Test Device, Assembly, and Method

Abstract

Analyte testing devices, assemblies, methods, operations, and systems are shown and described. In one embodiment, an apparatus for generating a test result from an assay when contacted with a sample includes a non-planar optical module for aligning the assay to an offset test position. A modular interface assembly can support a motherboard and at least one non-planar optical module.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 895,165, filed Sep. 3, 2019, and U.S. Provisional Patent Application No. 62 / 932,124, filed Nov. 7, 2019, the entireties of which are incorporated herein by reference.

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

Background Art

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

[0004] Generally, a lateral flow assay is a membrane-based test device in which a sample suspected of containing an analyte of interest is placed at or near one end of a membrane strip. The sample is carried to the opposite end of the membrane strip by a mobile phase that traverses the membrane strip, for example, by capillary action. While traversing the membrane strip, the analyte in the test sample encounters, if present, one or more reagents. The reagents can include a binding agent for the analyte. The binding agent can be mobile and thus can flow with the sample or can be immobilized on the test strip as a capture agent. Depending on the test configuration, either the analyte binding agent, the analyte itself, or some other reagent within the test system is captured by the immobilized capture agent, thereby generating a detectable signal. The signal can be generated by a label provided within the assay. The detectable signal can be measured by, for example, an optical reader device.

[0005] The presence and, in some cases, the concentration of an analyte on a reagent strip can be determined by measuring the light reflectance from the development region on the strip. For example, the development region on the strip can be a chromogenic region. The percent reflectance can be used to determine the result.

[0006] Tests are generally performed in a controlled environment such as a laboratory, but testing in a non-laboratory environment is also common. In some applications, speed and ease of use are particularly important. For example, in food processing, since the processor has to wait for the results, it is advantageous to perform the test in a non-laboratory setting. Additionally, it is also advantageous to perform the test on a truck during the transportation of goods. Therefore, it is advantageous to accelerate the testing speed, reduce the cost of the equipment and the test, improve the durability of the device, and enhance the ease of use and simplicity of operation. Furthermore, it is advantageous to have the reliability that the test results are valid. Thus, the systems, methods, and devices herein also help prevent the improper use of a previously run known negative assay that is not a true sample, or the use of an assay pre-marked to yield a negative result that does not reflect the true nature of the sample. It is also desirable to enhance the durability of the assay, system, and test procedure.

[0007] Accordingly, the present inventors desire a system and method for analyte detection without the drawbacks exhibited by conventional systems and methods. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0008] Overview The present disclosure provides improved analyte detection that is simple, efficient, and safe for the user, particularly when used to detect the presence or absence of at least one analyte.

[0009] In one embodiment, a device that generates a test result from an assay when in contact with a sample includes a non-planar optical module adapted to align the assay at an offset position, an incubator adapted to incubate the assay, and an optical detector adapted to image the assay at the offset position.

[0010] In certain examples, the optical module includes an overhang lip for positioning and aligning a proximal portion of an assay that protrudes around the optical module to an operating position. The optical module can include a substantially planar proximal portion and an opposing non-planar distal portion. The planar proximal portion and the non-planar distal portion can define a non-planar flow path around the assay at a test position. The planar proximal portion and the non-planar distal portion can define a raised flow path around the assay at a test position. The non-planar distal portion can be offset from the planar proximal portion by about 10 degrees to about 30 degrees. The non-planar distal portion can be offset from the planar proximal portion by about 20 degrees.

[0011] In certain examples, the device can include a pivot point positioned and aligned between the planar proximal portion and the non-planar distal portion. The device can include an open carrier thermal block. The optical module can include a proximity switch. The proximity switch can block the path of an optical interrupter to trigger at least one state selected from the group consisting of incubation, detection of light transmission around the assay, and imaging on the assay. The device can perform at least two image detections of the assay. The optical detector can monitor at least one pre-test parameter after receiving the assay.

[0012] In one embodiment, an assembly for generating test results from an assay includes an offset frame adapted to receive the assay, the frame including an upper platform angled and offset around a lower platform, and an optical system aperture positioned and aligned around the frame.

[0013] In one example, the offset frame positions the proximity portion of the assay outside the assembly in an operating position. The upper platform can be offset and positioned around the lower platform about a pivot point. The offset frame can receive a portion of the assay in a first substantially planar position. The offset frame can position a portion of the assay in a second substantially non-planar position. The optical module can image the assay adjacent to a bend around the assay in the operating position.

[0014] In one embodiment, in an apparatus for generating test results from an assay, the modular interface includes a housing adapted to position the assay in an offset position, a motherboard support positioned within the housing, an optical strip detector, a light level detector, an imaging device, a light source, and an integrated incubator.

[0015] In one embodiment, an apparatus for generating test results from an assay when in contact with a sample includes a non-planar optical module that positions the assay in an offset position, an incubator that incubates the assay, and an optical detector that detects the transmission of light over the assay, wherein the incubation of the assay and the detection of the transmission of light over the assay generate the test results.

[0016] In certain examples, the optical module includes a substantially planar proximal portion and an opposing non-planar distal portion. The planar proximal portion and the non-planar distal portion can define a non-planar flow path. The planar proximal portion and the non-planar distal portion can define a raised non-planar flow path. The device can include a pivot point that is positionally aligned between the planar proximal portion and the non-planar distal portion. The device can include a non-planar cavity. The cavity can include an elongated channel. The aperture carrier can be positioned within the cavity. The optical module can include a lower support. The optical module can include an interface shell. The optical module can include a drip receiver. The optical module can include an insulating base. The optical module can include an upper cover. The optical module can include a proximity switch. The proximity switch can block the path of the optical interrupter to trigger incubation. The proximity switch can block the path of the optical interrupter to trigger detection of the transmission of light that has passed through the assay. The proximity switch can block the path of the optical interrupter to trigger imaging on the assay.

[0017] In certain examples, the device performs continuous image detection on the assay. Additionally, the incubation environment may include a heating environment. The incubation environment may include a cooling environment. The incubation environment may include an environment maintained at a constant temperature. The optical detector can monitor at least one pre-test parameter after obtaining at least one image detection on the assay. The image detection can include an optical reflectance value. The assay can include a test strip having at least one test line and at least one control line, such that the theoretical reflectance value is a comparison between the reflectance value at the test line and the reflectance value at the control line. The test line and the control line can be positioned at the non-planar distal portion at the operating position. The device can include a user interface having a display board.

[0018] In another embodiment of the assembly that generates test results from an assay, the optical module is attachable around a base and includes an offset frame adapted to receive the assay, the frame including an upper platform angled and offset around a lower platform and an optical system aperture positioned and aligned within the frame.

[0019] In a particular example, the upper platform is positioned and aligned offset around the lower platform about a pivot point. The offset frame can receive the assay in a first substantially planar position. The offset frame can position and align the assay in a second substantially non-planar position. The device can include a housing. The assembly can perform serial image detection of the assay to generate test results. The device can include an incubator for incubating the assay. The device can include an optical detector for detecting transmission of light across the assay. Incubation of the assay and detection of transmission of light across the assay generate test results. The device can include an insulating base. The device can include an upper cover. The device can include a proximity switch. The proximity switch can block the path of a light interrupter to trigger incubation. The proximity switch can block the path of a light interrupter to trigger detection of transmission of light that has passed across the assay. The proximity switch device can block the path of a light interrupter to trigger imaging over the assay. The proximity switch device can initiate a test where the incubator already maintains the required temperature or where the incubator is inactive and the device is in a read-only mode.

[0020] In another embodiment, a modular interface that generates test results from an assay includes a motherboard support and at least one non-planar optical module positionable around the motherboard support.

[0021] In certain examples, the device includes at least one test unit. In one embodiment, a test and product delivery assembly, including but not limited to an in-line, includes a product supply having at least one outlet, a sample feed in fluid communication with the product supply, a reader, and a delivery line in fluid communication with the supply outlet and having a delivery output valve. In certain embodiments, the reader receives a sample from the sample feed and generates test results from an assay for detecting the presence or absence of an analyte. The reader can have an optical detector for imaging at least a first light on the assay and an incubator for incubating the assay. In certain embodiments, detection of an analyte triggers closure of the delivery output valve, while detection of the absence of an analyte triggers opening of the delivery output valve to release the supply through the delivery line.

[0022] In one example, the reader includes a hood for removably receiving a single-use rapid assay, the hood having a piercing tip that projects for piercing the assay. Further, the hood can include a sample supply line in fluid communication with the sample feed for dispensing the sample to the assay. For example, to increase the speed of the test, the sample feed can be positioned adjacent to the piercing tip and aligned such that the sample is dispensed to the assay at the piercing site.

[0023] In certain examples, the reader includes an inclined cavity having an elongate channel for receiving and maintaining the assay in an inclined test position. The inclined cavity can include a proximal portion and an opposing distal portion, the distal portion being positioned above the proximal portion at an inclination such as about 45 degrees. Further examples include a distal portion positioned above the proximal portion at an inclination less than 45 degrees.

[0024] In certain examples, the reader generates a final test result within about 15 seconds to about 1 minute; for example, the reader generates a final test result within about 30 seconds. In other certain examples, the reader generates a final test result within about 10 seconds to about 15 minutes. Further, the assembly can generally include an autosampler in fluid communication with the sample feed. The assembly can include a drip sampler in fluid communication with any of the system elements and embodiments shown and described herein. The sample feed can be a closed-loop recirculation system centered on the product supply. The assembly can include an autosampler in fluid communication with the closed-loop system at a sample release valve, and the recirculation loop has a re-entry port in fluid communication with the outlet and in fluid communication with the product supply. At least a portion of the recirculation loop can be a single-use disposable conduit and / or a washable conduit.

[0025] In certain examples, the optical detector of the reader detects the first light transmission on the assay, detects at least one subsequent light transmission on the assay, and the incubation of the assay and the detection of the light transmission on the assay generate the test result. Further, the reader can generate at least one border line test result.

[0026] In another embodiment, a non-planar test and product delivery system includes a product supply having at least one outlet, the outlet including at least one valve closure and a delivery line downstream of the valve closure; a recirculation closed loop in fluid communication with the outlet and the 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 recirculation closed loop for providing a sample to the reader. In certain examples, the reader has an inclined cavity for receiving and maintaining the assay in an inclined test position and a piercing tip for piercing the assay. In a particular embodiment, detection of the analyte triggers closure of the valve closure upstream of the delivery line, and detection of the absence of the analyte enables release of the supply to the delivery line.

[0027] In an example of a particular rapid test result, a single-use assay includes an overlap of about 3 millimeters of a binder-coated area on a nitrocellulose membrane. Additionally, the single-use assay can include an absorbent pad having a length of about 31 millimeters.

[0028] In another embodiment, in a non-planar test and product delivery device having a supply tank, a sample feeder, and a downstream delivery section, the reader controls access to the product between the supply tank and the downstream delivery section, and includes an inclined cavity for receiving a single-use assay, a sample portal in fluid communication with the sample feeder and aligned with the assay positioned within the cavity, a piercing tip extending into the cavity for piercing the assay, an optical detector adapted to monitor the assay, and an incubator for incubating the assay.

[0029] In a further embodiment, a non-planar test and product delivery assembly includes a product supply section having at least one outlet, a recirculation loop in fluid communication with the outlet and having a re-entry port in fluid communication with the product supply section, an autosampler for receiving a sample from the product supply section, a reader adapted to receive the sample from the autosampler and generate a test result from an assay for detecting the presence or absence of an analyte, and a delivery line in fluid communication with the product supply section and having at least one valve closure section, wherein a positive test result generated by the reader enables valve closure and a negative test result generated by the reader releases the product to the downstream delivery section.

[0030] In a particular example, the product supply section includes a milk tank. The analyte can be a toxin, an antibiotic, a chemical, a biochemical, a pesticide, an active metabolite, and combinations thereof. For example, the analyte can be a mycotoxin, an aflatoxin, zearalenone, ochratoxin, T-2, vomitoxin, and combinations thereof. The reader can generate a final test result within about 15 seconds to about 1 minute, for example within about 30 seconds. In a particular example, the reader generates a final mycotoxin test result within about 30 seconds.

[0031] In some examples, the autosampler is positioned in fluid communication with the recirculation loop. The autosampler may be a drip sampler. The delivery supply line can be positioned in fluid communication with the recirculation loop. The recirculation loop can include a shut-off valve. The recirculation loop, such as a disposable conduit, a washable conduit, etc. The recirculation loop can include a pump. The assembly can include a plurality of auxiliary conduits.

[0032] In certain examples, the reader includes an incubator. The reader can perform a diagnostic test on an assay while the incubator incubates the assay. The reader can generate at least one border line test result. The reader can perform one or more subsequent consecutive readings after performing the first reading of the diagnostic test to generate a test result. The reader can perform one or more subsequent consecutive readings after performing the first reading of the diagnostic test and extend the incubation of the assay to generate a final test result.

[0033] In certain examples, receiving a sample can include automatically sampling a product. The method can include automatic sampling from a recirculation loop. The method can include preventing downstream delivery of the product, including enabling delivery valve closure. Releasing the product can include enabling recirculation valve closure. Generating test results can include incubating an assay. Generating test results can include, while the incubator incubates the assay, reading a diagnostic test on the assay. Generating test results can include generating at least one border line test result. Generating test results can include performing one or more subsequent consecutive readings of the diagnostic test. Generating test results can include extending the incubation of the assay after performing an initial reading of the diagnostic test. Generating test results can include extending the incubation of the assay after performing an initial reading of the diagnostic test to generate a final test result.

[0034] In certain examples, reading a diagnostic test can include performing a diagnostic reading for about 30 seconds. Further, generating test results can include reading a predetermined difference between a reflectance value on a control line and a reflectance value on a test line. Generating a final test result can include reading a predetermined difference between a reflectance value of a control line and a reflectance value of a test line, and a predetermined reflectance value on the control line.

[0035] In certain examples, the method can include monitoring pre-assay analysis on the assay and / or decoding reference coding on the assay. For example, activating corresponding channels of a multi-channel reader to activate incubation of the assay. Further, the method can include monitoring pre-flow development along the assay. The method can include signaling an optical detector to perform continuous image detection of the assay to generate a test result, where the test result is a border test result. Further, the method can include developing subsequent image detection of the border test result to generate a final pass / fail test result.

[0036] In yet another embodiment, a method of analyzing a border test of an assay includes several image detections of the assay to provide a final pass / fail test result. In one example, the method includes incubating the assay within an incubation environment, aligning an optical detector within the 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. Typically, signaling the optical detector to perform a first image detection of the assay generates a border test result. Further, the method typically includes signaling the optical detector to perform at least a second subsequent image detection of the assay to generate a final pass / fail test result. Other examples include various subsequent image detections as shown and described herein.

[0037] In yet other embodiments, a method of detecting an analyte from an assay includes aligning an optical detector within an optical path with the assay, signaling the optical detector to perform continuous image detection of the assay to generate a final presence test result, and developing further image detection of the diagnostic test for the border test result. In some examples, the method can include incubating the assay within an incubation environment while the optical detector performs continuous image detection of the assay. In some exemplary embodiments, the method includes signaling the optical detector to perform image detection for one minute. Typically, detecting a final positive test result includes stopping the system. Similarly, detecting a final negative test result includes stopping the system.

[0038] In another embodiment, a method of generating a final test result from an assay for detecting the presence or absence of an analyte includes incubating the assay within an incubation environment, reading a diagnostic test on the assay while the incubator incubates the assay, continuously reading the diagnostic test, and incubating the assay for the border line test result to generate a final test result. In certain examples, reading the diagnostic test includes performing a one-minute diagnostic read. Typically, detecting a final positive test includes stopping the system. Similarly, detecting a final negative test includes stopping the system. Generating a final test result can include reading a predetermined difference between a reflectance value on a control line and a reflectance value on a test line. Similarly, generating a final test result can include reading a predetermined difference between a reflectance value of a control line and a reflectance value of a test line, and a predetermined reflectance value on the control line.

[0039] In other examples, the method includes monitoring a pre - assay analysis for the assay. Additionally, the method can include decoding a reference coding on the assay. Further, the method can include activating corresponding channels within a multi - channel reader and / or activating an incubation of the assay. The method can also include monitoring a pre - flow development along the assay.

[0040] In another aspect of the present disclosure, an assay measurement device for generating diagnostic test results from an assay includes an optical detector and a microprocessor. The optical detector can be positioned in alignment with the assay within an optical path. The optical detector can be adapted to obtain image detection on the assay due to aberrations on the assay. The microprocessor can communicate with the optical detector. The microprocessor can be adapted to signal the optical detector to perform continuous image detection of the assay to generate diagnostic test results.

[0041] The optical detector can comprise a decoding sensor positioned in alignment with the assay and adapted to decode a reference coding on the assay. In certain examples, the decoding sensor and the optical reader are a single device. However, one of ordinary skill in the art having the benefit of the present disclosure will recognize that other examples can include a decoding sensor and the optical reader can be a separate or separable device. The reference coding can activate a corresponding diagnostic test within the optical detector. The device can include a multi - channel reader and the reference coding can activate corresponding channels within the multi - channel reader. The device can include an incubator and the reference coding can activate a corresponding incubation temperature.

[0042] The decoding sensor may be a color sensor. The color sensor may be a photodiode having sensitivity to wavelengths selected from red, blue, green, and combinations thereof. The decoding sensor may be an RFID reader. The decoding sensor may be a barcode reader.

[0043] Decoding can be achieved using an algorithm that thresholds an assay, such as OCR, for character recognition to generate binary labeling for analysis of any of the systems and examples shown and described herein. Those skilled in the art having the benefit of this disclosure will recognize additional OCR mechanisms and methodologies.

[0044] In one example, the device includes a light source. The light source may be an array of discrete light sources. For example, the discrete light source may include one light-emitting diode and / or a plurality of light-emitting diodes. The light-emitting diode may be a colored diode selected from red, green, blue, and combinations thereof. The light source can include an illumination profile suitable for reflecting on the test strip assay. The light source may be positionally aligned with a light aperture that exposes light from the light source onto the assay. A first mirror may be below the light aperture. A focusing lens can receive light from the first mirror. A second mirror can be positioned to direct light from the focusing lens to an optical detector. An illumination processor can be adapted to trigger the light source to emit light in a desired pattern. The illumination processor can include a data storage device for the desired emission pattern.

[0045] In another example, the optical detector does not generate test results until the decoding sensor decodes the reference coding. The optical detector may be a light-voltage sensor. The optical detector may include a photodiode in an optical path having an assay 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 transmissive amplifier.

[0046] The device can include a memory adapted to store information corresponding to imaging parameters for image detection. The decoding sensor may be selected from a color sensor, an RFID reader, a barcode reader, and combinations thereof. The optical detector can include an optical window adapted to prevent debris from contacting the optical detector. The optical detector can include an optical system housing that encloses the optical detector and is adapted to prevent debris from contacting the optical detector. The optical detector can monitor the progress of a diagnostic test. The optical detector can monitor pre-test parameters before generating diagnostic test results. The optical detector can monitor at least one pre-test parameter after the optical detector has acquired at least one image detection on the assay.

[0047] In another embodiment, in an assay measurement device having an imaging detector and a microprocessor, a memory that communicates with the microprocessor and is adapted to store information corresponding to imaging parameters. The memory can include instructions for monitoring a pre-assay analysis of the assay. The memory can include instructions for generating diagnostic test results of the assay. The pre-test parameters can include theoretical reflectance values.

[0048] In one example, the assay can include at least one test line and at least one control line, such that the theoretical reflectance value is a comparison between the reflectance value in the test line and the reflectance value in the control line. A reflectance value on the assay that does not match the theoretical reflectance value can indicate an improper flow on the assay. The improper flow can trigger a detectable signal to generate a no-result response. In a particular example, the data of the no-result response is maintained and recorded as in any of the examples and embodiments shown and described herein. A reflectance value on the assay that does not match the theoretical reflectance value can indicate a previous analyte development on the assay. The reflectance value can suggest that the previous analyte development can trigger a detectable signal to stop the assay measurement device. A reflectance value on the assay that does not match the theoretical reflectance value can indicate a contaminated optical path.

[0049] A contaminated optical path can trigger a detectable signal to generate a no-result response. Instructions for generating test results can correspond to image detection on the assay. The image detection may be an optical reflectance value or a transmittance value. The assay can include at least one test line and at least one control line, such that the optical reflectance value is a comparison between the reflectance value in the test line and the reflectance value in the control line. The device can be adapted to perform continuous image detection on the assay. The assay may be a lateral flow assay. The assay may also be a lateral capillary flow length scale test strip.

[0050] The test results can be determined within about 30 seconds from the activation of the optical detector. The test results can be determined within about 60 seconds from the activation of the optical detector. The device can include a power source. The power source may be a vehicle battery. Further, the optical detector can communicate with an in-vehicle system.

[0051] In other embodiments, an assay measurement device for generating test results from an assay can include an imaging detector and a microprocessor having associated memory that communicates with the microprocessor. The imaging detector can be adapted to decode reference coding on the assay and obtain image detection on the assay due to aberration on the assay. The microprocessor can be adapted to signal the imaging detector to generate test results. The memory can communicate with the microprocessor and can be adapted to store information corresponding to a plurality of imaging parameters. The memory can include parameters for monitoring pre-assay analysis of the assay. The memory can include parameters for generating diagnostic test results from the assay.

[0052] Reference coding can activate corresponding diagnostic tests within an optical detector. A multi-channel reader and reference coding can activate corresponding channels within the multi-channel reader. The apparatus can include an incubator, and the reference coding can activate a corresponding incubation temperature.

[0053] The imaging detector can decode test reference coding and be adapted to include a decoding sensor. The decoding sensor may be a color sensor. In a particular example, the decoding sensor may be an OCR sensor or the like. The color sensor may be a photodiode having sensitivity to wavelengths selected from red, blue, green, and combinations thereof. The decoding sensor may be an RFID reader. The decoding sensor may also be a barcode reader.

[0054] Typically, the apparatus includes a light source. The light source may be an array of discrete light sources. The discrete light sources may include light emitting diodes. The light emitting diodes may be colored diodes selected from red, green, blue, and combinations thereof. The light source can include an illumination profile suitable for reflecting on a test strip assay. The light source may be positionally aligned with a light aperture that exposes the light source on the assay. The light source may include a first mirror below the light aperture. A focusing lens can receive light from the first mirror. A second mirror can be positioned to direct light from the focusing lens to the optical detector. An illumination processor can be adapted to trigger the light source to emit light in a desired pattern. The illumination processor can include a data storage device for a desired light emission pattern. The optical detector may not generate test results until the decoding sensor decodes the reference coding, or may not even initiate reading of the test.

[0055] The optical detector may be a photo-voltage sensor. The optical detector may be a camera. The optical detector may include a photodiode coupled to an integrated circuit in an optical path having an assay. The integrated circuit may be a monolithic integrated circuit. The optical detector may include an amplifier. The amplifier may be a transmissive amplifier. The optical detector can include an optical window adapted to prevent debris from contacting the optical detector. The optical detector can also include an optical system housing that encloses the optical detector and is adapted to prevent debris from contacting the optical detector.

[0056] In some examples, the optical detector can monitor the progress of a diagnostic test. The optical detector can monitor pre-test parameters before generating diagnostic test results. Further, the optical detector can monitor at least one pre-test parameter after the optical detector has obtained at least one image detection on the assay. The pre-test parameters can include theoretical reflectance values. The assay can include at least one test line and at least one control line, such that the theoretical reflectance value is a comparison between the reflectance value at the test line and the reflectance value at the control line. The theoretical reflectance value can also be a pre-set parameter value of the control line or the test line. For example, the control line can be a theoretical reflectance value. Reflectance values on the assay that do not match the theoretical reflectance value can indicate an improper flow on the assay. The improper flow can trigger a detectable signal to generate a no-result response. Further, reflectance values on the assay that do not match the theoretical reflectance value can indicate a previous analyte development on the assay. The previous analyte development can trigger a detectable signal to generate a no-result response. Still further, reflectance values on the assay that do not match the theoretical reflectance value can indicate a contaminated optical path. The contaminated optical path can trigger a detectable signal to obtain a no-result response readout and / or stop the assay measurement device.

[0057] Instructions for generating test results may be adapted to image detection on an assay. The image detection can be an optical reflectance value. The assay can include at least one test line and at least one control line, such that the optical reflectance value is a comparison between the reflectance value at the test line and the reflectance value at the control line. The apparatus can be adapted to perform continuous image detection on the assay. The assay may be a lateral flow assay. For example, the assay may be a lateral capillary flow length scale test strip. Further, the apparatus can include means for power supply.

[0058] In yet another embodiment, a lateral flow assay for detecting an analyte, the lateral flow assay having a test zone and a control zone and a surface having a reflectance profile, includes at least one flow reference and at least one test result reference. The at least one flow reference region can be adapted to enable monitoring of pre-flow development along the assay. The at least one test result reference region can be adapted to enable monitoring of pre-test detection of the analyte on the assay.

[0059] The reflectance profile may include theoretical optical reflectance measurements. The theoretical optical reflectance measurements can include non-flow development theoretical values. The non-flow development value can be a reflectance value of about 85. A reflectance value greater than about 85 can generate a signal to stop detection of the analyte. The flow reference region can include at least one downstream flow reference line. The downstream flow reference line can include the theoretical reflectance value after the flow reference line has received a reagent flow thereon. The flow reference region can include both an intermediate flow reference line and a downstream flow reference line. The intermediate flow reference line can include the theoretical reflectance value after the flow reference line has received a reagent flow thereon. The theoretical optical reflectance measurements can include non-analyte pre-test development theoretical values. The flow reference can also be the control zone.

[0060] The test result reference region can include at least one test line having a theoretical reflectance value. The test result reference region can include at least one control line having a theoretical reflectance value. The test result reference region can include at least one test line having a theoretical reflectance value and at least one control line having a theoretical reflectance value. A preset difference between the theoretical reflectance value of at least one test line and the theoretical reflectance value of at least one control line can activate the test result. Further, a preset difference between the theoretical reflectance value of at least one test line and the theoretical reflectance value of at least one control line can trigger an error. Due to the error, the test result may not be disclosed.

[0061] In other embodiments, the lateral capillary flow length scale test strip includes a test zone, a control zone, and a surface having a reflectance profile. The lateral capillary flow length scale test strip can have at least one reagent for detecting at least one analyte in a sample. A test zone capture agent adapted to capture at least one reagent may be immobilized thereon in the test zone. The control zone can include at least one control zone capture agent having a different binding affinity for at least one reagent. The reflectance profile can be adapted to enable continuous monitoring of the test strip until detection of the analyte. Typically, the test strip generates a detectable signal for detecting an analyte in a sample. In some examples, for example, insufficient development of the control line due to reflectance and / or transmittance at the control line can trigger an error. In these examples, the error can trigger a signal to generate a no result response.

[0062] The test strip can comprise a coding system having at least one reference code with a corresponding test sequence. The test sequence can include at least one temperature adjustment parameter. Further, the test sequence can include optical reader test parameters. The optical reader test parameters can include reader channel selection. The reader test parameters can include relevant features selected from standard curves, dose response curves, and combinations thereof. The reader test parameters can include at least one relevant positive control point and at least one relevant negative control point. The coding system can include a color matrix. The color matrix can include colors selected from red, blue, green, and combinations thereof. The color matrix can be associated with a corresponding diagnostic test. The coding system may include a barcode. The coding system may include an RFID tag.

[0063] The test strip can include a first end having a sample absorption material. The test strip can include a release strip for introducing a sample onto the sample absorption material. The release strip can include a release tab at one end of the release strip to facilitate moving the release strip. The sample absorption material can be adapted to receive from about 0.1 to about 1.0 mL of fluid. The sample absorption material may include a dry cellulose material. Further, the test strip can include an opposing second end having a reactant detection material. The test strip can include a release region having a mobile phase receptor for at least one analyte. The test strip can be sized to be enclosed within a test strip cavity and can be adapted as such. Further, the test strip can be sized to be enclosed within a test strip cavity of a removable incubation module and can be adapted as such. In certain examples, the test strip can be sized to be enclosed within a test strip cavity of a removable incubation and optical module and can be adapted as such. In certain examples, the test strip is adapted to select for the detection of a diagnostic test group selected from among antibiotic analytes, toxic analytes, analyte classes, combinations thereof, and the like.

[0064] The test zone can include at least one analyte reference line having a theoretical reflectance value. The theoretical reflectance value can be associated with flow parameters on the test strip. The test zone surface can include a first analyte reference line having a first theoretical reflectance value and a second analyte reference line having a second theoretical reflectance value. The control zone surface can include at least one control line having a theoretical reflectance value. For example, the theoretical reflectance value can be an optical reflectance value. The control zone can include a first control line having a first theoretical reflectance value and a second control line having a second theoretical reflectance value. In some examples, the reflectance profile is adapted to enable monitoring of the test strip prior to detection of the analyte. Further, the test result can be detected within about 30 to about 60 seconds.

[0065] In yet another embodiment, a lateral capillary flow length scale test strip includes a test zone having a test zone capture agent immobilized thereon that is adapted to capture at least one binder, a control zone including at least one control zone capture agent having a different binding affinity for the at least one binder, a surface having a reflectance profile adapted to enable monitoring of the test strip, and a coding system having at least one coding signal, e.g., a coding corresponding to a test sequence characterizing the test strip. The reflectance profile can include at least one flow reference region adapted to enable monitoring of flow development along the assay and at least one monitoring reference region adapted to enable monitoring of detection of the analyte on the assay.

[0066] The test sequence can include at least one temperature adjustment parameter. The test sequence can include optical reader test parameters. The optical reader test parameters can include reader channel selection. The optical reader test parameters can include relevant features selected from standard curves, dose response curves, and combinations thereof. Further, the optical reader test parameters can include at least one relevant positive control point and at least one relevant negative control point. The coding system can include a color matrix. The color matrix can be associated with a corresponding diagnostic test. The coding system may include a barcode. The coding system may include an RFID tag.

[0067] In some examples, the test strip can include a first end having a sample absorption material. The test strip can include a release strip for introducing the sample onto the sample absorption material. The release strip can include a release tab at one end of the release strip to facilitate moving the release strip. The sample absorption material can be adapted to receive from about 0.1 to about 1.0 mL of fluid. The sample absorption material may include a dry cellulose material. The test strip can include an opposing second end having a reactant detection material. The test strip can include a release region having a mobile phase receptor for at least one analyte. The test strip can be sized and adapted to be enclosed within a test strip cavity. Further, the test strip can be sized and adapted to be enclosed within a test strip cavity of a removable incubation and optical module. Typically, the test strip is adapted to select for the detection of a diagnostic test group selected from, for example, quantitative, qualitative, or both, antibiotic analytes, toxic analytes, analyte classes, combinations thereof, and the like.

[0068] The test zone can include at least one analyte reference line having a theoretical reflectance value. Typically, the theoretical reflectance value is associated with a flow parameter on the test strip. The test zone can include a first analyte reference line having a first theoretical reflectance value and a second analyte reference line having a second theoretical reflectance value. The control zone can include at least one control line having a theoretical reflectance value. The theoretical reflectance value can be an optical reflectance value. The control zone can include a first control line having a first theoretical reflectance value and a second control line having a second theoretical reflectance value. The theoretical optical reflectance measurement value can include a non-flow development theoretical value. The non-flow development value can be a reflectance value of about 85. A reflectance value exceeding about 85 can generate a signal for stopping the detection of the analyte.

[0069] In other examples, the flow reference region can include at least one downstream flow reference line. The downstream flow reference line can include a theoretical reflectance value after the flow reference line has received the reagent flow thereon. The flow reference region can include an intermediate flow reference line and a downstream flow reference line. The intermediate flow reference line can include a theoretical reflectance value after the flow reference line has received the reagent flow thereon. The theoretical optical reflectance measurement value can include a pre-analyte test pre-development theoretical value. The test result reference region can include at least one test line having a theoretical reflectance value. The test result reference region can include at least one control line having a theoretical reflectance value. The test result reference region can include at least one test line having a theoretical reflectance value and at least one control line having a theoretical reflectance value. A preset difference between the theoretical reflectance value of at least one test line and the theoretical reflectance value of at least one control line can activate the test result. Further, a preset difference between the theoretical reflectance value of at least one test line and the theoretical reflectance value of at least one control line can trigger an error. Typically, due to the error, a test result including the generation of a no-result response is not disclosed.

[0070] In yet another embodiment, in an assay system having an incubator and a reader that generate test results from an assay, the sensor can be adapted to continuously monitor the assay while the incubator incubates the assay and the reader generates the test results. The sensor can be adapted to stop the incubator when the sensor detects an aberration on the assay. The sensor may be an optical detector. The optical detector can be adapted to detect reflectance values. The assay can include at least one test zone and at least one control zone, such that the reflectance value is a comparison between the reflectance value in the test zone and the reflectance value in the control zone. Further, if the reader and / or the incubator hood is opened during incubation or reading, the signal can generate a no-result response. Further, if the assay is removed before the test results are generated, the signal can generate a no-result response.

[0071] In some examples, when the sensor detects a reflectance value on the assay that does not match a predetermined theoretical reflectance value on the assay, the assay can be stopped. For example, a reflectance value on the assay that does not match the theoretical reflectance value can indicate an improper flow on the assay. Further, a reflectance value on the assay that does not match the theoretical reflectance value can indicate a previous analyte development on the assay. Similarly, a reflectance value on the assay that does not match the theoretical reflectance value can indicate a contaminated optical path.

[0072] In other examples, the sensor can be adapted to stop the reading device when the sensor detects an aberration on the assay. The sensor can be an optical detector. The optical detector can be adapted to detect reflectance values. The assay can include at least one test zone and at least one control zone, such that the reflectance value is a comparison between the reflectance value in the test zone and the reflectance value in the control zone. When the sensor detects a reflectance value on the assay that does not match a predetermined theoretical reflectance value on the assay, a no-result response can be generated. A reflectance value on the assay that does not match the theoretical reflectance value can indicate an improper flow on the assay. Further, a reflectance value on the assay that does not match the theoretical reflectance value can indicate a previous analyte development on the assay. Similarly, a reflectance value on the assay that does not match the theoretical reflectance value can indicate a contaminated optical path.

[0073] The sensor can be a decoding sensor. The decoding sensor can be selected from a color sensor, an RFID reader, an OCR reader, a barcode reader, and combinations thereof. Typically, the sensor is triggered by an operating element selected from a hood sensor, an incubator sensor, a proximity switch, a trigger switch, and combinations thereof.

[0074] The device can include a housing adapted to substantially enclose the reading device and the incubator. The housing can include an insulator adapted to withstand deformation during incubation. The housing can also include a cavity adapted to hold the assay and receive light from the reading device. The cavity can include an optical aperture for receiving light from the reading device. The cavity can include an adjustable fastener adapted to position the cavity within the optical path having the reading device. The cavity can include an insulator adapted to withstand deformation during the incubation period. The assay can be a lateral capillary flow test strip.

[0075] In certain examples, the system can include a user interface. The user interface can include, for example, an integrated circuit board for supporting a display board. The user interface can also be adapted to view a fluidic development. Similarly, the user interface can be adapted to view test results including a no-result response. The user interface can also be adapted to view a fluidic development after a reading device has detected at least one fluidic development on the assay.

[0076] In another embodiment, a lateral flow assay system that generates test results from an assay includes an incubator adapted to incubate the assay and a reading device adapted to read a diagnostic test on the assay. The assay can be capable of undergoing a change when contacted with a sample and generating a test result.

[0077] In some examples, the system includes a removable assay module. The removable assay module can include an assay cavity adapted to align the assay with a reading device. The assay can be a lateral flow test strip. Accordingly, the assay cavity can be sized to receive a lateral flow test strip. The removable assay module can include a hood. The hood can enclose the assay in a closed test position and expose the assay in an open access position.

[0078] Furthermore, the removable assay module can include a bottom surface adapted to be positionally aligned with at least one optical aperture on the reading device. The bottom surface can include an adjustment fastener adapted to optically positionally align and fix the assay cavity with the reading device. The bottom surface can also include an engagement lip for positioning the bottom surface with the reading device. The removable assay module can include at least one optical window. The removable assay module can be adapted to be removed from the system and cleaned of debris.

[0079] In some examples, the incubator includes an insulating base. The incubator may be a temperature-adjustable incubator. The temperature-adjustable incubator can include at least one temperature control unit. Thereby, the temperature-adjustable incubator can include local temperature variations. For example, the incubator can compensate for local temperature variations. The incubator can compensate for local temperature variations by an analog proportional circuit. In other examples, the incubator can compensate for local temperature variations by a digital control circuit, for example, by utilizing a PID algorithm or a PID controller. Furthermore, the temperature-adjustable incubator can include a built-in temperature sensor. The temperature-adjustable incubator can include a potentiometer. The incubator can include a heater. The heater may be selected from a ceramic heater, a resistive heating element, etc. Similarly, the incubator can include a cooling system. In still other examples, the incubator incubates an assay in means for creating an incubation environment.

[0080] The reader can perform continuous image detection of the assay to generate test results. The continuous image detection can include monitoring the pre-flow development along the assay, including monitoring for excessive and inappropriate flow along the assay. The reader can include a light source oriented in a predetermined pattern with respect to the assay. The light source may include a first mirror below the light source. The light source can include a focusing lens adapted to receive light from the first mirror. Further, the light source can include a second mirror positioned to direct light from the focusing lens to the reader.

[0081] In certain examples, the reader can include a sensor. The sensor can be an optical detector that is positionally aligned with the light source to detect the transmission of light through the assay. For example, the transmission embodiments herein can include the analysis of refracted light from the assay. The sensor can be a decoding sensor. The decoding sensor can be adapted to decode at least one reference code having a corresponding test sequence on the assay. Further, the reader can include a plurality of channels. Each channel can include a related feature selected from, for example, a standard curve, a dose response curve, a positive cut-off value, a negative cut-off value, and the like.

[0082] In yet a further embodiment, a method of generating test results from an assay includes incubating the assay within an incubation environment and reading a diagnostic test of the assay while the incubator incubates the assay. The method can include continuously detecting the assay while the incubator incubates the assay. The method can include inactivating the assay when an aberration on the assay is detected. The method can include removing a removable assay module from the assay module to wash debris or the like, for example. The method can include adding a test sample to a test medium to create the assay. The method can also include encapsulating the test medium within a reading device. The method can include positioning a sensor relative to the test medium such that changes on the test medium are detectable by the sensor. The method can include decoding a reference coding on the assay. Thereby, the method can include selecting a channel within the reading device corresponding to the reference coding on the assay. Further, the method can include incubating the assay within the incubator according to the reference coding on the assay.

[0083] In one embodiment, a method for managing test data includes generating test results from a test instrument reading device, associating an application on a partner device with the test instrument such that test result output communication is enabled between the test instrument and the partner device, subscribing a first test result output from the device to the partner device, and transmitting at least one second result output selected from the group consisting of operator identification information, sample identification information, lot number, geographical location, geographical coordinates, sample notes, and test result notes, associated with the first output.

[0084] In certain examples, the method includes establishing an authorized connection between the device and the partner device. Further, the partner device application can scan for available test devices. The method can include real-time export of result output from the test device. In certain examples, the method includes relaying result output from the partner device to an external storage configuration. In certain examples, the method can include multiple test devices.

[0085] In another embodiment, a method for relaying test data generated from a sample on a test device includes performing a diagnostic test on the test device, interfacing the test device with a mobile partner device having a corresponding data communication interface to establish valid data communication with the test device, converting the test results into a result output format suitable for transmission, establishing data communication exchange of the result output between the test device and the partner device, and relaying the result output from the partner device to an external storage configuration. In certain examples, the test device can include one or more of a housing, a receiving port for receiving a sample on a sample device, a reading device for generating test results from the sample device, and a data communication interface.

[0086] In certain examples, the method includes establishing data communication between a test device and a partner device, such as by coupling an application on the partner device to the test device. The partner application can scan for available test devices. The partner application can subscribe to data from the test device. The method can include exporting, in real time, result outputs from the test device to record multiple subsequent sample results outputs. Further, the method can include merging multiple sample results outputs and associated geographical locations and mapping the multiple result outputs. Also, in certain examples, the method can include generating a map display indicative of the occurrence of toxin mapping. The method can include establishing an authorized wireless connection between the test device and the partner device, for example, using Bluetooth® Low Energy (BLE), a dongle, or a similar system. The method can include establishing a host IP address connection between the partner device and an external memory configuration.

[0087] In some examples, performing a diagnostic test includes receiving a test strip sample device and imaging the test strip sample device to generate a test result. In some examples, performing a diagnostic test includes incubating the sample device. In certain examples, the method includes transmitting at least one sample identifier corresponding to an individual sample test result selected from the group consisting of operator identification information, device identification information, sample identification information, lot number, geographical location, geographical coordinates, sample annotation, and test result annotation. In certain examples, relaying to an external storage device includes transmitting to a remote host website. Further, in certain examples, relaying to an external storage device 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 can have an indicator that provides a pairing signal when activated, and the indicator provides a visual indication of the pairing to the test device. The method can also include establishing a secondary messaging data communication exchange between the test device and the partner device.

[0088] In yet another embodiment, a method for use by a host site adapted to support a test device and test result data includes connecting to a valid test device having a first mode of operation for performing at least one test on a sample, wherein in a second mode the device has a data communication interface for communicating result output transmissions, receiving an authorized result output transmission, and converting a plurality of result outputs into a data display.

[0089] In certain examples, the method includes storing multiple result output data in a first database. Establishing result output communication can include first establishing data communication with a partner device. For example, the partner device may be a mobile phone, a tablet, a general-purpose computer, a PDA, a digital media player, a digital camera, a wireless information device, etc. In some examples, the data can ensure that the properly tested food is most efficiently delivered to the assigned destination according to the test results. In other examples, the data can be collected from multiple locations and sources and combined into a single database using low-cost tools and existing test equipment for illustrative purposes only.

[0090] Yet another embodiment of the present disclosure includes a central office that is an external storage configuration, such as a web-hosted external storage configuration. In certain examples, the external storage configuration is assigned a public static IP address to which any of the available deployed devices can send test data if available.

[0091] Another embodiment of the present disclosure includes an integrated system for data processing with minimal operator intervention. In some examples, the setup on the device requires downloading and installing an app on a smartphone, attaching a Bluetooth adapter to power, pairing a device such as a Bluetooth® device with the smartphone, and then launching the app. Real-time display of test data on the smartphone can present to the user that the test data has been properly transmitted to the phone and enable attaching notes to the test data as illustrated and described herein.

[0092] In certain examples, when GPS is enabled within a smartphone, the test data can include the latitude and longitude where the test was conducted. In these methods, when a test data packet is collected by the phone, the app processes communication with a host central office that attempts to transfer when an appropriate signal strength is available. The integrated communication protocol ensures that the data remains buffered on the phone until a signal from the host indicates successful collection.

[0093] In one embodiment, a method of preventing the migration of a product in a delivery system includes performing a diagnostic test, relaying the test results to an external administrator portal, generating a substantially continuous operating signal in a protocol converter and transmitting the signal to the administrator portal, receiving a trigger condition from the administrator portal if present in the protocol converter, and triggering a relay adapted to prevent downstream migration of the product. The test device can have a receiving port for receiving a sample on a sample device, a reading device for generating test results from the sample device, and a data communication interface.

[0094] In some examples, receiving a trigger condition includes receiving at least one positive test result. Performing a diagnostic test can include receiving a test strip sample device and imaging the test strip sample device to generate test results.

[0095] Furthermore, performing a diagnostic test can include receiving a plate sample device and imaging the plate sample device to generate test results. Additionally, performing a diagnostic test can include receiving a swab sample device and analyzing the swab sample device to generate test results.

[0096] In certain examples, interfacing the test equipment with the mobile partner device includes establishing effective data communication with the test equipment. The method can include exporting in real time a result output from the test equipment that records a plurality of subsequent sample results outputs. Further, preventing the migration of the product can include activating a relay trigger event such as, for example, an audible indicator, a visual indicator, an access arm, a barrier gate, a solenoid valve, a combination thereof, and the like.

[0097] In one embodiment, the communication protocol converter includes a data communication interface, a peripheral processor platform that communicates data with an external administrator portal, and at least one relay module that electrically communicates with the processor platform and at least one external peripheral device, and transmission of a trigger condition from the external administrator portal activates at least one relay module.

[0098] In certain examples, the device includes a housing that encloses the peripheral processor platform and the relay module. The housing can have a metal housing generally positioned within the data communication range of the test equipment. The data communication interface may include a WI-FI connection. The data communication interface may include an Ethernet (Ethernet is a registered trademark) connection. The relay module can include a single-pole double-throw relay. The single-pole double-throw relay can include two independently controlled contact relays. The single-pole double-throw relay can include two dry contact relays. In other examples, the relay module includes a double single-pole double-throw latching relay. The relay module can include an input / output port adapted to trigger the relay. The processor platform can interface any number of peripheral devices including sensors, identification devices, and the like. The device can include a power supply. Further, the device can include a user interface.

[0099] Another embodiment is a product delivery assembly, comprising a test instrument, a host database adapted to support test result data generated by the test instrument, a communication protocol converter for data communication with the host database, and a product transfer blocking means, wherein the product transfer blocking means is activated by the protocol converter after receiving a trigger condition, and the product delivery assembly is included.

[0100] In a further alternative embodiment, a method for managing test data includes generating test results from a test instrument, associating an application on a partner device with the test instrument to enable test result output communication between the test instrument and the partner device, subscribing to a first test result output from the device to the partner device, and transmitting at least one second result output selected from the group consisting of operator identification information, sample identification information, lot number, geographical location, geographical coordinates, sample notes, and test result notes related to the first output.

[0101] In a particular example, the method includes establishing an authorized connection between the device and the partner device. Further, the partner device application can scan for valid test instruments. The method can include real-time export of result output from the test instrument.

[0102] In a particular example, the method includes relaying result output from the partner device to an external storage configuration.

[0103] In another embodiment, a method for relaying 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 having a corresponding data communication interface to establish effective data communication with the test instrument, converting the test results into a result output format suitable for transmission, establishing data communication exchange of the result output between the test instrument and the partner device, and relaying the result output from the partner device to an external storage configuration. In a specific example, the test instrument can include one or more of a housing, a receiving port for receiving a sample on a sample device, a reading device for generating test results from the sample device, and a data communication interface.

[0104] In a specific example, the method includes establishing data communication between the test instrument and the partner device, such as by associating an application on the partner device with the test instrument. The partner application can scan for valid test instruments. The partner application can subscribe to data from the test instrument. The method can include exporting in real time the result output from the test instrument to record multiple subsequent sample result outputs. Further, the method can include merging multiple sample result outputs and associated geographical locations, and mapping the multiple result outputs. Also, in a specific example, the method can include generating a map display indicating the occurrence of toxin mapping. The method can include establishing an authorized wireless connection between the test instrument and the partner device using, for example, Bluetooth (R) Low Energy (BLE), a dongle, or a similar system. The method can include establishing a host IP address connection between the partner device and the external storage configuration.

[0105] The above summary is intended to summarize certain embodiments of the present disclosure. The embodiments will be described in more detail in the drawings and the following description of the embodiments. However, it is clear that the description of the embodiments is not intended to limit the invention, and its scope should be appropriately determined by the appended claims.

[0106] Brief Description of the Drawings Embodiments of the present disclosure will be better understood by reading the description of the embodiments together with the consideration of the drawings.

Brief Description of the Drawings

[0107]

Figure 1

Figure 1a

Figure 2

Figure 3

Figure 4

Figure 5

Figure 5a

Figure 5b

Figure 5c

Figure 5d

Figure 6

Figure 7

Figure 7a

Figure 8

Figure 9

Figure 10

Figure 11

Mode for Carrying Out the Invention

[0108] Description of Embodiments In the following description, like reference numerals indicate like or corresponding parts throughout several figures. Also, in the following description, terms such as "front", "rear", "left", "right", "upward", "downward", etc. are for convenience only and should not be construed as limiting terms. It should be understood that the examples are for the purpose of explaining embodiments of the present disclosure and are not intended to limit the present disclosure or any invention thereto.

[0109] In some embodiments, the test instrument is a lateral flow assay system configured to receive an assay sample device and analyze the assay to generate diagnostic test results. Typically, the assay sample device is a lateral flow test strip. However, it is within the scope of the present disclosure that any of the assay devices herein can be an assay other than lateral, including but not limited to capillary flow test strips. Further, any of the reading devices, incubators, combined reading device / incubator devices, and systems shown and described herein can include any optical analysis reading device, which often includes an imaging device, a light source, and an imaging detector including a sensor positioned such that light from the light source is incident on the assay and then imaged / reflected onto the imaging sensor. An example of a reading device component useful in embodiments herein is described in PCT / US2011 / 49170, filed Aug. 25, 2011, and U.S. Pat. No. 6,124,585, issued Sep. 26, 2000 (Apparatus for measuring the reflectance of strips having non-uniform color), both of which are hereby incorporated by reference in their entirety. Typically, the presence and optionally the concentration of an analyte on the assay can be determined, for example, by measuring imaging, light reflectance, etc. from the development region on the assay. In some examples, percent reflectance can be used to determine the result. In other examples, transmittance can be used to detect the result. For example, the assay can be transparent and can include a surface having a transmittance profile similar to the reflectance profile described below. This structure and function described in these references can be adapted by one of ordinary skill in the art in accordance with the disclosure herein to obtain functional units.

[0110] Often, over aspiration or other sample delivery to the assay can cause flooding of the assay and produce unreliable and inaccurate test results. FIGS. 1-8 introduce elements and embodiments of an optical module 500, such as an offset, non-planar, etc., that are compatible with any of the reader device element features shown and described herein to minimize or eliminate the uncertainties and undesirable results of sample flooding. The Applicants have unexpectedly discovered that the development and testing of non-planar assays reduces many of these problems.

[0111] As introduced in FIGS. 1 and 3, the non-planar optical module 500 generally includes a distal portion 532 that is positionally aligned adjacent to and substantially offset from a proximal portion 530. The distal portion 532 can include a protruding overhang lip 525 for efficient and convenient access for operating any of the assays shown and described herein for the device, for example, during loading and removal. The overhang lip 525 allows the user to conveniently positionally align the proximal portion of the assay so as to extend around the optical module in the operating position. For example, the proximal portion of the assay may protrude outside the device.

[0112] In certain embodiments, as shown in FIGS. 1-4, the non-planar optical module 500 can include a power switch 700, an electrical communication port 702, a lower support 502, an interface shell 504, a bracket 506, and a base 508 that supports the positioning of an offset frame 512 to enable non-planar positioning. An aperture carrier 510 that aligns any of the optical systems shown and described herein is generally supported within the offset frame 512. The offset frame 512 generally includes a lower layer platform 520 that is aligned with an opposing upper layer platform 522, for example, at a pivot point 516. A cover 514 or the like can secure any of the elements shown and described herein. In certain embodiments, the cover 514 is a spring-biased cover. As introduced in FIGS. 5a and 5b, the spring-biased cover can include a spring-biased support 534 that is aligned between the cover 514a and the offset slide frame 512 to facilitate access for aligning / removing an assay around the device. Other embodiments of the cover include a single cover(s) that includes at least a substantially integral cover(s) to provide access for aligning / removing an assay around the device in any of the examples shown and described herein. As introduced in FIGS. 5c and 5d, an embodiment of the integral cover includes a cover 514b that is aligned with an integral support 534b around the offset slide frame 512. Those skilled in the art having the benefit of this disclosure will recognize features such as additional covers, latches, doors, windows, etc. for providing access to the assay during operation and / or for hiding, housing, etc. the assay.

[0113] In any of the examples and embodiments of this specification, the planar proximal portion 530 can generally positionally align the assay elements in a planar position, while the non-planar distal portion 532 can generally positionally align the assay elements in a non-planar position. For example, as shown and described herein, any of the test lines 40, control lines 42, and combinations thereof can be positionally aligned adjacent to the pivot point 516', above it, or substantially adjacent thereto, at the pivot point generated by the assay positioning within the cradle module. In certain examples, the non-planar distal portion 532 is positionally aligned offset from the planar proximal portion 530 by about 10 degrees to about 30 degrees. For example, the non-planar distal portion 532 can be positionally aligned offset from the planar proximal portion 530 by about 20 degrees. Other examples include various degrees of offset between the distal portion 532 and the proximal portion 530. In an exemplary example, the optical module can image the assay adjacent to the bend in the assay at the operating position, for example, at point 516'.

[0114] As shown, a generally planar assay test strip is inserted into the cradle module 500, i.e., along the proximal portion 530, and then bends generally non-planarly as the assay test strip projects into the non-planar distal portion 532. Unexpectedly, Applicants have found that the wicking and flow elements allow the sample flow to proceed along the assay strip against, for example, gravity, towards the proximal portion 530, while the non-planar positional alignment with respect to, for example, the pivot point, prevents excessive sample flow into the test region of the distal portion 532. In a particular example, about 40% to about 70%, including about 60% of the length of the assay test strip, may be positionally aligned with the non-planar distal portion 532 at the operating position shown and described herein. Other examples include various length ratios between the distal portion 532 and the proximal portion 530 for adjustment, for example, to field test conditions, multiple test and control line deployments, analyte tests of interest, etc., as would be recognized by one of ordinary skill in the art having the benefit of this disclosure.

[0115] As introduced in FIG. 8, useful elements of the lateral flow assay system are shown for application at the test site. The lateral flow assay systems shown and described herein typically include, for example, a reader, a composite reader, and an incubator. The reader can include an imaging camera, such as a sensor, a device, a detector, etc., while any of the incubator embodiments herein can further include an insulating base, a thermal shield, or similar incubation environment components to deliver and maintain the desired test temperature. In some embodiments, the insulating base is a removable assay module. In a particular example, the reader first monitors the assay for one or more monitored values including flow rate, previous analyte development, and debris. In various examples, when appropriate monitored values are detected by the system, the incubator incubates the assay and the reader generates test results.

[0116] As shown in FIG. 8, the lateral flow assay system is configured to receive an assay and analyze the assay to generate a diagnostic test result. Typically, the assay is a lateral flow test strip. However, it is within the scope of the present disclosure that any assay herein can be other flow assays.

[0117] Any of a variety of housings may enclose the optical module 500, the reader, and / or the incubator as an integrated diagnostic unit. Other embodiments include a housing that partially encloses components of the lateral flow assay system. In a particular example, the cavity is surrounded by an insulating material such as a plastic material, such as a thermoplastic resin known as, for example, Delrin (DELRIN is a registered trademark of DuPont), that does not deform when heated to the temperature required to generate test results.

[0118] The present applicants unexpectedly discovered the advantages of the non-planar systems and assemblies herein when operating a test strip having multiple line developments in various regions on the test strip, e.g., along a multi-analyte detection test strip as described below and introduced in FIG. 9. For example, a multi-analyte detection test strip that tests multiple drug families, etc., can support various binder strengths due to the rapidity of binding limitations affected by over-suction, sample pooling, improper flow, etc.

[0119] Any of the reading devices shown and described herein can include various light sources, such as, for example, light bar(s) positionally aligned along the tilt pitch of the device, incandescent bulbs, fluorescent tubes, light emitting diodes. In some examples, the light source may be a discrete light source, e.g., an array of colored light emitting diodes selected from red, green, blue, and combinations thereof. In yet other examples, the light source may be an individual light source, e.g., a single diode. Typically, the light source is configured to emit an illumination pattern suitable for reflecting off the assay along, e.g., a long test strip and is current-driven. In a particular example, the light can be directed at the assay, e.g., through an opening 511 via a cavity. In a particular example, the light may be reflected from the assay, return through the cavity opening, and be directed at an optical detector.

[0120] In one example, the optical system circuit board can have a plurality of light emitting diodes (LEDs) mounted thereon in a predetermined pattern, for example, around a light emitting aperture. The LEDs may be mounted on one side of the optical system circuit board. An optical detector array may be mounted on the back side of the same optical system circuit board. Further, a first mirror may be positioned below the light emitting aperture at a predetermined angle with respect to the circuit board, for example, about 315 degrees. A second mirror may be positioned below the optical detector at an angle, for example, about 220 degrees with respect to the circuit board such that there is a substantially 90-degree angle between the first mirror and the second mirror. A focusing lens may be positioned between the first mirror and the second mirror. Thereby, the light emitted from the LED array can irradiate the assay, and then the light is reflected from there through the light emitting 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 that regard, the light hitting the optical detector can generate a measurable voltage in the optical detector. In an additional example, an optical processor can be coupled to the light source to activate the light source and supply appropriate currents to each light to generate a desired light emission pattern. The optical processor can be used to read and store data from the optical detector. The optical processor can also be used to adjust the output of the array of discrete light sources such that the light emission pattern hitting the optical detector array has a uniform intensity. The illumination processor can include a data storage device for the desired light emission pattern.

[0121] Furthermore, the light source may be an LED light source including red, green, and blue LED devices within a single package. For example, the LED light source of the color sensor may be three separate LEDs. Similarly, a single white LED having a narrow bandwidth response at red, green, and blue wavelengths and three separate photodiodes can be used as a detector front end.

[0122] In yet other examples, one LED is used with an optional feedback loop. The feedback loop can use a photodiode to detect fluctuations in the light output from a single LED. When the light output changes, a signal is sent so that appropriate adjustments can be made, such as increasing or decreasing the current to the LED. The change in reflectivity can be the result of the binding of labels containing colored particles such as gold beads. The change in reflectivity can also be the result of contaminants and interference within the optical path.

[0123] Some embodiments include a plurality of reading devices that can be positioned around a modular interface 600 (e.g., as shown in FIG. 2), and / or the reading devices can be programmed by a plurality of channels each having a distinct parameter associated with a related diagnostic test. Each channel selection parameter can include a standard curve, a dose response curve, and the like. A particular example includes a motherboard, e.g., any of a variety of offset position alignment cradles 500 positioned around slots 552 for supporting a plurality of optical units useful for multiple tests simultaneously. For example, a particular module provides specific test parameters for a plurality of test strips having the same specifications, or for test strips having unique incubation temperatures, incubation time frames, test development specifications, monitoring specifications. The modular interface can further accommodate any of a variety of test elements including a droplet receiver 556, a strip holder 554, a lens mechanism, etc., as will be understood by those skilled in the art having the benefit of this disclosure.

[0124] Embodiments include, but are not limited to, reading devices, modular interfaces, or any of a variety of user interfaces on tangential electronic devices, including handheld devices, telephones, computers, such as in-vehicle vehicle analytics during batch pickup, vehicle displays, etc. In a particular example, the user interface includes an integrated circuit board that supports a display board. In one example, the user interface enables a user to view a fluidic expansion. Further, the user interface can enable a user to monitor subsequent fluidic expansions after the reading device has detected at least one fluidic expansion on an assay. Similarly, the user interface can display final test results, including a no-result response.

[0125] FIG. 9 shows an embodiment of assay elements for a particular diagnostic test having components useful in embodiments herein, including those described in U.S. Patent No. 7,410,808, issued Aug. 12, 2008, U.S. Patent No. 7,097,983, issued Aug. 29, 2006, U.S. Patent No. 6,475,805, issued Nov. 5, 2002, U.S. Patent No. 6,319,466, issued Nov. 20, 2001, U.S. Patent No. 5,985,675, issued Nov. 16, 1999, and U.S. Patent Application No. 11 / 883,784, filed Aug. 6, 2007, all of which are incorporated herein by reference.

[0126] In certain embodiments, any of the inventions herein can prevent the transfer of contaminated and / or low-quality products, e.g., triggered by a positive test result, into a mixture of good products, e.g., a negative test result product. An example of an indicator triggered by an example herein is, for example, an audible and / or visual indicator positioned within a receiving bay or along various points of a process line to alert of the detection of a positive test result product. Further blocking means can include preventing a tank truck from accessing a receiving bay via a gate access control arm, a barrier gate, or blocking the flow of a product via a solenoid valve. Those skilled in the art having the benefit of this disclosure will recognize additional blocking means operative by any of the examples and embodiments shown and described herein.

[0127] For example, various embodiments include a communication protocol converter for data communicating with an administrator portal, a database, software, etc. to provide data exchange and trigger events to any of the product transfer blocking means shown and described herein. FIG. 10 shows the components of one communication platform embodiment having a display, a peripheral processor platform 14, a plurality of data communication interfaces including, but not limited to, a WiFi interface 20, an Ethernet interface 22, and channel connections 28, 28' for receiving relay modules 18, 18'.

[0128] In certain examples, the plug-in modules 18, 18' may be single-pole double-throw relays. A single-pole double-throw relay can have two independently controlled dry contact relays. In certain examples, the single-pole double-throw relay can activate any of the indicators shown and described herein. In other examples, the plug-in modules 18, 18' may be double single-pole double-throw latching relays, and the relays latch to reduce or minimize long-term activation of the current. Further, the relays may be rated at 250VAC with a 16-ampere current, while other examples include additional loads and currents to meet the needs of a particular site.

[0129] In certain examples, the system determines overall health and includes on-board diagnostics that generate any of the operational signals shown and described herein. Programmable trigger conditions from a portal, such as a "positive" test result, can initiate a transmission to perform a blocking operation. Further, an administrator portal, for example, can permit entry of the device's IP address. Each channel can have independent control, and the administrator portal can catalog / operate any of a variety of devices and systems.

[0130] In a particular module, the test equipment interfaces with a mobile partner device having a corresponding data communication interface, thereby establishing a valid, i.e., approved, authorized, and / or available data communication with the test equipment, including any of the data communication systems shown and described herein. An example of a partner device that receives test result data communication before relaying the test result output to an external storage configuration. In a particular example, the module can include causing an application on the partner device, such as a downloadable program application, to cooperate with the test equipment. Further, the module can include establishing a data communication exchange of result output between the test equipment and the partner device. Still further, the module can include establishing a secondary messaging data communication, including, but not limited to, secondary message exchange between the test equipment and the partner device, such as email, text, etc.

[0131] Any of the test equipment herein can interface with a partner device to relay test results to an external storage configuration, etc., or, in an alternative form, the test equipment can interface directly with an external storage configuration to provide any of the advantages shown and described herein. In a particular example, the partner device is a smartphone, but other partner devices can include tablets, general-purpose computers, PDAs, digital media players, digital cameras, wireless information devices, etc.

[0132] Those skilled in the art having the benefit of this disclosure, as well as the incorporated test equipment and sample apparatus, will recognize additional interface configurations between the partner device and the test device, communication exchanges between the partner device and the external storage configuration, direct exchanges between the test equipment and the external storage configuration, and other data communication and storage mechanisms within the scope of the inventive concept.

[0133] Generally, the lateral flow assay 21 is a generally planar membrane-based test device prior to the operation / test in any of the examples shown and described herein, where 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 traverses the membrane strip, for example, by capillary action. While traversing the membrane strip, the analyte in the test sample encounters, if present, one or more reagents. The reagent can include a binding agent for the analyte. The binding agent can be mobile and thus can flow with the sample or can be immobilized on the test strip as a capture agent. Depending on the test configuration, either the analyte binding agent, the analyte itself, or some other reagent within the test system is captured by the immobilized capture agent, thereby generating a detectable signal. The signal can be generated by a label provided within the assay. The detectable signal can be measured by, for example, an optical reader device. As shown and described herein, the Applicants have unexpectedly found the advantage of minimizing the effects of in-line sample delivery, including dripping, while the mobile phase moves along the assay, by positioning the assay or a portion thereof in a non-planar position.

[0134] Assay 21 can include at least one test line 40 within a test zone and at least one control line 42 within a control zone. The theoretical reflectance value can be a comparison between the reflectance value at the test line 40 and the reflectance value at the control line 42. A preset difference between the theoretical reflectance value at the test line 40 and the theoretical reflectance value at the control line 42 can operate a lateral flow assay system including a reader to generate a test result. Further, a separate preset difference between the theoretical reflectance value at the test line 40 and the theoretical reflectance value at the control line 42 can trigger an error. Triggering of the error may cause the microprocessor to not disclose the test result, including generating a no result response or stopping the reader and / or incubator. Other embodiments may include a comparison between the transmittance value at the test line 40 and the reflectance value at the control line 42.

[0135] The rapid result assay is beneficial for any of the non-planar test examples and embodiments shown and described herein. For example, the rapid result assay provides a final test result within about 15 seconds to about 1 minute, including a final test result within about 30 seconds. In other examples, the reading device generates test results within about 10 seconds to about 15 minutes. To increase the speed of the test results, the Applicant has unexpectedly discovered that by optimizing the overlap of the binder-coated regions on the nitrocellulose membrane in the assay, final test results beneficial for any of the non-planar test processes and embodiments shown and described herein are possible. In one example, a 3-millimeter overlap of the binder-coated regions on the nitrocellulose membrane optimizes the contact surface area between the binder-coated regions and the nitrocellulose membrane, increasing the flow and release of the sample to achieve the 30-second test herein. In certain embodiments, the binder-coated region may be, for example, POREX® (POREX is a registered trademark of Porex Technologies Corp in Georgia, USA) attached to a solid support. Further, in certain embodiments, the nitrocellulose membrane can be optimized to achieve the 30-second rapid test herein. For example, the nitrocellulose membrane can ensure that the sample is efficiently and rapidly and properly sucked up across the entire membrane to generate the rapid test result analysis shown and described herein. However, those skilled in the art having the benefit of this disclosure will recognize additional binder-coated region materials and / or the spacing of the binder-coated regions around the nitrocellulose membrane.

[0136] Furthermore, the Applicant has unexpectedly discovered that by optimizing the length of the absorption pad in the distal portion of the assay, capillary action is enhanced and the flow rate of the sample is adjusted to meet the requirements of a non-planar test, such as the 30-second rapid test herein. In one example, an absorption pad with a length of 31 millimeters optimizes the flow of the sample along the assay.

[0137] Reflectance values on the assay that do not match the theoretical reflectance values can indicate improper flow in the mobile phase on the assay. For example, Assay 21 can have a flow line 44 with corresponding theoretical optical reflectance measurements. The non-flow development value can be a reflectance value of about 85 on the reflectance scale. Such improper flow can trigger a detectable signal and generate a no-result response. Further examples include stopping the lateral flow assay system 1, including stopping the reader device and / or the incubator. In other examples, the flow reference region can include both an intermediate flow reference line 46 and a flow reference line 44 having corresponding theoretical reflectance values.

[0138] Similarly, reflectance values on the assay that do not match the theoretical reflectance values can also indicate previous analyte development on the assay. Such previous analyte development can trigger a detectable signal and generate a no-result response. Further, if the assay is removed before generating test results, the system can generate a no-response result.

[0139] In some embodiments, Assay 21 also includes a coding reference component having a corresponding test sequence for the lateral flow assay system. The coding can be, for example, alphanumeric coding, color-coding, barcodes, RFID tags, etc., and can be positioned at any location along the assay so that a decoder sensor can decode the reference code, for example, on the surface of the assay. For example, in some examples, the coding reference is positioned along the distal end of Assay 21. Depending on the type of coding on the test strip, the reader device may require an integrated decoder sensor, such as a barcode reader, RFID decoder, or color sensor.

[0140] In certain examples, the test sequence is at least one temperature adjustment parameter within the incubator and / or channel selection of the reading device. Further, the reading device test parameters can include relevant features selected from a standard curve, a dose response curve, and the like. Other embodiments include various test sequence parameters for related diagnostic tests being performed on the assay.

[0141] In some examples, a reference coding of one or more color matrices selected from red, blue, green, and combinations thereof can be associated with corresponding diagnostic test parameters. When color sorting is used on assay 21, the color can be read by the reading device, either by a separate optical reading system or the same system that reads the test results. That is, the assay can include a colored portion that is read by a color sensor to determine the reading device channels and / or appropriate incubator temperature after enclosure within the system and after the test is initiated. For example, as a detector, a photodiode having a wide dynamic range of sensitivity for red, green, and blue wavelengths can be used. As light sources, red, green, and blue LEDs can be used. Each LED can be turned on sequentially, and the detector is used to determine the reflectance of each color. A black surface (completely absorptive as it does not contain color) does not produce a reflectance for a given LED wavelength, and thus the detector produces a low output reading value. A white surface produces the maximum reflectance of all three LEDs. Various colors (depending on its content in the surface being measured) produce outputs from the detector at various levels.

[0142] Such color sensor components may be configured as separate sensing components within the system or as a single component that detects both the development and color separation on the test strip, depending on the sensor used to read the test strip results. In various examples, the assay can be coded by the color that defines the test being performed. For example, red can indicate a test strip used to detect beta-lactam antibiotics. Various matrices can also be drawn by color systems. In the example of red, after the system detects red on the test strip, the reader and / or incubator can be automatically configured for that particular assay 21, for example, by adjusting the temperature of the incubator and selecting the appropriate reflectance test parameters within the reader. Thus, in some embodiments, the system may be an integrated diagnostic test unit triggered by a specific reference coding on the assay.

[0143] In other examples, the coding reference may include a radio frequency identification (RFID) tag. Such radio frequency signals transmit a signal from the tag to a decoded RFID sensor module. This signal can be used to initiate analysis test sequences, events, channels, temperatures, etc. within the reader and / or incubator. Similarly, the reference coding may be a barcode, which is placed on the assay, and the barcode reader decodes the reference coding and associated test sequence information.

[0144] In certain examples of the closed test position, heating elements, incubators, etc. can incubate the assay 21 within the incubation environment. For example, an incubator can heat and / or cool the assay 21 to provide an appropriate incubation environment for the corresponding assay and diagnostic test. Typically, the incubator is in communication with the cavity and can maintain a constant temperature within the cavity by heating or cooling at a predetermined rate. In some examples, the incubator includes an insulating base. In other examples, the incubator incubates a removable assay module as described below. The incubator may be a temperature-adjustable incubator. In these examples, the temperature-adjustable incubator can include a temperature control unit. In further embodiments, the temperature-adjustable incubator may allow for local temperature variations.

[0145] The incubator can include a heater. The heater may be a ceramic heater, a resistive heating element, etc. In a specific example, the cavity is designed to be small so that the heater only draws a minimal current. In this way, only the essential areas are heated, and by providing insulation around those areas, the power requirements are minimized. The use of various heating algorithms can be useful. For example, proportional-integral-derivative (PID) can be used. In other examples, the incubator can compensate for local temperature variations from a selected target temperature, such as the target temperature according to a corresponding test sequence. The incubator can also compensate for local temperature variations by an analog proportional control circuit. In other examples, the incubator can also compensate for local temperature variations by a digital control circuit, for example, by utilizing a PID algorithm or a PID controller. Further, those skilled in the art will recognize that PI, PD, P, or I controllers, and / or algorithms do not exclude any of the inventions herein. For example, a temperature-adjustable incubator can include a digital control potentiometer that allows a microprocessor to select the temperature. In other examples, the algorithm is particularly useful when the test results are affected by minor temperature variations. Embodiments include an incubator control system that eliminates the need for manual adjustment by using an integrated digital temperature sensor and a digital potentiometer that provide both accurate temperature reporting and a mechanism by which a microcontroller can adjust a stand-alone analog incubator control circuit. In a specific embodiment shown in FIG. 7a, for example, an integrated heater 708 with a temperature fuse and a temperature sensor can incubate an assay in any of the incubation environments shown and described herein.

[0146] In further embodiments, cooling can be advantageous, for example, to lower the incubation environment temperature to stabilize the environment of the test medium and / or sample prior to incubation.

[0147] In certain examples, the test strip 21 can include a first end having a sample absorption material. Further, the test strip 21 can have a release strip 50 for introducing the sample onto the sample absorption material. The release strip 50 can include a release tab at one end of the release strip 50 to facilitate moving the release strip 50. The sample absorption material 50 can be sized to receive from about 0.1 to about 1.0 mL of fluid and can be adapted accordingly. Further, the sample absorption material can be composed of a dry cellulose material. The sample absorption material can be planar or non-planar. Other embodiments include other materials for the sample absorption material.

[0148] Typically, the assay 21 also includes an opposing second end having a reactant detection material. The assay 21 can support a release region having a mobile phase receptor for at least one analyte. Typically, the assay 21 is adapted to select for the detection of a diagnostic test group selected from antibiotic analytes, toxic analytes, analyte classes, combinations thereof, and the like.

[0149] In certain embodiments, the optical detector is positioned in alignment with the assay in the optical path and is adapted to acquire image detection on the assay and is performing continuous image detection acquisition of the assay. In one particular embodiment shown in FIG. 7a, the housing 508 can support a camera 706 supported, for example, on a camera ribbon from a substrate. Further, any illumination device, such as the light bar 710 shown in FIG. 7a, for example, can improve the imaging of the assay. The light level detector 706 can detect the internal illumination level during operation and trigger, for example, feedback to maintain consistent illumination for the assay, enhance imaging, and / or minimize the occurrence of unwanted shadows. Unexpectedly, the Applicants have discovered that by adding a wall base and a white reflective material adjacent to the imaging device, the occurrence of unwanted shadows is further minimized and any of the tests shown and described herein are improved.

[0150] The sensor may be a single camera, multiple cameras, a single photodiode, multiple photodiodes, a linear photodiode array, a charge-coupled device, a complementary metal-oxide semiconductor, and combinations thereof. Thus, during and simultaneously with incubation and flow, or before or after incubation and flow are completed, the optical sensor monitors the assay, compares optical readings such as reflectance and / or transmittance readings, and determines various aspects including sample flow, interference with the optical path due to debris in the optical path, line development, and test results. When the assay and line development fall within pre-set parameters, the test can continue until completion and provide a final result. Checking the assay by the optical sensor before test completion can provide the user with additional confidence that the test was properly processed.

[0151] In certain embodiments, the output may be a voltage, current, or digital output proportional to the light intensity determined by a signal conditioning circuit. Some examples of reading devices include the TSL12T and TSL13T sensors available from TAOS (Texas Advanced Optolectronic Solutions). The TSL12T and TSL13T sensors are highly integrated, cost-optimized, light-to-voltage optical sensors, each combining a photodiode and a transimpedance amplifier (feedback resistances = 80 MΩ and 20 MΩ respectively) on a single monolithic integrated circuit. The active area of the photodiode is 0.5 mm × 0.5 mm, and the sensor responds to light in the range of 320 nm to 1050 nm. The output voltage is linear with respect to the light intensity (irradiance) incident on the sensor over a wide dynamic range.

[0152] In some examples, the microprocessor can communicate with an optical detector, particularly a sensor. In other examples, the optical detector outputs to other logic means. Further, the microprocessor can be adapted to signal the optical detector to perform serial imaging detection of an assay to generate diagnostic test results. The microprocessor may include, or be associated with, memory for storing information corresponding to imaging parameters. The memory can include instructions for monitoring pre-assay analysis of the assay and generating diagnostic test results of the assay.

[0153] As discussed herein, in some embodiments having an assay with a coding reference, the optical detector can have decoding capabilities to decode the reference code on the assay. Thereby, the decoding sensor can thereby activate the corresponding diagnostic test within the reading device. For example, the decoding sensor can activate the corresponding channel within a multi-channel reader and / or activate the corresponding incubation temperature profile within an incubator.

[0154] The decoding sensor may be a color sensor. For example, the color sensor may be a photodiode having sensitivity to wavelengths selected from red, blue, green, and combinations thereof. In such an example, the color reading an array of photodiodes each having a specific color filter is used as the decoding sensor and a white LED (providing light over a broad spectrum through three bandwidths (red, green and blue)) is used as the light source. When the LED is turned on, the output from each photodiode is acquired to determine the reflectance of that particular color. The decoding sensor may also be an RFID reader or a barcode reader.

[0155] Although this specification often refers to a light reflectance and a light reflectance reader, various readers can be usefully utilized, including, for example, a transmittance reader, a fluorometer, a photometer, a barcode reader, a radiation detector (such as a scintillation counter), a UV detector, an infrared detector, an electrochemical detector, or an optical reader such as a spectrophotometer, and a charge-coupled device (CCD) or a complementary metal-oxide semiconductor (CMOS) can be used as an image sensor. The light reflectance reader can be programmed to analyze test strips by two-dimensional readings rather than one-dimensional 1×128 readings. This can be, for example, a 5×128 or 512×492 matrix of "pixels". Such two-dimensional readings expand the reflectance capture area to directly capture the reflectance from the side of the test strip.

[0156] In other examples, a transmittance reader, such as ultraviolet-visible-near-infrared (UV-Vis-NIR) spectroscopy, can enable characterization of the absorption, transmission, and / or reflection of an assay. For example, such an analytical technique can measure the amount of light absorbed by an assay at a given wavelength. One of ordinary skill in the art will understand that a molecule or a portion of a molecule can be excited by absorption. Typically, organic chromophores that strongly absorb within the UV or visible portion of the spectrum almost always contain multiple bonds such as C=C, C=O, or C=N. This molecular excitation energy can be dissipated as heat, such as kinetic energy, when the excited molecule collides with another molecule, such as 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, the excited molecule can hold any one of a set of discrete energy amounts, as described, for example, by the laws of quantum mechanics. In the examples of this specification, the major energy levels are primarily determined by the possible spatial distribution of electrons and, to a lesser extent, can be determined by the vibrational energy levels arising from the various vibrational modes of the molecule.

[0157] Accordingly, in certain examples herein, absorbance measurements can be determined by the concentration of the solute in the assay. For example, a spectrophotometer within a reader device can be used to track the progress of such a chemical reaction to measure the concentration of either the reactant or the product over time. In other examples, transmission spectroscopy can be used for sampling solids, liquids, and gases. Typically, light passes through the assay and is compared to the light that did not pass through. The resulting spectrum can depend on the path length or sample thickness, 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.

[0158] Furthermore, the sensor can monitor the flow development along the assay 21 to evaluate whether an inappropriate sample volume was applied to the assay 21 or whether an excessive volume was applied. For example, prior to determining the test result, the sensor can monitor the flow progress on the assay 21 along the flow line 44. In other examples, the sensor monitors the flow progress at the flow line 44 and also along the assay, for example, at the intermediate flow line 46. The sensor can be configured to detect whether an appropriate flow of reagent occurred on the assay 21 while the assay 21 was within the cavity and / or whether one or more lines, i.e., reflectivity or transmittance values, were present on the assay 21 prior to contacting the assay 21 with the sample to be tested.

[0159] Certain embodiments include configuring a lateral flow assay system to enable simultaneous incubation and reading of assay 21. This combination enables the use of sensors not only to detect test results, but also to check for parameters that can indicate whether flow has occurred on the assay and whether such flow has caused appropriate test results. That is, a sample containing one or more potential analytes of interest is flowing in the form of assay 21, and the assay is incubated while binding is occurring within the mobile phase and on assay 21. By combining a reading device and an incubator in such an integrated diagnostic unit, results can be achieved more quickly than when an assay, such as a test strip or other test medium, is incubated within one device and then transferred to a separate device for reading. For example, the speed to result can be improved to, for example, less than about 60 seconds, or even less than about 30 seconds. Generally, such a composite system can dynamically detect changes in the assay as they occur by looking for areas where reflectivity and / or transmittance has decreased somewhere in the unused or not fully developed assay.

[0160] A certain level of protection is provided to prevent the previously run assay from being read (e.g., the reading device determines whether line development in the flow line 44, intermediate flow line 44, test line 40 and / or control line 42 has occurred prior to the sample flow reaching such lines), and to prevent false readings caused by debris or similar interference with the system optics.

[0161] Various triggers can initiate an assay analysis of any of the systems and assemblies herein. For example, a test strip package can be inserted into holder 500, and a sample can be pipetted (or otherwise delivered) into the sample well. Insertion into holder 500 can trip a proximity switch that blocks the path of an optical interrupter, for example, to trigger an incubation time or a read operation as shown and described herein. Further, as introduced herein, if the reading device does not detect an appropriate flow, the reading device can trigger an interruption of the test sequence and, in certain instances, deliver an error message.

[0162] If Assay 21 is properly detected, any read sequence shown and described herein can be initiated. For example, optical measurements, such as detecting light reflected from Assay 21, can utilize values such as an average reflectance value in a particular region of Assay 21. First, the system can analyze the assay to determine whether there is interference from debris or the like in the optical path. Debris can be at any number of positions within the optical path, including on Assay 21 or the assay container. Concurrent with or subsequent to the analysis of the optical path for debris, the system can analyze the assay to determine whether line development has already occurred. That is, whether an appropriate assay has been inserted into the cavity. For example, a test strip configured to develop within a particular region, such as test lines and control lines, should not develop within those regions before the analyte and mobile phase have had sufficient time to reach them.

[0163] In some examples, lines configured to develop a change in reflectance and / or transmittance when in contact with a reagent and a sample should not develop until the sample and reagent flows have reached and binding has occurred. The flow has not reached during an initial read, for example, for about 3 seconds. Thus, if line development is detected during an initial assay analysis, an error message can be delivered to the user and further reads, for example, further optical measurements can be aborted. In this way, this mechanism can detect the use of a previously run (known negative) assay or a previously marked assay. Generally, if the reflectance decreases on an unused assay, either due to the presence of line development or some other darkening of the assay away from the baseline, the decrease in reflectance can inform the user that something has occurred either in the assay or in the optical path, and thus the result should not be acceptable.

[0164] Once it is determined that the first optical reading is satisfactory and appropriate reader device parameters and incubator temperature have been selected either manually or automatically, further optical readings, for example, an optical reading about 15 seconds after the sample has been applied, can be used to determine whether an appropriate flow has occurred. For example, the optical reading can determine whether the reagent has flowed between the sample application area and a downstream line such as a test line.

[0165] The presence of labeled colored particles flowing in the mobile phase, such as gold sol beads, and the resulting assay-based change in reflectance between the sample application area and the first test line can inform the user that flow is occurring and return an error message if no flow is detected. Assays lacking a predictable change in reflectance may indicate no or insufficient sample flow. Certain measurements can also indicate whether excessive flow has occurred, such as when an excessive volume of sample is applied to the test strip and any possible reflectance changes due to the reagent are overwhelmed by the excessive sample volume. The change in reflectance between the sample application area and the result detection areas, such as test lines and control lines, is transient and can disappear as the mobile phase flows. Such transient / non-permanent changes can be detected when optical measurements are made.

[0166] If an assay, including a test strip or other type of assay, passes the pre-read, the system can initiate the read to generate test results. For example, after about 30 seconds, the analysis of the test line and control line can be started. If there is a sufficient difference between the test and the control, such as a percent reflectance difference, the result can be provided. Typically, negative and more extreme results can be provided more quickly, while results near the threshold level take longer. For example, in a test where the reflectance value on the test line is inversely proportional to the amount of analyte, a negative result can be determined when the reflectance of the test line drops to a certain level. In some examples, if hood 2 is opened while the reader is reading the assay, the signal can generate a no-result response.

[0167] The reader and / or incubator can be powered by a power source. For example, in some examples of on-site analysis in harsh environments, the power source can be a vehicle battery. Additionally, the footprint of the reader is smaller than many conventional systems for enhanced use and communication with in-vehicle systems, for example, for enhanced efficient testing during batch pick-up, delivery, etc.

[0168] In certain embodiments, software applications, instrumentation, systems, and assemblies can use data communication exchanges, including adapters such as Bluetooth® interfaces, widely used telephones, and similar personal device technologies, to enable real-time data collection of test data, including but not limited to in-field data. For example, one device relay embodiment can include generating test results for any one or more of the test device readers shown and described herein, communicating the test results to a partner device module, and relaying the test result output to an external host module. Further, any of the test device readers herein can interface directly with an external storage configuration. In a particular example, the partner device is a smartphone, although other partner devices may include tablets, general purpose computers, PDAs, digital media players, digital cameras, wireless information devices, and the like.

[0169] The partner device can connect to the external storage configuration in various modes. In remote access mode, the partner device links to available test devices, enabling the system to deliver test data to the external storage configuration. The partner device can have an indicator that provides a pairing signal when activated, and the indicator provides a visual indication of the pairing to the test device reader.

[0170] In certain embodiments, the partner device is engaged in local data communication with one or more test devices, such as wireless Bluetooth® transmission / reception. Further, the partner device is engaged in host exchange communication with an external host, including any mobile communication technology such as Wi-Fi, 3G / 4G / 5G connections. In certain modules, the test device interfaces with a mobile partner device having a corresponding data communication interface, thereby establishing effective, i.e., approved, authorized, and / or available, data communication with the test device. In a particular example, the module can include causing an application on the partner device, such as a downloadable program application, to interface with the test device. Further, the module can include establishing data communication exchange of result output between the test device and the partner device. Still further, the module can include establishing secondary messaging data communication, including, but not limited to, secondary message exchange between the test device and the partner device, such as email, text, etc.

[0171] Typically, the partner device relays the result output to an external storage configuration. In a particular example, relaying to an external storage configuration includes sending to a remote host website. In other examples, relaying to an external storage device includes sending to a remote host server. In still other examples, relaying to an external storage device includes sending to two or more host providers for data storage and management.

[0172] In certain embodiments, the test instrument interfaces with a mobile partner device having a corresponding data communication interface, thereby establishing valid, i.e., approved, authorized, and / or available data communication with the test instrument. In a particular example, the module can include causing an application on the partner device, such as a downloadable program application, to interface with the test instrument. Further, the module can include establishing a data communication exchange of result output between the test instrument and the partner device. Still further, the module can include establishing secondary messaging data communication, including, but not limited to, secondary message exchange between the test instrument and the partner device, such as email, text, etc. The partner device can relay the result output to an external storage configuration. In a particular example, relaying to an external storage configuration includes transmitting to a remote host website. In another example, relaying to an external storage device includes transmitting to a remote host server. In yet another example, relaying to an external storage device includes transmitting to two or more host providers for data storage and management.

[0173] Specific methods for analyte analysis include incubating an assay, including any of the embodiments shown or described above, and reading the assay to generate test results, including any of the embodiments shown or described above. In a specific example, a diagnostic test method for detecting an analyte in a test sample is adding the test sample to a test medium, such as a lateral flow test strip, to create an assay, where the test medium is configured to provide a detectable test result after incubation with the test sample, adding, enclosing the test medium within a hood, where the hood is configured to enclose a cavity, the cavity is configured to receive the test medium and is connected to a temperature control source that can maintain a constant temperature, enclosing, positioning a sensor, such as an optical sensor capable of reading reflectance, relative to the test medium such that changes on the test medium are detectable by the sensor, and activating the sensor, such as by closing the hood, such that the sensor compares the test medium to a preset parameter. If the test medium is not within the preset parameters, no test result is provided, and if the test medium is within the preset parameters, a test result is determined from the test medium, and the test result indicates whether an analyte has been detected in the test sample.

[0174] In other embodiments of the method, preset parameters can be used to determine whether an appropriate flow of reagents has occurred on the test strip while the test strip is within the cavity and / or whether one or more test lines are present on the test strip prior to contact with the test sample. To do so, the sensor can be configured to continuously analyze changes on the test medium until a test result occurs. The test result can be determined by comparison between changes, such as changes in reflectance, at a first line, such as a test line, and a second line, such as a control line, on the test strip.

[0175] In certain embodiments, an apparatus that generates test results from an assay when in contact with a sample includes an incubator adapted to incubate the assay and an optical detector adapted to detect a first transmission of light occurring on the assay and adapted to detect at least subsequent transmissions of light occurring on the assay, wherein incubation of the assay and detection of light transmission on the assay generate the test results.

[0176] In certain embodiments, in an incubated apparatus that generates test results from an assay when in contact with a sample, the reading device includes an optical detector adapted to image a first transmission of light on the assay and adapted to image a plurality of subsequent transmissions of light on the assay, wherein incubation of the assay and imaging of light transmission on the assay generate the test results.

[0177] In certain embodiments, an in-vehicle system that generates test results from an antibiotic analyte assay includes an optical detector reading device that communicates with a vehicle microprocessor assembly to synchronize the transmission of light on the analyte assay with the development of test results in an in-vehicle test environment when in contact with a sample.

[0178] In certain embodiments, an in-vehicle system that generates antibiotic test results from an antibiotic analyte assay, the system comprising an optical detector reading device that communicates test results with a vehicle assembly to detect the transmission of light on the antibiotic analyte assay when in contact with a sample to generate the antibiotic test results.

[0179] In certain embodiments, an in-vehicle system that generates antibiotic test results from an antibiotic analyte assay, the system comprising an optical detector reading device that communicates test results with a vehicle assembly to synchronize the progress of antibiotic test result development with light detection when in contact with a sample within an in-vehicle test environment.

[0180] Further examples of the method include using pre-set parameters to compare the test strip to the actual strip on which the sample flows, including before sample application. For example, a blank strip before the flow of reagent or before sample deposition has a theoretical reflectance profile within a predictable range. If an area of reduced reflectance not resulting from the flow of sample / reagent on the strip is detected, not only may something adverse have occurred with the test strip, but the optical path may be contaminated and may require cleaning. Such contamination can be on the strip or within the reading device. Generally, an unused test strip should not have an area of reduced reflectance. Any such area may indicate a problem, such as dirt / debris, use of a previously run test strip, etc. In either case, the test results may not be valid.

[0181] With the details of the structure and function, a number of features and advantages are described in the foregoing description. Many of the novel features are pointed out in the appended claims. However, the present disclosure is merely exemplary, and within the scope of the principles of the present disclosure, changes can be made in detail, particularly in terms of the shape, size, and arrangement of the components, up to the broadest scope indicated by the broad general meaning of the terms in which the overall claims are expressed. It should be further noted that, as used in this application, the singular forms "a", "an", and "the" include plural referents unless explicitly and specifically limited to one referent.

Claims

1. An optical module within an apparatus for generating test results from a test strip, comprising: a. A frame adapted to receive the test strip and provide a non-planar position for the test strip, the frame including a lower platform adapted to receive a portion of the test strip and an upper platform adapted to receive another portion of the test strip, the upper platform being angled about the lower platform adapted to receive a portion of the test strip; b. A base supporting the positioning of the frame to provide the non-planar position; c. An optical system aperture positioned around the frame, the optical system aperture enabling light to be directed at the test strip. An optical module comprising the above.

2. The optical module according to claim 1, wherein the frame is adapted to align portions of the test strip.

3. The optical module according to claim 1, wherein the upper platform is aligned around the lower platform about a pivot point.

4. The optical module according to claim 1, wherein the frame receives a portion of the test strip at a first substantially planar entry position.

5. The optical module according to claim 4, wherein the frame aligns a portion of the test strip at a second substantially non-planar test position for generating the test results.

6. The optical module according to claim 1, wherein the optical module is adapted to image the test strip adjacent to a bend around the test strip at a test position for generating the test results.

7. An apparatus for generating test results from a test strip when in contact with a sample, comprising: a. The optical module according to any one of claims 1 to 6; b. An incubator adapted to incubate the test strip; c. An optical detector adapted to image the test strip. An apparatus comprising the above.

8. The apparatus according to claim 7, wherein the optical module is adapted to align a portion of the test strip protruding around the optical module.

9. The apparatus according to claim 7, wherein the optical module includes a substantially planar portion and an opposing substantially non-planar portion.

10. The apparatus according to claim 9, wherein the planar portion and the non-planar portion define a non-planar flow path around the test strip at a test position where the test result is generated.

11. The apparatus according to claim 9, wherein the planar portion and the non-planar portion define a raised flow path around the test strip at a test position where the test result is generated.

12. The apparatus according to claim 9, wherein the non-planar portion forms an angle of about 10 degrees to about 30 degrees with the planar portion.

13. The apparatus according to claim 12, wherein the non-planar portion forms an angle of about 20 degrees with the planar portion.

14. The apparatus according to claim 7, wherein the optical module includes a bent portion that is positionally aligned between the non-planar portion facing the planar portion.

15. The apparatus according to claim 7, including an aperture carrier.

16. The apparatus according to claim 7, wherein the optical module includes a switch.

17. The switch according to claim 16 is adapted to block the path of the optical interrupter to trigger at least one state selected from the group consisting of incubation, detection of light transmission around the test strip, and imaging on the test strip.

18. The apparatus according to claim 7 is adapted to perform at least one image detection of the test strip.

19. The apparatus according to claim 7, wherein the optical detector monitors a theoretical reflectance value after receiving at least one image detection of the test strip.

20. A modular interface within an apparatus for generating a test result from a test strip, an optical module according to any one of claims 1 to 6 comprising a modular interface.

Images