WO2017045992A1 - Dispositif commandé par chimie sèche pour l'analyse d'un échantillon de matériel biologique - Google Patents

Dispositif commandé par chimie sèche pour l'analyse d'un échantillon de matériel biologique Download PDF

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Publication number
WO2017045992A1
WO2017045992A1 PCT/EP2016/071163 EP2016071163W WO2017045992A1 WO 2017045992 A1 WO2017045992 A1 WO 2017045992A1 EP 2016071163 W EP2016071163 W EP 2016071163W WO 2017045992 A1 WO2017045992 A1 WO 2017045992A1
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WO
WIPO (PCT)
Prior art keywords
analysis
sample
evaluation
control
control device
Prior art date
Application number
PCT/EP2016/071163
Other languages
German (de)
English (en)
Inventor
Jochen Rupp
Jochen Hoffmann
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 WO2017045992A1 publication Critical patent/WO2017045992A1/fr

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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
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502715—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/143—Quality control, feedback systems
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • B01L2300/0654—Lenses; Optical fibres

Definitions

  • Dry chemical controlled device for analyzing a sample of biological material
  • Lab-on-a-chip systems are microfluidic devices in which a plurality of functionalities of a macroscopic laboratory are housed on a plastic credit card sized plastic substrate, for example, and can miniaturize and at least partially automate complex biological, diagnostic, chemical or physical processes.
  • Lab-on-a-chip systems are particularly suitable for analyzing samples of biological material, with such analyzes usually following a fixed schedule
  • Analysis steps are matched to the particular sample or intermediates of the sample.
  • a dry chemical test element also called a lateral-flow strip, can be used, for example as described in US Pat
  • the invention relates to an analysis device for analyzing a sample of biological material, wherein the device comprises at least one dry chemical test element for determining properties of the sample.
  • the Analysis device further comprises at least one read-out unit and a first interface to an evaluation device, in particular to a
  • Evaluation device of a control device wherein at least one of the read-out units is associated with one of the dry chemical test elements and wherein the first interface is set, a read-out of the at least one dry chemical determined by the readout unit
  • the analysis device can in particular be a microfluidic device, for example a lab-on-a-chip system,
  • a control device may, in particular, be understood to mean a device for controlling and / or regulating a microfluidic device, for example a
  • An evaluation device may, in particular, be understood as meaning an electronic circuit, in particular a processor, wherein the electronic circuit or the processor is set up, in particular programmed, to evaluate a readout result determined by the readout unit.
  • the analysis device has the advantage that the readout result determined by the readout unit can be automatically forwarded to a suitable evaluation device via the first interface to a further machine evaluation.
  • a suitable evaluation device via the first interface to a further machine evaluation.
  • the sample can be, for example, blood, urine or sputum.
  • the first interface comprises a light guide connected to the at least one readout unit.
  • the analysis device comprises a second interface to the evaluation device, wherein the second
  • Interface is arranged to transmit outputs of the evaluation or a control device comprising the evaluation device, for controlling the analysis of the sample to at least one analysis unit of the analysis device.
  • An analysis unit of the analysis device is understood in particular to mean a unit of the analysis device that is set up to physically, chemically or biologically change the recorded sample.
  • the unit may for example comprise a filter, in particular a filter for the selection of target cells or target molecules from a sample, for example a filter with a selection based on the principle of affinity chromatography.
  • the unit may comprise a heating device, in particular an inductive, resistive or radiation-based heater, as well as a mixer, in particular an active or a passive mixer.
  • the unit may also include means adapted to associate the sample with other substances for the purpose of reaction, to extract a portion of the sample, to lyse cells of the sample or to duplicate DNA from the sample, for example devices for performing a PCR.
  • An analysis unit may in particular also be understood to mean a unit for moving the sample within the analysis apparatus and may, for example, comprise a deflectable membrane or a valve, in particular one or more membranes as part of pumps for
  • an analysis unit may comprise a sensor for detecting properties of the sample, for example a fluorescence detector, resonator, spectroscopy sensor, nanoparticle sensor or an attenuated total reflection sensor.
  • Control of the analysis units is particularly advantageous because it allows an interactive analysis of the sample.
  • a further analysis of the biological material can be adjusted automatically, in particular by individual steps of the analysis are adapted and / or by repeating one or more steps of the analysis until a desired read-out result.
  • the at least one read-out unit comprises at least one optical detection unit, for example one
  • the first interface and the second interface are designed in the form of a common interface. This allows a reduction of the electronics in the analysis device and thus a saving of space for compact design of the analyzer.
  • the interface can comprise either the first and the second interface as separate units or as a single interface.
  • the at least one dry chemical test element can be removed in the analysis device
  • the analysis device has an opening through which the test elements can be introduced and removed from the analysis device.
  • the invention also relates to a control device with at least one
  • the at least one interface is adapted to communicate with the analysis device according to the invention for a control or regulation of the analysis device. Furthermore, the control device is set up, a received via the at least one interface
  • Readout result of at least one readout unit of the analysis device in an evaluation of an evaluation to process has the advantage a feedback of a triggering of the analysis device by the control device in the form of the read-out result can be evaluated and thus a check of a correct control or regulation of the analysis device by the control device is made possible.
  • control device is set up to control the analysis device for a control of the analysis of the sample, depending on the evaluation.
  • control device advantageously an interactive automated analysis can be a sample
  • biological material are carried out with the analysis device according to the invention.
  • control device comprises an output unit,
  • a display for displaying the readout result For example, a display for displaying the readout result, the
  • the invention also relates to a system, in particular a lab-on-a-chip system, for analyzing a sample of biological material comprising a
  • Analysis device and a control device, wherein the analysis device at least one dry chemical test element for a determination of
  • Characteristics of the sample comprises, wherein the system comprises at least one read-out unit associated with the dry chemical test element, wherein the read-out unit is a part of the analysis device or a part of the
  • control device Forms control device, and wherein the control device is set up, a readout result of the dry chemical test element transmitted via the readout unit in an evaluation of an evaluation device of
  • Control device to process and depending on the evaluation of the
  • the embodiment of the readout units as part of the analysis device has the advantage that the at least one readout unit can be arranged in the immediate vicinity of the at least one dry chemical test element for reliable readout.
  • the analyzer is to be designed as a disposable or disposable component, it is particularly advantageous that the Auslese units as part of the control device to train the
  • the invention further relates to a method for analyzing a sample of biological material.
  • the sample is placed in an analysis device for analysis.
  • a second step one or more steps of analyzing the sample are performed.
  • the sample is contacted with at least one dry chemical test element arranged in the analysis device during or after one of the steps of the analysis. This step can thus be carried out subsequently and / or during the execution of the second step.
  • the at least one dry chemical test element contacted with the sample is read out over at least one of the dry chemical test elements contacted with the sample
  • the method comprises a sixth step, wherein a control of the
  • Control device takes place, wherein a type of control depends on the evaluation
  • a not yet completed step of the analysis is either continued or terminated for a predetermined period of time, an already completed step of the analysis is repeated or a new step of the analysis is initiated.
  • This has the advantage that, if the result of a readout of one or more dry chemical test elements is insufficient, the analysis can be adapted automatically in a situation-dependent manner in order to improve the effectiveness and the efficiency of the analysis.
  • a not yet completed step of the analysis is prematurely terminated For example, if an intermediate result of the analysis based on a readout indicates one or more dry chemical test items, then a continuation of the currently performed step may not be required. This can advantageously resources, energy and time can be saved.
  • the analysis of the sample comprises a lysis of cells from the sample, wherein the evaluation comprises a determination of a lysis efficiency and wherein a further lysis of cells from the sample is controlled by the evaluation if the determined lysis efficiency below a predetermined Value is.
  • lysis efficiency may be estimated by determining an amount or density of nitrite, glucose, hemoglobin, urobilinogen and / or bilirubin by one or more dry chemical test elements.
  • Evaluation comprises a determination of a duplication efficiency and / or an amount of amplified DNA and wherein a further amplification of DNA from cells of the sample is driven by the evaluation device, if the determined amplification efficiency and / or the determined amount of amplified DNA is below a predetermined value.
  • the amplification efficiency and the amount of amplified DNA can be estimated by determining a protein concentration in the sample, a specific gravity, and / or a pH of the sample using one or more dry chemical test elements. This has the advantage, in particular when carrying out a polymerase chain reaction with the analyzer, that the number of PCR cycles to be carried out can be optimized by specifying an amount of amplified DNA to be achieved, and thus the overall duration of the PCR can be reduced.
  • the evaluation by the evaluation device preferably comprises a determination of a pH, a content, a concentration and / or a specific gravity of cells, pathogens, in particular bacteria and / or viruses, DNA, red and / or white blood cells, protein, nitrite, Glucose, hemoglobin, urobilinogen and / or bilirubin in the sample.
  • FIG 1 shows an embodiment of the analysis device according to the invention, the control device according to the invention and the inventive
  • FIG. 2 shows an embodiment of the system according to the invention
  • FIG. 1 shows an exemplary embodiment of the invention
  • the analysis device 100 comprises a first opening 101 for introducing a sample of biological material, for example blood, into the analysis device 100 and a second opening 102 for taking an analyzed sample from the analysis device 100.
  • the first and / or the second opening 101, 102 may be designed to be closed in a fluid-tight manner in order to reduce or completely avoid contamination of an environment around the analysis device. Alternatively, it is also possible that the analysis device 100 does not include an opening for taking the analyzed sample.
  • the first opening 101 and the second opening 102 are in series of chambers 103, 104, 105, 106 connected to each other, wherein one or more steps of the analysis of the sample in the chambers 103, 104, 105, 106 can be performed.
  • the chambers 103, 104, 105, 106 are dry chemical test elements 150 and the dry chemical test elements 150 associated readout units 160 for the selection of dry chemical
  • Test elements 150 arranged.
  • the readout units 160 may be optical detection units 160, such as lenses or cameras.
  • the chambers 103, 104, 105, 106 are separated from one another by valves 130. In the chambers 103, 104, 105, 106 further analysis units 140 for performing one or more analysis steps are arranged. Both
  • Analysis units 140 may be, in particular, filters, mixers or heaters.
  • the optical detection units 160, the analysis units 140 and the valves 130 are connected via connections 109 to a first interface 110 and to a second interface 120.
  • the connections 109 may comprise electrical connections and / or light guides.
  • Interface 110 and second interface 120 are part of a common interface 115.
  • test elements 150 may be withdrawn from the analysis device 100 through the first opening 101 or through the second opening and / or replaced by other dry chemical test elements.
  • FIG 1 also shows an embodiment of the invention
  • Control device 200 with an interface 210, wherein the interface 210 is connected via electrical connections 300 to the common interface 115 of the analysis device 100 according to the invention.
  • Interface 110 is set up to transmit to the control device 200 a readout result of the dry chemical test elements 150 determined by the optical detection units 160 after contacting with the sample introduced into the analysis device 100.
  • the transmission takes place via the interface 210 set up for this purpose to an evaluation device 250 of the
  • Control device 200 wherein the evaluation device 250 is programmed to evaluate the readout result.
  • the control device 200 is set up to control the analysis device 100 via the interface 210 of the control device 200, depending on the evaluation of the read-out result.
  • the control device 200 via the interface 210 the control device 200 and via the second interface 120 of
  • Analysis device 100 the analysis units 140, the valves 130 and the optical detection units 160 depending on the evaluation of
  • a lysis of cells of a recorded sample may be performed as parts of the analysis.
  • a dry chemical test element 150 is arranged, the four measuring ranges, for example, four test strips, for example, from the product series "Roche Combur-Test ®", “Macherey-Nagel ®”, “Health Mate ®”
  • Glucose concentration a hemoglobin concentration and a
  • Bilirubin concentration of the sample wherein one strength of a
  • Detection device 160 read and transmitted via the first interface 110 and the interface 210 of the control device 200 to the evaluation device 250.
  • a light source such as an LED, may be used to illuminate the dry chemical
  • Test element 150 may be disposed in the chamber 105.
  • the optical detection device 160 may comprise the light source.
  • Detector 160 may be, for example, a camera
  • one or more of the detectors 160 may also be one on the
  • matched color filters 161 include.
  • the evaluation device 250 is set up in this example, a
  • each RGB value of a pixel of a transmitted image may have a
  • Concentration are assigned, wherein the assignment of a certain concentration to an RGB value of a pixel in a memory of the
  • Evaluation device 250 can be stored.
  • Blood corpuscles are made via a comparison made by the evaluation device 250 of a determined over the test strip hemoglobin amount relative to a predetermined amount of red blood cells in the sample.
  • the control device 200 may be configured to control the analysis device 100 via the interface 210 of the analysis device 200, depending on the size of an estimated lysis efficiency, for example the estimated lysis efficiency of red blood cells. In particular, at a
  • Evaluation device 200 preferably includes a display 220 for displaying the determined concentration values and the estimated lysis efficiency to a user.
  • Figure 1 thus also shows an embodiment of the invention
  • System 400 which includes the analysis device 100 and the control device 200, and wherein the read-out units 160 in the form of optical
  • Detection units 160 form part of the analysis device 100.
  • FIG. 2 shows a further exemplary embodiment of the invention
  • System 400 with an analysis device 100 and a control device 200 in which example the readout units in the form of a single readout unit 160 are part of the control device 200.
  • the readout unit 160 is connected to the interface 210 of the control device 200 and to the
  • Evaluation device 250 of the control device is connected and is set up, read out an optical signal transmitted via the interface 210 and forward it to the output value device 250.
  • the interface 210 of the control device is connected and is set up, read out an optical signal transmitted via the interface 210 and forward it to the output value device 250.
  • Control device 200 is connected to the common interface 115 of the analysis device 100 via a connection 300 embodied as a light guide.
  • a connection 300 embodied as a light guide.
  • FIG. 2 by way of example, one of the chambers 104 of the analysis device is further illustrated
  • the chamber 104 may also comprise a transparent wall section to an outer area of the analysis device 100, so that an image of the test element 150 can be transmitted directly via the optical link 300 to the interface 210 of the control device 200 when the connection 300 at least partially with the transparent one
  • the arrangement of the read-out units as part of the control device is particularly advantageous when the analysis device represents a disposable or disposable component and thus manufacturing costs for the analysis device 100 can be reduced.
  • FIG. 3 shows an exemplary embodiment of the method 500 according to the invention.
  • a sample 501 of the sample is taken into an analysis device for analyzing the sample, followed by performing 502 one or more steps of the analysis of the sample.
  • a sample 501 of the sample is taken into an analysis device for analyzing the sample, followed by performing 502 one or more steps of the analysis of the sample.
  • a dry chemical test element arranged in the analysis device After contact 503 of the sample with at least one dry chemical test element arranged in the analysis device during or after one of the steps of the analysis, a
  • Control device via an interface of the analysis device, wherein the type of control depends on the evaluation 505.
  • the drive may repeat the execution 502 one or more Steps of analysis or initiation of one or more further steps of the analysis include.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Dispersion Chemistry (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un système (400), notamment un système laboratoire sur puce, pour l'analyse d'un échantillon de matériel biologique, comportant un dispositif d'analyse (100) et un dispositif de commande (200), le dispositif d'analyse (100) comprenant au moins un élément de chimie sèche (150) pour la détermination de propriétés de l'échantillon, le système comprenant également au moins une unité d'extraction (160) associée à l'élément de chimie sèche (150) et formant une partie du dispositif d'analyse (100) ou une partie du dispositif de commande (200), le dispositif de commande (200) étant conçu pour traiter un résultat d'extraction de l'élément de test de chimie sèche (150), transmis au moyen de l'unité d'extraction (160), dans une évaluation par un dispositif d'évaluation (250) du dispositif de commande (200).
PCT/EP2016/071163 2015-09-17 2016-09-08 Dispositif commandé par chimie sèche pour l'analyse d'un échantillon de matériel biologique WO2017045992A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015217785.8A DE102015217785A1 (de) 2015-09-17 2015-09-17 Trockenchemisch gesteuerte Vorrichtung zur Analyse einer Probe biologischen Materials
DE102015217785.8 2015-09-17

Publications (1)

Publication Number Publication Date
WO2017045992A1 true WO2017045992A1 (fr) 2017-03-23

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PCT/EP2016/071163 WO2017045992A1 (fr) 2015-09-17 2016-09-08 Dispositif commandé par chimie sèche pour l'analyse d'un échantillon de matériel biologique

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DE (1) DE102015217785A1 (fr)
WO (1) WO2017045992A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2050677A1 (fr) * 1990-09-06 1992-03-07 Ernest J. Kiser Methode de mesure visuelle de la glycemie
EP0953149A1 (fr) * 1997-01-15 1999-11-03 Axis Biochemicals ASA Systeme diagnostique
EP1710565A1 (fr) * 2005-04-05 2006-10-11 F. Hoffmann-La Roche Ag Système optique mobile pour diagnostics
US20110039261A1 (en) 2007-12-20 2011-02-17 Aj Innuscreen Gmbh Mobile rapid test system for nucleic acid analysis

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2050677A1 (fr) * 1990-09-06 1992-03-07 Ernest J. Kiser Methode de mesure visuelle de la glycemie
EP0953149A1 (fr) * 1997-01-15 1999-11-03 Axis Biochemicals ASA Systeme diagnostique
EP1710565A1 (fr) * 2005-04-05 2006-10-11 F. Hoffmann-La Roche Ag Système optique mobile pour diagnostics
US20110039261A1 (en) 2007-12-20 2011-02-17 Aj Innuscreen Gmbh Mobile rapid test system for nucleic acid analysis

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