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WO2023186369A1 - Dispositif analytique pour effectuer des tests biologiques microfluidiques ayant une cartouche à deux trajets - Google Patents

Dispositif analytique pour effectuer des tests biologiques microfluidiques ayant une cartouche à deux trajets Download PDF

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Publication number
WO2023186369A1
WO2023186369A1 PCT/EP2023/052398 EP2023052398W WO2023186369A1 WO 2023186369 A1 WO2023186369 A1 WO 2023186369A1 EP 2023052398 W EP2023052398 W EP 2023052398W WO 2023186369 A1 WO2023186369 A1 WO 2023186369A1
Authority
WO
WIPO (PCT)
Prior art keywords
analysis device
processing
paths
cartridge
path
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2023/052398
Other languages
German (de)
English (en)
Inventor
Peter Theunissen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Robert Bosch GmbH
Original Assignee
Robert Bosch GmbH
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 Robert Bosch GmbH filed Critical Robert Bosch GmbH
Publication of WO2023186369A1 publication Critical patent/WO2023186369A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices
    • B01L9/52—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
    • B01L9/527—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips for microfluidic devices, e.g. used for lab-on-a-chip
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/023—Sending and receiving of information, e.g. using bluetooth
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L7/00—Heating or cooling apparatus; Heat insulating devices
    • B01L7/52—Heating or cooling apparatus; Heat insulating devices with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples

Definitions

  • the invention relates to an analysis device for carrying out microfluidic biological tests, in particular for carrying out a copying of nucleic acid sections.
  • an analysis device can be used to carry out tests on site, i.e. at the point of care, in particular PCR tests to detect pathogens.
  • a human or animal sample can be processed in a microfluidic cartridge, also called a lab-on-(a) chip cartridge (LoC cartridge for short), in the analysis device.
  • a microfluidic cartridge also called a lab-on-(a) chip cartridge (LoC cartridge for short
  • the analysis device typically has all active technical means, in particular heaters, hydraulic or pneumatic controls for the cartridge, while the cartridge is generally designed as a disposable product without active components, but equipped with the necessary biochemical reagents and is cost-effective.
  • the patent DE 10 2014205 728 B3 describes such a LoC cartridge in which two subsets of a sample of biological material are divided into two separate paths referred to as sample processing areas and are processed and analyzed independently of one another.
  • An analysis device known as a microfluidic system can hold the cartridge and control the two paths for both processing and analysis using a (for example optical) evaluation device. Disclosure of the invention
  • the invention relates to an analysis device for carrying out microfluidic biological tests, in particular for carrying out a copying of nucleic acid sections.
  • the analysis device is set up to process a cartridge with a first path for carrying out a first biological test and a second path for carrying out a first biological test, wherein the analysis device is further set up to use one of the two paths or both paths depending on an input process and/or adapt processing for one or both paths.
  • the cartridge can in particular be a microfluidic cartridge, also referred to as a LoC cartridge as explained at the beginning.
  • the invention therefore also relates to a microfluidic system comprising an analysis device according to the invention and such a cartridge.
  • the cartridge comprises a layer structure, wherein a fluidic layer, also referred to as a fluidic layer or fluidic layer, is separated from a pneumatic layer by an elastic membrane.
  • a fluidic layer also referred to as a fluidic layer or fluidic layer
  • the cartridge comprises a layer structure, wherein a fluidic layer, also referred to as a fluidic layer or fluidic layer, is separated from a pneumatic layer by an elastic membrane.
  • a fluidic layer also referred to as a fluidic layer or fluidic layer
  • the fluidic layer there are chambers connected by channels in which processing and analysis of a sample taken can take place.
  • channels and chambers in the pneumatic layer in order to move the membrane in places with respect to the fluidic layer via an applied positive or negative
  • One or both paths can include such channels and/or chambers of the fluidic and/or pneumatic layer, in particular in their function as fluidic actuators such as pumps or valves.
  • the analysis device preferably comprises a pneumatic component for controlling the membrane via the pneumatic layer and thus for controlling the fluidic actuators.
  • Processing and/or analysis of at least part of a sample can thus advantageously take place in one or both paths, the Processing or analysis takes place depending on an input into the analysis device. For example, depending on the type of test to be carried out communicated via the input and/or the type of cartridge used, one or both paths can be processed.
  • the analysis device preferably includes several sequence programs or
  • the analysis device can be set up to carry out the same processing in both paths with appropriate input. In this way, a “double test” is advantageously carried out in order to increase the meaningfulness of the processing or analysis.
  • the analysis device is preferably set up to divide a sample between the two paths if necessary, in particular via a control of the cartridge to distribute the sample from a sample input chamber of the cartridge to the two paths.
  • the input can take place, for example, via wireless information transmission, for example via WLAN, Bluetooth® or radio. Alternatively or additionally, the input can be done manually, for example via a touch-sensitive display, or using an optical scanner on the analysis device by detecting a barcode or QR code.
  • the processing of one or both paths can be adapted, for example, to the type of sample transmitted via the input.
  • the sample type can be understood to mean at least one biological characteristic of the sample, for example information as to whether the sample includes blood, sputum, urine or a swab.
  • the type of sample can also be understood as meaning a substance, in particular added to the sample, in particular a transport medium such as eNATTM or UTMTM.
  • processing can include lysis of the sample depending on the transport medium communicated via the input.
  • the processing can be adapted in such a way that a lysis step of cells in the sample is carried out in the presence of a non-lysing transport medium such as UTMTM and no lysis step is carried out in the case of a lysing medium such as eNATTM.
  • the input can be a Further information includes whether lysis should be carried out as part of the processing in the presence of a non-lysing transport medium.
  • the invention therefore also has the advantage that, in addition to demand-oriented processing of one or both paths, the processing itself can also be adapted via the input.
  • the analysis device or the cartridge can include temperature control elements, i.e. heating elements and/or cooling elements, for example resistance heaters or Peltier elements, in order to control the temperature of fluid in the cartridge. Processing of one or both paths can therefore include a movement of fluid in a chamber of the cartridge and/or a temperature control of a chamber of the cartridge, in particular for carrying out thermal lysis, a polymerase chain reaction (PCR) and/or an isothermal amplification.
  • temperature control elements i.e. heating elements and/or cooling elements, for example resistance heaters or Peltier elements
  • the analysis device is set up to carry out processing of one of the two paths depending on processing of the other path, in particular depending on an evaluation of a step carried out in the processing of at least one of the paths, in particular the other path, for example an intermediate step of a PCR.
  • the processing of at least one of the paths can include carrying out a human control, with the processing of one of the paths or preferably both paths being aborted if the human control is negative.
  • a human control can in particular include the duplication and detection of a given human nucleic acid section.
  • the analysis device is therefore preferably set up to prematurely end the processing of one or, alternatively, both paths if an evaluation of a step in the processing of this path or alternatively of the other path leads to a predetermined result, in particular to detection of a predetermined substance.
  • the analysis device is therefore preferably set up to adapt at least one processing step when processing one path depending on at least one processing step when processing the other path.
  • the analysis device is set up, preferably depending on a corresponding input or configuration before the start of processing, to abort the processing in one or alternatively both paths in the event of a negative human control.
  • the analysis device can be set up to no longer (continue) carry out processing in one or, alternatively, both paths if a partial step of processing a path delivers a predetermined result, for example detection of a predetermined substance, for example a pathogen or a biomarker a processed part of the sample, so that, for example, further detection of the same substance or a different substance is no longer required (also referred to as “early detection”).
  • the analysis device is therefore preferably set up to prematurely end the processing of one or, alternatively, both paths if an evaluation of a step in the processing of this path and/or (in an alternative embodiment) of the other path leads to a predetermined result, in particular to proof or false proof a given substance.
  • the invention also relates to a method for carrying out a biological test with an analysis device according to the invention or a microfluidic system according to the invention, wherein depending on an input into the analysis device one of the two paths or both paths of the cartridge are processed and / or wherein processing for one or both paths are adjusted.
  • an analysis device according to the invention or a microfluidic system according to the invention, wherein depending on an input into the analysis device one of the two paths or both paths of the cartridge are processed and / or wherein processing for one or both paths are adjusted.
  • Figure 1 exemplary embodiments of the analysis device according to the invention and the system according to the invention and Figure 2 is a flowchart of an exemplary embodiment of the method according to the invention.
  • Figure 1 shows an exemplary embodiment of the system 100 according to the invention, comprising an exemplary embodiment of the analysis device 300 according to the invention.
  • a microfluidic cartridge 310 is accommodated in the analysis device 300, the cartridge 310 having a first path 311 and a second path 312 for each carrying out a biological test.
  • the paths 311, 312 can each have one or more fluidic elements such as channels, chambers, pumps and/or valves as sample processing devices 330, 340.
  • the biological tests can in particular be biological assays, in particular a multiplication of nucleic acid sections Polymerase chain reaction (PCR) or isothermal amplification.
  • PCR Polymerase chain reaction
  • An exemplary embodiment of the method 500 according to the invention can be carried out, for example, with an exemplary embodiment of the analysis device 300 or system 100 according to the invention shown in FIG.
  • a biological sample in particular a blood or saliva sample received in a transport medium, can be introduced into a sample receiving chamber 320 of the cartridge 310 via an introduction opening 322.
  • an input for processing in particular a wireless and/or optical input, is made into the analysis device 300.
  • the second step 502 can, for example, include reading a code from the cartridge and/or from the sample container.
  • the second step 502 can take place at least partially, in particular a reading of information applied to the sample container, before the first step 501, for example in order to check the compatibility of the sample with the cartridge 300.
  • processing of the paths 311, 312 in the analysis device 300 can be configured in a third step 503, for example with regard to the type of sample transmitted via the input, the transport medium of the sample and/or Properties of the cartridge 300, for example based on the GTIN (Global Trade Item Number), the production date and/or the lot number.
  • GTIN Global Trade Item Number
  • it can be set whether one of the two paths 311, 312 or whether both paths 311, 312 are processed.
  • one of several processing or sequence programs configured or stored in the analysis device can preferably be selected, preferably for each of the two paths.
  • processing that has already been configured can be adapted based on the information received via the input. For example, depending on information about the transport medium of the sample, a lysis step can be included in the processing of at least one of the paths or removed from the processing.
  • one or more process parameters of the processing can also be defined or changed based on the information in the input, for example a different definition of the parameters when processing a sample from just one patient compared to a sample which has a mixture of samples from several patients (so-called pooling or Pool test), for example an adjustment of the sample volume to be processed (for example 750 microliters in the pool test compared to 350 microliters in the individual test) and preferably a corresponding adjustment of the amounts of other substances required for processing, in particular buffers.
  • pooling or Pool test for example an adjustment of the sample volume to be processed (for example 750 microliters in the pool test compared to 350 microliters in the individual test) and preferably a corresponding adjustment of the amounts of other substances required for processing, in particular buffers.
  • the cartridge 310 can be included in the analysis device 310 and the processing can be carried out in a fifth step 505.
  • the analysis device 300 has, for example, a pneumatic control for the fluidic elements of the cartridge 310, for example (adjustable) pressure levels for applying pressure in pneumatic channels of the cartridge for actuating valves and pumps.
  • the analysis device 300 is preferably set up to introduce partial quantities of the sample from the sample receiving chamber 320 via a respective channel 324, 326 into the first path 311 or the second path 312 for processing in the sample processing devices 330, 340 and also to control the processing, in particular via the pneumatic control of pumps and valves in the cartridge 100 as well as via a control of heating and/or cooling elements of the analysis device 300 or the cartridge 310.
  • the processing therefore preferably includes several sub-steps in both paths 311, 312, such as sample preparation, lysis, nucleic acid amplification .
  • the execution of a sub-step in one path 311, 312 may preferably depend on the execution of a sub-step in the other path 312, 311.
  • a human check can be carried out in the first path 311 and, depending on the result of the human check, the processing can be continued or aborted in the second path 312 (and preferably also in the first path 311).
  • an evaluation of a sub-step in particular a detection of a predetermined substance (for example part of a pathogen or biomarker), can be carried out to prematurely terminate the processing of the affected path 312 or, alternatively, both paths 311, 312, with this evaluation preferably being output to the user , which enables advantageous early detection of the substance being sought (“early detection”).
  • an analysis of the processed sample quantities can preferably be carried out in sensor chambers 350, 360 each connected to the paths 311, 312, for example via, in particular, optical sensors 304, 306 of a sensor device 302 of the analysis device 300, according to a sixth step 506.
  • a result of the analysis can be displayed via a display of the analysis device 300, stored in a memory and/or transmitted to another device, for example (wirelessly) to a server.

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  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

L'invention concerne un dispositif analytique (300) pour effectuer des tests biologiques microfluidiques, en particulier pour effectuer une multiplication de sections d'acide nucléique, le dispositif analytique (300) étant configuré pour traiter une cartouche ayant un premier trajet (311) pour effectuer un premier test biologique et un second trajet (312) pour effectuer un premier test biologique, le dispositif analytique (300) étant en outre configuré pour traiter, en fonction d'une entrée, l'un des deux trajets (311, 312) ou les deux trajets (311, 312) et/ou pour adapter un traitement pour un trajet ou les deux trajets (311, 312).
PCT/EP2023/052398 2022-03-31 2023-02-01 Dispositif analytique pour effectuer des tests biologiques microfluidiques ayant une cartouche à deux trajets Ceased WO2023186369A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102022203201.2A DE102022203201A1 (de) 2022-03-31 2022-03-31 Analysegerät zur Durchführung von mikrofluidischen biologischen Tests mit einer Kartusche mit zwei Pfaden
DE102022203201.2 2022-03-31

Publications (1)

Publication Number Publication Date
WO2023186369A1 true WO2023186369A1 (fr) 2023-10-05

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PCT/EP2023/052398 Ceased WO2023186369A1 (fr) 2022-03-31 2023-02-01 Dispositif analytique pour effectuer des tests biologiques microfluidiques ayant une cartouche à deux trajets

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DE (1) DE102022203201A1 (fr)
WO (1) WO2023186369A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102024203387A1 (de) * 2024-04-12 2025-10-16 Robert Bosch Gesellschaft mit beschränkter Haftung Verfahren zum Testen einer insbesondere biologischen Probe auf vorgegebene Probenparameter mit einem mikrofluidischen System

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102014205728B3 (de) 2014-03-27 2015-03-05 Robert Bosch Gmbh Chiplabor-Kartusche für ein mikrofluidisches System zum Analysieren einer Probe biologischen Materials, mikrofluidisches System zum Analysieren einer Probe biologischen Materials sowie Verfahren und Vorrichtung zum Analysieren einer Probe biologischen Materials
WO2018065118A2 (fr) * 2016-10-07 2018-04-12 Boehringer Ingelheim Vetmedica Gmbh Cartouche et système d'analyse permettant de tester un échantillon
DE102016222072A1 (de) 2016-11-10 2018-05-17 Robert Bosch Gmbh Vorrichtung und Verfahren zur geneigten Prozessierung von mikrofluidischen Kartuschen
DE102016222075A1 (de) 2016-11-10 2018-05-17 Robert Bosch Gmbh Prozessiersystem und Verfahren zur Prozessierung einer mikrofluidischen Kartusche mit einer Prozessiereinheit

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8105783B2 (en) 2007-07-13 2012-01-31 Handylab, Inc. Microfluidic cartridge

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102014205728B3 (de) 2014-03-27 2015-03-05 Robert Bosch Gmbh Chiplabor-Kartusche für ein mikrofluidisches System zum Analysieren einer Probe biologischen Materials, mikrofluidisches System zum Analysieren einer Probe biologischen Materials sowie Verfahren und Vorrichtung zum Analysieren einer Probe biologischen Materials
WO2018065118A2 (fr) * 2016-10-07 2018-04-12 Boehringer Ingelheim Vetmedica Gmbh Cartouche et système d'analyse permettant de tester un échantillon
DE102016222072A1 (de) 2016-11-10 2018-05-17 Robert Bosch Gmbh Vorrichtung und Verfahren zur geneigten Prozessierung von mikrofluidischen Kartuschen
DE102016222075A1 (de) 2016-11-10 2018-05-17 Robert Bosch Gmbh Prozessiersystem und Verfahren zur Prozessierung einer mikrofluidischen Kartusche mit einer Prozessiereinheit

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