Automated region of interest selection for image-based urine analyzers

Abstract

A method and system for automatically selecting a region of interest in an image acquired by an optical inspection device are disclosed herein. One method includes analyzing pixels in an image of a liquid sample carrier to determine the position of an indicator in the image; determining the position of a read area of ​​the liquid sample carrier in the image based on the position of the indicator determined by analyzing the pixels in the image; and analyzing pixels in the image depicting the read area to determine the presence and / or absence of a given analyte in a liquid sample placed on the liquid sample carrier. The liquid sample carrier may be a reagent strip or a reagent cassette. The indicator may be a reference mark, a symbol, a colored area, or a material configured to appear differently when exposed to a specific wavelength of the electromagnetic spectrum.

Description

Technical Field

[0001] Research and development funded by the federal government Not applicable

[0002] Cross-reference to related applications This patent application claims priority to U.S. Provisional Application No. 63 / 502,239, filed May 15, 2023, the entire contents of which are incorporated herein by reference.

Background Art

[0003] A convenient way to screen and monitor a patient's disease is to perform point-of-care in vitro testing using body fluids such as blood, urine, saliva, sputum, etc. Among such body fluids, urine is a particularly important body fluid because it contains major physiological and pathological information. Furthermore, since a sample can be easily collected, urine is convenient for collecting multiple samples, performing test screening, monitoring diseases, and drawing definitive inferences. For example, by analyzing a patient's urine sample, preliminary conclusions may be drawn when diagnosing, for example, urinary tract infections, diabetes, and kidney and liver diseases.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Typically, analyzing a urine sample involves immersing a strip of dry reagent pad in the sample. Such tests are usually colorimetric; that is, the reagent pad changes color based on the concentration of a specific analyte present in the sample. These color changes are usually visually inspected by a human expert. However, visual inspection performed by humans can be error-prone, subjective, and time-consuming. To overcome such limitations, automated urine analyzers can be used. One such instrument may include a camera sensor, processor, and illumination source, enabling the instrument to extract clinical information from the color changes of the reagent pad. [Means for solving the problem]

[0005] In one embodiment, the present disclosure relates to a method comprising: a processor analyzing pixels in an image of a liquid sample carrier on which a liquid sample is placed to determine the position of an indicator in the image; a processor determining the position of a read area of ​​a read area of ​​a liquid sample carrier in the image, at least partially based on the position of the indicator determined by analyzing pixels in the image; and a processor analyzing pixels in an image depicting a read area to determine the presence and / or absence of a predetermined analyte in the liquid sample.

[0006] In another embodiment, the present disclosure relates to an optical inspection apparatus comprising: a housing having an interior surrounding an inspection area; an indicator located within the inspection area; a light source configured to illuminate the inspection area within the housing; a tray assembly configured to receive a liquid sample carrier, the tray assembly being insertable into the inspection area of ​​the housing; a sensor configured to acquire an image of the inspection area of ​​the housing including the indicator; and a controller having a processor operable to execute processor executable code, the processor executable code, when executed by the processor, causing the processor to: analyze pixels in an image acquired by the sensor to determine the position of the indicator in the image; determine the position of a reading area in the image based at least partially on the position of the indicator determined by analyzing the pixels in the image; and analyze pixels in the reading area of ​​the image to determine the presence and / or absence of a given analyte.

[0007] In yet another embodiment, the present disclosure relates to an optical inspection apparatus comprising: a housing having an interior surrounding an inspection area; a liquid sample carrier having an indicator; a light source configured to illuminate the inspection area within the housing; a tray assembly for receiving the liquid sample carrier, the tray assembly being insertable into the inspection area of ​​the housing; a sensor configured to acquire an image of the inspection area of ​​the housing including an indicator; and a controller having a processor operable to execute processor executable code, the processor executable code, when executed by the processor, causing the processor to: analyze pixels in an image acquired by the sensor to determine the position of an indicator in the image; determine the position of a reading area in an image based at least partially on the position of an indicator determined by analyzing pixels in the image; and analyze pixels in a reading area of ​​an image to determine the presence and / or absence of a predetermined analyte.

[0008] The accompanying drawings incorporated herein and forming part thereof illustrate and describe, together with the descriptions, one or more embodiments described herein. The drawings are not intended to be drawn to scale, and some configurations and some figures in the drawings may be exaggerated, to scale, or schematic for clarity and brevity. Not all components may be labeled in all drawings. Similar reference numerals in the drawings may represent and refer to the same or similar elements or functions. [Brief explanation of the drawing]

[0009] [Figure 1] This is a perspective view of an optical inspection apparatus configured in accordance with this disclosure, which can be used to perform various tests on bodily fluid samples. [Figure 2] Figure 1 is a block diagram of the circuit of the optical inspection device shown. [Figure 3] Figure 1 is a perspective view of a reagent strip for inspection using the optical inspection apparatus shown. [Figure 4] Figure 1 is a perspective view of a reagent cassette for inspection using the optical inspection device shown. [Figure 5] Figure 1 is an exploded perspective view of a tray assembly configured according to this disclosure for use with the optical inspection apparatus shown, showing the insert positioned in the support tray with its first surface facing upward so that a reagent strip can be held by the insert. [Figure 6] Figure 1 is an exploded perspective view of a tray assembly configured according to this disclosure for use with the optical inspection apparatus shown, showing the insert positioned in the support tray with its second surface facing upward so that the reagent cassette can be held by the insert. [Figure 7] Figure 5 is a perspective view of a portion of the tray assembly, showing the insert positioned within the support tray with its first surface facing upwards. [Figure 8]Figure 6 is a perspective view of a portion of the support tray of the assembly shown. [Figure 9] Figure 5 is a perspective view of the insert in the tray assembly shown. [Figure 10] Figure 1 is a perspective view of another tray assembly configured according to this disclosure for use with the optical inspection apparatus shown, showing the insert positioned in a first position within the support tray so that a reagent strip can be held by the insert. [Figure 11] Figure 10 is another perspective view of the tray assembly, showing the insert positioned within the support tray in a second position so that the reagent cassette can be held by the support tray. [Figure 12] Figure 1 is a perspective view of another tray assembly configured according to this disclosure for use with the optical inspection apparatus shown, showing the insert positioned in a first position within the support tray so that a reagent strip can be held by the insert. [Figure 13] Figure 12 is another perspective view of the tray assembly, showing the insert positioned within the support tray so that the reagent cassette can be held by the support tray. [Figure 14] This is a process flow diagram of a method for optically inspecting a liquid sample placed on a liquid sample carrier. [Figure 15] Figure 1 shows an exemplary image acquired by the optical inspection apparatus, which illustrates a reagent strip held by an insert. [Figure 16] Figure 1 is another exemplary screenshot of an image acquired by the optical inspection apparatus shown, where the image shows a reagent cassette held by an insert, and the reagent cassette has one or more symbols positioned on its top surface. [Figure 17]Another exemplary screenshot of an image acquired by the optical inspection device shown in FIG. 1, the image showing a reagent cassette held by an insert, the reagent cassette having a material disposed on its upper surface that is configured to appear different when illuminated by a specific wavelength of the electromagnetic spectrum. [Figure 18] Another exemplary screenshot of an image acquired by the optical inspection device shown in FIG. 1, the image showing a reagent cassette held by an insert, the reagent cassette having a colored region having a predetermined color value disposed on its upper surface. [Figure 19] An exemplary screenshot of a one-dimensional gradient representation of the image shown in FIG. 15. [Figure 20] An exemplary screenshot of a template gradient representation for correlating with the one-dimensional gradient representation shown in FIG. 19. [Figure 21] An exemplary screenshot of an enlarged and inverted portion of the one-dimensional gradient representation shown in FIG. 19.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Before explaining at least one embodiment of the concept of the present invention in detail by way of exemplary language and results, it should be understood that the concept of the present invention is not limited, in its application, to the details of the configurations and the arrangements of the components described in the following description. The concept of the present invention is capable of other embodiments or of being implemented or carried out in various ways. For this reason, the language used herein is intended to give the broadest possible scope and meaning; the embodiments are intended to be exemplary and not exhaustive. 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.

[0011] The headings are provided for convenience only and shall not be construed as limiting the invention in any way. Embodiments illustrated under any heading or in any part of the disclosure can be combined with embodiments illustrated under the same or any other heading or in any other part of the disclosure. Any combination in all possible variations of the elements described herein is encompassed by the present invention unless otherwise indicated herein or otherwise clearly inconsistent in context.

[0012] Unless the context requires otherwise, singular terms shall include the plural, and plural terms shall include the singular, except that the term "plural" as used herein excludes the singular.

[0013] All patents or published patent applications referred to in any part of this application are hereby expressly incorporated herein by reference in their entirety to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference.

[0014] All assemblies, systems, kits, and / or methods disclosed herein can be made and executed without undue experimentation from the perspective of the present disclosure. Where a method claim does not specifically recite in the claims or the specification that the steps are limited to a particular order, it is not intended that the order be inferred in any way. This applies to any possible implicit basis for interpretation, including logical issues regarding the arrangement or flow of operations of the steps, plain meaning derived from grammatical construction or punctuation, or the number or types of embodiments described herein.

[0015] As used in accordance with the present disclosure, the following terms shall be understood to have the following meanings unless otherwise indicated.

[0016] The use of the terms "a" or "an," when used in conjunction with the term "comprising" in the claims and / or herein, may mean "one," but also coincide with the meanings of "one or more," "at least one," and "one or more." The term "plural" refers to "two or more."

[0017] The use of the term "at least one" is understood to include one and any number greater than one. In addition, the use of the term "at least one of X, Y, and Z" is understood to include X only, Y only, and Z only, as well as any combination of X, Y, and Z.

[0018] The use of ordinal terms (i.e., "first," "second," "third," "fourth," etc.) is solely for the purpose of distinguishing between two or more items and does not imply any sequence, order, or importance of one item relative to another, or, for example, any additional order.

[0019] The use of the term "or" in the claims is intended to mean an inclusive "and / or" unless it is explicitly indicated that it refers only to the alternatives, or unless the alternatives are mutually exclusive.

[0020] Referring here to the drawings, particularly Figure 1 shown in the drawings, an optical inspection apparatus 100 (hereinafter, "apparatus 100") configured in accordance with this disclosure is shown. In some embodiments, apparatus 100 may include an optical reflectance-based or absorbance-based reader 203 (hereinafter, "reader 203") (shown in Figure 2) for optically inspecting a liquid sample, such as a bodily fluid sample, placed on a liquid sample carrier such as a reagent strip 300 (shown in Figure 3) or a reagent cassette 312 (shown in Figure 4). In one version, the reader 203 is a reflectance spectrometer.

[0021] The apparatus 100 may include: a housing 104 having an interior surrounding a testing area, the housing 104 having an opening 108 formed therein through which a tray assembly 400 (shown in Figures 5-6) can pass; a door 112 in the opening 108 that can be opened when the tray assembly 400 extends out of the opening 108; a touchscreen display 116 for user input that displays various messages related to the operation of the apparatus 100 (e.g., test results) to the user; and a start button 120. The testing area may be the location where the reagent strips 300 and / or reagent cassette 312 should be located within the housing 104.

[0022] As will be further described below, the tray assembly 400 can be adapted to receive a liquid sample carrier such as a reagent strip 300 or a reagent cassette 312. The user can then press one of the touchscreen display 116 or the start button 120 to move the tray assembly 400 inward toward the inspection area to perform the optical inspection, via the controller 202 (shown in Figure 2) (which may be housed within the housing 104 or located away from the apparatus 100).

[0023] When in use, the user can prepare the liquid sample carrier, such as a reagent strip 300 or reagent cassette 312, for optical inspection by placing the body fluid sample on the liquid sample carrier and then placing the liquid sample carrier in the tray assembly 400. The user can then press one of the touchscreen display 116 and / or start button 120 to cause the controller 202 to retract the tray assembly 400 inward so that a light source 204 (shown in Figure 2) located inside the housing 104 of the device 100 can illuminate the inspection area (including the reading area of ​​the liquid sample carrier) inside the housing 104, and a sensor 206 (shown in Figure 2) located inside the housing 104 of the device 100 can acquire an image of one or more of the illuminated liquid sample carriers. In some embodiments, the sensor 206 can acquire a time-based image sequence of the illuminated liquid sample carriers. As will be further explained below, the reading area of ​​the liquid sample carrier can be the reagent pad 308 (shown in Figure 3) or reagent pad area 310 (shown in Figure 3) of the reagent strip 300, or the window 324 (shown in Figure 4) of the reagent cassette 312.

[0024] Referring here to Figure 2, a circuit 200 configured according to this disclosure is shown. The circuit 200 can be housed within a housing 104 of the apparatus 100 and may include a controller 202, as well as a reader 203 including a light source 204 and a sensor 206. The light source 204 may be configured to illuminate inspection locations within the housing 104. The sensor 206 may be configured to acquire images of one or more inspection locations in the housing 104, as will be described in more detail below. Exemplary sensors 206 include: charge-coupled element sensors; complementary metal-oxide-semiconductor sensors; ultraviolet sensors; infrared sensors; and combinations thereof. The light source 204 may be implemented as a device that emits photons when activated by a processor 212. Exemplary light sources 204 include: incandescent bulbs; fluorescent lamps; light-emitting diodes; halogen lamps; neon lamps; gas discharge lamps; and combinations thereof.

[0025] In some embodiments, the controller 202 may be implemented as, but is not limited to, a personal computer, mobile phone, smartphone, network-enabled television set, tablet, laptop computer, desktop computer, network-enabled handheld device, server, digital video recorder, wearable network-enabled device, virtual reality / augmented reality device, etc.

[0026] In some embodiments, the controller 202 may include one or more input devices 208 (hereinafter, "input devices 208"), one or more output devices 210 (hereinafter, "output devices 210"), one or more processors 212 (hereinafter, "processors 212"), one or more communication devices 216 (hereinafter, "communication devices 216") capable of interfacing with a communication network 220, and one or more non-temporary computer-readable media 224 (hereinafter, "controller memory 224") that store processor executable code and / or one or more software applications 228 (hereinafter, "software applications 228") and a database 232, including, for example, a web browser that can access a website and / or communicate information and / or data over a wireless or wired network (e.g., communication network 220). The input devices 208, output devices 210, processors 212, communication devices 216, and controller memory 224 may be connected via a path 236 such as a data bus that enables communication between components of the controller 202.

[0027] In some embodiments, the processor 212 may include one or more processors 212 operating together or independently for reading and / or executing processor executable code and / or data stored in the controller memory 224. The processors 212 can create, manipulate, retrieve, modify, and / or store data structures in the controller memory 224. A processor 212 executing a software application 228 stored in the controller memory 224 can be a dedicated machine particularly suited to performing various actions, operations, analyses, etc., according to the systems and methods described herein and illustrated in the drawings. Each element of the controller 202 may be partially or entirely network-based or cloud-based, and may or may not be located in a single physical location.

[0028] Exemplary embodiments of the processor 212 may include, but are not limited to, a digital signal processor (DSP), a central processing unit (CPU), a field-programmable gate array (FPGA), a microprocessor, a multicore processor, an application-specific integrated circuit (ASIC), or a combination thereof. The processor 212 can communicate with the controller memory 224 via path 236. The processor 212 can communicate with the input device 208 and / or output device 210 via path 236.

[0029] When executed by the processor 212, the software application 228 can cause the controller 202 to perform actions such as, for example, method 800 (shown in Figure 14), and / or to communicate with or control one or more components of the device 100, the controller 202, and / or the communication network 220.

[0030] In some embodiments, the controller memory 224 can be located in the same physical location as the controller 202, and / or one or more controller memories 224 can be located at a location separate from the controller 202. For example, the controller memory 224 can be located at a location separate from the controller 202 and can communicate with the processor 212 via the communication network 220. In addition, if more than one controller memory 224 is used, the first controller memory 224 can be located in the same physical location as the processor 212, and one or more additional controller memories 224 can be located at a location separate from the processor 212. In addition, the controller memory 224 can be implemented as "cloud" non-temporary processor-readable memory (i.e., one or more of the controller memories 224 can be accessed partially or fully based on the communication network 220, or using the communication network 220).

[0031] In one embodiment, database 232 may be a time-series database, a relational database, or a non-relational database. Examples of such databases include DB2®, Microsoft® Access, Microsoft® SQL Server, Oracle®, MySQL, PostgreSQL, MongoDB, Apache Cassandra, InfluxDB, Prometheus, Redis, Elasticsearch, TimescaleDB, etc. These examples are provided for illustrative purposes only and should not be construed as limiting the concepts of the present invention. Database 232 may be centralized or distributed across multiple systems.

[0032] The input device 208 can receive information entered from the user, another computer, and / or the processor 212, and transmit such information to other components of the controller 202 and / or the communication network 220. The input device 208 may include, but is not limited to, a start button 120, a touchscreen display 116, a keyboard, a touchscreen, a mouse, a trackball, a microphone, a camera, a fingerprint reader, an infrared port, a slide-out keyboard, a flip-out keyboard, a mobile phone, a PDA, a remote control, a fax machine, a wearable communication device, a network interface, or a combination thereof.

[0033] The output device 210 can output information in a format perceptible to a user, another controller, and / or processor 212. For example, embodiments of the output device 210 may include, but are not limited to, a touchscreen display 116, a computer monitor, a screen, a touchscreen, a speaker, a website, a television set, a smartphone, a PDA, a mobile phone, a fax machine, a printer, a laptop computer, a haptic feedback generator, a network interface, or a combination thereof. In some exemplary embodiments, it should be understood that the input device 208 and the output device 210 may be implemented as a single device, such as a touchscreen display 116, or a touchscreen of a computer, tablet, or smartphone. Furthermore, it should be understood that the term “user” as used herein is not limited to a human being and may include, for example, a computer, a server, a website, a processor, a network interface, a user terminal, a virtual computer, or a combination thereof.

[0034] Referring here to Figure 3, a perspective view of a reagent strip 300 configured according to this disclosure is shown. The reagent strip 300 may have a thin, non-reactive substrate 304 (hereinafter, "substrate 304") on which reagent pads 308 are fixed within a reagent pad area 310. Each reagent pad 308 may be made of a relatively absorbent material (e.g., paper, cotton, and cellulose-based materials such as nitrocellulose membranes; glass fiber; and / or polyester) impregnated with its respective (i.e., different) reagent, and each reagent and reagent pad 308 is associated with a specific test performed based on the reagent used. When each reagent pad 308 comes into contact with a body fluid sample, the reagent pad 308 may change color over a period of time, depending on the properties of the reagent and body fluid sample used.

[0035] As will be further described below, in some embodiments, each reagent pad 308 is a separate reading area of ​​the reagent strip 300 for the purpose of optical inspection by the processor 212 of the apparatus 100 shown in Figure 1; however, in other embodiments, the entire reagent pad area 310 is the reading area of ​​the reagent strip 300 for the purpose of optical inspection by the processor 212 of the apparatus 100 shown in Figure 1. In some embodiments, the upper surface 311 of the substrate 304 of the reagent strip 300 has one or more letters or symbols 910 (hereinafter, "symbol 910") (shown in Figure 15) printed, engraved, or otherwise arranged thereon.

[0036] Referring here to Figure 4, a perspective view of a reagent cassette 312 configured according to this disclosure is shown. The reagent cassette 312 may be, for example, a disposable single-use cassette for performing a pregnancy test in a conventional manner. The reagent cassette 312 may have an opening or well 316 (hereinafter, "well 316") formed on its top surface 320, in which a bodily fluid sample is placed. The interior of the reagent cassette 312 may have a reagent strip 300 that can react with the bodily fluid sample placed in the well 316. Depending on the result of the test, the reagent strip 300 may change color (for example, a colored stripe may appear), which can be determined by observing the reagent strip 300 through a window 324 formed on the top surface 320 of the reagent cassette 312. The reagent cassette 312 may include first and second portions 328, 332, the first portion 328 having a curved end wall 336, and the first and second portions 328, 332 being separated by recesses 340a, 340b.

[0037] As will be further described below, the window 324 may be a reading area of ​​the reagent cassette 312 for the purpose of optical inspection by the processor 212 of the apparatus 100 shown in Figure 1. In some embodiments, the top surface 320 of the reagent cassette 312 may have one or more letters or symbols 916 (hereinafter, "symbol 916") (shown in Figure 16) printed, engraved, or otherwise placed thereon. Alternatively or in addition, as shown in Figure 17, the top surface 320 of the reagent cassette 312 may have a light-emitting material 918 (i.e., a material that looks different when exposed to a particular wavelength of the electromagnetic spectrum) placed thereon. Alternatively or in addition, as shown in Figure 18, the top surface 320 of the reagent cassette 312 may have a colored area 920 having a predetermined color value placed thereon. The processor 212 of the device 100 may use one or more of the symbol 916, the luminescent material 918, and the colored area 920 as indicators for determining the position of the reading area of ​​the reagent cassette 312, as described below.

[0038] The systems and methods described herein are described in relation to performing fluid analysis tests, particularly urine analysis tests, but it will be understood by those skilled in the art that the advantages and benefits described herein are applicable to performing any type of optical fluid analysis test. When urine analysis tests are performed, they may include, for example, testing for leukocytes in urine, testing for pH in urine, testing for blood in urine, etc.

[0039] Referring here to Figures 5 and 6, perspective views are shown of a tray assembly 400 configured according to this disclosure for use with the apparatus 100 shown in Figure 1. As described above, the tray assembly 400 can be adapted to receive either a reagent strip 300 or a reagent cassette 312; that is, the tray assembly 400 may include a support tray 404 and an insert 408 fitted into the support tray 404, the insert 408 having a first surface 412 (shown in Figure 5) adapted to hold the reagent strip 300 and a second surface 416 (shown in Figure 6) adapted to hold the reagent cassette 312. The first surface 412 and the second surface 416 may be positioned on opposing sides of the insert 408. In Figure 5, the tray assembly 400 is shown with the first surface 412 of the insert 408 facing upward so that the insert 408 can hold the reagent strip 300 in the support tray 404, and in Figure 6, the tray assembly 400 is shown with the second surface 416 facing upward so that the insert 408 can hold the reagent cassette 312 in the support tray 404. Thus, the user can choose to position the insert 408 in the support tray 404 with either the first surface 412 or the second surface 416 facing upward, depending on whether they wish to optically inspect the reagent strip 300 or the reagent cassette 312.

[0040] The first surface 412 of the insert 408 may have an elongated channel 420 sized to accommodate the reagent strip 300. The elongated channel 420 may be recessed relative to the rest of the first surface 412 so that the substrate 304 of the reagent strip 300 can be flush with the rest (i.e., non-recessed) portion of the first surface 412 when the reagent strip 300 is held by the insert 408. The first surface 412 of the insert 408 may also have an end wall 424 that closes the elongated channel 420 at the end of the insert 408. The upper surface 428 of the end wall 424 (hereinafter, "reference mark 428") may be white (or another appropriate color designed to be acquired in the image and detected by the processor 212 (e.g., having a different color from the background)). The processor 212 of the apparatus 100 shown in Figure 1 may use the end wall 424 to determine, for example, whether the reagent strip 300 is in proper contact with the end wall 424 during the inspection procedure. As will be further described below, the processor 212 of the device 100 may also use a reference mark 428 as an indicator for determining the position of the reading area of ​​the reagent strip 300. The elongated channel 420 may have an open end 426 so that the reagent strip 300 can be slidably inserted into the insert 408. Referring to Figure 6, the second surface 416 of the insert 408 may have a recess 430 molded to receive the first portion 328 of the reagent cassette 312. The end wall 432 of the recess 430 on the second surface 416 of the insert 408 may be curved to match the curved end wall 336 of the first portion 328 of the reagent cassette 312 to ensure that the user correctly orients the reagent cassette 312 into the insert 408. The insert 408 may include projections or bosses 434a, 434b at the open end 436 of the recess 430, which are received in recesses 340a, 340b within the reagent cassette 312, respectively, to prevent the reagent cassette 312 from sliding out of the insert 408.Alternatively, the bosses 434a and 434b may be located on the reagent cassette 312, and the recesses 340a and 340b may be located within the insert 408. The second portion 332 of the reagent cassette 312 may extend outward beyond the open end 436 of the recess 430 so that when the reagent cassette 312 is correctly positioned within the insert 408, only the first portion 328 is located within the recess 430. The second portion 332 of the reagent cassette 312 may be separated from the first portion 328 of the reagent cassette 312 by the recesses 340a and 340b of the reagent cassette 312.

[0041] As is evident in Figure 6, the second portion 332 of the reagent cassette 312 can be shorter than the first portion 328 of the reagent cassette 312 to further ensure that the user correctly orients the reagent cassette 312 within the insert 408. In addition, the bosses 434a, 434b of the recess 430 can be provided in slightly different sizes or shapes, and the recesses 340a, 340b of the reagent cassette 312 can also be provided in slightly different sizes or shapes to match the bosses 434a, 434b to prevent the reagent cassette 312 from being inserted upside down into the insert 408.

[0042] The first and second surfaces 412, 416 of the insert 408 can be oriented in opposite directions, and the insert 408 may also include first and second opposing ends 438, 440 connecting the first and second surfaces 412, 416, as well as first and second opposing sides 442, 444 connecting the first and second surfaces 412, 416 and extending between the first and second opposing ends 438, 440.

[0043] The support tray 404 may further include a top surface 456 having first and second opposing ends 448, 452, a compartment 460 extending between the first and second opposing ends 448, 452 and extending from the first end 448 toward the first end wall 464 to receive the insert 408. The compartment 460 may include a first end wall 464 that fits the second end 440 of the insert 408, and opposing first and second side walls 468, 472 that extend from the first end wall 464 toward the first end 448 of the support tray 404 and fit the first and second opposing sides 442, 444 of the insert 408.

[0044] The first and second opposing ends 438, 440 of the insert 408 have different shapes to ensure that the user correctly orients the insert 408 within the support tray 404 during use. In the embodiments shown in Figures 5-7 and 9, the first end 438 of the insert 408 is rectangular in shape, and the second end 440 of the insert 408 is curved.

[0045] The upper surface 456 of the support tray 404 may include an elongated channel 476 extending from a second end 452 of the support tray 404 toward a second end wall 478, and a white calibration strip (not shown) can be received within the elongated channel 476 of the support tray 404. The white calibration strip can be used by the apparatus 100 to determine the white balance so that any colorimetric analysis performed using the apparatus 100 can be properly calibrated. The elongated channel 476 may be recessed relative to the upper surface 456. The upper surface 456 of the support tray 404 may also include an inclined surface 480 extending from the center of the first end wall 464 of the compartment 460 toward the second end wall 478 of the elongated channel 476, and the inclined surface 480 is inclined downward toward the compartment 460. The first and second surfaces 412, 416 of the insert 408 may include valleys or recesses 484 corresponding to the inclined surface 480 of the support tray 404 when the insert 408 is positioned within the compartment 460. The inclined surface 480 can assist in proper optical inspection of the reagent strip 300 and reagent cassette 312 by providing a guide for proper alignment and positioning of the insert 408 within the support tray 404.

[0046] As shown in Figures 5 to 8, the side walls 468, 472 of the compartment 460 of the support tray 404 may include notches 488 to allow the sides 442, 444 of the insert 408 to be grasped when the insert 408 is positioned within the compartment 460. The support tray 404 may also include elongated guides 492 extending from the compartment 460 toward a second end 452 of the support tray 404, and as shown in Figures 5 to 7 and 9, the first and second surfaces 412, 416 of the insert 408 may include elongated guides 496 corresponding to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 may be grooves that receive wheels (not shown) mounted within the device 100 in Figure 1, which help to smoothly guide, extend, and retract the tray assembly 400 toward the housing 104 of the device 100. The insert 408 also defines a sink 500 within the elongated guide 496 of the first and second surfaces 412, 416, which prevents excess body fluid from flowing out of the insert 408 and down the guide 492 of the support tray 404 (and thus into the apparatus 100). Thus, the sink 500 holds back the overflow of excess body fluid and helps prevent contamination of the apparatus 100 by excess body fluid contained on the insert 408, reagent strip 300, or reagent cassette 312.

[0047] As shown in Figures 5-6 and 8, the compartment 460 may include a locking portion 504 for engaging with the insert 408 when it is positioned within the compartment 460, to prevent the insert 408 from sliding out of the compartment 460. In the shown embodiment, the locking portion 504 is positioned to engage with the first end 438 of the insert 408 when it is positioned within the compartment 460. The support tray 404 may also include a bottom surface 508 positioned at the first end 448 and in contact with the first end 448, with a lip 512 for capturing and retaining excess fluid that leaks from the insert 408 when it is positioned within the compartment 460. Thus, the bottom surface 508 and the lip 512 also help prevent contamination of the inside of the device 100 by excess bodily fluids contained on the insert 408 or the reagent strip 300 or reagent cassette 312.

[0048] As shown in Figures 5 and 6, the notch 516 can be provided within the side wall 472 of the support tray 404. The notch 516 can be used during the detection phase of the device 100 to detect that the support tray 404 is properly positioned by another detector of the device 100 shown in Figure 1 when the support tray 404 is inserted into the housing 104 of the device 100.

[0049] As shown in Figure 5, the support tray 404 may further include a cam surface 520. The cam surface 520 can be used to open the door 112 of the device 100 shown in Figure 1 when the support tray 404 is extending from the housing 104 of the device 100, and can be used to close the door 112 when the support tray 404 retracts into the housing 104 of the device 100. Closing the door 112 during the detection phase can prevent ambient light from entering the housing 104 of the device 100 and causing undesirable or inaccurate results. In the embodiment shown in Figure 7, the cam surface 520 may extend from a first side wall 468 of the support tray 404.

[0050] During use, the insert 408 of the tray assembly 400 can be removed from the support tray 404 and can be inverted and reinserted into the support tray 404, depending on whether the reagent strip 300 or the reagent cassette 312 is used with the tray assembly 400. Since the reagent strip 300 and the reagent cassette 312 do not come into direct contact with the support tray 404 but are instead supported by the insert 408, the support tray 404 is less likely to be contaminated by excess bodily fluids from the reagent strip 300 and the reagent cassette 312. Instead, the insert 408 can be removed from the support tray 404 and any excess bodily fluids can be cleaned as needed. In addition, the support tray 404 can be easily cleaned when the insert 408 is removed.

[0051] Figures 10-11 show a tray assembly 600 of another exemplary embodiment configured according to this disclosure for use with the apparatus 100 of Figure 1. The tray assembly 600 may include a support tray 604 and an insert 608 received to move within the support tray 604. The insert 608 can be made movable between a first position (shown in Figure 10) and a second position (shown in Figure 11), for example, via slidable movement within the support tray 604. In Figure 10, the insert 608 is shown in the first position so that a reagent strip 300 can be inserted into the insert 608 and used with the tray assembly 600. The insert 608 may have an elongated channel 612 (similar to the elongated channel 420 shown in Figure 5) sized to accommodate the reagent strip 300, an end wall 616 closing the elongated channel 612 at the end of the insert 608, and an open end 618 so that the reagent strip 300 can be slidably inserted into the insert 608. In Figure 11, the insert 608 is shown in a second position that allows the reagent cassette 312 to be inserted into the support tray 604.

[0052] The support tray 604 may include a top surface 628 having a compartment 632 that extends between the first and second opposing ends 620, 624 and between the first and second opposing ends 620, 624, and extends from the open end 636 at the first end 620 of the support tray 604 to the end wall 640 closer to the second end 624 of the support tray 604. The insert 608 can be movably supported within the compartment 632 of the support tray 604 and can be movable between a first position adjacent to the open end 636 of the compartment 632, as shown in Figure 10, and a second position adjacent to the end wall 640 of the compartment 632, as shown in Figure 11. The reagent cassette 312 can be inserted into the compartment 632 between the open end 636 of the compartment 632 and the insert 608 when the insert 608 is in the second position shown in Figure 11. As will be further described below, the reagent cassette 312 can be secured within the compartment 632 by a plurality of upwardly extending positioning members 664. The open end 618 of the insert 608 can abut against the reagent cassette 312.

[0053] In the exemplary embodiments shown in Figures 10-11, the insert 608 can be slidably movable between a first and a second position within the compartment 632 of the support tray 604. As shown, the side walls 648, 652 of the compartment 632 of the support tray 604 may include channels 656, and the sides of the insert 608 may include rails 660 that are received within the channels 656 to guide the sliding movement of the insert 608 within the compartment 632. In the embodiments shown in Figures 10-11, the insert 608 is not removable from the support tray 604. However, in some embodiments, the insert 608 can be slidably removable from the support tray 604.

[0054] The open end 636 at the first end 620 of the support tray 604 may have a positioning member 664, which may take the form of a pin, for example. When the reagent strip 300 or reagent cassette 312 is placed in the support tray 604, the positioning member 664 may be positioned within a plurality of openings or holes (not shown) formed in the bottom surface of the reagent strip 300 or reagent cassette 312 (thereby the positioning member 664 can prevent the reagent strip 300 or reagent cassette 312 from accidentally sliding out of the compartment 632). The support tray 604 may have a conventional calibration chip 668 of a certain color, such as white, located within the top surface 628 of the support tray 604 to facilitate calibration in the conventional method.

[0055] Further exemplary embodiments of a tray assembly 700 configured according to this disclosure for use with the apparatus 100 of Figure 1 are shown in Figures 12-13. The tray assembly 700 is similar to the tray assembly 600 shown in Figures 10-11, but includes an insert 704 that is rotatably movable within a compartment 708 of a support tray 712 between a first position (shown in Figure 12) and a second position (shown in Figure 13). When the insert 704 is in the first position, the tray assembly 700 can be applied to receive a reagent strip 300 within an elongated channel 716 on the surface of the insert 704, as similarly described with respect to the elongated channel 420 in Figure 5. When the insert 704 is in the second position, the tray assembly 700 can be applied to receive a reagent cassette 312 within a compartment 708 of the support tray 712. The reagent cassette 312 can be fixed within the compartment 708 by a positioning member 664, as similarly described with respect to compartment 632 in Figure 11.

[0056] The insert 704 can be rotatably attached to the support tray 712 by two pins 720 that extend through the side walls 724, 728 of the support tray 712 and through the hinge 732 of the insert 704. In the embodiment shown in Figures 12-13, the insert 704 is not removable from the support tray 712. An anchor 736 can be fixed to the bottom of the compartment 708 between the hinges 732 of the insert 704, providing an end wall 740 for the reagent strip 300 to abut and an end wall 744 for the reagent cassette 312 to abut.

[0057] Referring here to Figure 14, a method 800 for optically inspecting a liquid sample placed on a liquid sample carrier such as a reagent strip 300 and a reagent cassette 312 is shown. In some embodiments, a software application 228 stored in the controller memory 224 of the controller 202, when executed by the processor 212 of the controller 202, can cause the processor 212 to perform one or more steps of the method 800 described herein. As shown in Figure 14, the method 800 may include: a step of analyzing pixels in one or more images such as an image 900 of the liquid sample carrier (shown in Figures 15 to 18) (step 804); a step of determining the reading area position of a reading area of ​​the liquid sample carrier in one or more images (step 808); and a step of analyzing pixels in one or more images depicting the reading area to determine the presence and / or absence of a predetermined analyte in the liquid sample (step 812). This can be achieved, for example, by comparing the color of pixels within a reading area of ​​one or more images or a time-based series of images with a predetermined color and / or time stored in memory indicating the presence and / or absence of a given analyte.

[0058] Figure 15 shows an exemplary embodiment of an image 900 of a liquid sample carrier (i.e., reagent strip 300) acquired by the sensor 206 of the optical inspection apparatus 100 and stored in the controller memory 224 shown in Figure 2. As described above, in some embodiments, a reference mark 428 is positioned on the end wall 424 of the first surface 412 of the insert 408 and acquired in the image together with the liquid sample carrier (i.e., reagent strip 300). The processor 212 of the apparatus 100 can be configured to analyze the image 900 to locate the reference mark 428 and use the reference mark 428 as an indicator to determine the position of the reading area of ​​the reagent strip 300.

[0059] In some embodiments, during the manufacturing of the device 100, a known displacement 904 between the reference mark 428 and the reagent pad area 310 is measured, and data indicating the known displacement 904 and the direction to the reagent pad area 310, and therefore a predetermined configuration of the reagent pad 308a (e.g., the leading edge 905), is stored in the controller memory 224. Each reagent pad 308 has a leading edge 905, but for clarity purposes, only the reagent pad 308a is labeled. The known displacement 904 can be the number of pixels from the reference mark 428 to the leading edge 905. In some embodiments, during the manufacturing of the device 100, a plurality of known displacements 908 between the reference mark 428 and a predetermined configuration, for example, the leading edge 905 of each reagent pad 308, are measured, and data indicating the known displacements 908 is stored in the controller memory 224. In some embodiments, during the manufacturing of the device 100, a known displacement 909 between the first reagent pad 308a and the second reagent pad 308b is measured, and data indicating the known displacement 909 is stored in the controller memory 224. In some embodiments, during the manufacturing of the device 100, a plurality of known displacements 914 between each reagent pad 308 are measured, and data indicating the known displacements 914 is stored in the controller memory 224. For the purpose of clarity, only one of the known displacements 908 and only one of the known displacements 914 are labeled with reference codes. If the known displacements 914 are used to locate an additional reagent pad 308, the size (e.g., length) of the reagent pad 308 is also stored in the controller memory 224 and can be used to locate the additional reagent pad 308. For example, once the position of the reference mark 428 is determined, the leading edge 905 of the reagent pad 308a can be located using the known displacements 904 and direction. Next, using the known size and known displacement 914 of the reagent pad 308a, the reagent pad 308b can be located, for example, by adding or subtracting pixels in a known direction. This process can be repeated to locate other reagent pads 308.Once the positions of reagent pads 308a and / or 308b are determined, the positions of additional reagent pads 308 can be determined using the known displacements 904 and / or 914, and / or the size of reagent pad 308.

[0060] In some embodiments, the step of analyzing pixels in one or more images of the reagent strip 300 (step 804) may include analyzing pixels in one or more images to determine the location of indicators (e.g., reference mark 428 or symbol 910) in one or more images. Analyzing pixels in one or more images may further include calculating a one-dimensional gradient representation 1000 (hereinafter, "1D gradient 1000") of one or more images (shown in Figure 19). Calculating the 1D gradient 1000 may include calculating average values ​​(e.g., intensity, multiple color values ​​(e.g., averaging the red, green, and blue channels of a pixel to obtain a gray channel for each pixel in one of the rows), saturation, etc.) for each pixel location along the axis 912 aligned with the reagent strip 300, and plotting the average values ​​as shown in Figure 19.

[0061] In some embodiments, one or more images can be converted to a color space other than RGB, such as HSV or YCbCr, or any other format well known in the literature, which is suitable for processing.

[0062] In some embodiments, one or more images may be preprocessed by passing one or more images through at least one filter to highlight regions of interest within one or more images. Exemplary filters that may be used to highlight regions of interest may include Gaussian low-pass filters, Butterworth low-pass filters, edge detection filters, or those well known in the literature.

[0063] In some embodiments, the step of analyzing pixels in one or more images (step 804) may further include scanning the 1D gradient 1000 in a predetermined direction (e.g., from right to left or left to right as shown in Figure 19) to determine the first local maximum / minimum position 1004 of the 1D gradient 1000. Since the reference mark 428 is preferably provided to have a color value contrasting with the first surface 412 of the insert 408, the position of the reference mark 428 can be determined by the first local maximum / minimum position 1004. Determining the first local maximum / minimum position 1004 may include calculating the first derivative of the 1D gradient 1000 and determining a first point where the first derivative transitions from a positive value to a negative value or from a negative value to a positive value. However, it should be understood that determining the first local maximum / minimum position 1004 can be achieved by any number of conventional methods known to those skilled in the art.

[0064] In embodiments in which known displacements 904 and predetermined directions are stored in the controller memory 224, the step of determining the reading region position of the reading region of the reagent strip 300 in one or more images (step 808) can be further defined as analyzing pixels in one or more images by applying (i.e., adding) the known displacements 904 and predetermined directions to a first local maximum / minimum position 1004 to determine the reading region position of the reading region where the reading region is the reagent pad region 310.

[0065] In embodiments in which known displacements 908 are stored in the controller memory 224, the step (step 808) of determining the reading region positions of the reading regions of the reagent strip 300 in one or more images can be further defined as analyzing pixels in one or more images by applying (i.e., adding) the known displacements 908 to a first local maximum / minimum value position 1004 to determine the reading region positions of multiple reading regions, where multiple reading regions are multiple reagent pads 308. The known displacements 908 can be the number of pixels in one or more images from the position of the indicator.

[0066] In embodiments in which known displacements 909 are also stored in the controller memory 224, the step of determining the read area position of the read area of ​​the reagent strip 300 in one or more images (step 808) can be further defined as analyzing pixels in one or more images to determine the first read area position of the first read area of ​​the reagent strip 300 in one or more images, wherein the first read area is the first reagent pad 308a. In such embodiments, the step of determining the read area position of the read area of ​​the reagent strip 300 in one or more images (step 808) can further include analyzing pixels in one or more images to determine the second read area position of the second read area, wherein the second read area is the second reagent pad 308b, by applying the known displacements 909 and a predetermined direction (e.g., adding or subtracting) to the determined first read area position. Therefore, assuming that the reagent strip contains 10 reagent pads 308, the controller memory 224 can store nine known displacements 909 and one or more directions to assist the processor 212 in locating the reading areas of the other reagent pads 308 after the location of the first reading area has been located. The known displacements 909 can be the number of pixels in one or more images from the location of the first reading area.

[0067] In some embodiments in which known displacements 909 are also stored in the controller memory 224, the step (step 808) of determining the read region positions of the read regions of the reagent strip 300 in one or more images may further include analyzing pixels in one or more images by successively applying (i.e., adding) the known displacements 909 to a second read region position, a third read region position, etc., to determine the positions of multiple additional read regions of multiple additional read regions, where the multiple additional read regions are multiple reagent pads 308 (excluding the first reagent pad 308a and the second reagent pad 308b).

[0068] In embodiments in which known displacements 914 are also stored in the controller memory 224, the step (step 808) of determining the reading area position of the reading area of ​​the reagent strip 300 in one or more images may further include determining the positions of multiple additional reading areas, where multiple additional reading areas are multiple reagent pads 308 (excluding the first reagent pad 308a and the second reagent pad 308b), by applying one of the known displacements 914 to each of the second reading area position, third reading area position, etc.

[0069] In other embodiments, the step of determining the read area positions of the read area of ​​the reagent strip 300 in one or more images (step 808) can be further defined as scanning the 1D gradient 1000 in a predetermined direction to determine a plurality of additional local maximum / minimum positions 1008 of the 1D gradient 1000. In such embodiments, the plurality of read area positions of the plurality of read areas can be determined by the plurality of additional local maximum / minimum positions 1008. Determining the plurality of additional local maximum / minimum positions 1008 can be based on additional constraints such as a predetermined threshold 1012 and / or a minimum distance 1016 between each additional local maximum / minimum position 1008. In some embodiments, determining the plurality of additional local maximum / minimum positions 1008 can include calculating the first derivative of the 1D gradient 1000 and determining the point where the first derivative transitions from a positive value to a negative value, such point corresponding to an additional local maximum / minimum position 1008. However, it should be understood that determining multiple additional local maximum / minimum positions 1008 can be achieved by any number of conventional methods known to those skilled in the art.

[0070] In some embodiments, method 800 further includes determining whether the determined read area location has a homogeneity value within a predetermined range. For example, if the magnitude of a portion of the 1D gradient 1000 in the vicinity of the determined read area location is less than a predetermined threshold (e.g., a value of 2), the read area location can be determined to be valid. Conversely, if the magnitude of a portion of the 1D gradient 1000 in the vicinity of the determined read area location is greater than the predetermined threshold, the read area location can be determined to be incorrect, in which case method 800 further includes discarding the determined read area location and attempting to determine a valid read area location. Such homogeneity checks can be performed for each of a plurality of read area locations.

[0071] In some embodiments, to confirm the position of the reference mark 428, method 800 further includes: storing a template gradient 1100 (shown in Figure 20) in memory, wherein the template gradient 1100 represents a pure white indicator surrounded by pure black on either side; calculating a correlation coefficient 1204 (shown in Figure 21) between a portion 1200 of the 1D gradient 1000 in the vicinity of the reference mark 428 and the template gradient 1100, wherein the correlation coefficient 1204 is directly proportional to the correlation between a portion 1200 of the 1D gradient 1000 in the vicinity of the reference mark 428 and the template gradient 1100; and determining that the correlation coefficient 1204 is greater than a predetermined threshold, thereby ensuring reliability in the position of the reference mark 428 and the reading area position. If it is determined that the correlation coefficient 1204 is less than a predetermined threshold, method 800 may include warning the user that maintenance may be required.

[0072] In some embodiments, calculating the correlation coefficient involves calculating the sum of the products of the template gradient 1100 and a portion 1200 of the 1D gradient 1000 in the neighborhood of the reference mark 428. However, it should be understood that calculating the correlation coefficient 1204 can be achieved by any number of conventional methods known to those skilled in the art.

[0073] As described above, in some embodiments, the symbol 910 can be positioned on the upper surface 311 of the substrate 304 of the reagent strip 300. In such embodiments, the processor 212 running the software application 228 of the apparatus 100 can use the symbol 910 (as shown in Figure 15) instead of the reference mark 428 as an indicator for determining the position of the reading area of ​​the reagent strip 300. In such embodiments, the step of analyzing pixels in one or more images of the reagent strip 300 (step 804) may include the processor 212 analyzing pixels in one or more images to determine the position of an indicator (i.e., symbol 910) in one or more images.

[0074] Determining the location of symbol 910 by analyzing pixels in one or more images may involve performing one or more image-based algorithms, analyses, or operations. Non-limiting examples of one or more image-based algorithms, analyses, or operations include optical character recognition algorithms, Hough transforms, connected component analysis, or machine learning or deep learning models trained on a dataset of images of reagent strips 300 having symbol 910. Once the location of symbol 910 is determined, the relative location of the reagent pad 308 can be determined as described above using known displacements from symbol 910 to a particular reagent pad 308, known displacements between reagent pads, and combinations thereof. Next, the color of pixels in one or more images depicting the reading area of ​​the reagent pad 308 is analyzed to determine the presence and / or absence of a given analyte in the liquid sample. In other embodiments, a machine learning or deep learning model trained on a dataset of images of reagent strips 300 can be used to directly determine the location of the reagent pad 308 in one or more images.

[0075] Figures 16 to 18 show other exemplary embodiments of the image 900 of the liquid sample carrier (i.e., reagent cassette 312) acquired by the sensor 206 of the optical inspection apparatus 100 shown in Figure 1. As described above, in some embodiments, the symbol 916 (shown in Figure 16), the luminescent material 918 (shown in Figure 17), or the colored region 920 (shown in Figure 18) can be placed on the upper surface 320 of the reagent cassette 312.

[0076] In some embodiments, during the manufacture of the apparatus 100, multiple known displacements 922 between one or more of the symbols 916 and the window 324 are measured, and data indicating the known displacements 922 are stored in the controller memory 224. In some embodiments, during the manufacture of the apparatus 100, multiple known displacements 924 between one or more structural components of the reagent cassette 312 (e.g., the first part 328, the second part 332, the curved end wall 336, and / or recesses 340a, 340b) (hereinafter, "structural features") and the window 324 are measured, and data indicating the known displacements 924 are stored in the controller memory. For the purpose of clarity, only one of the known displacements 922 and only one of the known displacements 924 are labeled with reference numerals. As shown in Figure 16, each of the known displacements 922 and known displacements 924 may be an ordered pair having orthogonal x (e.g., horizontal) and y (e.g., vertical) components.

[0077] In some embodiments, the processor 212 running the software application 228 of the apparatus 100 may use one or more of the symbols 916, the luminescent material 918, the colored area 920, and structural features as indicators for determining the location of the reading area of ​​the reagent cassette 312. In such embodiments, the step of analyzing pixels in one or more images of the reagent cassette 312 (step 804) may include the processor 212 analyzing pixels in one or more images to determine the location of indicators in one or more images (i.e., symbols 916, the luminescent material 918, the colored area 920, or structural features).

[0078] Determining the location of symbol 916 or colored region 920 may involve performing one or more image processing-based algorithms, analyses, or operations. Non-exclusive examples of one or more image processing-based algorithms, analyses, or operations include optical character recognition algorithms, Hough transforms, connected component analysis, or machine learning or deep learning models trained on a dataset consisting of images from reagent cassette 312.

[0079] Determining the position of the light-emitting material 918 may involve the processor 212 activating the light source 204 to illuminate the light-emitting material 918 with a specific wavelength of the electromagnetic spectrum, and activating the sensor 206 to acquire one or more images so that the light-emitting material 918 appears differently.

[0080] In some embodiments, instead of using the symbol 916, the light-emitting material 918, or the colored region 920 as indicators, the processor 212 of the apparatus 100 may be configured to analyze one or more images to identify one or more structural features as indicators.

[0081] In embodiments in which one or more of the symbols 916 are used as indicators, the step of determining the reading area position of the reading area of ​​the liquid sample carrier (step 808) can be further defined as analyzing one or more pixels in the image by applying (i.e., adding) a known displacement 922 to the determined position of the symbol 916 to determine the reading area position of the reading area which is the window 324.

[0082] In embodiments in which one or more of the luminescent material 918 and the colored region 920 are used as indicators, the step of determining the reading region position of the reading region of the liquid sample carrier (step 808) can be further defined as determining the reading region position of the reading region which is the window 324 by analyzing pixels in one or more images by identifying the region enclosed by the luminescent material 918 and / or the colored region 920.

[0083] In embodiments in which one or more of the structural functions are used as indicators, the step of determining the reading region position of the reading region of the liquid sample carrier (step 808) can be further defined as analyzing one or more pixels in the image by applying (i.e., adding) a known displacement 924 to the determined position of the structural function to determine the reading region position of the reading region which is the window 324.

[0084] From the above description, it is clear that the concepts of the invention disclosed and claimed herein are well applicable to accomplish the objectives and advantages referred to herein, as well as to achieve those specific to the invention. While exemplary embodiments of the concepts of the invention are described for the purposes of this disclosure, it will be understood that a number of modifications can be readily suggested to those skilled in the art and achieved within the spirit of the concepts of the invention disclosed and claimed herein.

[0085] Non-exclusive exemplary embodiments The following is a numbered list of non-limiting exemplary embodiments of the concepts of the present invention disclosed herein.

[0086] Exemplary Embodiment 1. The method includes: a processor analyzing pixels in an image of a liquid sample carrier on which a liquid sample is placed to determine the position of an indicator in the image; a processor determining the position of a reading area of ​​a reading area of ​​a liquid sample carrier in the image, at least partially based on the position of the indicator determined by analyzing pixels in the image; and a processor analyzing pixels in an image depicting the reading area to determine the presence and / or absence of a predetermined analyte in the liquid sample.

[0087] Exemplary Embodiment 2. The method according to Exemplary Embodiment 1, wherein analyzing pixels in an image to determine the location of an indicator in the image is further defined as analyzing pixels in an image to determine the location of an indicator in the image that is separated from the liquid sample carrier.

[0088] Exemplary Embodiment 3. The method according to Exemplary Embodiment 1 or 2, wherein analyzing pixels in an image to determine the position of an indicator in the image is further defined as analyzing pixels in an image to determine the position of an indicator in the image that is positioned on the surface of a liquid sample carrier.

[0089] Exemplary Embodiment 4. The method according to any one of Exemplary Embodiments 1 to 3, wherein analyzing pixels in an image to determine the position of an indicator in the image comprises by a processor computing a one-dimensional gradient representation of the image, and by a processor scanning the one-dimensional gradient representation of the image in a predetermined direction to determine the first local maximum / minimum position of the first local maximum / minimum of the one-dimensional gradient representation of the image, the position of the indicator is determined by the first local maximum / minimum position.

[0090] Exemplary Embodiment 5. The method according to any one of Exemplary Embodiments 1 to 4, wherein determining the read region positions of read regions of liquid sample carriers in an image is further defined as the processor analyzing pixels in the image to determine multiple read region positions of multiple read regions of liquid sample carriers.

[0091] Exemplary Embodiment 6. The method according to any one of the preceding exemplary embodiments, wherein determining the multiple read area positions of the multiple read area is further defined as the processor determining the multiple read area positions based at least in part on a plurality of known displacements between the position of the indicator and each of the multiple read area positions.

[0092] Exemplary Embodiment 7. The method according to any one of the preceding exemplary embodiments, wherein determining multiple read region positions of multiple read regions is further defined by the processor as determining multiple additional local maximum / minimum positions of multiple additional local maximums of a one-dimensional gradient representation, and each of the multiple read region positions is determined based on each of the multiple additional local maximum / minimum positions.

[0093] Exemplary Embodiment 8. The method according to any one of the preceding exemplary embodiments, wherein determining the multiple read region positions of a plurality of read regions is defined by the processor as determining the second local maximum / minimum position of a second local maximum / minimum position of a one-dimensional gradient representation, wherein the first read region position of the first read region is determined based on the second local maximum / minimum position, and the processor determines the multiple additional read region positions of the plurality of additional read regions at least in part on a plurality of known displacements between the first read region position and each of the plurality of additional read regions.

[0094] Exemplary Embodiment 9. The method according to any one of the preceding exemplary embodiments, wherein the indicator is one or more symbols placed on the surface of a liquid sample carrier, and determining the position of the indicator is further defined as a processor performing optical character recognition on an image to detect the position of one or more symbols of one or more symbols, and the position of the indicator is determined by the position of one or more symbols.

[0095] Exemplary Embodiment 10. The method according to any one of the preceding exemplary embodiments, wherein the indicator is one or more colored regions placed on the surface of a liquid sample carrier, the colored regions having a predetermined color value, and determining the position of the indicator is further defined as a processor detecting the predetermined color value in a pixel in an image.

[0096] Exemplary Embodiment 11. The method according to any one of the preceding exemplary embodiments, wherein the indicator is a material configured to appear bright or dark when exposed to a particular wavelength of the electromagnetic spectrum, and determining the position of the indicator is further defined as the processor illuminating a liquid sample carrier with a particular wavelength of the electromagnetic spectrum and the processor determining the position of the indicator at least in part on the appearance of the indicator when illuminated with a particular wavelength of the electromagnetic spectrum.

[0097] Exemplary Embodiment 12. An optical inspection apparatus comprising: a housing having an interior surrounding an inspection area; an indicator located within the inspection area; a light source configured to illuminate the inspection area within the housing; a tray assembly configured to receive a liquid sample carrier, the tray assembly being insertable into the inspection area of ​​the housing; a sensor configured to acquire an image of the inspection area of ​​the housing including the indicator; and a controller having a processor operable to execute processor executable code, the processor executable code, when executed by the processor, causing the processor to: analyze pixels in an image acquired by the sensor to determine the position of the indicator in the image; determine the position of a reading area in the image based at least partially on the position of the indicator determined by analyzing pixels in the image; and analyze pixels in the reading area of ​​the image to determine the presence and / or absence of a predetermined analyte.

[0098] Exemplary Embodiment 13. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein the indicator is located on a tray assembly.

[0099] Exemplary Embodiment 14. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein the indicator is not located on the tray assembly.

[0100] Exemplary Embodiment 15. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein analyzing pixels in an image to determine the position of an indicator in the image comprises calculating a one-dimensional gradient representation of the image and scanning the one-dimensional gradient representation of the image in a predetermined direction to determine the first local maximum / minimum position of a first local maximum / minimum value of the one-dimensional gradient representation of the image, the position of the indicator is determined by the first local maximum / minimum position.

[0101] Exemplary Embodiment 16. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein determining the reading region position of the reading region of the liquid sample carrier in the image is further defined as analyzing a pixel in the image that is a predetermined distance and direction away from the position of the indicator.

[0102] Exemplary Embodiment 17. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein determining the reading area position is further defined as determining multiple reading area positions of multiple reading areas by analyzing pixels at multiple known displacements from the position of an indicator and each of the multiple reading area positions.

[0103] Exemplary Embodiment 18. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein determining multiple read region positions of multiple read regions is further defined as determining multiple additional local maximum / minimum positions of multiple additional local maximum / minimum positions of multiple additional local maximum / minimum positions of a one-dimensional gradient representation, and each of the multiple read region positions is determined based on each of the multiple additional local maximum / minimum positions.

[0104] Exemplary Embodiment 19. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein determining the read region position of a read region in an image is further defined as determining the read region positions of a plurality of read regions in an image, and determining the read region positions of a plurality of read regions in an image is defined as determining the second local maximum / minimum position of a second local maximum / minimum position of a one-dimensional gradient representation, wherein the first read region position of the first read region is determined based on the second local maximum / minimum position, and the processor determines the plurality of additional read region positions of the plurality of additional read regions at least in part on a plurality of known displacements between the first read region position and each of the plurality of additional read regions.

[0105] Exemplary Embodiment 20. An optical inspection apparatus comprising: a housing having an interior surrounding an inspection area; a liquid sample carrier having an indicator; a light source configured to illuminate the inspection area within the housing; a tray assembly for receiving the liquid sample carrier, the tray assembly being insertable into the inspection area of ​​the housing; a sensor configured to acquire an image of the inspection area of ​​the housing including an indicator; and a controller having a processor operable to execute processor executable code, the processor executable code, when executed by the processor, causing the processor to: analyze pixels in an image acquired by the sensor to determine the position of an indicator in the image; determine the position of a read area in the image based at least partially on the position of an indicator determined by analyzing pixels in the image; and analyze pixels in the read area of ​​the image to determine the presence and / or absence of a predetermined analyte.

[0106] Exemplary Embodiment 21. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein the liquid sample carrier has a surface, and the indicator is one or more symbols placed on the surface of the liquid sample carrier, and determining the position of the indicator is further defined as performing optical character recognition on an image to detect the position of one or more symbols of one or more symbols, and the position of the indicator is determined by the position of one or more symbols.

[0107] Exemplary Embodiment 22. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein the liquid sample carrier has a surface, and the indicator is one or more colored regions disposed on the surface of the liquid sample carrier, the colored regions having a predetermined color value, and the position of the indicator is determined at least in part on detecting the predetermined color value in a pixel in an image.

[0108] Exemplary Embodiment 23. An optical inspection apparatus according to any one of the preceding exemplary embodiments, wherein the liquid sample carrier has a surface, and the indicator is a material on the surface of the liquid sample carrier configured to appear bright or dark when exposed to a specific wavelength of the electromagnetic spectrum, and determining the position of the indicator is further defined as illuminating the liquid sample carrier with a specific wavelength of the electromagnetic spectrum by a light source, and the position of the indicator is determined at least in part on the appearance of the indicator when illuminated with a specific wavelength of the electromagnetic spectrum.

Claims

1. Method: The processor analyzes pixels in the image of the liquid sample carrier in which the liquid sample is placed to determine the position of indicators in the image; The processor determines the reading region position of the liquid sample carrier in the image, at least partially based on the position of indicators determined by analyzing pixels in the image; The processor analyzes the pixels in the image depicting the reading area to determine the presence and / or absence of a predetermined analyte in the liquid sample. The method, including the method described above.

2. The method according to claim 1, wherein analyzing pixels in an image to determine the position of an indicator in the image is further defined as analyzing pixels in an image to determine the position of an indicator in the image that is separated from the liquid sample carrier.

3. The method according to claim 1, wherein analyzing pixels in an image to determine the position of an indicator in the image is further defined as analyzing pixels in an image to determine the position of an indicator in the image that is positioned on the surface of a liquid sample carrier.

4. The method according to claim 1, wherein determining the position of an indicator in an image by analyzing pixels in the image includes, by a processor, calculating a one-dimensional gradient representation of the image, and by a processor, scanning the one-dimensional gradient representation of the image in a predetermined direction to determine the first local maximum / minimum position of the first local maximum / minimum value of the one-dimensional gradient representation of the image, and the position of the indicator is determined by the first local maximum / minimum position.

5. The method according to claim 4, wherein determining the reading region positions of reading regions of liquid sample carriers in an image is further defined as the processor analyzing pixels in the image to determine the reading region positions of multiple reading regions of liquid sample carriers.

6. The method according to claim 5, wherein determining the positions of multiple read regions is further defined as the processor determining the positions of multiple read regions based at least in part on a plurality of known displacements between the position of an indicator and each of the multiple read region positions.

7. The method according to claim 5, wherein determining multiple read region positions of multiple read regions is further defined by the processor as determining multiple additional local maximum / minimum positions of multiple additional local maximums of a one-dimensional gradient representation, and each of the multiple read region positions is determined based on each of the multiple additional local maximum / minimum positions.

8. The method according to claim 5, wherein determining the positions of multiple read regions is defined by the processor as determining the second local maximum / minimum position of a second local maximum / minimum in a one-dimensional gradient representation, wherein the first read region position of the first read region is determined based on the second local maximum / minimum position, and further defined by the processor as determining the positions of multiple additional read regions of the multiple additional read regions at least partially based on a plurality of known displacements and directions between the first read region position and each of the multiple additional read regions.

9. The method according to claim 3, wherein the indicator is one or more symbols placed on the surface of a liquid sample carrier, and determining the position of the indicator is further defined as a processor performing optical character recognition on an image to detect the position of one or more symbols of one or more symbols, and the position of the indicator is determined by the position of one or more symbols.

10. The method according to claim 3, wherein the indicator is one or more colored regions placed on the surface of a liquid sample carrier, the colored regions having a predetermined color value, and determining the position of the indicator is further defined as a processor detecting a predetermined color value in a pixel in an image.

11. The method according to claim 3, wherein the indicator is a material configured to appear differently when exposed to a specific wavelength of the electromagnetic spectrum, and determining the position of the indicator is further defined as illuminating a liquid sample carrier with a specific wavelength of the electromagnetic spectrum by a processor, and determining the position of the indicator by a processor on at least in part the appearance of the indicator when illuminated with a specific wavelength of the electromagnetic spectrum.

12. The method according to claim 1, wherein determining the position of an indicator in an image is further defined as checking the position of an indicator in a template gradient stored in non-temporary memory.

13. The method according to claim 12, wherein checking the position of an indicator with a template gradient is further defined as calculating a correlation coefficient between the determined position of an indicator in an image and the template gradient, and further includes issuing an alert if the correlation coefficient is below a predetermined threshold.

14. An optical inspection device: A housing having an interior that encloses the inspection area; Indicators located within the inspection area; A light source configured to illuminate the inspection area inside the housing; A tray assembly configured to receive a liquid sample carrier, the tray assembly being insertable into an inspection area of ​​a housing; A sensor configured to acquire images of the inspection area of ​​the housing, including the indicator; A controller having a processor capable of executing processor-executable code, wherein the processor-executable code, when executed by the processor, is directed to the processor: Analyzing pixels in an image acquired by a sensor to determine the position of an indicator in the image; The reading area position in the image is determined at least partially based on the position of the indicator determined by analyzing the pixels in the image; The process involves analyzing pixels within the image reading area to determine the presence and / or absence of a predetermined analyte. The controller and The optical inspection apparatus, including the optical inspection apparatus.

15. The optical inspection apparatus according to claim 14, wherein the indicator is located on the tray assembly.

16. The optical inspection apparatus according to claim 14, wherein the indicator is not located on the tray assembly.

17. The optical inspection apparatus according to claim 14, wherein determining the position of an indicator in an image by analyzing pixels in the image includes calculating a one-dimensional gradient representation of the image and scanning the one-dimensional gradient representation of the image in a predetermined direction to determine the first local maximum / minimum position of the first local maximum / minimum value of the one-dimensional gradient representation of the image, and the position of the indicator is determined by the first local maximum / minimum position.

18. The optical inspection apparatus according to claim 17, wherein determining the reading area position of the reading area of ​​the liquid sample carrier in the image is further defined as analyzing a pixel in the image that is located at a predetermined distance and direction from the position of the indicator.

19. The optical inspection apparatus according to claim 18, wherein determining the reading area position is further defined as determining multiple reading area positions of multiple reading areas by analyzing pixels at multiple known displacements from the position of the indicator and each of the multiple reading area positions.

20. The optical inspection apparatus according to claim 19, wherein determining multiple reading region positions of multiple reading regions is further defined as determining multiple additional local maximum / minimum positions of multiple additional local maximum / minimum values ​​of a one-dimensional gradient representation, and each of the multiple reading region positions is determined based on each of the multiple additional local maximum / minimum positions.

21. Determining the read region position of a read region in an image is further defined as determining the read region positions of multiple read regions in an image, and determining the read region positions of multiple read regions in an image is determining the second local maximum / minimum position of a second local maximum / minimum position of a one-dimensional gradient representation, wherein the first read region position of the first read region is determined based on the second local maximum / minimum position, and the processor determines the multiple additional read region positions of the multiple additional read regions at least partially based on a plurality of known displacements and directions between the first read region position and each of the plurality of additional read regions, the optical inspection apparatus according to claim 17.

22. The optical inspection apparatus according to claim 14, wherein determining the position of an indicator in an image is further defined as confirming the position of an indicator with a template gradient stored in non-temporary memory.

23. The method according to claim 22, wherein determining the position of an indicator using a template gradient is further defined as calculating a correlation coefficient between the determined position of an indicator in an image and the template gradient, and further includes issuing an alert if the correlation coefficient is below a predetermined threshold.

24. An optical inspection device: A housing having an interior that encloses the inspection area; A liquid sample carrier with an indicator; A light source configured to illuminate the inspection area inside the housing; A tray assembly for receiving a liquid sample carrier, the tray assembly being insertable into an inspection area of ​​a housing; A sensor configured to acquire images of the inspection area of ​​the housing, including the indicator; A controller having a processor capable of executing processor-executable code, wherein the processor-executable code, when executed by the processor, is directed to the processor: Analyzing pixels in an image acquired by a sensor to determine the position of an indicator in the image; The reading area position in the image is determined at least partially based on the position of the indicator determined by analyzing the pixels in the image; The process involves analyzing pixels within the image reading area to determine the presence and / or absence of a predetermined analyte. The controller and The optical inspection apparatus, including the optical inspection apparatus.

25. The optical inspection apparatus according to claim 24, wherein the liquid sample carrier has a surface, the indicator is one or more symbols placed on the surface of the liquid sample carrier, and determining the position of the indicator is further defined as performing optical character recognition on an image to detect the position of one or more symbols of one or more symbols, and the position of the indicator is determined by the position of one or more symbols.

26. The optical inspection apparatus according to claim 24, wherein the liquid sample carrier has a surface, and the indicator is one or more colored regions disposed on the surface of the liquid sample carrier, the colored regions having a predetermined color value, and the position of the indicator is determined at least in part on detecting the predetermined color value in a pixel in an image.

27. The optical inspection apparatus according to claim 24, wherein the liquid sample carrier has a surface, the indicator is a material on the surface of the liquid sample carrier and is configured to look different when exposed to a specific wavelength of the electromagnetic spectrum, and determining the position of the indicator is further defined as illuminating the liquid sample carrier with a light source at a specific wavelength of the electromagnetic spectrum, and the position of the indicator is determined at least in part on the appearance of the indicator when illuminated at a specific wavelength of the electromagnetic spectrum.

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