Optical module

Abstract

An optical module (100) for reading a test area of ​​a laboratory test. The optical module includes: a first light source (101) for illuminating the test area of ​​the laboratory test; an optical detector (103) including an optical input terminal and an electrical output terminal for receiving light emitted from the test area; a substrate (104) for mounting the first light source (101) and the optical detector (103); and a housing (105) including: a first opening (106) for providing a first optical path from the first light source (101) to the test area (103); wherein the housing (105) and the substrate (104) enclose the first light source (101) and the optical detector (103) and are aligned with the positions of the first light source (101) and the optical detector (103) relative to the first opening (106). The housing (105) may include one or more legs (108) that engage with the housing (105) to the substrate (104) by snap-fit ​​and extend vertically from the first and / or second outer surfaces of the housing (105).

Description

Technical Field

[0001] This invention relates to laboratory readers, and more particularly, but not limited to, optical modules for laboratory readers. Background Technology

[0002] One of three methods is typically used to identify diseases.

[0003] The first approach is central laboratory analysis, in which samples are collected and sent to a central laboratory for thorough analysis using expensive, large-scale, high-throughput equipment. The second approach is point-of-care testing using one of many different technology platforms, such as microfluidic-based testing, where appropriate expert diagnostic equipment is provided at the site, such as in a hospital. The third approach is point-of-care testing using lateral flow testing technology.

[0004] Sideflow technology is based on a series of capillary beds, such as porous paper, microstructured polymers, or sintered polymers. Each of these elements has the ability to spontaneously transport fluids (e.g., urine). The first element (sample pad) acts as a sponge to hold excess sample liquid. As the first element is wetted, the fluid migrates to the second element (conjugation pad), in which the manufacturer stores so-called conjugates, i.e., in the form of dried bioactive particles in a salt-sugar matrix containing everything that ensures an optimized chemical reaction between the target molecule (e.g., antigen) and a chemical chaperone (e.g., antibody) already immobilized on the surface of the particle. As the sample fluid dissolves the salt-sugar matrix, it also moves the particles, and, in this combined transport action, the sample and conjugates mix as they flow through the porous structure. In this way, the analyte binds to the particles while simultaneously migrating further through a third capillary bed. This material has one or more regions (often called strips or lines) in which the manufacturer has immobilized a third molecule. When the sample-conjugate mixture reaches these strips, the analyte is already bound to the particles, and the third "capture" molecule binds to the complex. Over time, as more and more liquid passes through the strip, particles accumulate, and the strip area changes color. Typically, there are at least two regions:

[0005] 1. A region (control) captures any particles to indicate that the reaction conditions and techniques are working well; typically, a test line appears on the test strip before the control line.

[0006] 2. The second region (test) contains specific capture molecules and only captures particles on which the analyte molecules are already immobilized. This makes the diagnostic results of the test visible.

[0007] After passing through these reaction zones, the fluid enters the final porous material, namely the absorbent core, which serves solely as a waste container and also helps control the flow rate. Multiple test lines can also be arranged adjacent to each other, with the last line on the test strip serving as a control line.

[0008] There are typically three types of sideflow tests.

[0009] Type 1: Sideflow test without any electronic devices. Users visually "read" color changes, receiving a "yes / no" answer. These types of sideflow tests are not suitable for diagnostic tests requiring quantitative analysis. Quantitative measurement is crucial for the identification of many diseases, and these qualitative "yes / no" tests are generally unsuitable for quantitative diagnostic testing.

[0010] The second type: Sideflow testing using external optical readings. This type of testing supports higher levels of quantification and sensitivity. Specifically, quantitative measurements typically use imaging techniques (e.g., fluorescence, luminescence, absorption, and / or reflectance imaging) to image the test area of ​​the sideflow strip, determining the quantification value based on the intensity of the color change in the test area in the simplest case. However, this type of sideflow testing requires an external reading device, such as a desktop reading device. Furthermore, an external device means that the distance between the quantified color change and the detector is typically large, for example, approximately greater than 5-10 cm. Increased distance between the quantified color change and the detector leads to a decrease in signal strength.

[0011] The third method involves lateral current testing using, for example, light sources and detectors assembled on a printed circuit board. One advantage of this reading system is its quantizability and ability to improve sensitivity without requiring external detector hardware. However, this approach utilizes discrete components such as LEDs, photodiodes, and various structural parts assembled by a pick-and-place mechanism. Typically, these components are held in place by glue and / or solder. This is described in WO / 2020 / 049066 and... Figure 1f An example of such a component is shown. One problem with this type of component is that the part may shift in an uncontrolled manner due to the reflow of solder or adhesive at high temperatures applied in one or more manufacturing steps. This problem can be particularly pronounced for larger structural components, such as housings that are heavier than other parts of the component and therefore more susceptible to reflow misalignment. For example, in the component described in WO / 2020 / 049066, this may occur... Figure 1f The shell 112 in the middle surrounds them Figure 1fTranslation and / or rotation of the printed circuit board 113 in the sample. This unpredictable misalignment results in less reliable quantitative measurements provided by such an assembly. For example, a weak detection signal from the test line might characterize a low analyte concentration in the sample, or it could be a result of misalignment. Therefore, such an assembly may be inaccurate and may cause unpredictable variations in quantitative measurements, thus reducing reproducibility and accuracy.

[0012] Despite the aforementioned challenges, lateral flow technology is cheaper and easier to scale than central laboratory methods and other field testing methods, partly because the raw materials, reagents, and equipment it relies on are more readily available and easier to mass-produce. Furthermore, if decentralized testing, or even testing performed by patients themselves, can be achieved, it can reduce the logistical costs and waiting times associated with transporting samples to centralized testing facilities.

[0013] Therefore, the purpose of this disclosure is to solve one or more of the above-mentioned problems, or at least to provide a useful alternative. Summary of the Invention

[0014] In general, this disclosure proposes to overcome the above-mentioned problems by providing an optical module, for example for a lateral flow test reader device, having an imaging component integrated and / or mounted on a substrate, and aligned with a housing that encloses the optical module and has one or more openings through which an image of the test area can be imaged. The housing may have shaped surfaces to receive the substrate and / or legs mating and engaging with the substrate in the alignment position, thereby securing the housing (especially the openings therein) relative to the substrate and the imaging components (e.g., a light source and a detector) thereon.

[0015] The housing is placed on the surface of the printed circuit board and secured with solder, glue, and / or other unsupported methods to minimize movement caused by backflow (e.g., as shown in the image). Figure 1f Unlike the assembly shown, the shaped surfaces and / or legs provide a mating engagement between the substrate and the housing. In this way, even in the event of reflow, any movement of the heavier housing relative to the substrate and the imaging components thereon is minimized. As a result, for example, compared to the assembly described in WO / 2020 / 049066, misalignment between the imaging components and one or more openings in the housing is minimized, and the accuracy and reliability of measurements performed by this module are improved.

[0016] Therefore, by integrating components onto a substrate having a mating engagement with the housing, which aligns the substrate and the components mounted on it with the housing (especially with the opening in the housing) in a manner unaffected by backflow issues, a miniaturized, pre-calibrated optical module is provided. This module can be integrated as a single unit onto the printed circuit board of a lateral flow test reader device (i.e., an optional but not mandatory printed circuit board other than the substrate on which imaging components are mounted and / or integrated). By minimizing the risk of misalignment in this way, manufacturing variability between the optical modules of this disclosure is significantly reduced, thus enabling the provision of accurate, quantitative, and reproducible lateral flow test results, and facilitating mass production suitable for global scale.

[0017] As mentioned above, one reason for the aforementioned problems with sideflow technology is that imaging components (such as light sources and detectors) and housings are assembled onto a printed circuit board by a pick-and-place machine and secured with solder and / or glue. During the remainder of the manufacturing process, temperature variations cause the solder and / or glue to partially liquefy and flow. This is called reflow, which can lead to component misalignment. Furthermore, since the housing may be one of the larger and heavier components, reflow misalignment can be significant, as the weight of the housing can cause significant translation and / or rotation over the liquefied solder and / or glue. Therefore, even if components are initially placed and secured precisely by the pick-and-place machine, they can become misaligned at the end of the manufacturing process due to reflow issues. In this case, the light signal intensity and quality will vary depending on the extent to which reflow affects the positional alignment, which is difficult to control consistently and reliably.

[0018] In contrast, the present invention overcomes this problem by providing shaped surfaces (e.g., within or on one or more walls of the housing and / or on legs extending from the housing) to provide the desired positional alignment and limit subsequent relative movement. Specifically, the mating engagement between the shaped surfaces and / or legs and the substrate minimizes the amount of movement of the housing relative to the substrate during reflow, thereby reducing the overall misalignment experienced by the optical module. In this way, consistent and reproducible alignment between the imaging components and the openings in the housing is achieved. Consequently, the resulting optical measurements are also more consistent, meaning reduced measurement variability between batches of the optical modules of this disclosure, making calibration easier.

[0019] According to a first aspect of this disclosure, an optical module for reading a test area of ​​an assay is provided. The optical module includes: a first light source for illuminating the test area of ​​the assay; an optical detector including a light input terminal and an electrical output terminal for receiving light emitted from the test area of ​​the assay; a substrate for mounting the first light source and the optical detector; and a housing including: a first opening for providing a first optical path from the first light source to the test area and from the test area to the optical detector; wherein the housing and the substrate enclose the first light source and the optical detector, and are aligned with the positions of the first light source and the optical detector relative to the first opening.

[0020] Advantageously, providing a housing as part of the optical module and thereby achieving proper alignment of the optical module components ensures that the optical module always returns reproducible results.

[0021] One or more walls of the housing may include shaped surfaces configured to receive the substrate at a predetermined location to provide the aforementioned positional alignment. Advantageously, this provides precise positional alignment and / or fixation of the substrate (on which the imaging components are mounted) to the housing of the optical module (which has one or more openings formed therein). Specifically, the shaped surfaces provide more precise alignment compared to mounting the housing onto the substrate without shaped surfaces to guide its alignment and minimize and / or prevent substrate movement due to reflow, etc., during manufacturing. The shaped surfaces may include one or more steps, slots, and / or ramps located on one or more surfaces of the walls of the housing.

[0022] The housing may include one or more legs extending from the outer surface of the housing, such that the legs extend vertically beyond the upper and / or lower surfaces of the substrate and / or housing. When one or more legs extend from the outer surface of the housing below, the legs may be configured to engage with one or more corresponding holes on the printed circuit board of the reader device to align the position of the optical module relative to the printed circuit board. For example, since the legs engage at the x / y positions of the corresponding holes, this allows control of in-plane x / y alignment on the surface of the printed circuit board, and / or since the legs engage to a certain depth of the corresponding holes, this allows control of z-axis alignment (i.e., how high or low the optical module is positioned within the housing of the reader device).

[0023] The printed circuit board of the diagnostic reader device is a substrate other than the substrate on which the light source and optical detector are mounted. The same technical effect can also be achieved using a reverse arrangement, whereby one or more legs extend from the printed circuit board, which can be received by holes in the housing. When one or more legs extend from the outer surface of the housing above the housing, these legs can be configured to mate with one or more corresponding holes, slots, and / or support structures in the housing of the diagnostic reader device to align the position of the optical module relative to the housing of the diagnostic reader device. For example, although the optical module is integrated with the optical module housing, the x, y, and z-axis alignment of the optical module in the housing of the diagnostic reader device can also be controlled by functioning as spacers. Similarly, the same technical effect can be achieved using a reverse arrangement, whereby one or more legs extend from the housing of the diagnostic reader device, which can be received by holes in the optical module housing. Or / or additionally, spacers can be provided on the optical module housing to abut against mating surfaces or spacers on the housing of the diagnostic reader device, thereby further controlling the z-axis alignment.

[0024] Advantageously, the one or more legs extending from the optical module housing improve the alignment of the optical module with other components of the analyzer device (e.g., the reader housing and / or the reader printed circuit board). For example, the printed circuit board of the reader device can be integrated with or fixed to the reader housing or its internal support structure, for example, using one or more screws and threads, glue, push-fit, and / or other fixing techniques. More advantageously, the use of legs extending above and below the optical module housing ensures that the optical module is simultaneously aligned with the printed circuit board of the analyzer device and the housing of the reader device in all x, y, and z directions.

[0025] Optionally, the one or more legs may include flexible hooks. These flexible hooks may be configured to secure the housing to the substrate via one or more corresponding holes in the substrate in a snap-fit ​​manner, thereby preventing relative movement between the substrate and the housing.

[0026] Advantageously, the snap-fit ​​engagement provided by the flexible hooks allows for the alignment and securing of the housing without the need for fasteners such as glue, screws, or threads, which can be difficult to control and / or pose a risk of housing misalignment.

[0027] Optionally, the substrate may include a printed circuit board of a laboratory reader device. Alternatively, the substrate does not necessarily have to be a printed circuit board of a laboratory reader device; it may be a separate substrate that can be placed on such a printed circuit board, thereby advantageously allowing the optical module to be manufactured and calibrated as a separate module, which can then be assembled onto a separate printed circuit board without the need for separate alignment and calibration.

[0028] Optionally, the one or more legs may also be configured to engage with one or more corresponding holes in the housing of the laboratory reader device.

[0029] Advantageously, this means that the legs not only align the optical module housing with the printed circuit board of the lab reader device, but also with the housing of the lab reader device simultaneously, without relying on other separate, non-integral alignment devices.

[0030] The optical module may include one or more first baffles, such as wall-like structures, located on a substrate between the optical detector and the first light source to block light from directly propagating from the first light source to the optical detector.

[0031] Beneficially, blocking direct light from the light source to the optical detector can reduce noise and signal drift in the detection signal.

[0032] The optical module may include a blocking portion located in the first optical path, the blocking portion being configured to block a portion of the light incident on or reflected from the test area, thereby reducing the intensity of the light received by the optical detector. Optionally, the blocking portion may be located between the inner surface of the housing and the one or more first baffles to block the central portion of the optical axis of the first optical path.

[0033] The light that causes the strongest specular reflection is located near the optical axis and is blocked. In contrast, the light that causes weaker specular reflection can reach the optical detector. Therefore, the advantage of this technique is that it improves the signal-to-noise ratio by preventing the optical detector from becoming saturated.

[0034] The optical module may include a second light source for illuminating a control area and / or another test area for analysis. This second light source may have an arrangement similar to the first light source; that is, the second light source may be mounted on a substrate, and the housing may include a second opening for providing a second optical path from the second light source to the control area and / or the other test area, and from there to an optical detector. Similarly, the housing and the substrate also enclose the second light source and align its position relative to the first and second openings in the housing and relative to the optical detector.

[0035] Advantageously, as in the case of the first light source, as described above, any misalignment of the housing and its openings relative to the imaging components is minimized (especially any misalignment of the second light source relative to other components).

[0036] The optical module may include one or more second baffles located on the inner surface of the housing between the first opening and the second opening to block light from propagating from the first light source to the control area and / or another area, and to block light from propagating from the second light source to the test area.

[0037] Beneficially, this reduces crosstalk in the detection signal. In particular, only light from one of the light sources illuminates each test area visible through the corresponding opening.

[0038] The first and second light sources and / or optical detectors can be encapsulated in a transparent molded polymer compound (e.g., a very thin transparent polymer film) and can provide a first optical path and / or a second optical path through the molded polymer compound.

[0039] Advantageously, this protects the light source and / or optical detector from dust, particles, fibers, and / or other contaminants that may enter the housing through the openings. Since the optical module includes its own housing, which, together with the substrate, provides a closed, protected space, neither the light source nor the optical detector requires separate protective caps (other than the transparent molding polymer compound).

[0040] The advantage is that this reduces the amount of material that light must pass through in the optical path, thereby reducing the amount of light attenuated and thus improving signal strength.

[0041] Alternatively, the first and second optical paths can be direct and uninterrupted. For example, this would involve molded compounds and caps that do not encapsulate / cover the light source and / or optical detector.

[0042] Beneficially, this further reduces the amount of material that light must pass through in the optical path, thereby reducing the amount of light attenuated and thus further improving signal strength. In particular, the presence of the cap and molding compound reduces signal strength, resulting in a performance reduction of approximately 74%. Therefore, omitting the cap and molding compound can lead to a corresponding improvement in signal strength and performance.

[0043] The dimensions of the device will depend on the dimensions of the test strips and the test and control lines. The overall dimensions can also be adjusted according to other factors such as user requirements. For example, a user with disabilities may prefer a device with a larger housing. Only some specific dimensions are provided here as examples. The height of the housing can be between 0.6 mm and 5.0 mm, preferably between 1.6 mm and 4.0 mm, and more preferably between 2.1 mm and 3.5 mm.

[0044] Advantageously, compared to sidestream readers using non-integrated external hardware, this allows the test area of ​​the read assay to be closer to the light source and optical detector, and improves signal strength compared to such readers. For example, the vertical distance between the optical detector and the first and / or second opening (if present) can be between 0.1 mm and 4.5 mm, preferably between 1.1 mm and 3.5 mm, and more preferably between 1.510 mm and 1.700 mm. In particular, by providing a lower height in this way, the distance between the optical detector of the optical module and the test strip is reduced compared to known devices, thereby providing higher signal strength.

[0045] The length of the first opening and / or the second opening can be between 2.5 mm and 6.5 mm, preferably 5 mm, and the width of the first opening and / or the second opening (if present) can be between 0.5 mm and 1.5 mm, preferably between 0.850 mm and 1.050 mm.

[0046] Beneficially, these dimensions reduce the amount of ambient light entering the opening, thereby reducing noise.

[0047] The optical module may include transparent material located on the first opening and / or the second opening.

[0048] Advantageously, this prevents dust, dirt, fibers, and / or other particles from entering the space enclosed by the housing, thereby protecting the components and preventing unwanted noise from these particles in the optical path within the housing. Furthermore, the transparent material provides a seal between the space enclosed by the housing and substrate and the space outside. This seal enhances protection and also waterproofs the optical module by preventing moisture from entering the enclosed space.

[0049] A portion of the housing may include a transparent material having an opaque material on its surface, and the first opening and / or the second opening may include gaps in the opaque material.

[0050] Advantageously, this allows the opening to be inherently sealed to prevent dust, dirt, fibers and / or other particles from entering the space enclosed by the housing.

[0051] The transparent material mentioned above may include glass or plastic sheets and / or a transparent filler material that at least partially fills the space enclosed by the module. The housing may preferably include a matte black material.

[0052] The optical module may include an electrical signal processor electrically coupled to the electrical output of the optical detector to process the electrical signal output by the optical detector. The electrical signal processor may be mounted on a substrate, such that the electrical coupling is provided by one or more electrical connections on and / or integrated with the substrate, or it may be provided separately, such that the electrical coupling is provided, for example, by one or more wire bonding points, contacts, or other electrical connections through the substrate to the printed circuit board of the assay reader device.

[0053] The first light source, the optical detector, and the second light source (if present) and / or the electrical signal processor may be arranged adjacent to each other in a first planar arrangement, wherein the first opening and the second opening may be arranged in a second planar arrangement parallel to and facing the first plane.

[0054] Advantageously, this arrangement allows the imaging components to be mounted on the substrate in a manner that enables the provision of a first optical path and a second optical path (if present) without the presence of mirrors and / or other optical components.

[0055] The optical module may include multiple optical detectors and an electrical signal processor and / or a third light source arranged to illuminate multiple test areas of the assay. The third light source (if present) may have an arrangement similar to or corresponding to the first and second light sources described above.

[0056] The advantage is that this allows multiple test areas to be read simultaneously.

[0057] According to a second aspect of this disclosure, a laboratory reader device including the aforementioned optical module is provided. The laboratory reader device includes: a reader housing; and a printed circuit board disposed within the reader housing. The printed circuit board includes one or more first holes for receiving a portion of the housing of the optical module therein for aligning the optical module relative to the reader housing. The reader housing includes one or more second holes for receiving a portion of the housing of the optical module therein for aligning the optical module relative to the reader housing.

[0058] Advantageously, this provides a laboratory reader device that has the aforementioned advantages of the optical module.

[0059] The substrate of the optical module may include a printed circuit board of the assay reader device. The housing portion received in a first hole of the printed circuit board or a second hole of the reader housing may be a leg of the optical module.

[0060] Advantageously, this allows for precise alignment of the analyte (e.g., its test area and / or control area) with the opening in the housing of the optical module in the test reader device, ensuring accurate, consistent, and reproducible test results.

[0061] The assay reader device can be configured to receive a test strip for a lateral flow test therein, and the reader housing can include one or more spacers arranged on the inner surface of the reader housing and facing the optical module, with a first opening and / or a second opening (if present) in the housing. The one or more spacers are arranged to receive the test strip thereon. The housing may also include one or more bias arms arranged on the inner surface of the reader housing and configured to apply force to one or more ends of the test strip to tension the test strip on the one or more spacers, thereby aligning the test strip position relative to the optical module. This can be achieved, for example, by controlling the z-axis alignment (i.e., the height at which the test strip is held in place above the optical module).

[0062] Advantageously, tensioning the test strip to the spacer by applying force to one or more ends (i.e., thus keeping the test strip taut on the spacer) allows for precise control over the height of the test / control area on the test strip relative to the optical module. This, in turn, ensures consistent and accurate readings of the test strip. Conversely, if the test strip is not kept taut and the height of the test area changes, the accuracy and consistency of the readings may vary.

[0063] According to a third aspect of this disclosure, a method for manufacturing the aforementioned optical module is provided. The method includes: mounting a first light source and an optical detector including a light input terminal and an electrical output terminal on a substrate; enclosing the first light source and the optical detector using the substrate and a housing; and aligning the position of the first light source and the optical detector relative to a first opening in the housing by placing the substrate on a shaped surface of one or more walls of the housing and / or engaging legs of the housing with corresponding holes or slots in the substrate, the shaped surface being configured to receive the substrate at a predetermined position to achieve the position alignment.

[0064] Advantageously, this method ensures that the housing, substrate, and components mounted on the substrate are aligned and / or secured relative to each other (especially relative to openings in the housing) with greater precision than simply bonding the housing to the surface of the substrate. The shaped surface may optionally include one or more steps, slots, and / or ramps located on one or more surfaces of the housing walls. If the optical module includes a second and / or additional light source as described above, and the housing includes a second and / or additional opening, the alignment step also aligns the second and / or additional light source relative to the second and / or additional opening in the housing, thus providing the advantages described above. Attached Figure Description

[0065] These and other aspects of this disclosure will now be described by way of example only with reference to the accompanying drawings.

[0066] Figure 1a A first view of the optical module of this disclosure is shown.

[0067] Figure 1b It shows Figure 1a A cross-sectional view of the optical module.

[0068] Figure 1c It shows Figure 1a Another cross-sectional view of the optical module.

[0069] Figure 1d It shows Figure 1a A top view of the optical module.

[0070] Figure 1e Showing different sizes Figure 1a A cross-sectional view of the optical module.

[0071] Figure 1f A known optical module is shown.

[0072] Figure 2a A cross-sectional view of the optical module of this disclosure is shown.

[0073] Figure 2b A cross-sectional view of a portion of the housing of the optical module of this disclosure is shown.

[0074] Figure 3 A cross-sectional view of the optical module of this disclosure is shown.

[0075] Figure 4 A cross-sectional view of the optical module of this disclosure is shown.

[0076] Figure 5 An exploded view of the substrate, optical detector, and electrical signal processor of this disclosure is shown.

[0077] Figure 6 A top view of the optical module of this disclosure is shown.

[0078] Figure 7 A top view of the optical module of this disclosure is shown.

[0079] Figure 7a A schematic top view of the optical module of this disclosure is shown.

[0080] Figure 8a A cross-sectional view of the optical module of this disclosure is shown.

[0081] Figure 8b A cross-sectional view of the optical module of this disclosure is shown.

[0082] Figure 9 A cross-sectional view of the optical module of this disclosure is shown.

[0083] Figure 10 The laboratory reader device of this disclosure is shown.

[0084] Figure 11a The laboratory reader device of this disclosure is shown.

[0085] Figure 11b The laboratory reader device of this disclosure is shown.

[0086] Figure 12a The laboratory reader device of this disclosure is shown.

[0087] Figure 12b The laboratory reader device of this disclosure is shown.

[0088] Figure 13a The laboratory reader device of this disclosure is shown.

[0089] Figure 13b The laboratory reader device of this disclosure is shown.

[0090] Figure 14a The laboratory reader device of this disclosure is shown.

[0091] Figure 14b The laboratory reader device of this disclosure is shown.

[0092] Figures 15a-15c The assembly phase of the laboratory reader device of this disclosure is illustrated schematically.

[0093] Figure 15d The assembled Figures 15a-15c A cross-sectional view of the laboratory reader device.

[0094] Figure 15e A cross-sectional view of the housing of the analyzer device of this disclosure is schematically shown.

[0095] Figure 16 This is a flowchart of the method disclosed herein.

[0096] Figure 17 The layout of the spectral sensor disclosed herein is schematically shown.

[0097] Figure 18 A functional block diagram of the spectral sensor and electrical signal processor circuit of this disclosure is schematically shown.

[0098] Figure 19 A functional block diagram of the spectral sensor and electrical signal processor circuit of this disclosure is schematically shown.

[0099] Figure 20a A top view of the optical module of this disclosure is shown.

[0100] Figure 20b It shows Figure 20a A cross-sectional view of the optical module.

[0101] Figure 20c It shows Figure 20a A cross-sectional view of the deformable scheme of the optical module.

[0102] Figures 21a-21b A cross-sectional view of the optical module of this disclosure is shown.

[0103] Figure 22a This is a vertical cross-sectional view of the optical module.

[0104] Figure 22b This is a top view of the optical module.

[0105] Figure 23a This is a vertical cross-sectional view of the optical module.

[0106] Figure 23b This is a vertical cross-sectional view of the optical module.

[0107] Figures 24a to 24d These are views of the optical module components at different assembly stages. Detailed Implementation

[0108] As described above, this disclosure provides an optical module, for example, for a lateral flow test reader device, having an imaging component integrated on a substrate and aligned with a housing that encloses the optical module and has one or more openings through which an image of the test area can be imaged. By integrating the component on the substrate and aligning the substrate and the component mounted on the substrate with the housing (especially with one or more openings in the housing), a miniaturized, pre-calibrated optical module is provided. This module can be integrated as a single unit onto the printed circuit board of a lateral flow test reader device without requiring independent, manual alignment of all components during the assembly of the lateral flow test reader device. The shaped surfaces of this disclosure ensure minimal movement of the housing relative to the substrate of the optical module itself (e.g., movement caused by reflow). Therefore, this module helps to provide accurate, quantitative, and reproducible lateral flow test results and is suitable for large-scale global production.

[0109] Figure 1a A first view of the optical module 100 for reading test areas (not shown) of this disclosure is shown. Figure 1b It shows Figure 1a A cross-sectional view of the optical module 100. As described above, the optical module 100 includes a first light source 101 for illuminating the test area of ​​the assay. Figure 1aThe optical module is also shown to include a second light source 102, optionally for illuminating a control area of ​​the test. The optical module also includes an optical detector 103. The optical detector 103 includes a light input for receiving light emitted from the test area and control area of ​​the test. The optical module may optionally include an electrical signal processor electrically coupled to the electrical output of the optical detector 103. Alternatively, the electrical signal processor may be separate from the optical module, for example, as part of a test reader device incorporating the optical module. If the electrical signal processor is part of the optical module, the optical detector 103 may be mounted on the electrical signal processor to optimize space utilization, and the electrical signal processor may, for example, include an application-specific integrated circuit, one or more dies, and / or any other microchip for processing the output signal of the optical detector 103. The optical module 100 includes a substrate 104 for mounting the first light source 101 and the second light source 102, the optical detector 103, and the electrical signal processor. The substrate 104 may be a printed circuit board (PCB) (i.e., as described below, in addition to any PCB in which the analytical reader device incorporates the optical module, a standalone PCB may be provided, or the substrate may be integrated with and be part of the PCB of the analytical reader device itself). The substrate 104 may be bonded to the light sources 101, 102, the optical detector 103, and / or the electrical signal processor (if present) by wire bonding, soldering, and / or metallized contact pads. The optical module 100 includes a housing 105. The housing 105 includes a first opening 106 for providing a first optical path from the first light source 101 to a test area for analysis and from the test area to the optical detector 103. Figure 1a The housing 105 also includes an optional second opening 107, which, when the second light source 102 is present, provides a second optical path from the second light source 102 to a control area for testing and from the control area to the optical detector 103. The housing 105 and the substrate 104 enclose the first light source 101 and the second light source 102, the optical detector 103, and the electrical signal processor (if present), and align and / or fix these components relative to the first opening 106 and the second opening 107.

[0110] The housing 105 is shown to have a generally square shape to match the generally square shape of the substrate 104. However, the housing 105, the substrate 104, and any components mounted thereon can have other shapes. For example, the substrate 104 can have a disk shape, whereby components mounted thereon are arranged around the center of the disk shape. Figure 7a This arrangement is illustrated, in which the housing 105 has a ring-like shape to fit the substrate. It can be manufactured by molding (e.g., injection molding), 3D printing, and / or combinations thereof. Figures 1a-1dThe housing 105 is shown in the example and in all other figures described herein. Molded housings offer a manufacturing tolerance of approximately 50 micrometers (i.e., the precision achievable by the design). 3D printing offers even higher manufacturing tolerances. Therefore, the amount of movement of the housing 105 relative to the substrate, for example, due to reflow during the manufacturing process, and the degree of any misalignment, is determined by the fit between the substrate and the formed surfaces of the housing 105. This can therefore be determined by the tolerances of the manufacturing technique used. Thus, this disclosure provides an optical module with a misalignment of approximately 50-250 micrometers or less.

[0111] The housing 105 may include one or more legs 108 extending in the vertical and / or horizontal directions from the outer surface of the housing 105 beyond the substrate 104, for example, four legs. If the housing has one or more corners, the legs 108 may be located at the corners of the housing 105. If the housing is round and has no corners, the legs 108 may be arranged towards the edge of the housing, or pass through the central portion of the housing and through the substrate 104, to provide an extension beyond the substrate 104, for example, in the vertical direction. The one or more legs 108 may be configured to mate with one or more corresponding holes on the printed circuit board of the assay reader device (refer to below). Figure 10-15d (Note) to align the optical module 100 with the printed circuit board of the laboratory reader device. The legs 108 can be secured in holes in the printed circuit board of the laboratory reader device, for example, using screws and threads, glue, push-fit, and / or other fixing techniques. The legs described above are not shown in the examples of Figures 2-9, but it is conceivable that they could be present to provide the aforementioned advantages.

[0112] One or more walls of the housing 105 may include a forming surface 109 configured to receive the substrate 104 at a predetermined position, thereby achieving precise and fixed alignment. By precisely controlling the forming surface 109 during manufacturing (e.g., by controlling manufacturing tolerances of the 3D printing and / or molding techniques used to manufacture the housing 105 as described above), the position of the substrate 104 and components mounted thereon relative to the housing 105, particularly relative to the openings 106, 107, can be controlled, and any relative movement can be minimized. Specifically, the position of the substrate mounted on the forming surface can be predetermined to coincide with the optimal alignment of the light sources 101, 102, the optical detector 103, and the openings 106, 107, thereby maximizing the strength of the measurement signal. This predetermined position can be estimated using known simulation techniques. Due to the forming surface 109, any deviation from this position caused by reflow motion is minimized.

[0113] The shaped surface may include one or more steps, slots, and / or ramps located on one or more surfaces of the wall of the housing 105. Figure 1b In the example shown, the shape is a step in the wall of housing 105.

[0114] As described above, the optical module 100 may include one or more first baffles 110, such as wall-like structures, located on a substrate 104 between the optical detector 103 and the first light source 101 and the second light source 102. The one or more first baffles 110 block the direct propagation of light from the first light source 101 and the second light source 102 to the optical detector, thereby reducing noise that could saturate the optical detector 103, for example, when using direct light. The one or more first baffles 110 may have any suitable shape or profile, such as rectangular, circular, V-shaped, or T-shaped profiles.

[0115] The optical module 100 may also include one or more second baffles 111 located on the inner surface of the housing 105 between the first opening 106 and the second opening 107. The one or more second baffles 111 minimize crosstalk by ensuring that only light from the first light source 101 passes through the first opening and only light from the second light source 102 passes through the second opening. The one or more second baffles 110 may have any suitable shape or profile, such as rectangular, circular, asymmetrical, V-shaped, or T-shaped profiles. In other words, materials are used to fill cavities not directly located in the optical path to reduce light pollution. The material is, for example, a molding material, and its actual shape can be optimized according to design parameters. The molding material is preferably matte black to absorb as much light as possible.

[0116] The inner surface of the wall of housing 105 may also have an internal shape structure, such as sloping edges and / or corners, to maximize the illumination of the available test or control area.

[0117] exist Figure 1b In the illustrated example, the shape and size of the first baffle 110 and the second baffle 111, as well as the internal shape of the housing 105, are optimized to maximize signal strength while minimizing noise and crosstalk. The optimal shape of the first and second baffles, as well as the inner surface, can be estimated through simulation. Specifically, the first and second baffles can be shaped to provide the maximum signal-to-noise ratio at the detector and reduce unwanted reflections, for example, by having a sloping shape with bevels. These bevels can be configured to face a certain direction, such as toward the corresponding light source, to maximize the reflection of any direct light source light away from the sensor without significantly affecting the light reflected from the test / control area. Figure 1bIn one example, the second baffle 111 has an inclined surface facing the first light source 101, but this inclined surface is approximately parallel to the optical path from the first opening to the optical detector. In this way, the amount of light from the first light source that might be directly reflected from the second baffle 111 to the optical detector 103 is reduced, but the light propagating from the first opening 106 to the optical detector 103 is essentially unaffected. The same applies to the second light source 102 and the second opening 107. These ramp-like shapes and other shapes can be determined using known three-dimensional numerical simulation techniques, such as ray tracing, and verified through known testing and design verification processes.

[0118] As described above, the first light source 101 and the second light source 102, the electrical signal processor, and / or the optical detector 103 can optionally be encapsulated in a protective molding polymer compound, providing an optical path through the molding polymer compound that weakens the signal strength. Alternatively, the signal strength can be improved by completely omitting the molding polymer compound. Instead, protection of the components is achieved by using a housing 105 and enclosing the components by placing a substrate on the molded surface of the housing. In instances where no protective compound or cap is present, the first and second optical paths are direct, uninterrupted optical paths.

[0119] Figure 1c and 1d Exemplary dimensions (in millimeters) of the features of housing 105 are schematically provided, wherein Figure 1c Is it through Figure 1d The cross-sectional view taken by line AA in the diagram. For easier observation, in Figure 1c and 1d Not shown in Figure 1b The functional features shown, such as optical detector 103 and light sources 101, 102, are, however, conceivable to be present. For example, the height of housing 105 can be between 1.5 mm and 5.0 mm, preferably between 2.5 mm and 4.0 mm, and more preferably between 3.0 mm and 3.5 mm. For example, in Figure 1cIn the diagram, the housing is shown with a height of 3.120 mm (indicated by line 114), excluding the additional length of the legs. Similarly, the vertical distance between the optical detector 103 and the first and / or second opening (indicated by line 115) can be between 1.0 mm and 4.5 mm, preferably between 2.0 mm and 3.5 mm, for example, 2.5 mm. This distance is preferably between 2.410 mm and 2.600 mm, taking into account manufacturing tolerances. Furthermore, the length of the first and / or second opening (indicated by line 116) can be between 2.5 mm and 6.5 mm, preferably 5 mm, and the width of the first and / or second opening (indicated by line 117) is between 0.5 and 1.5 mm, for example, 1 mm. This width is preferably between 0.850 mm and 1.050 mm, taking into account manufacturing tolerances.

[0120] As described above, the alignment of the components mounted on the substrate 104 and the openings in the housing 105 can be manufactured according to one or more predetermined manufacturing tolerances. Figure 1c Exemplary manufacturing tolerances for some measurements provided herein are as follows: The distance between optical detector 103 and light sources 101, 102 can have a tolerance of ±150 micrometers. The distance 115 from optical detector 103 to openings 106, 107 can have a tolerance of ±250 micrometers. The distance 118a from any of openings 106, 107 to its corresponding light source 101, 102 can have a tolerance of ±150 micrometers. The width 117 of openings 106, 107 can have a tolerance of +50 / -150 micrometers. The height 119 of the portion of housing 105 having the through openings 106, 107 can have a tolerance of +150 / -90 micrometers. The height 120 of one or more first or second baffles can have a tolerance of ±115 micrometers. The above tolerances are given by way of example only, and the same advantages described herein can also be achieved with other tolerances.

[0121] Figure 1e It shows Figure 1c The housing dimensions are optional, in millimeters. Specifically, the vertical distance 121 between the optical detector and the first and / or second opening can be approximately 1.6 millimeters. This alternative design can have the same features and advantages as other optical modules described herein, and can be implemented in accordance with the references above. Figure 1c and 1d Manufactured with the same tolerances as described.

[0122] Figure 2a A cross-sectional view of the optical module 200 of this disclosure is shown. In addition to the following aspects, Figure 2a The optical module 200 has the same characteristics as... Figures 1a-1dThe optical modules shown have the same features. For readability, these identical features are not individually labeled. First, a molding compound 201 encapsulating the first and second light sources is shown. Second, the walls of the housing have shaped surfaces that can be used for positioning alignment, and legs are not shown. These components can, for example, be arranged with... Figure 2a The views provided are in different planes. The housing may include a single integral part or separate 3D printed or injection molded parts 203, 204 (e.g. Figure 2b As shown), these parts can be glued together. One or more first baffles 205 have a T-shaped profile (in... Figure 2b (Not shown in the image), one or more second baffles 206 have a square outline. The optical module 200 is located on the printed circuit board 207 of the analyzer device, which may have one or more additional structural components 202, which will be referred to later. Figure 10-15d This will be explained further. Additionally, the shaped surface in the housing wall that provides alignment between the substrate and the housing may also have a vertical extension 208 beyond the substrate, extending beyond the outer surface of the substrate. This could be useful, for example, for ensuring further alignment with the printed circuit board 207 of the analyzer device. This can be referred to above. Figures 1a-1e The leg 108 is an alternative or supplement to the described leg. In particular, the leg 108 can be a shaped surface of one or more shapes. Figure 2a Sample 209, such as a test strip supplied to one or more openings of the housing, is also shown.

[0123] Figure 3 A cross-sectional view of the optical module 300 of this disclosure is shown. In addition to the following aspects, the optical module 300 has... Figure 2a The optical module shown has the same features. For simplicity, identical features are not shown. The optical module 300 includes a transparent material 301 located on a first opening and / or a second opening. The transparent material 301 prevents dirt, dust, fibers, or other particles from entering the housing. The transparent material 301 can provide a seal between the space enclosed by the housing and substrate and the space outside. This transparent material may, for example, include glass or a transparent plastic sheet. Figure 3 In some examples, the shaped surface of the housing wall that provides alignment between the substrate and the housing does not extend vertically beyond the outer surface of the substrate; of course, this can be an option if desired.

[0124] Figure 4 A cross-sectional view of the optical module 400 of this disclosure is shown. The optical module 400 can have any... Figures 1a-1d The optical modules shown in Figures 2 and 3, and illustrated with reference to these figures, have the same features. For the sake of readability, the same features are not labeled separately. Figure 4 The diagram schematically illustrates an optical path 401 between first light sources, which passes through a first opening in the housing to reach a test area for analysis, where the light is reflected back to the optical detector. The housing may include legs (the legs are in...) Figure 4 (Seen as one or more alignment structures 402) to aid in the alignment of the optical module 400 with other structures of the printed circuit board or assay reader device, which will be referred to later. Figure 10-15d This arrangement is similar to that shown in Figure 2-3. Figure 4 In the example shown, the light source 406 is not encapsulated in a protective molding compound. Figure 4 Different packaging options for the optical detector 404 and the electrical signal processor 405 (if present) are shown. The electrical signal processor 405 itself may include a substrate 409, in addition to the substrate 408 that encloses the housing of the optical module 400; however, this is optional and depends on the requirements of the electrical signal processor 405. In one option 403a, a cap 407b and a protective molding compound 407a are provided. In a second option 403b, only the protective molding compound 407a is provided. It is also conceivable, as described above, that neither the cap 407b nor the molding compound 407a is provided to improve signal strength.

[0125] Figure 5 An exploded view of the apparatus of this disclosure, having an electrical signal processor 501 and an optical detector 503, is shown. The electrical signal processor 501 has its own substrate 502 (separate from any substrate of the optical module and / or the substrate of the analytical reader device, and serving as a complement to any substrate of the optical module and / or the substrate of the analytical reader device, neither of which is on the same substrate). Figure 5 As shown in Figures 1-4, in this case, the optical detector 503 is integrated with the electrical signal processor 501. This device can be used with any optical module illustrated with reference to Figures 1-4. Molding compound 504 and protective cap 505 can be omitted to improve signal strength. The optical detector 503 and the electrical signal processor 501 can be glued together and fixed to the electrical signal processor substrate 502, and electrically coupled using one or more bonding wires 503, for example, eight bonding wires, depending on the number of connections required by the ASIC used.

[0126] Figure 6 and Figure 7 A top view is shown of any variation of the optical module described herein, for example, that can be used with any of the features in Figures 1-5. Figure 6 An optical module 600 is shown, in which one or more first baffles 601 are configured in a ring structure surrounding an optical detector 602 and an electrical signal processor. In this example, the optical detector 602 and the electrical signal processor are shown to have Figure 4 The features and layout shown in the example include a protective transparent molding compound and a separate substrate for the electrical signal processor; however, these are optional. The top of housing 603 is shown as transparent to allow observation of internal components, including light source 604; however, it is conceivable that the housing could be opaque. Figure 7 In the for ease of observation, the corresponding features are not marked. The one or more second baffles are configured as an elongated structure 701 between the two walls of the housing 702.

[0127] exist Figure 6 and Figure 7 In this configuration, substrates 605 and 703, which respectively enclose housings 603 and 702, have lateral extensions beyond the housings 603 and 702. For this purpose, substrates 605 and 703 may have one or more holes and / or recesses to achieve a mating fit with the corresponding shaped surfaces of the walls of housings 603 and 702. This may be advantageous where substrate 605 also serves as a printed circuit board for a laboratory reader device not provided separately, as will be referred to below. Figure 10-15d This will be explained. While this lateral extension of the substrate is not shown separately in other figures, its presence is conceivable.

[0128] As mentioned above, Figure 7a A variation of any optical module described herein is provided in which the substrate 7001 may have a disk shape, upon which the components 7002 mounted are arranged around the center of the disk shape. In this case, as described above, the housing (not shown) would have walls with corresponding shaped surfaces into which the substrate could be fitted. Other shapes are also conceivable, as described above.

[0129] Figure 8a A cross-sectional view of the optical module of this disclosure is shown, the optical module having a... Figure 2a The optical modules shown have the same features. For better readability, these identical features are not labeled separately. Figure 8a The image shows a magnified top view of the first and second openings, as well as an exemplary shape of the one or more first baffles. The top view of the baffles clearly shows that they have a similar shape to... Figure 7 The structure is due to the fact that they are arranged in an elongated structure between the walls of the shell.

[0130] Figure 8b A cross-sectional view of the optical module 800 of this disclosure is shown, which is similar to the optical module described above. Figure 8b The optical module shown is presented in an inverted view, with optical detectors 801 and 802 arranged along the top of the figure. Figure 8bThe optical module 800 includes an additional optical detector 802, an optional additional electrical signal processor, and optionally may include one or more additional light sources (not shown), which may be light sources other than the one or more light sources 803, 804, such as those described above with reference to FIG1 to 8a. This allows simultaneous imaging of more than one test line and one control line. It is conceivable that the optical module can be further extended in a suitable manner to have any additional number of light sources and optical detectors to match a selected number of additional test and / or control lines 806 according to design requirements. An additional baffle 805, as described herein with reference to FIG1-8a, may also be provided to prevent direct light from the light source from leaking onto the optical detector and / or to maximize the signal-to-noise ratio as described above. Using the additional baffle 805, one of the light sources can be used to illuminate multiple test and / or control lines 806. Figure 8b In one example, a light source 803 is arranged to illuminate two of the control lines and / or test lines 806. Therefore, any of the aforementioned optical modules may include multiple optical detectors, an electrical signal processor, and / or a third or more light sources arranged to illuminate multiple test and / or control areas of the assay.

[0131] As stated above, in accordance with this disclosure, Figure 8b The example includes a housing 807 with multiple openings to provide optical paths to / from the imaged test and / or control lines. The number of openings corresponds to the number of imaged test or control areas, in this case three, but other numbers are also conceivable. The housing 807 can be identical to the housing described with reference to any of Figures 1-8a above, thus enclosing the imaging components of the optical module 800 together with the substrate 808. Therefore, one or more walls of the housing 807 also have shaped surfaces 809 to hold the substrate in a predetermined alignment position, thereby minimizing any backflow misalignment. (See below for reference...) Figure 10-15d The optical module 800 may be mounted, for example, on a printed circuit board 810 of the laboratory test reader device and may be located near one or more support structures 811 of the laboratory test reader device. The support structure 811 is configured to hold a side-flow test strip 812 or test paper on which a test and / or control area 806 is provided. Optionally, the support structure 811 may be provided with one or more mirrors to modify one or more optical paths to / from optical detectors 801, 802, light sources 803, 804, and test and / or control lines 806, according to the design requirements of the laboratory test reader device.

[0132] Figure 8b Examples of which have optional transparent molding polymeric compounds, as referred to above. Figure 4 and Figure 5The portion of the device in the optical path is preferably transparent within the relevant wavelength range, while the portion outside the optical path is preferably matte black.

[0133] Figure 9 A cross-sectional view of the optical module of this disclosure is shown. In addition to the following aspects, Figure 9 The optical module 900 has the same characteristics as... Figures 1a-1d The optical module shown has the same features. For simplicity, the same features are not shown. First, a portion 901 of the optical module 900 may include a transparent material having an opaque material 902 on its surface. This portion may be formed as part of the housing itself, or may be as... Figure 9 Provided separately as shown. Openings 903, 904 in the housing may include gaps in an opaque material through which a transparent material forms part of the housing, or the openings may be gaps arranged in the optical path of an optical module. The transparent material may, for example, include glass or a transparent plastic sheet, and the opaque material may include black ink. Figure 9 Also shown is a sample 905, such as a laboratory test strip, placed on top of a transparent material.

[0134] Figure 10 A laboratory reader device 1000 of this disclosure is shown. The laboratory reader device 1000 includes any optical modules illustrated herein with reference to FIG1-9. For clarity, identical features are not shown. The laboratory reader device 1000 includes a reader housing 1001. If the laboratory reader device is a reusable device in which test strips can be used and used test strips can be replaced with new test strips without discarding the entire device, the device may have a slot (not shown) for removing used test strips and inserting new test strips. The reader housing 1001 is schematically shown as having a rectangular shape; however, those skilled in the art will understand that the reader housing 1001 may have any shape depending on design requirements. The laboratory reader 1000 also includes a printed circuit board 1002 located within the reader housing 1001. The printed circuit board 1002 includes one or more first holes 1003 for receiving one or more legs 108 (if present) of the housing of the optical module for aligning the optical module with respect to the reader housing 1001. Since the position of the printed circuit board 1002 within the reader is typically fixed in space relative to the test strip, this alignment ensures that the optical module is aligned with the test strip, particularly with its control and test lines. Optionally, the test reader device 1000 may include one or more additional support structures or legs 1005 and / or cylinders 1004 in which the test strip is incorporated. Support structures or legs 1005 (e.g., with...) Figure 8bThe structure 811 shown (similar to the one illustrated) can be arranged to mate with one or more corresponding second holes 1006 in the printed circuit board 1002 of the test reader device. If the test reader device is a reusable device, it is conceivable that the cartridge 1004 can be replaced via the aforementioned slot of the reader device 1000. If the device is a disposable device, and the test strips are incorporated into the device during manufacturing, the test strips can be positioned and secured using a support structure without the need for a removable cartridge 1004. In this way, the optical module, the components of the optical module, the housing of the optical module and its openings, and the test sample held by the support structure or in the cartridge are reliably and consistently aligned with each other to provide accurate and reproducible quantitative readings of the test sample.

[0135] Figure 11a The laboratory reader device 1100 of this disclosure is schematically illustrated. The laboratory reader device 1100 may have some or all of the same features as illustrated with reference to any of Figures 1-10. The components of the laboratory reader are shown in an inverted configuration, with the optical imaging components facing downward relative to the plurality of devices in Figures 1-10; however, it should be understood that this difference in configuration does not affect the advantages provided by these features.

[0136] Figure 11a The laboratory reader device 1100 is a disposable laboratory reader device in which a test strip 1101 having a test area 1112 and a control area 1113 is incorporated into a reader housing 1102. The reader housing 1102 includes an opening 1103 into which a user can insert a sample (e.g., blood, mucus, or other test sample). For example, the reader housing, which may be formed using injection molding and / or 3D printing technology, also includes multiple internal support structures 1105, which hold the printed circuit board 1106 and the test strip 1001 of the laboratory reader device 1100 in a fixed position within the laboratory reader device 1102. In the case of the printed circuit board 1106, this can be achieved by providing one or more holes through the printed circuit board 1106 into which one or more support structures 1105 can be inserted.

[0137] Figure 11a The assay reader device 1100 also includes an optical module 1107, such as the optical module described herein with reference to any of Figures 1-10. Figure 11a Optical module 1107 in the example and Figures 1a-1bThe optical module described herein is similar, as it includes a substrate 1108 and a housing 1109, on which imaging components, such as a light source and an optical detector, are mounted. The substrate 1108 encloses the light source and optical detector and aligns their positions relative to the opening in the housing 1109, thereby providing [the necessary conditions]. Figures 1a-1b The optical module has the same advantages. Similarly, housing 1109 includes legs 1110 that mate with one or more holes or recesses in printed circuit board 1106. In this way, optical module 1107 as a whole can be aligned and mounted to printed circuit board 1106 of analyzer device 1100. Optical module 1107 can also be secured in its aligned position using glue and / or solder. The mating engagement of legs 1110 with one or more holes or recesses in printed circuit board 1106, in a manner similar to the shaped surface of the wall of optical module housing 1109, prevents misalignment caused by backflow of substrate 1108 relative to optical module housing 1109, ensuring that any misalignment of optical module 1107 as a whole relative to reader housing 1102 is minimized.

[0138] The substrate 1108 and the components thereon can be electrically coupled to the printed circuit board 1106, for example, via solder, metallized contact pads, and / or wire bonding points. Those skilled in the art will understand that this allows signals to be sent to / from the optical module.

[0139] Figure 11b The present disclosure schematically illustrates a laboratory reader device, except that the printed circuit board 1106 of the laboratory reader device functions as a... Figure 11a In addition to replacing the substrate present in the middle, the assay reader device and Figure 11a The analyzer reader device is the same as the 1100. For ease of viewing, in... Figure 11b Only the relevant features are marked. Figure 11b In this example, the optical components are mounted directly onto the printed circuit board 1106 of the analyzer device 1100 without inserting into a substrate or stack. The housing 1109 can then be secured to its aligned position, for example, using glue and / or solder. As can be clearly seen from the area 1111 highlighted by the dashed circle, the shaped surface of the wall of the optical module housing 1109 directly engages with the printed circuit board 1106. This ensures that any misalignment of the housing 1109 relative to the components mounted on the printed circuit board 1106 that may occur due to reflow is minimized. Reflow movement of heavier and larger housings is generally more problematic than the reflow movement of lighter individual optical components. The legs 1110 may also engage with one or more holes or recesses in the printed circuit board 1106 to... Figure 11a The same method of mating and joining is used. Printed circuit board 1106 thus serves to... Figure 11a The substrate serves the function of enclosing the imaging component and aligning its position relative to the housing. In other words, it can be said that the same substrate as the printed circuit board 1106 of the reader device 1100 has a lateral extension beyond the wall of the optical module housing 1109, for example, as... Figure 6 and Figure 7 As shown.

[0140] Figure 12a The laboratory reader device 1200 of this disclosure is illustrated schematically. The laboratory reader device 1200 may have some or all of the same features as described with reference to any one of FIG1-10. Figure 12a The 1200 laboratory reader device is compatible with Figure 11a The same method is used as a disposable laboratory reader device. Specifically, a test strip 1201 with two test areas 1214, 1215 and a control area 1216 is incorporated into a reader housing 1202, which has an opening 1203 into which the user inserts the sample. Alternatively, it can be used in conjunction with... Figure 11a The support structure 1205 is configured in the same manner as in the reader device 1200. This support structure 1205 can be used to mount the printed circuit board 1206 and the test strip 1201 in the reader device 1200.

[0141] and Figure 11a The difference is that, apart from the control area 1216, Figure 12a The assay reader device 1200 also provides multiple test areas 1214, 1215. To achieve this, the optical module 1207 has a reference... Figure 8b The configuration described is similar, featuring multiple light sources and optical detectors to illuminate multiple test and / or control areas of the test strip 1201. Figure 12a In this example, two light sources 1208 and 1209 and two optical detectors 1210 and 1211 are provided; however, other numbers can be considered depending on the number of imaging areas. Figure 12a The design includes an optional protective transparent molding compound to cover optical detectors 1210 and 1211, as described above. Figure 4 and Figure 5 The above describes the provision. Additional electrical signal processors may also be provided, for example, one electrical signal processor for each additional optical detector, and / or the optical detectors may be mounted on these additional electrical signal processors to save space, as described in reference [reference needed]. Figure 4 and Figure 5 As stated above.

[0142] In addition, with Figure 11a and 11bThe difference is that the wall of the housing 1212 of the optical module 1207 is integral with the support structure 1205 of the reader housing 1202. This means that the wall of the housing 1212 of the optical module 1207 does not need a separate shaped surface or a separate support leg to achieve the above alignment. This is because, compared with Figure 11b The situation is similar; the 1206 printed circuit board plays a role in... Figure 11a The function of the substrate is to close and align the imaging components relative to the opening in the housing (which is integral with the support structure 1205 of the analyzer device 1200). Since the printed circuit board 1206 is fixed to the support structure 1205, and the support structure 1205 is integral, it is fixed in position relative to the housing, and there will be no movement of the housing 1212 caused by backflow or any misalignment that may result therefrom.

[0143] Figure 12b The laboratory reader device 1200 of this disclosure is schematically shown. Except for the housing 1212 of the optical module 1207, which also includes legs and / or shaped surfaces (not shown) indicated by dashed circles 1213 (e.g., the legs and / or shaped surfaces described above with reference to FIG1-10), the laboratory reader device 1200 is similar to... Figure 11a The same applies to the assay reader device 1100. Even when the housing 1212 is integrally formed with the reader housing support structure 1205, the advantage of providing the legs 1213 is that it provides additional structural stability for the alignment of the imaging components relative to the opening in the housing 1212. Specifically, if the printed circuit board 1206 is not properly secured to the support structure 1205, the legs and / or the formed surface 1213 of the housing 1212 provide fault protection to further minimize the risk of misalignment.

[0144] exist Figure 12a and 12b In both examples, each optical detector is equipped with its own electrical signal processor to process the signals output by the individual optical detectors on the chip. One advantage of this is that it provides a fully digital solution that does not require additional external processing or analog-to-digital conversion, thus also allowing the optical sensor to be a spectral sensor capable of performing reflection and fluorescence measurements based on the capabilities of the ASIC, one or more dies, and / or any other microchip that constitutes the electrical signal processor.

[0145] Figure 13a and 13b The laboratory reader device 1300 of this disclosure is shown separately, except that one of its optical detectors is a photodiode without its own electrical signal processor. Figure 12a and 12bThe assay reader device shown is the same (and therefore can have the same type described herein with reference to FIG1-12b). Figure 12a and 12b (Any features of the imaging components). Furthermore, the imaging components are rearranged such that the optical detector with its own on-chip electrical signal processor is placed in the optical path of light from the two test regions 1305, 1306, ensuring that the required reflectivity and fluorescence measurements, as well as additional on-chip signal processing, are still possible. Conversely, the optical detector without its own electrical signal processor is placed only in the optical path of light from the control region 1307. The control region 1307 typically does not require the substantial additional on-chip signal processing required for the signals from the test regions. Therefore, this arrangement is advantageous because it reduces the financial cost of the device, as the optical detector without an on-chip electrical signal processor is cheaper than one with such a processor. However, in some cases, this arrangement may be more difficult to accommodate fluorescence measurements and / or measurements where additional on-chip signal processing is not required in the control region.

[0146] like Figure 13a and 13b As shown, the assay reader device 1300 includes two light sources 1301 and 1302 located on either side of a first optical detector 1303. The first optical detector 1303 is equipped with an electrical signal processor suitable for reflection and fluorescence measurement. A second optical detector 1304, such as a photodiode without on-chip signal processing capability, is also provided on the side of the light source 1302 opposite to the first optical detector 1303, and the second optical detector 1304 is arranged in the optical path of the light from the control area.

[0147] Figure 14a and 14b The laboratory reader device 1400 of this disclosure is shown separately. Except for completely eliminating the need for a second optical detector in the optical path of the light from the control region 1405, this laboratory reader device 1400 is similar to... Figure 13a and 13b The assay reader device shown is the same as that described herein (and therefore can have the same applicability as that illustrated with reference to FIG1-13b). Figure 13a and 13b (Any features of the test). Instead, a window or opening 1401 is provided in the reader housing 1402, through which the control area 1405 can be observed with the naked eye to confirm whether the test was performed correctly. The test areas 1403 and 1404 are still imaged by an optical detector. This arrangement is similar to... Figure 13a and 13bCompared to other optical imaging devices, this arrangement has fewer components, resulting in lower production costs. However, since the control area 1405 is illuminated only by ambient light and is read manually by eye, the analytical reading device 1400 is not a fully digital solution. Furthermore, due to additional openings in the housing, ambient light may leak through the device and reduce the accuracy of measurements in the test areas 1403 and 1404. It is conceivable that... Figure 14a and 14b The arrangement with a window for the control area 1405 instead of for the optical detector can also be applied to an arrangement with only one test area instead of two test areas.

[0148] Figure 15a , 15b 15c schematically illustrates various views of the assembly phase of the laboratory reader device of this disclosure. Figures 15a-15c This is merely an example; one can imagine that it could be like this. Figures 15a-15c As shown, any laboratory reader device and / or optical module illustrated herein with reference to FIG1-14b may be assembled. Figure 15d The assembled diagram is shown schematically. Figure 15c The diagram shows a cross-sectional view of the laboratory reader device. As described above, the laboratory reader housing 1501 may include multiple components, including a shell 1502 (composed of one or more parts) and an internal support structure 1503, which may be, for example, an injection-molded or 3D-printed part. These can be fastened to each other using one or more known techniques, such as adhesive, push-fit, screws / threads, and / or other known methods. Laboratory test strips 1504, a printed circuit board 1505, and a power source (e.g., a battery 1506) are also provided. Corresponding structures on the inner side of the internal support structure 1503 and / or the shell 1502 are shaped to house the internal reader device components within the shell 1501 in their respective positions. As described above with reference to FIG1-14b, an optical module can be fixed to the printed circuit board 1505 of the laboratory reader device 1500. The optical module can be a standalone module with its own independent housing and substrate, as shown, for example, with reference to FIG1-11a, or the housing and / or substrate can be integrated with and / or form part of the reader housing and printed circuit board, as shown, for example, with reference to Figures 12a-14b The components mounted on the printed circuit board 1505 also support communication with external devices. For example, Bluetooth, Wi-Fi, USB, and / or other wired and / or wireless communication components can be mounted on the printed circuit board to provide a network interface for transmitting laboratory test results to external devices, such as mobile devices, computers, cloud servers, etc. In addition to the aforementioned electrical signal processor, the printed circuit board may have its own processor mounted thereon.

[0149] Figure 16 This is a flowchart of method 1600 of this disclosure. The method includes mounting a first light source 1601 and an optical detector including light input and electrical output on a substrate. Method 1600 further includes enclosing the first light source, optical detector, and electrical signal processor 1602 with a substrate and a housing, and aligning the position of the first light source and optical detector 1603 relative to a first opening in the housing by placing the substrate on a shaped surface of one or more walls of the housing and / or engaging legs of the housing with corresponding holes, slots, or recesses in the substrate, the shaped surface being configured to receive the substrate at a predetermined position to achieve the alignment. As described above, this method of aligning the substrate to the housing is more precise than mounting the housing on a substrate without shaped surfaces and / or legs for providing alignment.

[0150] Figure 16 This method can be performed using existing pick-and-place machines commonly used on printed circuit board assembly lines, making it particularly suitable for mass production without requiring significant modifications to existing assembly lines. In particular, pick-and-place machines (also known as surface mount technology component placement systems) are used to place electronic components onto a PCB with high precision. A pick-and-place machine may include one or more robotic arms, actuators, and control systems for placing components of an optical module stacked on top of each other as needed. By using such a pick-and-place machine to mount a first light source and optionally a second light source, an optical detector, and optionally an electrical signal processor onto a substrate, and by positioning housings and their openings in alignment with the substrate to enclose the components of the optical module, the aforementioned tolerances and the improved optical module component alignment they provide can be achieved. Additional manufacturing steps may include, for example, attaching the light source, optical detector, and / or electrical signal processor to the substrate with a thin layer of adhesive (a few micrometers) and wire-bonding them to the substrate from the side. When the optical module is finally assembled onto the PCB of a laboratory reader device as a surface mount device, alignment is based on the position of the test strip in / on the device, with the shaped surfaces and / or legs of the optical module designed according to that position. The stacking and / or mounting of light sources, optical detectors, and / or electrical signal processors on a substrate may include aligning electrical contacts at their bottoms and / or gluing and / or soldering them together (in some figures, the adhesive is shown as a thin line of material between components). The adhesive and / or solder may be approximately 100 micrometers thick, and during component tilting, solder reflow due to temperature can cause displacement in the x, y, and z directions. This is often a source of less precise manufacturing tolerances, therefore structural latches from the substrate to the housing and / or other structural alignment features described herein ensure that such displacement is minimized and / or reduced.

[0151] This disclosure describes each of the features described herein, as well as any combination of two or more such features, to the extent that such features or combinations can be implemented holistically based on the specification in accordance with common general knowledge of those skilled in the art, regardless of whether such features or combinations of features solve any problem disclosed herein, and without limiting the scope of the claims. It is conceivable that aspects of this disclosure can consist of any such individual features or combinations of features. In light of the foregoing description, it will be apparent to those skilled in the art that various modifications can be made within the scope of this disclosure.

[0152] Those skilled in the art will understand that in the foregoing description and appended claims, positional terms such as “above,” “along,” and “side” are given with reference to conceptual illustrations (e.g., the figures shown in the accompanying drawings). The use of these terms is for ease of reference and is not intended to be restrictive. Therefore, these terms should be understood to refer to objects in the orientation shown in the figures.

[0153] While this disclosure is illustrated according to the embodiments described above, it should be understood that these embodiments are merely exemplary and the claims are not limited to these embodiments. Modifications and substitutions can be made by those skilled in the art based on this disclosure, but such modifications and substitutions are considered to be within the scope of the appended claims. Each feature disclosed or shown in this specification may be combined in any embodiment, either alone or in any suitable combination with any other feature disclosed or shown herein.

[0154] For example, the optical detector of any of the optical modules described above may include a spectral sensor and two white LEDs. The spectral sensor may have a cap and a molding compound encapsulating it. In this case, the cap and the molding compound reduce performance (e.g., signal-to-noise ratio) by approximately 74%. Therefore, to improve performance by approximately 74%, the cap and molding compound can be removed.

[0155] Furthermore, in any of the aforementioned optical modules, the light source, optical detector, and / or electrical signal processor can be fixed to the substrate with adhesive, and can be electrically coupled to the substrate using one or more wire bonding points or coupling points.

[0156] Furthermore, in all the above examples, the first and second light sources, the optical detector, and the electrical signal processor are arranged adjacent to each other in the first planar arrangement, while the first and second openings are arranged in a second planar arrangement parallel to and facing the first plane. However, other arrangements are also conceivable, such as the light source and the optical detector being on different planes.

[0157] It should be understood that this disclosure can be used in conjunction with any type of sideflow testing assay, including fluorescence and reflectance measurements performed at any light wavelength. The improved alignment achieved using this disclosure enhances signal strength, thereby increasing the sensitivity of any quantitative measurement.

[0158] It should be understood that the laboratory reader device referred to herein may be a disposable laboratory reader device, for example, where the device is intended for single use only. Alternatively, the reader device may be a reusable reader device in which the cartridge is removed, the used test sample is replaced with a new test sample, and the cartridge is reinserted into the device.

[0159] It should be understood that many different laboratory tests can be used in conjunction with this disclosure. For example, as those skilled in the art know, test areas can be provided to test for the presence of immunoglobulins IgG, IgM, and / or IgA in a sample.

[0160] It should be understood that the optical module housing and the laboratory device reader housing, support structure, and other structural components can be manufactured using injection molding and / or 3D printing technologies, and / or can be provided as complete sets of components for assembly into the final product. Such assembly may include securing the components to each other using adhesives, screws / threads, push-fit mating, and / or other fastening techniques known to those skilled in the art.

[0161] Furthermore, it should be understood that printed circuit boards and any holes therein can be mass-produced with high-precision manufacturing tolerances of ±5 micrometers. Therefore, when the optical module and its components and openings are aligned to the tolerances described herein, their positional alignment relative to the printed circuit board of the assay reader device can achieve a much higher level of alignment accuracy than that achievable using methods such as manual workshop alignment.

[0162] In addition, such as Figure 15e As shown, it is conceivable that the reader housing described herein (e.g., combined with...) Figure 10-15d Any of the described reader housings may be provided with one or more spacers and one or more bias arms arranged on the inner surface of the reader housing. Figure 15eA schematic cross-sectional view of the housing 1508 of the laboratory reader device 1507 of this disclosure is shown, in which the optical module 1509 of this disclosure is housed. It is conceivable that one or more spacers 1510 face a first and / or second opening on the housing of the optical module 1509, and that a test strip 1511 for lateral flow testing can be received on the spacers 1510, with the test / control area facing the optical module 1509. One or more bias arms 1512 are arranged at one or more ends of the test strip 1511, and force is applied to the ends of the test strip 1511 to push or pull it against the spacers 1510. In this way, the test strip 1511 is held under tension in a positionally aligned manner, and the risk of misalignment caused by movement of the test strip 1511 within the reader housing 1508 is minimized. The height of the spacer 1510 controls the proximity of the optical module 1509 and the test strip 1511 to each other, and can be set during the manufacturing process of the reader housing 1508. The bias arm 1512 may include, for example, flexible plastic or metal, and tension may be applied, for example, when the reader device 1507 is assembled / fastened together, causing the test strips 1511 to be pushed against the bias arm 1512, thereby deforming them and inducing a restoring force in the bias arm 1512, which holds the test strips 1511 in a taut state and taut on one or more spacers 1510.

[0163] As described above, the optical detector of any optical module described herein may include a spectral sensor. By providing multiple output channels corresponding to different portions of the electromagnetic spectrum, a spectral sensor provides the ability to detect and distinguish multiple color changes in a single test region, which are associated, for example, with the presence of multiple corresponding analytes. Figure 4 and Figure 5 The exemplary optical detectors 404 and 503 shown are illustrated as including spectral sensors, and it is conceivable that such sensors can be used in any of the embodiments described herein, particularly when multiple signals of different wavelengths from the same test region are to be detected and distinguished simultaneously. Reference will now be made to... Figure 17-19 Further details are provided regarding the spectral sensors used in conjunction with any of the embodiments described herein.

[0164] Figure 17The layout of an exemplary spectral sensor 1700 of this disclosure is schematically shown, which can be used in conjunction with any of Figures 1-16. The spectral sensor 1700 includes a photodiode array 1701, each photodiode having a corresponding color filter F1, F2, F3, F4, F5, F6, F7, F8, C, NIR disposed in front of it, thereby controlling the wavelength of light received by each photodiode. One or more photodiodes may also be provided with a transparent filter C or no filter at all to allow all wavelengths to reach the respective photodiode. One or more photodiodes may also be equipped with a near-infrared (NIR) filter. Figure 17 The exemplary array 1701 includes paired photodiodes and a 4×4 filter array, thereby providing at least two photodiodes in each color channel to provide redundancy in the event of failure of one of the two photodiodes. Two photodiodes adjacent to the 4×4 array 1701 (but still forming part of the spectral sensor) are equipped with transparent filters, for example, to provide a reference signal against which color changes detected by other photodiodes can be calibrated or compared. One or more photodiodes are also equipped with NIR filters for detecting any infrared color changes in the test area. Figure 17 In the exemplary spectral sensor 1700, channels are provided corresponding to the following approximate spectral bands: F1 (350-440 nm), F2 (415-475 nm), F3 (445-515 nm), F4 (475-555 nm), F5 (515-595 nm), F6 (550-630 nm), F7 (580-680 nm), F8 (630-730 nm), C (390-1000 nm), and NIR (850-1000 nm). At least some bands can overlap with each other, and it is conceivable that any suitable arrangement of photodiodes and color filters can be used to control the spectral sensitivity of the sensor to different wavelengths, depending on the color change in the test area detected by the spectral sensor 1700. For example, channels can be omitted. Figure 17 The arrangement shown provides at least two photodiodes in pairs for each color, thus providing only one photodiode for each color, although this arrangement is less robust due to the lack of redundancy.

[0165] A particular advantage of providing not only color filters but also one or more transparent color filters C or a filterless optical path is that the spectral sensor does not require a separate reference signal from a separate optical detector located within or near the optical path of the analyzer device. This reduces the complexity of the device, thereby reducing manufacturing costs. Furthermore, since unobstructed channel photodiodes can be formed as part of the same die on the same substrate using the same process, all photodiodes are likely to have the same temperature and other operating condition variations (e.g., any drift caused by temperature variations is likely to be the same for all photodiodes, making it easier to compensate). In contrast, when obtaining a reference signal from a separate optical detector, the operating condition variations will differ from those of the spectral sensor, making such variations more difficult to compensate for.

[0166] As mentioned above Figure 4 and Figure 5 The spectral sensor can be integrated with the electrical signal processor on the same substrate or on the same substrate. Figure 18 A functional block diagram of a spectral sensor and electrical signal processor circuit 1800, which can be used in combination with any of the circuits in Figures 1-17, is schematically shown. Circuit 1800 may include one or more of the following pins: positive power supply terminal (VDD), ground (PGND and GND), serial interface clock signal line (SCL), serial interface data signal line (SDA), interrupt (INT), general purpose input / output (GPIO), and / or LED current sink input (LDR), to provide an interface between the photodiode of the spectral sensor 1801 and other components of the electrical signal processor (e.g., a microcontroller unit (MCU)). Those skilled in the art will understand that signal processing can be achieved through I... 2 A C-series serial communication bus is provided. Those skilled in the art will also understand that a power supply and / or any additional resistors, capacitors, and / or other electronic components may also be provided. The electrical signal processor may also include one or more multiplexers and analog-to-digital converters to optionally multiplex the analog signal output from the photodiode of the spectral sensor and subsequently convert it into a digital signal in the corresponding data channel, which may be output, for example, via a serial interface data signal line (SDA), for further processing and ultimately to read the intensity of the color change and / or perform fluorescence measurements in the assay test area.

[0167] Advantageously, by means of Figure 17 and 18The integrated approach shown provides both a spectral sensor and an electrical signal processor, eliminating the need to provide these components and circuitry as separate parts, such as separate components on the PCB of a laboratory reader device. Since all components providing the spectral sensing function are provided as part of a single optical module, which can be mounted onto the PCB of the laboratory reader device in a single step, the design of the laboratory reader device is simplified, thereby reducing the time and complexity of assembling the device after the optical module itself is assembled.

[0168] Figure 19 It schematically shows, as Figure 18 The functional block diagram shown is applied to an example of read-side current testing of this disclosure, such as the example described in conjunction with Figures 1-16. The spectral sensor 1901 and the electrical signal processor can be integrated into the same substrate or on the same substrate, and can include, for example... Figure 18 The circuit 1900 shown includes a positive power supply terminal (VDD), ground (PGND and GND), a serial interface clock signal line (SCL), a serial interface data signal line (SDA), an interrupt (INT), general purpose input / output (GPIO), and / or an LED current sink input (LDR) pin to provide an interface between the photodiode of the spectral sensor 1801 and other components of the electrical signal processor (e.g., a microcontroller unit (MCU)). Those skilled in the art will understand that signal processing can be achieved through I... 2 A C-series serial communication bus is provided. Those skilled in the art will also understand that a power supply and / or any additional resistors, capacitors, and / or other electronic components may also be provided. Figure 19 In this example, two light sources 1902 and 1903 (LEDs in this example) are also provided to illuminate the test areas 1904 and 1905 of the sideflow test strip 1906. The light sources 1902 and 1903 can be connected to an electrical signal processor, and their respective outputs can be controlled and driven by the electrical signal processor. This can be advantageous, for example, in situations where fluorescence measurements require synchronization between illumination and sensing.

[0169] like Figure 19 As shown, light from light sources 1902 and 1903 is reflected from test areas 1904 and 1905 and detected by the spectral sensor 1901. Each output channel of the spectral sensor 1901 outputs the signal intensity of different wavelengths of the reflected light, determined by the color of the filter in the spectral sensor 1901. In this way, multiple different color changes in each test area can be read simultaneously.

[0170] As described above, the one or more light sources illustrated herein in conjunction with all of Figures 1-19 may each comprise an LED configured to emit electromagnetic energy over a wide range of the electromagnetic spectrum. For example, each LED may be configured to emit white light. However, it is conceivable that light of any color may be used, depending on the requirements of the labeled particles being imaged in the assay. In the case of fluorescence measurements, the output signal of the LED may include a pulsed output controlled by an electrical signal processor and synchronized with a spectral sensor for time-gated measurements.

[0171] Now refer to Figures 20a-24c Different embodiments are described below, which can be used with the optical modules illustrated with reference to FIG1-10.

[0172] Figure 20a A top view of the optical module housing 2000 of this disclosure is shown. Like the optical module of Figures 1-10, the housing 2000 defines a first opening 2001 and an optional second opening 2002 to provide optical paths from one or more light sources to corresponding test and / or control areas of the assay and to the optical detector. Figure 20a The housing 2000 may optionally be provided with one or more legs 2003, 2004 extending vertically from a first outer surface and / or a second outer surface of the housing 2000. In this case, the legs 2003, 2004 extend above and below the housing. Furthermore, Figure 20a The housing 2000 also includes a blocking portion 2005 configured to block a portion of light incident on or reflected from the test area, thereby reducing the intensity of light received by the optical detector of the optical module. The blocking portion 2005 introduces a blind spot in the optical path to prevent specular reflection of light emitted from the light source from reaching the optical detector. Specular reflection from materials used to manufacture the side-flow test strips (e.g., nitrocellulose and / or wetted surfaces) can be particularly strong and may easily saturate the optical detector, reducing the signal-to-noise ratio and hindering accurate readings. Specular reflection is especially strong in the central region around the optical axis of the optical path between the light source and the optical detector, where the beam emitted by the light source is strongest. By providing the blocking portion 2005, for example, covering the central portion of the optical path around the optical axis, a significant portion of the specular reflection is blocked and cannot reach the optical detector. The unblocked portions of the openings 2001 and 2002 allow reflections from test / control areas with less strong specular reflection to reach the optical detector, thereby providing a higher signal-to-noise ratio and improving the performance of the optical module. It is conceivable that this performance improvement could be used for colorimetric and fluorescence measurements.

[0173] Figure 20aThe exemplary blocking portion 2005 is configured as an integral strip or band spanning the openings 2001, 2002 defined by the housing 2000. The blocking portion 2005 may also be provided on any optical module housing illustrated with reference to FIG1-10.

[0174] Figure 20b The cut along line AA is shown. Figure 20a A cross-sectional view of the housing 2000. The blocking portion 2005, passing through openings 2001 and 2002, is shown as integral with the housing 2000. Figure 20b Also shown is one or more baffles 2006 described above with reference to FIG1-10. Although in Figure 20a Although not shown in 20b, a shaped surface for achieving the above-mentioned positional alignment may be provided in the wall of the housing 2000, and a substrate attached to the printed circuit board of the laboratory reader device may also be provided to close the housing before the housing is placed on the printed circuit board of the laboratory reader device. Figures 20a-20c The housing 2100 shown may also have a flange or step 2007 around at least a portion of its outer wall. The flange or step provides a larger area or overlaps with adjacent surfaces (e.g., printed circuit boards of a laboratory reader device).

[0175] Figure 20a and 20b One potential problem with the housing 2000 is that when the blocking portion 2005 is formed as an integral strip or bar spanning the openings 2001, 2002, it is not easy to manufacture the blocking portion 2005 in the mold because the strip or bar prevents easy removal of the housing from the mold. Therefore, it is difficult to mass-produce such a housing cheaply. To overcome this problem, the blocking portion 2005 can also be formed as a vertical support extending between the inner surface of the housing 2000 and one or more baffles 2006. Figure 20c This arrangement is shown in the image.

[0176] However, although Figure 20c The arrangement is easier to injection mold and thus suitable for inexpensive mass production, but it has been found that the vertical struts between the inner surface of the housing 2000 and one or more baffles 2006 cause performance degradation. This is partly because the positions of the baffles and / or openings need to be adjusted away from the optimal positions with the highest signal-to-noise ratio to allow the vertical struts to engage between them.

[0177] Now refer to Figures 21a-23b The arrangement provided in the text illustrates a way to overcome... Figure 20c The aforementioned performance is reduced, while maintaining the ability to block specular reflections, and it can be mass-produced cheaply through injection molding.

[0178] Figure 21a A cross-sectional view of the housing 2100 of this disclosure is similarly shown. Like the optical modules of Figures 1-10 and 20a-20c, the housing 2100 defines a first opening 2101 and a second opening 2102 to provide an optical path from the light source 2103 to the corresponding test and / or control areas of the assay and to the optical detector 2104, as shown below. Figure 4 and Figure 5 As shown. Figure 21a The housing 2100 includes legs 2105 extending vertically from a first outer surface and / or a second outer surface of the housing 2100. Figure 21a The baffle 2108 is also shown in the image. Figure 21a The outriggers 2105 provided extend above and below the upper and lower surfaces of the housing 2100. Figure 21a The image shows substrate 2109. This substrate can be a printed circuit board of a laboratory reader device, on which an optical detector 2104 and a light source 2103 are mounted. When the housing is placed on substrate 2109, the flange or stepped shape in the wall of housing 2100 is used to increase the overlapping area. Although in Figure 21a Not shown, but a substrate may also be provided to be attached to the printed circuit board of the laboratory reader device to close the housing before the housing is placed on the printed circuit board of the laboratory reader device, for example as described in Figures 1-10.

[0179] An angled support 2107 extends from the inner surface of the housing 2100 between the first opening 2101 and the second opening 2102 to the baffle 2108. This angle allows the baffle 2108 and the openings 2101, 2102 to be positioned at the optimal location for the highest signal-to-noise ratio, for example, at least partially directly below the openings 2101, 2102, while still blocking the portion of the light with the strongest specular reflection. In this way, it overcomes the limitations of mass production via injection molding. Figures 20a-20c The performance degradation is shown.

[0180] Figure 21b It shows Figure 21a A cross-sectional view of the housing 2100. Figure 21b The range of the legs 2105 extending above and below the upper and lower surfaces of the housing 2100 can also be seen.

[0181] Figure 22a It shows Figures 21a-21b A cross-sectional view of a variation of the shell. Except that the blocking portion 2201 does not extend from the shell portion between the openings 2202, 2203 to one or more baffles 2204, but rather extends inward at a non-90-degree angle from the shell portion outside the openings to the outside of the baffles 2204. Figure 22a The housing 2200 and Figures 21a-21bThe casing of the 2100 is basically the same. Although in Figures 21a-21b A portion of the light reflected from the test area is blocked to reduce specular reflection, but Figure 22a The blocking portion 2201 blocks the light incident on the test area, thereby preventing strong specular reflection from occurring in the first place.

[0182] Figure 22b It shows Figure 22a Top view of the housing 2200. Figure 22b The oblique column-shaped blocking part 2201 can be seen in the middle.

[0183] Figure 23a and 23b It shows Figures 21a-21b Cross-sectional views of some other alternative forms of the shells 22a-22b. In particular, Figure 23a and 23b The shell 2300 is respectively with Figures 21a-21b The shell is substantially the same as that of 22a-22b, except that the blocking portion 2301 is formed as an inclined column that widens as it extends toward the inner upper surface of the shell away from one or more baffles. Figure 23a In this case, the increase in thickness is in the direction outside the openings 2302 and 2303, while... Figure 23b In the case of openings 2302 and 2303, the increase is in the direction of the shell portion.

[0184] As all Figures 20a-23b As shown, the legs of the housing can extend vertically from a first and / or second outer surface of the housing, which may include extensions above and below the height of the housing. One or more legs may include flexible hooks 2008, 2111, 2205, 2304. These flexible hooks are configured to secure the housing to the substrate. The housing is arranged through one or more corresponding holes in the substrate in a snap-fit ​​engagement manner (e.g., cantilever, annular, or torsional snap-fit ​​engagement). This snap-fit ​​engagement provides a sufficiently tight connection to prevent relative movement between the substrate and the housing without the use of glue or other less precise fixing methods, such as solder, which may be affected by backflow and / or have difficulty controlling their thickness. Optional flanges or stepped portions 2007, 2112, 2206, 2305 of the housing ensure that the forces generated by the flexible hooks 2008, 2111, 2205, 2304 are evenly distributed on the surface of the substrate.

[0185] Furthermore, when one or more legs 2004, 2105, 2207, 2306 extend vertically beyond the housing in the direction opposite to the substrate (e.g., beyond the height of an opening in the housing), the legs can be configured to mate with one or more corresponding holes in the housing of the laboratory reader device. In this way, the portion of the leg extending beyond the housing in the direction of the substrate can engage with the substrate, while the portion extending beyond the housing in the opposite direction can engage with the housing of the laboratory reader device. This arrangement ensures that the optical module housing is aligned not only with the printed circuit board of the laboratory reader device but also with the housing of the laboratory reader device itself.

[0186] exist Figures 20a-23b In the optical module housing, one or more legs 2004, 2105, 2207, 2306 are arranged offset from the housing wall. This can be achieved by using... Figure 22b This can be achieved using one or more arms 2208 as shown. Alternatively, as shown in Figures 1-10, the legs are located at the corners of the housing.

[0187] Figures 24a-24d Various views of the assembly stage of the laboratory reader device 2400 of this disclosure are schematically shown.

[0188] exist Figure 24a In the middle, the sideflow test strip 2400 was used in a manner similar to the reference. Figures 15a-15d The aforementioned arrangement is placed in the first part of the analyzer reader housing 2401. For example... Figures 15a-15d As shown, housing 2401 comprises multiple components, including an outer shell (composed of one or more parts) and an internal support structure and / or intermediate support layer 2402, which are injection-molded or 3D-printed parts. Side-flow test strips are arranged such that one or more support structures or spacers 2403 of the first portion of the analyzer reader housing 2401 are aligned with one or more optical module mounting structures 2404 (e.g., one or more slots) of housing 2401, which is configured to receive one or more legs of the optical module housing, as described below. The height and position of the one or more support structures or spacers 2403 are configured to reference... Figure 15e When assembling the analyzer device in the same manner, the side-flow test strip is made taut and / or tensioned on the support structure or spacer. It is conceivable that a pick-and-place mechanism can be used to place the side-flow test strip 2400 into the first part of the analyzer housing 2401, the pick-and-place mechanism having a tolerance of approximately ±10 micrometers in the XY direction (i.e., the plane of the test strip) and a tolerance of approximately ±3 micrometers in the Z direction (i.e., perpendicular to the test strip).

[0189] exist Figure 24b In, for example in Figures 20a-23b The optical module housing 2405, as described, is mounted onto the substrate 2406. Figure 24b In this example, substrate 2406 is also a printed circuit board for a laboratory reader device. Therefore, the optical module housing 2405 is located above one or more light sources and optical detectors already mounted on substrate 2406. (See above for reference...) Figures 20a-23b The one or more legs 2004, 2105, 2207, 2306 are configured to secure the optical module housing to the substrate via a snap-fit ​​engagement through one or more corresponding holes in the substrate, thereby preventing relative movement between the substrate and the housing without the use of glue or screws, which can be difficult to control and pose a risk of misalignment of the light source and optical detector relative to the openings in the optical module housing. Figures 24a-24b In this example, substrate 2406 is provided with battery contacts 2407. Those skilled in the art will understand that other electronic and circuit components may also be provided on substrate 2406.

[0190] exist Figure 24c In this configuration, after the sideflow test strip 2400 is installed, the intermediate support layer 2402 of the housing 2401 is placed on the first portion of the housing 2401. The intermediate support layer 2402 covers most of the sideflow test strip 2400, except for the portion of the sideflow test strip 2400 with the test and / or control areas. The test and / or control areas are visible through the gap 2409. Therefore, the sideflow test strip 2400 is held on the support structure or spacer 2403 by the intermediate support layer 2402 to ensure that the Z-position of the test and / or control areas is controlled to a tolerance of approximately 3 micrometers. For example, this can be done according to… Figure 15e The method described herein is used to achieve the desired XY positional tolerance. To achieve this, the test strip is provided with alignment lines 2408. The edge of this line is used to position the corresponding edge of the gap 2409, and the position of the optical module mounting structure 2404 is aligned with the corresponding holes 2410 in the intermediate support layer 2402, which are located midway between the test and / or control areas.

[0191] Therefore, if the first portion 2401 of the housing and the intermediate support layer 2402 are not aligned, the hole 2410 will not match, and the legs of the optical module housing cannot pass through the intermediate support layer 2402 and be inserted into the optical module mounting structure 2404. Thus, unless the intermediate support layer 2402 and the first portion of the housing 2401 (and the side-flow test strip mounted thereon) are also aligned, the analyzer device cannot be fully assembled. The intermediate support layer 2402 may also be provided with a battery holding portion 2411 in which the battery can be placed.

[0192] exist Figure 24dIn this configuration, substrate 2406 is arranged on intermediate support layer 2402. One or more extended legs of optical module housing 2405 are aligned with optical module support structure 2404 in the first portion of housing 2401 through corresponding holes in intermediate support layer 2402. Finally, a second portion (not shown) of the laboratory reader device housing can be used to enclose the laboratory reader device to provide the assembled device.

[0193] Align the optical module housing (especially the location of its opening) with the test and / or control area of ​​the sideflow test strip to the desired tolerance. Avoid using alignment pins or structures that are not integral with the optical module housing. Examples of non-integral alignment pins or structures include screws and / or holes on a printed circuit board.

[0194] While the invention has been described with reference to preferred embodiments as described above, it should be understood that these embodiments are merely exemplary and the claims are not limited to these embodiments. Modifications and substitutions can be made by those skilled in the art based on this disclosure, but such modifications and substitutions are considered to be within the scope of the appended claims. Each feature disclosed or shown in this specification may be incorporated into the invention, either individually or in any suitable combination with any other feature disclosed or shown herein.

Claims

1. An optical module (100) for reading a test area in a laboratory test, the optical module comprising: • A first light source (101) used to illuminate the test area for laboratory analysis; • An optical detector (103) includes an optical input and an electrical output for receiving light emitted from the test area of ​​the assay; • A substrate (104) for mounting the first light source (101) and the optical detector (103); • Housing (105) defining a first opening (106) for providing a first optical path from the first light source (101) to the test area and from the test area to the optical detector (103); The housing (105) and the substrate (104) enclose the first light source (101) and the optical detector (103), and are aligned with the positions of the first light source (101) and the optical detector (103) relative to the first opening (106); • A second light source (102) used to illuminate the control area for laboratory testing; The second light source (102) is mounted on the substrate (104). The housing (105) includes a second opening (107) for providing a second optical path from the second light source (102) to the reference area and from the reference area to the optical detector (103), and The housing (105) and the substrate (104) further enclose the second light source (102) and are aligned with the position of the second light source (102) relative to the first opening and the second opening (106, 107) and the optical detector (103); • One or more first baffles (110) are located on a substrate (104) between the optical detector (103) and the first light source (101) to block light from directly propagating from the first light source (101) to the optical detector (103); • An angled strut (2107) extends from the inner surface of the housing (105) between the first opening and the second opening (106, 107) to the first baffle (110), the angle allowing the first baffle, the first opening and the second opening to be in the optimal position with the highest signal-to-noise ratio.

2. The optical module of claim 1, wherein one or more walls of the housing (105) include a shaped surface (109) configured to receive a substrate (104) at a predetermined position to provide alignment.

3. The optical module of claim 2, wherein the shaped surface (109) comprises one or more steps, slots and / or ramps located on one or more surfaces of the wall of the housing (105).

4. The optical module according to any one of claims 1 to 3, wherein the housing (105) includes one or more legs (108) extending vertically from a first outer surface and / or a second outer surface of the housing (105).

5. The optical module of claim 4, wherein one or more of the one or more legs (108) include flexible hooks.

6. The optical module of claim 5, wherein the flexible hook is configured to secure the housing (105) to the substrate (104) by a snap-fit ​​engagement through one or more corresponding holes in the substrate (104), thereby preventing relative movement between the substrate (104) and the housing (105).

7. The optical module as described in claim 5, wherein, The one or more legs (108) are configured to engage with one or more corresponding holes on the printed circuit board of the laboratory reader device to align the position of the optical module (100) relative to the printed circuit board of the laboratory reader device.

8. The optical module as described in any one of claims 1 to 3, comprising: One or more second baffles (111) are located on the inner surface of the housing (105) between the first opening and the second opening (106, 107), the second baffles (111) being used to block light from propagating from the first light source (101) to the control area and to block light from propagating from the second light source (102) to the test area.

9. The optical module as described in any one of claims 1 to 3, The first and second light sources (101, 102) and / or the optical detector (103) are encapsulated in a molding polymer compound (407a), and The first and second optical paths are provided through a molded polymer compound (407a).

10. The optical module of any one of claims 1 to 3, wherein a portion (901) of the housing (105) comprises a transparent material having an opaque material (902) on its surface, and wherein the first opening and / or the second opening comprises gaps (903, 904) in the opaque material (902).

11. The optical module according to any one of claims 1 to 3, wherein the optical module includes an electrical signal processor, wherein the first light source (101), the optical detector (103), and the second light source (102) and / or the electrical signal processor are arranged adjacent to each other in a first planar arrangement, wherein the first opening (106) and the second opening (107) are arranged in a second planar arrangement parallel to and facing the first planar arrangement.

12. A laboratory reader device (1000) comprising an optical module (100) as claimed in any one of claims 1-11.

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