Analyzer with transparent shield for protecting the imaging system

Abstract

Receive an image of a test device through a transparent shield not associated with the imaging system, the transparent shield being located within the housing of the reagent analyzer; compare pixel data of the image of the test device received through the transparent shield to determine a degree of shielding of the transparent shield; determine whether the degree of shielding exceeds a baseline value indicative of potential shielding; initiate an alert in a human-perceivable form in response to the degree of shielding exceeding the baseline value; store data indicative of the degree of shielding detected in a first image that exceeds the baseline value; initiate a cleaning process configured to clean the transparent shield; and perform an action selected from the group consisting of replacing the transparent shield with a replacement transparent shield having a degree of shielding less than the baseline value, a method.

Description

[Technical Field]

[0001] Cross-Reference to Related Applications / Incorporation-by-Reference Statement This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 63 / 368,681, filed July 18, 2022. The entire contents of the above-referenced patent application are expressly incorporated herein by reference.

[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable

[0003] The summary of the inventions disclosed herein generally relate to analyzers having a transparent shield positioned between an optical reader and a sample holder, and more particularly, but not exclusively, to systems and methods configured to determine the degree of occlusion of a transparent shield while viewing the sample holder through the transparent shield. [Background technology]

[0004] A myriad of analytical procedures, compositions, and tools have been developed to meet the needs of the medical community and other expanding technologies such as the brewing industry, chemical manufacturing, etc. Whether the lateral flow immunoassay or dip-and-read test device is used to analyze biological fluids or tissues, or commercial or industrial fluids or substances, the general procedure involves contacting the test device with the sample or specimen to be tested and analyzing the test device manually or by instrumentation.

[0005] Lateral flow immunoassays are diagnostic devices used to confirm the presence or absence of a target analyte. Lateral flow immunoassays generally include a flow path that carries the sample past a control line and a test line. The control line at the control line position confirms proper functioning of the test, and the test line at the test line position provides the result of the lateral flow immunoassay. Lateral flow immunoassays have been developed for use in dipstick or house test formats. Both dipstick and house tests function similarly and generally fall into one of two categories: sandwich assays, in which a positive test is indicated by the presence of a colored line at the test line position, and competitive assays, in which a positive test is indicated by the absence of a colored line at the test line position.

[0006] Dip-and-read reagent test devices are widely used in many analytical applications, particularly in the chemical analysis of biological fluids, due to their relatively low cost, ease of use, and rapid results. For example, in the medical field, many physiological functions can be monitored by simply dipping a dip-and-read reagent test device into a sample of bodily fluid or tissue, such as urine or blood, and observing a detectable response, such as a change in color or a change in the amount of light reflected or absorbed by the test device.

[0007] Many dip-and-read reagent test devices for detecting bodily fluid constituents are capable of quantitative or at least semi-quantitative measurements. Thus, by measuring a detectable response after a predetermined time, a user can obtain not only a positive indication for the presence of a particular component in a test sample, but also an estimate of how much of that component is present. Such dip-and-read reagent test devices provide physicians and laboratory technicians with an easy diagnostic tool and the ability to assess the extent of disease or physical ailments.

[0008] Examples of currently used dip-and-read reagent test devices include those available from Siemens Healthcare Diagnostics, Inc. under the MULTISTIX trademark. Immunochemical, diagnostic, or serological test devices such as these typically include one or more carrier matrices, such as absorbent paper, incorporating specific reagents or reaction systems that exhibit a detectable response (e.g., a color change within the visible or ultraviolet spectrum) in the presence of specific test sample components or constituents. Depending on the reaction system incorporated into the specific matrix, these test devices can detect the presence of glucose, ketone bodies, bilirubin, urobilinogen, occult blood, nitrite, and other substances. Specific changes in color intensity observed within specific time ranges after contacting the dip-and-read reagent test device with the sample indicate the presence and / or concentration of specific components in the sample. Several other examples of dip-and-read reagent test devices and their reagent systems can be found in U.S. Patent Nos. 5,629,999; 5,729,949; and 5,729,949, the disclosures of which are incorporated herein by reference in their entireties.

[0009] However, dip-and-read reagent test devices have several limitations. For example, dip-and-read reagent test devices typically require a technician to manually dip the test device into the sample, wait a prescribed amount of time, and then visually compare the color of the test device to a color chart provided with the test device. This process is slow, the resulting reading is highly skill-dependent (e.g., precise timing, proper comparison to the color chart, ambient lighting conditions, and the technician's eyesight), and results may be inconsistent between two different technicians performing the same test. Finally, the act of manually dipping the test device into the sample can result in cross-contamination or improper deposition of the test sample on the test device due to incomplete insertion of the test device into the sample, insufficient time to deposit the sample on the test device, or too much sample on the test device, which may drip, leak, or splash onto the technician's work area, person, or clothing.

[0010] There has been a need in the art for testing tools and methods for performing multiple tests economically and quickly, particularly by using automated processing. Automated analyzer systems offer advantages over manual testing in terms of cost per test, test handling volume, and / or speed of obtaining test results or other information.

[0011] Currently available automated instruments for reading individual reagent test devices, such as lateral flow immunoassays or dip-and-read reagent test devices or reagent strips (e.g., CLINITEK STATUS reflectance photometers manufactured and sold by Siemens Healthcare Diagnostics, Inc.), require that each test device be manually loaded into the automated instrument after contacting the test device with the specimen or sample to be tested. Manual loading requires that the reagent test device be properly positioned within the automated instrument within a limited time period after contacting the solution or substance to be tested. Once the analysis is complete, the used reagent test device is removed from the instrument and disposed of in accordance with applicable regulations.

[0012] Another development is the introduction of multi-profile reagent cards and automated analyzers for multi-profile reagent cards. A multi-profile reagent card is essentially a card-like test device that includes multiple reagent-impregnated matrices or pads for simultaneously or sequentially performing multiple analyses of analytes, as described, for example, in U.S. Patent No. 5,929,999, the entire disclosure of which is incorporated herein by reference. The reagent pads on the multi-profile reagent card are typically arranged in a grid-like configuration to define several rows and columns of reagent pads, spaced a distance apart from each other. Adjacent reagent pads in the same row can be referred to, for example, as test strips, and can contain reagents for a pre-defined combination of tests to be performed on each sample.

[0013] Multi-profile reagent cards provide an efficient, economical, rapid, and convenient method of performing automated analyses. Automated analyzers configured to use multi-profile reagent cards typically retrieve the multi-profile reagent card from a storage drawer, cassette, or the like, and advance the multi-profile reagent card, typically one step at a time, along the analyzer's travel surface via a card movement mechanism so that one test strip (or row of reagent pads) is positioned at a sample dispensing position and / or one or more read positions. Exemplary card movement mechanisms include a conveyor belt, a ratchet mechanism, a sliding ramp, or a card gripping or pulling mechanism. As the multi-profile reagent card moves or advances along the travel surface and is positioned at a sample dispensing position, one or more pipettes (e.g., manually or automatically) deposit one or more sample volumes onto one or more of the reagent pads on the reagent card. The reagent pads are then positioned at one or more read positions and analyzed (e.g., manually or automatically) to evaluate the test results. The reagent card is placed within the field of view of an imaging system, such as an optical imaging system, microscope, or spectrometer, and one or more images of the reagent pads on the card (e.g., optical signals indicative of the color of the reagent pads) are captured and analyzed. Typically, the imaging system's field of view is relatively large, allowing for the capture of multiple images of the same reagent pad as the reagent card is moved or advanced through multiple reading positions within the imaging system's field of view. The field of view includes multiple reading positions or locations, and as the reagent card progresses through the imaging system's field of view, each reagent pad moves incrementally through these reading positions. Because the analyzer moves the card between various reading positions at known time intervals, for example, multiple images acquired within the imaging system's field of view enable the analyzer to determine the color change of the reagent pad as a result of the reagent pad reacting with the sample at each reading position, depending on the time it takes for the pad to move to each reading position. Finally, the used card is removed from the analyzer and appropriately disposed of.

[0014] In some analyzers, a sample tray holds consumables, such as reagent cards, to be read. The sample tray is moved by a motor from outside the analyzer housing to inside the housing, where sample measurements are performed by an optical reader. Surprisingly, it has been found that excess fluid not captured by the consumables splashes onto any optical components above the sample holding area during this movement. If the optical elements become dirty, the analyzer must be cleaned or replaced, requiring significant time and cost and potentially preventing results from being available when needed, due to the risk that erroneous results could be used by a physician to treat a patient. [Prior art documents] [Patent documents]

[0015] [Patent Document 1] U.S. Patent No. 3,123,443 [Patent Document 2] U.S. Patent No. 3,212,855 [Patent Document 3] U.S. Patent No. 3,814,668 [Patent Document 4] U.S. Patent No. 4,526,753 Summary of the Invention [Problem to be solved by the invention]

[0016] 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 the optical reader within the analyzer. The present disclosure is directed to an improved analyzer in which a transparent shield that can be conveniently removed, cleaned, or replaced protects the optical components of the imaging system. [Means for solving the problem]

[0017] In one embodiment, the inventive concept disclosed herein is a reagent analyzer that addresses the shortcomings of the prior art discussed above. The reagent analyzer includes a transparent shield, an imaging system, and a processor. The transparent shield has a first side, a second side, and an intermediate region extending between the first side and the second side. The imaging system has a field of view extending through the transparent shield and is configured to capture an image of a wet reagent test device positioned at a read position within the field of view, the image having a plurality of pixels. The processor is configured to receive the image and analyze the pixels of the image to determine the presence or absence of a target component in a sample applied to the wet reagent pad.

[0018] To assist those skilled in the 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 like reference numerals are intended to refer to the same or similar elements for purposes of consistency. For clarity, not every component is necessarily shown in every drawing. For clarity and conciseness, certain configurations and certain features of these figures may be exaggerated or shown in schematic form, not drawn to scale. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a front view of an exemplary embodiment of an analyzer in accordance with the inventive concepts disclosed herein, showing a transparent shield positioned within the field of view of its imaging system. [Figure 2] FIG. 2 is a side view of the analyzer of FIG. 1. [Figure 3] FIG. 1 is an end view of an analyzer having a transparent shield positioned within a slot formed in a housing in accordance with the inventive concepts disclosed herein. [Figure 4A] FIG. 1 is a bottom view of a circuit board having an aperture surrounded by an on-board light source in accordance with the inventive concepts disclosed herein to facilitate controlled illumination of a reagent card and reduce light scattering detected by an imaging system. [Figure 4B]1 is a side view of a transparent shield positioned below a circuit board having an aperture surrounded by one or more illumination sources in accordance with the inventive concepts disclosed herein. [Figure 5] 1 is a top view image of a sample holder and test device as viewed through a transparent shield in accordance with the inventive concepts disclosed herein. [Figure 6] 1 is a top view image of a sample holder and test device as viewed through a transparent shield having an exemplary degree of shielding based on the material present on a first surface of the transparent shield in accordance with the inventive concepts disclosed herein. [Figure 7] 6 is a top view image of the sample holder and test device as viewed through a transparent shield that has more obscuration than the top view image of FIG. 5. [Figure 8] 3 is a flow diagram of an exemplary embodiment of a method for determining the degree of occlusion of a transparent shield in accordance with the inventive concepts disclosed herein. [Figure 9] FIG. 2 is a bottom view of a transparent shield having an aperture in accordance with the inventive concepts disclosed herein. [Figure 10] 10 is a side view of the transparent shield of FIG. 9 constructed in accordance with the present disclosure and positioned in a slightly open position on a rail having an engagement member. [Figure 11] 10 is a side view of a transparent shield engaging a rail, with the engaging member of the rail positioned within the aperture of the transparent shield of FIG. 9. [Figure 12] 10 is a top view of the transparent shield of FIG. 9 engaging a rail with an engagement member according to the inventive concepts disclosed herein positioned within an aperture in the transparent shield. DETAILED DESCRIPTION OF THE INVENTION

[0020] Before describing in detail at least one embodiment of the inventive concepts disclosed herein, it is to be understood that the inventive concepts are not limited in their application to the details of construction and arrangement of the components or steps or methods set forth in the following description or illustrated in the drawings. The inventive concepts disclosed herein are capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the nomenclature and terminology employed herein is for the purpose of description and should not be construed as in any way limiting the inventive concepts disclosed and claimed herein.

[0021] In the following detailed description, numerous specific details are set forth in order to provide a more thorough understanding of the inventive concepts. However, it will be apparent to those skilled in the art that the inventive concepts disclosed herein may be practiced without these specific details. In other instances, well-known features have not been described in order to avoid unnecessarily complicating the present disclosure.

[0022] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "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 and may include other elements not specified or inherently present therein.

[0023] Unless stated to the contrary, "or" refers to an inclusive or, not an exclusive or. For example, 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).

[0024] Additionally, the use of "a" or "an" is utilized to describe elements and components of the invention. This is done merely for convenience and to give a general sense of the inventive concept. This description should be read to include one or at least one, and the singular also includes the plural unless it is clear that this is not meant.

[0025] Furthermore, as used herein, any reference to "one embodiment" or "an embodiment" means that a particular element, configuration, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Appearances of the phrase "in one embodiment" in various places in this specification do not necessarily all refer to the same embodiment.

[0026] As used herein, a "wet reagent test device" refers to a reagent device having a sample volume deposited thereon such that the reagent in the reagent device can react with its target component if such component is present in the sample. Wet reagent test devices can also have a negative control volume deposited thereon.

[0027] As used herein, a "reagent test device" refers to a carrier having a reagent. Exemplary reagent devices include the reagent pad of a dip-and-read test strip, or a control strip or test strip of a lateral flow immunoassay.

[0028] Finally, as used herein, modifiers such as "about," "approximately," and "substantially" are intended to indicate that the modified item is not limited to the exact value specified, but includes some slight variation or deviation therefrom caused by, for example, measurement error, manufacturing tolerances, stresses exerted on various parts, wear and tear, and combinations thereof.

[0029] The inventive concepts disclosed herein are generally directed to analyzers for reagent test devices and methods for reading reagent test devices, and more particularly, but not exclusively, to analyzers having a transparent shield within the field of view of an imaging system and a sample holder such that the imaging system is configured to capture an image of the sample holder through the transparent shield. In some embodiments, the analyzer includes a processor. The processor is configured to receive the image and analyze pixels of the image to determine the degree of obscuration of the transparent shield. Although the inventive concepts disclosed herein are described primarily in connection with automated analyzers using multiple-profile reagent cards as reagent test devices, the inventive concepts disclosed herein are not limited to automated analyzers or multiple-profile reagent cards. For example, as will be understood by one of ordinary skill in the art having the benefit of this disclosure, methods according to the inventive concepts disclosed herein can be implemented by manual analyzers or by automated analyzers that use reagent test devices other than multiple-profile reagent cards, such as lateral flow immunoassays, dip-and-read reagent test devices, or reels of reagent test devices on a substrate, and combinations thereof. Furthermore, the inventive concepts disclosed herein can be implemented by any reagent device imaging system that has at least one read position within its field of view.

[0030] In particular, when the reagent test device is exposed to a sample, a signal value indicating the color of the reagent test device, such as a reagent pad, control line, or test line, changes. For negative solutions, the change in signal value is known (or can be measured) and can therefore be an optional offset signal value. Any change outside the range of the offset signal value is likely caused by a reaction with the clinical component being measured.

[0031] 1-3, an exemplary embodiment of a reagent analyzer 10 in accordance with the inventive concepts disclosed herein is shown. The reagent analyzer 10 may be, for example, an automated reagent card analyzer. Exemplary embodiments of automated reagent card analyzers are described in detail in U.S. patent application Ser. No. 13 / 712,144, filed Dec. 12, 2012, and PCT application PCT / US2012 / 069621, filed Dec. 14, 2012, the entire disclosures of which are expressly incorporated herein by reference.

[0032] Generally, the exemplary reagent analyzer 10 includes a housing 14 having a slot 15, the housing 14 enclosing a cavity 18. The reagent analyzer 10 also includes at least one rail 19, and the imaging system 22 includes at least a camera 26, a sample tray 30 having a sample holder 32 located within the cavity 18, a transparent shield 31, and a circuit board 34 having an aperture 38 and one or more illumination sources 42a-n located within the cavity 18.

[0033] The housing 14 can be formed from one or more components configured to form a cavity 18 and support at least one rail 19, an imaging system 22, a sample tray 30, a transparent shield 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 another non-limiting embodiment, the housing 14 has a slot 15 within which the transparent shield 31 can be positioned and from which the transparent shield 31 can be removed from within the housing 14.

[0034] The transparent shield 31 has at least one sidewall 33, at least one end 35, a first surface 36 extending between the at least one sidewall 33 and the at least one end 35, a second surface 37 located opposite the first surface 36 and extending between the at least one sidewall 33 and the at least one end 35, and an intermediate region 41 extending between the first surface 36 and the second surface 37. In one non-limiting embodiment, the transparent shield 31 has a first sidewall 33 a, a second sidewall 33 b opposite the first sidewall 33 a, a first end 35 a, a second end 35 b opposite the first end 35 a, a first surface 36 extending from the first end 35 a to the second end 35 b, a second surface 37 extending from the first end 35 a to the second end 35 b opposite 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 shield 31 is transparent to visible light, allowing light to travel through the transparent shield 31 without significant scattering, allowing objects located beyond the transparent shield 31 to be clearly seen and imaged. In some embodiments, the transparent shield 31 can have a degree of translucency, allowing light to travel through the transparent shield 31 without scattering, which allows objects located beyond the transparent shield 31 to be seen with varying clarity. The first surface 36 and the second surface 37 are both planar and substantially parallel to avoid magnifying visible light passing through the transparent shield 31. As discussed in more detail below, the transparent shield 31 is configured to protect the imaging system 22 from splashes or other debris resulting from movement of the sample tray 30 in and out of the housing 14. In some non-limiting embodiments, the transparent shield 31 can be movable in and out of the housing 14 through the slot 15. For example, the transparent shield 31 can have a grip (not shown) on at least one end 35 of the transparent shield 31.The grip can be a textured surface, such as a frost or etching on the first surface 36 and / or the second surface 37, or can include a handle or the like extending from and / or connected to the first surface 36 and / or the second surface 37. In some non-limiting embodiments, the transparent shield 31 has an aperture 43 located on the edge of the transparent shield 31 that extends from the first surface 36 through an intermediate region 41 to the second surface 37 (FIG. 9).

[0035] In some non-limiting embodiments, the at least one rail 19 can be positioned adjacent to the slot 15 within the cavity 18, such that when the transparent shield 31 is placed in the slot 15, a surface 37 of the transparent shield 31 can rest on the at least one rail 19. In other non-limiting embodiments, the at least one rail 19 can be positioned within the cavity 18 adjacent to the slot 15, such that when the transparent shield 31 is placed in the slot 15, a surface 36 of the transparent shield 31 can rest on the at least one rail 19. In some non-limiting embodiments, the at least one rail 19 can have an engagement member 45 oriented such that when the transparent shield 31 is positioned within the cavity 18 of the engagement member 45, the transparent shield 31 is in a half-open position (FIG. 10). When the transparent shield 31 is completely inserted into the cavity 18, the second surface 37 of the transparent shield 31 rests on the at least one rail 19, and the engagement member 45 rests within the aperture 43 of the transparent shield 31 (FIGS. 11 and 12). To remove the transparent shield 31 from the cavity 18, a user can apply an upward force to the second surface 37 of the transparent shield 31 to remove the engagement member 45 from the aperture 43 of the transparent shield 31. Once the engagement member 45 is removed from within the aperture 43, the transparent shield 31 can be removed from the cavity 18. The transparent shield 31 can act as a barrier to prevent debris from the sample holder 32 from contacting the circuit board 34 and / or the imaging system 22.

[0036] Imaging system 22 includes at least one camera 26 and is supported by housing 14. In one embodiment, imaging system 22 may be fixed to housing 14, for example, or may be fixed at a relative distance from sample tray 30 or transparent shield 31. Imaging system 22 and / or camera 26 may include one or more lenses having a focal length selected to provide a field of view 40 to include at least aperture 38 of circuit board 34.

[0037] The imaging system 22 can be implemented and function as any desired reader, for example, such that the field of view 40 of the imaging system 22 includes substantially the entire aperture 38 of the circuit board 34. The imaging system 22 can be supported above, below, or adjacent to the sample tray 30. In some embodiments, the field of view 40 can extend in a linear direction from the imaging system 22 to the aperture 38. In other embodiments, the field of view 40 can extend in a non-linear direction from the imaging system 22 to the aperture 38 due to the presence of one or more optical steering components within the field of view 40. Exemplary optical steering components include mirrors, lenses, beam splitters, or combinations thereof. The imaging system 22 can be configured to detect or capture images or optical signals indicative of reflectance or color values ​​of, for example, a reagent pad, lateral flow assay, or the like, positioned within the field of view 40 of the imaging system 22 (shown in FIGS. 5-7 and discussed in more detail below). In other non-limiting embodiments, the imaging system 22 can be configured to detect or capture images or optical signals indicative of reflectance or color values ​​of the sample holder 32 located within the field of view 40 of the imaging system 22 through the transparent shield 31. However, it should be understood that in some exemplary embodiments, the field of view 40 of the imaging system 22 can include only a portion of the aperture 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 can include only a portion of the transparent shield 31. The camera 26 of the imaging system 22 can include any desired digital or analog imaging device, such as a digital camera, an analog camera, a CMOS imager, a diode, and combinations thereof. The imaging system 22 can also include, for example, a lens system, optical filters, a collimator, a diffuser, or any other optical signal processing device. Furthermore, the imaging system 22 is not limited to optical imaging devices in the visible spectrum, but can include, for example, an infrared imaging system, an ultraviolet imaging system, a microwave imaging system, an X-ray imaging system, and / or any other desired imaging system.Non-exclusive examples of imaging system 22 include, for example, optical imaging systems, spectrophotometers, gas chromatographs, microscopes, infrared sensors, and combinations thereof.

[0038] In one embodiment, the imaging system 22 includes at least one camera 26 and a lens, where 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 Inc., Carlsbad, CA), both configured to maintain a wide field of view 40 while reducing geometric image distortion, thereby providing a resolution of 1080 pixels by 1920 pixels, with each pixel representing an approximately 0.065 mm square area of ​​the sample tray 30 and / or sample holder 32.

[0039] The sample tray 30 can be configured to adjust the location of the sample holder 32 within the field of view 40. The sample holder 32 can be configured to receive at least one of the test devices 44, which can be reagent cards and reagent card cassettes, each having a sample 46. The sample 46 can be, for example, any bodily fluid, tissue, or any other chemical or biological sample, such as urine, saliva, or blood, and combinations thereof. The sample 46 can be, for example, liquid and can contain one or more target components, such as bilirubin, ketones, glucose, or any other desired target component.

[0040] A circuit board 34 having an aperture 38 can be positioned within the cavity 18 and interposed 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 sample holder 32, the test device 44, and / or the sample 46. The circuit board 34 is described in more detail below in FIGS. 1-2 and 4B. In one embodiment, the circuit board 34 is located in a fixed location between the imaging system 22 and the sample tray 30; however, in another embodiment, the circuit board 34 can be adjusted to a variable location between the imaging system 22 and the sample tray 30. If the circuit board 34 is adjustable, a calibration routine (described below) should be performed after every adjustment. In another non-limiting embodiment, the circuit board 34 can be positioned between the imaging system 22 and the transparent shield 31, such that the field of view 40 of the imaging system 22 is substantially unobstructed from the sample holder 32, the test device 44, and / or the sample 46.

[0041] 1 and 2, the housing 14 can include a plurality of connected sidewalls 80, 82, 84, and 86 that cooperate to enclose the cavity 18. Sidewall 80 is spaced apart from sidewall 82, and sidewall 84 is spaced apart from sidewall 86. The transparent shield 31 can be sized and dimensioned to span the cavity 18 between sidewalls 80 and 82, such that the sidewalls 84 and 86 divide the cavity 18 into a first portion 88 and a second portion 90. In some embodiments, the transparent shield 31 can have a length L of about 5 cm to about 21 cm. In some non-limiting embodiments, the transparent shield 31 can be a protective device for lenses, and the transparent shield 31 can have a length of about 5 cm. In other non-limiting embodiments, the transparent shield 31 can be a protective device for lenses and optical components, and the transparent shield 31 can have a length of about 14 cm. In some non-limiting embodiments, the transparent shield 31 is a protective device for the lenses and optical components, and the transparent shield 31 may not be removable from the reagent analyzer 10 .

[0042] Referring to FIG. 3 , an end view of a transparent shield 31 positioned within a slot 15 is shown in accordance with the inventive concepts disclosed herein. In some embodiments, the housing 14 includes a slot 15, the transparent shield 31 is positioned within the cavity 18 adjacent the slot 15, the slot having a width W1 and a height D1, and the transparent shield 31 has 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 can have a width W1 of about 4.5 cm and a height D1 of about 0.2 cm, and the transparent shield 31 can have a width W2 of about 4.3 cm and a thickness D2 of about 0.1 cm. In some non-limiting embodiments, the height D1 of the slot 15 can be greater than 0.1 cm. In some non-limiting embodiments, the thickness D2 of the transparent shield 31 can be between about 0.1 cm and about 0.3 cm. In some embodiments, the width W1 of the slot 15 can be between about 1.7 cm and about 4.5 cm. In some non-limiting embodiments, the width W2 of the transparent shield 31 can be about 1.5 to about 4.3 cm. In some embodiments, the transparent shield 31 is movably supported within the housing 14 and aligned with the slot 15 such that the transparent shield 31 is movable through the slot 15. In some embodiments, the surfaces 36 and 37 of the transparent shield 31 are planar and parallel within the intermediate region 41 to avoid distorting or scattering light passing through the transparent shield 31. The transparent shield 31 can be separate from the imaging system 22 and can be configured to prevent debris from the sample tray 30 from contacting the imaging system 22. The transparent shield 31 can be constructed from glass, ceramic, plastic, such as acrylic, polycarbonate, or the like.

[0043] The illumination sources 42a-n may be implemented, for example, 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 direction of propagation. The illumination sources 42a-n may be mounted on the circuit board 34 and 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 a controller 144 (see FIG. 4B , described in more detail below), whereby control and / or power signals may be provided to the illumination sources 42a-n by the controller 144. It is desirable that the intensity of the light signals emitted by the illumination sources 42a-n be maintained substantially constant throughout operation of the reagent analyzer 10, such as by control and power signals provided by the controller 144. In one embodiment, the optical signals emitted by illumination sources 42a-n may be conditioned or processed by one or more optical or other systems (not shown), such as, for example, filters, diffusers, polarizers, lenses, lens systems, collimators, and combinations thereof.

[0044] In some exemplary embodiments, one or more illumination sources 42a-n may be implemented, such as a first illumination source 42a and a second illumination source 42b, which may have different locations and / or orientations, whereby the first illumination source 42a and the second illumination source 42b cooperate to illuminate substantially the entire field of view 40 of the imaging system 22 (e.g., substantially the entire sample holder 32 and / or sample 46). The first illumination source 42a and the second illumination source 42b may, for example, emit light signals having different illumination intensities.

[0045] In one embodiment, the sample holder 32 can be adapted to receive a test device 44 in the form of, for example, a reagent card cassette having one or more multi-profile reagent cards 124. Exemplary reagent cards 124 are shown in FIGS. 5-7 and described in more detail below. Each reagent card 124 (described in more detail below) can include a substrate and one or more reagent pads located on or otherwise associated with the substrate. In an exemplary embodiment, the reagent pads can include fluidic or microfluidic compartments (not shown).

[0046] Each reagent pad of one or more reagent cards located within the testing device can include a reagent configured to undergo a color change in response to the presence of a target component, such as a molecule, cell, or substance, in a specimen sample 46 deposited on the reagent pad. Different reagents can be provided in the reagent pad to detect the presence of different target components. The different reagents can induce one or more color changes in response to the presence of a particular component, such as a particular type of analyte, in the sample 46. The color produced by the reaction of a particular component with a particular reagent can define a distinct spectrum characteristic of the light absorption and / or reflection for that particular component. The extent of the color change of the reagent and sample 46 can depend, for example, on the amount of target component present in the sample 46.

[0047] The presence and concentration of these target components in sample 46 may be determinable, for example, by analysis of the color change produced by one or more reagent pads after a predetermined time after application of sample 46 to the reagent pads and / or at a predetermined read location within the field of view 40 of imaging system 22. This analysis may involve a color comparison of each reagent pad after different time periods after application of sample 46 and / or at different read locations within the field of view 40 of imaging system 22.

[0048] Based on an analysis of the magnitude of the optical signal detected by the imaging system 22, the sample 46 can be assigned to one of a number of categories, for example, a first category corresponding to the absence of the target component in the sample 46, a second category corresponding to a low concentration of the target component present in the sample 46, a third category corresponding to a medium concentration of the target component present in the sample 46, and a fourth category corresponding to a high concentration of the target component present in the sample 46.

[0049] Additionally, the imaging system 22 can detect optical signals indicative of the color or reflectance value of a reagent pad and / or test strip at any time interval after a volume of sample 46 is dispensed onto the testing device 44, e.g., the reagent pad and / or test strip, regardless of the location of the particular reagent pad and / or test strip. In one exemplary embodiment, a video or series of images of the reagent pad and / or test strip can be captured at various time intervals after a volume of sample 46 is deposited onto the reagent pad and / or test strip.

[0050] 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 test devices 44, e.g., reagent pads, at any time and at any location within the field of view of the camera 26. In some exemplary embodiments, the imaging system 22 may capture an image indicative of the color or reflectance value of a test device 44, e.g., a reagent pad, for example, 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.

[0051] Referring now to FIG. 4A, a bottom view of a circuit board having an aperture surrounded by an on-board light source in accordance with the inventive concepts disclosed herein is shown to facilitate controlled illumination of the reagent card and reduce light scattering detected by the imaging system 22.

[0052] Controlled illumination is described herein, by way of example, as uniform illumination across the 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 includes a substrate 60 having a bottom surface 61 a and a top surface 61 b, a plurality of conductive leads extending on or within the substrate 60, and an aperture 38 extending between the bottom surface 61 a and the top surface 61 b.

[0053] In one embodiment shown in FIG. 4A, the one or more illumination sources 42a-n are a plurality of LEDs 64a-n and one or more infrared LEDs 68. The LEDs 64a-n shown in FIG. 4A include 20 visible light LEDs arranged as shown in FIG. 4A and one or more infrared LEDs 68. The LEDs 64a-n include any LEDs needed to produce a substantially uniform light intensity across the sample holder 32 and / or reagent card 124 or reagent cassette. The infrared LEDs 68 can be used, for example, to apply heat to the sample 46 or to identify an ID pad on the test device 44. In one embodiment, the ID pad is utilized to correlate the sample 46 on the test device 44 supported by the sample holder 32 to data acquired by the reagent analyzer 10.

[0054] 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 yet another embodiment, each LED 64a-n is positioned one or more distances from the test device 44 supported by the sample holder 32, such that the first LED 64 and the second LED 64 are positioned different distances from the test device 44 and / or the sample holder 32.

[0055] In some non-limiting embodiments, a substantially uniform light intensity can be achieved by adjusting the power level of each LED 64a-n. The substantially uniform light intensity can be 85% to 100% uniform. The construction, use, and calibration of circuit board 34 are described in U.S. Patent Nos. 63 / 064,609 and 63 / 225,124.

[0056] The circuit board 34 shown in FIG. 4A depicts a bottom surface 61a of the circuit board 34 having one or more illumination sources 42a. When placed within the reagent analyzer 10, the bottom surface 61a is oriented to face the sample tray 30, thereby allowing light generated by the one or more illumination sources 42a-n to be presented directly onto the sample holder 32 and / or sample 46. The illumination sources 42a-n are connected to a plurality of conductive leads on the circuit board 34, whereby the conductive leads provide electricity to each illumination source 42a-n. In one embodiment, the circuit board 34 further includes an illumination source circuit (not shown) connected to the plurality of conductive leads, the illumination source circuit configured to apply electricity independently to each illumination source 42a-n. For example, the illumination source circuit can be configured to supply a first power to the first illumination source 42a and a second power to the second illumination source 42b, where the first power and the second power are different, thereby causing differences in illumination intensity across the sample. The illumination sources 42a-n are positioned to provide a substantially uniform illumination intensity across the field of view 40 of the camera 26, thereby illuminating the reagent pad with a substantially uniform intensity and increasing the accuracy of reading the color change of the reagent pad (shown in more detail below and in FIGS. 5-7). As shown in FIG. 4B, the substrate 60 of the circuit board 34 is substantially planar, whereby each of the one or more illumination sources 42a-n is a similar distance from the sample tray 30. Depending on the location of the illumination source 42a-n relative to the sample 46, the distance between the illumination source 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, whereby one or more of the illumination sources 42a-n are at different distances from the sample tray 30. In one embodiment, one or more illumination sources 42a-n may be mounted on posts (not shown), each post attached to the circuit board 34 and providing one or more conductive paths to a specific one of the illumination sources 42a-n. When a support post is used, it brings a portion of one or more illumination sources 42 a - n closer to the sample 46 and / or sample tray 30 .

[0057] In one embodiment, the substrate 60 has a first region 62 a, a second region 62 b opposite the first region 62 a, and an intermediate region 62 c located between the first region 62 a and the second region 62 b. One or more illumination sources 42 a-n can be mounted to the substrate 60 in each of the first region 62 a, the second region 62 b, and the intermediate region 62 c, or in some combination thereof. In one embodiment, a first power may be applied to one or more illumination sources 42a-n in the first region 62a and the second region 62b, thereby causing the one or more illumination sources 42a-n in the first region 62a and the second region 62b to provide a first illumination intensity, and a second power may be applied to one or more illumination sources 42a-n in the intermediate region 62c, thereby causing the one or more illumination sources 42a-n in the intermediate region 62c to provide a second illumination intensity, wherein the first power and the second power are different and the first illumination intensity and the second illumination intensity are different.

[0058] The aperture 38 of the circuit board 34 extends from the top surface 61b to the bottom surface 61a, providing an opening for the field of view 40 of the imaging system 22 to pass from the imaging system 22 through the transparent shield 31 to the sample holder 32, providing a controlled view of the test device 44 associated with the sample holder 32 to the camera 26. The aperture 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 aperture 38. In one embodiment, the aperture 38 is located substantially within the intermediate region 62c. In one embodiment, the aperture 38 has a first major axis and a first minor axis, the sample holder 32 has a second major axis and a second minor axis, and the first major axis is aligned with the second major axis. 4A is shown as a rectangle to provide a controlled field of view of a rectangular reagent test device, it will be understood that aperture 38 can be configured in any shape such that field of view 40 is a controlled field of view of sample tray 30, and illumination source 42 can be calibrated to provide substantially uniform illumination of sample 46. In the example of FIG. 4A, aperture 38 does not extend to the edge of circuit board 34.

[0059] In one embodiment, aperture 38 extends to the edge of circuit board 34 without bisecting it, while in another embodiment, aperture 38 extends entirely through circuit board 34, bisecting it into first and second halves that are mounted in separate locations and supported by housing 14 such that field of view 40 is a controlled field of view of sample tray and illumination source 42.

[0060] In some non-limiting embodiments shown in FIGS. 6-8 , the reagent card 124 can include a substrate 128 and one or more reagent pads 132 a-n located on or otherwise associated with the substrate 128. The substrate 128 can be constructed of any suitable material, such as, for example, paper, photographic paper, polymers, fibrous materials, and combinations thereof. The reagent pads 132 a-n can be arranged on the substrate 128 in a grid-like configuration, for example, to define one or more test strips. In exemplary embodiments, the reagent pads 132 a-n can include fluidic or microfluidic compartments (not shown). The reagent pads 132 a-n can be spaced apart from one another, for example, such that the test strips are spaced apart, thereby allowing adjacent test strips and / or reagent pads 132 a-n to be simultaneously positioned at distinct locations within the field of view 40 of the imaging system 22. The reagent card 124 can be a multi-profile reagent card having multiple reagent pads 132a-n with different reagents and / or multiple different test strips. Additionally, in some exemplary embodiments, the reagent card 124 can include, for example, one or more calibration chips or reference pads, which do not have reagents and can serve as color standards. In another embodiment, the reagent card 124 includes an ID pad with an identifier that is visible under infrared light.

[0061] Each reagent pad 132a-n can include a reagent configured to undergo a color change in response to the presence of a target component, such as a molecule, cell, or substance, in the specimen sample 46 deposited on the reagent pad 132a-n. Different reagents can be provided in the reagent pads 132a-n to detect the presence of different target components. The different reagents can induce one or more color changes in response to the presence of a particular component in the sample 46, such as a particular type of analyte. The color produced by the reaction of a particular component with a particular reagent can define a distinct spectrum of light absorption and / or reflection characteristic of that particular component. The extent of the color change of the reagent and sample can depend, for example, on the amount of the target component present in the sample 46.

[0062] The color change can be read by the imaging system 22. Signals indicative of the color of the reagent pads 132a-n can be received / imaged by the imaging system 22, which can analyze the signals to determine the color change of the reagent pads 132a-n resulting from the reagent pads 132a-n reacting with the volume of sample 46 deposited thereon. Such color changes can be analyzed according to, for example, the read position of the reagent pads 132a-n when the optical signal or image indicative of the color of the reagent pads 132a-n was detected, and / or the known duration that the volume of sample 46 has been deposited on the reagent pads 132a-n, and / or combinations 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 within the volume of sample 46 deposited on the reagent pads 132a-n, as described above.

[0063] 4B, an analyzer diagram 140 is shown depicting the reagent analyzer 10 including the transparent shield 31 and an analyzer controller 144. The analyzer controller 144 has at least a 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 and / or be operatively coupled to other elements of the reagent analyzer 10. Although the analyzer controller 144 is depicted separate from the reagent analyzer 10, it will 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, such as the circuit board 34.

[0064] In one embodiment, the imaging system 22 can be operatively coupled to, for example, the analyzer controller 144 and / or the processor 148, such that the controller 144 can transmit one or more power and / or control signals to the camera 126 and / or one or more illumination sources 42a-n and transmit one or more signals from the camera 126 to the processor 148. The analyzer controller 144 can be configured to evaluate test results when a reagent card is extracted within the reagent analyzer 10, for example, by receiving one or more signals from the camera 126. The camera 126 can be configured to detect or capture one or more optical or other signals indicative of the reflectance value of a test device 44, such as a reagent pad, through the transparent shield 31 and transmit signals indicative of the reflectance value of the test device 44, e.g., a reagent pad, to the processor 118. For example, the camera 126 can detect one or more optical signals through the transparent shield 31 at each reading position, the optical signals having wavelengths indicative of the reflectance value of the reagent pad and / or test strip. Camera 126 can detect, for example, optical signals through transparent shield 31 indicative of the reflectance values ​​of the reagent pad and / or test strip at any desired reading position, location, or area within field of view 40, or any other desired location or areas. The signals transmitted by camera 126 to processor 148 can be, for example, electrical signals, optical signals, and combinations thereof. In one embodiment, the signals are in the form of an image file having a matrix of pixels, each pixel having a color code indicative of a reflectance value. In an exemplary embodiment, the image file can have two or more predetermined regions of pixels, each of which corresponds to a reading position of one of the reagent pads and / or test strips within field of view 40 of camera 126. In one embodiment, processor 148 can store the transmitted signals and / or image files in one or more databases 156 and / or memory 152.

[0065] The processor 148 can determine, for example, a reflectance value or color change of the reagent pad and / or test strip along with a sample (e.g., urine) placed thereon based on signals detected by the camera 126. Each optical or other signal indicating one or more reflectance readings detected by the camera 126 can have a magnitude related to a different wavelength of light (i.e., color). The response of one or more reagents to the color of the sample and / or target component in the reagent pad can be determined based on the relative magnitudes of the reflectance signals of various color components, e.g., red, green, and blue reflectance component signals. For example, the color of each reagent pad can be converted to a standard color model, which typically includes three or four values ​​or color components whose combinations represent a particular color (e.g., the RGB color model, including hue, saturation, and lightness (HLS) and hue, saturation, and value (HSV) point representations, and / or the CMYK color model, or any other suitable color model). In some embodiments, camera 126 may detect multiple optical signals at each reading position, each detected signal having one or more color components, such as, for example, a red component signal, a green component signal, and a blue component signal, and may transmit each of these component signals 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.

[0066] In one embodiment, the method for determining the degree of shielding 150 of transparent shield 31 (described below and shown in FIG. 8 ) can be implemented as a set of processor-executable instructions or logic stored on a non-transitory computer-readable medium, which, when executed by processor 148, causes processor 148 to determine the degree of shielding of transparent shield 31. The method for determining the degree of shielding 150 can be performed periodically at predetermined internal times, etc., as desired, in accordance with particular quality control procedures applicable to reagent analyzer 10, and combinations thereof, etc.

[0067] In some embodiments, processor 148 is further configured to have a set of processor-executable instructions or logic stored on a non-transitory computer-readable medium that, when executed by processor 148, causes processor 148 to perform an action at at least one periodic interval selected from the group consisting of: initiating an alert in a human-perceptible form, initiating a cleaning process configured to clean transparent shield 31, and replacing transparent shield 31. In some embodiments, the periodic interval is based on the duration or number of tests performed by reagent analyzer 10.

[0068] 5-7, exemplary images 170a-c are shown illustrating top views of the sample holder 32 and test device 44, in the form of a reagent card 172, as viewed through an exemplary transparent shield 31 located within the housing 14 of the reagent analyzer 10 according to the present disclosure. In one embodiment, the imaging system 22 can capture the images 170 of the sample holder 32 and test device 44 through the exemplary transparent shield 31, which has varying degrees of obscuration due to debris from the transparent shield 31 that may be caused by splashes from the test device 44 being moved by the sample holder 32.

[0069] FIG. 5 shows an exemplary top view 170a of a sample holder 32 having a test device 44 in the form of a sample card 174 as viewed through a transparent shield 31 without environmental contaminants 178 present on surfaces 36 or 37 of the transparent shield 31.

[0070] 6 shows an exemplary top view 170b of a sample holder 32 having a test device 44 in the form of a sample card 174 as viewed through a transparent shield 31 with environmental contaminants 178, such as dust, present on surface 36 or surface 37 of the transparent shield 31. Although multiple environmental contaminants 178 are shown in FIG. 6, only one environmental contaminant 178 is labeled for clarity.

[0071] FIG. 7 shows an exemplary top view 170c of a sample holder 32 in the form of a sample card 172 and a test device 44 as viewed through an exemplary transparent shield 31 having a number of environmental contaminants 178, such as moisture, dust, and dirt, present on surface 36 or surface 37 of the transparent shield 31.

[0072] 8, which is a flow diagram of an exemplary embodiment of a method 200 for determining the degree of occlusion of a transparent shield 31 in accordance with the inventive concepts disclosed herein. The method 200 for determining the degree of occlusion of a transparent shield 31 generally includes the steps of: receiving a first image 170 of a test device 44 located in a sample holder 32 through a transparent shield 31 not associated with an imaging system 22, the transparent shield 31 being located adjacent to the sample holder 32 within the housing 14 of the reagent analyzer 10 (step 202); comparing pixel data of the first image of the test device 44 located in the sample holder 32 received through the transparent shield 31 with reference data stored in a non-transitory computer-readable medium to determine the degree of occlusion of the transparent shield 31 (step 204); identifying a material on a surface of the transparent shield 31 to determine the degree of occlusion of the transparent shield 31 (step 206); and determining whether the degree of occlusion of the transparent shield 31 is greater than the degree of occlusion of the transparent shield 31 (step 207). determining whether a baseline value (stored in non-transitory computer-readable memory 152) indicating potential occlusion of the transparent shield 31 is exceeded (step 208); and, in response to the degree of occlusion exceeding the baseline value, storing time-stamped data indicating that the transparent shield 31 is occluded, and causing an action (step 210) selected from the group consisting of: initiating an alert in a human-perceptible form, storing data indicative of the degree of occlusion detected in the first image 170 that exceeds the baseline value in non-transitory computer-readable memory 152, initiating a cleaning process configured to clean the transparent shield 31, or replacing the transparent shield 31 with a replacement transparent shield 31 having a degree of occlusion less than the baseline value. In one non-limiting embodiment, the reference data may be manufacturing standard data for the test device 44 stored in a non-transitory computer-readable medium.

[0073] In one embodiment, the transparent shield 31 may not be associated with the imaging system 22. In this embodiment, the primary function of the transparent shield 31 is to provide protection to the imaging system 22 and not affect the optical properties of the imaging system 22. The transparent shield 31 may not be a lens or component of the imaging system 22. In some embodiments, the transparent shield 31 can function to both protect the imaging system 22 and affect the optical properties of the imaging system 22. For example, the transparent shield 31 can include one or more polarizers or filters suitable for affecting the optical properties of the imaging system 22. In any embodiment, the imaging system 22 can be calibrated to reduce any inadvertent optical effects of the transparent shield 31, as discussed below.

[0074] Cleaning or replacing the transparent shield 31 improves the accuracy of the analysis provided by the reagent analyzer 10. In some embodiments, cleaning the transparent shield 31 can be performed by moving the transparent shield 31 out of the housing 14 through the slot 15 (without having to disassemble the analytical device or directly access the optical system), cleaning the surface 36 or 37 of the transparent shield 31, and moving the transparent shield 31 back into the housing 14 through the slot 15. Cleaning the transparent shield 31 can be performed manually by a person grasping the transparent shield 31, or in an automated format. In automated versions, a motor-driven wiper can be used to wipe and clean the surface 36 or 37. In some embodiments, replacing the transparent shield 31 can be performed by moving the transparent shield 31 out of the housing 14 through the slot 15, discarding the transparent shield 31, and moving a replacement transparent shield 31 back into the housing 14 through the slot 15.

[0075] The data indicating the degree of shielding can be stored in memory 152, database 156, a non-transitory computer-readable medium, etc. In another non-limiting embodiment, the data indicating the transparent shield 31 with the degree of shielding can include a timestamp. In another non-limiting embodiment, when the degree of shielding of the transparent shield 31 does not exceed the baseline value, the method further includes processor 148 receiving a second image 170 of the sample holder 32 through the transparent shield 31, comparing the image of the sample holder 32 received through the transparent shield 31 with the reference data, determining the degree of shielding of the transparent shield 31, and determining whether the degree of shielding of the transparent shield 31 exceeds the baseline value, i.e., repeating steps 202 to 210 until the degree of shielding of the transparent shield 31 reaches or exceeds the baseline value.

[0076] Method 200 for determining the degree of occlusion of transparent shield 31 may be implemented as a set of processor-executable instructions or logic stored on a non-transitory computer-readable medium, which, when executed by processor 148, causes processor 148 to execute logic for calculating or determining the degree of occlusion of transparent shield 31. Method 200 for determining the degree of occlusion of transparent shield 31 may be executed periodically, such as at preset time intervals, or may be executed in accordance with a particular quality control procedure applicable to reagent analyzer 10, or a combination thereof.

[0077] In some non-limiting embodiments, the method 200 for determining the degree of obscuration can be via computer vision to determine at least one environmental contaminant 178 on the surface 36 or surface 37 of the transparent shield 31. In some non-limiting embodiments, the computer vision method 200 for determining at least one environmental contaminant 178 on the surface 36 or surface 37 of the transparent shield 31 can be via object detection. Object detection is a technique that includes training a neural network to determine the presence of at least one environmental contaminant 178 on the surface 36 or surface 37 of the transparent shield 31 in the image 170 captured by the imaging system 22. Methods by which the neural network can recognize the environmental contributors 178 include utilizing traditional region proposal methods; inputting the extracted candidate regions into the neural network for recognition and categorization; utilizing bounding box regression techniques to determine, for example, the environmental contributors 178; and extracting several candidate regions that may be objects to be detected from the image 170 by enclosing each environmental contributor 178 with a bounding box and determining whether the aggregated environmental contributors 178, i.e., the degree of occlusion, enclosed by the bounding boxes, exceed a baseline value indicative of potential occlusion by the transparent shield 31. In some non-limiting embodiments, the alert generated in response to the degree of occlusion exceeding the baseline value can be a notification of the location of the environmental contributor 178 on the surface 36 or surface 37 of the transparent shield 31 on an output device. The output device can be a tablet, a computing device, or the like.

[0078] In another non-limiting embodiment, computer vision for determining at least one environmental contributor 178 on surface 36 or surface 37 of transparent shield 31 can utilize object tracking techniques. Object tracking involves a trained neural network running on processor 148 to analyze changes in images over time. This can be accomplished by receiving a first image of sample holder 32 through transparent shield 31 captured at a first time point, where processor 148 receives a second image of sample holder 32 through transparent shield 31 captured at a second time point, where the second image is received by processor 148 after receiving the first image; detecting environmental contributors 178 in the first image to generate a bounding box, where environmental contributors 178 can be located within the bounding box; performing object recognition of environmental contributors 178 within the bounding box; repeating these steps for a second image; and determining whether the second image has the environmental contributors 178 present in the first image based on a predetermined object model.

[0079] In some non-limiting embodiments, computer vision for determining the at least one environmental contaminant 178 on the surface 36 or 37 of the transparent shield 31 can utilize semantic segmentation techniques. Semantic segmentation includes constructing a first 3D semantic model of the reagent analyzer 10 having the transparent shield 31 without the at least one environmental contaminant 178 present on the surface 36 or 37; and constructing a second 3D semantic model of the reagent analyzer 10 having the transparent shield 31 with the at least one environmental contaminant 178 present, such as dust, soot, ash, pollen, smoke, moisture, etc. The 3D semantic model is updated over time by segmenting current frames to form segmented frames. Segmented frames showing the reagent analyzer 10 with the transparent shield 31 in use can be compared to the 3D model using heuristic or Bayesian rules to form the current frame of the reagent analyzer 10.

[0080] In some non-limiting embodiments, the computer vision for determining the at least one environmental contributor 178 on the surface 36 or surface 37 of the transparent shield 31 can utilize instance segmentation techniques. In an instance segmentation machine learning model, the processor 148 can be trained to simultaneously process images of the sample holder 32 through the transparent shield 31 located within the housing 14 of the reagent analyzer 10 to detect the at least one environmental contributor 178 and classify the at least one environmental contributor 178 via placement of a segmented mask over the images of the sample holder 32 through the transparent shield 31 located within the housing 14 of the reagent analyzer 10. The segmented mask can be a pixel-by-pixel mask that identifies pixels of the at least one environmental contributor 178 present on the at least one surface 36 or surface 37 of the transparent shield 31.

[0081] In some non-limiting embodiments, the processor 148 can be configured to process images of the sample holder 32 through a transparent shield 31 having a degree of translucency located within the housing 14 of the reagent analyzer 10 to detect the translucency of the transparent shield 31. In some embodiments, the analyzer 10 can be configured to calibrate the translucency of the transparent shield 31 against known transparency standards for transparent shields 31 stored in memory 152 to normalize or correct for any inadvertent optical effects caused by light passing through the transparent shield 31. In some non-limiting embodiments, calibration of the translucency of the transparent shield 31 can occur at periodic intervals while the analyzer 10 is in use or by operator command.

[0082] In some non-limiting embodiments, processor 148 is further configured to have a set of processor-executable instructions or logic stored on a non-transitory computer-readable medium that, when executed by processor 148, causes processor 148 to perform an action at at least one periodic interval selected from the group consisting of: initiating an alert in a human-perceptible form, initiating a cleaning process configured to clean transparent shield 31, and replacing transparent shield 31. In some embodiments, the periodic interval is based on the duration or number of tests performed by reagent analyzer 10.

[0083] Non-limiting exemplary embodiments The following is a numbered list of non-limiting exemplary embodiments of the inventive concepts disclosed herein:

[0084] 1. A method comprising: receiving a first image of a test device located in a sample holder through a transparent shield not associated with the imaging system, the transparent shield being located within a housing of the reagent analyzer adjacent to the sample holder; comparing pixel data of a first image of the test device located in the sample holder received through the transparent shield to determine a degree of shielding of the transparent shield; determining whether the degree of shielding of the transparent shield exceeds a baseline value indicative of the potential shielding of the transparent shield; In response to the degree of occlusion exceeding the baseline value, performing an action selected from the group consisting of: initiating an alert in a form perceptible to a human; storing data indicative of the degree of occlusion detected in the first image exceeding the baseline value; initiating a cleaning process configured to clean the transparent shield; and replacing the transparent shield with a replacement transparent shield having a degree of occlusion less than the baseline value. A method comprising:

[0085] 2. When the degree of protection of the transparent shield exceeds the baseline value, the method is as follows: storing data indicative of a transparent shield having a degree of occlusion; communicating a notification to the user indicating the degree of coverage of the transparent shield; 10. The method of exemplary embodiment 1, further comprising:

[0086] 3. The method according to exemplary embodiment 1 or 2, wherein the data has a timestamp.

[0087] 4. When the degree of protection of the transparent shield does not exceed the baseline value, the method is as follows: receiving a second image of the test device positioned within the sample holder through the transparent shield; Determining the degree of shielding of the transparent shield; Determining whether the degree of shielding of the transparent shield exceeds a baseline value; The method of any one of exemplary embodiments 1 to 3, further comprising:

[0088] 5. The method according to any one of exemplary embodiments 1 to 4, wherein determining the degree of occlusion is performed using machine vision techniques.

[0089] 6. A method as described in any one of exemplary embodiments 1 to 5, further comprising: a processor analyzing the first image by executing processor executable code stored in a non-transitory computer-readable medium to determine the degree of occlusion of the transparent shield.

[0090] 7. The method of exemplary embodiment 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 indicative of environmental contaminants present on the surface of the transparent shield.

[0091] 8. A reagent analyzer comprising: Housing and; a sample holder configured to support a test device, the sample holder being movable into and out of the housing; With transparent shield; an imaging system having a field of view extending through the transparent shield and configured to capture an image of a test device positioned in the sample holder through the transparent shield at a reading position within the field of view, the image having a plurality of pixels; a processor configured to receive the image and analyze pixels of the image to determine the degree of occlusion of the transparent shield; a reagent analyzer comprising:

[0092] 9. The reagent analyzer of embodiment 8, further comprising a circuit board having a substrate and a plurality of conductive leads extending on or within the substrate, the substrate having a first major surface and a second major surface, the first major surface being located opposite the second major surface, the substrate having an opening extending between the first and second major surfaces, and the field of view extending through the opening.

[0093] 10. The reagent analyzer of exemplary embodiment 8 or 9, wherein the transparent shield is located between the sample holder and the imaging system.

[0094] 11. A reagent analyzer according to any one of exemplary embodiments 8 to 10, having a slot in the housing through which the transparent shield can be removably accessed.

[0095] 12. A reagent analyzer according to any one of exemplary embodiments 9 to 11, 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.

[0096] 13. The reagent analyzer of exemplary embodiment 12, wherein the test device is a wet reagent test device, the light source is a first light source, and the reagent analyzer further includes a second light source and circuitry configured to supply electricity to the first and second light sources, whereby the first and second light sources contribute an amount of illumination to the wet reagent test device calculated to provide controlled illumination.

[0097] 14. An apparatus comprising: a housing surrounding the cavity, the housing being opaque to visible light; an imaging system having a camera sensor with a field of view within the cavity; a sample tray located within the cavity, the sample tray having a sample holder within a field of view of a camera sensor, the sample tray being positioned at a distance from the camera sensor; a transparent shield positioned within the cavity, the transparent shield 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 shield being positioned within a field of view of an imaging system upstream of the sample tray and spaced a distance from the imaging system; 1. An apparatus comprising:

[0098] 15. The apparatus of exemplary embodiment 14, further comprising a test device located within a sample holder in a sample tray located within the cavity and within the field of view of the camera sensor, the sample tray being located at a distance from the camera sensor.

[0099] 16. An apparatus 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 within 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 located opposite the second major surface, the substrate having an opening extending between the first and second major surfaces, the opening located 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 field of view of a sample holder in 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 onto the substrate; a circuit attached to the conductive leads and configured to supply electricity to the light source via the conductive leads; 16. The apparatus of any one of exemplary embodiments 14 or 15, comprising:

[0100] 17. The apparatus of exemplary embodiment 16, wherein the light source includes a plurality of light sources arranged and supported in a planar configuration.

[0101] 18. An apparatus described in any one of exemplary embodiments 14 to 17, wherein a transparent shield divides a cavity within the housing into a first portion and a second portion, the imaging system being within the first portion and the sample tray being within the second portion.

[0102] 19. A device described in any one of exemplary embodiments 14 to 18, wherein the housing has a slot, a transparent shield is positioned within the cavity adjacent to the slot, the transparent shield has a width and a thickness, and the slot has a width greater than the width of the transparent shield and a height greater than the thickness of the transparent shield.

[0103] 20. The device of exemplary embodiment 19, wherein the transparent shield is movably supported within the housing and aligned with the slot such that the transparent shield is movable through the slot.

[0104] 21. A device described in any one of exemplary embodiments 14 to 20, wherein the first surface and the second surface of the transparent shield are planar and parallel within the intermediate region.

[0105] 22. An apparatus described in any one of exemplary embodiments 14 to 21, wherein the transparent shield is separate from the imaging system and configured to prevent debris from the sample tray from contacting the imaging system.

[0106] 23. A method comprising: determining whether a degree of shielding of a transparent shield between the sample tray and an imaging system in the reagent analyzer exceeds a baseline value indicative of potential shielding of the transparent shield; In response to the degree of occlusion exceeding the baseline value, performing an action selected from the group consisting of: initiating an alert in a form perceptible to a human; storing data indicative of the degree of occlusion detected in the first image exceeding the baseline value; initiating a cleaning process configured to clean the transparent shield; and replacing the transparent shield with a replacement transparent shield having a degree of occlusion less than the baseline value; A method comprising:

[0107] 24. The method of exemplary embodiment 23, wherein the step of determining whether the degree of occlusion of the transparent shield exceeds the baseline value is performed at periodic intervals.

[0108] 25. The method of exemplary embodiment 24, wherein the periodic interval is based on the duration or number of tests performed.

[0109] From the foregoing, it is apparent that the inventive concepts disclosed herein are well adapted to carry out these objects and attain the advantages set forth herein, as well as those inherent therein. While illustrative embodiments of the inventive concepts disclosed herein have been described for the purposes of this disclosure, it will be understood that numerous modifications, readily apparent to those skilled in the art, can be made thereto, and that such modifications are within the scope of the inventive concepts as disclosed and defined in the appended claims.

Claims

1. 1. A method comprising: receiving a first image of a test device located in a sample holder through a transparent shield, the transparent shield being located within a housing of the reagent analyzer adjacent to the sample holder; comparing pixel data of a first image of the test device located in the sample holder received through the transparent shield with data of a manufacturing standard for the test device to determine a degree of shielding of the transparent shield; determining whether the degree of occlusion of the transparent shield exceeds a baseline value indicative of potential occlusion of the transparent shield; In response to the degree of occlusion exceeding the baseline value, performing an action selected from the group consisting of: initiating an alert in a form perceptible to a human; storing data indicative of the degree of occlusion detected in the first image exceeding the baseline value; initiating a cleaning process configured to clean the transparent shield; and replacing the transparent shield with a replacement transparent shield having a degree of occlusion less than the baseline value. The method comprising:

2. When the degree of protection of the transparent shield exceeds the baseline value, the method is as follows: storing data indicative of a transparent shield having a degree of occlusion; communicating a notification to the user indicating the degree of coverage of the transparent shield; The method of claim 1 further comprising:

3. The method of claim 2 , wherein the data includes a timestamp.

4. If the degree of protection of the transparent shield does not exceed the baseline value, the method is: receiving a second image of the test device positioned within the sample holder through the transparent shield; Determining the degree of shielding of the transparent shield; Determining whether the degree of shielding of the transparent shield exceeds a baseline value; The method of claim 1 further comprising:

5. The method of claim 1 , wherein determining the degree of occlusion is performed using machine vision techniques.

6. The method of claim 1 , further comprising: a processor analyzing the first image by executing processor executable code stored in a non-transitory computer-readable medium to determine the degree of occlusion of the transparent shield.

7. 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 indicative of environmental contaminants present on the surface of the transparent shield.

8. The method of claim 1 , wherein the step of determining whether the degree of occlusion of the transparent shield exceeds the baseline value is performed at periodic intervals.

9. 9. The method of claim 8, wherein the periodic interval is based on the duration or number of tests performed by the reagent analyzer.

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