Analyzer with transparent barrier for protecting imaging system

Abstract

A method having: receiving an image of a detection device through a transparent barrier not associated with an imaging system, where the transparent barrier is positioned within a housing of a reagent analyzer; comparing the received pixel data of the image of the detection device penetrating through the transparent barrier to determine the shielding degree of the transparent barrier; determining whether the degree of occlusion exceeds a baseline value, the baseline value indicating a potential occlusion; and in response to the degree of occlusion exceeding the baseline value, causing a behavior selected from the group consisting of: initiating an alert in a form perceptible to a person; storing data indicating that the degree of occlusion detected within the image exceeds the baseline value; initiating a cleaning process, the cleaning process configured to clean the transparent barrier; and replacing the transparent barrier with a replaced transparent barrier having a degree of occlusion less than the baseline value.

Description

[0001] Cross-reference / Incorporation by Reference Statement of Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 368,681, filed on July 18, 2022, under 35 USC §119(e). The entire contents of the above patent application are hereby expressly incorporated herein by reference.

[0003] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0004] not applicable. Technical Field

[0005] The inventive concepts disclosed herein generally relate to an analyzer having a transparent barrier positioned between an optical reader and a sample holder, and more specifically, but not by way of limitation, to systems and methods configured to determine an obstruction of a transparent barrier when viewing a sample holder through the transparent barrier. Background Art

[0006] In order to meet the needs of the medical industry as well as other evolving technologies (e.g., brewing, chemical manufacturing, etc.), a large number of analytical procedures, compositions and tools have been developed, including lateral flow immunoassays and so-called "dip and read" type reagent detection devices. Whether the lateral flow immunoassay or dip and read detection device is used to analyze biological fluids or tissues, or to analyze commercial or industrial fluids or substances, the general procedure involves contacting the detection device with the sample or specimen to be detected, and analyzing the detection device manually or instrumentally.

[0007] Lateral flow immunoassay is a diagnostic device for confirming the presence or absence of a target analyte. Lateral flow immunoassays generally include a flow path that transfers a sample through a control line position and a test line position. The control line at the control line position confirms that the test is working properly, and the test line at the test line position provides the result of the lateral flow immunoassay. Lateral flow immunoassays are developed to be used in the form of test paper or packaged detection. The working mode of both test paper and packaged detection is similar, and generally falls into one of the following two categories: sandwich determination—the presence of a colored line at the test line position indicates a positive; and competitive determination—the absence of a colored line at the test line position indicates a positive.

[0008] Immerse and read reagent detection devices are widely used in many analytical applications, especially in chemical analysis of biological fluids, due to their relatively low cost, ease of use, and speed of obtaining results. In medicine, for example, a variety of physiological functions can be monitored by simply immersing an immerse and read reagent detection device in a sample of body fluid or tissue (e.g., urine or blood) and observing a detectable response (e.g., a color change or a change in the amount of light reflected from or absorbed by the detection device).

[0009] Many of the dip and read reagent test devices for detecting body fluid components are capable of quantitative or at least semi-quantitative measurements. Thus, by measuring the detectable response after a predetermined time, the user can obtain not only a positive indication that a particular component is present in the test sample, but also an estimate of the amount of that component present. Such dip and read reagent test devices provide physicians and laboratory technicians with a convenient diagnostic tool and the ability to gauge the extent of a disease or bodily dysfunction.

[0010] Examples of currently used dip and read reagent test devices are products available from Siemens Healthcare Diagnostics Inc. under the trademark MULTISTIX, among others. Immunochemical, diagnostic or serological test devices, such as these, typically include one or more carrier matrices (e.g., blotting paper) into which are bound specific reagents or reactant systems that exhibit a detectable response (e.g., a color change in the visible or ultraviolet spectrum) when a specific test sample component or component is present. Depending on the reactant system bound to the specific matrix, these test devices can detect the presence of glucose, ketone bodies, bilirubin, urobilinogen, occult blood, nitrites, and other substances. After the dip and read reagent test device is contacted with the sample, a specific change in color intensity observed within a specific time frame indicates the presence and / or concentration of a specific component in the sample. Some other examples of dip and read reagent detection devices and their reagent systems can be found in US Pat. Nos. 3,123,443, 3,212,855, and 3,814,668, the entire disclosures of which are hereby incorporated by reference herein.

[0011] However, there are some limitations in immersing and reading the reagent detection device. For example, immersing and reading the reagent detection device usually requires the technician to manually immerse the detection device in the sample, wait for the time amount of regulation, and visually compare the color of the detection device with the color table attached to the detection device. This process is slow and the final reading is highly dependent on skills (for example, accurate timing, appropriate comparison with the color table, ambient lighting conditions and the technician's eyesight), and may be inconsistent between two different technicians implementing the same detection. Finally, the behavior of manually immersing the detection device in the sample may cause cross contamination or detect the improper deposition of the sample on the detection device, for example, because the detection device is not fully inserted into the sample, the sample is deposited on the time deficiency on the detection device, or the sample on the detection device is too much, and it may drip, leak or splash on the technician's work area, personnel or clothing.

[0012] The art has been seeking detection tools and methods to economically and quickly perform multiple tests, especially through the use of automated processing. Automated analyzer systems have advantages over manual testing in terms of cost per test, test throughput, and / or speed of obtaining test results or other information.

[0013] Automated instruments currently available for reading a single reagent detection device via an instrument (e.g., lateral flow immunoassay or immersion and reading reagent detection device or reagent strip, such as the CLINITEK STATUS reflectance photometer manufactured and sold by Siemens Healthcare Diagnostics) require that each detection device be manually loaded into the automated instrument after the detection device contacts the sample or specimen to be detected. Manual loading requires that the reagent detection device be correctly positioned in the automated instrument within a limited period of time after contacting the solution or substance to be detected. At the end of the analysis, the used reagent detection device is removed from the instrument and disposed of in accordance with applicable laws and regulations.

[0014] Another development is the introduction of multiple-profile reagent cards and multiple-profile reagent card automated analyzers.Multiple-profile reagent cards are essentially card-shaped detection devices, which include a plurality of reagent-impregnated substrates or pads, for implementing the multiple analysis of analytes simultaneously or sequentially, such as the one described in U.S. Patent No. 4,526,753, for example, the entire disclosure of which is incorporated herein by reference at this time.The reagent pads on the multiple-profile reagent cards are usually arranged in a grid-like arrangement, and are spaced a certain distance apart from each other, thereby limiting several rows and several columns of reagent pads.For example, adjacent reagent pads in the same row can be referred to as test strips, and can include the reagent of the preset detection combination for each sample run.

[0015] Multi-stage reagent card causes efficient, economical, fast and convenient mode of implementing automated analysis.The automated analyzer that is configured to use multi-stage reagent card usually (for example from storage drawer or box) takes out multi-stage reagent card, and via card moving mechanism, multi-stage reagent card is advanced by analyzer on the travel surface, usually one step at a time, so that a detection strip (or a row of reagent pads) is positioned at the sample distribution position and / or one or more reading positions.Exemplary card moving mechanism comprises conveyor belt, ratchet mechanism, sliding ramp or card gripping or pulling mechanism.When multi-stage reagent card moves along the travel surface or travels and is positioned at the sample distribution position, one or more pipettes (for example, manually or automatically) deposit one or more samples of a certain volume on one or more reagent pads on the reagent card.Next, the reagent pad is positioned at one or more reading positions and analyzed (for example, manually or automatically) to measure the test result. Reagent card is for example placed in the visual field of an imaging system (for example, an optical imaging system, a microscope or a spectrometer), and one or more images of the reagent pad on the card are captured and analyzed (for example, an optical signal indicating the color of the reagent pad). Usually, the visual field of the imaging system is relatively large, to allow the multiple images of the same reagent pad to be captured when the reagent card moves in the visual field of the imaging system or steps across multiple reading positions. The visual field covers multiple reading positions or places, and when the reagent card advances across the visual field of the imaging system, each reagent pad passes through the reading position in a step-by-step manner. Because the analyzer moves the card between each reading position at known time intervals, the multiple images captured in the visual field of the imaging system allow the analyzer to determine the color change of the reagent pad, and the color change is the result of the reagent pad reacting with the sample at each reading position, for example, as a function of the time spent by the pad moving to the corresponding reading position. Finally, the used card is removed from the analyzer and properly processed.

[0016] In some analyzers, a sample tray holds consumables to be read, such as reagent cards. The sample tray is moved by a motor from outside the analyzer's housing to inside the housing, where an optical reader performs sample measurements. Surprisingly, it has been found that during this movement, excess fluid not captured by the consumables splashes onto any optical components above the sample holding area. When the optics become dirty, the analyzer needs to be cleaned or replaced, which can require a lot of time and cost and potentially hinder the ability to obtain results when needed, due to the risk that doctors may use incorrect results to treat patients.

[0017] Therefore, there is a need in the art for an analyzer having a sample tray that can be moved within the analyzer without contaminating the optics of an optical reader within the analyzer. For such an improved analyzer, the present disclosure relates to a transparent barrier that protects the optical components of the imaging system and that can be easily removed, cleaned, or replaced. Summary of the invention

[0018] In one embodiment, the inventive concept disclosed in the present invention is a reagent analyzer that solves the defects of the above-mentioned prior art. The reagent analyzer has a transparent barrier, an imaging system and a processor. The transparent barrier has a first side, a second side and an intermediate area extending between the first side and the second side. The imaging system has a field of view extending through the transparent barrier, and is configured to capture an image of a wet reagent detection device positioned at a reading position in the field of view, the image having a plurality of pixels. The processor is configured to receive an image, and analyze the pixels of the image to determine the presence or absence of a target component in a sample applied to a wet reagent pad. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] To assist one of ordinary skill in the relevant art in making and using the inventive concepts disclosed herein, reference is made to the accompanying drawings and schematic diagrams, which are not drawn to scale and in which, for consistency, like reference numerals are intended to refer to like or similar elements. For purposes of clarity, not every component is labeled in every figure. Certain features and certain views in the figures may be exaggerated and not shown to scale or in schematic form for the sake of clarity and conciseness. In the drawings:

[0020] Figure 1 is a front elevation view of an exemplary embodiment of an analyzer according to the inventive concepts disclosed herein, showing a transparent barrier positioned in the field of view of its imaging system.

[0021] Figure 2 yes Figure 1 Side elevation view of the analyzer.

[0022] Figure 3 is an end elevation view of an analyzer having a transparent barrier positioned within a slot formed in a housing according to the inventive concepts disclosed herein.

[0023] Figure 4A is a bottom plan view of a circuit board having an aperture surrounded by an onboard light source to facilitate controlled illumination of a reagent card and reduce light scatter detected by an imaging system in accordance with the inventive concepts disclosed herein.

[0024] Figure 4B is a side elevation view of a transparent barrier positioned beneath a circuit board having an aperture surrounded by one or more illumination sources according to the inventive concepts disclosed herein.

[0025] Figure 5 is a top plan view of a sample holder and detection device viewed through a transparent barrier according to the inventive concepts disclosed herein.

[0026] Figure 6 is a top plan view of a sample holder and a detection device viewed through a transparent barrier according to the inventive concepts disclosed herein, wherein the transparent barrier has an exemplary degree of obscuration based on the material present on the first surface of the transparent barrier.

[0027] Figure 7 is a top plan view of a sample holder and a detection device viewed through a transparent barrier, wherein the transparent barrier has a Figure 5 The top view of the floor plan has a higher degree of obstruction.

[0028] Figure 8 is a flow chart of an exemplary embodiment of a method for determining an occlusion degree of a transparent barrier according to the inventive concepts disclosed herein.

[0029] Fig. 9 is a bottom plan view of a transparent barrier with holes according to the inventive concepts disclosed herein.

[0030] Fig.10 yes Fig. 9 A side elevation view of a transparent barrier positioned half-open on a track constructed according to the present disclosure and having an engagement member.

[0031] Fig.11 is a side elevation view of a transparent barrier engaging a track, with the engaging member of the track positioned at Fig. 9 inside the hole of the transparent barrier.

[0032] Fig.12 yes Fig. 9 A top plan view of a transparent barrier engagement track having an engagement member according to the inventive concepts disclosed herein positioned within an aperture of a transparent barrier. DETAILED DESCRIPTION

[0033] Before explaining in detail at least one embodiment of the inventive concepts disclosed herein, it should be understood that the application of the inventive concepts is not limited to the details of the structure and arrangement of the components or steps or methods set forth in the following description or shown in the accompanying drawings. The inventive concepts disclosed herein can have other embodiments or be practiced or implemented in various ways. Also, it should be understood that the words and terms used herein are for descriptive purposes and should not be construed as limiting the inventive concepts disclosed and claimed herein in any way.

[0034] In the following detailed description of the embodiments of the inventive concepts, numerous specific details are set forth in order to provide a more thorough understanding of the inventive concepts. However, it will be apparent to one of ordinary skill in the art that the inventive concepts disclosed herein may be practiced without these specific details. In other cases, well-known features have not been described in detail to avoid unnecessarily complicating the present disclosure.

[0035] As used herein, the terms "comprises," "including," "comprising," "containing," "having," "having," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherently present therein.

[0036] Unless expressly stated otherwise, "or" refers to an inclusive or rather than an exclusive or. For example, a condition A or B is satisfied by any of the following: A is true (or exists) and B is false (or does not exist), A is false (or does not exist) and B is true (or exists), and both A and B are true (or exist).

[0037] In addition, the use of "a" or "an" is used to describe the elements and components of the embodiments herein. This is done only for convenience and to give an overall meaning of the inventive concept. This description should be understood to include one or at least one, and the singular also includes the plural, unless it is obvious that there is another meaning.

[0038] Furthermore, as used herein, any reference to "one embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in association with the embodiment is included in at least one embodiment. The phrase "in one embodiment" appearing in various places in the specification does not necessarily refer to the same embodiment.

[0039] As used herein, a "wet reagent detection device" refers to a reagent device having a volume of sample deposited thereon so that the reagent in the reagent device can react with a target component of the reagent in the reagent device if such component is present in the sample. The wet reagent detection device may also have a volume of a negative control deposited thereon.

[0040] As used herein, "reagent test device" refers to a carrier having reagents. Exemplary reagent devices include a reagent pad that is dipped into and read from a test strip or a control strip or test strip of a lateral flow immunoassay.

[0041] Finally, qualifiers such as "about," "approximately," and "substantially," as used herein, are intended to indicate that the modified item is not limited to the particular exact value, but rather includes some slight variations or deviations from that value, such as those resulting from measurement error, manufacturing tolerances, stresses imposed on various parts, wear and tear, and combinations thereof.

[0042] The inventive concepts disclosed herein generally relate to an analyzer for a reagent detection device and a method for reading a reagent detection device, and more particularly, but not in a limiting manner, to an analyzer having a transparent barrier in the field of view of an imaging system and having a sample holder, so that the imaging system is configured to capture an image of the sample holder through the transparent barrier. In some embodiments, the analyzer includes a processor. The processor is configured to receive an image and analyze the pixels of the image to determine the degree of occlusion of the transparent barrier. Although the inventive concepts disclosed herein will be mainly described in conjunction with an automatic analyzer using a multi-stage reagent card as a reagent detection device, the inventive concepts disclosed herein are not limited to automatic analyzers or multi-stage reagent cards. For example, the method according to the inventive concepts disclosed herein can be implemented with a manual analyzer, or can be implemented with an automatic analyzer using a reagent detection device other than a multi-stage reagent card, such as a lateral flow immunoassay, immersion and reading of a reagent detection device or a reagent detection device roll on a substrate and a combination thereof, as will be appreciated by those skilled in the art who benefit from the present disclosure. In addition, the inventive concepts disclosed herein can be implemented with any reagent device imaging system having a field of view, with at least one reading position in the field of view.

[0043] In particular, when the reagent detection device is exposed to the sample, the signal value indicating the color of the reagent detection device (e.g., reagent pad, control line, or test line) will change. For negative solutions, the change in the signal value is known (or can be measured), and therefore can become an optional offset signal value. Any change outside the offset signal value may be caused by the reaction with the clinical component being measured.

[0044] Reference now Figure 1-3 , which shows an exemplary embodiment of a reagent analyzer 10 according to the inventive concepts disclosed herein. The reagent analyzer 10 can be, for example, an automatic reagent card analyzer. Exemplary embodiments of automatic reagent card analyzers are described in detail in U.S. Patent Application Serial No. 13 / 712,144 filed on December 12, 2012 and PCT Application No. PCT / US2012 / 069621 filed on December 14, 2012, the entire disclosures of which are expressly incorporated herein by reference.

[0045] In general, the exemplary reagent analyzer 10 may include a housing 14 having a slot 15, the housing 14 surrounding a cavity 18. The reagent analyzer 10 also includes at least one track 19, an imaging system 22 including at least one camera 26, a sample tray 30 having a sample holder 32 positioned within the cavity 18, a transparent barrier 31, and a circuit board 34 positioned within the cavity 18 having an aperture 38 and one or more illumination sources 42a-n.

[0046] The housing 14 can be formed of one or more components configured to form a cavity 18 and support at least one track 19, an imaging system 22, a sample tray 30, a transparent barrier 31, and a circuit board 34. In one embodiment, the housing 14 is opaque to visible light. In another embodiment, the housing 14 is opaque to one or more wavelengths of light generated by one or more illumination sources 42a-n. In one embodiment, the housing 14 can normalize ambient light. In other non-limiting embodiments, the housing 14 has a slot 15 within which the transparent barrier 31 can be positioned into the housing 14 and from which the transparent barrier 31 can be removed from the housing 14.

[0047] The transparent barrier 31 has at least one side wall 33, at least one end 35, a first surface 36 extending between the at least one side wall 33 and the at least one end 35, a second surface 37 extending between the at least one side wall 33 and the at least one end 35 and positioned opposite to the first surface 36, and an intermediate region 41 extending between the first surface 36 and the second surface 37. In one non-limiting embodiment, the transparent barrier 31 has a first side wall 33a, a second side wall 33b positioned opposite to the first side wall 33a, a first end 35a, a second end 35b positioned opposite to the first end 35a, a first surface 36 extending from the first end 35a to the second end 35b, a second surface 37 extending from the first end 35a to the second end 35b and positioned opposite to the first surface 36, and an intermediate region 41 extending between the first surface 36 and the second surface 37. In one embodiment, the transparent barrier 31 is transparent to visible light, such that light can travel through the transparent barrier 31 without significant scattering, thereby allowing objects positioned on the other side of the transparent barrier 31 to be clearly seen and imaged. In some embodiments, the transparent barrier 31 may have a translucent property so that light can travel through the transparent barrier 31 with scattering, thereby allowing objects positioned on the other side of the transparent barrier 31 to be seen with different clarity. The first surface 36 and the second surface 37 may both be planar and substantially parallel to avoid amplifying visible light passing through the transparent barrier 31. As will be discussed in more detail below, the transparent barrier 31 is configured to protect the imaging system 22 from splashes or other debris generated by the sample tray 30 being moved into and out of the housing 14. In some non-limiting embodiments, the transparent barrier 31 can be moved into and out of the housing 14 through the slot 15. For example, the transparent barrier 31 may have a grip (not shown) on at least one end 35 of the transparent barrier 31. The grip may be a textured surface, such as frosting or etching on the first surface 36 and / or the second surface 37, or may include a handle extending from and / or connected to the first surface 36 and / or the second surface 37. In some non-limiting embodiments, the transparent barrier 31 has a hole 43 positioned on an edge of the transparent barrier 31, the hole 43 extending from the first surface 36 through the middle region 41 to the second surface 37 ( Fig. 9 ).

[0048] In some non-limiting embodiments, at least one track 19 may be positioned within cavity 18 adjacent to slot 15 such that when transparent barrier 31 is positioned within slot 15, surface 37 of transparent barrier 31 may be positioned on at least one track 19. In other non-limiting embodiments, at least one track 19 may be positioned within cavity 18 adjacent to slot 15 such that when transparent barrier 31 is positioned within slot 15, surface 36 of transparent barrier 31 may be positioned on at least one track 19. In some non-limiting embodiments, at least one track 19 may have an engagement member 45 oriented such that when transparent barrier 31 is positioned within cavity 18, engagement member 45 positions transparent barrier 31 in a half-open position ( Fig.10 When the transparent barrier 31 is inserted into the cavity 18, the second surface 37 of the transparent barrier 31 will be positioned on the at least one track 19, and the engaging member 45 will be positioned in the hole 43 of the transparent barrier 31 ( Fig.11 and 12 ). In order for a user to remove the transparent barrier 31 from the cavity 18, an upward force may be applied to the second surface 37 of the transparent barrier 31 to remove the engagement member 45 from the hole 43 of the transparent barrier 31. After the engagement member 45 is removed from the hole 43, the transparent barrier 31 may be removed from the cavity 18. The transparent barrier 31 may serve as a barrier to prevent debris from the sample holder 32 from contacting the circuit board 34 and / or the imaging system 22.

[0049] The imaging system 22 includes at least one camera 26 and is supported by the housing 14. In one embodiment, for example, the imaging system 22 may be fixed to the housing 14 or fixed at a relative distance from the sample tray 30 or the transparent barrier 31. The imaging system 22 and / or the camera 26 may include one or more lenses whose focal length is selected to provide a field of view 40 to include at least the hole 38 of the circuit board 34.

[0050] For example, the imaging system 22 can be implemented and used as any desired reader such that the field of view 40 of the imaging system 22 substantially includes the entire hole 38 of the circuit board 34. The imaging system 22 can be supported in a position above, below, or beside the sample tray 30. In some embodiments, the field of view 40 can extend from the imaging system 22 to the hole 38 in a linear direction. In other embodiments, due to the presence of one or more optical steering components in the field of view 40, the field of view 40 can extend from the imaging system 22 to the hole 38 in a non-linear direction. Exemplary optical steering components include (one or more) mirrors, (one or more) lenses, (one or more) beam splitters, or combinations thereof. The imaging system 22 can, for example, be configured to detect or capture an image or optical signal (such as a reflectance value or color value) indicative of a reagent pad, a lateral flow assay, or the like. Figure 5-734, and will be discussed in more detail below), the reagent pad, lateral flow assay, etc. are positioned in the field of view 40 of the imaging system 22. In other non-limiting embodiments, the imaging system 22 may be configured to detect or capture an image or optical signal indicating a reflectance value or color value of the sample holder 32 through the transparent barrier 31, and the sample holder 32 is positioned in the field of view 40 of the imaging system 22. However, it should be understood that in some exemplary embodiments, the field of view 40 of the imaging system 22 may include only a portion of the hole 38 of the circuit board 34. It should also be understood that in some exemplary embodiments, the field of view 40 of the imaging system may include only a portion of the transparent barrier 31. The camera 26 of the imaging system 22 may include any desired digital or analog imager, such as a digital camera, an analog camera, a CMOS imager, a diode, and combinations thereof. For example, the imaging system 22 may also include a lens system, an optical filter, a collimator, a diffuser, or any other optical signal processing device. Furthermore, imaging system 22 is not limited to optical imagers in the visible spectrum, and may include, for example, infrared imaging systems, ultraviolet imaging systems, microwave imaging systems, X-ray imaging systems, and / or other desired imaging systems. Non-exclusive examples of imaging system 22 include, for example, optical imaging systems, spectrophotometers, gas chromatographs, microscopes, infrared sensors, and combinations thereof.

[0051] In one embodiment, the imaging system 22 includes at least one camera 26 and a lens, wherein the at least one camera 26 is an AR0239: CMOS Image Sensor, 2.3MP, 1 / 2.7", and the lens is a DSL949 Sunex lens (Sunex Corporation, Carlsbad, CA), which are both configured to maintain a large field of view 40 while maintaining low geometric image distortion, thereby providing a resolution of 1080 pixels by 1920 pixels, wherein each pixel depicts approximately 0.065 mm of the sample tray 30 and / or sample holder 32. 2 area.

[0052] Sample tray 30 can be configured to adjust the position of sample holder 32 in visual field 40. Sample holder 32 can be configured to receive at least one of detection device 44, which can be a reagent card and a reagent cartridge, each of which has sample 46. For example, sample 46 can be any body fluid, tissue or any other chemical or biological sample and combination thereof, such as urine, saliva or blood. For example, sample 46 can be in liquid form and can include one or more target components, such as bilirubin, ketone, glucose or any other desired target component.

[0053] A circuit board 34 having an aperture 38 may be positioned within the cavity 18 and between the imaging system 22 and the sample tray 30 such that the field of view 40 of the imaging system 22 is substantially unobstructed from the view of the sample holder 32, the detection device 44, and / or the sample 46. Figure 1-2 and Figure 4B 30 and are described in more detail below. In one embodiment, the circuit board 34 is positioned at a fixed position between the imaging system 22 and the sample tray 30; however, in another embodiment, the circuit board 34 can be adjusted to a varying position between the imaging system 22 and the sample tray 30. If the circuit board 34 is adjustable, a calibration procedure (described below) must be performed after any adjustment. In other non-limiting embodiments, the circuit board 34 can be positioned between the imaging system 22 and the transparent barrier 31 so that the field of view 40 of the imaging system 22 is substantially unobstructed from the view of the sample holder 32, the detection device 44 and / or the sample 46.

[0054] Reference again Figure 1 and Figure 2 , the housing 14 may include a plurality of connected side walls 80, 82, 84, and 86 that cooperate to surround the cavity 18. The side wall 80 is spaced apart from the side wall 82, and the side wall 84 is spaced apart from the side wall 86. The transparent barrier 31 may be sized and dimensioned so that it traverses the cavity 18 between the side walls 80 and 82 and the side walls 84 and 86, thereby dividing the cavity 18 into a first portion 88 and a second portion 90. In some embodiments, the transparent barrier 31 may have a length L between about 5 cm and about 21 cm. In some non-limiting embodiments, the transparent barrier 31 may be a protective device for the lens, wherein the transparent barrier 31 may have a length of about 5 cm. In other non-limiting embodiments, the transparent barrier 31 may be a protective device for the lens and optical components, wherein the transparent barrier 31 may have a length of about 14 cm. In some non-limiting embodiments, wherein the transparent barrier 31 is a protective device for the lens and optical components, the transparent barrier 31 may not be removable from the reagent analyzer 10.

[0055] refer to Figure 3, which shows an end elevation view of a transparent barrier 31 positioned within a slot 15 according to the inventive concepts disclosed herein. In some embodiments, the housing 14 has a slot 15, and the transparent barrier 31 is positioned within the cavity 18, adjacent to the slot 15, the slot having a width W1 and a height d1, and the transparent barrier 31 having a width W2 less than the width W1 of the slot 15 and a thickness d2 less than the height d1 of the slot 15. In an exemplary, non-limiting embodiment, the slot may have a width W1 of approximately 4.5 cm, a height d1 of approximately 0.2 cm, and the transparent barrier 31 may have a width W2 of approximately 4.3 cm and a thickness d2 of approximately 0.1 cm. In some non-limiting embodiments, the height d1 of the slot 15 may be greater than 0.1 cm. In some non-limiting embodiments, the thickness d2 of the transparent barrier 31 may be between approximately 0.1 cm and approximately 0.3 cm. In some embodiments, the width W1 of the slot 15 may be between approximately 1.7 cm and approximately 4.5 cm. In some non-limiting embodiments, the width W2 of the transparent barrier 31 may be between about 1.5 cm and about 4.3 cm. In some embodiments, the transparent barrier 31 is movably supported within the housing 14 and aligned with the slot 15 so that the transparent barrier 31 can move through the slot 15. In some embodiments, the surface 36 and the surface 37 of the transparent barrier 31 are planar and parallel within the middle region 41 to avoid distorting or scattering light passing through the transparent barrier 31. The transparent barrier 31 may be separate from the imaging system 22 and configured to block debris from the sample tray 30 from contacting the imaging system 22. The transparent barrier 31 may be constructed of glass, ceramic, plastic (e.g., acrylic, polycarbonate), etc.

[0056] For example, the illumination sources 42a-n may be implemented as one or more of: light emitting diodes, light bulbs, lasers, incandescent light bulbs or tubes, fluorescent light bulbs or tubes, halogen light bulbs or tubes, or any other desired light source or object configured to emit light signals having any desired intensity, wavelength, frequency, or propagation direction. The illumination sources 42a-n may be attached to the circuit board 34 and may be oriented such that substantially the entire field of view 40 of the imaging system 22 is illuminated by the illumination sources 42a-n. In some exemplary embodiments, the illumination sources 42a-n may be operably coupled to the controller 144 (see Figure 4B - described in detail below) so that control and / or power signals can be supplied to the illumination sources 42a-n by the controller 144. Desirably, the intensity of the light signals emitted by the illumination sources 42a-n is maintained substantially constant during operation of the reagent analyzer 10, for example, by the control and power signals supplied by the controller 144. In one embodiment, for example, the light signals emitted by the illumination sources 42a-n can be conditioned or processed by one or more optical or other systems (not shown), such as filters, diffusers, polarizers, lenses, lens systems, collimators, and combinations thereof.

[0057] In some exemplary embodiments, one or more illumination sources 42a-n, such as first illumination source 42a and second illumination source 42b, may be implemented, and first illumination source 42a and second illumination source 42b may have different positions and / or orientations, resulting in first illumination source 42a and second illumination source 42b cooperating to illuminate substantially the entire field of view 40 (e.g., substantially the entire sample holder 32 and / or sample 46) of imaging system 22. For example, first illumination source 42a and second illumination source 42b may emit light signals having different illumination intensities.

[0058] In one embodiment, for example, the sample holder 32 may be adapted to receive a test device 44 in the form of a reagent cartridge having one or more multiple reagent cards 124 therein. Figure 5-7 1 and described in more detail below. Each reagent card 124 (described in detail below) may include a substrate and one or more reagent pads positioned thereon or otherwise associated therewith. In an exemplary embodiment, the reagent pad may include a fluid or microfluidic compartment (not shown).

[0059] Each reagent pad of one or more reagent cards positioned in the detection device may include a reagent that is configured to respond to the presence of a target component (e.g., molecule, cell, or material) in the sample 46 of the sample deposited on the reagent pad and a color change occurs. The reagent pad may be provided with different reagents for detecting the presence of different target components. Different reagents may cause one or more color changes in response to the presence of a certain component (e.g., an analyte of a certain type) in the sample 46. The color produced by the reaction of a specific component and a specific reagent may define the characteristic discrete spectrum of the absorption and / or reflection of the light of this specific component. For example, the degree of the color change of reagent and sample 46 may depend on the amount of the target component present in the sample 46.

[0060] For example, the presence and concentration of these target components in the sample 46 may be determined by analyzing the color change experienced by one or more reagent pads at predetermined times after the sample 46 is applied to the reagent pads and / or at predetermined reading locations in the field of view of the imaging system 22. Such analysis may involve comparing the color of each reagent pad to itself at different time periods after application of the sample 46 and / or at different reading locations in the field of view 40 of the imaging system 22.

[0061] For example, based on an analysis of the amplitude of the optical signal detected by the imaging system 22, the sample 46 can be assigned to one of a plurality of categories, for example, a first category corresponding to the absence of a target component in the sample 46, a second category corresponding to the presence of a small concentration of the target component in the sample 46, a third category corresponding to the presence of a medium concentration of the target component in the sample 46, and a fourth category corresponding to the presence of a large concentration of the target component in the sample 46.

[0062] In addition, for example, the imaging system 22 can detect an optical signal indicating the color or reflectivity value of a reagent pad and / or test strip at any time interval after a volume of sample 46 has been deposited onto a detection device 44 (e.g., a reagent pad and / or test strip), and regardless of the location of the particular reagent pad and / or test strip. In an exemplary embodiment, a sequence of videos or images of a reagent pad and / or test strip can be captured at various time intervals after a volume of sample 46 has been deposited onto the reagent pad and / or test strip.

[0063] For example, the imaging system 22 may be operated intermittently, continuously, or periodically to detect one or more reflectance signals indicative of the color or reflectance value of one or more detection devices 44 (e.g., reagent pads) at any time and at any location in the field of view of the camera 26. In some exemplary embodiments, for example, the imaging system 22 may capture an image indicative of the color or reflectance value of a detection device 44 (e.g., reagent pad) before any sample 46 is deposited on the reagent pad or at any known time after a volume of sample 46 has been deposited on the reagent pad.

[0064] Reference now Figure 4A , which shows a bottom plan view of a circuit board according to the inventive concepts disclosed herein, the circuit board having a hole surrounded by an onboard light source to facilitate controlled illumination of the reagent card and reduce light scatter detected by the imaging system 22.

[0065] Controlled illumination will be described herein by way of example as uniform illumination over a certain extent (i.e., length and width) of the sample holder 32 and / or sample 46 within acceptable limits. However, it should be understood that the present disclosure is not limited to uniform illumination. The circuit board 34 is comprised of a substrate 60 having a bottom surface 61a and a top surface 61b, a plurality of conductive leads extending on or in the substrate 60, and a hole 38 extending between the bottom surface 61a and the top surface 61b.

[0066] exist Figure 4A In one embodiment shown in FIG. 4 , the one or more illumination sources 42 a - n are a plurality of LEDs 64 a - n and one or more IR LEDs 68 . Figure 4A The LEDs 64a-n shown in FIG. 6 include LEDs arranged as shown in FIG. Figure 4A1 and 2. The LEDs 64a-n include any LEDs required to produce a substantially uniform light intensity on the sample holder 32 and / or reagent card 124 or reagent cartridge. For example, the IR LEDs 68 may be used to apply heat to the sample 46, or to identify an ID pad on the detection device 44. In one embodiment, the ID pad is used to associate the sample 46 on the detection device 44 supported by the sample holder 32 with the data obtained by the reagent analyzer 10.

[0067] In one embodiment, the plurality of LEDs 64a-n are selected to provide a fixed color, visible light, ultraviolet light, infrared light, or white light, or some combination thereof. In another embodiment, each LED 64a-n is positioned at an angle relative to the reagent card 124. In another other embodiment, each LED 64a-n is positioned at one or more distances from the detection device 44 supported by the sample holder 32, so that the first LED 64 and the second LED 64 are at different distances from the detection device 44 and / or the sample holder 32.

[0068] In some non-limiting embodiments, by adjusting the power level of each LED 64a-n, a substantially uniform light intensity can be achieved. Substantially uniform light intensity can be between 85%-100% uniform. The construction, use and calibration of the circuit board 34 are described in U.S. Serial Nos. 63 / 064,609 and 63 / 225,124.

[0069] like Figure 4A The circuit board 34 shown in the figure depicts that the bottom surface 61a of the circuit board 34 has one or more illumination sources 42a. When placed in the reagent analyzer 10, the bottom surface 61a is oriented to face the sample tray 30 so that the light generated by the one or more illumination sources 42a-n can directly irradiate the sample holder 32 and / or the sample 46. The illumination sources 42a-n are connected to a plurality of conductive leads of the circuit board 34 so that the conductive leads provide power to each illumination source 42a-n. In one embodiment, the circuit board 34 also includes an illumination source circuit (not shown) connected to a plurality of conductive leads and configured to independently apply power to each illumination source 42a-n. For example, the illumination source circuit can be configured to provide a first power to the first illumination source 42a and a second power to the second illumination source 42b, wherein the first power and the second power are different, thereby causing different illumination intensities on the sample. The illumination sources 42a-n are arranged so that the illumination intensity is substantially uniform across the field of view 40 of the camera 26, thereby increasing the accuracy of reading the color change of the reagent pad because the reagent pad is illuminated with a substantially uniform intensity (below and above the reagent pad). Figure 5-7 ). Figure 4BAs shown, the substrate 60 of the circuit board 34 is substantially planar, resulting in each of the one or more illumination sources 42a-n being located at a similar distance from the sample tray 30. Depending on the location of the illumination sources 42a-n relative to the sample 46, the distance between the illumination sources 42a-n and the sample 46 may be different for some of the illumination sources 42a-n. However, in other embodiments, the circuit board 34 may be non-planar, resulting in one or more of the illumination sources 42a-n being positioned at different distances from the sample tray 30. In one embodiment, the one or more illumination sources 42a-n may be secured to a bracket (not shown), wherein each bracket is secured to the circuit board 34 and provides one or more conductive paths to a specific one of the illumination sources 42a-n. When the bracket is used, this may result in a portion of the one or more illumination sources 42a-n being closer to the sample 46 and / or the sample tray 30.

[0070] In one embodiment, the substrate 60 has a first region 62a, a second region 62b opposite the first region 62a, and an intermediate region 62c between the first region 62a and the second region 62b. One or more illumination sources 42a-n may be fixed to the substrate 60 in each of the first region 62a, the second region 62b, and the intermediate region 62c, or in some combination thereof. In one embodiment, a first power may be applied to the one or more illumination sources 42a-n in the first region 62a and the second region 62b, so that the one or more illumination sources 42a-n in the first region 62a and the second region provide a first illumination intensity, and a second power may be applied to the one or more illumination sources 42a-n in the intermediate region 62c, so that the one or more illumination sources 42a-n in the intermediate region 62c provide a second illumination intensity, the first power and the second power are different, and the first illumination intensity and the second illumination intensity are different.

[0071] The hole 38 of the circuit board 34 extends from the top surface 61b to the bottom surface 61a to provide an opening for the field of view 40 of the imaging system 22 to pass from the imaging system 22 through the transparent barrier 31 to the sample holder 32, and to provide the camera 26 with a controlled field of view of the detection device 44 associated with the sample holder 32. The hole 38 can be further configured so that the bottom surface 61a of the circuit board 34 can include one or more illumination sources 42a-n on each side of the hole 38. In one embodiment, the hole 38 is substantially positioned within the middle region 62c. In one embodiment, the hole 38 has a first major axis and a first minor axis and the sample holder 32 has a second major axis and a second minor axis, wherein the first major axis is aligned with the second major axis. Although the hole 38 is Figure 4A38 is depicted as a rectangle in order to provide a controlled field of view of the rectangular reagent detection device, but it should be understood that the aperture 38 can be configured in any shape so that the field of view 40 is a controlled field of view of the sample tray 30 and the illumination source 42 can be calibrated to provide substantially uniform illumination of the sample 46. Figure 4A In the example shown, the hole 38 does not extend to the edge of the circuit board 34.

[0072] In one embodiment, the hole 38 extends to the edge of the circuit board 34 without bisecting the circuit board 34, while in another embodiment, the hole 38 extends through the entire circuit board 34, bisecting the circuit board into a first half and a second half, wherein the first half and the second half are mounted at separate locations and supported by the housing 14 so that the field of view 40 is a controlled field of view of the sample tray and the illumination source 42.

[0073] exist Figure 6-8 In some non-limiting embodiments shown in, reagent card 124 may include substrate 128 and one or more or a plurality of reagent pads 132a-n positioned thereon or otherwise associated therewith. Substrate 128 may, for example, be made of any suitable material, such as paper, photographic paper, polymer, fibrous material and combination thereof. For example, reagent pads 132a-n may be arranged on substrate 128 with a grid-like structure to limit one or more test strips. In an exemplary embodiment, reagent pads 132a-n may include fluid or microfluidic compartments (not shown). For example, reagent pads 132a-n may be spaced apart from each other by a certain distance so that the test strips are spaced apart so that adjacent test strips and / or reagent pads 132a-n may be positioned simultaneously in a separate position in the field of view 40 of imaging system 22. Reagent card 124 may be a multi-stage reagent card with a plurality of reagent pads 132a-n, and the reagent pads have different reagents and / or a plurality of different test strips. In addition, in some exemplary embodiments, the reagent card 124 may, for example, include one or more calibration chips or reference pads that may not have reagents and may be used as a color reference. In another embodiment, the reagent card 124 includes an ID pad having an identifier visible under IR light.

[0074] Each reagent pad 132a-n may include a reagent configured to change color in response to the presence of a target component (e.g., a molecule, a cell, or a substance) in a sample 46 of a sample deposited on the reagent pad 132a-n. The reagent pad 132a-n may be provided with different reagents for detecting the presence of different target components. Different reagents may cause one or more color changes in response to the presence of a certain component (e.g., a certain type of analyte) in the sample 46. The color produced by the reaction of a specific component with a specific reagent may define a characteristic discrete spectrum of light absorption and / or reflection of the specific component. For example, the degree of color change of the reagent and sample may depend on the amount of the target component present in the sample 46.

[0075] The color change can be read by the imaging system 22. The imaging system 22 can receive the signal of the color of the indication reagent pad 132a-n and / or capture it in the image, and the imaging system 22 can analyze the signal and determine that the reagent pad 132a-n reacts with the sample 46 of a certain volume deposited thereon and the color change of the reagent pad 132a-n caused by it. For example, this color change can be analyzed as a function of the reading position of the reagent pad 132a-n when the optical signal or image of the color of the indication reagent pad 132a-n is detected and / or analyzed as a function of the known duration of a certain volume of sample 46 deposited on the reagent pad 132a-n, and a combination thereof. The color change can be interpreted as a quantitative, qualitative and / or semi-qualitative indication of the presence and / or concentration or amount of the target component in the sample 46 of a certain volume deposited on the reagent pad 132a-n as described above.

[0076] Reference now Figure 4B , in which an analyzer diagram 140 is shown, which depicts an analyzer controller 144 and a reagent analyzer 10 including a transparent barrier 31. The analyzer controller 144 has at least one processor 148 and a non-transitory computer-readable memory 152. The memory 152 can store computer-executable instructions that, when executed by the processor 148, cause the processor 148 to communicate with other elements of the reagent analyzer 10 and / or be operably coupled to other elements of the reagent analyzer 10. Although the analyzer controller 144 is depicted separately from the reagent analyzer 10, it should be understood that in some embodiments, the analyzer controller 144 can be integrated into the reagent analyzer 10, for example, by way of example only, the analyzer controller 144 can be an additional component of the reagent analyzer 10, or can be integrated with another component of the reagent analyzer 10 (e.g., the circuit board 34).

[0077] In one embodiment, for example, the imaging system 22 may be operably connected to the analyzer controller 144 and / or the processor 148, such that one or more power and / or control signals may be transmitted by the controller 144 to the camera 126 and / or one or more illumination sources 42a-n, and such that one or more signals may be transmitted from the camera 126 to the processor 148. The analyzer controller 144 may be configured to measure the test results when the reagent card is sampled within the reagent analyzer 10, for example, by receiving one or more signals from the camera 126. For example, the camera 126 may be configured to detect or capture one or more optical or other signals indicating the reflectivity value of the detection device 44 (e.g., the reagent pad), for example, through the transparent barrier 31, and transmit the signal indicating the reflectivity value of the detection device 44 (e.g., the reagent pad) to the processor 118. For example, the camera 126 may detect one or more optical signals having a wavelength indicating the reflectivity value of the reagent pad and / or the test strip through the transparent barrier 31 at each reading position. For example, camera 126 can detect optical signals through transparent barrier 31, and the optical signal indicates any desired reading position, place or region in visual field 40, or the reflectivity value of reagent pad and / or detection strip at any other desired place or region or multiple places or regions.The signal transmitted to processor 148 by camera 126 can be an electrical signal, an optical signal and a combination thereof.In one embodiment, the form of signal is an image file with a pixel matrix, and each pixel has a color code indicating reflectivity value.In an exemplary embodiment, the image file can have two or more predetermined pixel areas, and each predetermined pixel area corresponds to a reading position in the reagent pad and / or detection strip in the visual field 40 of camera 126.In one embodiment, processor 148 can store the signal and / or image file of transmission in one or more databases 156 and / or in the memory 152.

[0078] For example, the processor 148 can determine the reflectivity value or color change of the sample (e.g., urine) of the reagent pad and / or the test strip and deposited on the reagent pad and / or the test strip based on the signal detected by the camera 126. Each optical or other signal indicating one or more reflectivity value readings detected by the camera 126 can have an amplitude associated with different light wavelengths (i.e., colors). The color of (one or more) samples and / or the reaction of one or more reagents with the target component in the reagent pad can be determined based on the relative amplitude of the reflection signal (e.g., red, green, and blue reflection component signals) of various color components. For example, the color of each reagent pad can be converted into a standard color model, which typically includes three or four values ​​or color components (e.g., RGB color model, including hue, saturation and brightness (HLS) and hue, saturation and color brightness (HSV) point representation and / or CMYK color model, or any other suitable color model), and its combination represents a specific color. In some embodiments, for example, camera 126 may detect multiple optical signals at each reading position, each detected signal having one or more color components, such as a red component signal, a green component signal, and a blue component signal, and each of the component signals may be transmitted to processor 148. In some exemplary embodiments, for example, camera 126 may detect a single optical signal at each reading position, and processor 148 may convert the signal received from camera 126 into separate color component signals, such as a red component signal, a green component signal, and a blue component signal.

[0079] In one embodiment, a method for determining the occlusion degree 150 of the transparent barrier 31 (described below and in Figure 8 140) may be implemented as a set of processor executable instructions or logic stored in a non-transitory computer readable medium, which, when executed by the processor 148, causes the processor 148 to determine the degree of occlusion of the transparent barrier 31. For example, the method for determining the degree of occlusion 150 may be performed periodically, such as at a preset internal time as desired according to a specific quality control program applicable to the reagent analyzer 10, and combinations thereof.

[0080] In some embodiments, the processor 148 is further configured to have a set of processor-executable instructions or logic stored in a non-transitory computer-readable medium, wherein the instructions or logic, when executed by the processor 148, cause the processor 148 to cause an action selected from the group consisting of the following actions at at least one periodic interval: initiating an alarm in a form perceptible to a human; initiating a cleaning process configured to clean the transparent barrier 31; and replacing the transparent barrier 31. In some embodiments, the periodic interval is based on a period of time or a number of tests performed by the reagent analyzer 10.

[0081] Reference now Figure 5-7 , therein are shown exemplary images 170a-c illustrating a top plan view of a sample holder 32 and a detection device 44 (in the form of a reagent card 172) viewed through an exemplary transparent barrier 31 positioned within the housing 14 of a reagent analyzer 10 according to the present disclosure. In one embodiment, the imaging system 22 can capture images 170 of the sample holder 32 and the detection device 44 through the exemplary transparent barrier 31 having different degrees of obstruction due to debris on the transparent barrier 31, which may be caused by splashes from the detection device 44 when the detection device 44 is moved by the sample holder 32.

[0082] Figure 5 An exemplary top plan view image 170a of a sample holder 32 with a detection device 44 in the form of a reagent card 174 viewed through a transparent barrier 31 without environmental objects 178 present on surface 36 or surface 37 of the transparent barrier 31 is illustrated.

[0083] Figure 6 An exemplary top plan view 170b of a sample holder 32 with a detection device 44 (in the form of a reagent card 174) viewed through a transparent barrier 31 with environmental objects 178, such as dust, present on a surface 36 or surface 37 of the transparent barrier 31 is shown. Figure 6 Many environmental objects 178 are shown in FIG. 1 , but for purposes of clarity, only one environmental object 178 is numbered.

[0084] Figure 7 An exemplary top plan view image 170c of a sample holder 32 having a detection device 44 (in the form of a reagent card 172) viewed through a transparent barrier 31 having a number of environmental objects 178, such as moisture, dust, and dirt, present on a surface 36 or a surface 37 of the transparent barrier 31 is illustrated.

[0085] Reference now Figure 8, which is a flow chart of an exemplary embodiment of a method 200 for determining an occlusion degree of a transparent barrier 31 according to the inventive concepts disclosed herein. The method 200 for determining an occlusion degree of a transparent barrier 31 generally includes the following steps: receiving a first image 170 of a detection device 44 positioned in a sample holder 32 through a transparent barrier 31 not associated with an imaging system 22, the transparent barrier 31 being positioned in the housing 14 of the reagent analyzer 10 and adjacent to the sample holder 32 (step 202); comparing pixel data of the received first image of the detection device 44 positioned in the sample holder 32 through the transparent barrier 31 with reference data stored in a non-transitory computer-readable medium to determine an occlusion degree of the transparent barrier 31 (step 204); identifying a material on a surface of the transparent barrier 31 to determine an occlusion degree of the transparent barrier 31 (step 206) ; determining whether the occlusion of the transparent barrier 31 exceeds a baseline value (which is stored in the non-transitory computer readable memory 152), the baseline value indicating potential occlusion of the transparent barrier 31 (step 208); and in response to the occlusion exceeding the baseline value, storing time-stamped data indicating that the transparent barrier 31 is occluded, and causing an action selected from the group consisting of the following actions: initiating an alarm in a form that can be perceived by a human; storing data in the non-transitory computer readable memory 152 indicating that the occlusion detected in the first image 170 exceeds the baseline value; initiating a cleaning process, the cleaning process is configured to clean the transparent barrier 31; replacing the transparent barrier 31 with a replacement transparent barrier 31 having an occlusion less than the baseline value (step 210). In a non-limiting embodiment, the reference data can be data of a manufacturing standard of the detection device 44 stored in a non-transitory computer readable medium.

[0086] In one embodiment, the transparent barrier 31 may not be associated with the imaging system 22. In this embodiment, the primary function of the transparent barrier 31 is to provide protection for the imaging system 22 and not affect the optical properties of the imaging system 22. The transparent barrier 31 may not be a component or lens of the imaging system 22. In some embodiments, the transparent barrier 31 may be used to protect the imaging system 22 and also affect the optical properties of the imaging system 22. For example, the transparent barrier 31 may include one or more polarizers or filters suitable for affecting the optical properties of the imaging system 22. In either embodiment, the imaging system 22 may be calibrated, as discussed below, to reduce any unintentional optical effects of the transparent barrier 31.

[0087] Cleaning or replacing the transparent barrier 31 improves the accuracy of the analysis provided by the reagent analyzer 10. In some embodiments, cleaning the transparent barrier 31 can be achieved by moving the transparent barrier 31 out of the housing 14 through the slot 15 (without disassembling the analysis device or directly accessing the optical system), cleaning the surface 36 or surface 37 of the transparent barrier 31, and moving the transparent barrier 31 into the housing 14 through the slot 15. Cleaning the transparent barrier 31 can be achieved manually by a person grasping the transparent barrier 31, or in an automated manner. In an automated version, a motor-driven wiper can be used to wipe and clean the surface 36 or surface 37. In some embodiments, replacing the transparent barrier 31 can be achieved by moving the transparent barrier 31 out of the housing 14 through the slot 15, discarding the transparent barrier 31, and moving the replacement transparent barrier 31 into the housing 14 through the slot 15.

[0088] The data indicating the occlusion degree may be stored in the memory 152, the database 156, a non-transitory computer-readable medium, etc. In other non-limiting embodiments, the data indicating that the transparent barrier 31 has an occlusion degree may have a timestamp. In other non-limiting embodiments, when the occlusion degree of the transparent barrier 31 does not exceed the baseline value, the method further includes: the processor 148 receives a second image 170 of the sample holder 32 through the transparent barrier 31; compares the received image of the sample holder 32 through the transparent barrier 31 with the reference data; determines the occlusion degree of the transparent barrier 31; and determines whether the occlusion degree of the transparent barrier 31 exceeds the baseline value; that is, repeats steps 202-210 until the occlusion degree of the transparent barrier 31 has reached or exceeded the baseline value.

[0089] The method 200 for determining the occlusion degree of the transparent barrier 31 may be implemented as a set of processor-executable instructions or logic stored in a non-transitory computer-readable medium, which, when executed by the processor 148, causes the processor 148 to execute the logic to calculate or determine the occlusion degree of the transparent barrier 31. For example, the method 150 for determining the occlusion degree of the transparent barrier 31 may be performed periodically, such as at a preset time interval or according to a specific quality control program applicable to the reagent analyzer 10, and combinations thereof.

[0090] In some non-limiting embodiments, the method 200 for determining the occlusion degree may determine at least one environmental object 178 on the surface 36 or the surface 37 of the transparent barrier 31 via computer vision. In some non-limiting embodiments, the computer vision method 200 for determining at least one environmental object 178 on the surface 36 or the surface 37 of the transparent barrier 31 may be via object detection. Object detection is a technique that includes training a neural network to determine whether there is at least one environmental object 178 on the surface 36 or the surface 37 of the transparent barrier 31 in the image 170 captured by the imaging system 22. The method of identifying the environmental object 178 by the neural network may include extracting several candidate regions that may be objects to be detected from the image 170 using a conventional region proposal method; inputting the extracted candidate regions into the neural network for recognition and classification; and determining the environmental objects 178 using, for example, a bounding box regression technique; enclosing each environmental object 178 with a bounding box, and determining whether the total environmental objects 178 enclosed by the bounding box, that is, the occlusion degree, exceeds a baseline value indicating potential occlusion of the transparent barrier 31. In some non-limiting embodiments, the alarm generated in response to the occlusion exceeding the baseline value may be a notification on an output device of the location of the environmental object 178 on the surface 36 or the surface 37 of the transparent barrier 31. The output device may be a tablet computer, a computer device, etc.

[0091] In other non-limiting embodiments, computer vision for determining at least one environmental object 178 on the surface 36 or the surface 37 of the transparent barrier 31 may utilize object tracking technology. Object tracking includes a trained neural network running on the processor 148 to analyze changes in the image over time. This can be achieved by: receiving a first image of the sample holder 32 through the transparent barrier 31 captured at a first time, the processor 148 receiving a second image of the sample holder 32 through the transparent barrier 31 captured at a second time, wherein the second image is received by the processor 148 after the reception of the first image; detecting the environmental object 178 in the first image to generate a bounding box, wherein the environmental object 178 can be located within the bounding box; performing object recognition on the environmental object 178 within the bounding box; repeating these steps for the second image, and determining whether the second image has the environmental object 178 present in the first image based on a predetermined object model.

[0092] In some non-limiting embodiments, the computer vision for determining at least one environmental object 178 on the surface 36 or the surface 37 of the transparent barrier 31 may utilize semantic segmentation technology. Semantic segmentation includes: constructing a first 3D semantic model, wherein the 3D semantic model includes that the transparent barrier 31 of the reagent analyzer 10 does not have at least one environmental object 178 present on the surface 36 or the surface 37; constructing a second 3D semantic model of the reagent analyzer 10, wherein the transparent barrier 31 has at least one environmental object 178 present, such as dust, soot, ash, pollen, smoke, moisture, etc. The 3D semantic model is updated over time by segmenting the current frame to form a segmented frame. A segmented frame depicting the reagent analyzer 10 with the transparent barrier 31 in use can be compared with the 3D model using a heuristic rule or a Bayesian rule to form the current frame of the reagent analyzer 10.

[0093] In some non-limiting embodiments, computer vision for determining at least one environmental object 178 on the surface 36 or the surface 37 of the transparent barrier 31 may utilize instance segmentation techniques. In the instance segmentation machine learning model, the processor 148 may be trained to simultaneously process an image of the sample holder 32 through the transparent barrier 31 positioned within the housing 14 of the reagent analyzer 10, and detect at least one environmental object 178, and classify the at least one environmental object 178 by positioning a segmentation mask on the image of the sample holder 32 through the transparent barrier 31 positioned within the housing 14 of the reagent analyzer 10. The segmentation mask may be a per-pixel mask that identifies pixels of at least one environmental object 178 present on at least one surface 36 or the surface 37 of the transparent barrier 31.

[0094] In some non-limiting embodiments, the processor 148 may be configured to process an image of the sample holder 32 through a transparent barrier 31 having translucency positioned within the housing 14 of the reagent analyzer 10, and detect the translucency of the transparent barrier 31. In some embodiments, the analyzer 10 may be configured to calibrate the translucency of the transparent barrier 31 to a known transparency standard of the transparent barrier 31 stored in the memory 152 to normalize or correct for any unintentional optical effects caused by light passing through the transparent barrier 31. In some non-limiting embodiments, calibration of the translucency of the transparent barrier 31 may be performed at periodic intervals during use of the analyzer 10 or by operator command.

[0095] In some non-limiting embodiments, the processor 148 is further configured to have a set of processor-executable instructions or logic stored in a non-transitory computer-readable medium, wherein when the instructions or logic are executed by the processor 148, the processor 148 is caused to cause an action selected from the group consisting of the following actions at at least one periodic interval: initiating an alarm in a form that can be perceived by a human; initiating a cleaning process that is configured to clean the transparent barrier 31; and replacing the transparent barrier 31. In some embodiments, the periodic interval is based on a period of time or a number of tests performed by the reagent analyzer 10.

[0096] Non-limiting illustrative embodiments

[0097] The following is a counting list of non-limiting illustrative embodiments of the inventive concepts disclosed herein:

[0098] 1. A method comprising: receiving a first image of a detection device positioned within a sample holder through a transparent barrier not associated with an imaging system, the transparent barrier being positioned within a housing of a reagent analyzer and adjacent to the sample holder; comparing pixel data of the received first image of the detection device positioned within the sample holder through the transparent barrier to determine an occlusion of the transparent barrier; determining whether the occlusion of the transparent barrier exceeds a baseline value, the baseline value indicating potential occlusion of the transparent barrier; and in response to the occlusion exceeding the baseline value causing an action selected from the group consisting of: initiating an alarm in a form perceptible to a human; storing data indicating that the occlusion detected within the first image exceeds the baseline value; initiating a cleaning process, the cleaning process being configured to clean the transparent barrier; and replacing the transparent barrier with a replacement transparent barrier having an occlusion less than the baseline value.

[0099] 2. The method of illustrative embodiment 1, wherein when the occlusion degree of the transparent barrier exceeds the baseline value, the method further comprises: storing data indicating that the transparent barrier has the occlusion degree; and conveying a notification indicating the occlusion degree of the transparent barrier to a user.

[0100] 3. The method of any one of Illustrative Embodiments 1 or 2, wherein the data has a time stamp.

[0101] 4. A method as described in any one of illustrative embodiments 1 or 3, wherein, when the occlusion degree of the transparent barrier does not exceed the baseline value, the method further includes: receiving a second image of the detection device positioned in the sample holder through the transparent barrier; determining the occlusion degree of the transparent barrier; and determining whether the occlusion degree of the transparent barrier exceeds the baseline value.

[0102] 5. The method of any of Illustrative Embodiments 1-4, wherein determining the occlusion level is performed using machine vision techniques.

[0103] 6. The method of any of illustrative embodiments 1-5, further comprising analyzing the first image by executing, by a processor, processor executable code stored in a non-transitory computer readable medium to determine the occlusion degree of the transparent barrier.

[0104] 7. The method of illustrative embodiment 6, wherein analyzing the first image by the processor executing processor executable code is further defined as analyzing pixels in the image for a predetermined color, the predetermined color indicating an environmental object present on a surface of the transparent barrier.

[0105] 8. A reagent analyzer, comprising: a housing; a sample holder, the sample holder being configured to support a detection device, the sample holder being capable of being moved into and out of the housing; a transparent barrier; an imaging system having a field of view extending through the transparent barrier and being configured to capture an image of the detection device positioned in the sample holder through the transparent barrier at a reading position in the field of view, the image having a plurality of pixels; and a processor, the processor being configured to receive the image and analyze pixels of the image to determine a degree of occlusion of the transparent barrier.

[0106] 9. The reagent analyzer as described in illustrative embodiment 8 also includes a circuit board, wherein the circuit board has a substrate and a plurality of conductive leads extending on or in the substrate, the substrate has a first major surface and a second major surface, the first major surface is opposite to the second major surface, the substrate has an opening extending between the first major surface and the second major surface, and the field of view extends through the opening.

[0107] 10. The reagent analyzer of any of Illustrative Embodiments 8 or 9, wherein the transparent barrier is positioned between the sample holder and the imaging system.

[0108] 11. The reagent analyzer of any of illustrative embodiments 8-10 having a slot in the housing through which the transparent barrier is removably accessible.

[0109] 12. The reagent analyzer of any of illustrative embodiments 9-11, wherein the first major surface faces the imaging system, and the reagent analyzer further comprises a light source attached to the second major surface of the substrate.

[0110] 13. A reagent analyzer as described in illustrative embodiment 12, wherein the detection device is a wet reagent detection device, and wherein the light source is a first light source, and wherein the reagent analyzer further comprises a second light source, and a circuit configured to supply power to the first and second light sources so that the first and second light sources contribute to illumination of the wet reagent detection device in an amount calculated to provide controlled illumination.

[0111] 14. An apparatus comprising: a housing surrounding a cavity, the housing being opaque to visible light; an imaging system having a camera sensor having a field of view within the cavity; a sample tray positioned within the cavity, the sample tray having a sample holder within the field of view of the camera sensor, the sample tray being positioned a distance from the camera sensor; and a transparent barrier positioned within the cavity, the transparent barrier having a first surface, a second surface, and an intermediate region extending between the first surface and the second surface, the intermediate region of the transparent barrier being positioned within the field of view of the imaging system, upstream of the sample tray, and positioned a distance from the imaging system.

[0112] 15. The apparatus of illustrative embodiment 14, further comprising: a detection device positioned within the sample holder of the sample tray and within the field of view of the camera sensor, the sample tray being positioned within the cavity, the sample tray being positioned at a distance from the camera sensor.

[0113] 16. The apparatus of any one of illustrative embodiments 14 or 15, further comprising: a circuit board positioned within the cavity between the camera sensor and the sample tray, the circuit board having a substrate and a plurality of conductive leads extending on or in the substrate, the substrate having a first major surface facing the camera sensor and a second major surface facing the sample tray, the first major surface being opposite to the second major surface, the substrate having an opening extending between the first major surface and the second major surface, the opening being positioned within the field of view of the camera sensor so that the field of view of the imaging system passes through the opening, thereby providing the camera sensor with a controlled field of view of the sample holder of the sample tray; a light source attached to the second major surface of the substrate and connected to at least a portion of the plurality of conductive leads extending on the substrate; and a circuit attached to the conductive leads and configured to supply power to the light source via the conductive leads.

[0114] 17. The apparatus of illustrative embodiment 16, wherein the light source comprises a plurality of light sources arranged and supported in a planar configuration.

[0115] 18. The apparatus of any of illustrative embodiments 14-17, wherein the transparent barrier divides the cavity within the housing into a first portion and a second portion, the imaging system is within the first portion, and the sample tray is within the second portion.

[0116] 19. The device of any of illustrative embodiments 14-18, wherein the housing has a slot, and wherein the transparent barrier is positioned within the cavity adjacent to the slot, the transparent barrier having a width and a thickness, and the slot having a width greater than the width of the transparent barrier and a height greater than the thickness of the transparent barrier.

[0117] 20. The apparatus of illustrative embodiment 19, wherein the transparent barrier is movably supported within the housing and aligned with the slot such that the transparent barrier is movable through the slot.

[0118] 21. The device of any of illustrative embodiments 14-20, wherein the first surface and the second surface of the transparent barrier are planar and parallel within the intermediate region.

[0119] 22. The apparatus of any of illustrative embodiments 14-21, wherein the transparent barrier is separate from the imaging system and is configured to block debris from the sample tray from contacting the imaging system.

[0120] 23. A method comprising: determining whether an occlusion level of a transparent barrier between a sample tray and an imaging system within a reagent analyzer exceeds a baseline value, the baseline value indicating potential occlusion of the transparent barrier; and in response to the occlusion level exceeding the baseline value, causing an action selected from the group consisting of: initiating an alarm in a form perceptible to a human; storing data indicating that the occlusion level detected within a first image exceeds the baseline value; initiating a cleaning process, the cleaning process being configured to clean the transparent barrier; and replacing the transparent barrier with a replacement transparent barrier having an occlusion level less than the baseline value.

[0121] 24. The method of illustrative embodiment 23, wherein the step of determining whether the occlusion degree of the transparent barrier exceeds a baseline value is performed at periodic intervals.

[0122] 25. The method of illustrative embodiment 24, wherein the periodic interval is based on a period of time or a number of detections performed.

[0123] From the above description, it is clear that the inventive concepts disclosed herein are well adapted to achieve the objects and obtain the advantages mentioned herein as well as those inherent to the inventive concepts disclosed herein. Although exemplary embodiments of the inventive concepts disclosed herein have been described for the purposes of this disclosure, it will be appreciated that many variations may be made which will readily occur to those skilled in the art and which are implemented within the scope of the inventive concepts disclosed and as defined in the appended claims.

Claims

1. A method comprising: receiving a first image of a detection device positioned within a sample holder through a transparent barrier not associated with an imaging system, the transparent barrier being positioned within a housing of the reagent analyzer and adjacent to the sample holder; comparing pixel data of a first image of the detection device positioned in the sample holder through the transparent barrier to determine an obstruction degree of the transparent barrier; determining whether the occlusion degree of the transparent barrier exceeds a baseline value, the baseline value indicating potential occlusion of the transparent barrier; as well as causing, in response to the occlusion level exceeding the baseline value, an action selected from the group consisting of: initiating an alarm in a form perceptible to a human; storing data indicating that the degree of occlusion detected within the first image exceeds the baseline value; initiating a cleaning process configured to clean the transparent barrier; and replacing the transparent barrier with a replacement transparent barrier having an occlusion level less than the baseline value.

2. The method of claim 1, wherein: When the shading degree of the transparent barrier exceeds the baseline value, the method further includes: storing data indicating that the transparent barrier has the occlusion degree; and A notification is communicated to a user indicating the degree of occlusion of the transparent barrier.

3. The method of claim 2, wherein: The data has a time stamp.

4. The method of claim 1, wherein: When the shading degree of the transparent barrier does not exceed the baseline value, the method further includes: receiving a second image of the detection device positioned within the sample holder through the transparent barrier; determining the occlusion degree of the transparent barrier; and It is determined whether the occlusion degree of the transparent barrier exceeds a baseline value.

5. The method of claim 1, wherein: The occlusion degree is determined by using machine vision technology. 6 . The method of claim 1 , further comprising analyzing the first image by a processor executing processor executable code stored in a non-transitory computer readable medium to determine the occlusion level of the transparent barrier.

7. The method of claim 6, wherein: Analyzing the first image by the processor executing the processor executable code is further defined as analyzing pixels in the image for a predetermined color, the predetermined color indicating an environmental object present on a surface of the transparent barrier.

8. A reagent analyzer, comprising: shell; a sample holder configured to support a detection device, the sample holder being movable into and out of the housing; Transparent barrier; an imaging system having a field of view extending through the transparent barrier and configured to capture an image of the detection device positioned within the sample holder through the transparent barrier at a reading position in the field of view, the image having a plurality of pixels; as well as A processor is configured to receive the image and analyze pixels of the image to determine an occlusion degree of the transparent barrier.

9. The reagent analyzer of claim 8, further comprising a circuit board having a substrate and a plurality of conductive leads extending on or in the substrate, the substrate having a first major surface and a second major surface, the first major surface being opposite to the second major surface, the substrate having an opening extending between the first major surface and the second major surface, the field of view extending through the opening.

10. The reagent analyzer according to claim 8, wherein: The transparent barrier is positioned between the sample holder and the imaging system.

11. The reagent analyzer of claim 8 having a slot in the housing through which the transparent barrier is removably accessible.

12. The reagent analyzer according to claim 9, wherein: The first major surface faces the imaging system, and the reagent analyzer further includes a light source attached to the second major surface of the substrate.

13. The reagent analyzer according to claim 12, wherein: The detection device is a wet reagent detection device, and wherein the light source is a first light source, and wherein the reagent analyzer further comprises a second light source, and a circuit configured to supply power to the first and second light sources such that the first and second light sources contribute to illumination of the wet reagent detection device in an amount calculated to provide controlled illumination.

14. A device comprising: a housing surrounding the cavity, the housing being opaque to visible light; an imaging system having a camera sensor having a field of view within the cavity; a sample tray positioned within the cavity, the sample tray having a sample holder within the field of view of the camera sensor, the sample tray being positioned a distance from the camera sensor; as well as a transparent barrier positioned within the chamber, the transparent barrier having a first surface, a second surface, and an intermediate region extending between the first surface and the second surface, the intermediate region of the transparent barrier being positioned within the field of view of the imaging system, upstream of the sample tray, and positioned a distance from the imaging system.

15. The apparatus of claim 14, further comprising: A detection device is positioned within the sample holder of the sample tray and within the field of view of the camera sensor, the sample tray is positioned within the cavity, the sample tray is positioned a distance from the camera sensor.

16. The apparatus of claim 14, further comprising: a circuit board positioned within the cavity between the camera sensor and the sample tray, the circuit board having a substrate and a plurality of conductive leads extending on or in the substrate, the substrate having a first major surface facing the camera sensor and a second major surface facing the sample tray, the first major surface being opposite the second major surface, the substrate having an opening extending between the first major surface and the second major surface, the opening being positioned within the field of view of the camera sensor such that the field of view of the imaging system passes through the opening to provide the camera sensor with a controlled view of the sample holder of the sample tray; a light source attached to the second major surface of the substrate and connected to at least a portion of the plurality of conductive leads extending on the substrate; as well as A circuit is attached to the conductive leads and is configured to supply power to the light source via the conductive leads.

17. The apparatus of claim 16, wherein: The light source includes a plurality of light sources arranged and supported in a planar configuration.

18. The apparatus of claim 14, wherein: The transparent barrier divides the cavity within the housing into a first portion and a second portion, the imaging system is within the first portion, and the sample tray is within the second portion.

19. The apparatus of claim 18, wherein: The housing has a slot, and wherein the transparent barrier is positioned within the cavity adjacent to the slot, the transparent barrier having a width and a thickness, and the slot having a width greater than the width of the transparent barrier and a height greater than the thickness of the transparent barrier.

20. The apparatus of claim 19, wherein: The transparent barrier is movably supported within the housing and aligned with the slot such that the transparent barrier is movable through the slot.

21. The apparatus of claim 14, wherein: The first surface and the second surface of the transparent barrier are planar and parallel within the intermediate region.

22. The apparatus of claim 14, wherein: The transparent barrier is separate from the imaging system and is configured to block debris from the sample tray from contacting the imaging system.

23. A method comprising: determining whether an occlusion degree of a transparent barrier between a sample tray and an imaging system within a reagent analyzer exceeds a baseline value, the baseline value indicating potential occlusion of the transparent barrier; as well as In response to the occlusion level exceeding the baseline value, causing an action selected from the group consisting of: initiating an alarm in a form perceptible to a human; storing data indicating that the degree of occlusion detected within the first image exceeds the baseline value; initiating a cleaning process configured to clean the transparent barrier; and replacing the transparent barrier with a replacement transparent barrier having an occlusion level less than the baseline value.

24. The method of claim 23, wherein: The step of determining whether the shading degree of the transparent barrier exceeds a baseline value is performed at periodic intervals.

25. The method of claim 24, wherein: The periodic intervals may be based on a period of time or a number of tests performed.

Images