WO2018136859A1 - Préparation de panneaux de test personnalisés - Google Patents

Préparation de panneaux de test personnalisés Download PDF

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Publication number
WO2018136859A1
WO2018136859A1 PCT/US2018/014640 US2018014640W WO2018136859A1 WO 2018136859 A1 WO2018136859 A1 WO 2018136859A1 US 2018014640 W US2018014640 W US 2018014640W WO 2018136859 A1 WO2018136859 A1 WO 2018136859A1
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WO
WIPO (PCT)
Prior art keywords
test
panel
arrays
array
biological testing
Prior art date
Application number
PCT/US2018/014640
Other languages
English (en)
Inventor
David Lewis
Mary MCKINNON
Robert CARRERAS
Veena VANGANI
Original Assignee
Beckman Coulter, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Beckman Coulter, Inc. filed Critical Beckman Coulter, Inc.
Publication of WO2018136859A1 publication Critical patent/WO2018136859A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/0092—Scheduling
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices
    • B01L9/06—Test-tube stands; Test-tube holders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/026—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having blocks or racks of reaction cells or cuvettes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/143—Quality control, feedback systems
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B01L2300/022—Transponder chips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5085—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
    • B01L3/50855—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates using modular assemblies of strips or of individual wells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00346—Heating or cooling arrangements
    • G01N2035/00356—Holding samples at elevated temperature (incubation)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0401—Sample carriers, cuvettes or reaction vessels
    • G01N2035/0412—Block or rack elements with a single row of samples
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0401—Sample carriers, cuvettes or reaction vessels
    • G01N2035/0427—Sample carriers, cuvettes or reaction vessels nestable or stockable
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0401—Sample carriers, cuvettes or reaction vessels
    • G01N2035/0429—Sample carriers adapted for special purposes
    • G01N2035/0436—Sample carriers adapted for special purposes with pre-packaged reagents, i.e. test-packs
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/046—General conveyor features
    • G01N2035/0465—Loading or unloading the conveyor

Definitions

  • microbes are microscopic living organisms such as bacteria, fungi, or viruses, which may be single-celled or multicellular.
  • Biological samples containing the patient's microorganisms may be taken from a patient's infections, bodily fluids or abscesses and may be placed in test panels or arrays, combined with various reagents, incubated, and analyzed to aid in treatment of the patient.
  • An antimicrobial is an agent that kills microorganisms or inhibits their growth, such as antibiotics which are used against bacteria and antifungals which are used against fungi.
  • antibiotics which are used against bacteria
  • antifungals which are used against fungi.
  • the demand for biochemical testing has increased in both complexity and in volume.
  • Microbial growth is an increase in cell number, rather than cell size.
  • microbial growth in bacteria is provided through binary fission, where the cell divides from one cell into two daughter cells. No growth results when the binary fission is inhibited through some environmental factor such as temperature or lack of nutrients.
  • Automated microbiological analyzers function as a diagnostic tool for determining both the identity of an infecting microorganism and of an antimicrobic effective in controlling growth of the microorganism.
  • identification and in vitro antimicrobic susceptibility patterns of microorganisms isolated from biological samples are ascertained.
  • Conventional versions of such analyzers may place a small sample to be tested into a plurality of small sample test wells in panels or arrays that contain different enzyme substrates or antimicrobics in serial dilutions.
  • ID testing of microorganisms may utilize color changes, fluorescence changes, the degree of cloudiness (turbidity) in the sample test wells created in the arrays, or other information derived from the testing.
  • AST and ID measurements and subsequent analysis may be performed by computer controlled microbiological analyzers to provide advantages in reproducibility, reduction in processing time, avoidance of transcription errors and standardization for all tests run in the laboratory.
  • a standardized dilution of the patient's microorganism sample known as an inoculum
  • This inoculum is placed in a plurality of test wells that may contain or thereafter be supplied with predetermined test media. Depending on the species of microorganism present, this media will facilitate changes in color, turbidity, fluorescence, or other characteristics after incubation. These changes are used to identify the microorganism in ID testing.
  • a plurality of test wells are filled with inoculum and an increasing concentrations of a number of different antimicrobial agents, for example antibiotics.
  • the different antimicrobial agents may be diluted in a growth medium or liquid medium to concentrations that include those of clinical interest. After incubation, the turbidity will be increased or unchanged in test wells where growth has not been inhibited by the antimicrobics in those test wells.
  • the MIC of each antimicrobial agent is measured by lack of growth with respect to each concentration of antimicrobial agent. It follows that the lowest concentration of antimicrobial agent displaying a lack of growth is the MIC.
  • FIG. 1A depicts a portion of a diagrammatic view of an exemplary biological testing system
  • FIG. IB depicts another portion of the diagrammatic view of the exemplary biological testing system of FIG. 1A;
  • FIG. 2 depicts a perspective view of the biological testing system of FIGS. 1A and IB;
  • FIG. 3 depicts a diagrammatic view of exemplary consumable elements of biological testing system of FIGS. 1A and IB;
  • FIG. 4 depicts a diagrammatic view of an exemplary computer system that may be incorporated into or otherwise associated with the biological testing system of FIGS. lA and IB;
  • FIG. 5 depicts a diagrammatic view of exemplary test array magazines and an exemplary test panel formed by a consumable preparation system of the biological testing system of FIG. IB;
  • FIG. 6A depicts a perspective view of an exemplary test array used in the biological testing system of FIGS. 1A and IB and having an unpierced foil layer;
  • FIG. 6B depicts a perspective view of the exemplary test array of FIG. 6A having a pierced foil layer
  • FIG. 7 depicts a perspective view of exemplary consumables for use with the biological testing system of FIGS. 1A and IB, including an exemplary test array magazine, an exemplary test array, and two exemplary test panels;
  • FIG. 8 depicts a perspective view of an exemplary panel tray for use with the biological testing system of FIGS. 1A and IB, with an exemplary test array disposed therein;
  • FIG. 9 depicts a cross-sectional view of the panel tray of FIG. 8 taken along line
  • FIG. 10 depicts a cross-sectional view of another exemplary panel tray similar to the panel tray depicted in FIG. 9;
  • FIG. 11 depicts a diagrammatic view of exemplary elements utilized in an exemplary hammer method of forming a test panel in the biological testing system of FIGS. lA and IB;
  • FIG. 12 depicts another diagrammatic view of exemplary elements utilized in the exemplary hammer method of forming a test panel in the biological testing system of FIGS. lA and IB;
  • FIG. 13 depicts a flow chart of the hammer method of forming a test panel in the biological testing system of FIGS. 1A and IB;
  • FIG. 14 depicts a diagrammatic view of exemplary elements utilized in an exemplary gripper method of forming a test panel in the biological testing system of FIGS. lA and IB;
  • FIG. 15 depicts a flow chart of the gripper method of forming a test panel in the biological testing system of FIGS. 1A and IB;
  • FIG. 16 depicts a flow chart of an exemplary heuristic method of determining what inventory needs to be loaded into the biological testing system of FIGS. 1A and IB.
  • FIGS. 1A and IB depict a diagrammatic example of various components available in a biological testing system 1.
  • Biological testing system 1 broadly includes a consumable preparation system 3, an inoculating system 5, an incubator system 7, and an optics system 9.
  • the various systems within biological testing system 1 coordinate with each other and work automatically once loaded with adequate material by a user.
  • a microbe sample may be obtained from an agar plate 11 or under certain circumstances, a blood sample may be used.
  • the user prepares an inoculum suspension by transferring the microbes into a tube containing a suitable liquid medium.
  • a suitable liquid medium is shown in FIG. 1A as an inoculum 13.
  • the liquid medium or broth may be an approximately 0.5 mM phosphate buffered solution with small amounts of sodium and potassium chloride to aid in maintaining the viability of the microbes introduced into solution without adversely interfering with the MIC determination or other associated testing.
  • each inoculum 13 is placed into an inoculum rack 15 and the entire inoculum rack 15 is placed into inoculating system 5.
  • the inoculum in each inoculum 13 is adjusted if necessary to a standard turbidity value of 0.5 McFarland to create an inoculum 17.
  • a 1 microliter plastic loop or swab may be provided to the user to easily pick colonies from the agar plate and to minimize the amount of adjustment needed to bring the inoculum to the desired turbidity value.
  • the inoculum is finalized. The finalized inoculum will be referred to hereinafter as inoculum 17, as depicted in FIG.
  • Inoculum 17 may be further diluted into a 1:250 dilution and converted into an inoculum 18.
  • the inoculum contained in each inoculum 17 is applied to an identification (ID) test panel 21, while the inoculum contained in each inoculum 18 is applied to an AST test panel 23.
  • ID test panel 21 and AST test panel 23 are assembled by consumable preparation system 3 and provided to inoculating system 5 for use with inoculum 17 and inoculum 18.
  • Consumable preparation system 3 is loaded with magazines of test arrays 19, which may contain various antimicrobials or other agents required by biological testing system 1 disposed in a series of test wells 20.
  • test array 19 may comprise an antimicrobic dilution array or an identification array.
  • Consumable preparation system 3 may also be loaded with a bulk diluent 29 (FIG. 3) and/or various other elements for preparing and finalizing ID test panel 21 and AST test panel 23 and the inoculate therein.
  • consumable preparation system 3 operates to retrieve test arrays 19 as required and combine each retrieved test array 19 into either ID test panel 21 or AST test panel 23.
  • Test arrays 19 may be selected and assembled by a robotic gripper (not shown) or other mechanical features as dictated by the prescribed testing. For example, a physician may order biological testing using the antibiotic amoxicillin. Test arrays 19 relating to amoxicillin testing are therefore retrieved and inserted into a frame or tray to assemble the appropriate ID test panel 21 and AST test panel 23.
  • test array 19 may be formed of a styrene material to aid in reducing fluorescent crosstalk, fallout, and/or bubbles when digitally examining each test well 20. It has been found that a test array 19 formed of a styrene material is adequate for rehydration and does not require a corona treatment to prevent inoculum or diluents from flaking out of test wells 20.
  • An exemplary method of insertion may include direct pipetting into the frame or tray. However, the piercing of the trays or test wells due to direct pipetting may increase or facilitate evaporation of the contents therein as the test well remains open after insertion.
  • the frame or tray itself may include pathways to allow for inoculation of the test wells via pressure or vacuum methods instead of pipetting.
  • inoculating system 5 facilitates the dispensing of the generally undiluted inoculum from inoculum 17 into test wells 20 of ID test panel 21 and the diluted inoculum from inoculum 18 into test wells 20 of AST test panel 23.
  • the time between applying inoculum 17 to ID test panel 21 or inoculum 18 to AST test panel 23 and the start of logarithmic growth of the microbes disposed therein is known as "lag time.”
  • Lag time may be decreased by using enhanced broth such as a broth with yeast extract, vitamins, and/or minerals.
  • Lag time may also be decreased by increasing the inoculum.
  • the amount of inoculum may be doubled to decrease the lag time by approximately 30 minutes without affecting the accuracy of the MIC determination.
  • the dispensing may be accomplished via an XY or XYZ robot (not shown) with a gripper (not shown) and pipettor (not shown), along with various circuitry, channels, and tubing as necessary, as may be shown in co-pending application having Attorney Docket reference 16US0032-PRO.
  • the XYZ robot is tasked with retrieving inoculum from inoculum racks 15 and dispensing the inoculum into test wells 20 of ID test panel 21 and AST test panel 23. Once ID test panel 21 and AST test panel 23 are sufficiently loaded with inoculum, each ID test panel 21 and AST test panel 23 are moved into incubator system 7.
  • biological testing system 1 is generally sized to allow a user to manually manipulate the various components therein.
  • the manual user interaction may include inserting various components into biological testing system 1, such as consumable materials.
  • biological testing system 1 a user inserts test array magazines 25 into a test array magazine receptacle 35 and bulk diluent 29 into a diluent receptacle 31.
  • Some versions of biological testing system 1 require a panel frame 27 for forming ID test panel 21 and/or AST test panel 23.
  • a user may insert panel frames 27 into panel frame receptacle 33 for use by biological testing system 1.
  • the user also inserts bulk diluted inoculum elements 22 into an inoculum receptacle 39. Diluted inoculum elements 22 may be later used by biological testing system 1 to form inoculums 17 and 18.
  • the user may also insert elements relating to the patient's sampled microbes, for example inoculum rack 15, which may be inserted into a sample receptacle 37.
  • biological testing system 1 may incorporate one or more computing devices or systems, such as an exemplary computer system 48.
  • any one of consumable preparation system 3, inoculating system 5, incubator system 7, and/or optics system 9 may incorporate one or more computing systems such as exemplary computer system 48.
  • each of these subsystems of biological testing system 1 may function via commands from one overall computing system such as exemplary computer system 48.
  • Computer system 48 may include a processor 50, a memory 52, a mass storage memory device 54, an input/output (I/O) interface 76, and a Human Machine Interface (HMI) 58.
  • Computer system 48 may also be operatively coupled to one or more external resources 60 via a network 62 or I/O interface 76.
  • External resources may include, but are not limited to, servers, databases, mass storage devices, peripheral devices, cloud- based network services, or any other suitable computer resource that may used by computer system 48.
  • Processor 50 may include one or more devices selected from microprocessors, micro-controllers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines, logic circuits, analog circuits, digital circuits, or any other devices that manipulate signals (analog or digital) based on operational instructions that are stored in memory 52.
  • Memory 52 may include a single memory device or a plurality of memory devices including, but not limited, to read-only memory (ROM), random access memory (RAM), volatile memory, non-volatile memory, static random access memory (SRAM), dynamic random access memory (DRAM), flash memory, cache memory, or any other device capable of storing information.
  • Mass storage memory device 54 may include data storage devices such as a hard drive, optical drive, tape drive, non-volatile solid state device, or any other device capable of storing information.
  • Processor 50 may operate under the control of an operating system 64 that resides in memory 52.
  • Operating system 64 may manage computer resources so that computer program code embodied as one or more computer software applications, such as an application 66 residing in memory 52, may have instructions executed by the processor 50.
  • processor 50 may execute application 66 directly, in which case the operating system 64 may be omitted.
  • One or more data structures 68 may also reside in memory 52, and may be used by processor 50, operating system 64, or application 66 to store or manipulate data.
  • the I/O interface 76 may provide a machine interface that operatively couples processor 50 to other devices and systems, such as network 62 or external resource 60.
  • Application 66 may thereby work cooperatively with network 62 or external resource 60 by communicating via I/O interface 76 to provide the various features, functions, applications, processes, or modules comprising embodiments of the invention.
  • Application 66 may also have program code that is executed by one or more external resources 60, or otherwise rely on functions or signals provided by other system or network components external to computer system 48.
  • HMI 58 may be operatively coupled to processor 50 of computer system 48 in a known manner to allow a user to interact directly with the computer system 48.
  • HMI 58 may include video or alphanumeric displays, a touch screen, a speaker, and any other suitable audio and visual indicators capable of providing data to the user.
  • HMI 58 may also include input devices and controls such as an alphanumeric keyboard, a pointing device, keypads, pushbuttons, control knobs, microphones, etc., capable of accepting commands or input from the user and transmitting the entered input to the processor 50.
  • a database 70 may reside on mass storage memory device 54, and may be used to collect and organize data used by the various systems and modules described herein.
  • Database 70 may include data and supporting data structures that store and organize the data.
  • database 70 may be arranged with any database organization or structure including, but not limited to, a relational database, a hierarchical database, a network database, or combinations thereof.
  • a database management system in the form of a computer software application executing as instructions on processor 50 may be used to access the information or data stored in records of the database 70 in response to a query, where a query may be dynamically determined and executed by operating system 64, other applications 66, or one or more modules.
  • a user may insert multiple test array magazines 25 into biological testing system 1.
  • a user may insert test array magazine 25A into test array magazine receptacle 35 A, test array magazine 25B into test array magazine receptacle 35B, and test array magazine 25C into test array magazine receptacle 35C.
  • multiple test array magazines 25 may be stacked or otherwise grouped and inserted into a single test array magazine receptacle 35.
  • Each test array magazine 25 incudes a particular antimicrobic dilution or other testing element and therefore includes a magazine identifier 41 (FIG. 7) thereon.
  • Identifier 41 may comprise a bar code, quick response (QR) code, an RFID tag, and/or some other element configured to be read by computer system 48. Identifier 41 may also include human readable content in addition to the computer readable content. The human readable content of identifier 41 allows a user to select a desired antimicrobic or testing element and insert a particular test array magazine 25 containing this testing element into biological testing system 1. The selection and insertion of the desired test array magazine 25 ensures biological testing system 1 may form test panels 21, 23 which include this testing element, such as a desired antimicrobic.
  • Biological testing system 1 operates to separate individual test arrays 19 from test array magazines 25 to form test panel 21 or test panel 23 as needed to perform biological testing. As described previously, a user inserts panel frames 27 into biological testing system 1. As will be discussed in greater detail below, biological testing system 1 thereafter separates the required test arrays 19 from the various test array magazines 25 and inserts the separated test arrays 19 into panel frame 27 to form test panel 21 or test panel 23. The assembled test panel 21 or test panel 23 is thereafter used by biological testing system 1 for testing of a biological sample or microbe.
  • FIGS. 6A and 6B depict an exemplary test array 19. Some versions of test array
  • test array 19 may be rounded or disk-like, while other versions may be square shaped.
  • Exemplary test array 19 generally extends from a front end 43 to a back end 45, with individual test wells 20 disposed therebetween.
  • Some versions of front end 43 may include two surfaces 47 which converge to form a tip 49.
  • Some version of back end 45 may include a surface 51 formed in a generally rounded shape.
  • a top surface 53 and a pair of side surfaces 55 extend between front end 43 and back end 45.
  • An alignment fin 56 may extend outwardly away from each side surface 55. Alignment fins 56 are used to facilitate the insertion of test arrays 19 into panel frames 27 to form a firm abutment between test array 19 and panel frame 27.
  • Top surface 53 may include an identifier 57 for reading and identification of the particular test array 19 by computer system 48.
  • Top surface may also include a foil layer 59 or other material for use in protection of the testing elements contained in test wells 20 during shipping, human handling, and machine handling.
  • foil layer 59 may be pierced by biological testing system 1 to form an opening 61 associated with each test well 20. Openings 61 are formed in foil layer 59 after test panels 21, 23 are formed and prior to dispensing inoculum contained in inoculum 17 or inoculum 18 into test wells 20.
  • Test arrays 19 may also include a bottom surface 63 having a set of runners 65 that facilitate the lifting of test array 19 off bottom surface 63 to protect bottom surface 63 from debris and abrasion. Inasmuch as test wells 20 of test array 19 are optically read through the bottom surface 63, minimizing abrasion on bottom surface 63 may be desirable.
  • Panel frame 27 is filled with test arrays 19 in accordance with a selection protocol.
  • the selection protocol may be comprised of a physician's explicit instructions, a physician's preferred or default selection protocol, a predefined selection protocol stored in computer system 48, a user input selection protocol, or a combination or subset thereof.
  • the selection protocol for the formation of a particular AST test panel 23 may also be based at least in part on results obtained from an identification test done on the particular microbe at issue. For example, if the microbe is identified in through an identification test as a gram-positive bacterium, a first selection protocol might be used in the formation of AST test panel 23. If the microbe is identified as a gram-negative bacterium, a second selection protocol might be used in the formation of AST test panel 23.
  • each desired test array 19 is separated from the associated test array magazine 25 and inserted generally horizontally or laterally into panel frame 27 to form test panel 21 or test panel 23.
  • test array 19A is separated from test array magazine 25 and moved in the direction of Arrow A to be received into panel frame 27.
  • panel frame 27 includes a plurality of slots 67 defining a slot opening 69.
  • front end 43 of test array 19 enters slot opening 69 and proceeds to be received into slot 67.
  • the angle of surfaces 47 and tip 49 act to guide test array 19A into slot opening 69A and into slot 67 A.
  • the area surrounding each slot 67 of panel frame 27 may include a recess or other guide channel (not shown) for receiving alignment fins 56.
  • the coupling of alignment fins 56 with guide channels of panel frame 27 facilitates aligning each test array 19 as it is received into slot 67 and the firm holding of test array 19 therein.
  • some versions of biological testing system 1 may include a panel tray 71 for use with a test array 73.
  • Panel tray 71 is similar in many respects to panel frame 27 and like numbering will refer to like elements.
  • Test array 73 is similar in many respect to test array 19 and like numbering will refer to like elements. While test array 19 is configured to be generally horizontally inserted into panel frame 27, test array 73 is configured to be generally vertically inserted into panel tray 71.
  • test array 73 includes a pair of end fins 75, whereby one end fin 75 extends from front end 43 and the other end fin 75 extends from back end 45.
  • End fin 75 includes a blister or locking feature 77 extending therefrom.
  • Panel tray 71 defines a pocket 79 sized to receive end fin 75 of test array 73 therein.
  • Panel tray 71 further defines a detent feature 81 sized to receive locking feature 77 therein.
  • locking feature 77 of each end fin 75 is received into detent feature 81 of pocket 79 to hold each end of test array 73 firmly within panel tray 71.
  • Panel tray 71 includes detent features 81 for each available test array slot. For example, if panel tray 71 is configured to hold ten test arrays 73, panel tray 71 will correspondingly include ten detent features 81 on each side for receiving corresponding locking features 77 of each test arrays 73.
  • some versions of panel tray 71 may define a pocket 83.
  • Pocket 83 is proximate a locking flange 85 having a cam surface 87.
  • Locking flange 85 is resilient and may be pivoted in response to end fins 75 of test array 73 sliding over cam surface 87. The pivoting of locking flange 85 allows end fin 75 to slide over cam surface 87 and into pocket 83.
  • Test array 73 is thereby latched within panel tray 71 as locking flange 85 prevents test array 73 from moving in the vertical or horizontal direction along the longitudinal axis of test array 73. In operation, as test array 73 is vertically lowered into panel tray 71, end fins 75 press against cam surface 87 of locking flange 85.
  • locking flange 85 This pivots locking flange 85 outwardly to allow end fins 75 to slide past locking flange 85 and into pocket 83.
  • the resilient nature of locking flange 85 allows locking flange 85 to pivot back to a default generally vertical position and thereby lock end fins 75 in pocket 83 and thereby lock test array 73 in panel tray 71.
  • FIGS. 11-13 illustrate an exemplary hammer method 101 of forming ID test panel
  • Hammer method 101 utilizes an internal carousel 103 and a hammer element 105 to form test panels 21 and test panels 23 in accordance with selection protocols and using panel frames 27 and test array magazines 25. Hammer method 101 operates to move test arrays 19 generally horizontally or laterally into panel frame 27 to build ID test panel 21 and AST test panel 23.
  • Carousel 103 defines a series of carousel slots 107 angularly spaced around the periphery of carousel 103, with each carousel slot 107 sized to receive a corresponding test array magazine 25 therein.
  • hammer method 101 will be described with respect to forming test panel 23, an antimicrobial susceptibility testing (AST) style test panel.
  • AST antimicrobial susceptibility testing
  • ID identification testing
  • Hammer method 101 is generally coordinated through computer system 48, which actuates the various features and elements utilized by hammer method 101 once a user supplies consumable preparation system 3 with the necessary consumable supplies.
  • a user loads consumable preparation system 3 with empty panel frames 27 through panel frame receptacle 33 and test array magazines 25 through test array magazine receptacle 35.
  • a sensor 110 disposed proximate test array magazine receptacle 35 reads identifier 41 for each inserted test array magazine 25 and reports identifier 41 to computer system 48.
  • Computer system 48 coordinates with database 70 to determine an empty carousel slot 107 and to rotate carousel 103 to align the empty carousel slot 107 with the test array magazine receptacle 35. The user thereafter inserts the particular test array magazine 25 into the empty carousel slot 107. Information regarding the particular identifier 41 and placement of the particular test array magazine 25 within a particular carousel slot 107 is collected and stored in database 70 for later use in forming test panel 23. Alternatively, in some version of consumable preparation system 3, a user might load a stack of array magazines 25 whereby sensor 110 reads each test array magazine 25 in the stack and moves the particular test array magazine 25 into a particular empty carousel slot 107.
  • each carousel slot 107 defines an insertion opening 109.
  • Insertion opening 109 is configured to allow the passage of one test array 19 therethrough and in response to a force applied by hammer element 105.
  • Carousel 103, hammer element 105, and insertion openings 109 work in conjunction with a test panel assembly stage 111.
  • Test panel assembly stage 11 retrieves an empty panel frame 27 and moves the retrieved panel frame 27 to align an empty slot 67 of panel frame 27 with hammer element 105.
  • Computer system 48 rotates carousel 103 to align a desired test array 19 between hammer element 105 and panel frame 27.
  • an arm (not shown) moves the selected magazine array 25 to align the outermost test array 19 with insertion opening 109 of carousel slot 107 and between hammer element 105 and empty slot 67 of panel frame 27.
  • test array 19 is disposed between hammer element 105 and empty slot 67 of panel frame 27, hammer element 105 moves to apply a force to back end 45 of test array 19. This force separates test array 19 from test array magazine 25. Once test array 19 is separated from test array magazine 25, hammer element 105 continues to apply force to test array 19 and to move test array 19 out of carousel slot 107, through insertion opening 109, and into empty slot 67 of panel frame 27.
  • test panel assembly stage 111 moves test panel 23 to an elevator assembly 113.
  • Elevator assembly 113 moves test panel 23 into contact with a piercing feature 115.
  • Piercing feature 115 pierces foil layer 59 proximate each test well 20 (FIG. 6B) to open each test well 20 for further processing and the later introduction of either inoculum 17 or inoculum 18.
  • elevator assembly 113 moves the pierced test panel 23 out of consumable preparation system 3 and into inoculating system 5 for further processing.
  • hammer method 101 may be generally depicted as a series of steps.
  • Hammer method 101 begins with a step 117, whereby a user loads consumable preparation system 3 with panel frames 27 and test array magazines 25.
  • computer system 48 coordinates the insertion and tracking of each test array magazine 25 within consumable preparation system 3.
  • Step 117 thereafter proceeds to a step 119, whereby computer system 48 collects the next selection protocol for use in determining the necessary test arrays 19 for forming test panel 23.
  • step 119 proceeds to a step 121.
  • step 121 an empty panel frame 27 is selected and placed onto test panel assembly stage 111 and step 121 moves to a step 123.
  • step 123 carousel 103 is moved to align a desired test array 19 with hammer element 105. Step 123 thereafter proceeds to a step 125. In step 125, panel frame 27 is moved to align an empty slot 67 with hammer element 105 and step proceeds to a step 127.
  • step 127 hammer element 105 applies a force to the desired test array 19 to separate test array 19 from test array magazine 25 and slide test array 19 into the empty slot 67 of panel frame 27.
  • step 127 thereafter proceeds to a step 129.
  • step 129 a determination is made by computer system 48 regarding whether test panel 23 is complete in accordance with the selection protocol. If test panel 23 requires more test arrays 19, step 129 proceeds back to step 123. If test panel 23 is complete, step 129 proceeds to a step 131.
  • step 131 test panel 23 is moved from test panel assembly stage 111 to elevator assembly 113 and pierced by piercing feature 115 to open each test well 20. Thereafter, step 131 moves to a step 133 where test panel 23 is moved from consumable preparation system 3 into inoculating system 5.
  • FIGS. 14 and 15 illustrate an exemplary gripper method 201 of forming ID test panel 21 and AST test panel 23 in biological testing system 1.
  • Gripper method 201 utilizes an internal XYZ-robot 203 having a gripper element 205 to form test panels 21 and test panels 23 in accordance with selection protocols and using panel trays 71 and test array magazines 25.
  • Gripper method 201 operates to move test array 73 generally vertically into panel tray 71 to build ID test panel 21 and AST test panel 23.
  • XYZ-robot 203 may operate in any direction to select desired test arrays 73 from test array magazines 25 and place the test array 73 into panel tray 71. Similar to hammer method 101, test array magazines 25 are inserted into consumable preparation system 3, identified, and stored in accordance with commands issued by computer system 48. However, rather than a carousel 103, some versions of gripper method 201 stack each test assembly magazine 25 in a horizontal plane for direct overhead access by gripper element 205. Test assembly magazines 25 may be stacked on controllable shelving 207, which opens and closes to reveal different test assembly magazines 25 as desired.
  • XYZ-robot 203 uses gripper element 205 to pick the topmost panel tray 71 from a stack and place the selected panel tray 71 onto a working platform 209. Thereafter, for each required test array 73, the associated shelving 207 opens to reveal the particular test array magazine 25 and allow gripper element 205 to pick up the required test array 73. In some versions of gripper method 201, the lifting of test array 73 by gripper element 205 separates test array 73 from test array magazine 25. XYZ-robot 203 then moves the selected test array 73 over the selected panel tray 71 and deposits test array 73 therein. This process is repeated until test panel 23 is fully formed in accordance with the particular selection protocol.
  • gripper method 201 may be generally depicted as a series of steps. Method 201 presumes consumable preparation system 3 is appropriately loaded with test array magazines 25 and panel trays 71 and a selection protocol is loaded in computer system 48.
  • Method 201 begins with a step 211, whereby XYZ-robot 203 moves over the stack of panel trays 71 and grips the topmost panel tray 71 via gripper element 205. XYZ-robot 203 thereafter moves the selected panel tray 71 over working platform 209 and deposits the selected panel tray 71 thereon. Step 211 thereafter moves to a step 213. In step 213, computer system 48 works in conjunction with shelving 207 to expose the desired test array 73. Once the desired test array 73 is exposed to XYZ-robot 203, step 213 moves to a step 215.
  • step 215 XYZ-robot 203 moves over the desired test array 73 and grips test array 73 via gripper element 205. Step 215 thereafter moves to a step 217.
  • step 217 XYZ-robot 203 moves over panel tray 71 and deposits the gripped test array 73 into panel tray 71. Once the gripped test array 73 is deposited into panel tray 71, step 217 moves to step 219.
  • step 219 a determination is made by computer system 48 regarding whether test panel 23 is complete in accordance with the selection protocol. If test panel 23 is not fully assembled, step 219 proceeds back to step 213. If test panel 23 is fully assembled, step 219 proceeds to a step 221. In step 221, the assembled test panel 23 is moves out of consumable preparation system 3 and into inoculating system 5.
  • Biological testing system 1 requires a supply of test array magazines 25 during a given shift or run cycle. At the beginning of the next shift or run cycle, biological testing system 1 will require loading of additional test array magazines 25 to prevent workflow disruptions due to low or empty inventory for a given type of test array magazine 25. The user will know the inventory that was previously loaded, but will not know which test array magazines 25 to select for loading to fill the inventory of biological testing system 1 in the most efficient manner to prepare for the next run cycle. Issues can arise when usage variances during different run cycles lead to low or empty inventory for a given type of test array magazine 25. For example, streptococcus bacteria tests may increase during winter months due to the season increase in influenza infections.
  • a smart inventory loading method 301 may be used to determine the type and amount of test array magazines 25 necessary to load and prepare biological testing system 1 for the next shift.
  • Smart inventory loading method 301 is a learning algorithm that is initiated with a list of the types and amount of test array magazines 25 used in the previous shift. This information is used to derive the actual current inventory of biological testing system 1.
  • Smart inventory loading method 301 thereafter incorporates metrics and data such as the day of the week, month, workflow or test array magazine 25 changes between shifts (i.e. inventory used in the previous shift, the number of samples analyzed in the previous shift), type of ward (i.e. type of hospital ward), type of institution (i.e. hospital lab or reference lab), and throughput data to determine the appropriate amount and types of test array magazines 25 for loading into biological testing system 1 to ensure the instrument has enough inventory to complete the shift without reloading.
  • shifts i.e. inventory used in the previous shift, the number of samples analyzed in the previous shift
  • type of ward i.e. type of hospital
  • method 301 begins with a step 303, whereby the initial loading of consumable preparation system 3 of biological testing system 1 is performed.
  • Step 303 thereafter moves to a step 305, whereby a testing shift is performed.
  • Various ID test panels 21 and AST test panels 23 are formed and microbe samples are tested diminishing the supply of various test array magazines 25.
  • Step 305 thereafter moves to a step 307, whereby computer 48 considers the usage of test array magazines 25 in the current shift, test array magazine 25 usage for other shifts, and other metrics relating to workflow and test array magazine 25 usage in consumable preparation system 3.
  • the metrics may be entirely automated or may include user inputted data or manual overrides which are forward looking.
  • step 307 moves to a step 309, whereby the learning algorithm determines the preferred test array magazines 25 for loading into consumable preparation system 3 prior to the next testing shift.
  • step 309 moves to a step 311, whereby the user is prompted to load the preferred test array magazines 25 into consumable preparation system 3 in preparation for the next testing shift.
  • step 311 returns to step 305 to repeat the process and iteratively collect data as well as prompt a user to load a particular set of test magazine arrays 25.
  • the prompting of a user to load a particular set of test magazine arrays 25 may be actuated by a signal.
  • the actuation of the signal may be based on a set of metrics collected regarding the test array magazines, their current usage, their historical usage, or any other metrics which may be relevant to predicting needs and actuating a request for additional test magazine arrays 25.
  • the set of metrics may be based on whether the inventory of test magazines is below a certain threshold and/or the number or frequency of the formation of the ID test panels 21 and/or AST test panels 23.
  • the set of metrics may be based on timing information involving the usage of ID test panels 21 and/or AST test panels 23.
  • Temporal information such as the time of day, the day of the week, the day of the month, the week of the month, or a time of year when particular ID test panels 21 and/or AST test panels 23 are formed may be incorporated into the set of metrics. For example, some infections tend to follow season variations. Therefore, collecting information regarding the time of the year when a particular ID test panel 21 or AST test panel 23 are more frequently formed may be beneficial in determining when to actuate the signal to request more test magazine arrays 25 the following year.
  • information associated with the formation of the ID test panels 21 and/or AST test panels 23, the number or frequency of the loading of the test magazine arrays 25 or any other metric associated with the formation of ID test panels 21 and/or AST test panels 23 may be incorporated into the set of metrics.
  • a learning algorithm for predictive modeling of when a particular set of test magazine arrays 25 may be needed based on historical context may incorporate these set of metrics and the signal actuation may be based on the results of this learning algorithm.
  • a method comprising: (a) receiving a plurality of test arrays into a biological testing system, wherein each test array in the plurality of test arrays includes a plurality of test wells; (b) receiving a panel frame into the biological testing system; (c) receiving a selection protocol into the biological testing system; (d) selecting a group of test arrays from the plurality of test arrays based at least in part on the selection protocol; (e) disposing the group of test arrays into the panel frame to form a test panel; and (f) dispensing an inoculum into each test well in the test panel.
  • Example 2 Example 2
  • Example 1 The method of Example 1 or any of the subsequent Examples, further comprising transferring the test panel to an incubator system of the biological testing system after the inoculum is dispensed into each test well of the test panel.
  • test array alignment element and the test panel alignment element are a recess
  • other one of the test array alignment element and the test panel alignment element is an alignment fin
  • a biological testing system comprising: (a) a consumable preparation system comprising: (i) a panel frame receptacle; and (ii) a test array receptacle; (b) an inoculating system comprising: (i) a sample receptacle; (c) an incubator system; (d) an optics system comprising: (i) a camera; and (e) a movement system configured to move a panel frame disposed in the panel frame receptacle between the consumable preparation system, inoculating system, incubator system, and optics system.
  • Example 14 The biological testing system of Example 14 or any of the subsequent Examples, wherein the consumable preparation system further comprises a diluent receptacle.
  • a method comprising: (a) receiving a plurality of test arrays into a biological testing system, wherein each test array in the plurality of test arrays includes a plurality of test wells; (b) receiving a panel frame into the biological testing system; (c) selecting a group of test arrays from the plurality of test arrays; (d) disposing the group of test arrays into the panel frame to form a test panel; (e) dispensing an inoculum into each test well in the test panel; (f) after the inoculum is dispensed into each test well, transferring the test panel to an incubator system of the biological testing system; (g) after transferring the test panel to the incubator system, transferring the test panel to an optics system of the biological testing system; and (h) obtaining a digital image of each test well in the test panel.
  • Example 18 The method of Example 18 or any of the subsequent Examples, further comprising: (a) receiving a selection protocol by the biological testing system; and (b) selecting the group of test arrays from the plurality of test arrays based at least in part on the selection protocol.
  • Example 20 [000118] The method of any of the previous or any of the subsequent Examples, further comprising: (a) in response to selecting the group of test arrays, updating an inventory associated with the plurality of test arrays; (b) determining whether the inventory is below a threshold; and (c) in response to determining the inventory is below the threshold, actuating a signal.
  • any of the examples described herein may include various other features in addition to or in lieu of those described above.
  • any of the examples described herein may also include one or more of the various features disclosed in any of the various references that are incorporated by reference herein.

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Abstract

L'invention concerne des panneaux de test personnalisés préparés afin d'être utilisés dans un système de test biologique. Tout d'abord, un utilisateur charge un système de préparation consommable du système de test biologique à l'aide d'éléments consommables tels qu'un cadre de panneau ou un plateau de panneau et un ou plusieurs magasin(s) de barrette(s) de test. Le système de préparation consommable sépare ensuite une barrette de test d'un magasin de barrettes de test conformément à un protocole de sélection et insère la barrette de test dans le cadre/plateau de panneau. Ledit processus de séparation et d'insertion est répété jusqu'à ce qu'un panneau de test soit entièrement formé conformément au protocole de sélection. Le panneau de test est ensuite utilisé dans un système de test biologique afin d'identifier et/ou de déterminer une sensibilité antimicrobienne pour un microbe donné.
PCT/US2018/014640 2017-01-23 2018-01-22 Préparation de panneaux de test personnalisés WO2018136859A1 (fr)

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US201762449402P 2017-01-23 2017-01-23
US62/449,402 2017-01-23
US201762574804P 2017-10-20 2017-10-20
US62/574,804 2017-10-20

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USD907465S1 (en) 2019-03-07 2021-01-12 Gen-Probe Incorporated Serpentine retainer spring for a receptacle rack
USD907987S1 (en) 2019-03-07 2021-01-19 Gen-Probe Incorporated Serpentine retainer spring for a receptacle rack
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WO2020072890A1 (fr) 2018-10-05 2020-04-09 SeLux Diagnostics, Inc. Support pour traitement automatisé d'échantillons microbiologiques
US11287436B2 (en) 2018-10-05 2022-03-29 Selux Diagnostics, Inc Carrier for automated microbiology sample processing
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USD907465S1 (en) 2019-03-07 2021-01-12 Gen-Probe Incorporated Serpentine retainer spring for a receptacle rack
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US11511283B2 (en) 2019-03-07 2022-11-29 Gen-Probe Incorporated Carrier for holding a plurality of multi-receptacle units

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