WO2022053785A1 - Sample container manipulation assembly and optical test machine comprising the assembly - Google Patents

Sample container manipulation assembly and optical test machine comprising the assembly Download PDF

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Publication number
WO2022053785A1
WO2022053785A1 PCT/GB2021/052275 GB2021052275W WO2022053785A1 WO 2022053785 A1 WO2022053785 A1 WO 2022053785A1 GB 2021052275 W GB2021052275 W GB 2021052275W WO 2022053785 A1 WO2022053785 A1 WO 2022053785A1
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WO
WIPO (PCT)
Prior art keywords
sample container
assembly
test
slide
light
Prior art date
Application number
PCT/GB2021/052275
Other languages
French (fr)
Inventor
Greg COMPTON
Peter Saunderson
Original Assignee
I-Abra Limited
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 I-Abra Limited filed Critical I-Abra Limited
Publication of WO2022053785A1 publication Critical patent/WO2022053785A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L1/00Enclosures; Chambers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/02Identification, exchange or storage of information
    • B01L2300/025Displaying results or values with integrated means
    • B01L2300/027Digital display, e.g. LCD, LED
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0822Slides
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5029Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00Supporting devices; Holding devices
    • B01L9/52Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/2813Producing thin layers of samples on a substrate, e.g. smearing, spinning-on
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N2021/3181Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths using LEDs
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00039Transport arrangements specific to flat sample substrates, e.g. pusher blade
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099Characterised by type of test elements
    • G01N2035/00138Slides
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N2035/1027General features of the devices
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00Features of devices classified in G01N21/00
    • G01N2201/06Illumination; Optics
    • G01N2201/062LED's
    • G01N2201/0627Use of several LED's for spectral resolution

Definitions

  • the invention relates to a sample container manipulation assembly.
  • the invention further relates to an optical test machine comprising a sample container manipulation assembly.
  • the sample container manipulation assembly and optical test machine are particularly suitable for use in pathogen screening platforms for testing patients for one or more types of viruses.
  • Known sample pots for use in testing patient samples typically comprise a transparent container and a removable cap which is screwable onto the container. When a sample is tested, the whole, or part, of the sample is removed from the container and tested in a laboratory or other testing environment using one or more known techniques.
  • Such tests are known as ‘wet’ tests in which a reagent is mixed with the sample to detect the presence of one or more pathogens.
  • sample pots for wet testing has a number of limitations.
  • the sample pots have to be handled by a clinician and manually opened and closed to access the sample stored inside the container for testing.
  • the sample may easily be spilled or contaminated.
  • test plate is used herein to refer to a component for receiving a patient sample e.g. a smear. It may, but need not, have any specific technical features associated with any known or commercially available types of test plate. It may be a very simple or basic component, for example a substrate made from glass or any other suitable material that may have a circular or rectangular shape, or any other suitable shape that will be apparent to the skilled person.
  • the invention in a first aspect, provides a sample container manipulation assembly for an optical test machine, comprising: a channel for receiving a sample container comprising a removable test plate; a remover assembly configured to remove a test plate from a sample container for testing; and an ejector assembly configured to eject a sample container from the channel.
  • the assembly may be suitable for use in an optical test machine for testing a patient sample on a removable test plate of a sample container.
  • the sample container manipulation assembly may be particularly suitable for use in an optical test machine. Such an assembly may provide an optical test machine capable of testing a patient sample in an automated way. It may also enable a test to be performed more reliably and/or more quickly than known testing procedures. It may also enable a test result to be returned more quickly.
  • the sample container manipulation assembly may enable more effective testing of patient samples.
  • An optical test machine comprising the sample container manipulation assembly may enable more effective testing of patient samples.
  • a machine may be capable of performing dry tests.
  • a test e.g. a pathogen or virus test
  • a result may be obtainable with little or no intervention by a clinician and no requirement for any test to be performed in a laboratory. In other words, it may avoid the need for a clinician, or other user, to manually open a sample container and perform a wet test.
  • the sample container manipulation assembly may therefore provide an optical test machine that is effective for use in a mass and/or rapid testing program.
  • the sample container manipulation assembly for an optical test machine is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4. This may ensure that a sample container is sealable before and after testing. It may ensure that a sample container need only be opened during testing inside the machine where it is isolated. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
  • the remover assembly comprises a first motor drive.
  • This may provide a simple and/or effective and/or reliable means for operating the remover assembly.
  • the remover assembly may be manually operated, for example using a level or plunger or other suitable device.
  • the ejector assembly comprises a second motor drive.
  • This may provide a simple and/or effective and/or reliable means for operating the ejector assembly.
  • the ejector assembly may be manually operated, for example using a level or plunger or other suitable device.
  • the assembly further comprises a reinserter assembly configured to reinsert a test plate in to a sample container.
  • a reinserter assembly configured to reinsert a test plate in to a sample container. This may ensure that a sample container is sealed before, and after, testing. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
  • the reinserter assembly comprises a third motor drive.
  • This may provide a simple and/or effective and/or reliable means for operating the reinserter assembly.
  • the reinserter assembly may be manually operated, for example using a level or plunger or other suitable device.
  • the remover assembly comprises a first linear slide assembly comprising a first slide for engagement with a test plate, a first slide rail, and a first gear rack coupled to the first slide, the first gear rack being movable by a motor so as to engage and move a test plate.
  • a first linear slide assembly comprising a first slide for engagement with a test plate, a first slide rail, and a first gear rack coupled to the first slide, the first gear rack being movable by a motor so as to engage and move a test plate.
  • This may provide a simple and/or effective and/or reliable means for operating the remover assembly to engage and move a test plate. It may have a long service life, thereby reducing the need for downtime of the machine for maintenance and/or repair.
  • the ejector assembly comprises a second linear slide assembly comprising a second slide for removably obstructing at least a portion of the channel, a second slide rail, and a second gear rack coupled to the slide, the second gear rack being movable by a motor so as to at least partially open the channel.
  • This may provide a simple and/or effective and/or reliable means for operating the ejector assembly. It may have a long service life, reducing the need for downtime of the machine for maintenance and/or repair.
  • the reinserter assembly comprises a third linear slide assembly comprising a third slide for engagement with a test plate, a third slide rail, and a third gear rack coupled to the third slide, the gear being movable by a motor so as to engage and move a test plate.
  • This may provide a simple and/or effective and/or reliable means for operating the reinserter assembly. It may have a long service life, reducing the need for downtime of the machine for maintenance and/or repair.
  • At least one of the first, second and third motor drives comprises a DC motor.
  • This may provide a simple and/or effective and/or reliable means for operating the remover assembly and/or the ejector assembly and/or the reinserter assembly.
  • a DC motor of at least one of the first, second and third motor drives is a stepper motor.
  • This may provide a simple and effective means for controlling a position of the slide of the remover assembly and/or the ejector assembly and/or the reinserter assembly.
  • Other suitable types of motor will be apparent to the skilled person.
  • the invention in a second aspect, provides an optical test machine comprising The sample container manipulation assembly of the present invention in the first aspect.
  • This may provide an optical test machine capable of more effective testing of patient samples while avoiding a need for a clinician or other user to open a sample container and perform a wet test.
  • a machine may be capable of performing dry tests.
  • a test e.g. a pathogen or virus test
  • a result may be obtainable with little or no intervention by a clinician and no requirement for any test to be performed in a laboratory. It may therefore be more effective than known testing equipment for use in a mass and/or rapid testing program.
  • the optical test machine of the invention in the second aspect is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4. This may ensure that a sample container is sealable before and after testing. It may ensure that a sample container need only be opened for testing inside the machine where it is isolated. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container.
  • the optical test machine further comprises a light source.
  • the light source may be configured to emit light proximate a test plate. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
  • the optical test machine further comprises a camera.
  • the camera may be a digital camera.
  • the camera may be suitable for imaging a pattern of light emittable from the light source and passable through a test plate. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
  • the sample container manipulation assembly is operable to remove a test plate from a sample container in the channel and move it to a test location between the light source and the digital camera.
  • the invention in a third aspect, provides an optical test machine for testing a patient sample, comprising:- a channel configured to receive a sample container comprising removable a test plate; a light source; a digital camera; and a sample container manipulation assembly; the machine being operable: to cause The sample container manipulation assembly to remove a test plate from a sample container and move it to a test location; to cause the light source to emit light; and to cause the digital camera to image a pattern of light emittable from the light source and passable through a test plate in the test location.
  • the optical test machine of the invention in the third aspect is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4. This may ensure that a sample container is sealable before and after testing. It may ensure that a sample container need only be opened during testing inside the machine where it is isolated. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
  • the sample container manipulation assembly comprises: a remover assembly configured to remove a test plate from a sample container; and an ejector assembly configured to eject a sample container from the channel.
  • a remover assembly configured to remove a test plate from a sample container
  • an ejector assembly configured to eject a sample container from the channel.
  • the light source is configured to emit light at at least two different wavelengths. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
  • the light source comprises three light emitters, each configured to emit light at different wavelengths. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
  • a different number of light emitters may be provided, for example 2 or 3 or 4 or 5 light emitters. Some or all of the emitters may be capable of emitting light at different wavelengths. Some or all of the emitters may be capable of emitting light at the same, or substantially the same, wavelength.
  • a single light source capable of emitting light at three different wavelengths may be provided.
  • the three light emitters are LEDs configured to emit light of different colours. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
  • three light emitters are activatable in sequence to sequentially emit light at different wavelengths. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
  • the machine further comprises a light tube for channelling light from the light source to proximate a test location.
  • a light tube for channelling light from the light source to proximate a test location. This may be an effective means for directing light from the light source to a test location.
  • the light tube comprises a conical tip.
  • This may be configured to scatter light emittable by the light source. This may help to provide a fast and/or effective dry test solution in which a pattern of light passing through a test plate is imagable in a reliable way to obtain an accurate test result.
  • the light tube comprises at least one leveller.
  • This may be a simple and effective means for calibrating the light tube to ensure accurate positioning relative to a test plate. This may help to provide a fast and/or effective dry test solution for obtaining an accurate test result.
  • the digital camera is a Charge-Coupled Device.
  • This may be a simple and effective means for imaging a pattern of light passing through a test plate in a reliable way to obtain an accurate test result.
  • the machine further comprises a display screen. This may provide an effective and user-friendly means for displaying a result of a test performed on a test plate.
  • the machine further comprises a receptacle beneath the machine for receiving an ejected sample container.
  • a receptacle beneath the machine for receiving an ejected sample container. This may reduce a need for manual handling of a sample containers. It may also provide a safe, convenient and user-friendly means for collecting and disposing of tested sample containers.
  • the machine further comprises further comprising at least one vibration damper.
  • This may help to minimise or eliminate a risk of vibration affecting the imaging process. This may provide an effective and reliable test for obtaining an accurate test result.
  • the machine further comprises at least one sensor for sensing a position of a sample container in the channel. This may ensure that a sample cartridge is correctly positioned for the sample container manipulation assembly to engage with a test plate for testing a sample. Additionally, or alternatively, it may also ensure that an inserted sample container is compatible with the optical test machine.
  • the machine may have a casing. This may provide structural integrity to the machine and/or protection for the internal components. This reduces or eliminates ingress of ambient light into the machine.
  • the casing may provide for improved optical stability during testing.
  • the casing may segregate the machine from surrounding electrical equipment and reduce or eliminate the effects of any electrical noise on the optical stability.
  • the invention in a fourth aspect, provides a method of performing a pathogen test, including the steps of: providing an optical test machine according to the present invention in the second or the third aspect; inserting a sample container comprising a removable test plate into a channel; and reading a displayed test result.
  • This may provide a simple and/or effective method for producing a reliable and accurate test result from the optical test machine.
  • any feature in one aspect of the invention may be applied to other aspects of the invention, in any appropriate combination.
  • method aspects may be applied to apparatus aspects, and vice versa.
  • any, some and/or all features in one aspect can be applied to any, some and/or all features in any other aspect, in any appropriate combination. It should also be appreciated that particular combinations of the various features described and defined in any aspects of the invention can be implemented and/or supplied and/or used independently.
  • FIGS. 1A-C is a series of views of an optical test machine embodying the present invention.
  • FIGS. 2A-C is a series of views of a sample container particularly suitable for use with the optical test machine of FIGS. 1A-C;
  • FIGS. 3A-B is a series of views of a test plate insertable into and removable from a sample container of FIGS. 2A-C;
  • FIGS. 4A-C is a series of views of a test plate of FIGS. 3A-B being removed from a sample container of FIGS. 2A-C;
  • FIGS. 5A-B is a series of views of a casing of the optical test machine of FIGS. 1 A-C;
  • FIGS. 6A-C is a series of views of the optical test machine of FIGS. 1A-C with the casing of FIGS. 5A-B removed;
  • FIGS. 7A-E is a series of views of a sample container manipulation assembly embodying the present invention for use in the optical test machine of FIGS. 1A-C;
  • FIG. 8 is an exploded view of the sample container manipulation assembly of FIGS. 7A-E;
  • FIG. 9 is an exploded view of a remover assembly of the sample container manipulation assembly of FIGS. 7A-E;
  • FIG. 10 is an exploded view of an ejector assembly of the sample container manipulation assembly of FIGS. 7A-E;
  • FIG. 11 is an exploded view of a reinserter assembly of the sample container manipulation assembly of FIGS. 7A-E;
  • FIG. 12 is a close up view of a motor of the optical test machine of FIGS. 1A-C;
  • FIG. 13 is a close up view of a camera of the optical test machine of FIGS. 1A-C
  • FIG. 14 is a close up view of a light tube of the optical test machine of FIGS. 1A-C;
  • FIGS. 15A-B is a series of close up views showing operation of the sample container manipulation assembly of FIGS. 7A-E.
  • a camera is removed to show a test plate passing under it;
  • FIGS. 16A-D is a further series of section views showing operation of the sample container manipulation assembly of FIGS. 7A-E showing various stages of movement of the assembly.
  • an optical test machine assembly 1 is provided.
  • the machine assembly is a standalone machine.
  • the machine assembly is suitable for testing a patient sample.
  • the machine assembly is particularly suitable for testing a patient sample on a test plate that is part of a sample container.
  • the machine assembly is particularly suitable for testing a patient sample stored on a test plate or test slide that is removable from a sample container.
  • the machine assembly is particularly suitable for testing a patient sample stored on a test plate that is both removable from, and re-engagable with, or reinsertable into, a sample container.
  • the optical test machine assembly generally comprises a machine 2 and a receptacle 3.
  • the optical test machine is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4 which is incorporated herein by reference.
  • a sample container is briefly described below.
  • a suitable sample container 4 is shown in FIGS 2A to 4C.
  • a sample container may be a test cartridge or sample tube. Such a container is suitable for insertion into the test machine for testing of a sample.
  • a sample container has a generally tubular body 5.
  • the body is hollow so as to define an internal cavity for receiving a swab 6.
  • the body is shaped for complementarity with a shape of a channel in the optical test machine as will be described further below. It may for example have one or more protrusions 7 from the body to ensure that the container can only be inserted into the optical test machine in a correct orientation.
  • the body has a neck portion 8.
  • the neck portion is hollow and forms part of, or an extension of, or leads to, the cavity.
  • a cap 9 is engagable with the neck portion so as to close the internal cavity.
  • the cap is configured to receive and to hold a swab.
  • the cap is engagable with the neck portion so that a swab is positionable within the cavity.
  • test plate comprises a smooth glass substrate 11 provided in or on a carrier 12.
  • the glass substrate may be pushed or clipped or slid into a correspondingly shaped recess in the carrier.
  • it may also be secured in the carrier using an appropriate retaining means, such as an adhesive or one or more retaining clips.
  • a test plate is insertable into an aperture in the container body so that at least part of a test plate extends into the cavity and is generally aligned with the neck portion.
  • the carrier is provided with at least one locking feature 13. This helps to ensure a secure engagement between the carrier and the body.
  • This may comprise one or more clips, which may be sprung clips, for engagement with one or more corresponding recesses in the wall of the container body. These may ensure that the body is sealed to prevent contamination or leakage of the sample from the cavity.
  • the cavity When a test plate and cap are engaged with the body, the cavity may be sealed.
  • the cavity may be sealed, for example, to a IP rating of at least IP43, according to the Ingress Protection Code, I EC standard 60529 - i.e. protected from water spray less than 60 degrees from vertical. It may also be sealed to a higher IP rating. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
  • a sample container is operable to deposit a patient sample or smear from a swab onto a removable test plate.
  • the cap is slidable along the neck portion and rotatable relative to the neck portion to deposit a patient sample or smear from a swab onto a test plate.
  • a test plate is removable from a sample container for testing of the sample.
  • a sample container may be provided with one or identifiable elements, identification features or traceability features (not shown).
  • the machine has a casing 14.
  • An aperture 15 is provided through the casing for allowing a sample container to be inserted into the machine.
  • the machine includes a sample container manipulation assembly 16 for manipulating a sample container.
  • the assembly comprises a channel 17 in communication with the aperture and extending through the machine from a top surface to a bottom surface.
  • This may be formed by a tube along which a sample container may pass.
  • the channel may be positioned centrally located in the machine.
  • a shape of the channel may be complimentary with an external shape of a sample container.
  • the channel may also be configured so that a sample container is insertable in only one orientation.
  • a sensor (not shown) is provided for sensing the presence of a sample container in the channel.
  • the sensor may also detect the position of a sample container in the channel.
  • One suitable sensor is a photodiode receiver. Other suitable sensors will be apparent to the skilled person.
  • a sensor or system may be provided for detecting the type of sample container inserted into the channel to ensure that it is of an appropriate size and/or shape and/or configuration and is compatible with the testing machine.
  • the sample container manipulation assembly includes a remover assembly 18 configured to remove a test plate from a sample container for testing.
  • the sample container manipulation assembly further includes an ejector assembly 19 configured to eject a sample container from the channel.
  • a container ejected from the machine may pass into the receptacle.
  • the remover assembly generally comprises a first motor drive assembly. More particularly, it comprises a support 20, and a first linear slide assembly comprising a slide 21 for engagement with a test plate, a slide rail 22, and a gear rack 23 coupled to the slide. A pinion 24 coupled to the motor output shaft engages with the gear rack.
  • the gear rack is movable by the motor to move the slide between an inactive position in which the slide is out of engagement with a sample container and an active position in which the slide engages with a test plate of a sample container.
  • the slide may be provided with a tool 25 for engaging with a test plate of a sample container and advance it to a test location.
  • the tool is a plate having a II- shaped slot for accommodating the body of a sample container and a pair of extension portions for engagement with the test slide of a sample container.
  • the slide may be provided with a pair protrusions extending from an end of the slide or tool, or from the extension portions of the tool.
  • test slide Other suitable means for engaging with the test slide will be apparent to skilled person. In essence, a particular size and/or shape and/or configuration of the slide or tool is not critical. Instead, the tool, or the slide itself if no tool is provided, needs to be of a size and/or shape and/or configuration suitable for engaging with a test plate.
  • the ejector assembly generally comprises a second motor drive. More particularly, it comprises a second linear slide assembly comprising a support 26, a slide 27 for removably obstructing at least a portion of the channel, a slide rail 28, and a gear rack 29 coupled to the slide. A pinion coupled to the motor output shaft engages with the gear rack.
  • the gear rack is movable by the motor to move the slide between an active position in which the slide obstructs the channel to prevent a sample container from passing out of the channel and an inactive position in which the channel is opened and a sample container may pass out from the channel.
  • the slide may be provided with a tool 30 for closing the channel.
  • the tool is a plate having a block at an end supporting a pin.
  • the slide may be provided with a one or more protrusions extending from an end of the slide or tool.
  • the sample container manipulation assembly further comprises a reinserter assembly 31 configured to reinsert a test plate into a sample container.
  • this generally comprises a third motor drive. More particularly, it comprises a third linear slide assembly comprising a support 32, a slide 33 for engagement with a test plate, a slide rail 34, and a gear rack 35 coupled to the slide. A pinion coupled to the motor output shaft engages with the gear rack. The gear rack is movable by the motor to move the slide between an inactive position in which the slide is out of engagement with a sample container and an active position in which the slide engages with a test plate of a sample container.
  • the slide may be provided with a tool 36 engaging with and moving a test plate.
  • the tool is a plate having an extension at an end to engage with a test plate.
  • the slide may be provided with a one or more protrusions extending from an end of the slide or tool.
  • test slide Other suitable means for engaging with the test slide will be apparent to skilled person.
  • a particular size and/or shape and/or configuration of the slide or tool is not critical. Instead, the tool, or the slide itself if no tool is provided, needs to be of a size and/or shape and/or configuration suitable for engaging with and moving a test plate.
  • the remover assembly the reinserter assembly are configured and positioned so that the respective slides move a test plate linearly along a track.
  • the remover assembly is operable to move a test plate from a sample container to the test location and the reinserter assembly is operable to move a test plate from the test location to a sample container.
  • the first, second and third motor drives include direct current (DC) motors.
  • DC direct current
  • One suitable motor is a stepper motor.
  • Other suitable motors will be apparent to the skilled person.
  • Each motor has a mount 37.
  • a motor driver 38 is provided for driving each motor.
  • the motors may be orientated so that an axis of rotation of each of the output shafts is parallel.
  • the axes may all be substantially aligned in the same plane. This may enable a volume of the machine to be reduced. It may also serve to constrain vibration generated by the motors.
  • sample container manipulation assembly The various components of the sample container manipulation assembly are mounted to a backing plate 39.
  • This provides a sample container manipulation module that may be assembled outside of the machine and is then insertable into the machine. The module may be removed from the machine for maintenance and/or repair.
  • the machine further comprises a light source 40.
  • the light source is configured to emit light in the proximity of a test plate and so as to pass through a test plate in the test location.
  • the light source is capable of a high intensity output.
  • the machine includes a digital camera 41 for imaging a pattern of light from the light source and passable through a test plate.
  • the camera is positioned on an opposite side of the test location from the light source.
  • the camera is aligned with the light source.
  • the camera may be a camera chip.
  • One suitable camera is a Charge-Coupled Device.
  • the camera may be a camera chip of the type used in smart devices incorporating a camera.
  • the light source comprises three light emitters configured to emit light of three different wavelengths.
  • One suitable type of light emitters is Light Emitting Diodes (LED). These are coupled to a base of the machine.
  • the three LEDs are configured to emit light of different colours.
  • the LEDs are activatable to emit, in sequence, light of three different wavelengths.
  • the intensity of the light emitted by the LEDs may be variable by varying an LED drive current. This may be controllable using Pulse Width Modulation (PWM).
  • PWM Pulse Width Modulation
  • a light tube or light pipe 42 is provided for channelling light from the light source to a test location.
  • the light tube resembles a manifold and has three input tubes, one from each LED, and an output tube leading to the test location. It is installed over the top of the LEDs so that each LED is positioned in, or below, a respective one of the input tubes.
  • the light tube may be affixed to a base of the machine.
  • the light tube has a conical tip and is configured to scatter light emerging from the output tube.
  • the light tube may comprise at least one support bracket 43 for holding the light tube in a desired position and opposing any movement of it.
  • Two support brackets may be provided for supporting the light tube in different directions or planes.
  • the light tube may be made from Poly(methyl methacrylate) (acrylic). This may be metallised.
  • At least one leveller may be provided for ensuring that the light tube is correctly orientated during initial set up of the machine or following maintenance or calibration etc.
  • This may be a spirit level. More than one spirit level may be provided for monitoring the position of the light tube in two different directions or planes.
  • the one or more spirit levels may be a separate component coupled to the light tube. Alternatively, the one or more spirit levels may be integrally formed with the light tube.
  • a computer 44 is provided. This may be a single board computer is provided.
  • One suitable computer is a Printed Circuit Board (PCB) or Printed Circuit Board Assembly (PCBA).
  • the computer is coupled to the screen. The controls the operation of the various components of the machine, guided by a software program. It particular, the computer controls the operation of the sample container manipulation assembly.
  • the computer may enable partial or fully automated operation of the machine.
  • An integrated circuit is provided (not shown - located behind the screen). This analyses image(s) captured by the digital camera and processes the images to obtain a test result.
  • the computer is in communication with the integrated circuit.
  • One particularly suitable type of integrated circuit is a Field-Programmable Gate Array (FPGA).
  • a display screen 45 is provided for displaying information to a user to guide them through the steps required to test a sample. It also displays a result of a test performed on a test plate.
  • the screen may also be capable of receiving user inputs.
  • the monitor may be a touch screen.
  • a power unit and/or power controller (not shown) is provided for supplying and controlling power to the machine.
  • the power unit may include a transformer.
  • the power unit may be integrated or external to the machine.
  • One or more cooling fans 46 may be provided for cooling the machine.
  • the machine may also include circulation space for air to circulate.
  • One or more anti-vibration features or vibration dampers are provided. These may include one or more of: vibration-damping feet 47 for the machine; one or more vibration-damping mounts for coupling machine components to the casing or base plates; and a vibrationdamping mount for the digital camera. This may improve the stability of the machine and accuracy of the optical testing.
  • Suitable vibration-damping features include feet and/or washers and/or mounts. These may be made from a rubber.
  • a suitable material is a polyurethane rubber.
  • Other suitable vibration damping means and materials for vibration damping or isolation will be apparent to the skilled person.
  • the receptacle has an aperture 48 through which dispensed sample containers may pass. It has a hinged door 49 to permit emptying of used sample containers. The door is lockable using a known type of lock 50.
  • the receptacle is provided with one or more anti-vibration features or vibration dampers, for example, feet 51. These may be made from a rubber. A suitable material is a polyurethane rubber. Other suitable vibration damping means and materials for vibration damping or isolation will be apparent to the skilled person.
  • a sample container is inserted through the aperture in the machine casing and passes into the channel.
  • the sensor(s) detect the presence of a sample container and/or that it is compatible with the test machine.
  • the machine performs some or all of the following steps which are controlled by the computer.
  • Step 1 - The machine may be activated by the computer, for example by a user pressing a button the screen. Further instructions may be provided on the screen to guide the user.
  • Step 2 - A sample cartridge is inserted through the aperture and into the channel. This may automatically activate the machine without any manual action being required under Step 1.
  • Step 3 The remover assembly is activated by the computer.
  • the motor causes the slide to move towards a sample container and engage with a test plate.
  • the tool with II- shaped slot accommodates a body of a sample container. Further movement of the slide causes the pair of protrusions or pins to be brought into engagement with a test plate. Further movement of the slide causes a test plate to be pushed out from or removed from a sample container. Further movement of the slide pushes a test plate along a track or channel 52 and passing under the camera to a test location situated between the light source and the digital camera. A stop 53 may define an end of the track.
  • the motor reverses and withdraws the slide. A test plate remains at the test location.
  • Step 4 - The light source is activated by the computer.
  • the LEDs are sequentially operated and the light passes through the light tube to the tip where the light is scattered and passes through a test plate.
  • Step 5 - The camera is activated by the computer and images a pattern of light passing through a test plate as required.
  • Step 6 The reinserter assembly, where present, is activated by the computer.
  • the motor causes the slide to engage with a test plate. Further movement of the slide causes a test plate to be moved towards a sample container. Further movement of the slide pushes a test plate into engagement with the test container.
  • the motor reverses and withdraws the slide. A test plate remains coupled to the container. A sample container remains in the channel.
  • Step 7 - The ejector assembly is activated by the computer.
  • the motor withdraws the slide from the active position to the inactive position which opens the channel.
  • Step 8 A sample container is ejected though the base of the machine and drops through the aperture and into the receptacle.
  • Step 9 The ejector assembly is activated by the computer and the motor reverses and moves the slide from the inactive position to the active position which closes the channel.
  • Step 10 - The image(s) captured by the camera is analysed by a suitable software program running on the computer in communication with the integrated circuit.
  • Step 11 - A result of the test is displayed on the screen.
  • any or all of these steps may be performed in a different order. Some steps may be performed simultaneously. One or more additional steps may occur.
  • the machine is reset and a new test may then be performed.
  • the receptacle may be emptied when full, or at desired frequency.
  • An alternative embodiment of the machine may not require the reinserter assembly. Instead, the remover assembly and the ejector assembly are operable as described above to remove a test plate from a sample container and to eject a sample container from the channel. When a test is complete, a test plate may be ejected, for example by further advancement of the remover assembly, into a separate receptacle for disposal.

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Abstract

A sample container manipulation assembly for an optical test machine comprises a channel for receiving a sample container comprising a removable test plate, a remover assembly configured to remove a test plate from a sample container for testing, and an ejector assembly configured to eject a sample container from the channel. An optical test machine comprises the sample container manipulation assembly.

Description

SAMPLE CONTAINER MANIPULATION ASSEMBLY AND OPTICAL TEST MACHINE COMPRISING THE ASSEMBLY
FIELD OF THE INVENTION
The invention relates to a sample container manipulation assembly.
The invention further relates to an optical test machine comprising a sample container manipulation assembly.
The sample container manipulation assembly and optical test machine are particularly suitable for use in medical testing, virus screening and pathogen screening.
The sample container manipulation assembly and optical test machine are particularly suitable for use in pathogen screening platforms for testing patients for one or more types of viruses.
BACKGROUND TO THE PRESENT INVENTION
Known sample pots for use in testing patient samples typically comprise a transparent container and a removable cap which is screwable onto the container. When a sample is tested, the whole, or part, of the sample is removed from the container and tested in a laboratory or other testing environment using one or more known techniques.
Such tests are known as ‘wet’ tests in which a reagent is mixed with the sample to detect the presence of one or more pathogens.
The use of these known sample pots for wet testing has a number of limitations. For example, the sample pots have to be handled by a clinician and manually opened and closed to access the sample stored inside the container for testing. The sample may easily be spilled or contaminated.
In view of the drawbacks associated with the known types of wet test equipment, the inventors of the present invention have appreciated a need for an optical test machine for use in medical testing, virus screening and pathogen screening.
SUMMARY OF THE INVENTION
The term “test plate” is used herein to refer to a component for receiving a patient sample e.g. a smear. It may, but need not, have any specific technical features associated with any known or commercially available types of test plate. It may be a very simple or basic component, for example a substrate made from glass or any other suitable material that may have a circular or rectangular shape, or any other suitable shape that will be apparent to the skilled person.
The invention, in a first aspect, provides a sample container manipulation assembly for an optical test machine, comprising: a channel for receiving a sample container comprising a removable test plate; a remover assembly configured to remove a test plate from a sample container for testing; and an ejector assembly configured to eject a sample container from the channel.
The assembly may be suitable for use in an optical test machine for testing a patient sample on a removable test plate of a sample container. The sample container manipulation assembly may be particularly suitable for use in an optical test machine. Such an assembly may provide an optical test machine capable of testing a patient sample in an automated way. It may also enable a test to be performed more reliably and/or more quickly than known testing procedures. It may also enable a test result to be returned more quickly. The sample container manipulation assembly may enable more effective testing of patient samples.
An optical test machine comprising the sample container manipulation assembly may enable more effective testing of patient samples. Such a machine may be capable of performing dry tests. In other words, it may provide a test, e.g. a pathogen or virus test, that does not require any reagent to be added to obtain a result. A result may be obtainable with little or no intervention by a clinician and no requirement for any test to be performed in a laboratory. In other words, it may avoid the need for a clinician, or other user, to manually open a sample container and perform a wet test.
The sample container manipulation assembly may therefore provide an optical test machine that is effective for use in a mass and/or rapid testing program.
The sample container manipulation assembly for an optical test machine is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4. This may ensure that a sample container is sealable before and after testing. It may ensure that a sample container need only be opened during testing inside the machine where it is isolated. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
Preferably, the remover assembly comprises a first motor drive. This may provide a simple and/or effective and/or reliable means for operating the remover assembly. Alternatively, the remover assembly may be manually operated, for example using a level or plunger or other suitable device.
Preferably, the ejector assembly comprises a second motor drive. This may provide a simple and/or effective and/or reliable means for operating the ejector assembly. Alternatively, the ejector assembly may be manually operated, for example using a level or plunger or other suitable device.
Preferably, the assembly further comprises a reinserter assembly configured to reinsert a test plate in to a sample container. This may ensure that a sample container is sealed before, and after, testing. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
Preferably, the reinserter assembly comprises a third motor drive. This may provide a simple and/or effective and/or reliable means for operating the reinserter assembly. Alternatively, the reinserter assembly may be manually operated, for example using a level or plunger or other suitable device.
Preferably, the remover assembly comprises a first linear slide assembly comprising a first slide for engagement with a test plate, a first slide rail, and a first gear rack coupled to the first slide, the first gear rack being movable by a motor so as to engage and move a test plate. This may provide a simple and/or effective and/or reliable means for operating the remover assembly to engage and move a test plate. It may have a long service life, thereby reducing the need for downtime of the machine for maintenance and/or repair.
Preferably, the ejector assembly comprises a second linear slide assembly comprising a second slide for removably obstructing at least a portion of the channel, a second slide rail, and a second gear rack coupled to the slide, the second gear rack being movable by a motor so as to at least partially open the channel. This may provide a simple and/or effective and/or reliable means for operating the ejector assembly. It may have a long service life, reducing the need for downtime of the machine for maintenance and/or repair.
Preferably, the reinserter assembly comprises a third linear slide assembly comprising a third slide for engagement with a test plate, a third slide rail, and a third gear rack coupled to the third slide, the gear being movable by a motor so as to engage and move a test plate. This may provide a simple and/or effective and/or reliable means for operating the reinserter assembly. It may have a long service life, reducing the need for downtime of the machine for maintenance and/or repair.
Preferably, at least one of the first, second and third motor drives comprises a DC motor. This may provide a simple and/or effective and/or reliable means for operating the remover assembly and/or the ejector assembly and/or the reinserter assembly.
Preferably, a DC motor of at least one of the first, second and third motor drives is a stepper motor. This may provide a simple and effective means for controlling a position of the slide of the remover assembly and/or the ejector assembly and/or the reinserter assembly. Other suitable types of motor will be apparent to the skilled person.
The invention, in a second aspect, provides an optical test machine comprising The sample container manipulation assembly of the present invention in the first aspect.
This may provide an optical test machine capable of more effective testing of patient samples while avoiding a need for a clinician or other user to open a sample container and perform a wet test. Such a machine may be capable of performing dry tests. In other words, it may provide a test, e.g. a pathogen or virus test, that does not require any reagent to be added to obtain a result. A result may be obtainable with little or no intervention by a clinician and no requirement for any test to be performed in a laboratory. It may therefore be more effective than known testing equipment for use in a mass and/or rapid testing program.
The optical test machine of the invention in the second aspect is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4. This may ensure that a sample container is sealable before and after testing. It may ensure that a sample container need only be opened for testing inside the machine where it is isolated. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container.
Preferably, the optical test machine further comprises a light source. The light source may be configured to emit light proximate a test plate. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
Preferably, the optical test machine further comprises a camera. The camera may be a digital camera. The camera may be suitable for imaging a pattern of light emittable from the light source and passable through a test plate. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
Preferably, The sample container manipulation assembly is operable to remove a test plate from a sample container in the channel and move it to a test location between the light source and the digital camera.
The invention, in a third aspect, provides an optical test machine for testing a patient sample, comprising:- a channel configured to receive a sample container comprising removable a test plate; a light source; a digital camera; and a sample container manipulation assembly; the machine being operable: to cause The sample container manipulation assembly to remove a test plate from a sample container and move it to a test location; to cause the light source to emit light; and to cause the digital camera to image a pattern of light emittable from the light source and passable through a test plate in the test location.
The optical test machine of the invention in the third aspect is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4. This may ensure that a sample container is sealable before and after testing. It may ensure that a sample container need only be opened during testing inside the machine where it is isolated. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
Preferably, the sample container manipulation assembly comprises: a remover assembly configured to remove a test plate from a sample container; and an ejector assembly configured to eject a sample container from the channel. This may provide a machine capable of testing a patient sample in an automated way. It may also enable a test to be performed more reliably and/or more quickly than known testing procedures. It may also enable a test result to be returned more quickly. It may therefore be more effective for use in a mass and/or rapid testing program.
Preferably, the light source is configured to emit light at at least two different wavelengths. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening. Preferably, the light source comprises three light emitters, each configured to emit light at different wavelengths. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
Alternatively, a different number of light emitters may be provided, for example 2 or 3 or 4 or 5 light emitters. Some or all of the emitters may be capable of emitting light at different wavelengths. Some or all of the emitters may be capable of emitting light at the same, or substantially the same, wavelength.
Alternatively, a single light source capable of emitting light at three different wavelengths may be provided.
Preferably, the three light emitters are LEDs configured to emit light of different colours. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
Preferably, three light emitters are activatable in sequence to sequentially emit light at different wavelengths. This may help to provide a fast and/or effective dry test solution that is particularly suitable for use in pathogen or virus screening.
Preferably, the machine further comprises a light tube for channelling light from the light source to proximate a test location. This may be an effective means for directing light from the light source to a test location.
Preferably, the light tube comprises a conical tip. This may be configured to scatter light emittable by the light source. This may help to provide a fast and/or effective dry test solution in which a pattern of light passing through a test plate is imagable in a reliable way to obtain an accurate test result.
Preferably, the light tube comprises at least one leveller. This may be a simple and effective means for calibrating the light tube to ensure accurate positioning relative to a test plate. This may help to provide a fast and/or effective dry test solution for obtaining an accurate test result.
Preferably, the digital camera is a Charge-Coupled Device. This may be a simple and effective means for imaging a pattern of light passing through a test plate in a reliable way to obtain an accurate test result. Preferably, the machine further comprises a display screen. This may provide an effective and user-friendly means for displaying a result of a test performed on a test plate.
Preferably, the machine further comprises a receptacle beneath the machine for receiving an ejected sample container. This may reduce a need for manual handling of a sample containers. It may also provide a safe, convenient and user-friendly means for collecting and disposing of tested sample containers.
Preferably, the machine further comprises a casing for opposing ingress of ambient light. This may help to minimise or eliminate a risk of ambient light affecting the imaging process. This may provide an effective and reliable test for obtaining an accurate test result.
Preferably, the machine further comprises further comprising at least one vibration damper. This may help to minimise or eliminate a risk of vibration affecting the imaging process. This may provide an effective and reliable test for obtaining an accurate test result.
Preferably, the machine further comprises at least one sensor for sensing a position of a sample container in the channel. This may ensure that a sample cartridge is correctly positioned for the sample container manipulation assembly to engage with a test plate for testing a sample. Additionally, or alternatively, it may also ensure that an inserted sample container is compatible with the optical test machine.
The machine may have a casing. This may provide structural integrity to the machine and/or protection for the internal components. This reduces or eliminates ingress of ambient light into the machine. The casing may provide for improved optical stability during testing. The casing may segregate the machine from surrounding electrical equipment and reduce or eliminate the effects of any electrical noise on the optical stability.
The invention, in a fourth aspect, provides a method of performing a pathogen test, including the steps of: providing an optical test machine according to the present invention in the second or the third aspect; inserting a sample container comprising a removable test plate into a channel; and reading a displayed test result. This may provide a simple and/or effective method for producing a reliable and accurate test result from the optical test machine.
Any feature in one aspect of the invention may be applied to other aspects of the invention, in any appropriate combination. In particular, method aspects may be applied to apparatus aspects, and vice versa. Furthermore, any, some and/or all features in one aspect can be applied to any, some and/or all features in any other aspect, in any appropriate combination. It should also be appreciated that particular combinations of the various features described and defined in any aspects of the invention can be implemented and/or supplied and/or used independently.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the present invention will now be described with reference to the accompany drawings in which:-
FIGS. 1A-C is a series of views of an optical test machine embodying the present invention;
FIGS. 2A-C is a series of views of a sample container particularly suitable for use with the optical test machine of FIGS. 1A-C;
FIGS. 3A-B is a series of views of a test plate insertable into and removable from a sample container of FIGS. 2A-C;
FIGS. 4A-C is a series of views of a test plate of FIGS. 3A-B being removed from a sample container of FIGS. 2A-C;
FIGS. 5A-B is a series of views of a casing of the optical test machine of FIGS. 1 A-C;
FIGS. 6A-C is a series of views of the optical test machine of FIGS. 1A-C with the casing of FIGS. 5A-B removed;
FIGS. 7A-E is a series of views of a sample container manipulation assembly embodying the present invention for use in the optical test machine of FIGS. 1A-C;
FIG. 8 is an exploded view of the sample container manipulation assembly of FIGS. 7A-E;
FIG. 9 is an exploded view of a remover assembly of the sample container manipulation assembly of FIGS. 7A-E;
FIG. 10 is an exploded view of an ejector assembly of the sample container manipulation assembly of FIGS. 7A-E;
FIG. 11 is an exploded view of a reinserter assembly of the sample container manipulation assembly of FIGS. 7A-E;
FIG. 12 is a close up view of a motor of the optical test machine of FIGS. 1A-C;
FIG. 13 is a close up view of a camera of the optical test machine of FIGS. 1A-C
FIG. 14 is a close up view of a light tube of the optical test machine of FIGS. 1A-C; FIGS. 15A-B is a series of close up views showing operation of the sample container manipulation assembly of FIGS. 7A-E. In FIG. 15B, a camera is removed to show a test plate passing under it; and
FIGS. 16A-D is a further series of section views showing operation of the sample container manipulation assembly of FIGS. 7A-E showing various stages of movement of the assembly.
DESCRIPTION OF EXAMPLE EMBODIMENTS
With reference to FIGS. 1A & 1B, an optical test machine assembly 1 is provided. The machine assembly is a standalone machine. The machine assembly is suitable for testing a patient sample. The machine assembly is particularly suitable for testing a patient sample on a test plate that is part of a sample container. The machine assembly is particularly suitable for testing a patient sample stored on a test plate or test slide that is removable from a sample container. The machine assembly is particularly suitable for testing a patient sample stored on a test plate that is both removable from, and re-engagable with, or reinsertable into, a sample container.
The optical test machine assembly generally comprises a machine 2 and a receptacle 3.
The optical test machine is particularly suitable for use with a sample container described in the present Applicant’s co-pending UK patent application number 2013961.4 which is incorporated herein by reference. A sample container is briefly described below.
A suitable sample container 4 is shown in FIGS 2A to 4C. A sample container may be a test cartridge or sample tube. Such a container is suitable for insertion into the test machine for testing of a sample.
A sample container has a generally tubular body 5. The body is hollow so as to define an internal cavity for receiving a swab 6. The body is shaped for complementarity with a shape of a channel in the optical test machine as will be described further below. It may for example have one or more protrusions 7 from the body to ensure that the container can only be inserted into the optical test machine in a correct orientation. The body has a neck portion 8. The neck portion is hollow and forms part of, or an extension of, or leads to, the cavity. A cap 9 is engagable with the neck portion so as to close the internal cavity. The cap is configured to receive and to hold a swab. The cap is engagable with the neck portion so that a swab is positionable within the cavity.
The container is provided with a test plate 10. A test plate comprises a smooth glass substrate 11 provided in or on a carrier 12. The glass substrate may be pushed or clipped or slid into a correspondingly shaped recess in the carrier. Optionally, it may also be secured in the carrier using an appropriate retaining means, such as an adhesive or one or more retaining clips. A test plate is insertable into an aperture in the container body so that at least part of a test plate extends into the cavity and is generally aligned with the neck portion.
The carrier is provided with at least one locking feature 13. This helps to ensure a secure engagement between the carrier and the body. This may comprise one or more clips, which may be sprung clips, for engagement with one or more corresponding recesses in the wall of the container body. These may ensure that the body is sealed to prevent contamination or leakage of the sample from the cavity.
When a test plate and cap are engaged with the body, the cavity may be sealed. The cavity may be sealed, for example, to a IP rating of at least IP43, according to the Ingress Protection Code, I EC standard 60529 - i.e. protected from water spray less than 60 degrees from vertical. It may also be sealed to a higher IP rating. This may reduce or eliminate a risk of spillage from a sample container. It may also reduce or eliminate a risk of contamination of a sample stored within a sample container. It may also ensure that a clinician does not need to manually open a sample container to access a sample stored within a sample container for testing.
A sample container is operable to deposit a patient sample or smear from a swab onto a removable test plate. In particular, the cap is slidable along the neck portion and rotatable relative to the neck portion to deposit a patient sample or smear from a swab onto a test plate. A test plate is removable from a sample container for testing of the sample.
A sample container may be provided with one or identifiable elements, identification features or traceability features (not shown).
With reference to FIGS. 5A & 5B, the machine has a casing 14. An aperture 15 is provided through the casing for allowing a sample container to be inserted into the machine. With reference to FIGS 6A to 8, the machine includes a sample container manipulation assembly 16 for manipulating a sample container.
The assembly comprises a channel 17 in communication with the aperture and extending through the machine from a top surface to a bottom surface. This may be formed by a tube along which a sample container may pass. The channel may be positioned centrally located in the machine. A shape of the channel may be complimentary with an external shape of a sample container. The channel may also be configured so that a sample container is insertable in only one orientation.
A sensor (not shown) is provided for sensing the presence of a sample container in the channel. The sensor may also detect the position of a sample container in the channel. One suitable sensor is a photodiode receiver. Other suitable sensors will be apparent to the skilled person.
A sensor or system (not shown) may be provided for detecting the type of sample container inserted into the channel to ensure that it is of an appropriate size and/or shape and/or configuration and is compatible with the testing machine.
With reference to FIG. 9, the sample container manipulation assembly includes a remover assembly 18 configured to remove a test plate from a sample container for testing.
With reference to FIG. 10, the sample container manipulation assembly further includes an ejector assembly 19 configured to eject a sample container from the channel. A container ejected from the machine may pass into the receptacle.
The remover assembly generally comprises a first motor drive assembly. More particularly, it comprises a support 20, and a first linear slide assembly comprising a slide 21 for engagement with a test plate, a slide rail 22, and a gear rack 23 coupled to the slide. A pinion 24 coupled to the motor output shaft engages with the gear rack. The gear rack is movable by the motor to move the slide between an inactive position in which the slide is out of engagement with a sample container and an active position in which the slide engages with a test plate of a sample container.
The slide may be provided with a tool 25 for engaging with a test plate of a sample container and advance it to a test location. In the depicted embodiment, the tool is a plate having a II- shaped slot for accommodating the body of a sample container and a pair of extension portions for engagement with the test slide of a sample container. Alternatively, the slide may be provided with a pair protrusions extending from an end of the slide or tool, or from the extension portions of the tool.
Other suitable means for engaging with the test slide will be apparent to skilled person. In essence, a particular size and/or shape and/or configuration of the slide or tool is not critical. Instead, the tool, or the slide itself if no tool is provided, needs to be of a size and/or shape and/or configuration suitable for engaging with a test plate.
The ejector assembly generally comprises a second motor drive. More particularly, it comprises a second linear slide assembly comprising a support 26, a slide 27 for removably obstructing at least a portion of the channel, a slide rail 28, and a gear rack 29 coupled to the slide. A pinion coupled to the motor output shaft engages with the gear rack. The gear rack is movable by the motor to move the slide between an active position in which the slide obstructs the channel to prevent a sample container from passing out of the channel and an inactive position in which the channel is opened and a sample container may pass out from the channel.
The slide may be provided with a tool 30 for closing the channel. In the depicted embodiment, the tool is a plate having a block at an end supporting a pin. Alternatively, the slide may be provided with a one or more protrusions extending from an end of the slide or tool.
Other suitable means for closing a channel will be apparent to skilled person. In essence, a particular size and/or shape and/or configuration of the slide or tool is not critical. Instead, the tool, or the slide itself if no tool is provided, needs to be of a size and/or shape and/or configuration suitable for selectively opening and closing the channel.
Preferably, the sample container manipulation assembly further comprises a reinserter assembly 31 configured to reinsert a test plate into a sample container. With reference to FIG. 11 , this generally comprises a third motor drive. More particularly, it comprises a third linear slide assembly comprising a support 32, a slide 33 for engagement with a test plate, a slide rail 34, and a gear rack 35 coupled to the slide. A pinion coupled to the motor output shaft engages with the gear rack. The gear rack is movable by the motor to move the slide between an inactive position in which the slide is out of engagement with a sample container and an active position in which the slide engages with a test plate of a sample container.
The slide may be provided with a tool 36 engaging with and moving a test plate. In the depicted embodiment, the tool is a plate having an extension at an end to engage with a test plate. Alternatively, the slide may be provided with a one or more protrusions extending from an end of the slide or tool.
Other suitable means for engaging with the test slide will be apparent to skilled person. In essence, a particular size and/or shape and/or configuration of the slide or tool is not critical. Instead, the tool, or the slide itself if no tool is provided, needs to be of a size and/or shape and/or configuration suitable for engaging with and moving a test plate.
The remover assembly the reinserter assembly are configured and positioned so that the respective slides move a test plate linearly along a track. The remover assembly is operable to move a test plate from a sample container to the test location and the reinserter assembly is operable to move a test plate from the test location to a sample container.
With reference to FIG. 12, the first, second and third motor drives include direct current (DC) motors. One suitable motor is a stepper motor. Other suitable motors will be apparent to the skilled person. Each motor has a mount 37. A motor driver 38 is provided for driving each motor.
The motors may be orientated so that an axis of rotation of each of the output shafts is parallel. The axes may all be substantially aligned in the same plane. This may enable a volume of the machine to be reduced. It may also serve to constrain vibration generated by the motors.
The various components of the sample container manipulation assembly are mounted to a backing plate 39. This provides a sample container manipulation module that may be assembled outside of the machine and is then insertable into the machine. The module may be removed from the machine for maintenance and/or repair.
The machine further comprises a light source 40. The light source is configured to emit light in the proximity of a test plate and so as to pass through a test plate in the test location. The light source is capable of a high intensity output.
With reference to FIG. 13, the machine includes a digital camera 41 for imaging a pattern of light from the light source and passable through a test plate. The camera is positioned on an opposite side of the test location from the light source. The camera is aligned with the light source. The camera may be a camera chip. One suitable camera is a Charge-Coupled Device. The camera may be a camera chip of the type used in smart devices incorporating a camera. The light source comprises three light emitters configured to emit light of three different wavelengths. One suitable type of light emitters is Light Emitting Diodes (LED). These are coupled to a base of the machine. The three LEDs are configured to emit light of different colours. The LEDs are activatable to emit, in sequence, light of three different wavelengths. The intensity of the light emitted by the LEDs may be variable by varying an LED drive current. This may be controllable using Pulse Width Modulation (PWM).
With reference to FIG. 14, a light tube or light pipe 42 is provided for channelling light from the light source to a test location. The light tube resembles a manifold and has three input tubes, one from each LED, and an output tube leading to the test location. It is installed over the top of the LEDs so that each LED is positioned in, or below, a respective one of the input tubes. The light tube may be affixed to a base of the machine. The light tube has a conical tip and is configured to scatter light emerging from the output tube.
The light tube may comprise at least one support bracket 43 for holding the light tube in a desired position and opposing any movement of it. Two support brackets may be provided for supporting the light tube in different directions or planes.
The light tube may be made from Poly(methyl methacrylate) (acrylic). This may be metallised.
At least one leveller (not shown) may be provided for ensuring that the light tube is correctly orientated during initial set up of the machine or following maintenance or calibration etc. This may be a spirit level. More than one spirit level may be provided for monitoring the position of the light tube in two different directions or planes. The one or more spirit levels may be a separate component coupled to the light tube. Alternatively, the one or more spirit levels may be integrally formed with the light tube.
A computer 44 is provided. This may be a single board computer is provided. One suitable computer is a Printed Circuit Board (PCB) or Printed Circuit Board Assembly (PCBA). The computer is coupled to the screen. The controls the operation of the various components of the machine, guided by a software program. It particular, the computer controls the operation of the sample container manipulation assembly. The computer may enable partial or fully automated operation of the machine.
An integrated circuit is provided (not shown - located behind the screen). This analyses image(s) captured by the digital camera and processes the images to obtain a test result. The computer is in communication with the integrated circuit. One particularly suitable type of integrated circuit is a Field-Programmable Gate Array (FPGA).
A display screen 45 is provided for displaying information to a user to guide them through the steps required to test a sample. It also displays a result of a test performed on a test plate. The screen may also be capable of receiving user inputs. The monitor may be a touch screen.
A power unit and/or power controller (not shown) is provided for supplying and controlling power to the machine. The power unit may include a transformer. The power unit may be integrated or external to the machine.
One or more cooling fans 46 may be provided for cooling the machine. The machine may also include circulation space for air to circulate.
One or more anti-vibration features or vibration dampers are provided. These may include one or more of: vibration-damping feet 47 for the machine; one or more vibration-damping mounts for coupling machine components to the casing or base plates; and a vibrationdamping mount for the digital camera. This may improve the stability of the machine and accuracy of the optical testing. Suitable vibration-damping features include feet and/or washers and/or mounts. These may be made from a rubber. A suitable material is a polyurethane rubber. Other suitable vibration damping means and materials for vibration damping or isolation will be apparent to the skilled person.
The receptacle has an aperture 48 through which dispensed sample containers may pass. It has a hinged door 49 to permit emptying of used sample containers. The door is lockable using a known type of lock 50. The receptacle is provided with one or more anti-vibration features or vibration dampers, for example, feet 51. These may be made from a rubber. A suitable material is a polyurethane rubber. Other suitable vibration damping means and materials for vibration damping or isolation will be apparent to the skilled person.
Operation of the machine will now be described, with reference to FIGS. 15A to 16D.
A sample container is inserted through the aperture in the machine casing and passes into the channel. The sensor(s) detect the presence of a sample container and/or that it is compatible with the test machine.
The machine performs some or all of the following steps which are controlled by the computer. Step 1 - The machine may be activated by the computer, for example by a user pressing a button the screen. Further instructions may be provided on the screen to guide the user.
Step 2 - A sample cartridge is inserted through the aperture and into the channel. This may automatically activate the machine without any manual action being required under Step 1.
Step 3 - The remover assembly is activated by the computer. The motor causes the slide to move towards a sample container and engage with a test plate. The tool with II- shaped slot accommodates a body of a sample container. Further movement of the slide causes the pair of protrusions or pins to be brought into engagement with a test plate. Further movement of the slide causes a test plate to be pushed out from or removed from a sample container. Further movement of the slide pushes a test plate along a track or channel 52 and passing under the camera to a test location situated between the light source and the digital camera. A stop 53 may define an end of the track. The motor reverses and withdraws the slide. A test plate remains at the test location.
Step 4 - The light source is activated by the computer. The LEDs are sequentially operated and the light passes through the light tube to the tip where the light is scattered and passes through a test plate.
Step 5 - The camera is activated by the computer and images a pattern of light passing through a test plate as required.
Step 6 - The reinserter assembly, where present, is activated by the computer. The motor causes the slide to engage with a test plate. Further movement of the slide causes a test plate to be moved towards a sample container. Further movement of the slide pushes a test plate into engagement with the test container. The motor reverses and withdraws the slide. A test plate remains coupled to the container. A sample container remains in the channel.
Step 7 - The ejector assembly is activated by the computer. The motor withdraws the slide from the active position to the inactive position which opens the channel.
Step 8 - A sample container is ejected though the base of the machine and drops through the aperture and into the receptacle. Step 9 - The ejector assembly is activated by the computer and the motor reverses and moves the slide from the inactive position to the active position which closes the channel.
Step 10 - The image(s) captured by the camera is analysed by a suitable software program running on the computer in communication with the integrated circuit.
Step 11 - A result of the test is displayed on the screen.
Any or all of these steps may be performed in a different order. Some steps may be performed simultaneously. One or more additional steps may occur.
The machine is reset and a new test may then be performed. The receptacle may be emptied when full, or at desired frequency.
An alternative embodiment of the machine may not require the reinserter assembly. Instead, the remover assembly and the ejector assembly are operable as described above to remove a test plate from a sample container and to eject a sample container from the channel. When a test is complete, a test plate may be ejected, for example by further advancement of the remover assembly, into a separate receptacle for disposal.

Claims

1. A sample container manipulation assembly for an optical test machine, comprising:- a channel for receiving a sample container comprising a removable test plate; a remover assembly configured to remove a test plate from a sample container for testing; and an ejector assembly configured to eject a sample container from the channel.
2. A sample container manipulation assembly according to Claim 1 , wherein the remover assembly comprises a first motor drive.
3. A sample container manipulation assembly according to Claim 1 or 2, wherein the ejector assembly comprises a second motor drive.
4. A sample container manipulation assembly according to any Claims 1 to 3, further comprising a reinserter assembly configured to reinsert a test plate in to a sample container.
5. A sample container manipulation assembly according to Claim 4, wherein the reinserter assembly comprises a third motor drive.
6. A sample container manipulation assembly according to any of the preceding Claims, wherein the remover assembly comprises a first linear slide assembly comprising a first slide for engagement with a test plate, a first slide rail, and a first gear rack coupled to the first slide, the first gear rack being movable by a motor so as to engage and move a test plate.
7. A sample container manipulation assembly according to any of the preceding Claims, wherein the ejector assembly comprises a second linear slide assembly comprising a second slide for removably obstructing at least a portion of the channel, a second slide rail, and a second gear rack coupled to the slide, the second gear rack being movable by a motor so as to at least partially open the channel.
8. A sample container manipulation assembly according to any of Claims 4 to 7, wherein the reinserter assembly comprises a third linear slide assembly comprising a third slide for engagement with a test plate, a third slide rail, and a third gear rack coupled to the third slide, the gear being movable by a motor so as to engage and move a test plate. A sample container manipulation assembly according to any of the preceding Claims, wherein at least one of the first, second and third motor drives comprises a DC motor. A sample container manipulation assembly according to Claim 9, wherein a DC motor of at least one of the first, second and third motor drives is a stepper motor. An optical test machine comprising a sample container manipulation assembly of any of the preceding Claims. An optical test machine according to Claim 11, further comprising a light source. An optical test machine according to Claim 12, further comprising a digital camera. An optical test machine according to Claim 13, wherein a sample container manipulation assembly is operable to remove a test plate from a sample container in the channel and move it to a test location between the light source and the digital camera. An optical test machine for testing a patient sample, comprising:- a channel configured to receive a sample container comprising removable a test plate; a light source; a digital camera; and a sample container manipulation assembly; the machine being operable: to cause a sample container manipulation assembly to remove a test plate from a sample container and move it to a test location; to cause the light source to emit light; and to cause the digital camera to image a pattern of light emittable from the light source and passable through a test plate in the test location. An optical test machine according to Claim 15, wherein a sample container manipulation assembly comprises:- a remover assembly configured to remove a test plate from a sample container; and an ejector assembly configured to eject a sample container from the channel. An optical test machine according to any of Claims 12 to 16, wherein the light source is configured to emit light at at least two different wavelengths. An optical test machine according to Claim 17, wherein the light source comprises three light emitters, each configured to emit light at different wavelengths. An optical test machine according to Claim 18, wherein the three light emitters are LEDs configured to emit light of different colours. An optical test machine according to Claim 19, wherein the three light emitters are activatable in sequence to sequentially emit light at three different wavelengths. An optical test machine according to any of Claims 12 to 20, further comprising a light tube for channelling light from the light source to proximate a test location. An optical test machine according to Claim 21 , where in the light tube comprises a conical tip configured to scatter light emittable by the light source. An optical test machine according to Claim 21 or 22, where in the light tube comprises at least one leveller. An optical test machine according to any of Claims 13 to 23, wherein the digital camera is a Charge-Coupled Device. A method of method of performing a pathogen test, including the steps of: providing an optical test machine according to any of Claims 11 to 24; inserting a sample container comprising a removable test plate into the machine; and reading a displayed test result.
PCT/GB2021/052275 2020-09-09 2021-09-03 Sample container manipulation assembly and optical test machine comprising the assembly WO2022053785A1 (en)

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Citations (3)

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EP2713168A2 (en) * 2012-09-28 2014-04-02 Sysmex Corporation Specimen storage device and specimen storing method
US20140362436A1 (en) * 2013-06-07 2014-12-11 Clemex Technologies Inc. Automatic slide loading system and method

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