, page 69 / 156 63 / 97

[00194] In one embodiment, an apparatus for generating a test result from an assay upon contact with a sample comprises a non-planar optical module 500 adapted for aligning the assay in a displacement position, wherein the displacement position includes an angled upper portion displaced around a lower portion; an incubator adapted for incubating the assay; an imaging device adapted for imaging the assay in the displacement position; and a dynamically controlled direct illumination assembly aligned around the assay. In certain examples, as introduced in Figures 1b to 1d, the optical module 500 may have interchangeable optics, for example, removable optics 507, from a slot 509 in the apparatus. The optical module may include a calibration sequence.Any of the calibration sequences in this document can be stored in the module, for example, to enhance the support of replaceable and removable optics modules. The optics module can include any aligned bend between the upper and lower portions shown and described in this document.

[00195] Certain embodiments include modular systems, for example, which provide a plurality of integrated modules to provide any single or multiple test result shown and described in this document. For example, Figure 3a introduces an assembly with multiple modules 500', 500'', 500''' and 500''' that perform any of the operations shown and described in tests 21', 21'', 21''' and 21'''', respectively. The plurality of modules can be operated simultaneously or at different stages in time, to provide any of the associated test results shown and described in this document. Furthermore, the multiple modules can perform the test of the same type or a plurality of different test types to provide any combination of result(s). Petition 870250082244, dated 12 / 09 / 2025, p. 70 / 156 64 / 97 test. As shown, the plurality of test results can be integrated into a display, as shown in Figure 3a, or communicated to a different source, for example, a truck operator, external third-party source or similar, as shown in Figures 3a and 1i / 1j. Those skilled in the art who have the benefit of this invention will recognize a variety of combinations, operations and orientations of the modular system.

[00196] In certain examples, the apparatus may include an aperture carrier, as illustrated in Figures 4 to 5h, for example, a thermal aperture carrier block 510 or similar. The thermal aperture carrier block may include an elongated optical aperture 511'. The elongated optical aperture 511' may provide an elongated test viewing area for any test shown and described in this document. Unexpectedly, imaging advantages have been found over a substantial length, including the entirety, of the test development area. In specific examples, the apparatus generates a viewing development area of ​​about one hundred and fifty by about one thousand five hundred pixels in length; however, other examples include any combination of pixel size development area.

[00197] The apparatus may include a test line development imaging area 546. The thermal aperture carrier block may include a reference coding aperture 540. The reference coding aperture 540 may provide a viewing area for any reference coding shown and described herein. For example, the reference coding may include a barcode. The apparatus may include a reference coding imaging area 548. The thermal aperture carrier block may include a reference writing aperture 542. The reference writing aperture may provide a viewing area for Petition 870250082244, dated 12 / 09 / 2025, page 71 / 156 65 / 97 tion of any reference writing shown and described in this document. The device may include any corresponding writing area. The writing image area may include an optical character recognition image area 555.

[00198] In certain examples, the thermal opening carrier block may include a chamfered edge 563, for example, to prevent, including eliminate, unintentional movement, misalignment, blocking and / or the like around a raised portion, or similar, of the test. The thermal opening carrier block may include a clearance channel 561, for example, to provide clearance for any test manipulation around the thermal opening carrier block shown and described herein. In certain examples, the bottom side of the thermal opening carrier block may include a temperature sensor slot 567, for example, to thermally couple to any temperature sensor shown and described herein. Furthermore, the bottom side of the thermal opening carrier block may include at least one mounting opening 565.Also shown, the bottom side of the thermal aperture carrier block may include a recessed, contoured surface 569. As illustrated, the recessed, contoured surface 569 may be recessed relative to an upper surface 571. For example, the apparatus may include a wall 573 that is generally spacing the recessed, contoured surface 569 from the upper surface 571, to provide any of the lighting environments around the test shown and described herein.

[00199] In certain examples, the optical module may include a proximity switch adapted to break a path from an optical switch to trigger an incubation, a detection of a light transmission around the assay, an imaging of the assay, a combination thereof, and the like. The apparatus may rea Petition 870250082244, dated 12 / 09 / 2025, page 72 / 156 66 / 97 perform at least two image detections of the assay. The imaging device may monitor at least one pretest parameter after receiving the assay. The dynamically controlled direct illumination set may include a plurality of light sources. The plurality of light sources is adapted to provide illumination around the assay with minimal specular reflection in at least a portion of the assay. The plurality of light sources may provide illumination around the assay free of specular reflection. The plurality of light sources may be aligned along an imaging clamp. The imaging clamp may include an angled alignment relative to a surface. As shown throughout the various figures, including but not limited to Figures 7 to 7g, the light sources may be positioned on opposite sides of the imaging clamp to provide any illumination shown and described herein.For example, multiple light sources can be positioned substantially towards the test in a test setup. Multiple light sources can provide an edge of a scattering angle outside a section of the test. The edge of a scattering angle can be outside a section of the test free from specular reflection.

[00200] Any of the light sources shown and described in this document may be independently variable to assist in a supply, control, or similar system. For example, the apparatus may include a dual digital-to-analog converter. The dual digital-to-analog converter may include two independent control voltage sources. The dual digital-to-analog converter may maintain a constant current. And, as shown in Figure 7c, the dual digital-to-analog converter may monitor a voltage across a current-limiting resistor to maintain a constant current. The apparatus may monitor a voltage across a current-limiting resistor. Petition 870250082244, dated 12 / 09 / 2025, page 73 / 156 67 / 97 are proportional to the light intensity of at least one of a plurality of light sources. The device may include monitoring a low-impedance voltage output. The low-impedance voltage output may be proportional to the current through at least one of a plurality of light sources.

[00201] Any housing variety can confine the 500 optical module, reader and / or incubator as an integral diagnostic unit. Other embodiments include a housing that partially confines components of the lateral flow test system. In certain examples, the cavity is surrounded by insulating material, such as a plastic material, for example, a thermoplastic like polyoxymethylene, known as Delrin (DELRIN is a registered trademark of DuPont) to insulate the cavity, and does not deform when heated to the temperatures required to generate a test result.

[00202] The benefits of non-planar systems and assemblies were unexpectedly observed in this document when operating test strips with multi-line developments in various areas of the test strip, as described below and introduced in Figure 9, for example, along multiple analyte detection test strips. For example, the testing of multiple analyte detection test strips for multiple drug families and the like can support variable ligand lengths with limitations in binding speed impacted by excessive pipetting, sample clumping, inadequate flow, and the like.

[00203] Any of the readers shown and described in this document may comprise a variety of light sources, including light bar(s), for example, aligned along an angled slope of the device, an incandescent lamp, a fluorescent tube, a light-emitting diode, or similar. In some examples, the light source may be an arrangement of discrete light sources. Petition 870250082244, dated 12 / 09 / 2025, p. 74 / 156 68 / 97 tests, for example, colored light-emitting diodes chosen from red, green, blue, and a combination thereof. In still other examples, the light source may be a single light source, for example, a single diode. Typically, the light source is configured and the current is activated to emit a suitable illumination pattern to reflect onto the test, for example, along an elongated test strip. In specific examples, the light may be directed onto the test, for example, through the 511 aperture via the cavity. In certain examples, the light may be reflected onto the test, back through the cavity aperture, and directed to an optical detector.

[00204] In certain examples, an optical circuit board may have a plurality of light-emitting diodes (LEDs) mounted on it, for example, in a predetermined pattern around the light-emitting aperture. LEDs may be mounted on one side of the optical circuit board. An optical detector arrangement may be mounted on the reverse side of the same optical circuit board. Furthermore, a first mirror may be positioned below the light-emitting aperture at a predetermined angle, for example, of about three hundred and fifteen degrees, relative to the circuit board. A second mirror may be positioned below the optical detector, for example, at an angle of about two hundred and twenty degrees relative to the circuit board, so that a substantial ninety-degree angle exists between the first and second mirrors. A focusing lens may be positioned between the first and second mirrors.Through it, the light emitted from the LED array can illuminate a test, and then the light reflected from it through the light emission aperture, for example, to the first mirror, from the first mirror through the focusing lens to the second mirror, and from the second mirror to the optical detector. In this sense, the light that reaches the optical detector can cause the optical detector to generate. Petition 870250082244, dated 12 / 09 / 2025, p. 75 / 156 69 / 97 a measurable voltage. In further examples, a light processor can be coupled to the light source to drive the light source and supply each light with the appropriate current to generate the desired emission pattern. The light processor can be used to read and store data from the optical detector. The light processor can also be used to adjust the output of an array of discrete light sources so that the emission pattern reaching the light detector array has a uniform intensity. The light processor may include data storage for the desired light emission pattern.

[00205] Furthermore, the light source can be an LED light source, which includes a red, green, blue LED device in a single package. For example, the LED light source for the color sensor can also be three discrete LEDs. Similarly, a single white LED and three discrete photodiodes, with narrow bandwidth responses in the red, green, and blue wavelengths, can be used as a detector front-end.

[00206] In still other examples, an LED is used with an optional feedback loop. The feedback loop may use a photodiode to capture the variation in light output from the single LED. If the light output changes, a signal is sent so that a suitable adjustment can be made, for example, an increase or decrease in the current to the LED. Changes in reflectance may be the result of the attachment of a label, including colored particles such as gold microspheres. Changes in reflectance may also be a result of contaminants and interference in the optical path.

[00207] Some embodiments include multiple readers that can be positioned around the modular 600 interface (for example, shown in Figure 2) and / or the readers can be programmed with multiple channels, Petition 870250082244, dated 12 / 09 / 2025, page 76 / 156 70 / 97 each of which may have separate parameters associated with a related diagnostic test. Each channel selection parameter may include a standard curve, a dose-response curve, and the like. Specific examples include any variety of offset alignment slots 500 positioned around a carrier plate, for example, slots 552 to support multiple optical units beneficial for multiple simultaneous tests. For example, specific modules provide specific test parameters for multiple test strips with identical specifications or for test strips that have unique incubation temperatures, incubation time frames, test development specification, monitoring specifications.The modular interface can additionally accommodate any variety of test elements, including collection trays 556, strip holders 554, lens features and the like, as understood by those skilled in the art who have the benefit of this invention.

[00208] The embodiments include any variety of user interface in the reader, modular interface or tangential electronics, including, but not limited to, handheld devices, telephones, computers, on-board vehicle analysis, for example, during batch harvesting, vehicle displays and the like. In specific examples, a user interface includes an integrated circuit board that supports a display board. In certain examples, the user interface allows a user to view flow development. Furthermore, the user interface may allow a user to monitor subsequent flow development after the reader has already detected at least one flow development in the assay. Similarly, the user interface may display a final test result, including a no-result response.

[00209] Figure 9 illustrates one type of test element. Petition 870250082244, dated 12 / 09 / 2025, page 77 / 156 71 / 97 for specific diagnostic tests that have components useful for modalities in this document, which include those described in U.S. Patents Nos.: 7,410,808, issued August 12, 2008; 7,097,983, issued August 29, 2006; 6,475,805, issued November 5, 2002; 6,319,466, issued November 20, 2001; 5,985,675, issued November 16, 1999 and U.S. Patent Application 11 / 883,784, filed August 6, 2007, all of which are incorporated herein by reference.

[00210] In specific embodiments, any of the inventions in this document may inhibit the transfer of contaminated and / or poor-quality product, for example, triggered by a positive test result, to a mixture of good product, for example, a product with a negative test result. Examples of the indicator triggered by the examples in this document include audible and / or visual indicators, for example, positioned in a receiving bay or along various points in the process line to alert to the detection of a product with a positive test result. Additional inhibitors may include preventing a tanker truck from accessing a receiving bay by means of a gate access control arm, a barrier gate, or inhibiting product flow by means of a solenoid valve.Those skilled in the art who have the benefit of this invention will recognize additional inhibitors activated by any of the examples and embodiments shown and described in this document.

[00211] For example, various embodiments include communication protocol converters in data communication with an administrator portal, database, software or similar, to provide data exchange and trigger events for any of the product transfer inhibitors shown and described herein. Petition 870250082244, dated 12 / 09 / 2025, p. 78 / 156 72 / 97 document. Figure 10 illustrates components of an embodiment of the communication platform that has a display, a peripheral processor platform 14, a plurality of data communication interfaces, including, but not limited to, WiFi interface 20, Ethernet interface 22, channel connections 28, 28' to receive relay modules 18, 18'.

[00212] In specific examples, the 18, 18' extension modules may be a single-pole dual projection relay. The single-pole dual projection relay may have two independently controlled dry contact relays. In certain examples, the single-pole dual projection relay may activate any of the indicators shown and described in this document. In other examples, the 18, 18' extension modules may be a single-pole dual engagement relay, where the relays engage to reduce, or minimize, the current to long-term activation. Furthermore, the relays may be rated for 250VAC at 16 amps of current, while other examples include additional loads and currents to meet a specific local demand.

[00213] In certain examples, the systems include onboard diagnostics to determine overall health to generate any of the operational signals shown and described in this document. A programmable trigger condition of the portal, such as a Positive test result, can initiate a transmission to act for inhibition. Furthermore, the administrator portal, or similar, can allow the entry of the IP address on the device. Each of the channels can have independent control, and the administrator portal can catalog / operate any variety of devices and systems.

[00214] In specific modules, the test instrument interfaces with a partner mobile device that has a communication interface. Petition 870250082244, dated 12 / 09 / 2025, page 79 / 156 73 / 97 corresponding data communication, thus establishing enabled data communication, i.e., approved, authorized and / or available, including any of the data communication systems shown and described in this document, with the test instrument. Certain examples of a partner device receiving test result data communication before retransmitting the test result output to the external storage configuration. In specific examples, the module may include linking an application, for example, a downloadable program application, on the partner device to the test instrument. Furthermore, the module may include establishing the exchange of data communication of a result output between the test instrument and the partner device.Furthermore, the module includes establishing secondary data communication via messaging, including, but not limited to, email, text, and similar methods, enabling secondary message exchange between the test instrument and the partner device.

[00215] Any of the test instruments in this document may interface with a partner device to relay test results to an external storage configuration and the like, or alternatively, the test instrument may interface directly with the external storage configuration, to provide any advantages shown and described in this document. In specific examples, the partner device is a smartphone; however, other partner devices may include a tablet, a general-purpose computer, a PDA, a digital media player, a digital camera, a wireless information device, and the like.

[00216] Those skilled in the art who have the benefit of this invention, and incorporating test instruments and sample apparatus, will recognize the additional interface arrangements between the device Petition 870250082244, dated 12 / 09 / 2025, page 80 / 156 74 / 97 partner and the test instrument, the exchange of communication between the partner device and the external storage configuration, direct exchange between the test instrument and the external storage configuration, and other communication and data storage features within the spirit of these inventions.

[00217] In certain embodiments, the devices and assemblies in this document may be operated by means of a power-through-Ethernet or similar power scheme. For example, as shown in Figures 12 to 12e, the main carrier board 800 may support a power-through-Ethernet 804 interface to provide a power supply to one or more of the elements shown and described in this document. As shown in Figures 12 to 12e, the main carrier board 800 / power-through-Ethernet 804 interface may pass electrical power along with data in a cabling for Ethernet or similar, to any reader, incubator and communication element shown and described in this document. Those skilled in the art who have the benefit of this invention will recognize useful PoE elements and descriptions at https: / / wikipedia.org / Power_over_Ethernet and similar materials, whose teachings are incorporated herein by reference. In certain instances, the main carrier board 800 provides data communication for any display interface shown and described herein, for example, a unit display, a truck display, an external display, a touch panel interface, and the like. In specific instances shown in Figures 12 to 12e, the power-over-Ethernet interface 804 may include a DC power decoupler, transceiver, Bob Smith plane 810 communicating with chassis 820.

[00218] Generally, the lateral flow test 21 is usually a flat membrane-based test device before operation Petition 870250082244, dated 12 / 09 / 2025, page 81 / 156 75 / 97 tion / test in any of the examples shown and described in this document, wherein a sample suspected of containing the analyte of interest is placed at or near one end of the membrane strip. The sample is carried to the opposite end of the membrane strip by a mobile phase that travels along the membrane strip, for example, by capillary action. As it travels along the membrane strip, the analyte in the test sample, if present, encounters one or more reagents. The reagents may include binders for the analyte. The binders may be mobile and therefore flow with the sample, or they may be immobilized on the test strip as a capture agent. Depending on the test configuration, the analyte binder, the analyte itself, or some other reagent in the test system will be captured by the immobilized capture agent and thus produce a detectable signal. The signal may be generated by a label provided within the assay.The detectable signal can be measured, for example, by means of an optical reader. As shown and described in this document, the advantage of aligning the assay or a portion thereof in a non-flat position to minimize the impact of in-line sample distribution, including dripping and the like, during the mobile phase that occurs throughout the assay was unexpectedly found.

[00219] Test 21 may include at least one test line 40 in a test zone and at least one control line 42 in a control zone. A theoretical reflectance value may be a comparison between a reflectance value on test line 42 and a reflectance value on control line 40. A predefined difference between a theoretical reflectance value on test line 42 and a theoretical reflectance value on control line 40 may activate the lateral flow test system, including reader, to generate a test result. Furthermore, a separate predefined difference between a theoretical reflectance value on test line 40 and a theoretical reflectance value on control line 40 may activate the lateral flow test system, including reader, to generate a test result. Petition 870250082244, dated 12 / 09 / 2025, page 82 / 156 76 / 97 control line 42 may trigger an error. Triggering the error may cause the microprocessor to fail a test result, including generating a no-result response or disabling the reader and / or incubator. Other modes include a comparison between a transmission value on test line 40 and a reflectance value on control line 42.

[00220] Rapid result tests are beneficial for any of the non-planar test examples and modalities shown and described in this document. For example, rapid result assays provide a definitive test result within about fifteen seconds to about one minute, including a definitive test result within about thirty seconds. In other examples, the reader generates a test result within about ten seconds to about fifteen minutes. To increase the speed of a test result, the optimization of overlapping a binder application area onto a nitrocellulose membrane in the assay was unexpectedly found, allowing a definitive test result beneficial for any of the non-planar test processes and modalities shown and described in this document.In certain examples, a three-millimeter overlap of the binder application area onto the nitrocellulose membrane optimizes the contact surface area between the binder application area and the nitrocellulose membrane to increase flow and release the sample to satisfy the thirty-second test in this document. In specific embodiments, the binder application area may be, for example, POREX® (POREX is a registered trademark of Porex Technologies Corp, Georgia, USA), fixed to a solid support. Furthermore, in certain embodiments, the nitrocellulose membrane may be optimized to satisfy the rapid thirty-second test in this document; for example, the nitrocellulose membrane may ensure capillarity. Petition 870250082244, dated 12 / 09 / 2025, page 83 / 156 77 / 97 of adequate sample efficiently and readily rapidly through the membrane to generate the rapid test result analysis shown and described in this document. However, those skilled in the art who have the benefit of this invention will recognize additional binder application area materials and / or binder application area spacings around the nitrocellulose membrane.

[00221] Furthermore, it was unexpectedly found that optimizing the length of an absorbent pad in the distal portion of the assay enhances capillary action to adjust the sample flow rate to meet the demands of the non-planar test, for example, the thirty-second rapid test in this document. In certain examples, an absorbent pad with a length of thirty-one millimeters optimizes the sample flow throughout the assay.

[00222] In certain embodiments, a reflectance value in the assay that is inconsistent with the theoretical reflectance value may indicate inadequate flow in the mobile phase in the assay. For example, assay 21 may have a flow line 44 with a corresponding theoretical light reflectance measurement. A flow-free development value may be a reflectance value of approximately 85 on a reflectance scale. Such inadequate flow may trigger a detectable signal to generate a no-result response. Additional examples include disabling the lateral flow assay system 1, including disabling the reader and / or incubator. In other examples, the flow reference area may include either an intermediate flow reference line 46 with a corresponding theoretical reflectance value or a flow reference line 44.

[00223] Similarly, a reflectance value in the assay that is inconsistent with the theoretical reflectance value may also indicate prior analyte development in the assay. Such development of Petition 870250082244, dated 12 / 09 / 2025, page 84 / 156 78 / 97 prior analyte may trigger a detectable signal to generate a no-result response. Furthermore, if the assay is removed before generating a test result, the system may generate a no-response result.

[00224] In some embodiments, the packaging and / or support material, or similar, of tests 21 also includes a coding reference component with a corresponding test sequence for the lateral flow test system. The coding may be, for example, an alphanumeric code, a color code, a barcode, an RFID tag or similar, and may be positioned anywhere along the test so that the decoder sensor can decode the reference code, for example, on the packaging, support, etc., test surface. For example, in some embodiments, the coding reference is positioned along the distal end of the test 21. Depending on the type of coding on the test strip, the reader may require an integrated decoding sensor, for example, a barcode reader, an RFID decoder or a color sensor.

[00225] In certain examples, the test sequence is at least one temperature setting parameter in the incubator and / or a reader channel selection. Furthermore, the reader test parameter may include an associated feature chosen from a standard curve, a dose-response curve, and the like. Other embodiments include a variety of test sequence parameters for the associated diagnostic test that is performed in the assay.

[00226] In some examples, a reference color matrix, or matrices, that includes a color chosen from red, blue, green, and combinations thereof, may be associated with a corresponding diagnostic test parameter. When a color coding is used in assay 21, the color can be read by the reader, whether Petition 870250082244, dated 12 / 09 / 2025, p. 85 / 156 79 / 97 by an optical reading system or the same system that reads the test result. That is, the assay may include a color portion which, after confinement in the system and initiation of the test, will be read by the color sensor to determine the reader channel and / or the appropriate incubator temperature. For example, a photodiode with a wide dynamic range of sensitivity to red, green, and blue wavelengths can be used as the detector. Red, green, and blue LEDs can be used as the light source. Each LED can be triggered sequentially and the detector used to determine the reflectance of each of the colors. A black surface (fully absorbent since it contains no color) will not produce reflectance of the given wavelength of LEDs and therefore the detector will produce low output readings. A white surface will produce maximum reflectance of all three LEDs.Various colors (depending on their content on the measured surface) will be produced by the detector output at varying levels.

[00227] Such a color sensor component can be configured as a separate capture component in the system, or depending on the sensor used to read the test strip result, a single component that detects both development on the test strip and color coding. In several examples, assays can be color-coded that defines the test being performed. For example, a red color might indicate a test strip to be used to detect beta-lactam antibiotics. Various matrices can also be outlined by the color system. In the red example, after the system detects the red color on the test strip, the reader and / or incubator can be automatically configured for that specific assay 21, for example, by adjusting the incubator temperature and selecting appropriate reflectance test parameters within the reader. Therefore, in some embodiments, the system can Petition 870250082244, dated 12 / 09 / 2025, page 86 / 156 80 / 97 provides a comprehensive diagnostic test unit that is triggered by specific reference codes in the assay.

[00228] In other examples, the encoding reference may comprise a radio frequency identification (RFID) tag. Such a radio frequency signal transmits a signal from the tag to a decoding RFID sensor module. This signal may be used to initiate the analytical, event, channel, temperature, or similar test sequence in the reader and / or incubator. Similarly, the encoding reference may be a barcode, where the barcode is placed in the assay and a barcode reader decodes the encoding reference and associated test sequence information.

[00229] In specific examples of the closed test position, a heating element, incubator, or similar device may incubate assay 21 in an incubation environment. For example, the incubator may heat and / or cool assay 21 to provide the appropriate incubation environment for a corresponding assay and diagnostic test. Typically, the incubator is in communication with the cavity and is capable of maintaining a consistent temperature within the cavity by either heating or cooling at a predefined rate. In some examples, the incubator includes an insulated base. In other examples, the incubator incubates the removable assay module, as described hereinafter in this document. The incubator may be a temperature-adjustable incubator. In these examples, the temperature-adjustable incubator may include a temperature control. In further embodiments, the temperature-adjustable incubator may allow for localized temperature changes.

[00230] The incubator may include a heater. The heater may be a ceramic heater, a resistive heating element, and the like. In certain examples, the cavity is designed to be pe Petition 870250082244, dated 12 / 09 / 2025, page 87 / 156 81 / 97 quena, so that the heater only needs to consume the minimum current. In this way, heating only essential areas and providing insulation around these areas minimizes power requirements. The use of various heating algorithms can be useful. For example, a proportional integrated derivative (PID) can be used. In other examples, the incubator can compensate for localized temperature variations from the selected target temperature, for example, a target temperature according to a corresponding test sequence. The incubator can also compensate for localized temperature variations with a proportional, analog control circuit. In other examples, the incubator can also compensate for localized temperature variations within a digital control circuit, for example, using a PID algorithm or a PID controller.Furthermore, those skilled in the art would recognize that PI, PD, P, or I controllers and / or algorithms do not preclude any of the inventions in this document. For example, an incubator with adjustable temperature may include a digitally controlled potentiometer to allow microprocessor-based temperature selection. In other examples, the algorithms are particularly useful when test results are affected by small temperature variations. Embodiments include incubator control systems that eliminate the need for manual adjustment by using digital temperature sensors and built-in digital potentiometers that provide both accurate temperature reporting and a mechanism by which a microcontroller can adjust an independent, analog incubator control circuit.In a specific embodiment shown in Figure 7a, an integrated heater 708, for example, with a thermal fuse and temperature sensor, can incubate the assay in any of the incubation environments shown and described in this document. Petition 870250082244, dated 12 / 09 / 2025, page 88 / 156 82 / 97

[00231] In additional embodiments, cooling may be advantageous to reduce the temperature of the incubation environment, for example, to stabilize the environment of a test medium and / or sample before incubation.

[00232] In certain examples, the test strip 21 may include a first end that has a sample-absorbing material, for example, a sample-absorbing material that can be exposed by manipulating a limb. For example, the test strip 21 may have a peel-off strip 50 for introducing the sample into the sample-absorbing material. The peel-off strip 50 may include a peel-off tab at one end of the peel-off strip 50 to facilitate movement of the peel-off strip 50. The sample-absorbing material 50 may be sized and configured to receive about 0.1 to about 1.0 ml of a fluid. Furthermore, the sample-absorbing material may be composed of a dry cellulosic material. The sample-absorbing material may be flat or non-flat. Other embodiments include other sample-absorbing material materials.

[00233] In certain embodiments, assay 21 also includes a second opposite end having a reactor detector material. Assay 21 may support a release area that has a mobile phase receptor for at least one analyte. Typically, assay 21 is adapted to select detection of a diagnostic test group chosen from an antibiotic analyte, toxic analyte, analyte class, a combination thereof, and similar analytes.

[00234] In specific embodiments, the optical detector is aligned in an optical path with the assay and is adapted to acquire an image detection in the assay and is performing a continuous image detection acquisition of the assay. In a specific embodiment shown in Figure 7a, housing 508 can support a câ Petition 870250082244, dated 12 / 09 / 2025, p. 89 / 156 83 / 97 mera 706, for example, supported on a camera tape from the plate. Furthermore, any lighting arrangement can enhance the imaging of the test, for example, light bars 710, or similar, shown in Figure 7a. A light level detector 706 can detect internal lighting levels during operation to trigger consistent lighting maintenance around the test, i.e., feedback and the like, to enhance imaging and / or minimize the development of unwanted shadows. Unexpectedly, the addition of a wall foundation adjacent to the imaging device and the white reflective material further minimizes the development of unwanted shadows to improve any test shown and described in this document.

[00235] The sensor can be a single camera, multiple cameras, a single photodiode, multiple photodiodes, a linear photodiode array, a charged coupling device, a complementary metal-oxide semiconductor, and a combination thereof. Therefore, at the same time as incubation and flow, or before or after incubation and flow are completed, optical sensors can monitor the assay and compare optical readings, such as reflectance and / or transmission readings, to determine various aspects including sample flow, interference with the optical path such as debris in the optical path, line development, and test result. When the assay and line development are within predefined parameters, the test can proceed to completion and provide a final result. Verification of the assay by the optical sensor before test completion can provide the user with additional confidence that the test was processed properly.

[00236] In specific modes, the output can be a voltage, current, or a digital output proportional to the light intensity, as determined by the set of signal conditioning circuits. Petition 870250082244, dated 12 / 09 / 2025, page 90 / 156 84 / 97 Some examples of readers include the TSL12T and TSL13T sensors available from TAOS (Texas Advanced Optoelectronic Solutions). The TSL12T and TSL13T sensors are highly integrated and cost-optimized light-voltage optical sensors, each combining a photodiode and a transimpedance amplifier (feedback resistor = 80 MΩ and 20 MΩ, respectively) in a single monolithic integrated circuit. The photodiode active area is 0.5 mm x 0.5 mm, and the sensors respond to light in the range of 320 nm to 1050 nm. The output voltage is linear with incident light intensity (irradiance) over a wide dynamic range.

[00237] In some examples, the microprocessor may be in communication with the optical detector and, in particular, with the sensor. In other examples, the optical detector outputs to other logic media. Furthermore, the microprocessor may be adapted to signal the optical detector to perform continuous image detection of the assay to generate the diagnostic test result. The microprocessor may include, or have associated with it, memory to store information corresponding to an imaging parameter. The memory may include instructions to monitor a pre-test analysis in the assay and to generate a diagnostic test result in the assay.

[00238] In some embodiments that have assays with coding references, as discussed in this document, the optical detector may have a decoding capability to decode a reference code in the assay. Through it, the decoding sensor can, through it, activate a corresponding diagnostic test in the reader. For example, the decoding sensor may activate a corresponding channel in a multichannel reader and / or activate a corresponding incubation temperature profile in the incubator.

[00239] The decoding sensor can be a color sensor. For example, the color sensor can be a photodiode with sensitivity pa Petition 870250082244, dated 12 / 09 / 2025, p. 91 / 156 85 / 97 wavelengths are chosen from red, blue, green, and combinations thereof. In such an example, a color reading from an array of photodiodes, each with a specific color filter, is used as the decoding sensor, and a white LED (which provides a broad spectrum of light across the three bandwidths (Red, Green, and Blue)) is used as the light source. When the LED is activated, the output of each photodiode is obtained to determine the reflectance of that specific color. The decoding sensor could also be an RFID reader or a barcode reader.

[00240] Although reference is frequently made in this document to optical reflectance and optical reflectance readers, a variety of readers can be usefully employed including, for example, transmittance readers, fluorometers, luminometers, barcode readers, radiation detectors (such as scintillation counters), UV detectors, infrared detectors, electrochemical detectors, or optical readers such as spectrophotometers, charged-coupled devices (CCDs), or complementary metal-oxide-semiconductor (CMOS) can be used as an image sensor. An optical reflectance reader can be programmed to analyze the test strip via two-dimensional readings, rather than via one-dimensional readings, 1 x 128. For example, a 5 x 128 or 512 x 492 pixel array. Such two-dimensional reading expands the reflectance capture area to capture reflectance directly from the sides of the test strip.

[00241] In other examples, a transmittance reader, such as ultraviolet Near-Visible Infrared (UV-VisNIR) spectroscopy, can provide a characterization of the absorption, transmission, and / or reflectivity of the assay. For example, such an analytical technique can measure the amount of light absorbed in the assay at a given wavelength. Petition 870250082244, dated 12 / 09 / 2025, page 92 / 156 86 / 97 wave. Those skilled in the art would observe that a molecule, or part of a molecule, can be excited by absorption. Typically, organic chromophores that absorb strongly in the UV or visible portions of the spectrum almost always involve multiple bonds, such as C=C, C=O, or C=N. This molecular excitation energy can be dissipated as heat, for example, kinetic energy, through the collision of the excited molecule with another molecule, for example, a solvent molecule, as the molecule returns to the ground state. In other embodiments, the excitation energy can be dissipated by the emission of light via fluorescence. Regardless of the process, an excited molecule can process any one of a set of discrete energy quantities, for example, as described by the laws of quantum mechanics.In the examples in this document, the large energy levels can be determined primarily by the possible spatial distributions of the electrons, and to a lesser extent, by the vibrational energy levels that arise from the various vibrational modes of the molecule.

[00242] Therefore, in specific examples in this document, absorption measurements can be determined by the concentration of a solute in the assay. For example, the progress of such a chemical reaction can be followed using a spectrophotometer in the reader to measure the concentration of a reactant or a product over time. In other examples, transmission spectroscopy can be used for solid, liquid, and gaseous sampling. Typically, light has passed through the assay and is compared with light that has not passed through. The resulting spectrum may depend on the path length or thickness of the sample, the absorption coefficient of the sample, the reflectivity of the sample, the angle of incidence, the polarization of the incident radiation, and, for particulate matter, the particle size and orientation. Petition 870250082244, dated 12 / 09 / 2025, page 93 / 156 87 / 97

[00243] Furthermore, the sensor can monitor the flow development along assay 21 to assess whether an inadequate sample volume was applied to assay 21, or whether an excess volume was applied. For example, before determining the test result, the sensor can monitor the flow progress in assay 21 along flow line 44. In other examples, the sensor will monitor the flow progress both at flow line 44 and along the assay, for example, at intermediate flow line 46. The sensor can be configured to detect whether adequate flow of a reagent occurred in assay 21 while assay 21 was inside the cavity, and / or whether one or more lines, i.e., reflectance or transmission values, were present in assay 21 before assay 21 contacted the sample being tested.

[00244] Specific embodiments include configuring the lateral flow assay system to allow for the concomitant incubation and reading of assay 21. The combination allows sensors to be used to detect not only test results, but also to verify parameters that may indicate whether or not flow occurred in the assay and that such flow caused an appropriate test result. That is, although the sample, which includes the analyte, or analytes, of potential interest, is flowing in assay 21 and binding is occurring in a mobile phase and in assay 21, the assay is being incubated. By combining the reader and incubator in such an integral diagnostic unit, results can be achieved faster than when assays, such as test strips or other test media, are incubated in one device and then moved to a separate device for reading.For example, the acceleration of the result can be improved, for instance, to as little as less than about sixty seconds or even less than about thirty seconds. Generally, such a combined system can be dynamic, capturing changes in the test as it goes. Petition 870250082244, dated 12 / 09 / 2025, page 94 / 156 88 / 97 where they occur when searching for areas of decreased reflectance and / or transmission anywhere in the test that is not used or not fully developed.

[00245] A level of protection is provided to prevent pre-run tests from being read (e.g., the reader will determine whether line development, for example, on flow line 44, intermediate flow line 44, test line 40 and / or control line 42 occurred before the time when the sample flow could have reached that line) and to prevent incorrect readings caused by debris or similar interference with system optics.

[00246] Several triggers can initiate the test analysis of any of the systems and assemblies in this document. For example, a test strip packet can be inserted into clamp 500 and sample can be pipetted (or otherwise delivered) to a sample well. Insertion into clamp 500 can displace a proximity switch breaking a path of an optical switch, for example, to trigger the activation of the incubation time or reading shown and described in this document. Furthermore, as introduced in this document, if the reader does not detect the appropriate flow, the reader can trigger the abort of the test sequence and, in specific examples, deliver an error message.

[00247] If test 21 is properly detected, any reading sequence shown and described in this document can be initiated. For example, optical measurement, such as to detect reflected light from test 21, can use values, such as average reflectance values, in certain areas of test 21. Initially, the system can analyze the test to determine if the optical path is free of interference, such as debris. Debris can be in any number of locations in the optical path, including on test 21 or the test container. Concomitantly with the path analysis Petition 870250082244, dated 12 / 09 / 2025, p. 95 / 156 89 / 97 optical with regard to debris, or subsequent to the same, the system can analyze the assay to determine if line development has already occurred. That is, if a suitable assay has been inserted into the cavity. For example, test strips configured to develop within certain areas, such as the test line and control line, should not develop in those areas before the analyte and mobile phase have had adequate time to reach each other.

[00248] In some examples, lines configured to develop a change in reflectance and / or transmission upon contact with reagents and the sample should not develop until the flow of sample and reagents has been achieved and binding has occurred. This flow will not have arrived at the time of an initial reading, for example, about three seconds. Thus, if line development is detected in the initial assay analysis, then an error message will be delivered to the user and further readings, for example, additional optical measurements, may be aborted. In this way, this mechanism can detect the use of pre-run assays (known negative) or pre-marked assays.Generally, when reflectance is reduced in an unused test, whether due to line development or darkening of the test away from the baseline, the reduction in reflectance may inform the user that something occurred in the test or optical path, so the result should not be accepted.

[00249] After initial optical readings are deemed satisfactory and appropriate reader parameters and incubator temperatures are selected, manually or automatically, additional optical readings, for example, approximately fifteen seconds after the sample has been applied, can be used to determine that flow has occurred. For example, optical readings can determine whether or not reagents have flowed between a sample application region and Petition 870250082244, dated 12 / 09 / 2025, page 96 / 156 90 / 97 a downstream line, like a test line.

[00250] The presence of labels, such as colored particles, for example, colloidal gold microspheres, flowing in the mobile phase, and the resulting changes in reflectance in the assay between the sample application area and a first test line, can inform the user that flow is occurring and return an error message if no flow is detected. An assay lacking predictable reflectance changes may have no sample flow or have inadequate sample flow. Certain measurements may also indicate whether excessive flow has occurred, such as in the case where too large a sample volume has been applied to a test strip and the possible reflectance change due to reagents is dominated by the excessive sample volume. Reflectance changes between the sample application area and result detection areas, such as the test line and control line, may be temporary and disappear as the mobile phase flows.If optical measurements are taken, such temporary / non-permanent changes can be detected.

[00251] If an assay, including a test strip or other type of assay, has passed the preliminary readings, the system may initiate readings to generate a test result. For example, after approximately thirty seconds, the analysis of the test line and control line may begin. When there is sufficient differentiation, for example, the percentage reflectance difference, between test and control, a result may be provided. Typically, negative results and more extreme results may be provided sooner, and results closer to the limit levels will take longer. For example, in the case of a test where the reflectance value on the test line is inversely related to the amount of analyte, if the test line reflectance is reduced to a certain level, then a negative result may be signaled. In some examples, if cap 2 is opened en Petition 870250082244, dated 12 / 09 / 2025, page 97 / 156 91 / 97 while the reader is reading the essay, a signal can generate a response without result.

[00252] The reader and / or incubator can be powered by a power source. In some examples, for on-site analysis, for example in harsh environments, the power source may be a vehicle battery. Furthermore, the reader's footprint is smaller than that of many traditional systems for intensive use and communication with an onboard vehicle system, for example, for enhanced and efficient testing during batch harvesting, distribution and the like.

[00253] In certain embodiments, software applications, instrumentation, systems, and assemblies may provide real-time data collection of test data, including but not limited to field data, using data communication exchange, including Bluetooth® interface technology and similar, adapters, and widely used telephone and similar personal devices. For example, an instrument relay embodiment may include generating a test result on any one or more of the test instrument readers shown and described herein; communicating the test result to a partner device module; and relaying a test result output to an external host module. Furthermore, any of the test instrument readers in this document may directly interface with the external storage configuration.In specific examples, the partner device is a smartphone; however, other partner devices may include a tablet, a general-purpose computer, a PDA, a digital media player, a digital camera, a wireless information device, and the like.

[00254] The partner device can connect to the external storage configuration in a variety of modes. In one mode Petition 870250082244, dated 12 / 09 / 2025, page 98 / 156 In 92 / 97 remote access, the partner device connects to an available test instrument and allows the system to deliver test data to the external storage configuration. The partner device may have an indicator, and when activated, provides a pairing signal, and the indicator provides a visual indication of pairing to the test instrument reader.

[00255] In specific embodiments, a partner device is in local data communication, such as wireless transmission / reception via Bluetooth®, with one or more test instruments. Furthermore, the partner device is in host-switching communication, including any mobile telecommunications communication technology such as Wi-Fi, 3G / 4G / 5G connectivity, with an external host. In certain modules, the test instrument interfaces with a mobile partner device that has a corresponding data communication interface, thereby establishing enabled, i.e., approved, authorized, and / or available data communication with the test instrument. In specific examples, the module may include linking an application, for example, a downloadable program application, on the partner device to the test instrument.Furthermore, the module may include establishing data communication for output results between the test instrument and the partner device. Additionally, the module may include establishing secondary data communication via messaging, including but not limited to email, text, and similar methods, between the test instrument and the partner device.

[00256] Typically, the partner device relays the output results to an external storage configuration. In specific examples, relaying to the external storage configuration includes transmitting to a host website. Petition 870250082244, dated 12 / 09 / 2025, page 99 / 156 93 / 97 remote. In other examples, relaying to external storage includes transmitting to a remote host server. In still other examples, relaying to external storage includes transmitting to two or more host providers for data storage and management.

[00257] In certain embodiments, the test instrument interfaces with a mobile partner device that has a corresponding data communication interface, thereby establishing enabled, i.e., approved, authorized, and / or available data communication with the test instrument. In specific examples, the module may include linking an application, for example, a downloadable program application, on the partner device to the test instrument. Furthermore, the module may include establishing the exchange of data communication of a result output between the test instrument and the partner device. Additionally, the module includes establishing secondary message data communication, including, but not limited to, email, text, and similar secondary message exchanges between the test instrument and the partner device. The partner device may transmit result outputs to an external storage configuration.In specific examples, relaying to external storage configuration includes relaying to a remote web host site. In other examples, relaying to external storage includes relaying to a remote host server. In still other examples, relaying to external storage includes relaying to two or more hosting providers for data storage and management.

[00258] Specific methods for analyte analysis include incubating the assay, for example, including any of the modalities previously shown or described, and reading the assay to generate a result. Petition 870250082244, dated 12 / 09 / 2025, pp. 100 / 156 94 / 97 of the test, for example, including any of the modalities previously shown or described.In specific examples, a diagnostic testing method for detecting an analyte in a test sample includes adding a test sample to a test medium, such as a lateral flow test strip, to create an assay; the test medium is configured to provide a detectable test result after incubation with the test sample; confining the test medium in a hood, the hood being configured to confine a cavity, the cavity configured to receive the test medium and connected to a temperature control source, the temperature control source being capable of maintaining a consistent temperature; positioning a sensor, such as an optical sensor capable of reading the reflectance of the test medium, relative to the test medium so that a change in the test medium is detectable by the sensor; and activating the sensor, such as by closing the hood, the activation causing the sensor to compare the test medium to a predefined parameter.When the test medium is not within the predefined parameter, a test result is not provided, and when the test medium is within the predefined parameter, the test result is determined from the test medium, with the test result indicating whether an analyte was detected in the test sample.

[00259] In other embodiments of the methods, a predefined parameter can be used to determine either or both whether an adequate flow of reagents occurred in the test strip while the test strip was inside the cavity and whether one or more test lines are present in the test strip before it is placed in contact with the test sample. To do this, the sensor can be configured to continuously analyze changes in the test medium until a test result occurs. The test result can be determined by a comparison between changes, such as changes in reflection Petition 870250082244, dated 12 / 09 / 2025, pp. 101 / 156 95 / 97 distance, in a first line, for example, a test line, and a second line, for example, a control line, on the test strip.

[00260] In specific embodiments, an apparatus for generating a test result from an assay upon contact with a sample includes an incubator adapted for incubating the assay; and an optical detector adapted for detecting a first light transmission result in the assay and adapted for detecting at least one subsequent light transmission result in the assay, wherein the incubation of the assay and detection of the light transmissions in the assay generates the test result.

[00261] In specific embodiments, in an apparatus incubated to generate a test result from an assay, when in contact with a sample, a reader includes an optical detector adapted to image a first light transmission in the assay and adapted to image a plurality of subsequent light transmissions in the assay, and in which the incubation of the assay and imaging of the light transmissions in the assay generates the test result.

[00262] In specific embodiments, an on-board vehicle system for generating a test result from an antibiotic analyte assay includes an optical detector reader in communication with a vehicle microprocessor assembly to synchronize light transmissions in an analyte assay, upon contact with a sample, with development of the test result in an on-board vehicle test environment.

[00263] In specific embodiments, a vehicle-mounted onboard system for generating an antibiotic test result from an antibiotic analyte assay, the system comprises: an optical detector reader in a test result communication with a vehicle assembly to detect light transmissions in an antibiotic analyte assay upon contact with a sample to generate the result. Petition 870250082244, dated 12 / 09 / 2025, pp. 102 / 156 96 / 97 antibiotic test results.

[00264] In specific embodiments, an on-board vehicle system for generating an antibiotic test result from an antibiotic analyte assay, the system comprises: an optical detector reader in a test result communication with a vehicle assembly to synchronize the progression of an antibiotic test result development with optical detection upon contact with a sample in an on-board vehicle testing environment.

[00265] Any of the devices and assemblies shown and described herein may be free of a hood or hood-like feature. For example, advantages of the enhanced reader and non-planar optical modules have been unexpectedly found herein that are free of a hood or hood-like feature.

[00266] A further example of the methods includes using predefined parameters to compare the test strip, before sample flow onto it, including before sample application, with the actual strip being used. For example, a blank strip, before reagent flow or before sample application, will have a theoretical reflectance profile within a predictable range. If areas of reduced reflectance are detected that did not result from sample / reagent flow onto the strip, then it is possible not only that something unintended has occurred with the test strip, but also that the optical path has become contaminated and requires cleaning. Such contamination may 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 a problem, whether due to dust / debris, the use of a test strip that has already been run, or otherwise.In any case, the test result may not be valid.

[00267] Numerous features and disadvantages can be established in the aforementioned description, along with Petition 870250082244, dated 12 / 09 / 2025, pp. 103 / 156 97 / 97 details of the structure and function. Many of the innovative features are pointed out in the appended claims. The invention, however, is only illustrative, and changes may be made in details, especially regarding the shape, size, and arrangement of parts, within the principle of the invention, to the full extent indicated by the broad general meaning of the terms in which the general claims are expressed. It is further noted that, as used in this application, the singular forms a, an, and the include plural referents unless expressly stated and are mistakenly limited to one referent.

Claims

1. Independent optical module, characterized in that it comprises: a. an interface connector; b. a microcontroller in electrical communication with said interface connector; and c. an optical imaging device, wherein said optical imaging device is in communication with said interface connector, but is independent of said microcontroller.

2. Device, as defined in claim 1, characterized in that said optical module is under independent control of a host system.

3. Device, as defined in claim 1, characterized in that said optical module comprises a calibration sequence.

4. Device, as defined in claim 2, characterized in that said host system is adapted to provide at least one chosen from a group consisting of: a. ensuring selection of a general-purpose input / output pin; b. denying selection of a general-purpose input / output pin; and c. denying an enabled signal and releasing an image capture command.

5. Device, as defined in claim 1, characterized in that it includes a non-planar optical module adapted to align said assay in a displacement position, wherein said displacement position includes an angled upper portion displaced around a lower portion.

6. Device, as defined in claim 1, characterized by the fact that it includes an incubator adapted for incubating said assay.

7. Device, as defined in claim 1, characterized in that it includes a lighting assembly that has a dynamically controlled direct lighting assembly aligned around said assay.

8. Device according to claim 7, characterized in that said dynamically controlled direct lighting assembly includes a plurality of light sources adapted to provide illumination around said test with minimal specular reflection in at least a portion of said test.

9. Device according to claim 7, characterized in that said dynamically controlled direct lighting assembly includes a dual digital-to-analog converter.

10. Device, as defined in claim 1, characterized in that it includes an aperture retainer aligned around a frame and adapted to provide a plurality of optical windows with said test in a test position and to provide a clearance for manipulation of said test.

11. Device, as defined in claim 1, characterized in that said optical module is adapted to perform at least two image detections of said assay.

12. Device, as defined in claim 1, characterized in that it includes a stabilizer adapted to stabilize said test device received in an operational position while generating said test result.

13. Device according to claim 12, characterized in that said stabilizer includes a cover.

14. Device, according to claim 12, as per Petition 870250082244, dated 12 / 09 / 2025, page 115 / 156 3 / 4, characterized by the fact that said cover comprises a spring-loaded cover.

15. Lateral flow reader, characterized in that it is intended to generate a test result upon contact with a sample, wherein said device comprises: a. an interface connector in electrical communication with at least one optical module; b. a module multiplexer circuit in communication with said interface connector, wherein said module multiplexer circuit is adapted to provide an enabled signal for subsequent multiplexing; and c. a host controller in electrical communication with said module multiplexer circuit, wherein said host controller is adapted to control a plurality of optical modules and to determine a specific imager among said plurality of optical modules to generate said test result.

16. Device according to claim 15, characterized in that said optical module is under independent control from a host system, and said host system is adapted to deny said enabled signal and release an image capture command.

17. Device according to claim 15, characterized in that said at least one optical module comprises a non-planar optical module adapted to align said assay in a displacement position, said displacement position including an angled upper portion displaced around a lower portion.

18. System for analyte detection, characterized in that it comprises: a. an apparatus adapted to receive an assay in contact with a sample and to generate a test result from it, wherein said apparatus includes a non-planar optical module adapted to align said assay in a displacement position and an imaging device adapted to capture at least two images of said assay during development; and b. a camera multiplexer circuit in communication with said imaging device, wherein said camera multiplexer circuit is adapted to multiplex the imaging from at least one camera directed to different regions of said assay, and wherein said camera multiplexer circuit provides an enabled signal to selectively activate said at least one camera.

19. System according to claim 18, characterized in that said non-planar optical module is under independent control from a host system, and said host system is adapted to negate said enabled signal and release an image capture command.

20. System according to claim 18, characterized in that said at least one optical module comprises a non-planar optical module adapted to align said assay in a displacement position, said displacement position including an angled upper portion displaced around a lower portion.

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