• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to a test set (1) for a photometric measuring device, comprising a mixing container (2) having a filling opening (3) and a metering container (8) which can be inserted sealingly into the filling opening (3) of the mixing container (2) Cavity (9) contains a liquid reagent (13), wherein the cavity (9) at a first end of the dosing (8) has a in the cavity (9) axially displaceable closure piston (11), a specifiable filling pressure in the reagent (13) generated. For ease of manufacture and handling, the metering container (8) at its second end which can be inserted into the mixing container (2) has a closure membrane (10) which is provided with a predetermined breaking point (20) which is triggered by a defined overshoot of the filling pressure axial displacement of the closure piston (11) - breaks.
    公开号:AT513559A1
    申请号:T50489/2012
    申请日:2012-11-06
    公开日:2014-05-15
    发明作者:Gerhard Bonecker
    申请人:Gerhard Bonecker；
    IPC主号:
    专利说明:

    1 16226
    The invention relates to a test set for a photometric measuring device, comprising a mixing container having a filling opening, and with a sealing insertable into the filling opening of the mixing container dosing container containing a liquid reagent in a sealed cavity, wherein the cavity at a first end of the dosing a in the cavity axially displaceable closure piston which produces a predetermined filling pressure in the reagent. Furthermore, the invention relates to a photometric measurement method for a sample liquid.
    In many medical tests, the sample to be measured must first be contacted with a first liquid to condition the sample, prepare it for measurement, or initiate a first chemical or biological reaction. In a second step, a second liquid is then added in order to convert the analyte of the sample to be determined into a state suitable for the photometric measurement or to trigger a second chemical or biological reaction. For example, in a so-called CRP measurement (C-Reactive Protein), which serves to distinguish viral or bacterial infections, a blood sample is mixed with a lysis reagent and then a latex reagent is added and mixed, the chemical reaction being measured by means of a photometer.
    A test set of the type mentioned is known for example from WO 2007/053870 A2. The test set comprises a mixing container and a dosing container which can be inserted into the mixing container. The mixing container is equipped with a removable from a filling port closure element and includes a first liquid, wherein the dosing can be used after the removal of the closure element and the addition of the sample liquid in the first liquid in the filling opening of the mixing container. The dosing container has a second liquid in a closed cavity, the cavity being closed on one side by a closure piston and on the opposite side by a movable plug, which after pressurization of the closure piston, the second liquid together with the movable plug in the Carried inside the mixing container. After mixing the sample with the first liquid and the second liquid, the mixing container is placed in a 1/22 2 photometric analyzer, after which the sample contents are measured photometrically. The known methods are error-prone, since exact sample quantities must be supplied, which are exactly prescribed for the respective test set and the respective medical test.
    From WO 2005/071388 A1 a sampling and measuring element has become known, which consists of several cylindrical compartments, which are axially slidably inserted into one another, wherein the interior spaces are closed in the initial position by a pierceable membrane. Two of the elements contain reagents, in the third element can be introduced with a swab a sample. The compartments are then pushed into each other by applying pressure to the two outer elements, which ruptures the membranes at the junctions and simultaneously mixes the two reagent liquids with the sample. An analysis is carried out either by optical inspection or by use in a measuring device.
    DE 24 41 724 A1 describes an analysis cartridge for photospectrometric measurements, which has a first container for receiving a first liquid, wherein the container is initially closed by a closure element. After the closure element has been removed, the sample to be analyzed is introduced into the container and then a container insert is placed, which has a reagent liquid in an auxiliary chamber. The auxiliary chamber is provided with a protruding in the starting position on the container insert cylindrical plunger, which tears when depressing using a front cutting edge a membrane of the auxiliary chamber and thus discharges the second liquid from the auxiliary chamber into the container with the first liquid. After the liquids have completely dissolved and mixed, the container is heated in the manner required for the analysis method and the sample is measured photometrically.
    The object of the invention is to propose a simpler in use photometric measurement method for a sample liquid, wherein an improved test set is to be used, which is easier and less expensive to produce. Furthermore, should be possible in a simple manner, an accurate dosage of the individual reagents and the sample liquid. 2/22 3
    This object is achieved in that the metering container at its second end insertable into the mixing container has a closure membrane which is equipped with a predetermined breaking point, which breaks at a defined excess of the filling pressure - triggered by an axial displacement of the closure piston.
    Preferably, the closure membrane can be injection-molded directly onto the end of the dosing container which can be inserted into the mixing container by means of 2K injection molding technology. For example, the fill pressure in the float space of the dosing container after the machine filling in a range < 2 bar and the bursting pressure of the predetermined breaking point of the sealing membrane in the range > Be predetermined 3 bar, so that in a further axial displacement of the closure piston in the direction of the closure membrane, the bursting pressure is exceeded and the reagent exits into the mixing vessel. The predetermined breaking point of the sealing membrane can be embodied as a linearly extending material taper of the sealing membrane.
    According to an embodiment variant according to the invention, the closure membrane may have a tapering, funnel-shaped formation leading from the dosing container, which directs the reagent emerging from the dosing container onto the bottom region of the mixing container.
    Further advantages in the production arise when the metering container in its sealing region for filling opening of the mixing container has a molded by 2K injection molding sealing sleeve, wherein the closure membrane and the sealing sleeve are connected by a longitudinally extending along the dosing container web and can be molded in one step ,
    By using an integrated sampling system (see also WO 2011/047902 A1) with a capillary open on both sides (end-to-end capillary), the test set according to a variant embodiment becomes considerably more user-friendly for the user. The capillary automatically fills after sample contact with the volume specified by the inner diameter and the length of the capillary, for example between 5 pl and 25 μΙ, so that the user does not have to perform any separate pipetting steps. The user only has to touch the surface of the sample liquid 3/22 4 with the end of the capillary tube, whereby the tube is filled by the capillary action and exactly the sample volume specified for the respective sample measurement is absorbed.
    A measuring method according to the invention, in which a sample liquid is mixed with a reagent present in a mixing container and with a liquid reagent, wherein the liquid reagent is present in a metering container, the cavity of which is closed at one end by an axially displaceable sealing piston, is thus characterized by the following Steps out: opening the mixing container;
    Adding the sample liquid to the mixing container;
    Inserting the dosing into a filling opening of the mixing container;
    Mixing the sample liquid with the reagent to a precursor;
    Introducing liquid reagent from the dosing into the mixing container, wherein on the axially displaceable closure piston pressure is exerted on the reagent until a arranged on the metering closure membrane breaks at its predetermined breaking point and releases the reagent into the mixing container;
    Mixing the precursor and the liquid reagent into a final product;
    Photometric measurement of the chemical reaction in an analyzer and
    Calculate the concentration of at least one sample in ha Itsstoffes of the final product.
    In this case, the reagent in the mixing container may be liquid, gel-form, freeze-dried, in powder or tablet form or in the form of a wall film.
    After mixing the reagent with the sample liquid, a photometric calibration measurement can be performed. 4/22 5
    The invention will be explained in more detail below with reference to drawings. Show it:
    1 shows an inventive test set with a mixing container and a metering container inserted into the mixing container in a sectional view.
    FIG. 2 shows the metering container of the test kit according to the invention in a sectional representation; FIG.
    3 shows a detail of the dosing container according to detail III in FIG. 2;
    4 is a sectional view of the dosing container according to line IV-IV in Fig. 3rd
    5 shows a truncated, three-dimensional representation of a variant of the dosing container according to FIG. 2.
    6 shows a detail of the embodiment according to FIG. 5; such as
    Fig. 7 is a splash guard for the dosing in a sectional view.
    The embodiment variant of the test set 1 illustrated in FIGS. 1 to 4 serves for use in a photometric measuring device or an analyzer, as described in detail in WO 2007/053380 A2, for example.
    The filling opening 3 of the tube-shaped mixing container 2 of the test set 1 is first sterile sealed with a removable closure element, not shown here, wherein in the interior 4 according to the illustrated embodiment, a first liquid 5 and a magnetic stir bar or a steel ball 6 are. Above the first liquid 5 is an air space, wherein the liquid surface is indicated by 7.
    The usable in the mixing container 1 dosing 8 has a cylindrical cavity 9, which is equipped at one end (outlet side) with a closure membrane 10. On the opposite side is located in the cavity 9 5/22 6 an axially slidable into the cavity in the closure piston 11, on which an actuating punch of an analyzer, not shown here can exert pressure. When filling the dosing container 8 with a reagent 13, a predeterminable filling pressure is generated in the reagent 13 when the closure piston 11 is inserted. The closure membrane 10 is equipped with a predetermined breaking point 20, which breaks at a defined excess of the filling pressure - triggered by an axial displacement of the closure piston 11 - breaks.
    The predetermined breaking point 20 of the sealing membrane 10 can be embodied, for example, as a linearly extending material tapering of the sealing membrane 10 (see FIGS. 3, 4), wherein the sealing membrane 10 is preferably injection-molded by means of 2K injection molding technology on the end of the dosing container 8 which can be inserted into the mixing vessel 2 , The metering container 8 consists for example of polypropylene (PP) and the coextruded sealing membrane 10 e.g. from a crosslinked thermoplastic elastomer based on olefins (TPE-V).
    Preferably, the material taper is off-center, in the region of an elongated opening 24 in the bottom 23 of the substantially cylindrical metering 8 arranged in order to ensure optimum discharge of the reagent from the metering.
    The axially displaceable closure piston 11 is disposed entirely within the dosing container 8 and is actuated by a punch of the analyzer. An erroneous erroneous operation by the laboratory staff is thereby largely excluded. In the region of the sealing seat of the closure piston 11, the cavity 9 has a slightly smaller inside diameter than in a collar region 26 located outside the sealing seat. During manufacture, the closure piston 11 can be brought up to the sealing seat without substantial friction and then pressed into the sealing seat, wherein a predeterminable filling pressure arises in the reagent. Different quantities of reagent can be realized in a simple manner by different height of the sealing seat.
    In order to keep away the pressurized jet of the reagent from the walls of the mixing container 2, the closure membrane 10 may comprise a tapered, funnel-shaped formation 25, which carries the dosing container 8 (see FIGS. 5, 6). 6/22 7
    For use in the mixing container 2, the metering container 8 has a cylindrical sealing surface 12, which is integrally formed on the metering container 8 with an annular flange 14 and forms an annular space 15, wherein at least one vent opening 16 is arranged in the annular flange 14 (see also FIG. 2 and FIG 5). When inserting the metering container 8 into the mixing container 2, the air displaced from the metering container 8 can escape from the interior 4 through the gas-permeable, approximately drop-tight vent 16. For better sealing, the metering container 8 in its sealing region to the filling opening 3 of the mixing container 2 on a preferably molded by means of 2K injection molding sealing sleeve 27.
    The sealing collar 27 and the sealing membrane 10 are preferably made of the same plastic material which is softer compared with the metering container 8 and are interconnected by a web 28 extending along the metering container 8, whereby the production is simplified by means of 2K injection molding technology.
    The metering container 8 may have a sampling device 21 in the form of a capillary 22 which is open on both sides, the volume of which is exactly matched to the requirements of the respective measuring method and preferably lies between 5 μl and 50 μm. The user must bring the laterally attached to the dosing 8 and over the end of the dosing 8 protruding capillary 22 only with the surface of the sample liquid to be contracted, after which the sample liquid automatically by capillary action and in the predetermined by the volume of the capillary 22 amount in the Sampling device 21 is sucked.
    Subsequent to the cylindrical sealing surface 12 of the metering container 8, a cylindrical or ergonomically optimized grip element 17 is formed, which defines an annular space 18 and is lockable to the outside by an annular splash guard element 19. By the splash guard element 19, the escape of liquid from the test set 1 can be effectively prevented.
    As shown in Fig. 7, the annular splash guard element 19 and the axially displaceable closure piston 11 can be produced as a one-piece injection molded part 30, with thin, breakable or separable connecting webs 29 are provided between the splash guard 19 and the closure piston 11. After mechanical filling of the dosing 8 with the reagent 7/22 8 13 can be used in one operation, the splash guard 29 in the handle member 17 and the closure piston 11 in the dosing. During the axial displacement of the closure piston 11 in its position in the sealing seat, the connecting webs 29 are separated.
    First example: INR / PTTest
    The INR test is a test of how fast a person's blood coagulates. The normal value of INR is 1, with an INR value of e.g. 4 the blood coagulates four times slower. A high INR value means that the blood clotting does not work as well as in healthy people. For the examination one uses whole blood which is taken directly from the patient and introduced into the capillary or blood plasma from citrate offset collection tubes.
    In the mixing container 2 is the first INR test reagent (first liquid 5), in the dosing 8, the second INR reagent (liquid reagent 13, see Fig. 1).
    Test procedure of the INR test:
    Blood sample is contacted with the capillary 22 of the dosing 8 and sucked in a defined sample volume;
    Mixing container 2 is initially closed with a closure element and filled with lysis reagent (80 pl - 150 μΙ); - Closing element is removed, dosing (contains latex reagent) is used together with the integrated capillary 22 in the mixing container 2 sealing;
    Mixing container 2 and dosing 8 are shaken in the closed state until sample liquid has leaked from the end-to-end capillary 22 into the mixing container 2; 8/22 9
    Mixing container 2 and metering container 8 are used in a measuring device (for example analyzer from WO 2007/053380 A2); - Test identification by the measuring device (by RFID chip in the packaging or on the mixing container);
    Lysis reagent and sample liquid are mixed by means of a magnetic stirrer of the measuring device (optional);
    Calibration value is measured (optional)
    Latex reagent (50 pl - 200 μΙ) is metered by means of a punch of the measuring device by pressure on the closure piston 11, wherein the closure membrane 10 tears at the predetermined breaking point 20;
    Lysis reagent, sample fluid and latex reagent are mixed using the magnetic stirrer;
    Chemical reaction is measured with the help of the photometer; - Clotting time is determined.
    The measuring range of the photometric measuring device is for example INR 0.5 - INR 5.
    Second example: HCY test
    Chemically, homocysteine (HCY) belongs to the group of so-called amino acids. In the body, homocysteine is made from methionine, another amino acid that is supplied with food. Homocysteine is normally rapidly broken down, requiring vitamin B6 (pyridoxine), vitamin B12 (cobalamin) and folic acid.
    Homocysteine has been identified as a stand-alone risk factor for atherosclerotic or thromboembolic events (peripheral vascular disease, stroke, coronary heart disease, heart attack, narrowing of the carotid artery). At a number of other 9/22 10
    Diseases such as senile dementia, development of neural tube defects (spina bifida) of the child's womb and anemia have been associated with elevated homocysteine levels.
    In the mixing container 2 is the first HCY reagent, in the dosing 8, the second HCY reagent. The test procedure is carried out as in Example 1.
    Target range for homocysteine is below 10 pmol / L in serum.
    Third example: CRP test
    As a third example, a measurement sequence of a CRP test (C-reactive protein, mainly used to distinguish viral or bacterial inflammation) is shown.
    In the mixing container 2 is the first liquid, a lysis reagent (1000 μΙ).
    With the capillary 22 of the dosing 8 8 5 μΙ whole blood are absorbed. The dosing container 8 contains a latex reagent (250 μΙ). First, the lysis reagent is mixed with the whole blood sample and a calibration value is measured. Thereafter, the latex reagent is metered in and, after the chemical reaction, the concentration value is determined photometrically. The test procedure is carried out as in Example 1
    The measuring range of the photometric measuring device is for example 0.2 mg / dl to 6 mg / dl.
    Fourth example: Variant of the INR / PT test
    Unlike the first example, the first INR test reagent is present as a dry chemical coating (e.g., recombinant thromboplastin), or as a gel, powder, or tablet in the mixing container 2, with the dosing container 8 containing the second INR reagent as the liquid reagent. Use is made of a metering container 8 according to FIG. 5 with a closure membrane 10 together with predetermined breaking point 20 and a funnel-shaped formation 25 (without closure piston 11 and reagent 13).
    The sample, for example 20 μΙ capillary blood, is dosed by hand into the mixing container 2 by means of capillaries, after which the dry chemical coating can at least partially dissolve. Thereafter, the dosing tank 8 with the 10/22 11 liquid reagent (e.g., buffer solution) is placed in the mixing tank. The further test procedure is carried out as in Example 1.
    The measuring range of the photometric measuring device is here, for example, at INR 1 - INR 6.
    The advantages of the test kit according to the invention include, in particular: - The user does not have to carry out separate pipetting steps; - high accuracy of the recorded sample volume; - large time savings during sampling; - Cost savings by eliminating separate sampling facilities. 11/22
    权利要求:
    Claims (16)
    [1]
    12. PATENT CLAIMS 1. Test set (1) for a photometric measuring device, comprising a mixing container (2) having a filling opening (3) and a metering container (8) which can be inserted sealingly into the filling opening (3) of the mixing container (2) a sealed cavity (9) containing a liquid reagent (13), wherein the cavity (9) at a first end of the dosing (8) in the cavity (9) axially displaceable sealing piston (11), which has a predetermined filling pressure in the reagent (13), characterized in that the metering container (8) at its second, in the mixing container (2) insertable end has a closure membrane (10) which is equipped with a predetermined breaking point (20), at a defined exceeding the filling pressure - triggered by an axial displacement of the closure piston (11) - breaks.
    [2]
    2. Test set (1) according to claim 1, characterized in that the closure membrane (10) is preferably molded by means of 2K injection molding technology at the in the mixing container (2) insertable end of the dosing container (8).
    [3]
    3. test set (1) according to claim 1 or 2, characterized in that the predetermined breaking point (20) of the closure membrane (10) is designed as a linearly extending material taper of the closure membrane (10).
    [4]
    4. test set (1) according to claim 3, characterized in that the material taper is off-center, in the region of an opening (24) in the bottom (23) of the substantially cylindrical metering container (8) is arranged.
    [5]
    5. test set (1) according to one of claims 1 to 4, characterized in that the filling pressure in the cavity (9) of the dosing (8) in a range < 2 bar and the bursting pressure of the predetermined breaking point (2) of the closure membrane (10) in the range > 3 bar is located.
    [6]
    6. test set (1) according to one of claims 1 to 5, characterized in that the closure membrane (10) from the dosing (8) forrollende, tapered, funnel-shaped Anformung (25). 12/22 13
    [7]
    7. test set (1) according to one of claims 1 to 6, characterized in that the axially displaceable closure piston (11) is arranged entirely within the dosing container (8), wherein the cavity (9) in the region of the sealing seat of the closure piston (11 ) has a slightly smaller inner diameter than in a collar region 26 located outside the sealing seat.
    [8]
    8. test set (1) according to one of claims 1 to 6, characterized in that the metering container (8) in its sealing region to the filling opening (3) of the mixing container (2) molded by means of 2K injection molding sealing sleeve (27).
    [9]
    9. test set (1) according to claims 8, characterized in that the closure membrane (10) and the sealing sleeve (27) by a longitudinally of the metering container (8) extending web (28) are connected.
    [10]
    10. test set (1) according to one of claims 1 to 9, characterized in that the dosing container (8) at the in the mixing container (2) insertable end has an integrated sampling device (21) which after insertion of the dosing (8) into the filling opening (3) of the mixing container (2) with a present in the mixing container (2) liquid (5) is in contact.
    [11]
    11. Test set (1) according to claim 10, characterized in that the sampling device (21) has a capillary open on both sides (22) whose volume is preferably between 5 pl and 50 μΙ.
    [12]
    12. Test set (1) according to any one of claims 1 to 9, characterized in that the dosing (8), for example, a cylindrical or ergometrically optimized handle element (17) is formed, which defines an annular space (18) and outwardly by an annular splash guard (19) is lockable.
    [13]
    13. Test set (1) according to claim 12, characterized in that the annular splash guard element (19) and the axially displaceable closure piston (11) can be produced as a one-piece injection molded part (30), wherein thin, breakable or separable connecting webs (29) between 13 / 22 14 the splash guard element (19) and the closure piston (11) are provided.
    [14]
    14. Photometric measuring method in which a sample liquid with a present in a mixing container (2) reagent and a liquid reagent (13) is mixed, wherein the liquid reagent is present in a metering container (8), the cavity (9) at one end an axially displaceable closure piston (11) is closed, characterized by the following steps: opening the mixing container (1); Adding the sample liquid to the mixing container (2); Inserting the dosing container (8) into a filling opening (3) of the mixing container (2); Mixing the sample liquid with the reagent to a precursor introducing liquid reagent (13) from the dosing (8) in the mixing container (2), over the axially displaceable closure piston (11) pressure on the reagent (13) is applied to one of the dosing (8) arranged closure membrane (10) at the predetermined breaking point (20) breaks and the reagent (13) in the mixing container (2) releases; Mixing the precursor and the liquid reagent (13) into a final product; Photometric measurement of the chemical reaction in an analyzer and calculating the concentration of at least one sample in ha Itsstoffes of the final product. 14/22 15
    [15]
    15. A knife method according to claim 14, characterized in that after mixing the reagent with the sample liquid, a photometric calibration measurement is performed.
    [16]
    16. Knife method according to claim 14 or 15, characterized in that the reagent in the mixing container (2) is liquid, gel, freeze-dried, in powder or tablet form or as a wall film. 2012 11 06 Lu 15/22
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    同族专利:
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    WO2014072170A1|2014-05-15|
    HRP20180427T1|2018-04-20|
    CN104955573A|2015-09-30|
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    法律状态:
    2019-03-15| PC| Change of the owner|Owner name: EUROLYSER DIAGNOSTICA GMBH, AT Effective date: 20190115 |
    优先权:
    申请号 | 申请日 | 专利标题
    ATA50489/2012A|AT513559B1|2012-11-06|2012-11-06|Photometric measuring device and photometric measuring method for a sample liquid|ATA50489/2012A| AT513559B1|2012-11-06|2012-11-06|Photometric measuring device and photometric measuring method for a sample liquid|
    BR112015010190-9A| BR112015010190B1|2012-11-06|2013-10-22|test set for a photometric test device, and photometric measurement method for a test liquid|
    MX2015005616A| MX356696B|2012-11-06|2013-10-22|Test set for a photometric measuring device, and photometric measuring method for a sample liquid.|
    PCT/EP2013/072037| WO2014072170A1|2012-11-06|2013-10-22|Test set for a photometric measuring device, and photometric measuring method for a sample liquid|
    US14/440,737| US9804095B2|2012-11-06|2013-10-22|Test set for a photometric measuring device, and photometric measuring method for a sample liquid|
    CN201380057943.1A| CN104955573B|2012-11-06|2013-10-22|The photometric method of test device and sample liquids for photometric device|
    EP13785391.7A| EP2916950B1|2012-11-06|2013-10-22|Test set for a photometric measuring device, and photometric measuring method for a sample liquid|
    HRP20180427TT| HRP20180427T1|2012-11-06|2018-03-12|Test set for a photometric measuring device, and photometric measuring method for a sample liquid|
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