Method and apparatus adapted to identify the 3D center position of a specimen container using a single image capture device - Patents.com

Abstract

A method for determining a 3D center position of a specimen container on a track. The method includes: providing a calibration object on the track; providing an initial calibration image capture device adjacent to the track; moving the calibration object to at least two different longitudinal points along the track; capturing a first image with the calibration object located at the first longitudinal point; capturing a second image with the calibration object located at the second longitudinal point; and determining a three-dimensional path trajectory of the center position along the track based on at least the first image and the second image. The method can be used to determine the 3D center position of a specimen container imaged anywhere within the visibility region. A characterization apparatus and specimen testing apparatus adapted to perform the method are described as well as other aspects.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 148,529, filed February 11, 2021, and entitled “METHODS AND APPARATUS ADAPTED TO IDENTIFY 3D CENTER LOCATION OF A SPECIMEN CONTAINER USING A SINGLE IMAGE CAPTURE DEVICE,” the disclosure of which is incorporated by reference in its entirety for all purposes.

[0002] The present disclosure relates to methods and apparatus for use in testing biological specimens, and more particularly, to methods and apparatus for characterizing specimen containers in testing biological specimens. [Background technology]

[0003] Automated testing systems can perform immunoassays or clinical chemistry analyses to identify analytes or other components in specimens, such as serum, plasma, urine, interstitial fluid, cerebrospinal fluid, etc. For convenience and safety reasons, the specimens are almost always contained in specimen containers (e.g., blood collection tubes), which may be capped with a colored cap. Some of the specimens are removed from the specimen containers and subjected to analysis by assays and / or clinical chemistry analyses. Reactions during the assays or clinical chemistry analyses produce various changes that can be read and / or manipulated to determine the concentration of the analyte or other component in the specimen, which in some embodiments may be indicative of a patient's disease state.

[0004] Improvements in automated testing technology have been realized through corresponding advances in pre-analytical sample preparation and handling operations, such as centrifugation of specimen containers to separate sample components, capping (uncapping) to facilitate access to the specimen, preparation of aliquots, and quality testing, which can be used to identify specimen container dimensions such as height and width, and / or the presence of interfering factors such as hemolysis, icterus, or lipemia (HIL), or the presence of artifacts such as clots, bubbles, or foam. Such pre-analytical devices can be part of a laboratory automation system (LAS). The LAS can automatically transport specimens in specimen containers to one or more pre-analytical sample processing stations on a track so that the specimens can undergo various pre-processing operations before analysis.

[0005] The LAS can handle several different specimens contained in barcode labeled specimen containers (e.g., tubes). The barcode label can include an accession number related to demographic information from a laboratory information system (LIS) along with test instructions and other desired information. An operator or robot can place the labeled specimen container on the LAS system, which can automatically send the specimen container along a track for pre-analytical operations before subjecting the specimen to full assay or clinical chemistry analysis by one or more analyzers that can be connected to or part of the LAS.

[0006] In such testing systems, the specimen containers presented for analysis may be of different sizes, such as different heights and different widths (eg, diameters), the identification of which is desired. Summary of the Invention [Means for solving the problem]

[0007] According to a first aspect, the present disclosure is directed to a method for determining a location of a specimen container on a track, the method including: providing a calibration object on the track; providing an initial calibration image capture device adjacent to the track; moving the calibration object to at least two different longitudinal points along the track, including a first longitudinal point and a second longitudinal point different from the first longitudinal point; capturing a first image using the image capture device with the calibration object located at the first longitudinal point; capturing a second image using the image capture device with the calibration object located at the second longitudinal point; and determining a three-dimensional path trajectory of a center location along the track based on at least the first image and the second image.

[0008] According to another aspect, a characterization apparatus is provided, the characterization apparatus comprising: a calibration object movable on a track; a calibration image capture device located adjacent to the track; and a computer connected to the calibration image capture device, the computer configured and operable to: move the calibration object to at least two different longitudinal points along the track, including a first longitudinal point and a second longitudinal point different from the first longitudinal point; capture a first image using the calibration image capture device with the calibration object located at the first longitudinal point; capture a second image using the calibration image capture device with the calibration object located at the second longitudinal point; and determine a three-dimensional path trajectory of a center position along the track based on at least the first image and the second image. The 3D center position of the specimen container can be determined based on the three-dimensional path trajectory of the center position regardless of where it is stopped within the imaging region.

[0009] In another aspect, an analyte testing apparatus is provided, the testing apparatus comprising: a track; a specimen carrier movable on the track configured to carry a specimen container; one or more characterization devices disposed about the track, each of the one or more characterization devices including: a calibration image capture device adjacent to the track; and a computer, the computer being connected to the calibration image capture device and configured to: determine a three-dimensional path trajectory of a center position along a segment of the track based on at least a first image and a second image of a calibration object taken in an imaging region; move a specimen container carried by the carrier on the track to the imaging region; image the specimen container in the imaging region to obtain a container image; determine a mid-plane between lateral edges of the specimen container; and back-project the mid-plane to detect an intersection of the mid-plane and the three-dimensional path trajectory, the intersection being the three-dimensional center of the specimen container at the point of the mid-plane.

[0010] Further other aspects, configurations, and advantages of the present disclosure will become readily apparent from the following description, by illustrating several exemplary embodiments and implementations, including the best mode contemplated for carrying out the present disclosure. The present disclosure is also capable of other various embodiments, and its several details can be modified in various respects without departing from the scope of the present disclosure. Thus, the drawings and description should be regarded as illustrative in nature, and not restrictive. The present disclosure includes all modifications, equivalents, and alternatives that fall within the scope of the claims.

[0011] The drawings described below are for illustrative purposes and are not necessarily drawn to scale. The drawings are not intended to limit the scope of the present disclosure in any way. Like numbers are used to refer to like elements in each drawing. [Brief description of the drawings]

[0012] [Figure 1]A top view of a specimen testing device including one or more characterization devices configured to determine the 3D center position of a specimen container and one or more analyzers (e.g., clinical chemistry or assay equipment) in accordance with one or more embodiments of the present disclosure. [Diagram 2] 1 shows a side view of a labeled specimen container, the location of the three-dimensional (3D) center of the container being quantifiable by a characterization method and characterization apparatus according to one or more embodiments of the present disclosure. [Figure 3A] 1 illustrates a perspective view of a characterization device configured to capture multiple images in accordance with one or more embodiments of the present disclosure (with the outline of the housing portion shown in dashed lines to aid in illustration), with a calibration object shown at a second point along the track. [Figure 3B] 1 illustrates a perspective view of a characterization device configured to capture an image of a specimen container at a point along a track within an imaging area and determine its 3D center position, in accordance with one or more embodiments of the present disclosure. [Figure 3C] FIG. 1 illustrates a schematic top view of a characterization device configured to capture images of a calibration object at first and second points spaced apart along a track and determine a 3D path trajectory along the track, in accordance with one or more embodiments of the present disclosure. [Figure 3D] An image of a side of the specimen container at a point along a track within an imaging area is shown, from which the 3D center position of the specimen container at that point can be determined in accordance with one or more embodiments of the present disclosure. [Figure 4A] 1 shows a schematic top view of a characterization device configured to determine a 3D center position of a specimen container at a point along a track within an imaging area, in accordance with one or more embodiments of the present disclosure. [Figure 4B]4B shows a schematic side view of the characterization device of FIG. 4A (with the outline of the housing portion shown in dashed lines to aid in illustration) in accordance with one or more embodiments of the present disclosure (light source 300B is not shown for illustration purposes). [Diagram 5] 1 illustrates a flow chart of the functional components of a characterization device adapted to characterize specimen containers and specimens in accordance with one or more embodiments. [Figure 6] 1 shows a flowchart of a method adapted to characterize a 3D trajectory path of a specimen container, according to one or more embodiments. [Figure 7] 1 shows a flowchart of a method for characterizing a 3D center position of a specimen container according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Due to tolerance stackup and variations, the exact location of the three-dimensional (3D) center position of the specimen container may be unknown at positions along the track, particularly at positions in front of the various pre-analytical operations and the analyzer. Due to the challenges faced in determining the exact location of the specimen container in 3D (its center position) and / or the size or type of the specimen container, there is an unmet need for methods and apparatus adapted to easily and accurately determine such center position as well as such size.

[0014] In particular, it may be desirable to obtain the 3D center positions and sizes of various specimen containers at one or more pre-analytical stages, as this information can help inform pre-analytical devices (e.g., centrifuges, decappers, aspirators, etc.) of the alignment to follow. Additionally, this acts as a fail-safe in case the geometry of the tubes being placed into the specimen testing system is not supported. In another aspect, when handling specimen containers by a robot, knowing the size and 3D center position of the specimen container can help the robot's gripper to be properly aligned to the specimen container in 3D space, thus avoiding or minimizing collisions between them. Additionally, knowing the size and 3D center position of the specimen container can assist in lowering the pipette for aspiration at the correct location, avoiding specimen container / pipette collisions and / or poor aspiration.

[0015] In some prior art quality inspection modules configured to assess container size, specimen level, and specimen quality, such as determining HIL levels in the specimen, three cameras are provided that assist in providing a full 360 degree view of the specimen contained in the specimen container. Thus, in such prior art quality inspection modules, when the cameras are properly calibrated, it is possible to reconstruct the geometry of the specimen container in 3D space. Once such reconstruction is completed using inputs from multiple cameras, the height and width (e.g., diameter) can be determined with some accuracy.

[0016] However, some systems with three cameras for multi-view imaging are not practical from a cost perspective. Therefore, the present disclosure provides, in some embodiments, a method, apparatus, and system that can measure the geometry of a specimen container and also calculate the 3D center coordinate of the specimen container's 3D center position using only one image capture device (e.g., using a single camera). Furthermore, in some LAS systems, accurate track placement is difficult due to tolerance stackup and installation variability, so knowing the specimen container's 3D center position in the quality inspection module may not lead to accurate location of the center position at other positions on the track. By using a single image capture device in the characterization device in conjunction with a track that enables the movement of the specimen container on the track, a simple and effective method and apparatus is realized to determine the 3D center position and size of the specimen container at any desired position along the track of the LAS.

[0017] In some existing test systems, the geometry of the specimen container is measured in a quality inspection module using only one of multiple cameras in one of two ways: In the first method, a specimen container (e.g., a tube) of known geometry (such as a cylindrical calibration tool) is moved to a predetermined point on a track in the quality inspection module, and then its image is captured. The height (HT) and width (W) are measured in pixels. When a specimen container of a different size is encountered, it is moved to exactly the same point on the track as before, and its height HT and width W can be derived proportionally based on the previously acquired image measurement in pixels. Although the method can derive the height HT and width W with some accuracy, it cannot provide a precise 3D center position estimate for the specimen container.

[0018] Thus, in a first broad aspect, embodiments of the present disclosure provide characterization methods, characterization apparatus, and specimen testing systems configured and operable to determine the 3D center position and physical dimensions of a specimen container, such as width W and height HT.

[0019] In one or more embodiments, the characterization method does not require the specimen container to be moved to a predetermined exact point every time, and does not require prior computer aided drafting (CAD) information about the track geometry. Furthermore, the characterization method derives an accurate estimate of the 3D coordinates of the specimen container center location (which can be used for robotic gripper and pipette alignment tasks) without requiring extremely tight tolerances on the machine setup. Finally, the characterization method does not strictly require the track to be parallel to the image capture device (e.g., camera), and can even handle cases where the track is slightly tilted or even curved, as long as there are no overlapping points on the track along each line of sight from the image capture device.

[0020] Knowing the width W of the specimen container can be used for further quantification (e.g., volume) of various portions of the specimen, such as quantification of the volume of serum or plasma portions, precipitated blood portions, or both. The height HT of the specimen container can be used by any robotic system of the test system to establish a reference height for the pipette of the liquid aspirating system to minimize collisions between the specimen container and the pipette when moving the pipette to perform the aspiration. Knowing the exact 3D center location of the specimen container also allows the robotic gripper to lift the specimen container while avoiding collisions between the specimen container and the robotic gripper. Additionally, HT and W, as well as the exact 3D center location, can be used to locate and properly space the jaws of any robotic gripper so that the gripper can properly grip the specimen container.

[0021] According to the present disclosure, the characterization method can use a single image capture device (e.g., a camera) located along the track at any location where it is useful to know the 3D center location and / or size of the specimen container. For example, the characterization apparatus can be implemented at a location within the quality inspection module, at the centrifuge station, such as at the centrifuge lift location, the aliquotter aspirate / dispense location, any other robotic lift and / or deposit location on the track, the analyzer location, or any other suitable location where repetitive robotic lift or deposit operations occur.

[0022] The characterization method first includes planning a track path in a desired region of interest in three-dimensional (3D) space. For example, the characterization method can include taking multiple images of the same calibration object (e.g., a calibration tool) at various longitudinal points along a track in the imaging region and determining from the images a 3D trajectory of the center along the track. This is done for a calibration object of known geometry, and using the trajectory, the characterization method can map the center of the calibration object in three-dimensional space. The method can be used with any image capture device (e.g., camera) and track setup, such as in automated diagnostic equipment.

[0023] Specifically, the track carries specimens in specimen containers on carriers at various locations for analysis (e.g., analytical tests or assays), and other locations on the track can use the geometric dimensions (W and HT) and 3D center location determined from the quality inspection module, even though they may not be completely accurate at those locations. For more accurate 3D center location, one or more characterization devices can be included at other locations around the track. Subsequent pre-screening, chemical analysis, or assays in the quality inspection module can be performed in an appropriate analyzer. The term "analyzer" is used herein to mean a clinical chemistry analyzer and / or assay instrument and / or the like. In one embodiment, a quality inspection module can be provided on the track, so that the specimen containers can be characterized in terms of dimensions while on the track, such as on the input lane of the track or at another location along the track.

[0024] Further details of the inventive characterization methods, characterization apparatus, and test systems including one or more characterization apparatus will now be described with reference to FIGS.

[0025] FIG. 1 illustrates an exemplary embodiment of an analyte testing device 100 capable and operable to automatically process a plurality of sample containers 102 that may be accommodated in one or more racks 104 provided in a loading area 105 prior to analysis by one or more analyzers (e.g., first, second, and third analyzers 106, 108, 110, respectively) disposed about a track 121 of the analyte testing device 100. It should be apparent that more or fewer analyzers may be used. The analyzers 106, 108, 110 may be one or more clinical chemistry analyzers and / or one or more assay instruments, or the like, or a combination thereof. The sample containers 102 may generally be any transparent or translucent container, such as a blood collection tube (see FIG. 2). As described later herein, the sample containers 102 may be moved on a carrier 122 on the track 121. More specifically, the analyte tester 100 may include a base 120 (eg, a frame or other structure) on which a track 121 may be mounted or supported.

[0026] As shown in FIG. 2, specimens 212 to be automatically processed can be provided to the specimen testing device 100 in specimen containers 102 that can be capped with caps 214. The caps 214 can have a variety of shapes and / or colors (e.g., red, dark blue, light blue, green, gray, tan, yellow, or other colors). The color and / or shape can provide useful information about the test to be performed and / or additives provided to the specimen containers 102. Each specimen container 102 can include a tube 213 that can be provided with a label 218 that includes identification information 215, such as a bar code, alphabetic, numeric, or alphanumeric indicia, or combinations thereof, that can be machine readable at various locations on the specimen testing device 100. The identification information 215 can indicate, for example, the patient's identity and possibly the test to be performed on the specimen 212. The identification information 215 can be coupled to a laboratory information system (LIS) 147 to provide additional information, such as the test being ordered. The label 218 is adhered to the specimen container 102 or is otherwise provided on its side. The label 218 generally does not extend all the way around or along the entire length of the specimen container 102. Thus, the label 218 may obscure a portion of the specimen 212, but the portion of the specimen 212 may still be visible. In some embodiments, there may be multiple labels 218 that overlap slightly. In some embodiments, the rack 104 may have additional identification information thereon that may be used for specimen tracking. As should be appreciated, the unobstructed area may be oriented by manual or automated means while on the carrier 122 to face a desired location, such as toward a particular image capture device.

[0027] 1, a suitably calibrated robot 124 can pick up a desired specimen container 102 from one or more racks 104 and, via control commands from a computer 123, place the specimen container 102 in a carrier 122 located at a preprogrammed position on the track 121 or in an input lane (not shown) of the track. The computer 123 can include a microprocessor-based central processing unit CPU, appropriate memory, software, and conditioning electronics, as well as drivers for operating the various test system components. The computer 123 can be housed as part of the base 120 of the specimen tester 100 or can be separate from the base 120. The computer 123 is operable to control the movement of the carrier 122 to and from the loading area 105, movement on the track 121, movement to and from the centrifugation station 125, the operation of the centrifugation station 125, movement to and from the quality inspection module 130, movement to and from the aliquoting station 131, and movement to and from each of the analyzers 106, 108, 110. The computer 123 may also interface with, and perform calculations and operations of, one or more characterization devices 101 located about the track 121. In most instances, the operation of each analyzer 106, 108, 110 performing various types of tests (e.g., assays and / or clinical chemistry) is performed by built-in software to which the computer 123 interfaces.

[0028] The loading area 105 may serve a dual function of also allowing the unloading of the specimen container 102 from the carrier 122 after processing. The robotic gripper of the robot 124 may be configured to grab a specimen container 102 from one or more racks 104 and move and load the specimen container 102 onto the carrier 122, typically one container per carrier 122. In some embodiments, the robot 124 may be configured to remove the specimen container 102 from the carrier 122 when a test is completed. The robot 124 may include one or more (e.g., a minimum of two) robotic arms or components capable of X and Z (perpendicular to the XY plane), Y and Z, X, Y, and Z, or r and theta motions, and the robot 124 may include a robotic gripper adapted to pick up and place the specimen container 102 by gripping the sides of the specimen container 102. However, any suitable type of robot 124 may be used.

[0029] The specimen container 102 carried by the carrier 122, when loaded onto the track 121 by the robot 124, can proceed to the centrifuge station 125 (e.g., an automated centrifuge configured to perform fractionation of the specimen 212). The characterization device 101 can be provided at a location adjacent to the centrifuge station 125 and the track 121, such as at a location where the load / unload robot 126 can pick up the specimen container 102 from the carrier 122 and place it in a centrifuge at the centrifuge station 125. Knowing the exact 3D center location of the specimen container 102 at the location where the carrier 122 stops (or any other location on the track) helps to avoid collisions between the robot gripper and the container that could spill the specimen 212 or damage the specimen container 102, since the robot knows the exact point of the center location of the specimen container 102 at that location. As will be appreciated, the characterization device 101, as described herein, can be used at any location where it is desired to know the 3D center location. For example, the characterization device 101 may be located in the loading area 105, the quality inspection module 130 (using one of its image capture devices), the aliquoting station 131 to avoid pipette-container collisions that could spill the specimen 212 or damage the specimen container 102 or the pipette, and one or more of the analyzers 106, 108, 110 to avoid pipette-container collisions or robot-container collisions. The characterization device 101 may be located in other locations.

[0030] 3A-3D show an exemplary embodiment of the characterization device 101. The characterization device 101 includes a calibration object 325 movable on a track 121 (only a portion of the track 121 is shown in FIGS. 3A-3C). The track 121 can be a railed track (e.g., a monorail track or a multi-rail track), a collection of conveyor belts, a chain, a movable platform, or other suitable transport mechanism. In some embodiments, the track 121 can have a circular, serpentine, or other shape and can be a closed track (i.e., an endless track). In some embodiments, the track 121 can transport individual specimen containers 102 by carriers 122 or multiple specimen containers 102 on each carrier 122. In some embodiments, the specimen containers 102 are configured to be received in receptacles of the carriers 122 that are movable on the track 121 in an upright position.

[0031] In the illustrated embodiment, the carriers 122 can be carried on the track 121, for example, by a cart 324. The cart 324 can be programmable, commandable, or otherwise forced to stop at a desired position along the track 121. The carriers 122 can be removable from the cart 324 and can include any suitable means for registering to the cart 324, such as, for example, a number of pins that register with holes. This positions the carriers 122 in a fixed orientation on the cart 324. In some embodiments, the cart 324 can include an on-board drive motor, such as a linear motor, configured to move the specimen containers 102 on the track 121 and stop at a desired position along the track 121 according to programmed instructions. Each of the carriers 122 can include a holder 122H (FIG. 3B) adapted to hold and secure the specimen containers 102 in a defined upright position. The holders 122H can include three or more leaf springs or fingers that provide a common center when the specimen containers 102 are inserted therein. The use of leaf springs allows various widths W of specimen containers 102 to be received by the carrier 122 while still disposing the specimen containers 102 in a common central location on the carrier 122. In some embodiments, the cart 324 and the carrier 122 may be integral.

[0032] The calibration object 325 may include a V-shaped marker tool having at least a first planar surface 325A and a second planar surface 325B disposed at an angle therefrom, as best shown in FIG. 3A and FIG. 3C. For example, the two surfaces 325A, 325B may be disposed at an inclined angle from each other of about 90 degrees to about 150 degrees. In some embodiments, a third planar surface is provided that may have about 120 degrees between all surfaces. Specifically, the calibration object 325 includes a three-dimensional tool having a known geometry and one or more calibration patterns 325P provided on each of the surfaces 325A, 325B whose points on the three-dimensional tool are known. Any suitable pattern may be used, such as a checkerboard pattern or one or more geometric objects with identifiable edges. The calibration object 325 may include a central location, designated axis 329, that may be located on the base 331 at the same central location as the center of the holder 122H of the carrier 122, i.e., the central location 329 of the specimen container 102 when held in the holder 122H. In this manner, the center 329 of the calibration object 325 is the same as the center 329 of the holder 122H of the carrier 122, i.e., the central location 329 of the specimen container 102 when held in the holder 122H. The base 331 is located on the cart 324 in a fixed orientation, and thus the calibration object 325 and the base 331 move with the cart 324. The dimensions and location of the calibration pattern 325P are known, as is the spatial relationship of the axis 329 to the base 331. In some embodiments, the V-shaped marker tool has a Hoffman marker thereon that has a known location and geometry relative to center 329 and base 331 , and therefore relative to cart 324 .

[0033] The characterization apparatus 101 further includes a calibration image capture device 328 located at a point adjacent to the track 121, such as a point along a side of the track 121. The calibration image capture device 328 is calibrated by any suitable means to obtain the internal characteristics (e.g., focal length, image center, skew, and lens distortion coefficients) of the image capture device 328, such as standard auto-calibration techniques (e.g., camera calibration techniques). These calibration techniques typically include using a printed flat target of known dimensions (e.g., a Hoffman marker grid or a checkerboard pattern) and utilizing an iterative refinement technique to determine the internal parameters of the image capture device 328. Knowing the internal characteristics of the image capture device 328 is essential for any 3D imaging task, as it enables estimation of the structure of the scene in Euclidean space while overcoming at least some inaccuracies caused by lens distortions (e.g., that may result from imperfect lens manufacturing).

[0034] The calibration image capture device 328 can be any combination of a focus lens system and one or more sensors. For example, the calibration image capture device 328 can be a conventional digital camera (e.g., a color or monochrome camera), or a charge-coupled device (CCD) coupled with any suitable focus lens system, a photodetector array, one or more CMOS sensors, etc. For example, the calibration image capture device 328 can be configured to capture images at a number of different imaging positions along the track 121 (including a first position A and a second position B). The calibration image capture device 328 can be a device capable of capturing digital images (i.e., pixelated images) at a number of different imaging positions. The image resolution of each image can be about 0.5 MP or greater, for example, 0.5 MP to 10 MP. Other pixel resolutions can be used. The calibration image capture device 328 may be a high speed image capture device, and preferably the calibration object 325 is stopped at a first position A and a second position B and the carrier 122 is stopped at an imaging position, but if the speed is high enough the carrier 122 or base 331 and calibration object 325 may remain in motion while images are taken.

[0035] The characterization apparatus 101 further includes a computer 123 connected to the calibration image capture device 328, such as by a USB cable. The computer 123 is configured and operable to cause the calibration image capture device 328 to capture lateral images of the calibration object 325 at multiple imaging locations (A and B) along the track 121. The calibration object 325 can be illuminated as the imaging occurs. For example, the illumination of the calibration object 325 can be by one or more light sources 330A, 330B, such as, for example, a light panel as described in U.S. Patent Application Publication No. 2019 / 0041318 that provides illumination. The light sources can be positioned relative to the calibration object 325 to illuminate their faces 325A, 325B. For example, the light panel can provide front illumination and can be located in front of the calibration object 325, and can include multiple light sources 330A, 330B located on either lateral face of the calibration image capture device 328, for example. Other arrangements and configurations of light sources may be used.

[0036] Specifically, the computer 123 can move the calibration object 325 along the track 121 by a drive signal to the cart 324 to at least two distinct longitudinal points within the imaging area 335 (e.g., a wide-angle visible area), including at least a first longitudinal point A and a second longitudinal point B (shown by dotted lines) as shown in FIG. 3C, where the second longitudinal point B is different from the first longitudinal point A. The computer 123 can cause the calibration image capturing device 328, via an appropriately timed trigger signal, to capture a first image of the calibration object 325 using the calibration image capturing device 328 with the calibration object 325 located at the first longitudinal point A. The computer 123 can further instruct the cart 324 to move the calibration object 325 to a second longitudinal point B, and capture a second image of the calibration object 325 using the calibration image capture device 328 with the calibration object 325 located at the second longitudinal point B. The second longitudinal position B should be far enough away from the first longitudinal position A to obtain a representative and accurate path of movement between those positions when the carrier 122 is carrying a specimen container 102 therein, in front of the position where the 3D center position 350 is desired to be determined later. Furthermore, images can be captured at multiple longitudinal points between the first point A and the second point B for increased accuracy or when the track segments are not linear. For example, a wide-angle lens (35 mm or less) with a short focal length and a wide field of view (e.g., 50 degrees or more) can be used. Other wide angle lenses can be used as long as the calibration object 325 is located within the field of view (view window) of the calibration image capture device 328 .

[0037] According to the method, a three-dimensional path trajectory of a center position 340 along the track 121 is determined based on at least a first image and a second image. The center position 340 can be at any predetermined height on the calibration object 325 and can be determined in association with the imaged positions of two or more calibration patterns 325P. In particular, if the path is other than linear, such as along a curved portion of the track 121, one or more additional images can be taken. Once the internal camera parameters such as focal length, image center, skew, and possibly lens distortion coefficients (if more precise) are calculated, the method can calculate the relative external pose of the 3D center position 350 of the calibration object 325 with respect to the calibration image capture device 328 for at least the first image and the second image. An algorithm such as Perspective-n-Point can be used to calculate the relative external pose of the 3D center position 350 of the calibration object 325 with respect to the calibration image capture device 328 for each image, such as the first image and the second image and any other captured images. Perspective-n-Point is the problem of estimating the pose of a calibrated image capture device (e.g., a camera) given a set of n 3D points in the world and their corresponding 2D projections in an image. The pose of the image capture device 328 consists of six degrees of freedom consisting of the rotation (roll, pitch, and yaw) and 3D translation (X, Y, Z) of the image capture device 328 relative to the world. Given a set of n 3D points in the world reference frame and their corresponding 2D image projections, as well as the intrinsic parameters to be calibrated, the 6DOF pose of the image capture device 328 in the form of its rotation and translation relative to the world can be determined as follows: sp c K[R│T]p w

[0038] Here, p w =[xyz 1] T is a point in the homogeneous world, and p c =[uv 1] Tare the corresponding homogeneous image points, K is the intrinsic parameter matrix of the image capture device 328, where fx and fy are the scaled focal lengths, γ is a skew parameter that is assumed to be zero, (u0,v0) is the principal point, s is the reference scale factor for the image point, and R and T are the calculated desired 3D rotation and 3D translation (extrinsic parameters) of the image capture device. This leads to the following equation for the model:

number

[0039] In some cases, P3P can be used when n=3 points, or EPnP can be used when n>=4 points. RANSAC can be used in case of outliers.

[0040] Now that the three-dimensional path trajectory of the center position 340 along the track 121 has been determined, in the next step, the exact location of the 3D center position 350 of any specimen container 102 parked within the imaging area 335 of the characterization device 101 can be obtained. One particular advantage is that the carrier 122 does not need to be parked exactly in the imaging area 335, since the method can determine the 3D center position 350 anywhere within the imaging area 335 as long as the sides and top of the specimen container 102 can be seen / imaged within that area. The imaging area 335 is the area that can be imaged by the calibration image capture device 328. The imaging area 335 can be at least as tall as the expected specimen container 102 and can be wide-angle as disclosed herein.

[0041] Once the three-dimensional path trajectory of the center position 340 along the track 121 has been determined, a 3D center position 350 of the specimen container 102 is determined at the imaging location in the imaging area 335 where the specimen container 102 was imaged. As shown in Figure 3D, a container image 336 of the specimen container 102 is captured at the imaging location 333 using the calibrated image capture device 328 with the carrier 122 parked in the imaging area 335. As shown in the expanded view, it is not necessary for the carrier 122 to be parked in the exact center of the imaging area 335 to find the 3D center position 350, since any point on the trajectory can be mapped back into the 2D image space. In particular, since the method previously calculated the extrinsic relationship between the track trajectory and the calibrated image capture device 328, we now also have a corresponding 2D trajectory in the image space. Using this method, it is even possible to estimate the 3D center position 350 of the specimen container 102 along a slightly curved track, such as by fitting to a polynomial function rather than a straight line, where three or more imaging positions are used.

[0042] Calculate the center position of the sample container When a specimen container 102 is present in the carrier 122 at the imaging position 333 of the characterization device 101, the method can capture a container image 336 and estimate a 3D center position 350 of the specimen container 102 in a first two dimensions (2D) from the captured container image 336. In image space, the method first calculates the center of the specimen container 102 in the X dimension by determining the positions of a first edge 341 and a second edge 342 in pixel space, such as at the same height as the center position 340. The trajectory of the center point is taken as line 344. The edges 341, 342 can be detected by any edge detection routine, such as a raster scan across the trajectory path 344 that detects abrupt changes in light intensity beyond a pre-set threshold. One or more raster scans above and / or below the trajectory path 344 can be performed to confirm that the edges 341, 342 are indeed edges when abrupt changes in intensity are detected at the same X position in the pixel, such as in the upper and / or lower space. Once the locations of the vertical edges 341 and 342 have been determined, a center point in 2D space (in the XY plane) along the orbital path 344 can be found by adding the two dimensions and dividing by two. The determined 2D centerline is shown as center plane 346. The intersection of the orbital path 344 and center plane 346 contains the 2D center point. The 2D center point can then be mapped into 3D space, i.e., to the closest point on the 3D trajectory (in the Z dimension into and out of the page), to determine a 3D center location 350. The 3D center location of 350 is calculated by using the 2D image coordinates from the imaging of the specimen container 102 and projecting it into the Z dimension using the internal parameters of the calibrated image capture device 328. The idea about this is to draw a line from the center of the image capture device 328 through 350 (in 3D Euclidean space) to infinity and find the closest point on the 3D trajectory of 340 (i.e., 344 in 3D Euclidean space) that intersects it. If there is no intersection point, then one can select a point on 344 (in 3D Euclidean space) that minimizes the distance to the Z projection of the 3D center position 350. That point on the trajectory path 344 is the 3D center position 350 of the specimen container 102.As a result, the robot 126 can accurately recognize the 3D center position 350 of the specimen container 102, which is used to load the specimen container 102 into the centrifuge of the centrifuge station 125 and to lift the specimen container 102 back into the carrier 122 after separation.

[0043] After fractionation by the centrifuge, the specimen 212 may include a serum or plasma portion 212SP, a precipitated blood portion 212SB, contained within a tube 213, as best shown in FIG. 2. Air 217 may be above the serum and plasma portions 212SP, and the line or boundary between the air 217 and the serum or plasma portion 212SP is defined herein as the liquid-air interface (LA). The boundary line between the serum or plasma portion 212SP and the precipitated blood portion 212SB is defined herein as the serum-blood interface (SB). The interface between the air 217 and the cap 214 is referred to herein as the tube-cap interface (TC). The tube height (HT) is defined as the height from the physical bottom of the tube 213 to the bottom of the cap 214. The height of the serum or plasma portion 212SP (HSP) is defined as the height from the top of the precipitated blood portion 212SB to the top of the serum or plasma portion 212SP, i.e., from SB to LA. The height of the precipitated blood portion 212SB (HSB) is defined as the height from the bottom of the precipitated blood portion 212SB to the top of the precipitated blood portion 212SB. In embodiments where a gel separator is used, there is an interface between the serum or plasma portion 212SP and the gel separator. Similarly, there is an interface between the precipitated blood portion 212SB and the gel separator. HTOT is the sum of HSB and HSP. W is the width of the tube 213. In some embodiments, the size of the specimen container 102 can be represented by a combination of the width W and the height HT.

[0044] As previously indicated, the carrier 122 can be moved to the quality inspection module 130. Optionally, centrifugation can precede and the specimen 212 contained in the specimen container 102 can be loaded directly to the quality inspection module 130 located in a loading area 105, e.g., part of an input lane. The quality inspection module 130 is configured and adapted to automatically determine / characterize physical attributes of the specimen container 102 containing the specimen 212 to be processed by the specimen testing device 100. Characterization can include characterizing the tube size, cap type, and / or cap color. Once characterized, the specimen 212 can be further characterized to determine the depth and / or volume of the specimen 212 screened for the presence of one or more artifacts, such as hemolysis, icterus, or lipemia (HIL), and / or blood clots, bubbles, or foam. If found to be free of HIL and / or artifacts, the specimens 212 can continue on the track 121 and then be analyzed in one or more analyzers (e.g., the first, second, and third analyzers 106, 108, and / or 110) before each specimen container 102 is returned to the loading area 105 for unloading.

[0045] In some embodiments, quantification of the physical attributes of the specimen container 102 may occur in the quality inspection module 130 (i.e., determining the height HT, width W, cap color, cap type, and / or tube type). In some embodiments, quantification of the specimen 212 may also occur in the quality inspection module 130 and may include determining the HSB, HSP, HTOT, and may determine the longitudinal positions of the SB and LA.

[0046] The specimen testing instrument 100 may include a number of sensors 116 at one or more locations around the track 121. The sensors 116 may be used to sense the location of the specimen containers 102 along the track 121 by reading identification information 215 (FIG. 2) or similar information (not shown), such as a bar code, placed on a label 218 provided on each carrier 122. Other means for tracking the location of the carriers 122 may be used. All of the sensors 116 are interfaced with a computer 123 so that the location of each specimen container 102 and specimen 212 is known at all times. The computer 123 may interface with and communicate with a laboratory information system (LIS) 147 in a known manner to provide test results and status information to requesters.

[0047] The embodiments of the present disclosure may be implemented using a computer interface module (CIM) 145 that provides a user with easy and quick access to various control and status display screens. These control and status screens may describe some or all aspects of multiple interrelated automated devices used to prepare and analyze the specimens 212. The CIM 145 may be employed to provide the status of operation of multiple interrelated automated devices, as well as information describing the location of any specimens 212, and the status of any screening or testing that is planned or being performed on the specimens 212. The CIM 145 may be adapted to facilitate operator interaction with the analyte tester 100. The CIM 145 may include a display screen adapted to display menus including icons, scroll bars, boxes, and buttons through which the operator may interface with the analyte tester 100. The menus may include a number of function buttons programmed to display functional aspects of the analyte tester 100.

[0048] 4A-4B, an embodiment of a quality check module 430 is shown and described. The quality check module 430 can be configured and applied to automatically characterize the physical structure (e.g., size) of the specimen container 102 as shown. The characterization method can be performed by the quality check module 430 before being automatically processed by one or more analyzers 106, 108, 110. In this manner, the size (e.g., width W and height HT) of the specimen container 102 is known for any subsequent processing. The quality check module 430 can also be used to quantify the specimen container 102, i.e., to quantify certain physical dimensional features of the specimen container 102, such as the TC, HT position, and / or W of the specimen container 102, and / or the color and / or type of the cap 214.

[0049] In addition to specimen container quantification, other sensing methods may be performed on the specimen 212 contained in the specimen container 102 in the quality testing module 430. For example, the quality testing module 430 may be used to quantify the specimen 212, i.e., determine certain physical dimensional characteristics of the specimen 212 (e.g., physical location of LA, SB, and / or determination of HSP, HSB, and / or HTOT, and / or volume of serum or plasma portion and / or volume of precipitated blood portion).

[0050] 4A and 4B, an inexpensive form of quality inspection module 430 may include a single (only) calibrated image capture device 328 (e.g., a single conventional digital camera, such as a color or monochrome camera) or a lens system connected to a charge-coupled device (CCD), photodetector array, CMOS sensor, or the like. For example, the single calibrated image capture device 328 may be configured to capture images of the specimen container 102 and specimen 212 at an imaging position 333 from a single viewpoint. In this embodiment, the specimen container 102 may be positioned in a rotational orientation to allow a clear image of the specimen 212, such as by a user or robot determining an unobstructed orientation (one that is not obstructed by the label 218) and then inserting the specimen container into the carrier 122 in that orientation.

[0051] This embodiment of the quality inspection module 430, including a single image capture device 328, can be used to determine the geometric attributes (e.g., width W and height HT) of the specimen container 102 as well as to perform pre-screening for HIL, such as that described in U.S. Patent No. 10,816,538 to Kluckner et al., entitled "Methods and Apparatus for Detecting an Interferent in a Specimen," and / or to perform pre-screening for the presence of artifacts, such as that described in U.S. Patent No. 10,746,665 to Kluckner et al., entitled "Methods and Apparatus for Classifying an Artifact in a Specimen." For example, backlighting using a backlight source 400C, such as a panel light source, can be used to perform HIL pre-screening.

[0052] In one or more embodiments, the characterization method for determining the 3D center location 350 can be performed using the characterization apparatus 101 as a subcomponent of the quality check module 430. The characterization apparatus 101 includes one or more light sources 300A, 300B, a calibration image capture device 328, and a calibration object 325 as previously described in FIG. 3B, and the characterization apparatus 101 and the characterization method can be performed within the quality check module 430. Knowledge of the 3D center location 350 at the imaging location 333 can be used as a rough estimate of the 3D center location elsewhere along the track 121, at least on any linear segment thereof. If a finer determination of the 3D center location at another location is desired, the characterization apparatus 101 and the characterization method can be performed at that location.

[0053] In operation, each of the front-lit and back-lit images captured by the quality inspection module 430 can be triggered and captured in response to a trigger signal. The trigger signal can be generated by the computer 123 and provided to a communication line connected to the computer 123. Each of the captured images can be processed according to one or more embodiments of the characterization method provided herein. In particular, image processing can be used to determine the width W, height HT. Additionally, the cap color and cap type can be determined using known methods. Furthermore, pre-screening for the presence of HIL and / or artifacts can be determined using back-lit images, such as by backlighting using the light source 400C.

[0054] To improve discrimination, more than one wavelength spectrum can be used. In that case, a multispectral image can be captured by the image capture device 328. Each color spectrum image (represented by a nominal wavelength with a relatively narrow wavelength band) is captured sequentially with one or more exposures (e.g., 4-8 or more exposures). Each exposure can be of different duration. The spectrum images can be taken in any order, such as multiple exposures of red, multiple exposures of green, and multiple exposures of blue. For the detection method, a transmittance image can be calculated, and each transmittance image (for each of the R, G, and B illumination) can be calculated from the optimal exposure image. The optimal exposure images can be normalized by their respective per-pixel intensities.

[0055] In one or more embodiments, the characterization device 101 and the quality inspection module 430 can include a housing 345 that at least partially surrounds or covers the track 121 and can provide a closed or semi-closed environment for image capture, such as by minimizing the effects of external lighting. The specimen containers 102 are located inside the housing 345 during capture of each image. The housing 345 can include one or more doors that allow the carriers 122 to enter and / or exit the housing 345. In some embodiments, the roof can include an opening that allows the specimen containers 102 to be loaded from above into the carriers 122 stationary within the housing 345 by a robot (e.g., robot 124) that includes a movable robotic gripper, such as when the characterization device 101 and / or the quality inspection module 430 are located in the loading area 105. When front lighting and not back lighting is used (eg, FIGS. 3A-3C), the characterization device 101 can include a backflow prevention wall in the housing 345 to improve image contrast.

[0056] FIG. 5 illustrates a functional diagram 500 of a characterization apparatus and method, in which characterization of a specimen container 102 containing a specimen 212 is just one of many items that can be characterized or classified by a broader method using a quality inspection module 430. According to one or more embodiments of the method, an image is captured by a calibrated image capture device 328 (e.g., a calibrated monochrome camera), or the like. The image captured by the image capture device 328 can be a multispectral image and / or a multiple exposure image, as discussed above. In particular, multiple exposures (e.g., 4-8 or more exposures) can be made for each wavelength of light used for illumination (e.g., R, G, and B). Front-illuminated images can be captured (acquired) using front-light sources 300A, 300B, and back-illuminated images can be acquired using a back-light source 400C, as described in FIGS. 4A-4B. Optionally, front-illuminated multiple exposure images can be acquired using a white light source and a color camera.

[0057] The image can then be further processed to determine segmentation 550 in the manner described in U.S. Patent No. 10,816,538 to Kluckner et al., entitled "Methods And Apparatus For Detecting An Interferent In A Specimen," and U.S. Patent Application Publication No. 2019 / 0041318 to Wissmann et al., entitled "Methods And Apparatus For Imaging A Specimen Container Using Multiple Exposures." Other suitable segmentation methods based on artificial intelligence, such as convolutional neural networks (CNNs), can be used. In some embodiments, images from front illumination are best used for segmentation 550. Similarly, images captured using back illumination are best used for HILN classification 552 and / or artifact detection 556, using the methods previously described.

[0058] Liquid quantification 554 may also be performed following segmentation 550. Quantifying the liquid may include determining the physical location of the LA, SB, and / or HSP, HSB, and / or HTOT, and / or determining certain physical dimensional characteristics of the specimen 212, such as the volume of the serum or plasma portion and / or the volume of the precipitated blood portion. Identification may be performed by selecting pixels in those boundary regions and averaging their position values ​​in pixel space to obtain values ​​for the LA and SB. From that information, the volume of the serum or plasma portion 212SP may be determined using the width W and cross-sectional shape of the specimen container 102. Correlation from pixel space to mechanical measurements may be performed by calibrating the pixels in pixel space to mm of mechanical space using any suitable calibration method.

[0059] Further characterization of the specimen container 102 may also be performed according to a characterization method such as determining the 3D center position 350. As discussed above, the 3D path trajectory is first determined using 3D path trajectory determination 551, followed by determining the 3D center position 350 in 3D center position determination block 553. Tube type detection 558, cap type detection 560, and cap color detection 562 may be performed based on processing of images from the image capture device 328 using conventional methods.

[0060] 6 illustrates a flowchart of a characterization method 600 for determining a position (3D center position 350) of a specimen container (e.g., specimen container 102) at an imaging position on a track (e.g., track 121) in accordance with one or more embodiments. The method 600 includes providing a calibration object (e.g., calibration object 235) on the track at block 602 and providing an initial calibration image capture device (e.g., calibration image capture device 328) adjacent to the track at block 604. Calibration of the initial calibration image capture device 328 may be performed by any suitable method, such as using a marker grid of known dimensions (e.g., checkerboard or Hoffman markers) and using non-linear refinement techniques to optimize internal parameters such as focal length, image center, skew, and distortion coefficients.

[0061] The method 600 further includes moving the calibration object to at least two different longitudinal points along the track 121, including a first longitudinal point (e.g., longitudinal point A in FIG. 3B ) and a second longitudinal point different from the first longitudinal point (e.g., longitudinal point B in FIG. 3B ), at block 606, capturing a first image using a calibration image capture device with the calibration object 325 located at the first longitudinal point A, at block 608, and capturing a second image using the image capture device with the calibration object 325 located at the second longitudinal point B, at block 610. Once the images are acquired, the method 600 includes determining a three-dimensional path trajectory 344 of a center position along the track (a segment of the track 121 within the imaging area 335) based on at least the first image and the second image, at block 612.

[0062] Once the three-dimensional path trajectory (3D path trajectory 344) is known within the imaging area 335, it can be used to determine the 3D center position (e.g., 3D center position 350) of any specimen container 102 brought into the imaging area on the carrier 122.

[0063] As shown in FIG. 7, a flow chart of a method 700 for determining a 3D center position (e.g., 3D center position 350) of a specimen container (e.g., specimen container 102) on a track (e.g., track 121) according to one or more embodiments is presented. The method 700 includes, in block 702, moving a specimen container (e.g., specimen container 102) carried by a carrier (e.g., carrier 122) on a track (e.g., track 121) to an imaging area (e.g., imaging area 335). No precise position is required for imaging in the imaging area 335. Preferably, the specimen container 102 can be stopped in the imaging area 335 for imaging, but if the image capture speed is sufficient, the specimen container 102 may not need to be stopped there. Next, in block 704, the method includes imaging the specimen container (e.g., specimen container 102) in the imaging area (e.g., imaging area 335) to obtain a container image (e.g., container image 336). The method 700 further includes detecting a midplane (e.g., midplane 346), such as by detecting lateral edges (e.g., edges 341, 342) of a specimen container (e.g., specimen container 102) in a container image (e.g., container image 336) at block 706 and determining a midplane (e.g., midplane 346) between the edges at block 708. Finally, the method 700 operates to backproject the midplane to detect the intersection of the midplane 346 and the three-dimensional path trajectory 344 (e.g., from method 600 described above), which is the 3D center location 350 of the specimen container 102 at the point of the midplane 346.

[0064] As part of the edge detection block 706, the method 700 may include identifying the width W of the specimen container 102. The pixel width may simply be converted to a distance in mm based on the calibration of the image capture device 328. The height HT of the specimen container 102 may be determined using a similar edge detection routine to determine the top of the tube 213 at TC. Edge detection may be performed by segmentation or alternatively by looking for a change in light intensity above a threshold within an area in the imaging field 335 where the tube-cap interface TC may be expected to be located.

[0065] In some embodiments, the volume of the specimen 212 can be obtained when the specimen container 102 is given a size characterization, such as a width W and height HT. The inner width can be determined by using a look-up table or the like based on the size of the specimen container 102. The inner width can be used to accurately calculate the volume of the serum or plasma portion 212SP and / or the volume of the precipitated blood portion 212SB, for example, based on the positions of the serum-blood interface SB and the liquid-air interface LA obtained from the segmentation.

[0066] In view of the foregoing, it should therefore be apparent that the characterization method 600, 700 performed by the characterization device 101, which may be included in the quality inspection module 130, 430 or may be a stand-alone characterization device 101, can rapidly characterize the 3D trajectory path 344 and 3D center position 350 of the specimen container 102. Physical attributes of the specimen container 102, such as tube size (W and HT), cap type, and cap color, can also be obtained using the characterization device 101. In some embodiments including backlighting, such as shown in Figures 4A-4B, HIL detection and / or artifact detection can also be performed.

[0067] While the disclosure is susceptible to various modifications and alternative forms, specific apparatus embodiments and methods have been shown by way of example in the drawings and are described herein. However, it is to be understood that there is no intention to limit the disclosure to the particular apparatus or methods disclosed, but on the contrary, the invention includes all modifications, equivalents, and alternatives coming within the scope of the claims and equivalents thereof.

Claims

1. 1. A method for determining a location of a specimen container on a track, comprising: Providing a calibration object on the track; Providing an initial calibration image capture device adjacent to the track; moving the calibration object to at least two different longitudinal points along the track, including a first longitudinal point and a second longitudinal point different from the first longitudinal point; capturing a first image using an initial calibration image capture device with the calibration object located at a first longitudinal point; capturing a second image using the initial calibration image capture device with the calibration object located at a second longitudinal point; determining a three-dimensional path trajectory of a center position along the track based on at least the first image and the second image; moving a specimen container carried by a carrier on a track to an imaging region; imaging a specimen container within an imaging region to obtain a container image; detecting lateral edges of a specimen container within the container image; determining a midplane between the lateral edges; back-projecting the center plane to find an intersection of the center plane with the three-dimensional path trajectory, the intersection being the three-dimensional center of the specimen container at the point of the center plane; The method comprising:

2. The method of claim 1 , further comprising parking the specimen container on the track within the imaging area during imaging.

3. The method of claim 1 , comprising determining a width W of a specimen container.

4. The method of claim 1 , further comprising determining a height HT of the specimen container.

5. The method of claim 1 , wherein the calibration object comprises a three-dimensional tool of known geometry and one or more calibration patterns provided thereon.

6. The method of claim 1 , wherein the calibration object comprises a V-shaped marker tool including at least two flat surfaces.

7. The method of claim 6 , wherein the V-shaped marker tool includes a Hoffman marker thereon.

8. The method of claim 1 , comprising calculating a relative external pose of a three-dimensional center of the calibration object with respect to the initial calibration image capture device for at least the first image and the second image.

9. The method of claim 8 , wherein computing the relative external pose is performed using Perspective-n-Point.

10. 10. The method of claim 1, comprising capturing one or more additional images using the initial calibration image capture device with the specimen container positioned at one or more additional longitudinal points along the track.

11. 1. A characterization apparatus comprising: a calibration object movable on a track; an initial calibration image capture device located adjacent to the truck; a computer connected to the initial calibration image capture device; the computer comprising: moving the calibration object to at least two different longitudinal points along the track, including a first longitudinal point and a second longitudinal point different from the first longitudinal point; capturing a first image using an initial calibration image capture device with the calibration object located at a first longitudinal point; capturing a second image using the initial calibration image capture device with the calibration object located at a second longitudinal point; determining a three-dimensional path trajectory of a center position along the track based on at least the first image and the second image; moving a specimen container carried by a carrier on a track to an imaging region; imaging a specimen container within an imaging region to obtain a container image; detecting lateral edges of a specimen container within the container image; determining a midplane between the lateral edges; back-projecting the center plane to find an intersection of the center plane with the three-dimensional path trajectory, the intersection being the three-dimensional center of the specimen container at the point of the center plane; The characterization apparatus is configured and operable to cause.

12. 12. The characterization device of claim 11, located adjacent to one or more of an analyzer, a loading station, a centrifuge station, a quality control module, and an aliquotter station.

13. 12. The characterization device of claim 11, comprising one or more light sources configured to illuminate a front surface of the specimen container during imaging.

14. The characterization apparatus of claim 11 , wherein the calibration object comprises a three-dimensional tool of known geometry and one or more calibration patterns provided thereon.

15. The calibration object includes a V-shaped marker tool including at least two flat surfaces.

15. The characterization apparatus according to claim 14.

16. The characterization device of claim 15 , wherein the V-shaped marker tool includes a Hoffman marker thereon.

17. The characterization apparatus of claim 11 , wherein the initial calibration image capture device is an RGB camera of a quality inspection module.

18. 1. An analyte testing device comprising: Trucks and; a sample carrier movable on the track, the sample carrier being configured to carry a sample container; one or more characterization devices disposed about the track; wherein each of the one or more characterization devices comprises: a calibration image capture device adjacent to the track; a computer connected to the calibration image capture device; The computer includes: determining a three-dimensional path trajectory of a center position along a segment of the track based on at least a first image and a second image of the calibration object taken in the imaging region; moving a specimen container carried by a carrier on the track to an imaging region; taking an image of the specimen container within the imaging area to obtain a container image; Determining a center plane between lateral edges of the specimen container; Back-project the center plane to find the intersection of the center plane with the 3D path trajectory, which is the 3D center of the specimen container at the point of the center plane. The specimen testing device is configured as follows.

Images