EP2848304A1 - Vorrichtung zur vorbereitung von proben zur analyse, system zur vorbereitung von proben zur analyse, verfahren zur vorbereitung von proben und verfahren zur analyse einer probe - Google Patents

Vorrichtung zur vorbereitung von proben zur analyse, system zur vorbereitung von proben zur analyse, verfahren zur vorbereitung von proben und verfahren zur analyse einer probe Download PDF

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Publication number
EP2848304A1
EP2848304A1 EP13742837.1A EP13742837A EP2848304A1 EP 2848304 A1 EP2848304 A1 EP 2848304A1 EP 13742837 A EP13742837 A EP 13742837A EP 2848304 A1 EP2848304 A1 EP 2848304A1
Authority
EP
European Patent Office
Prior art keywords
chamber
reagents
housing
analysis
preparing samples
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.)
Withdrawn
Application number
EP13742837.1A
Other languages
English (en)
French (fr)
Other versions
EP2848304A4 (de
Inventor
Javier Escobal Gonzalo
Paloma Aldamiz-Echebarria Zulueta
Gorka DÍEZ BARCENILLA
Dolores Verdoy Berastegui
Pablo LASCURAIN AREITIOAURTENA
Aitor MADINABEITIA UGALDE
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.)
Fundacion Gaiker
Original Assignee
Fundacion Gaiker
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 Fundacion Gaiker filed Critical Fundacion Gaiker
Publication of EP2848304A1 publication Critical patent/EP2848304A1/de
Publication of EP2848304A4 publication Critical patent/EP2848304A4/de
Withdrawn legal-status Critical Current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
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/52—Containers specially adapted for storing or dispensing a reagent
    • B01L3/527—Containers specially adapted for storing or dispensing a reagent for a plurality of reagents
    • 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
    • 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
    • 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
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0689—Sealing
    • 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
    • B01L2300/0672—Integrated piercing tool
    • 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
    • B01L2300/0867—Multiple inlets and one sample wells, e.g. mixing, dilution
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0481—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure squeezing of channels or chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber

Definitions

  • the present invention relates to a device adapted to preparing samples for analysis which allows dosing reagents in a reaction body with a single chamber which allows handling samples and reagents from the outside thereof; the device assures maintenance of reagent sterility conditions until the reagent is exposed to the sample and minimizes the risk of sample handling by users.
  • the invention also relates to a support for the device, a system comprising the device and the support, a method for preparing samples using the system and a method of analysis comprising a step for preparing samples as indicated.
  • the main technical problem of these devices of the state of the art is that it is not possible to perform a preparation completely avoiding contact between the user performing the analysis with one of the reagents, with the subsequent risk of contaminating the reagents during the analytical process, and even with the sample itself, which can constitute an intrinsic biological risk, without using auxiliary equipment such as, for example, electronic systems, pumps, etc., which allow the movement and/or dosing of the different samples or reagents.
  • the present invention solves the problems described above by means of a device according to claim 1, a support according to claim 11, a system according to claim 13, a method for preparing samples according to claim 14 and a method of analysis according to claim 15.
  • the dependent claims define the preferred embodiments of the invention.
  • the first inventive aspect relates to a device adapted to dosing and preparing samples for analysis and adapted to housing at least reagents and magnetizable particles.
  • This device can be used for packaging or dosing molecular reagents, for example, for aliquoting, extracting and preparing samples for analysis by means of methods of molecular analysis, including, among others, PCR (Polymerase Chain Reaction), Q-PCR/RT-PCR, immuno-PCR, pyrosequencing, isothermal nucleic acid amplification, etc., characterized in that it comprises:
  • the device has a first independent storage chamber leak-tight closed in a manner for storing the reagents of one or several of the following components: lysis buffer, capture buffer, resuspension buffer, washing buffer and amplification buffer.
  • This chamber can also store magnetizable particles if it is going to perform a process for concentrating/capturing target analytes: nucleic acids, proteins, antibodies, peptides etc.
  • the magnetizable particles consist of synthetic polymers incorporating a magnetizable material core and are chemically modified to allow binding thereof with a specific substance, for example: silene, peptides, antibodies, proteins, nucleic acids, etc.
  • Such particles can be concentrated from a suspension by means of exposing them to a magnetic field, therefore being an alternative to centrifugation.
  • the magnetizable particles in the present invention allow capturing nucleic acids, proteins, antibodies, peptides, etc., from the sample to analyse.
  • means capable of generating a magnetic field which can be incorporated by the user must be used.
  • the chamber is leak-tight closed by means of sealing means preventing the loss of reagents or preventing the reagents from falling uncontrollably, or preventing them from coming into contact with the outside, thus preventing the risk of unwanted contaminations or changes in the physical and chemical parameters of the reagents housed therein: dehydration, wetting, oxidation, etc., entry of organic and inorganic biological contaminant particles, etc., which would result in reagent alteration, affecting functionality, being able to completely or partially compromise method reliability. Opening means are used to enable the reagents to exit the chamber.
  • the second chamber is an independent storage chamber leak-tight closed for storing the reagents of one or several of the following components: lysis buffer, capture buffer, resuspension buffer, washing buffer and amplification buffer. It can also optionally house magnetizable particles.
  • the main chamber of the device, or reaction chamber is made of a sterilized material and allows holding the liquid sample.
  • the material used for forming the main chamber corresponds to conventional materials for such devices for dosing and preparing samples, comprising any polymer material, preferably thermoplastic material.
  • the following materials are mentioned by way of example: polyethylene (PE), high density polyethylene (HDPE), low density polyethylene (LDPE), polystyrene (PS), polytetrafluoroethylene (PTFE), PTFE perfluoroalkoxy (PFA), polypropylene (PP), polymethylpentene (PMP), neoprene, perbunan, etc.
  • the reagents are added in said reaction chamber either simultaneously or sequentially, according to the practice for which the device is used.
  • the reagents housed in at least one of the storage chambers contact the sample for analysis in this reaction chamber. It can also be used as an individual housing.
  • the chambers adapted to storing reagents contact the reaction chamber upon acting on the opening means, preventing direct contact of the handler with the sample, drastically minimizing exposure to a possible biological risk and the reagents, preventing the risk of test contamination.
  • the sample prepared with the device is introduced in the main chamber or reaction chamber using these suction means.
  • the suction means are used to introduce the sample such that the volume of air inside the body is expelled by compressing said suction means.
  • the inlet-outlet port is then submerged in the liquid sample. Finally, the suction means are released and the sample is introduced through the inlet-outlet means.
  • the sample for analysis Once the sample for analysis has reacted with the reagents, it is placed in the tube to be used for analysis which, in the case of performing PCR, Q-PCR/RT-PCR or immuno-PCR, is inside a thermal cycler for polymerase chain reaction and specific nucleic acid sequence amplification depending on the reagents added in the mixture and the nature of the sample to be analyzed. This is achieved by means of expelling the sample from the main chamber of the device through the inlet-outlet port.
  • the advantage of this device is that it allows using any variant of the molecular analysis technique, such as for example: Q-PCR/RT-PCR, immuno-PCR, isothermal amplification, pyrosequencing, etc., in clinical laboratories, with staff who are not highly skilled, therefore generalizing technique accessibility and competitiveness on different markets, preferably on the health product market.
  • the fundamental difference with respect to devices of the state of the art is that it comprises a single reaction chamber which allows maximally reducing losses as well as standardizing the inter- and intra-analysis test method.
  • the second inventive aspect relates to a support for a device such as the one of the first inventive aspect, furthermore comprising a removable element for suctioning the sample.
  • the support comprises extraction means for extracting the removable element.
  • This support for the device has a configuration such that the main chamber of the device for preparing samples is immobilized when the support is coupled thereto. This immobilization allows the reagents to fall from the storage chambers by gravity and remain perfectly positioned.
  • the support comprises extraction means for extracting the removable element to enable separating the two elements, i.e., the device and the removable element. These extraction means provide the advantage that the user does not have to touch the removable element which contacts a sample that may be contaminated.
  • the third inventive aspect relates to a system adapted to dosing and preparing samples for analysis by means of a method of analysis, characterized in that it comprises a device according to the first inventive aspect, and a support according to the second inventive aspect.
  • the fourth inventive aspect relates to a method for preparing samples for analysis which comprises preparing samples by means of the device according to the first inventive aspect, or a system according to the second inventive aspect.
  • the fifth inventive aspect relates to a method for analyzing a sample which comprises preparing said sample by means of the method of the fourth inventive aspect.
  • the device comprises at least a first branch (12) housing at least the first chamber (2) and at least a second branch (13) housing at least the second chamber (3).
  • These two branches (12, 13) open into the main chamber (4).
  • This design allows housing the chambers in an individual and spatially separated manner such that they are independent of the main reaction chamber (4).
  • Figure 2 shows this way of positioning chambers (2, 3) with respect to the main chamber (4).
  • the main chamber is prepared with an elastic material, such as plastic, for example, therefore allowing the suction means (15) to be the main chamber (4) itself.
  • the operating principle is such that by pressing on the body of the main chamber (4), the inner volume of air is expelled allowing subsequent sample suction.
  • the suction means are formed with a nipple in an additional branch without the main chamber (4) having to be elastic.
  • the device incorporates a removable element (1), preferably in a frustoconical tubular shape, for sample suction.
  • Figure 3 shows the removable element (1) as a tip fitted in the reaction chamber of the device. It is easier to perform the liquid sample suction step through this tip.
  • the end of the removable element (1) fitting with the inlet-outlet means (5) of the device has a configuration which allows fitting thereof with a complementary fitting area envisaged for such purposes in a support for said device.
  • filtering means (16) are incorporated in the removable element (1) which allow filtering solid particles that can contaminate the sample before being prepared for reaction with the reagents in the main chamber (4).
  • the device incorporates means capable of generating a magnetic field, for example a magnet, which allow immobilizing the magnetizable particles in the main chamber (4), making expelling the rest of the reagents easier, if necessary.
  • a magnetic field for example a magnet
  • This case can be, for example, the need to immobilize the magnetizable particles once these particles have captured specific sequences of DNA, RNA, proteins, peptides, antibodies, etc.; this allows expelling the rest of the reagents and excess liquid sample from the main chamber or reaction chamber.
  • the device as shown in Figure 4 includes a third branch (14) housing a third chamber (10) with third sealing means (11) and third opening means (19).
  • the third branch (14) is arranged equidistant together with the first branch (12) and the second branch (13).
  • the third chamber (10) also opens into in the main chamber (4) and releases its content when the third sealing means (11) have been opened with the third opening means (19).
  • Figure 4 also shows the removable element (1).
  • the sealing means (7, 8, 11) are manufactured from a material the composition of which comprises aluminum and polypropylene and are heat sealable to their respective chambers (2, 3, 10).
  • the sealing means (7, 8, 11) opening means' (17, 18, 19) are punches the punching end of which is arranged facing the wall of the sealing means (7, 8, 11). The forward movement of these opening means (17, 18, 19) causes the sealing means (7, 8, 11) to break, allowing the reagents to exit towards the reaction chamber or main chamber.
  • the chambers (2, 3, 10) have an outer elastic area which the user presses on to act on the punches, causing them to move and break the sealing means with the subsequent opening of the chambers (2, 3, 10).
  • the sealing means (7, 8, 11) opening means' (17, 18, 19) are blades the cutting end of which is arranged facing the wall of the sealing means (7, 8, 11). The forward movement of these opening means (17, 18, 19) causes the sealing means (7, 8, 11) to break, allowing the reagents to exit towards the reaction chamber or main chamber.
  • the chambers (2, 3, 10) have an outer elastic area which the user presses on to act on the blades, causing them to move and break the sealing means with the subsequent opening of the chambers (2, 3, 10).
  • One embodiment of the device includes sealing means' (7, 8, 11) opening means in the form of windows that open by means of rotating the end of the branches (12, 13, 14).
  • the sealing means (7, 8, 11) break by tearing.
  • the sealing means (7, 8, 11) break by detachment.
  • the device for dosing and preparing samples described above can cooperate with a complementary support which, in one embodiment, comprises securing means (20) for securing the removable element (1).
  • the securing means (20) have a configuration which allows the fitting thereof with the end area of the removable element (1) coupled with the inlet/outlet port (5).
  • said fitting configuration has a deformable toothed area in the securing means (20), as depicted in Figure 5B , fitting with the surface at said end of the removable element (1).
  • This configuration of the securing means (20) allows extracting the removable element (1) by means of rotating the device such that the user never contacts the removable element (1).
  • the height of the support (9) is essentially greater than the height of the removable element (1) to allow housing the device with the removable element (1) for suctioning the sample.
  • the support contains housing means (21) for housing the means (22) capable of generating a magnetic field if they are not located in the device and not incorporated into the system by the user.
  • Figure 6 shows a section view of the support.
  • These housing means (21) are in the position of the support coinciding with the position of the main chamber (4) of the device for preparing samples when it is arranged.
  • the magnetizable particles can thus be magnetized inside the main chamber (4).
  • Figure 7 shows a view of an embodiment of the system comprising one of the embodiments of the device and the support.
  • the embodiment of the device comprises sealing means' (7, 8, 11) opening means (17, 18, 19) in the form of blades.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Medicinal Chemistry (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
EP13742837.1A 2012-02-02 2013-02-01 Vorrichtung zur vorbereitung von proben zur analyse, system zur vorbereitung von proben zur analyse, verfahren zur vorbereitung von proben und verfahren zur analyse einer probe Withdrawn EP2848304A4 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201230157A ES2427548B1 (es) 2012-02-02 2012-02-02 Dispositivo de preparación de muestras de análisis, soporte, sistema de preparación de muestras de análisis, método de preparación de muestras y método de análisis de una muestra
PCT/ES2013/070054 WO2013113969A1 (es) 2012-02-02 2013-02-01 Dispositivo de preparación de muestras de análisis, soporte, sistema de preparación de muestras de análisis, método de preparación de muestras y método de análisis de una muestra

Publications (2)

Publication Number Publication Date
EP2848304A1 true EP2848304A1 (de) 2015-03-18
EP2848304A4 EP2848304A4 (de) 2016-03-09

Family

ID=48904448

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13742837.1A Withdrawn EP2848304A4 (de) 2012-02-02 2013-02-01 Vorrichtung zur vorbereitung von proben zur analyse, system zur vorbereitung von proben zur analyse, verfahren zur vorbereitung von proben und verfahren zur analyse einer probe

Country Status (3)

Country Link
EP (1) EP2848304A4 (de)
ES (1) ES2427548B1 (de)
WO (1) WO2013113969A1 (de)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL141111A0 (en) * 2001-01-25 2002-02-10 Biopreventive Ltd Reaction vessel and system incorporating same
US20020131892A1 (en) * 2001-03-16 2002-09-19 Baruch Glattstein Molded casing for a test kit
US20020173046A1 (en) * 2001-05-18 2002-11-21 Ahmed Hafez Chemical reaction vessel
US20050123456A1 (en) * 2001-12-04 2005-06-09 Lutz Eichacker Device and method for processing biological or chemical substances or substance mixtures thereof
SE524730C2 (sv) * 2002-11-20 2004-09-21 Boule Medical Ab Blodprovsapparat
SE0401145D0 (sv) * 2004-04-30 2004-04-30 Mats Malmqvist Continuous flow reaction vessel system
US7727473B2 (en) * 2005-10-19 2010-06-01 Progentech Limited Cassette for sample preparation
US20080293156A1 (en) * 2007-05-22 2008-11-27 3M Innovative Properties Company Devices and methods for dispensing reagents into samples

Also Published As

Publication number Publication date
WO2013113969A1 (es) 2013-08-08
ES2427548B1 (es) 2014-10-01
EP2848304A4 (de) 2016-03-09
ES2427548A1 (es) 2013-10-30

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