Site-specific adaptation of automated diagnostic analysis systems.

Abstract

A method for characterizing a sample container or biological sample in an automated diagnostic analytical system using an artificial intelligence (AI) algorithm includes retraining the AI ​​algorithm in response to a characterization confidence level determined to be insufficient. The AI ​​algorithm is retrained using data (including image data and / or non-image data) having characteristics that are prevalent in the location where the automated diagnostic analytical system is operated that were not sufficiently or at all included in the training data used to initially train the AI ​​algorithm. Systems for characterizing a sample container or biological sample using an AI algorithm are also provided, 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 / 219,342, filed July 7, 2021, entitled "SITE-SPECIFIC ADAPTATION OF AUTOMATED DIAGNOSTIC ANALYSIS SYSTEMS," the disclosure of which is incorporated herein by reference in its entirety for all purposes.

[0002] The present disclosure relates to automated diagnostic analysis systems. [Background technology]

[0003] In medical testing, automated diagnostic analysis systems can be used to analyze biological samples to identify analytes or other components contained in the samples. Biological samples can be, for example, urine, whole blood, serum, plasma, interstitial fluid, cerebrospinal fluid, etc. Such samples are typically contained in sample containers (also called collection tubes, test tubes, vials, etc.). Sample containers are transported between various imaging, processing, and analyzer stations within the automated diagnostic analysis system via container carriers on automated tracks.

[0004] Automated diagnostic analysis systems typically include sample pretreatment or prescreening procedures to "characterize" various features of the sample container and / or the sample therein. Characterization (e.g., feature identification or classification) is performed by artificial intelligence (AI) algorithms running on the system controller, processor, or similar device of the automated diagnostic analysis system. The AI algorithm may perform "segmentation," in which various regions of the sample container and / or the sample therein are identified and / or classified. Sample characterization using an AI algorithm may also perform a HILN determination. The HILN determination identifies whether interferents, such as hemolysis (H), icterus (I), and / or lipemia (L), that may adversely affect test results are present in the sample being analyzed, or whether the sample is normal (N) and can be further processed. If an interferent is present, the degree of the interferent is also classified by the AI algorithm.

[0005] Characterization is typically performed using imaging data of the sample container and the sample therein, which can be first captured by an imaging station in an automated diagnostic analysis system and then analyzed using AI algorithms.

[0006] Before an AI algorithm is used for characterization, it is "trained" to characterize features that are likely to be present in the imaged specimen data. Training is performed by providing the AI algorithm with training data (e.g., imaged specimen data) that has annotated (identified) features. This training data is called "ground truth."

[0007] To ensure that automated diagnostic analysis systems perform consistently wherever they are deployed, AI algorithms are trained using a standard set of training data that includes a sampling of common features that the AI algorithms will characterize.

[0008] However, AI algorithms may be unable or unlikely to accurately characterize certain features or certain variations of features that may not be included in the training data used to train the AI algorithm. Summary of the Invention [Problem to be solved by the invention]

[0009] Therefore, improvements in the training of AI algorithms for use in automated diagnostic analysis systems are desirable. [Means for solving the problem]

[0010] In some embodiments, a method for characterizing a sample container or sample in an automated diagnostic analysis system is provided. The method includes capturing an image of a sample container containing the sample using an imaging device, characterizing the image using a first artificial intelligence (AI) algorithm executing on a system controller of the automated diagnostic analysis system, determining a characterization confidence level of the image using the system controller, and triggering retraining of the first AI algorithm using retraining data in response to determining that the characterization confidence level is below a preselected threshold. The triggering is initiated by the system controller, and the retraining data includes image data or non-image data captured by the imaging device that includes features prevalent in the current location of the automated diagnostic analysis system that were not sufficiently or completely included in the training data used to initially train the first AI algorithm.

[0011] In some embodiments, an automated diagnostic analysis system is provided that includes an imaging device configured to capture images of sample containers containing samples and a system controller coupled to the imaging device. The system controller is configured to: characterize the images captured by the imaging device using a first artificial intelligence (AI) algorithm executing on the system controller; determine a characterization confidence level for the images using the system controller; and trigger retraining of the first AI algorithm in response to determining that the characterization confidence level is below a preselected threshold. The retraining is performed by the system controller using retraining data that includes image data or non-image data captured by the imaging device that includes features commonly recognized at the current location of the automated diagnostic analysis system that were not sufficiently or completely included in the training data used to initially train the first AI algorithm.

[0012] In some embodiments, a method for characterizing a sample container or sample in an automated diagnostic analytical system is provided. The method includes capturing data representing a sample container containing the sample using one or more optical, acoustic, humidity, liquid level, vibration, weight, photometric, thermal, temperature, current, or voltage sensing devices; characterizing the data using a first artificial intelligence (AI) algorithm running on a system controller of the automated diagnostic analytical system; determining a characterization confidence level for the data using the system controller; and triggering retraining of the first AI algorithm using retraining data in response to determining that the characterization confidence level is below a preselected threshold. The triggering is initiated by the system controller, and the retraining data includes features prevalent in the current location of the automated diagnostic analytical system that were not sufficiently or completely included in the training data used to initially train the first AI algorithm.

[0013] Further aspects, features, and advantages of the present disclosure will be readily apparent from the following detailed description and illustrations of several exemplary embodiments and implementations, including the best mode contemplated for carrying out the invention. The present disclosure is also capable of other different embodiments, and its several details may be modified in various respects, all without departing from the scope of the present invention. For example, while the following description is directed to AI algorithms used to pre-process / pre-screen sample containers and samples therein based on imaging data, the methods and systems described herein are readily applied to AI algorithms for analyzing measurements based on sensor, text, and / or other non-image data, and / or for other uses, where the original training data does not adequately include features, conditions, and constraints prevalent in the location where the AI algorithm is run.

[0014] This disclosure is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the appended claims (see further below).

[0015] The drawings described below are provided for illustrative purposes and are not necessarily drawn to scale. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature and not as restrictive. The drawings are not intended to limit the scope of the invention in any way. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a top-view schematic diagram of an automated diagnostic analysis system configured to perform pre-treatment / pre-screening characterization and one or more biological sample analyses according to embodiments provided herein. FIG. [Figure 2A] FIG. 1 is a side elevation view of a sample container containing a separated sample containing a serum or plasma portion that may contain interferents, according to embodiments provided herein. [Figure 2B]2B is a side view of the sample container of FIG. 2A held in an upright orientation in a transportable holder within the automated diagnostic analyzer system of FIG. 1 according to embodiments provided herein. [Figure 3] FIG. 2 is a block diagram of a computer for use with the automated diagnostic analysis system of FIG. 1 according to embodiments provided herein. [Figure 4] 2 is a flowchart of a method for characterizing a sample container and / or a sample in the automated diagnostic analysis system of FIG. 1 according to embodiments provided herein. [Figure 5] FIG. 2 is a schematic top view of a quality inspection station of the automated diagnostic analysis system of FIG. 1 (with the chamber top removed for clarity) configured to capture images according to embodiments provided herein. [Figure 6] FIG. 2 is a block diagram of a pre-screening characterization architecture including an AI algorithm configured to perform segmentation and interferent determination of a sample container and / or the sample contained therein in the automated diagnostic analysis system of FIG. 1 according to embodiments provided herein. DETAILED DESCRIPTION OF THE INVENTION

[0017] The automated diagnostic analytical systems described herein perform pretreatment / prescreening characterization of sample containers and the biological samples contained therein to facilitate automated container handling, prepare the samples for analysis, and determine the sample's suitability for one or more biological analyses performed by the automated diagnostic analytical system. Characterization may include identifying and / or classifying recognizable features in captured images of the sample container and the biological sample contained therein. Note that in alternative embodiments, non-image data (e.g., from one or more sensors, such as, for example, temperature, acoustic, humidity, liquid level, weight, vibration, current, and / or voltage sensors) and / or text data are used as input instead of or in addition to the captured images. Sample container characterization may indicate, for example, the size and type of container, the liquid level or volume within the container, whether the container has a cap, and, if so, what type of cap it has. This information can be used to program the automated diagnostic analytical system's robotic container handler to facilitate transport and positioning of sample containers and the aspiration of samples from the sample containers. Characterization of a biological sample can, for example, determine the presence and / or extent of interferents (e.g., hemolysis, icterus, and / or lipemia) and therefore determine whether the biological sample is sufficient / acceptable for further processing and analysis.

[0018] The pre-processing / pre-screening characterization is performed using an artificial intelligence (AI) algorithm running on a computer (e.g., a system controller, processor, or similar device) of the automated diagnostic analysis system. The AI algorithm may be any suitable machine learning software application capable of "learning" (i.e., reprogramming itself) as it processes more data. The AI algorithm may be trained using training data to characterize expected or common features. The training data may include images of the features to be characterized. In some embodiments, a large training dataset of images of the features to be characterized may be captured by one or more imaging devices (e.g., cameras, etc.) in various views and / or lighting conditions. In some embodiments, the training data may additionally or alternatively include non-image data.

[0019] After pretreatment / prescreening, the sample container and the biological sample contained therein are transported to an appropriate analyzer station of the automated diagnostic analysis system, where the sample is combined with one or more reagents and / or other substances in a reaction vessel. An analytical measurement is then performed using a photometric or other analytical technique. In some embodiments, the analytical measurement can be analyzed using an appropriately trained AI algorithm to determine the amount of an analyte or other component in the sample and / or identify one or more disease states. While the following disclosure is primarily described with respect to AI algorithms used for pretreatment / prescreening characterization, the methods and systems for retraining AI algorithms based on location-specific (current location) features disclosed herein also apply to AI algorithms used for other purposes, such as analyzing sample measurement results.

[0020] To monitor the performance of an automated diagnostic analysis system, and particularly an AI algorithm used therein, a "confidence" level is routinely or continuously determined (by the AI algorithm itself and / or) by (one or more other algorithms or programs of) the automated diagnostic analysis system, according to one or more embodiments. The determined confidence level indicates the likelihood that the characterization and / or analysis performed by the AI algorithm is accurate and / or correct. In some embodiments, the determined confidence level can be in the form of a value (e.g., 1 to 100, or 0.0 to 1.0) or a percentage (0% to 100%). Other suitable measures of confidence can be used. A low confidence level below a predetermined threshold may indicate that the AI algorithm is poorly trained.

[0021] For example, a low characterization confidence level may occur when operating an automated diagnostic analysis system in a current location (including a particular geographic region) or in a particular manner (e.g., performing a particular type of diagnostic analysis associated with a particular geographic region) and a particular feature or feature variation is unique or more prevalent than the features included in the training data used to initially train the AI algorithm of the automated diagnostic analysis system. A low characterization confidence level may also occur after operating the automated diagnostic analysis system for a period of time when new or different types of sample containers may begin to be used and / or new or different characteristics of biological samples may emerge, for example, due to seasonal or regional disease outbreaks.

[0022] If a low confidence level is determined, it may be desirable to retrain the AI algorithm. The process of retraining an AI algorithm in traditional systems can be relatively cumbersome and labor-intensive. For example, in some traditional systems, a flaw in the AI algorithm is not identified until the system malfunctions (e.g., the confidence level is not determined during routine operation). Troubleshooting an inaccurate test result can be manual, time-consuming, and costly, especially if the system is taken offline due to a malfunction. When the cause is identified as a flaw in the AI algorithm, retraining data is collected (again, typically manually) and sent to the diagnostic system manufacturer's engineering team. The AI algorithm is then retrained at the manufacturer and shipped back to be re-installed in the system at the user's location. Clearly, the traditional retraining process can be very expensive and time-consuming.

[0023] According to one or more embodiments, improved automated diagnostic analysis systems and methods for characterizing sample containers or samples in an automated diagnostic analysis system are described in more detail below with reference to Figures 1-6. The improved systems and methods may include monitoring AI algorithm performance, collecting and annotating location-specific data for retraining, and / or retraining AI algorithms at the location (current location) where the automated diagnostic analysis system is operated.

[0024] 1 illustrates an automated diagnostic analysis system 100 according to one or more embodiments. The automated diagnostic analysis system 100 is configured to automatically characterize, process, and / or analyze biological samples contained in sample containers 102. The sample containers 102 are received by the system 100 in one or more racks 104 located in an input area 106 and then transported to a quality inspection station 107 where they are characterized and analyzed in one or more analyzer stations 108A-108D of the system 100.

[0025] At least one of the analyzer stations 108A-108D (e.g., analyzer station 108D) can perform pre-processing, such as by including a centrifuge for separating various components of the biological sample and / or a decapper for removing caps from sample containers 102. One or more of the analyzer stations 108A-108D can include one or more clinical chemistry analyzers, assay instruments, and / or the like, used to chemically analyze or assay the presence, quantity, or functional activity of target entities (analytes), such as DNA or RNA. Analytes typically tested in clinical chemistry analyzers include chemical entities such as metabolites, antibodies, enzymes, hormones, lipids, substrates, electrolytes, certain proteins, drugs of abuse, and therapeutic drugs. System 100 can use more or fewer analyzer stations 108A-108D.

[0026] A robotic container handler 110 is provided in the loading area 106 and is capable of grabbing a sample container 102 from one or more racks 104 and transferring the sample container 102 to a container carrier 112 located on a track 114, via which the sample container 102 is transported throughout the system 100.

[0027] The sample container 102 may be any suitable container, including a transparent or translucent container such as a blood collection tube, test tube, sample cup, cuvette, or other container that can accommodate and image a biological sample contained therein. The sample containers 102 can vary in size and can have different types of caps and / or cap (indicator) colors.

[0028] 2A and 2B illustrate embodiments of a sample container and a biological sample therein. Sample container 202 can represent sample container 102 (FIG. 1), and biological sample 216 can represent the sample in sample container 102. Sample container 202 can include tubing 218 and is capped with cap 220. The caps for different sample containers can be of different types and / or colors (e.g., red, royal blue, light blue, green, gray, brown, yellow, or a combination of colors), which can indicate, for example, the particular test for which sample container 202 is used, the type of additive contained therein, whether the sample container contains a gel separator, etc. In some embodiments, the type of cap is identified by characterization of sample container 202, as described further below.

[0029] The sample container 202 can include at least one label 222 that can include identifying information 222I (i.e., indicia), such as a bar code, letters, numbers, or a combination thereof. The identifying information 222I can include or be associated with patient information via a laboratory information system database (e.g., the LIS 124 of FIG. 1). The database can include patient information (referred to as text data) such as the patient's name, date of birth, address, health condition or disease, and / or other personal information described herein. The database can also include other text data, such as tests performed on the sample 216, the date and time the sample 216 was obtained, medical facility information, and / or tracking and routing information.

[0030] The identification information 222I may be machine-readable and may be a darker color (e.g., black) than the label material (e.g., white paper) so that the identification information 222I can be easily imaged or scanned. The identification information 222I may indicate or otherwise correlate via an LIS or other test ordering system with the patient's identity as well as the test to be performed on the sample 216. The identification information 222I may be provided on a label 222 that is adhered or otherwise provided to the exterior surface of the tube 218. In some embodiments, the label 222 may not extend around the entire circumference of the sample container 202 or along the entire length / height of the sample container 202.

[0031] The sample 216 may include a serum or plasma portion 216SP and a sedimented blood portion 216SB contained within a tube 218. A gel separating agent 216G is disposed between the serum or plasma portion 216SP and the sedimented blood portion 216SB. Air 226 may be present above the serum or plasma portion 216SP. The boundary between the serum or plasma portion 216SP and the air 226 is defined as a liquid-air interface LA. The boundary between the serum or plasma portion 216SP and the gel separating agent is defined as a serum-gel interface SG. The boundary between the sedimented blood portion 216SB and the gel separating agent 216G is defined as a blood-gel interface BG. The interface between the air 226 and the cap 220 is defined as a tube-cap interface TC.

[0032] The tube height HT is defined as the height from the bottom of the tube 218 to the bottom of the cap 220 and is used to determine tube size (e.g., tube height and / or tube volume). The height of the serum or plasma portion 216SP is HSP, which is defined as the height from the top of the serum or plasma portion 216SP at LA to the top of the gel separating agent 216G at SG. The height of the gel separating agent 216G is HG, which is defined as the height between SG and BG. The height of the settled blood portion 216SB is HSB, which is defined as the height from the bottom of the gel separating agent 216G at BG to the bottom of the settled blood portion 216SB. HTOT is the total height of the sample 216 and is equal to the sum of HSP, HG, and HSB. The width of the inner cylindrical portion of the tube 218 is W. An AI algorithm (described below) may determine one or more of the above dimensions as part of the segmentation characterization performed in the quality inspection station 107 of the automated diagnostic analysis system 100.

[0033] 2B shows sample containers 202 positioned on a carrier 214. Carrier 214 may represent carrier 112 of FIG. 1. Carrier 214 may include a holder 214H configured to hold sample containers 202 in a defined upright position and orientation. Holder 214H may include multiple fingers or leaf springs that secure sample containers 202 to carrier 214, some of which may be movable or flexible to accommodate different sizes (widths) of sample containers 202. In some embodiments, carrier 214 is transported from input area 106 of FIG. 1 after being removed from one of racks 104 by robotic container handler 110.

[0034] Returning to FIG. 1 , the automated diagnostic analysis system 100 may include a computer 128 or may be configured to remotely communicate with an external computer 128. The computer 128 may be, for example, a system controller or the like and may have a microprocessor-based central processing unit (CPU). The computer 128 may include appropriate memory, software, electronics, and / or device drivers for operating and / or controlling the various components of the system 100 (including the quality inspection station 107 and the analyzer stations 108A-108D). For example, the computer 128 may control the movement of the carrier 112 to and from the loading area 106, around the track 114, between the quality inspection station 107 and the analyzer stations 108A-108D, and between other stations and / or components of the system 100. The quality inspection station 107 and one or more of the analyzer stations 108A-108D may be directly coupled to the computer 128 or may communicate with the computer 128 via a network 130, such as a local area network (LAN), a wide area network (WAN), or other suitable communication network, including wired and wireless networks. The computer 128 may be housed as part of the system 100 or may be separate from the system 100.

[0035] In some embodiments, the computer 128 is coupled to a computer interface module (CIM) 134. The CIM 134 and / or the computer 128 are coupled to a display 136, which may include a graphical user interface. The CIM 134, in conjunction with the display 136, allows a user to access various control and status display screens and input data into the computer 128. These control and status display screens may display and enable control of some or all aspects of the quality inspection station 107 and analyzer stations 108A-108D, which prepare, pre-screen (characterize), and analyze the sample container 102 and / or the sample therein. The CIM 134 is used to facilitate interaction between a user and the system 100. The display 136 is used to display menus, including icons, scroll bars, boxes, and buttons, through which a user (e.g., a system operator) can interface with the system 100. The menus may include several functional elements programmed to display and / or operate functional aspects of the system 100.

[0036] FIG. 3 shows one embodiment of computer 328, which may be a system controller of automated diagnostic analysis system 100, and computer 128. Computer 328 may include processor 328A and memory 328B, where processor 328A is configured to execute programs 328C stored in memory 328B. Program 328C may operate components of automated diagnostic analysis system 100 and may further perform characterization and / or retraining of AI algorithms as described herein. One or more of programs 328C may be artificial intelligence (AI) algorithms that characterize, process, and / or analyze image data and other types of data (e.g., non-image data (e.g., sensor data) and / or text data). In some embodiments, memory 328B may store a first AI algorithm 332A and a second AI algorithm 332B.

[0037] The first AI algorithm 332A and the second AI algorithm 332B are each executable by the processor 328A and implemented in any suitable form of artificial intelligence programming, including, but not limited to, neural networks, including convolutional neural networks (CNNs), deep learning networks, regenerative networks, and other types of machine learning algorithms or models. Correspondingly, it should be noted that the first AI algorithm 332A and the second AI algorithm 332B are not, for example, simple lookup tables. Rather, the first AI algorithm 332A and the second AI algorithm 332B are each trained to recognize a variety of different imaging features and are each capable of improving (making more accurate determinations or predictions) without being explicitly programmed. In some embodiments, the first AI algorithm 332A and the second AI algorithm 332B can each perform different tasks. For example, the first AI algorithm 332A may be configured to perform characterization of sample containers and / or samples in the automated diagnostic analysis system 100 as described herein, and the second AI algorithm 332B may be configured to analyze sample measurement results. In other embodiments, the first AI algorithm 332A may be the AI algorithm initially provided to the system 100, and the second AI algorithm 332B may be a retrained version of the first AI algorithm 332A.

[0038] 4 illustrates a method 400 for characterizing a sample container and / or a sample in an automated diagnostic analysis system according to one or more embodiments. For example, a sample container 102 or 202 and / or a sample 216 is characterized in a quality inspection station 107 of the automated diagnostic analysis system 100.

[0039] At process block 402, the method 400 may begin with capturing an image of a sample container containing a sample using an imaging device. For example, capturing the image of the sample container may be performed at the quality inspection station 107 of the automated diagnostic analysis system 100, as described in more detail in connection with FIG. 5 .

[0040] 5 illustrates a quality inspection station 507, which may represent the quality inspection station 107, according to one or more embodiments. The quality inspection station 507 may perform pre-screening of samples and / or sample containers based on images captured thereby. The quality inspection station 507 may include a housing 534 that may at least partially surround or cover the track 114 to minimize the effect of external lighting. The sample container 102 or 202 may be disposed within the housing 534 and positioned within the carrier 112 at an imaging position 536 during an image capture sequence. The housing 534 may include one or more openings or doors (not shown) that allow the carrier 112 to enter and / or exit the quality inspection station 507 via the track 114.

[0041] The quality inspection station 507 may further include one or more light sources 538A, 538B, and / or 538C configured to illuminate the sample container 102 or 202 and / or sample 216 during an image capture sequence. The light sources 538A, 538B, and / or 538C are controlled (e.g., on / off and possibly brightness level) by the computer 128, but may also illuminate with light of different wavelengths.

[0042] Quality inspection station 507 may further include one or more imaging devices 540A, 540B, and / or 540C, which may be any suitable device configured to capture digital images. In some embodiments, imaging devices 540A, 540B, and / or 540C may each be a conventional digital camera capable of capturing pixelated images, a charge-coupled device (CCD), an array of photodetectors, one or more CMOS sensors, etc. In some embodiments, the size of the captured image may be approximately 2560 x 694 pixels. In other embodiments, the size may be approximately 1280 x 387 pixels. The captured image may have other suitable pixel sizes.

[0043] Each of the imaging devices 540A, 540B, and 540C can be positioned to capture images of the sample container 102 or 202 and the sample 216 at the imaging location 536 from a different viewpoint (e.g., viewpoints labeled 1, 2, and 3). While three imaging devices 540A, 540B, and / or 540C are shown, two, four, or more imaging devices can be used, depending on the situation. Viewpoints 1-3 can be approximately equally spaced from one another, such as approximately 120° apart, as shown. Images are captured in a round-robin fashion, for example, sequentially capturing one or more images from viewpoint 1, followed by one or more images from viewpoints 2 and 3. Other sequences for capturing images can be used, and other arrangements of the imaging devices 540A, 540B, and / or 540C can be used. Each of the imaging devices 540A, 540B, and / or 540C is triggered by a trigger signal generated by the computer 128. Each captured image is processed by computer 128 as further described below in connection with FIG.

[0044] 4, method 400 may include, at process block 404, characterizing the image using a first AI algorithm executing on a system controller of the automated diagnostic analysis system. For example, the image characterization is performed by first AI algorithm 332A executing on computer 128. The image characterization may facilitate handling of the sample container within the automated diagnostic analysis system 100 and / or determine whether the quality of the sample is suitable for analysis by one or more of the analyzer stations 108A-108D of the system 100.

[0045] More specifically, the characterization can provide segmentation data that can identify various regions of the sample container and sample, such as the serum or plasma portion, the sedimented blood portion, the gel separator (if used), the air region, one or more label regions, the type of specimen container (e.g., indicating the height and width or diameter), and / or the type and / or color of the cap of the sample container. The segmentation data can include specific physical dimensional characteristics of the sample container and sample. For example, the dimensions and / or locations of the TC, LA, SG, BG, HSP, HSB, HT, W, and / or HTOT of the sample container 202 and sample 216 (of FIGS. 2A and 2B) can be determined. Also, one or more volumes can be estimated, such as the serum or plasma portion 216SP and / or the sedimented blood portion 216SB. Other quantifiable characteristics can also be determined.

[0046] Characterization can further provide information regarding the presence and possibly the degree of interferences (e.g., hemolysis (H), icterus (I), and / or lipemia (L)) in sample 216, or whether the sample is normal (N), prior to analysis by one or more analyzer stations 108A-108D (of FIG. 1). Pre-screening in this manner can allow for additional processing and / or sample discard and / or re-extraction, if necessary, without wasting valuable analyzer resources due to the presence of sufficient amounts of interference that could adversely affect the test results.

[0047] FIG. 6 illustrates a pre-screening characterization architecture 600 including an AI algorithm 632, which may represent the first AI algorithm 332A, according to one or more embodiments. The pre-screening characterization architecture 600 is implemented in the quality inspection station 107 and / or 507 and controlled by the computer 128 or 328 (and program 328C). In function block 642, raw images captured by the imaging devices 540A, 540B, and / or 540C and / or measurement data from the measurement sensor 132 are processed and / or integrated by the program 328C running on the computer 128 to generate image and / or measurement data 644. The image data may be optimally exposed and normalized image data. In some embodiments, the raw images are processed and integrated as described in U.S. Patent Application Publication No. 2019 / 0041318 to Wissmann et al. The image data is input to the pre-screening characterization architecture 600, and more particularly to the AI algorithm 632.

[0048] In other embodiments, raw images and / or measurement data are input directly to pre-screening characterization architecture 600 and AI algorithms 632. In yet other embodiments, alternative or additional data is processed and / or integrated in function block 642 by program 328C executing on computer 128. Alternative or additional data may include measurement data generated by measurement sensors 132 of system 100, including, but not limited to, light-sensing devices, sound-sensing devices, humidity-sensing devices, liquid level-sensing devices, vibration-sensing devices, weight-sensing devices, photometric-sensing devices, heat-sensing devices, temperature-sensing devices, current-sensing devices, or voltage-sensing devices. In yet other embodiments, alternative or additional data may be text data.

[0049] Thus, image and / or measurement data 644 may include, for example, 1D / 2D / 3D sensor images, as well as alternatively or additionally, measurement data such as univariate or multivariate time series data, text labels, or system logs.

[0050] The pre-screening characterization architecture 600 is configured to use an AI algorithm 632 to perform characterization, such as the segmentation and / or HILN determination described above, on image and / or measurement data 644. The AI algorithm 632 can be trained at the factory using a standard set of training data that includes a sampling of common features to be characterized. The AI algorithm 632 is then validated using a validation data set 646 before the automated diagnostic analysis system 100 is put into service. The validation data set 646 verifies that the AI algorithm 632 performs as expected on inputs such as the validation data set and that the automated diagnostic analysis system 100 meets regulatory standards, as applicable.

[0051] In some embodiments, the validation data set 646 is included in the automated diagnostic analysis system 100 (e.g., stored in memory 328B of computer 328). In other embodiments, the validation data set 646 can be stored and / or executed remotely, such as on a cloud server accessible by the automated diagnostic analysis system 100 via network 130 (of FIG. 1). The validation data set 646 can also be used to validate the retrained AI algorithm 632, as described further below.

[0052] In some embodiments, the AI algorithm 632 can perform pixel-level classification and provide detailed characterization of one or more of the captured images. The AI algorithm 632 can include, for example, one or more of a front-end vessel segmentation network (CSN), a segmentation convolutional neural network (SCNN), and / or a deep semantic segmentation network (DSSN). The algorithm 632 can additionally or alternatively include other types of networks to perform segmentation and / or HILN determination.

[0053] The CSN is configured to output segmentation information 648 based on the image of the sample container and / or the sample contained therein. The segmentation information 648 may include identification of various regions of the sample container and sample, the type of sample container (e.g., indicating the height and width or diameter), the type and / or color of the cap of the sample container, and / or various physical dimensional characteristics of the sample container and the sample contained therein, as described above.

[0054] The SCNN and / or DSSN can output an interferent classification 650. In some embodiments, the SCNN and / or DSSN can be operable to assign a classification index to each pixel of the image based on the appearance of each pixel. The pixel index information can be further processed by the SCNN and / or DSSN to determine a final classification index for the group of pixels representing the sample. In some embodiments, only a classification index indicating the presence of a particular interferent, a normal (N) sample (e.g., no detectable interferent), or an uncentrifuged (U) sample (which may require centrifugation before further processing) may be output. For example, the interferent classification 650 may include an uncentrifuged class 650U, a normal class 650N, a hemolysis class 650H, a jaundice class 650I, and a lipemia class 650L. In some embodiments, the SCNN and / or DSSN can provide an estimate of the extent of the identified interferent. For example, in some embodiments, the hemolysis class 650H may include subclasses H0, H1, H2, H3, H4, H5, and H6. Jaundice class 650I can include subclasses 10, 11, 12, 13, 14, 15, and 16. Lipemia class 650L can include subclasses L0, 11, L2, L3, and L4. Hemolysis class 650H, jaundice class 650I, and / or lipemia class 650L can each have a number of smaller subclasses.

[0055] In some embodiments, the SCNN and / or DSSN may each include over 100 operational layers, including, for example, BatchNorm, ReLU activation, convolutional (e.g., 2D), dropout, and deconvolutional (e.g., 2D) layers, to extract features such as simple edges, textures, and portions of serum or plasma fractions and label-containing regions of the image. A top layer, such as a fully convolutional layer, may be used to provide correlation between features. The output of this layer is fed to a SoftMax layer, which generates a per-pixel (or per super-pixel (patch) containing n×n pixels) output regarding whether each pixel or patch contains HIL, is normal, or is not centrifuged. In some embodiments, the CSN may have a network structure similar to the SCNN and / or DSSN but with fewer layers.

[0056] Returning to FIG. 4 , method 400 may include, at process block 406, using the system controller to determine a characterization confidence level for the image. The characterization confidence level indicates the probability or likelihood that the first AI algorithm correctly identified a feature in the captured image. In other words, the characterization confidence level indicates how closely the feature in the captured image visually matches the feature in the training data that the first AI algorithm determined to be the most likely same feature. For example, a characterization confidence level of 50 (on a scale of 0 to 100) or 0.5 (on a scale of 0.0 to 1.0) indicates a 50% chance that the first AI algorithm correctly identified the feature in the captured image. Similarly, a characterization confidence level of 90 or 0.9 indicates a 90% chance that the first AI algorithm correctly identified the feature in the captured image. A confidence level of zero indicates that the first AI algorithm failed to identify one or more features in the captured image.

[0057] 6, the characterization confidence level 652 is generated by the AI algorithm 632 executing on the computer 128 or 328 using a variety of known techniques to quantify how closely the appearance of an identified feature in the captured image matches a feature in the training data. Alternatively, the characterization confidence level is determined by another AI algorithm or program stored, for example, in memory 328B and executed by the computer 128 or 328 as a subroutine of the AI algorithm 632.

[0058] 4, the method 400 can include triggering retraining of the first AI algorithm using retraining data, initiated by the system controller, in response to determining that the characterization confidence level is less than a preselected threshold. The retraining data includes image data captured by an imaging device that includes features prevalent in the current location of the automated diagnostic analysis system that were not sufficiently or at all included in the training data used to initially train the first AI algorithm.

[0059] In some embodiments, the preselected threshold may be, for example, 0.7 or greater (on a scale of 0.0 to 1.0), indicating a high probability that the characterization is correct. In other embodiments, the preselected threshold may be, for example, 0.9 or greater, indicating a higher confidence that the characterization is correct. The preselected threshold is determined by the user or based on regulatory requirements in the geographic region in which the automated diagnostic analysis system is currently located and operated.

[0060] Characterized features with confidence levels below a preselected threshold can be automatically flagged by the system controller. For example, referring again to Figures 1, 3, and 6, computer 128 or 328 can automatically flag characterized features with confidence levels below a preselected threshold and store their corresponding captured images in a currently located local database 654, which may be part of memory 328B, for example. Alternatively, characterized images with confidence levels below a preselected threshold are stored in cloud database 131 accessible via network 130.

[0061] Stored images having characterized features with a confidence level below a preselected threshold (hereinafter referred to as "low-confidence characterized images") likely contain sample container features and / or sample features and / or variations thereof that are prevalent in the current geographic location where the automated diagnostic analysis system 100 is operating, but that were not adequately or at all included in the training data used to initially train the first AI algorithm. For example, sample containers used in the current geographic location where the automated diagnostic analysis system 100 is operating may include container configurations or types with sizes and / or shapes that were adequately or at all included in the training data used to initially train the first AI algorithm. Similarly, biological samples collected from the geographic location where the system is operating may contain HILN subclasses that were adequately or at all included in the training data used to initially train the first AI algorithm.

[0062] In addition to the low-confidence characterized images stored in database 654 of FIG. 6 , non-image data 656 is also stored in database 654. The non-image data 656 may be associated with the current geographic location in which automated diagnostic analysis system 100 is operating. Such non-image data 656 may include, for example, sensor data, text data, and / or user-entered data. The sensor data may include, for example, data measured by and received from one or more measurement sensors 132, such as temperature sensors, acoustic sensors, humidity sensors, fluid level sensors, weight sensors, vibration sensors, current sensors, voltage sensors, and other sensors associated with the operation of automated diagnostic analysis system 100 at the current location. The text data may be associated with the low-confidence characterized images and / or may include a self-assessment and analysis report of the characterization performed by AI algorithm 632. The text data may alternatively or additionally indicate, for example, the test being performed (e.g., assay type), patient information (e.g., age, symptoms, etc.), test date, test time, system logs (e.g., system status), and any other data related to the test being performed by the automated diagnostic analyzer system 100. Some of the non-image data 656 is generated automatically by the computer 128 or 328, for example, at the same time as the image data is generated and / or during or after the characterization. Some of the non-image data 656 is also manually generated and entered by a user via test or patient information accessed from the CIM 134 or LIS 124 or hospital information system (HIS) 125 (of FIG. 1 ).

[0063] In some embodiments, method 400 may include automatically annotating the stored low-confidence characterized images via a system controller. For example, with reference to FIGS. 1, 3, and 6, automated diagnostic analysis system 100 may automatically annotate the stored low-confidence characterized images via computer 128 or 328. Additionally or alternatively, manual annotation of the low-confidence characterized images is performed by a user via CIM 134 (of FIG. 1). The annotated low-confidence characterized images, and in some embodiments, a portion of the non-image data 656, are formed or identified by computer 128 or 328 as retraining data 658 used to retrain AI algorithm 632.

[0064] In some embodiments, method 400 may include automatically retraining the first AI algorithm using the retraining data via a system controller operating in background mode. For example, in some embodiments, AI algorithm 632 is retrained using training data 658 via computer 128 or 328 operating in background mode while automated diagnostic analysis system 100 continues to operate on AI algorithm 632. The resulting retrained AI algorithm 632 is stored in memory 328B as second AI algorithm 332B. The retrained algorithm is then validated using validation data set 646.

[0065] In some embodiments of method 400, retraining of the first AI algorithm is automatically triggered by the system controller whenever the determined confidence level falls below a preselected threshold, and the automated diagnostic analysis system is operating in a continuous or continuous retraining mode.

[0066] In other embodiments, method 400 may include, in response to determining that the characterization confidence level is below a preselected threshold, first notifying a user via a user interface of the automated diagnostic analysis system that the first AI algorithm will be retrained using retraining data. In response to the notification within a predetermined period of time, the user may delay the retraining by replying so via the user interface. If the user does not reply within the predetermined period of time, the retraining is automatically initiated.

[0067] In yet other embodiments of method 400, retraining is automatically triggered when a certain number of low-confidence characterized images have been flagged and stored (e.g., in database 654). In other embodiments, retraining is automatically triggered after a predetermined period of system operation time (e.g., several days or 1-2 weeks), or when the sample container / sample has been characterized a predetermined number of times after the determination of the first low-confidence characterized image. Other criteria based on a determined characterization confidence level below a preselected threshold can be used to automatically trigger retraining of the first AI algorithm.

[0068] In some embodiments, after retraining the first AI algorithm to generate the second AI algorithm, method 400 may further include a process block (not shown) that includes automatically replacing the first AI algorithm with the second AI algorithm. In other embodiments, method 400 may include reporting the availability of the second AI algorithm to a user via a user interface and replacing the first AI algorithm with the second AI algorithm in response to user input received via the user interface. If the second AI algorithm does not perform as expected or does not perform better than the first AI algorithm, the user can effect the replacement of the second AI algorithm with the first AI algorithm via the user interface (e.g., using CIM 134). For example, after retraining the AI algorithm 632, then validating the retrained AI algorithm 632 using the validation data set 646, and storing the retrained AI algorithm 632 in memory 328B as the second algorithm 332B, the computer 128 or 328 may report to the user via the CIM 134 and the display 136 that the second algorithm 332B is available for use in the pre-screening characterization architecture 600. The user can then replace the AI algorithm 632 with the second algorithm 332B via the CIM 134. The original AI algorithm 632 (stored as the first AI algorithm 332A) remains stored and available in case the second algorithm 332B does not perform as expected and needs to be replaced with the first AI algorithm 332A (the original AI algorithm 632).

[0069] While the present disclosure is susceptible to various modifications and alternative forms, specific method and apparatus embodiments have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the specific methods and apparatus disclosed herein are not intended to limit the scope of the disclosure or the claims.

Claims

1. 1. A method for characterizing a sample container or sample in an automated diagnostic analysis system, comprising: capturing an image of a sample container containing the sample by using an imaging device; characterizing the image using a first artificial intelligence (AI) algorithm executing on a system controller of the automated diagnostic analysis system; determining a characterization confidence level of the image using a system controller; and triggering retraining of the first AI algorithm using the retraining data in response to determining that the characterization confidence level is less than a preselected threshold, the triggering being initiated by a system controller, wherein: The retraining data includes image data or non-image data captured by an imaging device that includes features widely recognized in the current state of the automated diagnostic analysis system that were not sufficiently or at all included in the training data used to initially train the first AI algorithm; The preselected threshold value is determined by the user or based on regulatory requirements in the geographic region in which the automated diagnostic analysis system is currently located and operated; The method.

2. Triggering is: further including, in response to determining that the characterization confidence level is less than the preselected threshold, notifying a user via a user interface of the automated diagnostic analysis system, wherein the notifying signifies that the first AI algorithm is retrained using the retraining data, and the triggering is initiated by the system controller; Triggering can also be delaying retraining of the first AI algorithm with the retraining data in response to receiving a user input to delay the retraining. The method of claim 1 , comprising:

3. The method of claim 1 , wherein characterizing comprises determining the presence of hemolysis, icterus, or lipemia in a sample contained within a sample container imaged by the imaging device.

4. The method of claim 1 , wherein characterizing comprises determining whether a cap is present on a sample container imaged by the imaging device.

5. The method of claim 1 , further comprising storing captured images for which the determined characterization confidence level is below a preselected threshold.

6. 10. The method of claim 1, wherein the currently recognized features of the automated diagnostic analysis system include sample container configurations or types that are not sufficiently or at all included in the training data used to initially train the first AI algorithm.

7. 10. The method of claim 1, wherein a currently recognized feature of automated diagnostic analysis systems includes HILN subclasses of samples that are not sufficiently or at all included in the training data used to initially train the first AI algorithm.

8. The method of claim 1 , wherein the retraining data has annotations generated automatically by a system controller or manually annotated by a user.

9. The method of claim 1 , wherein the retraining data further comprises data provided by a user via a user interface of the automated diagnostic analysis system.

10. 10. The method of claim 1, wherein a second AI algorithm is generated by retraining the first AI algorithm, and the method further comprises validating the second AI algorithm with a validation dataset.

11. 10. The method of claim 1, wherein a second AI algorithm is generated by retraining the first AI algorithm, and the method further includes reporting availability of the second AI algorithm to a user via a user interface of the automated diagnostic analysis system.

12. 10. The method of claim 1, wherein a second AI algorithm is generated by retraining the first AI algorithm, the method further comprising replacing the first AI algorithm with the second AI algorithm in response to user input received via a user interface of the automated diagnostic analysis system.

13. 13. The method of claim 12, further comprising substituting the second AI algorithm for the first AI algorithm in response to further user input received via the user interface.

14. 1. An automated diagnostic analysis system comprising: an imaging device configured to capture an image of a sample container containing the sample; a system controller coupled to the imaging device; the system controller comprising: characterizing an image captured by an imaging device using a first artificial intelligence (AI) algorithm executing on the system controller; determining a characterization confidence level of the image using a system controller; In response to determining that the characterization confidence level is less than a preselected threshold, retraining the first AI algorithm, executed by the system controller, using retraining data including image data or non-image data captured by an imaging device that includes features widely recognized at the current location of the automated diagnostic analysis system that were not sufficiently or completely included in the training data used to initially train the first AI algorithm. configured to trigger a training The preselected threshold value is determined by the user or based on regulatory requirements in the geographic region in which the automated diagnostic analysis system is currently located and operated; The automated diagnostic analysis system.

15. The system controller: In response to the triggering, notifying a user via a user interface of the automated diagnostic analysis system that the first AI algorithm will be retrained using the retraining data; 15. The automated diagnostic analysis system of claim 14, further configured to delay retraining of the first AI algorithm in response to receiving user input within a predetermined period of time to delay retraining.

16. 15. The automated diagnostic analyzer system of claim 14, wherein the system controller is further configured to store captured images in a storage device of the automated diagnostic analyzer system where the determined characterization confidence level is below a preselected threshold.

17. Current widely recognized features of automated diagnostic analysis systems include: sample container configurations or types that are not sufficiently or at all included in the training data used to initially train the first AI algorithm; or 15. The automated diagnostic analysis system of claim 14, including HILN subclasses of samples that were not sufficiently or at all included in the training data used to initially train the first AI algorithm.

18. 15. The automated diagnostic analysis system of claim 14, wherein retraining the first AI algorithm generates a second AI algorithm, and the system controller is further configured to validate the second AI algorithm with the validation data set.

19. 15. The automated diagnostic analysis system of claim 14, wherein retraining the first AI algorithm generates a second AI algorithm, and the system controller is further configured to report availability of the second AI algorithm to a user via a user interface of the automated diagnostic analysis system.

20. 15. The automated diagnostic analysis system of claim 14, wherein retraining the first AI algorithm generates a second AI algorithm, and the system controller is further configured to replace the first AI algorithm with the second AI algorithm in response to user input received via a user interface of the automated diagnostic analysis system.

21. 15. The automated diagnostic analysis system of claim 14, wherein the non-image data is received from one or more measurement sensors at the current location.

22. 22. The automated diagnostic analyzer system of claim 21, wherein the one or more measurement sensors are one or more of a temperature sensor, an acoustic sensor, a humidity sensor, a liquid level sensor, a weight sensor, a vibration sensor, a current sensor, or a voltage sensor.

23. The automated diagnostic analysis system of claim 14 , wherein the non-image data associated with the current location is text data.

24. 24. The automated diagnostic analysis system of claim 23, wherein the text data is a self-assessment and analysis report of a characteristic assessment performed by the first AI algorithm, data related to an ongoing test, or patient information.

25. 1. A method for characterizing a sample container or sample in an automated diagnostic analysis system, comprising: capturing data representative of a sample container containing the sample by using one or more of an optical sensing device, an acoustic sensing device, a humidity sensing device, a liquid level sensing device, a vibration sensing device, a weight sensing device, a photometric sensing device, a heat sensing device, a temperature sensing device, a current sensing device, or a voltage sensing device; characterizing the data using a first artificial intelligence (AI) algorithm executing on a system controller of the automated diagnostic analysis system; determining a characterization confidence level for the data using a system controller; and triggering retraining of the first AI algorithm using the retraining data in response to determining that the characterization confidence level is less than a preselected threshold, the triggering being initiated by a system controller, wherein: The retraining data includes features that are widely recognized in the current state of the automated diagnostic analysis system that were not sufficiently or at all included in the training data used to originally train the first AI algorithm. The preselected threshold value is determined by the user or based on regulatory requirements in the geographic region in which the automated diagnostic analysis system is currently located and operated; The method.

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