WO2025019638A1

WO2025019638A1 - Automated laboratory system, and cloud laboratory system

Info

Publication number: WO2025019638A1
Application number: PCT/US2024/038483
Authority: WO
Inventors: Lawrence Cary Gunn; Ashraf HANNA; Alex COLEMAN; Darius Chan; Iain CLARKE; Christopher Patti; Jim FEELER; William Zhang
Original assignee: Genalyte, Inc.
Priority date: 2023-07-18
Filing date: 2024-07-18
Publication date: 2025-01-23

Abstract

An automated laboratory system that operates under supervision of a cloud laboratory system is disclosed. The automated laboratory system can include a housing having a receptacle configured to receive a biological specimen, one or more biological specimen testing instruments disposed within a cavity of the housing, a processor that receives, from a remote cloud laboratory system, instruction for operating a biological specimen testing instrument from the plurality of biological specimen testing instruments to carry out a test on the biological specimen, and a robotic arm that delivers the biological specimen to the biological specimen testing instrument. The cloud laboratory system comprises a management interface configured that connects to multiple automated laboratory systems via a communications network and a cloud laboratory processor that receives test orders, analyzes the test orders, selects a biological specimen testing instrument, and forwards instructions for carrying out the test to the laboratory system.

Description

AUTOMATED LABORATORY SYSTEM, AND CLOUD LABORATORY SYSTEM

Cross-Reference to Related Applications

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 63/527,443, filed on July 18, 2023, which is entirely incorporated herein by reference.

Technical Field

[0002] The present disclosure relates to an automated laboratory system for conducting, on various and integrated instrumentations and related methods, various tests and assessments on a biological specimen obtained from a test subject.

Background

[0003] In traditional medical practices, orders for laboratory testing are often placed after a patient is first seen by a practitioner. For example, a primary care physician can place an order for bloodwork for a patient during or after an encounter with that patient, and instruct the patient to visit a laboratory to provide a blood sample. The blood sample is then forwarded for testing and the results of the test are forwarded to the physician. The physician reviews the test results and determines if a follow up visit and/or additional sample extraction or testing is necessary. If a follow up visit and/or additional testing is deemed necessary, the patient would need to return to complete the required actions.

Brief Summary

[0004] The present disclosure relates to a fully automated laboratory system, integrated instrumentations, and related methods for operating same. The automated laboratory is configured to operate under the direction of a remote monitoring cloud lab.

[0005] In one aspect, an automated laboratory system is disclosed. The automated laboratory system can comprise a housing comprising a receptacle configured to receive a biological specimen, a plurality of biological specimen testing instruments disposed within a cavity of the housing, a processor configured to receive, from a remote cloud laboratory system, instruction for operating a biological specimen testing instrument from the plurality of biological specimen testing instruments to carry out a test on the biological specimen, and a robotic arm connected to the processor and configured to deliver the biological specimen to the biological specimen testing instrument.

[0006] In another aspect, a cloud laboratory system is disclosed. The cloud laboratory system can comprise a management interface configured to connect to a plurality of automated laboratory systems via a communications network, each laboratory system comprising a plurality of biological specimen testing instruments disposed within a housing and a cloud laboratory processor configured to receive a test order indicating a test for carrying out a test using a laboratory system, analyze the test order, select a biological specimen testing instrument from among the plurality of biological specimen testing instruments in the laboratory system, and forward instructions for carrying out the test to the laboratory system.

Brief Description of the Drawings

[0007] FIG. 1 A is a high-level block diagram of a laboratory system according to some embodiments disclosed herein.

[0008] FIG. IB is a high-level block diagram of an automated laboratory system according to some embodiments disclosed herein.

[0009] FIG. 1C is a high-level block diagram of a cloud laboratory system according to some embodiments disclosed herein.

[0010] FIG. 2A is a high-level block diagram of an automated laboratory system according to some embodiments disclosed herein.

[0011] FIG. 2B is a high-level block diagram of a specimen loader for receiving a specimen container according to some embodiments disclosed herein.

[0012] FIG. 2C is a high-level block illustration of a consumable receptacle according to some embodiments disclosed herein.

[0013] FIG. 3 is a flow diagram of example procedures for verifying a specimen container according to some embodiments disclosed herein. [0014] FIG. 4 is a high-level block diagram of a robotic arm according to some embodiments disclosed herein.

[0015] FIG. 5 is a high-level block diagram of an electronic circuitry that can be used with the embodiments disclosed herein.

[0016] FIG. 6 is a flow diagram of example procedures carried out by the automated laboratory system.

[0017] FIG. 7 graphically illustrates a decapper-recapper plate according to some embodiments disclosed herein.

[0018] FIG. 8 graphically illustrates a consumable storage compartment according to some embodiments disclosed herein.

[0019] FIG. 9 graphically illustrates an example debagger according to embodiments disclosed herein.

[0020] FIG. 10 is a graphical illustration of a sample preparation station according to some embodiments disclosed herein.

[0021] FIG. 11 is a high-level diagram of a cloud laboratory system according to some embodiment disclosed herein.

[0022] FIG. 12 is a high-level diagram of procedures for carrying out a test via some embodiments disclosed herein.

[0023] FIG. 13 is a high-level diagram of procedures for testing a test subject via the laboratory system disclosed herein.

[0024] FIG. 14 is a high-level block diagram of an example of the operation of the laboratory system disclosed herein.

Detailed Description

[0025] The present disclosure relates to a fully automated laboratory system, integrated instrumentation, and related methods for a free-standing automated laboratory, which can carry out a comprehensive set of tests on biological specimens obtained from a test subject, while operating under remote monitoring and oversight by a cloud laboratory. The disclosed system can provide a compact and comprehensive laboratory onsite of any medical facility, while being remotely monitored by the cloud laboratory. The disclosed systems can be utilized at medical offices and retail clinics to conduct comprehensive tests of various specimens without requiring access to a traditional laboratory. The cloud laboratory is configured as a centralized laboratory system that is utilized to remotely access, monitor, and manage the laboratory sites and/or validate tests conducted at various other laboratory sites and forward validated results to appropriate databases.

[0026] FIG. 1 A is a high-level block diagram of a laboratory system 100 (“virtual laboratory”) according to some embodiments disclosed herein. As shown, the laboratory system/virtual laboratory 100 can include one or more automated laboratory systems 120, . . . , 120’ (“automated lab”) that are connected to a remote laboratory system 140 (hereinafter “cloud laboratory”) via a communications network 110. In addition to the one or more automated laboratory systems 120, . . . , 120’, the virtual laboratory system 100 can comprise other available laboratory systems and machines 190 (collectively “auxiliary laboratories”) that are also configured to connect to the cloud laboratory 130 via the communication network 110. The auxiliary laboratory systems 190 can generally include any standalone laboratory facility, system, or device that can be used to detect, diagnose, and/or monitor a biological characteristic of a test subject by performing a test on a specimen collected from the test subject. An auxiliary laboratory 190 or an automated laboratory 120 can be disposed at any suitable location and configured to be connected to the cloud laboratory 130 via a communications network 110. For example, an auxiliary laboratory 190 can be a system (e.g., benchtop system) utilized at a private practice (e.g., a physician’s office) that is coupled to the cloud laboratory 130 via the communication network 110. The automated laboratory 120 can, for example, be a Merlin™ Automated Laboratory Solution manufactured by Genalyte, Inc., San Diego, CA. that is utilized at a private practice (e.g., a physician’s office). The specimen can generally include any physiological material obtained from the test subject, such as blood, urine, saliva, other bodily fluid, tissue, or any other physiological material.

[0027] The cloud laboratory 130 can comprise a gateway interface 140 that comprises one or more Application Programming Interfaces (APIs) 145 configured to connect to and/or interact with various software and hardware of the virtual laboratory 100 in order to direct and/or manage the operations of the various components of the virtual laboratory 100. The one or more APIs of the gateway interface 140 can be configured to allow monitoring and management of transmission and reception of data and information from the automated labs 120/120’ and the auxiliary labs 190 to the cloud laboratory 130. Further, the gateway interface 140 can be configured to provide an interface for management of the communication between the automated laboratory 120 and the cloud laboratory 130, management of the communication between the various instruments of the automated laboratory 120, management the operation of the various components of the automated laboratory 120, and/or management the communication between the auxiliary labs 190 and the cloud laboratory 130. As detailed below, the gateway interface can include a visual interface that allows an operator to access the gateway interface and manage the operation of the various components of the virtual laboratory 100.

[0028] The gateway interface 140 can be coupled to one or more on-site applications 150 as well as one or more back-end applications 160. As explained in further details below, the onsite 150 and back-end applications 160 can include the applications and interfaces that enable the cloud laboratory 130 to provide commands and instructions to the automated labs 120/120’, control the operation of the automated labs, access and view information and data relating to the operation of automated labs 120/120’ and/or auxiliary labs 190, and/or access, view, and validate the clinical data and information gathered by these systems. Generally, the on-site applications 150 can provide an operator with the ability to review the workflow of the various connected instruments (e.g., automated laboratory 120 and auxiliary labs 190) and run quality control tests (e.g., sample quality checks) while the back-end applications 160 can provide an operator with the results of laboratory testing conducted for a patient using the various connected instruments (e.g., automated laboratory 120 and auxiliary labs 190). The reports can be provided via any suitable means, for example, via reporting to appropriate databases (e.g., an electronic health record database).

[0029] FIG. IB is a high-level block diagram of an automated laboratory 120 according to embodiments disclosed herein. The automated laboratory system 120 can include one or more laboratory instruments 121-126 and a robotic system 170 configured to operate the one or more laboratory instruments 121-126.

[0030] The one or more instruments 121-126 can comprise any physiological sample testing system(s) or device(s) available in the art that can be used to carry out a test on a biological specimen. For example, the one or more instruments 121-126 can comprise testing systems and devices commonly used in traditional clinical laboratories to carry out blood chemistry tests and/or devices or systems used to identify or measure presence and concentration of various analytes in a specimen collected from a test subject. The test can be any suitable test available in the art. Non-limiting examples of such tests can include a complete blood count (CBC) test, a blood chemistry test, comprehensive metabolic panel (CMP), lipid panel, general chemistry panel, tests for measuring sodium, potassium, chloride, calcium in a specimen, tests for determining pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, glucose, hematocrit, lactate, blood urea nitrogen (BUN) and/or creatinine. Alternatively or additionally, examples of the tests can include but are not limited to immunoassay tests (e.g., SARS-CoV-2 Semi -Quantitative Multi-Antigen Serology Panel, tests for detection of MERS, Influenza, etc., Anti-Nuclear Antibody (ANA) tests, C-Reactive Protein (CRP) tests, HbAlc tests, HIV screening panel, Thyroid Stimulating Hormone (TSH) tests, etc.), and molecular tests (e.g. detection or quantification of DNA, RNA, ribosomal RNA, mRNA, etc.).

[0031] Alternatively or additionally, the one or more instruments 121-126 can comprise systems and devices used to detect, diagnose, and/or monitor a biological characteristic of a test subject by performing a test on a specimen collected from the test subject. The specimen can include any physiological material obtained from the test subject, such as blood, urine, saliva, other bodily fluid, tissue, or any other physiological material.

[0032] The automated laboratory 120 can be coupled to the cloud laboratory 130 via the communications network 110 and configured to operate under the direction and oversight of the cloud laboratory 130. Specifically, as detailed below, the automated laboratory 120 can be configured to receive instructions regarding management and operation of at least one of the instruments 121-126 and/or the robotic arm 170. For example, the automated laboratory 120 can be configured to receive instructions from the cloud laboratory 130 that direct the robotic arm 170 to utilize an instrument 121-126 for carrying out a test, direct the robotic arm 170 to obtain the required components (e.g., cartridge) for that test, direct the instrument 121-126 to carry out the test, etc. The automated laboratory 120 can further be configured to deliver the results of the test to the cloud laboratory 130 for validation and distribution. Specifically, the results of the test(s) carried out by the one or more instruments 121-126 can be forwarded from the automated laboratory system 120 to the cloud laboratory 130. As detailed above, the automated laboratory system 120 can be disposed at a remote location from the cloud laboratory 140 and configured to send/receive information and data to/from the automated laboratory 120 via the communication network 110. Generally, the automated laboratory system 120 can connect to the cloud laboratory 130 via any suitable means available in the art. For example, the automated laboratory system 120 can connect to the cloud laboratory 130 via a communications network 110, such as the Internet. The communications network 110 can generally be any suitable communications network, and transmission and reception of data and information between the automated laboratory system 120 and the cloud laboratory 130 can be established via any suitable means. For example, the automated laboratory system 120 can connect to the cloud laboratory 130 via a wired or wireless (e.g., via Bluetooth® or WiFi® connection).

[0033] FIG. 1C is a high-level block diagram of a cloud laboratory 130 (cloud lab) according to some embodiments disclosed herein. As noted above, the cloud laboratory 130 can include one or more on-site applications 150, one or more back-end applications 160, and a gateway interface 140 that connects the cloud laboratory 130 to the automated 120 and auxiliary 190 labs.

[0034] The on-site applications 150 can include application software 154 for implementing and supporting the operations of the cloud laboratory 130. The application software 154 can be implemented across one or more applications. The functionality of these applications can enable the laboratory personnel (e.g., laboratory operator) to understand the state of the automated laboratory 120 and its onboard instruments 121-126, and also enable the laboratory personnel to monitor and manage auxiliary labs 190. For example, the application software 154 can implement an operator interface 135 that enables a laboratory operator to interact with the on-site applications 150 of the cloud laboratory 130. The operator interface 135 can allow an operator to interact with the cloud laboratory 130 to receive alerts and notifications of possible issues with the connected automated lab(s) 120, monitor the environmental conditions within the connected automated lab(s) 120, search for patient information and retrieve the patient test information from the connected lab(s) and/or auxiliary labs 190, and collect supplementary information about the patient, such as insurance information from relevant databases (e.g., insurance provider databases 148). The on-site applications 150 can also include the application software 154 for collecting and presenting laboratory testing results for a patient to the operator via the operator interface 135 for validation. The collected information can be presented to the operator via any suitable means, for example via a visual interface 137 of the operator interface 135. [0035] The on-site applications 150 can further include application software 154 for providing an operator and/or clinician (e.g., clinical laboratory operators and specialists, collectively “operator”) oversight for operating the automated laboratory system 120 via the operator interface 135. For example, the on-site applications 150 can provide an operator with an overview of working status of each automated laboratory system 121-126 (FIG. IB). Such information can, for example, include information regarding current run status of the device workflow, temperature, humidity, safety and access ports, readiness and availability of sample-tube carousels, on-board inventory of consumables, calibration and maintenance status of the system and internal devices and instruments, and/or any other suitable information that can influence/impact test performance of a connected device (e.g., automated laboratory or auxiliary lab). This information can be presented to the operator via the visual interface 137 of the operator interface 135.

[0036] The visual interface 137 can provide an interface that allows an operator (e.g., laboratory personnel) to interact with the cloud laboratory 130 to manage and/or review the operations of the various components of the virtual laboratory 100. For example, the operator can use the visual interface 137 to connect to the automated laboratory 120 (via the communication network 110) to determine the operating status of the automated laboratory 120, the specific status of laboratory testing systems 121-126 included in the automated lab, the specific status of laboratory testing systems in the auxiliary labs 190, and/or other functions or components of the virtual laboratory 100.

[0037] The on-site applications 150 can further include application software 154 for providing the operator access and oversight over the auxiliary labs 190. For example, the onsite applications 150 can implement an auxiliary laboratory interface 156 that provides the cloud laboratory 130 with the ability to access, monitor, and/or manage connected auxiliary labs 190 (FIG. 1A). The operator can utilize the auxiliary laboratory interface 156 to connect to a remote auxiliary laboratory 190, manage and monitor the functions of the auxiliary laboratory 190, obtain data and information from the auxiliary laboratory 190, and/or validate the results of the tests conducted using the auxiliary laboratory 190.

[0038] The on-site applications 150 can generally control and monitor all functions of the automated laboratory 120, and only require that an operator (e.g., nurse) obtains a sample specimen (e.g., blood) from the patient and insert the specimen (e.g., tube) into a receptacle (disclosed below with reference to FIG. 2A) of the automated laboratory 120. Once the tube is inserted into the automated laboratory 120, the automated laboratory 120 can monitor, control, and manage all required tasks for testing and obtaining test results based on the sample specimen, while the on-site applications 150 monitor the internal activity of the automated laboratory.

[0039] The application software 154 and on-site applications 150 can further support and implement various other applications and interfaces that facilitate management of remote laboratories (automated labs 120, auxiliary labs 190) and oversight on completion of laboratory tests. For example, the on-site applications 150 can support an accessioning interface 152 that allows an operator to link a specimen to a particular test subject and/or to a particular test subject’s medical records. Alternatively or additionally, the accessioning interface 152 can allow an operator (e.g., a phlebotomist, who may be a different person than the automated laboratory operator) to link a specimen identifier, which the automated laboratory understands as belonging to a specific patient, to a specimen.

[0040] The back-end applications 160 can include application software 164 for implementing and supporting the operations of the cloud laboratory 130. For example, the application software 164 can implement a laboratory information system 162 that collects and tracks the information necessary for completing laboratory tests. The laboratory information system 162 can comprise a billing system (not shown) that tracks and stores the necessary information (insurance information) for billing the costs associated with the test. Additionally or alternatively, the laboratory information system 162 can be coupled to various databases that provide the necessary information for conducting the laboratory tests. For example, the laboratory information system 162 can be coupled to Electronic Health Record (EHR) 146 systems and/or insurance provider databases 199. Connection to such databases can be established via the communication network 110. The information obtained from the EHR system 146 can be reviewed by an operator via the operator interface 135. Such information can include, for example, patient demographics, ordering history, specimen ID, open orders, etc.

[0041] The back-end applications 160 of the cloud laboratory 130 can further include the necessary modules for operating the virtual laboratory system 100 and/or remote monitoring of various connected automated laboratory systems 120. For example, the back-end applications 160 can include a clinical interface 168 that is configured to present the test results uploaded from the automated laboratory system 120 and/or auxiliary labs 190 to a clinical laboratory scientist for verification. Laboratory professionals can use the clinical interface 168 to review test control factors and patient test results. The clinical interface 168 can be coupled to a visual screen (c.g, visual screen 137) that allows an operator to interact with the cloud laboratory 130.

[0042] Additionally or alternatively, the back-end applications 160 can provide the operator with the ability for management of panels, including management of tests currently on the panel, specimen tube requirements for a panel, including type, draw volumes, and pipette volumes type requirements, thereby ensuring that both the automated laboratory 120 and the clinician (e.g., phlebotomist) have the requisite information in obtaining the required specimen from the test subject (e.g., the automated laboratory and the phlebotomist have the requisite information to perform a blood draw). The operator can access the panels via the visual interface 137 and manage and control all required tasks for testing and obtaining test results based on the sample specimen.

[0043] The back-end applications 160 can further display the results of laboratory testing conducted for a patient using the various connected instruments (e.g., automated laboratory 120 and auxiliary labs 190). As noted, this information can be presented via the visual interface 137 of the clinical interface 168. Meanwhile, the on-site applications 150 can provide an operator with the ability to review the workflow (e.g., handling and loading of specimen tubes, interfacing with internal device systems, etc.) of the various connected devices (e.g., automated laboratory 120 and auxiliary labs 190) and run quality control tests (e.g., sample quality checks).

[0044] As detailed above, the gateway interface 140 can comprise one or more Application Programming Interfaces (APIs) 145 configured to connect to and/or interact with various software and hardware of the virtual laboratory 100 in order to direct and/or manage the operations of the various components of the virtual laboratory 100. In some implementations, the gateway interface 140 can comprise an integrated operator interface 147 that allows the operator of the virtual laboratory 100 to connect to the various components of the automated labs 120 and/or the auxiliary labs 190. The operator interface 147 can comprise a visual interface (not shown) that provides the operator with access to the various components of the automated laboratory 120 in order to manage the operation of these components and/or determine the operating status of these components. For example, the operator interface 147 can allow the operator to use the visual screen to remotely operate a particular automated laboratory 120, obtain information and data about that particular automated laboratory 120 via the cloud laboratory 130, obtain operating status of the particular automated laboratory 120, and/or control the operations of the particular automated laboratory 120. Alternatively or additionally, the operator can use the operator interface 147 to access clinical data and test results obtained from the one or more automated labs 120/120’ and/or the auxiliary labs 190 and manage the operation of the auxiliary labs 190. It should be noted that the operator interface 147 can be disposed at a remote location from the gateway interface 140 and configured to connect to the gateway interface 140 via the communications network 110 (e.g., Internet).

[0045] The cloud laboratory 130 can provide the required management tools for monitoring a fleet of automated laboratory systems 120/120’ as well as their onboard instruments 121-126. For example, the cloud laboratory 130 can store the required workflow information that ensures the automated laboratory systems 120/120 are properly able to follow the instructions for use (IFU) for respective assays. The cloud laboratory 130 can also include information for ongoing monitoring of the automated laboratory systems 120 as well as other management tools for clinical staff to manage the various consumables and controls of the automated laboratory systems 120/120’.

[0046] FIG. 2A is a high-level block diagram of an automated laboratory system 120 according to some embodiments disclosed herein. As shown, the automated laboratory system 120 can include one or more instruments 121-126 disposed within a housing 299. As explained in further details below, the automated laboratory can further comprise a processor 210 that controls the various functions of the automated laboratory system 120, an automation system 170 that operates under the direction of the processor 210 to carry out various tasks within the automated laboratory system 120, a specimen tube queue 255 for receiving test subject specimens, a scanner that scans containers carrying the specimens to allow association of a specimen with a test subject and a test order, a consumable receptacle 250 configured to receive the consumables necessary for carrying out various tests using the one or more instruments 121-126, a decapper-recapper 270 that removes and replaces a specimen container cap, and a sample preparation station 280 that prepares the samples prior to evaluation and testing using the one or more instruments 121-126.

[0047] The one or more instruments 121-126 can each be configured to carry out one or more tests on a specimen collected from a test subject. The one or more instruments 121-126 can comprise any suitable testing system available in the art. For example, the one or more instruments 121-126 can comprise the MAVERICK™ Immunoassay Analyzer manufactured by Genalyte, Inc., PICCOLO XPRESS® by Abbott Point of Care, SYSMEX pocH, or any other laboratory instrument available in the art. Generally, the one or more instruments 121- 126 can comprise any device or testing system that can carry out a test on a specimen collected from a subject. For example, the one or more instruments 121-126 can comprise systems that can carry out hematology tests (e.g., WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM#, LYM%, MXD#, MXD%, NEUT#, NEUT%, RDW-SD, RDW-CV, MPV, etc ), chemistry tests (e.g, Na+, K+, TP, tCO₂, TBIL, BUN, Ca, AST, ALP, ALB, ALT, eGFR*, GLU, C1-, CRE, etc.), immunoassays (SARS-CoV-2 Semi-Quantitative MultiAntigen Serology Panel which can include, SARS-CoV-2 related tests such as Anti- Nucleocapsid IgG and IgM, Anti-Spike SI RBD IgG and IgM, Anti-Spike S1S2 IgG and IgM, Anti-Spike S2 IgG and IgM, Anti-Spike SI IgG and IgM, Benign CoV related tests such as Anti-CoV OC43 IgG and IgM, Anti-Cov HKU1 IgG and IgM, Anti-Cov nl63 IgG and IgM, Anti-Cov 229E IgG and IgM, SARS-CoV, Anti-Nucleocapsid IgG and IgM, MERS related tests such as Anti-Sl IgG and IgM, Influenza related tests such as Anti -Hl IgG and IgM, Anti-H3 IgG and IgM), Anti-Nuclear Antibodies (ANA) related tests such as Anti-Cenp B IgG, Anti-dsDNA IgG, Anti-Jo-1 IgG, Anti-RNP IgG, Anti-Scl-70 IgG, Anti-Sm IgG, Anti- SS-A 60 IgG, Anti-SS-B IgG, nucleic acid tests (e.g., virus, bacteria, genetic markers, etc.), etc.

[0048] In some implementations, the housing 299 can comprise a security feature 298 that is configured to allow and/or prevent access to the specimen loader 251. The security feature 298 can be any suitable feature, for example a barcode scanner, a proximity sensor, an RFID tag. For example, the security feature 298 can be a feature that allows access to the specimen loader 251 in response to scanning of a keycard or a barcode (e.g., keycard of a technician at a specimen collection facility, a barcode on a mobile device of a test subject dropping off a specimen, etc.).

[0049] The one or more instruments 121-126 can utilize one or more consumables and/or cartridges 122c for carrying out the test(s) offered by the laboratory system(s). The consumables 122c can be configured to allow conducting multiple diagnostic assays and/or tests using a single specimen and/or a single laboratory system. The consumable can include any suitable internal components, for example a specimen entry point, relevant fluidic channels and fluid pathways, relevant detection channels and sensors, a reagent channel, a waste compartment, etc. The consumables can be packaged in any suitable packaging. For example, the consumables can be packaged in paper or plastic and/or shrink-wrapped.

[0050] The housing 299 can be configured to store the one or more instruments 121-126. For example, the housing can comprise one of more shelves 297 (shown in FIG. 2C) configured to house each of the instruments. The shelves can be adjustable to accommodate instruments of various shapes and sizes. The housing 299 can further be configured to include a temperature-controlled chamber 296 to house consumables and specimens at appropriate temperatures, and present those consumables upon request to the robotic arm 170. For example, the housing can comprise a refrigerated module (e.g., temperature-controlled module) that is configured to store the consumables and specimens at reduced temperatures (e.g., between 2°C to 8°C). In some implementations, the chamber 296 can comprise one or more compartments 297, some of which can be independently controlled to different temperature specifications. For example, as shown in FIG. 2C, the housing can comprise one or more consumable compartments 295 with temperature-controlled zones. The temperature- controlled compartments/zones can be configured to store specimens and/or consumables that require storage at set temperatures.

[0051] The housing can further comprise a consumable compartment 290 configured to receive consumables. The consumable compartment 290 can be a removable and refillable compartment that is located, for example, in proximity of a door 291 (on the front of the housing 299) that allows access to the cavity of the housing. As detailed below with reference to Fig. 8, the consumable compartment 290 can be configured to receive one or more consumables. The compartment can include one or more trays, shelves, or compartments, each configured to receive a certain number of consumables. In some implementations, each shelf can allow storage of a number of consumables. For example, each shelf can be configured to receive 20, 40, 60, etc. consumables.

[0052] Each of the one or more instruments 121-126 can comprise an interactive medium through which the laboratory system is operated. For example, as shown in FIG. 2A, a laboratory system 121 can include a laboratory interface 12 li through which the various operations of the laboratory system 121 is conducted. The interactive medium 12 li can be any interface known in the art, for example a key, a switch, a Liquid Crystal Display LCD screen, a keypad, a manual pushbutton, a touch sensitive button, a smart button, a button with physical feedback, a wheel, a hold switch, etc. Additionally or alternatively, the interface 12 li can be a smart or a touch sensitive interface and/or a manually actuated interface.

[0053] The automated laboratory system 120 can further comprise a specimen tray or a specimen loader 251 that allows loading of a specimen 201 into the system 120 via a specimen tray receptacle 250. As noted, the specimen 201 can comprise any physiological material obtained from the test subject, such as blood, urine, saliva, other bodily fluid, tissue, or any other physiological material. The specimen 201 can be secured or deposited in a specimen container 202. Generally, the specimen 201 can be included in any container 202 or medium known and available in the art. For example, the specimen container 202 can be comprise a specimen tube (e.g., test tube), a specimen cup (e.g., urine sample), a specimen jar, a specimen slide (e.g., microscope slide), a specimen bottle, etc. The specimen container 202 can further comprise a covering 203 (e.g., a cap) configured to secure the specimen 201 within the specimen container 202.

[0054] The specimen loader 251 can be configured to receive any number of specimen containers 202. For example, the specimen loader 215 can include one or more compartments 251 (e.g., 5, 6, 8, 12, 16 compartments), each configured to receive a specimen container 251. The one or more compartments 251 can receive specimen containers 251 of any suitable form and/or shape. For example, in some implementations, the one or more compartments can be configured to receive vacutainer-form tubes. In some implementations, the specimen loader 251 can comprise one or more specimen loading trays and/or a carousel-type configuration. For example, in some implementations, up to 20 specimen containers can be stored and selected at random for testing.

[0055] The specimen container 202 can further comprise a label 204 that contains information that can be used to identify the source of the specimen 201 (i.e., the test subject). The information can comprise any suitable information, for example, a barcode linking the label 204 to the subject and/or the subject’s medical records, a QR code linking the label 204 to the subject. Once scanned, the identification information for a specimen can be stored in local software and delivered with the test results to the cloud laboratory 130 upon completion of the test.

[0056] FIG. 2B is a high-level block diagram of a specimen loader 251 or a specimen drawer for receiving a specimen container 202 according to embodiments disclosed herein. As shown, the specimen container 202 can comprise a cap 203 configured to secure the specimen and/or prevent leakage or contamination. The cap 203 can be coupled with the specimen container via any suitable connection. For example, the cap 203 can comprise a screw cap or a friction fitted cap. In some implementations, uncapped containers 202 (e.g., uncapped tubes) are not accepted by the automated laboratory system 120.

[0057] The specimen loader 251 can comprise at least one sensor 253 configured to detect presence of a specimen container 202 within the specimen loader 251. The sensor 253 can be positioned at any suitable position on the specimen loader 251, for example within at least one compartment 252 of the specimen loader 251. The sensor 253 can be any suitable sensor available in the art. For example, the sensor 253 can comprise a motion sensor that is activated in response to placement of a specimen container 202 within a compartment 252. Alternatively or additionally, the sensor 253 can comprise an optical sensor and/or a proximity sensor configured to detect placement or presence of a specimen container 202 within the compartment 252. Further, the sensor 253 can be configured to be activated in response to opening or closing of the specimen container 202 to detect presence/placement of a specimen container 202 within a compartment 252. For example, several sensors can be used to ensure custody of the tube during tube drop and scanning and presentation to the robot arm for pickup. Further, the sensors can be monitored by local software and relevant error signals are generated if workflow is disrupted or incomplete.

[0058] As noted, the specimen loader 251 can comprise any suitable shape. For example, the specimen loader can comprise a tray-shaped configuration and/or a carousel design. Further, the specimen loader 251 can comprise one or more specimen loaders (e.g., one or more specimen trays or specimen carousels). In some implementations, at least one specimen loader or carousel can be configured as a working specimen loader 251 (or a working carousel) and include the specimen container(s) 202 that are under evaluation/testing by the system at that time. Further, the specimen loader 251 can be configured to track removal of a specimen from the specimen container and addition of the specimen to the working specimen loader. In some implementations, the automated laboratory system 120 can include one working carousel and two or more loading carousels.

[0059] As explained in further details below, a processor 210 can be configured to control and/or monitor various functions and operations of the system 120. The processor 210 can be included in the digital circuitry and/or hardware of the system 120 and be configured to control, monitor, and/or carry out various functions needed for carrying out the functions of the system 120. For example, the processor 210 can be configured to monitor the at least one sensor 253 and receive and process signals from the at least one sensor 253 indicating placement and/or presence of a specimen container 202 within the specimen loader 251. As noted above, the at least one sensor 253 and other components of the system can be monitored and managed remotely, for example via the gateway interface 140, by the cloud lab 130.

[0060] Further, the working specimen loader 251 can be coupled to a scanner 260 configured to scan the label 204 of the specimen container 202 in order to extract the subject’s information. Barcode scanning can be a part of the intake process. Further, the scanner 260 can be a part of an intake assembly module that is mounted next to the working carousel and pointed at the tubes as they are rotated in the scan position.

[0061] The scanner 260 can comprise any suitable mechanism that allows obtaining the subject’s information from the label 204. For example, the scanner 260 can be a barcode reader and/or a QR scanner. The scanner 260 can be connected to the processor 210 and configured to forward the information obtained from the label 204 to the processor 210. In response, the processor 210 forwards this information to the cloud lab 130. The cloud lab 130 compares the information obtained from the scanner to a database 540 (shown later in FIG. 5) that stores relevant subject information and associates the specimen container 202 with the label 204 and corresponding test subject information. All patient and test data are obtained from the cloud laboratory 130, and the instrument 120 only tracks and stores the barcode information for a specimen.

[0062] The processor can further receive the test orders for the test subject from the cloud lab 130. For example, as detailed above, the cloud lab 130 can access a database (e.g., Electronic Health Record Database) that stores test orders for the test subjects to determine if an outstanding test order for the test subjects exists and forward this information to the processor 210. The automated laboratory 120 can obtain this information from the cloud laboratory 130 via the communication network 110. Upon verifying that an outstanding test order exists, the processor 210 can add the specimen container 202 to a queue for processing. The samples in the queue can be organized based on certain priority rules, which may be provided by the cloud lab 130. For example, the specimens can be arranged based the date/time a specimen is collected from the subjected, the expiration date/time of the specimen, priority levels set by a practitioner (e.g., specimens marked as urgent), and based on the sample type (e.g., blood, urine, plasma, etc.).

[0063] FIG. 3 is a flow diagram of example procedures for verifying a specimen container. As explained above, the processor can obtain and process the information included on the specimen label (310) and associate the specimen label with a test subject profile (320) under the direction of the cloud lab 130. The processor can further receive instructions from the cloud lab 130 that indicate whether an outstanding laboratory test order exists for the test subject (330). For example, the Cloud lab 130 can access an electronic medical record (EMR) database that stores information on the test subject to obtain the subject’s information and review outstanding test orders for the subject. The EMR can be a remote database and the cloud lab 130 can access the EMR via the communications network 110. A similar process can be used for specimens that are not patient specimens, such as validations, proficiency, and controls, as required by regulatory agencies. In these cases, the automated laboratory performs similarly, except that there is no involvement of an EMR and no patient result is generated. The results of validations, proficiency or control runs can be reported on as needed.

[0064] If no test order exists (331), the specimen container 335 is returned to the operator of the automated laboratory (335).

[0065] Upon determining that a test order exists for the test subject (340), the cloud lab 130 can identify the appropriate tests and corresponding instruments 121-126 in the automated lab 120 for carrying out the tests in the test order (350). For example, if the test order includes a blood chemistry test, the cloud lab 130 can determine that the laboratory system 121 that is most suitable for conducting that specific test and select that laboratory system 121 for carrying out the test. The cloud lab 130 can further determine if the selected laboratory system 121 requires a specific consumable for carrying out the test and/or if any sample preparation procedures are required before a test can be completed using the selected laboratory system (360). The cloud lab 130 can subsequently direct the automated lab 120 to add the sample to a processing queue (370) for being processed using the selected laboratory instrument 121-126.

[0066] Further, in response to detection of a verified specimen container 202 within the specimen loader 251 and/or upon completion of the verification procedures, the cloud lab 130 can direct the robotic system 170 to obtain the specimen container 202 from the specimen loader 251. For example, the cloud laboratory 130 can instruct the robotic system 170 to obtain the verified specimen container 202 and add the specimen container 202 to a working specimen tray 251 and/or to a queue for further using the one or more instruments 121-126. The instructions issued by the cloud lab 170 can be forwarded to the processor 210, and the processor 210 can in turn direct the robotic system 170 to function as instructed by the cloud lab 170.

[0067] FIG. 4 is a high-level block diagram of a robotic system 170 according to some embodiments disclosed herein. The robotic system 170 can comprise one or more robotic arms 410-413 that are configured to rotate around one or more respective joints 420-423 in one or more dimensions. The rotation of the arms 410-413 about the joints 420-423 can collectively provide the robotic system 170 with movement in multiple dimensions (e.g., four, five, six, or more) dimensions.

[0068] The robotic system 170 can further comprise a pair of actuators and/or grippers 430a, 430b that are configured to provide the robotic system 170 with the ability to interact with various elements of the automated system 120, handle specimen containers 202, and/or handle various consumables (detailed above) of the system. The grippers 430a, 430b can be coupled to the robotic arms 410-413 (e.g., robotic arm 410 in the example shown in FIG. 4) via one or more joints 431a, 43 lb that allow movement and/or rotation of the gripper(s) about the robotic arm 410. The joints 431a, 431b can provide the grippers 431a, 431b with rotation and movement in multiple dimensions and along multiple directions. The combination of the rotations and movements of the robotic arms 410-413 and the grippers 430a-430b allows the robotic arms and the grippers to move and rotate freely along multiple directions and dimensions (e.g., 3, 4, 5, 6 dimensions) within the housing (enclosure) 299 of the automated laboratory system 120 to access various interfaces 121-126 and/or handle the specimen container 202.

[0069] The grippers 430a, 430b can be formed of any suitable material. For example, the grippers 430a, 430b can comprise injection molded silicone pad mechanically anchored into anodized aluminum. In some implementations, the grippers can be customized for operation with the automated laboratory system 120, the specific instruments 121-126, their respective interfaces 12 li, and their respective consumables. The robotic arms 410-413 and grippers 430a, 430b can generally comprise any suitable mechanical element and/or configuration that can carry out the functions disclosed herein. The robotic system 170 can be secured, fixed, and/or coupled to a frame/base 440 within the housing 299 of the system 120.

[0070] As noted, the grippers 430a, 430b can be configured to interact with the one or more instruments 121-126. For example, the grippers 430a, 430b can comprise of a stylus, force feedback sensor) that is configured to sense and interact with the interactive medium 12 li of the laboratory system 121. Generally, the grippers 430a, 430b can comprise any element capable of interacting with the interactive medium 12 li. For example, in some implementations, at least one gripper 430a, 430b can comprise an extension (e.g., a stylus) configured to interact with an interactive (e.g., touch sensitive) screen of a laboratory system.

[0071] As noted above, the robotic system 170 can be coupled to the processor 210 and configured to be controlled via instructions executed by the processor 210. The processor functions under the instruction of the cloud lab 130 and is configured to control the robotic system 170 and the grippers 430a, 430b to perform various functions including handling of specimen containers 202, handling of laboratory system consumables, interacting with interactive screens of the one or more instruments 112-126, etc.

[0072] Each consumable (e.g., discs, stripwells, reagents) can be stored in a designated location in the temperature-controlled chamber 296, the working carousel, or the stripwell loader to allow the robotic arm to retrieve these items. The processor can maintain a mapping of the location of each scanned or unscanned item in local memory of the system 120. Upon retrieval, each consumable is scanned before use to ensure that the correct consumable for the ordered test is being retrieved and also to check the expiration date and time of the consumable.

[0073] The processor 210 can be part of the digital circuitry of the automated laboratory system 120 and be configured to control the actions of the robotic system 170 based on instructions received from the cloud laboratory 130. For example, the processor 210, upon verifying the specimen container 201, can direct the robotic arm 170 to obtain the specimen container 201 from the specimen tray, remove the cap/cover 203 of the specimen container (detailed below), prepare the specimen for testing (detailed below), and direct the prepared specimen to a specific laboratory testing system 121.

[0074] FIG. 5 is a high-level block diagram of an electronic circuitry 500 that can be used with the embodiments disclosed herein. The electronic circuitry 500 can be included in various components of the virtual laboratory system 100. For example, the digital circuitry 500 can be onboard the cloud laboratory system 130 and implement the various components and/or functions of the cloud laboratory 130. Alternatively or additionally, the digital circuity 500 can be onboard of the automated laboratory system 120 and configured to control or implement the various functions of the automated laboratory system 120.

[0075] The digital circuitry 500 can include a processor 510 that is configured to control, monitor, and/or carry out various functions needed for analysis, interpretation, tracking, and reporting of information and data used or collected by the virtual laboratory system 100. Generally, these functions can be carried out and implemented by any suitable computer system and/or in digital circuitry or computer hardware, and the processor 510 can implement and/or control the various functions and methods described herein. The processor 510 can be connected to a main memory 530, and comprise a central processing unit (CPU) 522 that includes processing circuitry configured to manipulate instructions received from the main memory 530 and execute various instructions. The CPU 522 can be any suitable processing unit known in the art. For example, the CPU 522 can be a general and/or special purpose microprocessor, such as an application-specific instruction set processor, graphics processing unit, digital signal processor, image processor, coprocessor, floating- point processor, network processor, and/or any other suitable processor that can be used in a digital computing circuitry. Alternatively or additionally, the processor 210 can comprise at least one of a multicore processor and a on-site processor.

[0076] Generally, the processor 510 and the CPU 522 can be configured to receive instructions and data from the main memory 530 (e.g., a read-only memory or a randomaccess memory or both) and execute the instructions. The instructions and other data can be stored in the main memory 530. The processor 510 and the main memory 530 can be included in or supplemented by special purpose logic circuitry. The main memory 530 can be any suitable form of volatile memory, non-volatile memory, semi-volatile memory, or virtual memory included in machine-readable storage devices suitable for embodying data and computer program instructions. For example, the main memory 530 can comprise magnetic disks (e.g., internal disks or removable disks), magneto-optical disks, one or more of a semiconductor memory device (e.g., EPROM or EEPROM), flash memory, CD-ROM, and/or DVD-ROM disks. [0077] The main memory 530 can comprise an operating system 532 that is configured to implement various operating system functions. For example, the operating system 532 can be responsible for controlling access to various devices, memory management, and/or implementing various functions of the virtual laboratory system 100. Generally, the operating system 532 can be any suitable system software that can manage computer hardware and software resources and provide common services for computer programs.

[0078] The main memory 530 can also hold application software 534. Specifically, the main memory 530 and application software 534 can include various computer executable instructions, application software, and data structures, such as computer executable instructions and data structures that implement various aspects of the embodiments described herein. For example, the main memory 530 and application software 534 can include computer executable instructions, application software, and data structures, which can be employed to operate the virtual laboratory system 100 as well as software instructions used to process, analyze and forward information obtained by the virtual laboratory system 100 to the user interfaces 137/147.

[0079] Generally, the functions performed by the virtual laboratory system 100 can be implemented in digital electronic circuitry or in computer hardware that executes software, firmware, or combinations thereof. The implementation can be as a computer program product (e.g., a computer program tangibly embodied in a non-transitory machine-readable storage device) for execution by or to control the operation of a data processing apparatus e.g., a computer, a programmable processor, or multiple computers).

[0080] The main memory 530 can also be connected to a cache unit (not shown) configured to store copies of the most frequently used data stored in the main memory 530. The program codes that can be used with the embodiments disclosed herein can be implemented and written in any form of programming language, including compiled or interpreted languages, and can be deployed in any form, including as a stand-alone program or as a component module, subroutine, or other unit suitable for use in a computing environment. A computer program can be configured to be executed on a computer or on multiple computers, at one site or distributed across multiple sites and interconnected by a communications network, such as the Internet. All onboard software and firmware, including the robotic routines on the automated laboratory system can be remotely updateable, in order to provide enhanced capabilities, security updates, and any fixes as needed. [0081] The processor 510 can further be coupled to a database or data storage 540. The data storage 540 can be configured to store information and data relating to various functions and operations of the virtual laboratory system 100. For example, the data storage 540 can store the data collected by virtual laboratory system 100, data relating to operation of the one or more instruments 121-126, etc.

[0082] The processor 510 can further be connected to various interfaces. The connection to the various interfaces can be established via a system or an input/output (I/O) interface 544 (e.g., Bluetooth, USB connector, audio interface, FireWire, interface for connecting peripheral devices, etc.).

[0083] The processor 510 can further be coupled to a communication interface 546, such as a network interface. For example, the communications interface 546 can be a communications interface that is configured to provide the virtual laboratory system 100 with a connection to a suitable communication network 110, such as the Internet. Transmission and reception of data, information, and instructions can occur over the communication network 110. For example, the communication interface 546 can be an interface that is configured to allow communication between the electronic circuitry 500 and another entity via any suitable communications means such as a wired or wireless communications protocols including WIFI and Bluetooth communications schemes.

[0084] FIG. 6 is a flow diagram of example procedures carried out by the automated laboratory system 120. As detailed above, the automated laboratory system can receive a specimen container that holds a specimen obtained from a test subject and is sealed by a cap (610). The specimen container can include a label that contains information that can link the container to the test subject. The scanner scans the label (615) and validates the specimen by associating the specimen with a subject profile. As noted above, the cloud lab 130 can access an electronic health record system that contains subject data and validate the specimen by matching the specimen to a test subject included in the electronic health system. Once the specimen is validated (622), the specimen is added to a queue for further processing by the automated laboratory system (630). If the label cannot be validated (623) (e.g., there is no match for the patient, there is no label on the specimen, the label cannot be read by the scanner), the specimen container is ejected from the laboratory testing system (640). [0085] The cloud lab 130 can further determine if a test order exists for the specimen (635). The cloud lab 130 can determine the presence of the test order by accessing the subject’s profile in the subject’s electronic medical record. If a test order does not exist (637), the cloud lab 130 can instruct the automated lab 120 to forward the specimen container for storage (638) within the housing of the automated laboratory system, or, alternatively, return the specimen container to the operator. As noted, the cloud lab 130 can direct the robotic system to utilize its grippers to remove the specimen container from the queue and transfer the specimen container to an appropriate storage compartment (e.g., a refrigerated compartment) within the housing. The specimen can be stored in the storage compartment until a test order for the specimen is received by the cloud lab 130. Once a test order is received, the cloud lab 130 can direct the automated laboratory 120 and the robotic system 170 to retrieve the specimen from the storage compartment (639).

[0086] If a test order is available for the specimen (636), the cloud lab 130 selects an appropriate laboratory testing system for carrying out the test (650). In doing so, the processor of the cloud lab 130 can access a database that stores a list of available tests and one or more appropriate laboratory systems for carrying out that test, and choose an appropriate and available instrument 651-653 for carrying out that test. For example, if the test is a chemistry test, the cloud lab 130 can determine that two of the instruments 651-653 can be used to carry out that chemistry test. The cloud lab 130 can select one of the instruments 651 for carrying out that test. In selecting between the two instruments 651-652, the cloud lab 130 can review the specimens in queue for testing and select the instrument 651 with fewer specimens in queue for testing.

[0087] If the cloud lab 130 determines that an appropriate laboratory system for carrying out the test does not exist (e.g., the test cannot be completed via any of the available instruments 651-653, the specimen is returned to the operator and a notification is issued via the visual interface 147. The clinician (or a staff member at the location where the specimen is obtained) can make determine if the returned specimen should be sent out to another facility and/or laboratory for processing.

[0088] Depending on the instrument selected, the cloud lab 130 can determine if the specimen should be prepared prior to being forwarded to the laboratory system. If the specimen does not require preparation 651a, the cloud lab 130 can direct the robotic system to remove the specimen queue and deliver the specimen to a receptacle of laboratory system 651. [0089] If the cloud lab 130 determines that the sample requires preparation, the cloud lab 130 can direct the robotic arm 170 to prepare the sample 660 prior to processing by the appropriate instrument 652-653. Depending on the type of specimen, a specimen being sent out for processing by other facilities can also be prepared before being sent out. Such operations can include centrifuging, aliquoting, serum/ plasma separation, pipetting into relevant consumables, and dilution/mixing. These operations can also be performed by a qualified operator prior to loading of the sample, if required.

[0090] Sample preparation 660 can begin by decapping (z.e., removing the cover) of the specimen container. The decapping of the specimen container 662 can be carried out under the direction of the cloud lab 130. For example, the cloud lab 130 can direct the robotic arm to carry the specimen container to a decapper-recapper 270 (shown later in FIG. 7) that removes the cover of the specimen container. Prior to decapping, the robotic arm can hold the specimen container within its grippers, invert the sample container a predetermined number of times, and carry the specimen container to a module that removes the cap from the container.

[0091] FIG. 7 graphically illustrates a decapper-recapper 270 according to some embodiments disclosed herein. The decapper-recapper 270 can comprise a collector mechanism 710 configured to form a tight grip (e.g., tight, diametrical grip of a specimen tube) of the cap of the specimen container. In operation, the tight grip is formed when the robotic arm brings a specimen container in contact with the collector mechanism. Once the tight grip between the collector 710 and the cap is formed, the robotic arm can perform a function to remove the cap from the specimen container. For example, the robotic arm can pull (e.g., for a friction fit cap) or twist (e.g., for a screw top cap) to remove the cap from the container. The decapper-recapper 270 can further be utilized to recap a specimen container in order to save any remaining portion of the specimen. The robotic arm can use force feedback functionality to ensure correct placement of the cap onto the specimen container. The specimen container 202, with or without the attached cap 203, can be moved by the robotic arm after decapping.

[0092] Depending on the instrument being used to carry out testing of the specimen, the cloud lab 130 can determine if additional elements (z.e., consumables) are required to carry out the test. For example, the processor can determine if a reaction strip or a strip well plate 663a, any reagent discs 663b, or any pipetting tips 663c are required for carrying out the test. Upon determining that additional elements are required for carrying out the test, the cloud lab 130 can direct the robotic arm to obtain these elements/consumables from their corresponding storage space within the automated laboratory system 120.

[0093] As noted, the automated laboratory system 120 can comprise a storage compartment 290 for storing the consumables. FIG. 8 graphically illustrates a consumable storage compartment 290 according to some embodiments disclosed herein. Generally, the consumable storage compartment 290 can be disposed within the housing of automated laboratory system 120 at a location that allows access and loading of the consumables. For example, the consumable compartment can be disposed on or near the front surface of the automated laboratory system 120 to allow easy access for loading of the consumables (e.g., by a human user or a computerized robot). The consumable storage compartment 700 can further be configured such that it allows removal of the consumables from within the cavity of the housing. For example, the consumable storage compartment 700 can be configured such that it allows the robotic arm to access the back of the compartment 700 (from inside the cavity of the housing) to remove a consumable.

[0094] The consumable compartment 290 can comprise one or more receptacles 810, each configured to receive at least one consumable. Each receptacle 820 can comprise at least one sensor 821 configured to sense correct loading of a consumable into the receptacle 810. Each receptacle 810 can further comprise an indicator 830 configured to indicate that the consumable has been correctly loaded into the receptacle 810. The indicator 830 can generally be any suitable indicator available in the art. For example, the indicator 830 can be a visual indicator (e.g., green light to indicate correct placement) and/or an audio indicator (e.g., an alarm to indicate incorrect placement). In some implementations, each loading station can comprise a sensor and an LED light configured to visually communicate to the user that the consumable is correctly loaded. The location of a loaded consumable can be sent to the robotic arm by the processor, based on test order received. As detailed above, each consumable is scanned after retrieval to ensure that the consumable is the correct consumable and has valid expiry/stability.

[0095] Referring back to FIG. 6, at least some of the consumables 663a-633b can be packaged in factory packaging, such as a shrink-wrap or a wrapping bag. Once the robotic arm has obtained the relevant consumables, the processor determines if a consumable needs to be removed from its packaging. The process of removing a consumable from its packaging is referred to herein as “debagging” (665). [0096] FIG. 9 graphically illustrates an example debagger 900 according to embodiments disclosed herein. The debagger 900 can be configured to separate and remove packaging 802 of consumables 901 and other elements handled by the various components of the automated laboratory system 120. The debagger 900 can comprise a plurality of sensors 910 configured to detect successful removal of a consumable 801 from its packaging 902. This knowledge can be based on the test order (as directed by the processor). For example, most or all chemistry tests can require debagging of consumables. The debagger 900 can comprise a clamping mechanism 930 that engages the consumable 901 and its packaging 902 while the consumable packaging 902 is being handled by the robotic arm. A cutting mechanism 920 utilizes a blade 940 to cut the packaging. The debagger 900 can further comprise a package separator mechanism 950 that separates the packaging from the consumable and locates the consumable 901 for removal from its packaging 902. The packaging 902 can be delivered (e.g., by the robotic arm) to a waste receptacle of the automated laboratory system 120. The waste receptacle can be disposed within the housing 299 of the automated laboratory system.

[0097] Referring back to FIG. 6, sample preparation 660 further includes pipetting 668 at a sample preparation station 280. Pipetting 668 can be carried out under the direction of the cloud lab 130 by controlling the robotic arm. For example, the cloud lab 130 can direct the robotic arm to bring the specimen container to the sample preparation station 280, where pipetting 668 can be carried out, while utilizing the consumables obtained from the consumable receptacle(s) 290. FIG. 10 is a graphical illustration of a sample preparation station 280 (e.g., sample bay) according to some embodiments disclosed herein. The sample preparation station 280 can comprise one or more sample bays 1010, 1020. Each sample bay can comprise at least five dimensions of movement (e.g., along the X, Y, and Z dimensions, pipetting, and disc spin). The specimen can be dispensed from the specimen container into various consumables (e.g., a strip well or a reagent disc), or into a secondary specimen container. For example, the specimen can be pipetted into a strip well, which is subsequently delivered to a laboratory testing system for testing. Any remaining specimen within the specimen container can be saved for potential later use (FIG. 6, 670). For example, once pipetting is completed, the robotic arm can transfer the specimen container to the decapper- recapper 270 and recap the specimen container and deliver the container to a storage compartment (e.g. a refrigerated storage container) for potential later use (FIG. 6, 638). The sample preparation station 280 can be configured to provide for simultaneous preparation of various samples from various test subjects. Additionally, sample preparation can be performed simultaneously in cases where there are multiple test orders that each require a consumable appropriate for that instrument. In some implementations, the cloud lab 130 can determine if the remaining sample needs to be frozen (FIG. 6, 667). If a sample requires freezing (FIG. 6, 669), it can be ejected (FIG. 6, 640) so that it can be frozen at a suitable location outside of the automated laboratory system. The sample preparation station bays can be configured to operate in concert with the robotic arm 170 or other lab automation mechanisms.

[0098] Referring back to FIG. 6, the pipetted samples can be forwarded to appropriate laboratory testing systems 652-653 for analysis and testing. As detailed with respect to FIG. 1, the results of the tests can be forwarded via the communications network to the cloud laboratory 130 for validation. Any remaining specimen after the completion of the test via the laboratory testing systems 652-653 can be forwarded to a specimen waste bin 690 onboard of the automated laboratory system 120. Alternatively, the specimen can be returned to the onboard refrigerated storage for storing for possible future use. For example, the specimen can be stored to allow for a possible retest order or additional follow-on test orders. In the example shown in FIG. 6, the remaining sample is discarded in the waste bin at the end of daily operation.

[0099] FIG. 11 is a high-level diagram of a virtual laboratory system 100 according to some embodiment disclosed herein. The virtual laboratory system can include one or more automated laboratory systems 120, 120’, 120” that are connected via a communications network 110 to a cloud laboratory 140. Each automated laboratory system 120, 120’, 120” can be disposed at a different facility 1101, 1101’, 1101”. Each facility 1101, 1101’, 1101’ can be a facility where a specimen is obtained or received from a test subject. The cloud laboratory 140 enables remote monitoring of each connected automated laboratory system 120, 120’, 120” and provides oversight for conducting laboratory tests via the connected automated laboratory systems 120, 120’, 120”. For example, the cloud laboratory 140 can monitor and control the initialization, calibration, and other functions of the onboard instruments of each connected automated laboratory system 120, 120’, 120”. The cloud laboratory 140 can also enforce a workflow for each instrument included in each automated laboratory system 120, 120’, 120” and prevent operators from running patient samples on any onboard instrument that has not been subjected to and passed the relevant quality controls check. [00100] The cloud laboratory 140 receives the test results obtained at each of the connected automated laboratory system 120, 120’, 120” and presents the results (for example, via an interface 135) to a certified clinical laboratory scientist for review. In the case of patient samples, once approved by a certified laboratory scientist, the test results can be forwarded to an EHR system 146 for inclusion in the test subject’s electronic medical/health records and reviewed by the ordering physician.

[00101JFIG. 12 is a high-level diagram of procedures for carrying out a test via the virtual laboratory system 100 disclosed herein. As detailed above, the operations carried out by the virtual laboratory system 100 can be conducted at a testing facility 1101 (e.g., at a physician’s office where a physician places an order for certain tests for the patient) via the automated laboratory system and verified and confirmed at the remote cloud laboratory 130 before being presented to a clinician at the testing facility 1101. At the testing facility 1101, a physician places an order for a test for a patient via an EMR system 146. Upon release of the results from the virtual lab 100, the result(s) is passed back to the physician’s EMR and saved in an appropriate database 146 (e.g., patient’s Electronic Medical/Health Records (EMR/EHR)).

[00102] The patient presents to an operator, who obtains a specimen from the patient and deposits the specimen into a specimen container. The specimen container (e.g., a sample tube) is then inserted into the automated laboratory system 120 (by an operator at the testing facility 1201). Once the specimen container is in the housing of the automated laboratory system 120, the cloud lab 130 is responsible for providing commands and control functions necessary for scanning incoming samples, communicating with the cloud laboratory for disposition, and directing sample preparation and executing various tests. The automated laboratory 120 is configured communicate with the cloud lab 130 and accept predefined standards for input, granting the ability to differentiate between external controls, maintenance and cleaning routines, patient samples, etc. Based on the input, the automated laboratory 120 executes appropriate sample preparation and provide results of the test at hand. The operator can continue to insert samples into the automated laboratory system 120, which dynamically updates its operational queue to continuously optimize the turn around times (TAT) of the system. Upon completion of any individual test, the test results are transmitted via a communications network 110 to the cloud laboratory 130. Once validated at the cloud laboratory 130, the test results are uploaded into the test subject’s Electronic Medical/Health Records (EMR/EHR) for viewing by the ordering clinician. [00103] FIG. 13 is a high-level diagram of procedures for testing a test subject via the virtual laboratory systems disclosed herein. A clinician can order one or more tests to be carried out on a specimen obtained from a test subject 1310. The test order is transmitted to the cloud laboratory system 1320. During the patient visit, the phlebotomist accessions the specimen to the patient, which is also transmitted to the cloud laboratory. When an operator inserts that specimen tube to the automated laboratory system, the automated laboratory system retrieves the associated order(s) from the cloud laboratory. The test order is carried out at the automated laboratory testing system and the results are forwarded back to the cloud laboratory 1350 for review and approval by a certified clinician 1360. Once approved, the results are uploaded to an EMR/EHR for viewing by the test subject’s care team.

[00104] FIG. 14 is a high-level block diagram of an example of the operation of the virtual laboratory system disclosed herein. A clinician (e.g., a primary care physician) can review their appointments for the day and determine which tests they would like to order for each patient. The clinician can enter the desired test orders for each patient in the patient’s electronic medical records 1540. This order is transmitted into the virtual laboratory via the EMR integration. A test subject (e.g., a human patient) can arrive at the clinician’s office (e.g., the primary care office) some time (e.g., thirty minutes) before a scheduled appointment with their practitioner. The staff at the clinician’s office will obtain the relevant specimens from the patient (e.g., blood, urine, etc.) and place the specimen container in the receptacle of the automated laboratory testing system at that location. The automated testing system detects the new specimen container and carries out the requested tests in the test order 1370. The test results are forwarded by the automated laboratory testing system to a cloud laboratory system for review and approval 1370. Once approved, the results are uploaded and reported into the patient’s electronic medical record for the physician’s review 1440. The physician and the patient can review the test results during the patient’s scheduled appointment 1450. If the physician decides that additional testing is required, they can place another order for the additional tests. As the patient’s specimens are stored onboard of the automated laboratory testing system, there is no need to obtain another sample from the patient. The system automatically detects the presence of a new test order and conducts the additional test 1420.

[00105] While specific embodiments of the present disclosure have been outlined above, many alternatives, modifications, and variations will be apparent to those skilled in the art. The embodiments set forth herein are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the disclosure. Although the methods and procedures described above indicate certain events occurring in a certain order, those of ordinary skill in the art having the benefit of this disclosure recognize that the ordering of certain elements may be modified, and such modification is in accordance with the variations of the invention. Further, certain of the steps may be performed concurrently in a parallel process, when possible, as well as performed sequentially as described above. The embodiments have been particularly shown and described, but it will be understood that various changes in form and details may be made.

Claims

1. An automated laboratory system, comprising: a housing comprising a receptacle configured to receive a biological specimen; a plurality of biological specimen testing instruments disposed within a cavity of the housing; a processor configured to receive, from a remote cloud laboratory system, instruction for operating a biological specimen testing instrument from the plurality of biological specimen testing instruments to carry out a test on the biological specimen; and a robotic arm connected to the processor and configured to deliver the biological specimen to the biological specimen testing instrument.

2. A cloud laboratory system, comprising: a management interface configured to connect to a plurality of automated laboratory systems via a communications network, each laboratory system comprising a plurality of biological specimen testing instruments disposed within a housing; and a cloud laboratory processor configured to receive a test order indicating a test for carrying out a test using a laboratory system, analyze the test order, select a biological specimen testing instrument from among the plurality of biological specimen testing instruments in the laboratory system, and forward instructions for carrying out the test to the laboratory system.

3. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the automated laboratory system is configured to connect to the cloud laboratory via a communications network.

4. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the biological specimen comprises at least one of: blood, urine, saliva, and tissue.

5. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to receive, from the cloud laboratory, information pertaining to a consumable required for carrying out the test using the biological specimen testing instrument.

6. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to instruct the robotic arm to obtain the consumable and deliver the consumable to the biological specimen testing instrument.

7. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the consumable is stored within the housing.

8. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the housing comprises a consumable storage compartment.

9. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to receive, from the cloud laboratory, instructions for operating the biological specimen testing instrument.

10. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein instructions comprise instructions for selecting a consumable to use with the biological specimen testing instrument.

11. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein instructions comprise location of the consumable within the housing.

12. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein instructions comprise instructions for directing the robotic arm to deliver the consumable to the biological specimen testing instrument.

13. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein instructions comprise instructions for directing the robotic arm to remove the consumable from its packaging.

14. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the instructions include directions for interacting with an interactive screen of the biological specimen testing instrument to carry out the test.

15. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to receive results of the test from the biological specimen testing instrument and forward the results to the cloud laboratory for validation.

16. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to forward information relating to operating status of the biological specimen testing instrument to the cloud laboratory.

17. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the information relating to the operating status comprises at least one of alerts and notifications of possible issues with the biological specimen testing instrument.

18. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the information relating to the operating status comprises information relating to environmental conditions of the biological specimen testing instrument to the cloud laboratory.

19. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the receptacle comprises at least one sensor configured to detect presence of the biological sample within the receptacle.

20. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the biological specimen is disposed in a container, the container comprising a label including information relating to the biological specimen.

21. The automated laboratory and cloud laboratory systems of any of the previous claims, further comprising a scanner disposed within the housing and configured to scan the label to extract the information relating to the biological specimen from the label, the scanner being connected to the processor and configured to forward the extracted information to the processor.

22. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to forward the information relating to the biological specimen to the cloud laboratory.

23. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the information comprises a specimen identifier.

24. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to receive, from the cloud laboratory, instructions for carrying out the test the biological specimen testing instrument.

25. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the instructions are received in response to transmission of the information relating to the biological specimen to the cloud laboratory.

26. The automated laboratory and cloud laboratory systems of any of the previous claims, further comprising a temperature-controlled compartment disposed within the housing.

27. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to receive instructions from the cloud laboratory instructing storage of the biological specimen in the temperature-controlled compartment.

28. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is further configured to receive instructions for directing the robotic arm to deliver the biological specimen to the temperature-controlled compartment.

29. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is configured to direct the robotic arm to deliver the biological specimen to the temperature-controlled compartment and store the specimen therein.

30. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is further configured to receive, from the cloud laboratory, instructions for directing the robotic arm to prepare the biological specimen prior to storage.

31. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the processor is further configured to receive instructions for directing the robotic arm to prepare the biological specimen prior to use for testing using the biological specimen testing instrument.

32. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the robotic arm comprises at least one gripper structure.

33. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the at least one gripper is configured to handle the container carrying the biological specimen.

34. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the robotic arm is configured to rotate in at least six dimensions within the housing.

35. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the robotic arm is configured to hold the container carrying the biological specimen and rotate the specimen within the container.

36. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the robotic arm comprises a first end fixed to a platform within the housing and a second end having at least two extensions configured to move independent of one another.

37. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the at least two extensions are configured to form a gripper structure.

38. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the gripper structure is configured to handle the biological specimen.

39. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein at least one extension comprises a stylus configured to interact with an interactive interface of the biological specimen testing instrument.

40. The automated laboratory and cloud laboratory systems of any of the previous claims, further comprising a sample preparation station disposed within the housing and configured to prepare the biological specimen prior to use by the biological specimen testing instrument selected for carrying out the test.

41. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the sample preparation station comprises an engagement mechanism configured to engage a cover of the container in which the biological specimen is disposed.

42. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the cloud laboratory system processor is configured to forward instructions, to the automated laboratory, that direct the robotic arm to carry the container to the engagement mechanism and engage the cover of the container in the engagement mechanism.

43. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the cloud laboratory system processor is configured to forward instructions, to the automated laboratory, that direct the robotic arm to carry the container, upon removal of the cover, to a pipetting station.

44. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the cloud laboratory system processor is configured to determine whether the biological specimen testing instrument selected for carrying out the test requires a consumable for preparing the biological specimen and direct the robotic arm to carry the consumable to the selected biological specimen testing instrument.

45. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the biological specimen comprises a blood sample.

46. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the automated laboratory is configured to connect to the remote laboratory management system via a communication network, the laboratory management system being configured to provide the automated laboratory with operating instruction for operating at least one of the plurality of biological specimen processing instruments.

47. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the management interface is configured to determine a consumable required for carrying out the test using the biological specimen testing instrument and forward information identifying the consumable to the laboratory system.

48. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the management interface is further configured to connect to a database configured to store patient information.

49. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the database comprises an Electronic Health Record database.

50. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the database comprises an insurance provider database.

51. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the management interface is configured to connect to at least one auxiliary biological specimen testing instrument via the communications network.

52. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the at least one auxiliary biological specimen testing instrument comprises a benchtop instrument.

53. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the management interface is configured to obtain information relating to at least one of: a workflow of the plurality of biological specimen testing instruments and workflow of the at least one auxiliary biological specimen testing instrument.

54. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the management interface is configured to receive results of the test carried out by the laboratory system.

55. The automated laboratory and cloud laboratory systems of any of the previous claims, further comprising a visual interface configured to provide an operator operating access to the management interface.

56. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the visual interface is configured to provide the operator with access to information regarding the workflow of the plurality of biological specimen testing instruments.

57. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the visual interface is configured to provide the operator with access to information regarding the workflow of the at least one auxiliary biological specimen testing instrument.

58. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the visual interface is configured to provide the operator with access to patient information.

59. The automated laboratory and cloud laboratory systems of any of the previous claims, wherein the patient information comprises information obtained from at least one of the Electronic Health Record database and the insurance provider database.

60. The automated laboratory and cloud laboratory systems any of the previous claims, wherein the at least one auxiliary biological specimen testing instrument comprises at least one of: a standalone laboratory facility and a standalone laboratory system.

61. The automated laboratory and cloud laboratory systems any of the previous claims, wherein the cloud laboratory system is configured to receive working status of the automated laboratory.

62. The automated laboratory and cloud laboratory systems any of the previous claims, wherein the working status of the automated laboratory comprises at least one current run status of biological specimen testing instrument, temperature, humidity, safety and access ports, readiness and availability of sample-tube carousels, on-board inventory of consumables, calibration and maintenance status of biological specimen testing instruments.

63. The automated laboratory and cloud laboratory systems any of the previous claims, wherein the cloud laboratory system is configured to receive working status of the auxiliary laboratories.