EP2377770A1 - Collecte d'échantillons biologiques - Google Patents

Collecte d'échantillons biologiques Download PDF

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Publication number
EP2377770A1
EP2377770A1 EP11173826A EP11173826A EP2377770A1 EP 2377770 A1 EP2377770 A1 EP 2377770A1 EP 11173826 A EP11173826 A EP 11173826A EP 11173826 A EP11173826 A EP 11173826A EP 2377770 A1 EP2377770 A1 EP 2377770A1
Authority
EP
European Patent Office
Prior art keywords
container
volume
separation
sample
filling
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Withdrawn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
EP11173826A
Other languages
German (de)
English (en)
Inventor
Vera HOLLÄNDER
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.)
Qiagen GmbH
Original Assignee
Qiagen 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 Qiagen GmbH filed Critical Qiagen GmbH
Publication of EP2377770A1 publication Critical patent/EP2377770A1/fr
Withdrawn legal-status Critical Current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
    • B01L3/50—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
    • B01L2200/0605—Metering of fluids
    • 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
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se

Definitions

  • the present invention relates generally to the collection of biological samples, and more particularly to a sample collection container, such as a body fluid collection container, such as saliva, sputum, urine, sperm, blood, etc., and any associated use.
  • a sample collection container such as a body fluid collection container, such as saliva, sputum, urine, sperm, blood, etc.
  • liquid biological samples must be present in a defined volume in order, for example, to carry out analyzes or to stabilize biomolecules therein or to fix the morphology of the cells possibly contained therein.
  • the known procedure provides to collect the liquid sample first in a container, such as a urine cup, and then measure and remove the required volume outside the container, for example by pipetting, and then add the measured volume, for example, reagents for possible detection reaction ,
  • a container such as a urine cup
  • the measured volume for example, reagents for possible detection reaction
  • the opening of the container and the contact with several vessels in the volume dimension on the one hand lead to contamination of the sample.
  • this procedure is particularly problematic if the sample is infectious, and the health of the sample handling person is thus endangered by the shuffling of the sample.
  • the complicated decanting and measuring steps delay further processing, so that any necessary stabilization can not be sufficient and, for example, transcriptome, proteome or metabolites can be changed during this time (eg by degradation, induction, modification).
  • solid, absorbent matrices eg, Quantisal-Saliva collection device from Immunalysis Corp.
  • a liquid-wicking matrix is attached to a stalk, the matrix is taken into the mouth and absorbs saliva.
  • a color reaction can be seen on the stalk.
  • the matrix is then placed in the associated container containing a stabilizing solution. It has been shown in some tests that the method appears to be unfavorably incompatible with nucleic acid isolation and that the subject's mouth becomes uncomfortably dry on delivery. If the method is used for other samples, it is additionally necessary to collect the sample in another container.
  • the invention relates to a container for holding a liquid biological sample with a volume for receiving the liquid biological sample, with a filling and / or removal opening for filling the volume with the sample or for removing the sample from the Volume.
  • the invention is characterized in that a breakthrough-forming constriction or separation with breakthrough is arranged in the volume in order to separate a predefined measurement volume from the volume.
  • the biological sample is generally any substantially fluid biological sample, such as a human or animal body fluid, such as serum, plasma, saliva, sputum, a substantially liquid excretion product, such as urine, sputum, rinses and washes (eg Mouthwashes), solutions of biological samples as well as a liquid environmental sample, eg a water sample or rinsing, washing, flooding etc.
  • a liquid environmental sample eg a water sample or rinsing, washing, flooding etc.
  • liquid is understood to mean that the flowability of the sample is such that a separation with the measurement volume provided according to the invention succeeds, so that viscous sample liquids are also suitable.
  • the invention is not limited to biological samples, but may be used for liquids to be collected and examined of any kind with the advantages provided according to the invention.
  • constricting or separating the volume in the container in a further chamber with predefined measurement volume succeeds after dumping the supernatant sample liquid, the retention of the sample liquid in the amount, as determined by the separation or constriction in the predefined measurement volume.
  • the comparatively small aperture and its arrangement for example on the side of the separation or constriction which is as far as possible from the removal opening, largely prevents a loss of sample liquid in the pouring off of the protruding, ie beyond the predefined volume, amount of sample liquid predefined measurement volume.
  • a decrease in the sample liquid and a measurement of the quantity of sample liquid corresponding to the defined measurement volume are achieved quickly and with only one container. Reducing the number of hand grips when removing the sample and reducing the number of vessels required dramatically reduces the risk of infection from infectious sample fluids.
  • the processes are also simple, that they from non-medically trained persons or the subject itself can be performed.
  • the container consists for example of plastic, in particular polypropylene, PE, such as LDPE or PET, PVC, PVF, preferably of biodegradable plastic and is produced, for example, in a plastic injection molding, plastic injection blow molding or a plastic extrusion blow molding.
  • the bale is in the form of an Eppendorf tube for small volumes of sample fluid, in the form of a Falcon tube at volumes in the range of 50 ml, and in larger volumes in the shape of a known urine cup.
  • the container may be designed so that it is suitable for further processing in commercially available centrifuges.
  • the container is, for example, transparent or translucent in order to be able to more easily control the degree of filling and the discharge of the supernatant sample liquid.
  • an opening in the container is provided as a filling opening and the removal opening.
  • the filling opening is adapted to the conditions at the delivery and designed accordingly.
  • a mouthpiece is provided when the sample is sputum or spit.
  • the removal opening is also adapted to the corresponding conditions for further processing. For example, it is a simple beak spout or Luer connector, etc.
  • the breakthrough is arranged such that it is visible via the filling and / or removal opening.
  • a fill level check of the amount of the sample liquid, which is located in the volume predefined by the separation or constriction can easily take place. If this predefined volume is completely filled, the surface tension in the breakthrough of the separation or the constriction and the associated refraction of light in the lenticular distortion of the surface ensure that this state is easily reached via the filling or removal opening can be seen.
  • the region of the separation or constriction surrounding the aperture may be marked in color or provided with a dye which indicates the desired level upon contact with the sample liquid by means of a color change.
  • the breakthrough in the separation or constriction has, for example, a diameter such that a commercially available pipette can be introduced into the defined volume in order to draw further samples from it.
  • the container and the constriction or separation are integrally formed.
  • the device according to the invention can be manufactured comparatively inexpensively.
  • the constriction or separation is formed funnel-shaped in an advantageous embodiment. This prevents that the sample liquid comes to lie on the separation or constriction, but runs through the passage in the predefined volume.
  • the surface of the area of constriction around the aperture is provided with an adhesion reducing coating which, for example, improves the drainage of viscous sample liquids, such as saliva and sputum, into the predefined volume.
  • the separation into the volume of the container is configured usable. As a result, it is advantageously possible to remove the constriction or separation that might hinder the further processing of the sample.
  • the access to the sample fluid is no longer limited by the breakthrough.
  • the constriction or separation is realized by a funnel which can be inserted into the container. This is used, for example, only for the delivery of the sample, its transfer into the volume and the measurement of the predefined volume. Thereafter, the funnel can be advantageously removed, whereby the access to the sample liquid is facilitated.
  • a lid is provided for closing the filling and / or removal opening in order to preclude contamination of the sample during storage and transport of the sample.
  • a separation volume for example for a reagent which is separated from the measurement volume by a further breakable separation, for example a septum, is provided in the measurement volume.
  • Breakable within the meaning of the invention is to be understood that after the filling with the sample liquid, the separation is broken, partially or completely destroyed in order to achieve a mixing of the solid or liquid substances contained in the separation volume, with the sample liquid.
  • the separation of reagent and sample liquid is particularly advantageous where during the collection procedure a contact of reagent and sample liquid is not desired and / or it depends on a precise dosage of the reagent.
  • the further breakable separation by ultrasound or thermal action is destroyed or reacts under its own decomposition with the sample liquid, etc.
  • a reagent for stabilizing biomolecules or for fixing morphological structures or for direct analysis of the sample liquid eg analysis reagents for Color reactions to detect certain molecules or to prevent foaming.
  • sample liquid and reagent can be promoted by shaking or "vortexing".
  • an actuatable from the outside of the container refractive element which causes a destruction of the separation.
  • the refractive element is a sharpened punch which, with its tip, causes a cutting and thus a breakthrough in the breakable separation.
  • a destructibility of the breakable separation can be realized comparatively inexpensively.
  • the destruction it is only important that there is a contact between the material in the separation volume and the sample liquid and this is therefore to be interpreted broadly and includes, for example, perforation, cutting etc.
  • the refractive element is attached to the lid. This allows the container to be manufactured inexpensively and the refractive element is at hand.
  • the breaking element is attached to the lid in such a way that, in the closed position of the lid, for example when the lid is completely opened or unscrewed on the filling or removal opening, destruction of the further breakable separation is effected. This makes the handling of the sample and further processing with the substance located in the separation volume particularly safe.
  • the container has, according to a further advantageous embodiment, a closing element for closing the opening in the partition for the measuring volume.
  • a closing element for closing the opening in the partition for the measuring volume.
  • the lid is adjustably mounted on the container and movable at least from a filling or removal opening non-sealing position in a Brownungs predominantly removal opening sealing, closing position in, wherein in the non-sealing position by the closing element closing the Breakthrough is effected.
  • the lid and container are provided in the region of the filling or removal opening with a cooperating screw thread to screw the lid up and down or to be able to rotate between the two positions.
  • the handling of the sample liquid in the container is particularly simple, since a sample quantity correction can be subsequently made simple by removing sample liquid protruding in the non-sealing position from the container, i. can be poured off without due to the closure of the opening in the separation sample liquid from the measurement volume passes. This increases the accuracy of the dimension by avoiding losses in the measuring volume.
  • the measurement is facilitated with turbid sample liquids, such as urine, in which the visual dimension is difficult.
  • the container contains a human or animal body fluid, preferably saliva, sputum, urine and sperm.
  • the container contains a reagent.
  • a reagent for stabilizing biomolecules or for fixing morphological structures or for direct analysis of the sample liquid (eg analysis reagents for color reactions for the detection of certain molecules) or Prevention of foaming.
  • the reagent may not be separated in the measurement volume. For example, it is applied in a so-called “spray-dry" process on the inner walls of the container or the measuring volume.
  • the invention further relates to the use of the container in one of the previously described embodiments for collecting body fluid, preferably saliva, sputum, urine and sperm.
  • body fluid preferably saliva, sputum, urine and sperm.
  • Fig. 5a -5c show embodiments in which an actuatable from the Au ⁇ enseite of the container 1 closing element 12, 12 'in the form of a punch is able to close the breakthrough in the separation 3' and thus the measuring volume. Supernatant sample liquid can then be poured off without sample liquid escaping from the measuring volume 2.
  • a plate-like resting closing element 12 for example made of soft plastic, rubber.
  • the handling of the sample liquid 8 in the container 1 is particularly simple, since a sample quantity correction can be made subsequently simply by removing the sample liquid 8 projecting from the container 1 via the removal opening 13 in the non-sealing position, ie by pouring it off, without due to the closure 12 of the aperture 4 in the separation 3 "sample liquid 8 comes out of the measuring volume 2.
  • This increases by avoiding losses in the measurement volume on the one hand, the accuracy of the dimension.
  • turbid sample liquids, such as urine in which the visual Measurement is difficult to succeed, making measuring easier Fig. 5f
  • the adjustability of the lid 7 can be achieved for example by a latching when pressing the lid 7 or by rotation of the lid 7, by means of screw thread with the container.
  • Fig. 6a shows the simplest form of a discharge opening 13 'in the form of a beak-shaped spout.
  • the Figures 6b and 6c show different embodiments in which the removal opening 13 'is sealed in different ways by the lid.
  • the seal is achieved by a sealing element 14 arranged in the cover 7.
  • the seal is achieved by pinching the spout 13 ', which consists for example of deformable material.
  • FIGS. 7a-7d Reference is made; in the container 1 with subsequent volume correction is a pre-filled reagent in the separation volume 9, among other things, because it depends on a defined ratio of sample liquid and reagent.
  • a pre-filled reagent in the separation volume 9 is a pre-filled reagent in the separation volume 9, among other things, because it depends on a defined ratio of sample liquid and reagent.
  • the supernatant sample liquid 8 can be removed via the removal opening 13, without sample liquid from the measurement volume 2 passing through the sealing effect of the closure element 12 in the opening 4.
  • the lid 7 is completely placed or screwed into the sealing position, as in FIG. 7b is shown.
  • the container 1 is closed.
  • the container 1 in the in Fig. 7c and 7d shown embodiments only differs from those in the Fig. 7a and 7b shown in that on the closing element 12, a lance-shaped refractive element 11 is arranged to effect the destruction of the further breakable separation.
  • a lance-shaped refractive element 11 is arranged to effect the destruction of the further breakable separation.
  • the closing element 12 closes the opening 4 in the partition 3 "' to the measuring volume.
  • the refractive element 11 continues to advance with the closing element 12.
  • the closing element 12 releases the opening 4, which is insignificant since the container 1 is sealed in this state by means of the lid 7.
  • the refractive element 11 now comes into contact with the separation and ensures its destruction.
  • the invention encompasses a container having the features of any one of claims having a biological sample therein, for example, a human or animal body fluid, preferably serum, plasma, saliva, sputum, sperm, excretory products such as urine.
  • a biological sample for example, a human or animal body fluid, preferably serum, plasma, saliva, sputum, sperm, excretory products such as urine.
  • the invention encompasses a container having the features of one of the claims and / or the features of the preceding paragraph with a solid, biological, substantially liquid sample therein, for example, vomit, rinses, suspensions or solutions thereof.
  • the invention encompasses a container having the features of one of the claims and / or the features of the preceding paragraph with a reagent therein, for example for a detection and stabilization reaction and / or with a biological sample, for example a human or animal, contained therein Body fluid, preferably serum, plasma, saliva, sputum, semen, excretory products, such as urine.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
EP11173826A 2006-12-12 2007-12-12 Collecte d'échantillons biologiques Withdrawn EP2377770A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006058786A DE102006058786A1 (de) 2006-12-12 2006-12-12 Sammeln biologischer Proben
EP07859229A EP2089285A1 (fr) 2006-12-12 2007-12-12 Collecte d'échantillons biologiques

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP07859229.2 Division 2007-12-12

Publications (1)

Publication Number Publication Date
EP2377770A1 true EP2377770A1 (fr) 2011-10-19

Family

ID=39226694

Family Applications (2)

Application Number Title Priority Date Filing Date
EP07859229A Withdrawn EP2089285A1 (fr) 2006-12-12 2007-12-12 Collecte d'échantillons biologiques
EP11173826A Withdrawn EP2377770A1 (fr) 2006-12-12 2007-12-12 Collecte d'échantillons biologiques

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP07859229A Withdrawn EP2089285A1 (fr) 2006-12-12 2007-12-12 Collecte d'échantillons biologiques

Country Status (4)

Country Link
US (1) US20100021351A1 (fr)
EP (2) EP2089285A1 (fr)
DE (1) DE102006058786A1 (fr)
WO (1) WO2008072086A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230372935A1 (en) * 2008-09-23 2023-11-23 Bio-Rad Laboratories, Inc. Partition-based method of analysis
AU2010241535A1 (en) * 2009-12-17 2011-07-07 Vollrath, Klaus Michael Andreas Mr Device for Facilitating Semen Collection
JP6665655B2 (ja) * 2016-04-19 2020-03-13 株式会社デンソー 電力変換装置
US11305273B2 (en) * 2017-07-27 2022-04-19 Biomerieux, Inc. Isolation tube with a rheological control member and a plunger
WO2019070833A1 (fr) * 2017-10-06 2019-04-11 Ancestry.Com Dna, Llc Systèmes, dispositifs et procédés de collecte d'échantillon
EP3747467A3 (fr) * 2019-06-03 2021-03-03 Nanobacterie Système cryogénique comprenant des nanoparticules pour le traitement d'une partie du corps d'un individu par cryothérapie

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1032974A (fr) * 1951-02-21 1953-07-07 Pharma Debarge Lab Perfectionnements apportés aux dispositifs destinés à contenir des matières pulvérulentes ou liquides, notamment des produits pharmaceutiques qui sont à mélanger au moment voulu
BE712390A (fr) * 1966-05-13 1968-07-31
US3713780A (en) * 1971-02-01 1973-01-30 Becton Dickinson Co Apparatus for chemical testing
US3830702A (en) * 1973-02-02 1974-08-20 Diagnostic Research Bacteriological media tube
FR2658484A1 (fr) * 1990-02-21 1991-08-23 Lenoir Alain Perfectionnements aux recipients a deux compartiments.
US5128104A (en) * 1987-04-27 1992-07-07 Murphy Harold R Cuvette for automated testing machine

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4022576A (en) * 1975-06-09 1977-05-10 I. C. L. Scientific Method and apparatus for preparation of liquids containing suspended material for examination
US4927605A (en) * 1987-04-22 1990-05-22 Wadley Technologies, Inc. Specimen collection and sampling container
GB2271759A (en) * 1992-10-17 1994-04-27 Ronald William Driver Containers.
US6277646B1 (en) * 1997-05-05 2001-08-21 Dade Behring Inc. Fluid specimen collecting and testing apparatus
US7758815B2 (en) * 2004-08-03 2010-07-20 Hartselle R Lawrence Specimen collection, storage, transportation and assaying device

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1032974A (fr) * 1951-02-21 1953-07-07 Pharma Debarge Lab Perfectionnements apportés aux dispositifs destinés à contenir des matières pulvérulentes ou liquides, notamment des produits pharmaceutiques qui sont à mélanger au moment voulu
BE712390A (fr) * 1966-05-13 1968-07-31
US3713780A (en) * 1971-02-01 1973-01-30 Becton Dickinson Co Apparatus for chemical testing
US3830702A (en) * 1973-02-02 1974-08-20 Diagnostic Research Bacteriological media tube
US5128104A (en) * 1987-04-27 1992-07-07 Murphy Harold R Cuvette for automated testing machine
FR2658484A1 (fr) * 1990-02-21 1991-08-23 Lenoir Alain Perfectionnements aux recipients a deux compartiments.

Also Published As

Publication number Publication date
DE102006058786A1 (de) 2008-06-19
EP2089285A1 (fr) 2009-08-19
WO2008072086A1 (fr) 2008-06-19
US20100021351A1 (en) 2010-01-28

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