Analyzer with a transparent shield for protecting an 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 Jul. 18, 2022. The entire content of the above - referenced patent application is hereby expressly incorporated by reference herein.

[0002] Statement Regarding Federally Sponsored Research or Development Not applicable

[0003] The invention disclosed herein generally relates to an analyzer having a transparent shield positioned between an optical reader and a sample holder, and more particularly, but not limited to, to a system and method configured to determine the opacity of a transparent shield while viewing a sample holder through the transparent shield.

Background Art

[0004] To meet the needs of the medical community and other expanding technologies such as the brewing industry, chemical manufacturing, etc., countless analytical procedures, compositions, and tools have been developed, including lateral flow immunoassays and so - called "dip - and - read" reagent test devices. Whether a lateral flow immunoassay or a dip - and - read test device is used for the analysis of biological fluids or tissues or for the analysis of commercial or industrial fluids or substances, the general procedure involves the test device contacting the sample or specimen to be tested and the test device being analyzed 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 transports a sample beyond a control line position and a test line position. The control line at the control line position determines that the test is functioning 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 a dipstick format or a home test format. Both dipsticks and home tests function similarly and generally fall into one of two categories: sandwich assays where a positive test is indicated by the presence of a colored line at the test line position, and competitive assays where 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, especially in the chemical analysis of biological fluids, because they are relatively low-cost, easy to use, and provide quick results. For example, in the medical field, by dipping a dip-and-read reagent test device into a sample of body fluid or tissue such as urine or blood and observing a detectable response such as a color change or a change in the amount of light reflected or absorbed by the test device, numerous physiological functions can be monitored.

[0007] Many dip-and-read reagent test devices for detecting body fluid components are capable of performing 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 of the presence of a particular component in the test sample but also an estimate of how much of that component is present. Such dip-and-read reagent test devices provide an easy diagnostic tool and the ability to assess the degree of disease or physical disorder to physicians and laboratory technicians.

[0008] Examples of dip-and-read reagent test devices currently in use are products such as those available from Siemens Healthcare Diagnostics, Inc. under the MULTISTIX trademark. Such immuno-chemical, diagnostic, or serological test devices typically include one or more carrier matrices such as absorbent paper, and such carrier matrices incorporate a specific reagent or reaction system that clearly indicates a detectable response (e.g., a color change within the visible or ultraviolet spectrum) in the presence of a particular test sample component or ingredient. Depending on the reaction system incorporated into a particular matrix, these test devices can detect the presence of glucose, ketones, bilirubin, urobilinogen, occult blood, nitrite, and other substances. A specific change in the intensity of the color observed within a specific time range after contacting the dip-and-read reagent test device with a sample indicates the presence and / or concentration of a particular component in the sample. Some other examples of dip-and-read reagent test devices and their reagent systems can be found in Patent Document 1, Patent Document 2, and Patent Document 3, the entire disclosures of which are hereby incorporated by reference into this specification.

[0009] However, dip-and-read reagent test devices have several limitations. For example, in the case of dip-and-read reagent test devices, generally, a technician has to manually immerse the test device into a sample, wait for a specified amount of time, and visually compare the color of the test device with a color chart provided with the test device. This process is slow, and the resulting readings are highly technique-dependent (e.g., accurate timing, proper comparison with the color chart, ambient lighting conditions, and the technician's eyesight), and the results may not be consistent between two different technicians performing the same test. Finally, the act of manually immersing the test device into the sample may lead to 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 onto the test device, or excessive sample on the test device dripping, leaking, or splashing onto the technician's work area, person, or clothing.

[0010] In particular, by using automated processes, there has been a need in the art for test tools and methods for performing multiple tests economically and rapidly. Automated analyzer systems have advantages over manual tests with respect to the cost per test, throughput of the tests, and / or the speed at which test results or other information are obtained.

[0011] In the case of current available automated instruments for reading individual reagent test devices such as lateral flow immunoassay or dip-and-read reagent test devices or reagent strips (e.g., CLINITEK STATUS reflectance photometer manufactured and sold by Siemens Healthcare Diagnostics, Inc.), it is necessary to manually load each test device into the automated instrument after contacting the test device with the specimen or sample to be tested. For manual loading, the reagent test device needs to be properly positioned within the automated instrument within a limited 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 discarded in accordance with the applicable regulations.

[0012] Another development example is the introduction of a multi-profile reagent card and an automated analyzer for the multi-profile reagent card. The multi-profile reagent card is an essentially card-shaped test device that includes a plurality of reagent-impregnated matrices or pads for performing multiple analyses of an analyte simultaneously or sequentially, as described, for example, in Patent Document 4, which is hereby incorporated by reference in its entirety. The reagent pads on the multi-profile reagent card are typically arranged in a grid pattern so as to define several rows and columns of reagent pads, spaced apart from each other. Adjacent reagent pads within the same row can be referred to as, for example, test strips and can contain reagents for a preset combination of tests to be performed on each sample.

[0013] A multiple-profile reagent card provides an efficient, economical, rapid, and convenient way to perform automated analysis. An automated analyzer configured to use a multiple-profile reagent card typically removes the multiple-profile reagent card from a storage drawer or cassette, etc., and advances the multiple-profile reagent card typically one step at a time on the advancing surface of the analyzer via a card movement mechanism such that one test strip (or one row of reagent pads) is positioned at the sample dosing position and / or one or more reading positions. Exemplary card movement mechanisms include a conveyor belt, a ratchet mechanism, a sliding ramp, or a card gripping or pulling mechanism. When the multiple-profile reagent card moves or advances along the advancing surface and is positioned at the sample dosing position, one or more pipettes deposit (e.g., manually or automatically) the volume of one or more samples onto one or more of the reagent pads on the reagent card. Next, the reagent pads are positioned at one or more reading 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, a microscope, or a spectrometer, etc., and one or more images of the reagent pads on the card (e.g., optical signals indicating the color of the reagent pads) are captured and analyzed. Typically, the field of view of the imaging system is relatively large, and multiple images of the same reagent pad can be captured as the reagent card is moved or advanced across multiple reading positions within the field of view of the imaging system. The field of view includes multiple reading positions or locations, and as the reagent card progresses through the field of view of the imaging system, each reagent pad moves stepwise through these reading positions. Since the analyzer moves the card between various reading positions at known time intervals, for example, based on the time it takes for the pads to move to their respective reading positions as indicated by multiple images obtained within the field of view of the imaging system, the analyzer can determine the color change of the reagent pads as a result of the reaction of the reagent pads with the sample at each reading position. Finally, the used card is removed from the analyzer and properly discarded.

[0014] In some analyzers, the sample tray holds consumables such as reagent cards to be read. The sample tray is moved by a motor from the outside of the analyzer housing to the inside of the housing, and in the housing, sample measurement is performed by an optical reader. Surprisingly, it has been found that excess fluid not taken up by the consumables splashes onto any optical components above the sample holding area during this movement. When the optical elements become dirty, there is a risk that incorrect results may be used by the doctor to treat the patient, so the analyzer needs to be cleaned or replaced, which requires a great deal of time and cost and may prevent results from being available when potentially needed.

Prior Art Documents

Patent Documents

[0015]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Summary of the Invention

Problems to be Solved by the Invention

[0016] Accordingly, there is a need in the art for an analyzer having a sample tray that can be moved within the analyzer without contaminating the optical elements 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 Problems

[0017] In one embodiment, the inventive concept disclosed herein is a reagent analyzer that addresses the drawbacks of the prior art described above. The reagent analyzer has 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 that extends through the transparent shield and is configured to capture an image of a wet reagent test device located at a reading 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 added to the wet reagent pad.

[0018] To assist those skilled in the art in constructing and using the inventive concept 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 consistency. For clarity, not all components are shown in all of the drawings. For clarity and brevity, the specific configurations and specific appearances of these figures may not be drawn to scale and may be shown emphasized or schematically.

Brief Description of the Drawings

[0019]

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DETAILED DESCRIPTION OF THE INVENTION

[0020] Before describing in detail at least one embodiment of the inventive concept disclosed herein, it should be understood that the inventive concept is not limited in its application to the details of the components or steps or methods of construction and arrangement described in the following description or shown in the drawings. The inventive concept disclosed herein may have other embodiments or may be implemented or executed in various ways. Also, it should be understood that the nomenclature and terminology employed herein are for the purpose of description and should not be regarded as limiting the inventive concept disclosed and claimed herein in any way.

[0021] In the following detailed description of the inventive concept, numerous specific details are set forth in order to provide a more thorough understanding of the inventive concept. However, it will be apparent to one of ordinary skill in the art that the inventive concept disclosed herein may be practiced without these specific details. In other instances, well-known structures 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 comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to the item.

[0023] Unless expressly stated to the contrary, "or" refers to an inclusive disjunction and not an exclusive disjunction. For example, condition A or B is satisfied by any of the following: A is true (or present) and B is false (or absent), A is false (or absent) and B is true (or present), and both A and B are true (or present).

[0024] In addition, the use of "a" or "an" is utilized to describe elements and components of the present invention. This is done solely for convenience and to give a general sense of the concepts of the present invention. This description should be read to include one or at least one, and the singular includes the plural unless it is clear that it is meant otherwise.

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

[0026] As used herein, a "wet reagent test device" refers to a reagent device on which a volume of sample is deposited, and the reagent within the reagent device is capable of reacting with its target component, if such a component is present in the sample. A wet reagent test device can also deposit a negative control volume.

[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 the control strip or test strip of a lateral flow immunoassay.

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

[0029] The concepts of the inventions disclosed herein generally relate to an analyzer for a reagent test device and a method for reading a reagent test device. More particularly, but not by way of limitation, the concepts relate to an analyzer having a transparent shield within the field of view of an imaging system and a sample holder configured such that the imaging system is adapted 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 the pixels of the image to determine the degree of shielding of the transparent shield. The concepts of the inventions disclosed herein will be described primarily in relation to an automated analyzer that uses a multiple-profile reagent card as the reagent test device, but the concepts of the inventions disclosed herein are not limited to automated analyzers or multiple-profile reagent cards. For example, as will be appreciated by those skilled in the art having the benefit of this disclosure, the methods according to the concepts of the inventions disclosed herein can be implemented by a manual analyzer or by an automated analyzer that uses a reagent test device other than a multiple-profile reagent card, such as a lateral flow immunoassay, a dip-and-read reagent test device, or a reel of reagent test devices on a substrate, and combinations thereof. Further, the concepts of the inventions disclosed herein can be implemented by any reagent device imaging system having at least one reading position within the field of view.

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

[0031] Next, referring to FIGS. 1-3, an exemplary embodiment of a reagent analyzer 10 according to the concepts of the invention disclosed herein is shown. The reagent analyzer 10 can be, for example, an automated reagent card analyzer. Exemplary embodiments of automated reagent card analyzers are described in detail in U.S. Patent Application No. 13 / 712,144, filed December 12, 2012, and PCT Application PCT / US2012 / 069621, filed December 14, 2012, the entire disclosures of which are hereby expressly incorporated herein by reference.

[0032] Generally, the exemplary reagent analyzer 10 includes a housing 14 having a slot 15, the housing 14 surrounding 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 positioned within the cavity 18, a transparent shield 31, and a circuit board 34 having an aperture 38 and one or more light sources 42a-n positioned within the cavity 18.

[0033] The housing 14 can be formed from one or more components configured to form the cavity 18 and support at least one rail 19, the imaging system 22, the sample tray 30, the transparent shield 31, and the 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 of the light 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 shield 31 can be positioned within the housing 14 and from which the transparent shield 31 can be removed from within the housing 14.

[0034] The transparent shield 31 has at least one side wall 33, at least one end 35, a first surface 36 extending between at least one side wall 33 and at least one end 35, a second surface 37 located opposite the first surface 36 and extending between at least one side wall 33 and 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 side wall 33a, a second side wall 33b located opposite the first side wall 33a, a first end 35a, a second end 35b located opposite the first end 35a, a first surface 36 extending from the first end 35a to the second end 35b, a second surface 37 located opposite the first surface 36 and extending from the first end 35a to the second end 35b, 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, whereby light can pass through the transparent shield 31 without significant scattering that would prevent clear viewing and imaging of objects located beyond the transparent shield 31. In some embodiments, the transparent shield 31 can have some degree of translucency, whereby light can pass through the transparent shield 31 without scattering that would cause objects located beyond the transparent shield 31 to be visible with varying clarity. The first surface 36 and the second surface 37 are coplanar 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 the 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) at at least one end 35 of the transparent shield 31.The grip can be a frosted or etched surface with a rough texture, for example, on the first surface 36 and / or the second surface 37, or can include a handle or the like that extends from and / or is 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 the intermediate region 41 to the second surface 37 (FIG. 9).

[0035] In some non-limiting embodiments, 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 disposed within the slot 15, the surface 37 of the transparent shield 31 can be positioned on at least one rail 19. In other non-limiting embodiments, 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 disposed within the slot 15, the surface 36 of the transparent shield 31 can be positioned on at least one rail 19. In some non-limiting embodiments, 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 semi-open position. (FIG. 10). When the insertion of the transparent shield 31 into the cavity 18 is complete, the second surface 37 of the transparent shield 31 is positioned on at least one rail 19 and the engagement member 45 is positioned within the aperture 43 of the transparent shield 31 (FIGS. 11 and 12). To remove the transparent shield 31 from the cavity 18 by the user, an upward force can be applied 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. When 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 function as a barrier to prevent debris from the sample holder 32 from contacting the circuit board 34 and / or the imaging system 22.

[0036] The imaging system 22 includes at least one camera 26 and is supported by the housing 14. In one embodiment, the imaging system 22 can be fixed to, for example, the housing 14, or can be fixed at a relative distance from the sample tray 30 or the transparent shield 31. The imaging system 22 and / or the camera 26 can include one or more lenses having a focal length selected to provide a field of view 40 for including at least the aperture 38 of the 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 substantially encompasses 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 linearly from the imaging system 22 to the aperture 38. In other embodiments, the field of view 40 can extend non-linearly 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 an image or optical signal indicative of a reflection value or color value, such as a reagent pad, lateral flow assay, etc., disposed 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 an image or optical signal indicative of a reflection value or color value 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 also include only a portion of the aperture 38 of the circuit board 34. Also, it should be understood that in some exemplary embodiments, the field of view 40 of the imaging system can also 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, analog camera, CMOS imaging device, diode, and combinations thereof. The imaging system 22 can also include, for example, a lens system, optical filter, collimator, diffuser, or any other optical signal processing device. Further, the imaging system 22 is not limited to optical imaging devices within the visible spectrum and can 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 the 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. The at least one camera 26 is an AR0239: CMOS image sensor, 2.3MP, 1 / 2.7”. The lens is a DSL949 SUNEX lens (Sunex Inc., Carlsbad, CA). Both are configured to maintain a wide field of view 40 while suppressing geometric image distortion, thereby providing a resolution of 1080 pixels × 1920 pixels. Each pixel represents an area of approximately 0.065MM of a square of the sample tray 30 and / or the 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. The test devices 44 can be reagent cards and reagent card cassettes, each having a sample 46. The sample 46 can be any body fluid, tissue, or any other chemical or biological sample, such as, for example, urine, saliva, or blood, and combinations thereof. The sample 46 can be, for example, in a liquid state and can contain one or more target components such as bilirubin, ketone, glucose, or any other desired target component.

[0040] The circuit board 34 having the aperture 38 is located within the cavity 18 and can be interposed between the imaging system 22 and the sample tray 30, whereby the field of view 40 of the imaging system 22 is substantially unobstructed by the sample holder 32, the test device 44, and / or the sample 46. The circuit board 34 will be described in more detail below with reference to FIGS. 1-2 and 4B. In one embodiment, the circuit board 34 is located at a fixed location between the imaging system 22 and the sample tray 30; in another embodiment, the circuit board 34 can also 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) must be executed after any adjustment. In other non-limiting embodiments, the circuit board 34 can be located between the imaging system 22 and the transparent shield 31, whereby the field of view 40 of the imaging system 22 is substantially unobstructed by the sample holder 32, the test device 44, and / or the sample 46.

[0041] Referring again to FIGS. 1 and 2, the housing 14 can include a plurality of connected sidewalls 80, 82, 84, and 86 that cooperate to surround the cavity 18. The sidewall 80 is spaced from the sidewall 82, and the sidewall 84 is spaced from the sidewall 86. The transparent shield 31 can be sized and dimensioned to extend across the cavity 18 between the sidewalls 80 and 82, whereby 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 from about 5 cm to about 21 cm. In some non-limiting embodiments, the transparent shield 31 can be a lens protection device and can have a length of about 5 cm. In other non-limiting embodiments, the transparent shield 31 can be a protection device for the lens and optical components and can have a length of about 14 cm. In some non-limiting embodiments, the transparent shield 31 is a protection device for the lens and optical components and may not be removable from the reagent analyzer 10.

[0042] Referring to FIG. 3, an end view of the transparent shield 31 located within the slot 15, according to the concepts of the invention disclosed herein, is shown. In some embodiments, the housing 14 has a slot 15, the transparent shield 31 is located within a cavity 18 adjacent to the slot 15, the slot has 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 from about 0.1 cm to about 0.3 cm. In some embodiments, the width W1 of the slot 15 can be from about 1.7 cm to about 4.5 cm. In some non-limiting embodiments, the width W2 of the transparent shield 31 can be from about 1.5 to about 4.3 cm. In some embodiments, the transparent shield 31 is movably supported within the housing 14 and is 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 an 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 originating 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, etc.

[0043] The illumination sources 42a - n can be implemented as, for example, one or more of a light - emitting diode, an incandescent bulb, a laser, an incandescent lamp or tube, a fluorescent lamp or tube, a halogen lamp or tube, or any other desired light source or object configured to emit an optical signal having any desired intensity, wavelength, frequency, or propagation direction. The illumination sources 42a - n can be attached to 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 can be operably coupled to a controller 144 (see FIG. 4B, detailed below), whereby control and / or power signals can be supplied to the illumination sources 42a - n by the controller 144. It is desirable that the intensity of the optical signal emitted by the illumination sources 42a - n be maintained substantially constant over the operation of the reagent analyzer 10, such as by control and power signals supplied by the controller 144. In one embodiment, the optical signal emitted by the illumination sources 42a - n can be adjusted or processed by one or more optical systems 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, such as a first illumination source 42a and a second illumination source 42b, can be implemented, and the first illumination source 42a and the second illumination source 42b can 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 can emit optical signals having, for example, 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 are described in more detail below. Each reagent card 124 (detailed 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 fluid or microfluidic compartments (not shown).

[0046] Each reagent pad of one or more reagent cards located within the test device can include a reagent configured to cause a color change in response to the presence of a target component such as a molecule, cell, or substance in the sample 46 of the specimen deposited on the reagent pad. Different reagents can be provided to the reagent pads to detect the presence of different target components. The different reagents can cause 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 an individual spectrum characteristic of the absorption and / or reflection of light with respect to that particular component. The degree of color change of the reagent and the sample 46 can depend, for example, on the amount of the target component present in the sample 46.

[0047] The presence and concentration of these target components in the sample 46 can be made determinable, for example, by analysis of the color change produced by one or more reagent pads after a predetermined time after adding the sample 46 to the reagent pads and / or at a predetermined reading position within the field of view of the imaging system 22. This analysis can involve color comparison of each reagent pad at different times after adding the sample 46 and / or at different reading positions within the field of view 40 of the imaging system 22.

[0048] Based on the analysis of the magnitude of the optical signal detected by the imaging system 22, 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, the sample 46 can be assigned to one of the plurality of categories.

[0049] Furthermore, the imaging system 22 can detect an optical signal indicating the color or reflection value of the reagent pad and / or the test strip at any time interval after the volume of the sample 46 is dispensed onto the test device 44, such as the reagent pad and / or the test strip, regardless of the location of the specific reagent pad and / or the test strip. In one exemplary embodiment, videos or a series of images of the reagent pad and / or the test strip can be captured at various time intervals after the volume of the sample 46 is deposited on the reagent pad and / or the test strip.

[0050] The imaging system 22 can be operated intermittently, continuously, or periodically to detect one or more reflection signals indicating the color or reflection value of one or more test devices 44, such as the reagent pad, at any time and at any position within the field of view of the camera 26. In some exemplary embodiments, the imaging system 22 can capture an image of the test device 44, such as the color or reflection value of the reagent pad, before any sample 46 is deposited on the reagent pad or at any known point in time after the volume of the sample 46 is deposited on the reagent pad.

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

[0052] For controlled lighting, in this specification, as an example, it will be described as uniform lighting over the range of the sample holder 32 and / or the sample 46, i.e., the length and width, within an acceptable limit. However, it should be understood that the present disclosure is not limited to uniform lighting. The circuit board 34 includes a substrate 60 having a bottom surface 61a and a top surface 61b, a plurality of conductive leads extending on or within the substrate 60, and an aperture 38 extending between the bottom surface 61a and the top surface 61b.

[0053] In one embodiment shown in FIG. 4A, one or more light 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 required to produce a substantially uniform light intensity over the sample holder 32 and / or the reagent card 124 or the reagent cassette. The infrared LED 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 with the 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 obliquely with respect to the reagent card 124. In yet another embodiment, each LED 64a - n is positioned at one or more distances away from the test device 44 supported by the sample holder 32, whereby the first LED 64 and the second LED 64 are positioned at different distances away from the test device 44 and / or the sample holder 32.

[0055] In some non-limiting embodiments, by adjusting the power levels of each of the LEDs 64a-n, a substantially uniform light intensity can be achieved. The substantially uniform light intensity can be 85% to 100% uniform. The structure, use, and calibration of the 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 represents the bottom surface 61a of the circuit board 34 having one or more illumination sources 42a. When disposed within the reagent analyzer 10, the bottom surface 61a is oriented to face the sample tray 30, whereby the light generated by one or more of the illumination sources 42a-n can be directed directly onto 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, whereby the conductive leads provide electricity to each of the illumination sources 42a-n. In one embodiment, the circuit board 34 further includes an illumination source circuit (not shown) connected to the plurality of conductive leads, and the illumination source circuit is configured to apply electricity regardless of each of the illumination sources 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, and the first power and the second power are different, thereby causing a difference in illumination intensity across the sample. The illumination sources 42a-n are arranged such that the illumination intensity is substantially uniform across the field of view 40 of the camera 26, whereby the reagent pad is illuminated with a substantially uniform intensity, thus 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 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 some of the illumination sources 42a-n and the sample 46 may be different. However, in other embodiments, the circuit board 34 can 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 of the illumination sources 42a-n can be attached to a support (not shown), and each support is attached to the circuit board 34 to provide one or more conductive paths to a particular one of the illumination sources 42a-n. When the support is used, this causes a portion of one or more of the illumination sources 42a-n to be closer to the sample 46 and / or the sample tray 30.

[0057] 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 located between the first region 62a and the second region 62b. One or more light sources 42a - n can be attached to the substrate 60 in each of the first region 62a, the second region 62b, and the intermediate region 62c, or in any combination thereof. In one embodiment, a first power can be applied to one or more of the light sources 42a - n in the first region 62a and the second region 62b, whereby one or more of the light sources 42a - n in the first region 62a and the second region can provide a first illumination intensity, and a second power can be applied to one or more of the light sources 42a - n in the intermediate region 62c, whereby one or more of the light sources 42a - n in the intermediate region 62c can 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.

[0058] The aperture 38 of the circuit board 34 extends from the top surface 61b to the bottom surface 61a, provides 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, and provides a controlled field of view of the test device 44 associated with the sample holder 32 to the camera 26. The aperture 38 can be further configured such 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. In order to provide a controlled field of view of the rectangular reagent test device, the aperture 38 is shown as rectangular in FIG. 4A, but the aperture 38 can be configured in any shape such that the field of view 40 is a controlled field of view of the sample tray 30, and it is understood that the illumination source 42 can be calibrated to provide substantially uniform illumination of the sample 46. In the example of FIG. 4A, the aperture 38 does not extend to the edge of the circuit board 34.

[0059] In one embodiment, the aperture 38 extends to the edge of the circuit board 34 without bisecting the circuit board 34, but in another embodiment, the aperture 38 extends through the entire circuit board 34, bisecting the circuit board into a first half and a second half, and the first half and the second half are attached at separate locations and are supported by the housing 14 such that the field of view 40 is a controlled field of view of the sample tray and the 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 or a plurality of reagent pads 132a-n, and the reagent pads 132a-n are located on the substrate 128 or otherwise associated with the substrate 128. The substrate 128 can be constructed from any suitable material such as, for example, paper, photographic paper, polymers, fibrous materials, and combinations thereof. The reagent pads 132a-n can be arranged on the substrate 128 in a grid-like configuration, for example, so as to define one or more test strips. In an exemplary embodiment, the reagent pads 132a-n can include fluids or microfluidic compartments (not shown). The reagent pads 132a-n can be spaced apart from each other, for example, such that the test strips are spaced apart, such that adjacent test strips and / or reagent pads 132a-n can be simultaneously located at separate positions within the field of view 40 of the imaging system 22. The reagent card 124 can be a multi-profile reagent card having a plurality of reagent pads 132a-n with different reagents and / or a plurality of different test strips. Further, in some exemplary embodiments, the reagent card 124 can include, for example, one or more calibration chips or reference pads, such calibration chips or reference pads having no reagent and being able to act as color references. In another embodiment, the reagent card 124 includes an ID pad having an identifier that can be seen under infrared light.

[0061] Each of the reagent pads 132a - n can contain a reagent configured to cause a color change in response to the presence of a target component such as a molecule, cell, or substance in the sample 46 deposited on the reagent pads 132a - n. Different reagents can be provided to the reagent pads 132a - n to detect the presence of different target components. The different reagents can cause 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 an individual spectrum characteristic of the absorption and / or reflection of light with respect to that particular component. The degree of color change of the reagent and the 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 / incorporated into an image by the imaging system 22, which can analyze those signals and determine the color change of the reagent pads 132a - n resulting from the reaction with the volume of the sample 46 deposited on the reagent pads 132a - n. Such color changes can be analyzed, for example, according to the reading position of the reagent pads 132a - n when an optical signal or image indicative of the color of the reagent pads 132a - n is detected, and / or the known duration for which the volume of the sample 46 has been deposited on the reagent pads 132a - n, and combinations thereof. The color change can be interpreted, as described above, 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 the sample 46 deposited on the reagent pads 132a - n.

[0063] Next, referring to FIG. 4B, there is shown an analyzer diagram 140 depicting a reagent analyzer 10 that includes a 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 is capable of storing computer-executable instructions that, when executed by the processor 148, cause the processor 148 to communicate with and / or be operably coupled to other elements of the reagent analyzer 10. Although the analyzer controller 144 is shown separately from the reagent analyzer 10, in some embodiments, the analyzer controller 144 can be integrated into the reagent analyzer 10. For example, for illustrative purposes 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 circuit board 34.

[0064] In one embodiment, the imaging system 22 can be operably coupled to, for example, the analyzer controller 144 and / or the processor 148, and thus one or more power and / or control signals can be transmitted by the controller 144 to the camera 126 and / or one or more illumination sources 42a - n, and one or more signals can be transmitted 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, through the transparent shield 31, one or more optical signals or other signals indicative of the reflection value of a test device 44, such as a reagent pad, and transmit a signal indicative of the reflection value of the test device 44, such as a reagent pad, to the processor 118. For example, at each reading position, the camera 126 can detect, through the transparent shield 31, one or more optical signals having wavelengths indicative of the reflection value of the reagent pad and / or the test strip. The camera 126 can detect, through the transparent shield 31, optical signals indicative of the reflection value of the reagent pad and / or the test strip at any desired reading position, location, or region within the field of view 40, or at any other desired one or more locations or regions. The signals transmitted to the processor 148 by the camera 126 can be, for example, electrical signals, optical signals, and combinations thereof. In one embodiment, the signal is in the form of an image file having a matrix of pixels, and each pixel has a color code indicative of a reflection value. In an exemplary embodiment, the image file can have pixels in two or more predetermined regions, and the pixels in each predetermined region correspond to one reading position of the reagent pad and / or the test strip within the field of view 40 of the camera 126. In one embodiment, the processor 148 can store the transmitted signal and / or the image file in one or more databases 156 and / or the memory 152.

[0065] Based on the signals detected by, for example, camera 126, processor 148 can determine the reflection value or color change of the reagent pad and / or test strip together with the sample (e.g., urine) placed on the reagent pad and / or test strip. Each optical signal or other signal indicating the reading of one or more reflection values detected by camera 126 can have magnitudes for different light wavelengths (i.e., colors). The color of the sample and / or the reaction of one or more reagents to the target components in the reagent pad can be determined based on the relative magnitudes of the reflection signals of various color components, such as the red, green, and blue reflection 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 combination represents a specific color (e.g., the RGB color model including hue, saturation, and lightness (HLS) and the point representation of hue, saturation, and value (HSV), and / or the CMYK color model, or any other suitable color model). In some embodiments, camera 126 can detect a plurality of optical signals at each reading position, and each detected signal can have one or more color components, such as a red component signal, a green component signal, and a blue component signal, and each of these component signals can be transmitted to processor 148. In some exemplary embodiments, for example, camera 126 can detect a single optical signal at each reading position, and processor 148 can 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, a method for determining the shielding degree 150 of the transparent shield 31 (described below and shown in FIG. 8) can 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 shielding degree of the transparent shield 31. The method for determining the shielding degree 150 can be executed periodically at a preset internal time or the like as desired, in accordance with specific quality control procedures applicable to the reagent analyzer 10 and combinations thereof.

[0067] 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, and when the instructions or logic are executed by the processor 148, the processor 148 is caused to start an alert in a form perceptible to humans, start a cleaning process configured to clean the transparent shield 31, and perform at least one action selected from the group consisting of replacing the transparent shield 31 at at least one periodic interval. In some embodiments, the periodic interval is based on the period or number of tests performed by the reagent analyzer 10.

[0068] Referring now to FIGS. 5-7, exemplary images 170a-c are shown of top views of the sample holder 32 and the test device 44 in the form of a reagent card 172 as seen from 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 an image 170 of the sample holder 32 and the test device 44 through an exemplary transparent shield 31 having a shielding degree that varies due to debris on the transparent shield 31 that may be caused by splashing 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 seen through a transparent shield 31 that does not have environmental contaminants 178 present on its surface 36 or surface 37.

[0070] FIG. 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 seen through a transparent shield 31 that has environmental contaminants 178 such as dust present on its surface 36 or surface 37. A number of environmental contaminants 178 are shown in FIG. 6, but only one environmental contaminant 178 is labeled for the purpose of clarity.

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

[0072] Referring now to FIG. 8, FIG. 8 is a flow diagram of an exemplary embodiment of a method 200 for determining the opacity of a transparent shield 31 according to the concepts of the invention disclosed herein. The method 200 for determining the opacity of the transparent shield 31 generally includes: receiving a first image 170 of a test device 44 located within a sample holder 32 through a transparent shield 31 not associated with the imaging system 22, wherein the transparent shield 31 is positioned within the housing 14 of the reagent analyzer 10 adjacent to the sample holder 32 (step 202); comparing the pixel data of the first image of the test device 44 located within the sample holder 32 received through the transparent shield 31 with reference data stored on a non-transitory computer-readable medium to determine the opacity of the transparent shield 31 (step 204); identifying a material on the surface of the transparent shield 31 to determine the opacity of the transparent shield 31 (step 206); determining whether the opacity of the transparent shield 31 exceeds a baseline value (stored in the non-transitory computer-readable memory 152) indicative of potential shielding of the transparent shield 31 (step 208); in response to the opacity exceeding the baseline value, storing timestamped data indicating that the transparent shield 31 is shielded and causing an action to be performed selected from the group consisting of initiating an alert in a human-perceivable form, storing data indicative of the opacity detected in the first image 170 that exceeds the baseline value in the non-transitory computer-readable memory 152, initiating a cleaning process configured to clean the transparent shield 31, and replacing the transparent shield 31 with a replacement transparent shield 31 having an opacity less than the baseline value (step 210). In one non-limiting embodiment, the reference data can be data of the manufacturing standard specifications of the test device 44 stored on 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 main function of the transparent shield 31 is to provide protection to the imaging system 22 and not to affect the optical characteristics 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 protect the imaging system 22 and also affect the optical characteristics of the imaging system 22. For example, the transparent shield 31 can include one or more polarizers or filters suitable for affecting the optical characteristics 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] By cleaning or replacing the transparent shield 31, the accuracy of the analysis provided by the reagent analyzer 10 is improved. 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 the need to disassemble the analysis device or access the optical system directly), cleaning the surface 36 or surface 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 gripping the transparent shield 31 or in an automated format. In the 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 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 into the housing 14 through the slot 15.

[0075] Data indicating the degree of shielding can be stored in the memory 152, the database 156, a non-transitory computer-readable medium, and the like. In other non-limiting embodiments, the data indicating the transparent shield 31 having the shielding degree can have a time stamp. In other non-limiting embodiments, when the shielding degree of the transparent shield 31 does not exceed the baseline value, the method includes the 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 shielding degree of the transparent shield 31, and determining whether the shielding degree of the transparent shield 31 exceeds the baseline value, that is, further including repeating steps 202 to 210 until the shielding degree of the transparent shield 31 reaches or exceeds the baseline value.

[0076] The method 200 for determining the shielding degree of the transparent shield 31 can be implemented as a set of processor-executable instructions or logic stored in a non-transitory computer-readable medium, and when the instructions or logic are executed by the processor 148, the processor 148 is caused to execute logic for calculating or determining the shielding degree of the transparent shield 31. The method 200 for determining the shielding degree of the transparent shield 31 can be executed periodically at a preset time interval or the like, or can follow specific quality control procedures applicable to the reagent analyzer 10 and combinations thereof.

[0077] In some non-limiting embodiments, method 200 for determining the degree of shielding can be via computer vision to determine at least one environmental contaminant 178 on surface 36 or surface 37 of transparent shield 31. In some non-limiting embodiments, the computer vision method 200 for determining at least one environmental contaminant 178 on surface 36 or surface 37 of 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 surface 36 or surface 37 of transparent shield 31 in image 170 captured by imaging system 22. The way for the neural network to recognize the environmental contaminant 178 utilizes the conventional region proposal method; inputs the extracted candidate regions into the neural network for recognition and categorization; utilizes the bounding box regression technique to determine, for example, the environmental contaminant 178; surrounds each environmental contaminant 178 with a bounding box, and determines whether the aggregated environmental contaminant 178 surrounded by the bounding box, that is, the degree of shielding, exceeds the baseline value indicating the potential shielding of transparent shield 31, and can include extracting some candidate regions that may be objects detected from image 170. In some non-limiting embodiments, the alert generated in response to the degree of shielding exceeding the baseline value can be a notification of the location of the environmental contaminant 178 on surface 36 or surface 37 of transparent shield 31 on the output device. The output device can be a tablet, a computer device, etc.

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

[0079] In some non-limiting embodiments, computer vision for determining at least one environmental contaminant 178 on surface 36 or surface 37 of the transparent shield 31 can utilize semantic segmentation techniques. Semantic segmentation is constructing a first 3D semantic model, the 3D semantic model including a reagent analyzer 10 having a transparent shield 31 that does not have at least one environmental contaminant 178 present on surface 36 or surface 37; and constructing a second 3D semantic model of the reagent analyzer 10, the transparent shield 31 having at least one environmental contaminant 178 such as dust, soot, ash, pollen, smoke, moisture, etc. present. The 3D semantic model is updated over time by segmenting the current frame to form a segmented frame. The segmented frame showing the reagent analyzer 10 with the transparent shield 31 in use can be compared to the 3D model using discovery rules or Bayesian rules to form the current frame of the reagent analyzer 10.

[0080] In some non-limiting embodiments, computer vision for determining at least one environmental contaminant 178 on surface 36 or surface 37 of the transparent shield 31 can utilize instance segmentation techniques. In an instance segmentation machine learning model, a processor 148 can simultaneously process an image of a sample holder 32 through a transparent shield 31 located within a housing 14 of the reagent analyzer 10, detect at least one environmental contaminant 178, and be trained to classify at least one environmental contaminant 178 through the placement of a segmented mask over the image 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-level mask that identifies pixels of at least one environmental contaminant 178 present on 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 an image of the sample holder 32 through a transparent shield 31 having a certain degree of translucency located within the housing 14 of the reagent analyzer 10 and 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 a known transparency standard of the transparent shield 31 stored in the memory 152 and to normalize or correct any accidental optical effects caused by the light passing through the transparent shield 31. In some non-limiting embodiments, the calibration of the translucency of the transparent shield 31 can be performed at periodic intervals during the use of the analyzer 10 or by an operator command.

[0082] 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, and when the instructions or logic are executed by the processor 148, to cause the processor 148 to perform at least one action selected from the group consisting of initiating an alert in a human-perceivable form, initiating a cleaning process configured to clean the transparent shield 31, and replacing the transparent shield 31 at at least one periodic interval. In some embodiments, the periodic interval is based on the duration or number of tests performed by the 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 within a sample holder through a transparent shield not associated with an imaging system, the transparent shield being located within a housing of a reagent analyzer adjacent to the sample holder; Comparing pixel data of a first image of a test device located within a sample holder received through a 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 potential shielding of the transparent shield; In response to the degree of shielding exceeding the baseline value, initiating an alert in a human-perceivable form; storing data indicative of the degree of shielding detected within the first image that exceeds the baseline value; initiating a cleaning process configured to clean the transparent shield; and causing an action to be performed selected from the group consisting of exchanging the transparent shield with a replacement transparent shield having a degree of shielding less than the baseline value; A method comprising.

[0085] 2. When the degree of shielding of the transparent shield exceeds the baseline value, the method: Storing data indicative of the transparent shield having the degree of shielding; Communicating a notification indicative of the degree of shielding of the transparent shield to a user; The method according to 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 shielding of the transparent shield does not exceed the baseline value, the method: Receiving a second image of a test device located 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 the baseline value; The method according to any one of exemplary embodiments 1 to 3, further comprising.

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

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

[0090] 7. Analyzing a first image by a processor executing processor-executable code, as further defined in exemplary embodiment 6, comprises analyzing pixels in the image with respect to a predetermined color indicative of environmental contaminants present on the surface of the transparent shield.

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

[0092] 9. The reagent analyzer according to 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 major surface and the second major surface, and the field of view extending through the opening.

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

[0094] 11. The reagent analyzer according to any one of exemplary embodiments 8 to 10, having a slot in the housing and being removably accessible to the transparent shield through the slot.

[0095] 12. The first main surface faces the imaging system, and the reagent analyzer further includes a light source attached to the second main surface of the substrate, the reagent analyzer according to any one of exemplary embodiments 9 to 11.

[0096] 13. 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 a circuit configured to supply electricity to the first and second light sources, whereby the first and second light sources contribute to illuminating the wet reagent test device with a calculated amount so as to provide controlled illumination, the reagent analyzer according to exemplary embodiment 12.

[0097] 14. An apparatus comprising: A housing surrounding a 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 the field of view of the camera sensor and being located at a distance from the camera sensor; A transparent shield located within the cavity, the transparent shield having a first surface, a second surface, and an intermediate region extending between the first and second surfaces, the intermediate region of the transparent shield being located within the field of view of the imaging system upstream of the sample tray and being located at a distance from the imaging system; The apparatus comprising.

[0098] 15. The apparatus according to exemplary embodiment 14, further including a test device located within the sample holder of the sample tray 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, A circuit board located between a camera sensor and a sample tray within a cavity and 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 being located opposite the second major surface, the substrate having an opening extending between the first major surface and the second major surface, the opening being 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 a controlled field of view of a sample holder of the sample tray to the camera sensor; 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; A circuit attached to the conductive leads and configured to supply electricity to the light source via the conductive leads, The apparatus according to any one of exemplary embodiments 14 or 15, comprising.

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

[0101] 18. The apparatus according to 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 is within the first portion, and the sample tray is within the second portion.

[0102] 19. The housing has a slot, the transparent shield is located 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. The apparatus according to any one of exemplary embodiments 14 to 18.

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

[0104] 21. The apparatus according to 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. The apparatus according to any one of exemplary embodiments 14 to 21, wherein the transparent shield is separate from the imaging system and is configured to prevent debris originating 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 a sample tray and an imaging system within a reagent analyzer exceeds a baseline value indicative of potential shielding of the transparent shield; in response to the degree of shielding exceeding the baseline value, causing an action to be performed selected from the group consisting of initiating an alert in a human-perceivable form, storing data indicative of the degree of shielding detected in a 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 shielding less than the baseline value; The method comprising.

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

[0108] 25. The method according to exemplary embodiment 24, wherein the periodic intervals are based on the duration or number of tests to be performed.

[0109] From the above description, it is clear that the concept of the invention disclosed in this specification is well adapted to carry out these objects and to achieve the advantages described herein as well as the advantages inherent in the concept of the invention disclosed herein. Although exemplary embodiments of the concept of the invention disclosed herein have been described for the purposes of this disclosure, numerous modifications readily apparent to those skilled in the art can be made, and such modifications are understood to be within the scope of the concept of the invention as disclosed and defined in the appended claims.

Claims

1. A method comprising: Receiving a first image of a test device located within a sample holder through a transparent shield not associated with an imaging system, wherein the transparent shield is located within a housing of a reagent analyzer adjacent to the sample holder; Comparing pixel data of the first image of the test device located within the sample holder received through the transparent shield to determine a degree of obscuration of the transparent shield; Determining whether the degree of obscuration of the transparent shield exceeds a baseline value indicative of potential obscuration of the transparent shield; In response to the degree of obscuration exceeding the baseline value, initiating an alert in a human-perceivable form; storing data indicative of the degree of obscuration detected within the first image exceeding the baseline value; initiating a cleaning process configured to clean the transparent shield; and causing an action to be performed selected from the group consisting of replacing the transparent shield with a replacement transparent shield having a degree of obscuration less than the baseline value; The method as described above.

2. When the degree of obscuration of the transparent shield exceeds the baseline value, the method further comprises: Storing data indicative of the transparent shield having the degree of obscuration; Communicating a notification indicative of the degree of obscuration of the transparent shield to a user; The method according to claim 1, further comprising the above.

3. The method according to claim 2, wherein the data has a timestamp.

4. When the degree of obscuration of the transparent shield does not exceed the baseline value, the method further comprises: Receiving a second image of the test device located within the sample holder through the transparent shield; Determining the degree of obscuration of the transparent shield; Determining whether the degree of obscuration of the transparent shield exceeds the baseline value; The method according to claim 1, further comprising the above.

5. Determining the degree of obscuration is performed using machine vision techniques, the method according to claim 1.

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

7. The method according to claim 6, wherein the processor analyzes the first image by executing processor-executable code, which is further defined as analyzing pixels in the image with respect to a predetermined color indicating environmental contaminants present on the surface of the transparent shield.

8. A reagent analyzer comprising: a housing; a sample holder configured to support a test device, the sample holder being movable into and out of the housing; a 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 located within 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 a degree of shielding of the transparent shield; the reagent analyzer comprising the above.

9. The reagent analyzer according to claim 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 major surface and the second major surface, and the field of view extending through the opening.

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

11. The reagent analyzer according to claim 8, having a slot within the housing through which the transparent shield can be removably accessed.

12. The reagent analyzer according to claim 9, 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.

13. The test device is a wet reagent test device, the light source is a first light source, the reagent analyzer further comprises a second light source and a circuit configured to supply electricity to the first and second light sources, whereby the first and second light sources contribute to the illumination of the wet reagent test device in a calculated amount so as to provide controlled illumination.

14. An apparatus comprising: a housing surrounding a 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 the field of view of the camera sensor, the sample tray being located at a distance from the camera sensor; A transparent shield located 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 located within the field of view of the imaging system upstream of the sample tray and at a distance from the imaging system; The apparatus comprising the above.

15. The apparatus according to claim 14, further comprising a test device located within the sample holder of the 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.

16. An apparatus, A circuit board located between the camera sensor and the sample tray within the cavity, the circuit board having a substrate and a plurality of conductive leads extending on or within the substrate, the substrate having a first main surface facing the camera sensor and a second main surface facing the sample tray, the first main surface being located opposite the second main surface, the substrate having an opening extending between the first main surface and the second main surface, the opening being 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 a controlled field of view of the sample holder of the sample tray to the camera sensor; A light source attached to the second main surface of the substrate and connected to at least a portion of the plurality of conductive leads extending on the substrate; The apparatus according to claim 14, comprising a circuit attached to the conductive leads and configured to supply electricity to the light source via the conductive leads.

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

18. The apparatus according to claim 14, wherein the transparent shield divides the 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.

19. The apparatus according to claim 18, wherein the housing has a slot, the transparent shield being located within the cavity adjacent to the slot, the transparent shield having a width and a thickness, the slot having a width greater than the width of the transparent shield and a height greater than the thickness of the transparent shield.

20. The apparatus according to claim 19, wherein the transparent shield is movably supported within the housing and is aligned with a slot such that the transparent shield is movable through the slot.

21. The apparatus according to claim 14, wherein the first and second surfaces of the transparent shield are planar and parallel within an intermediate region.

22. The apparatus according to claim 14, wherein the transparent shield is separate from the imaging system and is configured to prevent debris originating from the sample tray from contacting the imaging system.

23. A method comprising: determining whether a degree of shielding of a transparent shield between a sample tray and an imaging system within a reagent analyzer exceeds a baseline value indicative of potential shielding of the transparent shield; initiating an alert in a human-perceivable form in response to the degree of shielding exceeding the baseline value; storing data indicative of the degree of shielding detected in a first image exceeding the baseline value; initiating a cleaning process configured to clean the transparent shield; and causing an action to be performed 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. The method, comprising the above.

24. The method according to claim 23, wherein the step of determining whether the degree of shielding of the transparent shield exceeds the baseline value is performed at periodic intervals.

25. The method according to claim 24, wherein the periodic intervals are based on a period or number of tests being performed.

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