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EP1538444A1 - Dispositif de test - Google Patents

Dispositif de test Download PDF

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Publication number
EP1538444A1
EP1538444A1 EP04101025A EP04101025A EP1538444A1 EP 1538444 A1 EP1538444 A1 EP 1538444A1 EP 04101025 A EP04101025 A EP 04101025A EP 04101025 A EP04101025 A EP 04101025A EP 1538444 A1 EP1538444 A1 EP 1538444A1
Authority
EP
European Patent Office
Prior art keywords
holder
test
zone
test device
reagent carrier
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Withdrawn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
EP04101025A
Other languages
German (de)
English (en)
Inventor
Michael Dreher
Rainer Brodt
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.)
Human Gesellschaft fur Biochemica und Diagnostica Mbh
Original Assignee
Human Gesellschaft fur Biochemica und Diagnostica Mbh
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 Human Gesellschaft fur Biochemica und Diagnostica Mbh filed Critical Human Gesellschaft fur Biochemica und Diagnostica Mbh
Publication of EP1538444A1 publication Critical patent/EP1538444A1/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Withdrawn legal-status Critical Current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
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • 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
    • B01L2200/12—Specific details about manufacturing devices
    • 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
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • 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
    • B01L2300/087—Multiple sequential 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
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces

Definitions

  • the invention relates to a test device, in particular for immunological or chemical tests, such as sandwich assays for the detection of human hemoglobin or competitive Assays for the detection of drugs of abuse.
  • Such immunological or chemical tests are known to be by means of absorbent Test strips performed in an application zone with the liquid test sample in contact and, because of their absorbency, part of the test sample from the application zone suck through a test zone into a suction zone.
  • Specific reagents located in the test zone provide there by immunological or chemical reactions a visible test result.
  • ELISA test between the application zone and the test zone is a mobile for the ordered test substance specific reagent, which corresponds to the substance sought in the Test sample binds to a complex that is transported from the liquid test sample to the test zone where it binds to an immobilized specific reagent.
  • the mobile reagent has an enzyme label, concentrated in the test zone using the immobilized specific reagent and here gives a visible color reaction with a suitable substrate.
  • the mobile reagent instead of an enzyme label followed by substrate conversion, also contain a dye which, with the aid of the immobilized specific reagent in the Test zone gives a directly visible color reaction.
  • test substances In other test substances, the visibility in the test zone can occur by chemical reaction.
  • the various test options are generally known to the person skilled in the art.
  • the absorbent test strip is immersed with its application zone in the test liquid, wherein the test liquid is sucked by the absorbency of the test strip to the suction zone and thereby passes through the test zone.
  • test devices In layman tests, however, it is often undesirable to work with open vessels in which the body fluid in which the test substance is to be detected, such as urine, must be filled. For this reason, test devices have been provided for such tests, in particular those which are to be carried out by the patient himself and therefore also by inexperienced persons.
  • test strips are contained in a liquid-impermeable housing, with only the application zone directly or via a indirectly connected to the environment with its absorbent body connected.
  • This device impermeable to the application zone, is held in the urine stream with the application zone, without wetting the test strip in a manner that could falsify the result.
  • Such test devices are described for example in EP-A-0 291 194.
  • test devices in which the entire test strip is in a liquid-impermeable manner Housing is material-consuming, since the housing are used only once can, and are also difficult to assemble, with involuntary shifting of the test strip in the housing is often not immediately detectable, but to erroneous test results can lead.
  • test strip on a holder made of liquid impermeable Material is attached and the holder a remote from the application zone grip area has.
  • the holder has a shield covering at least the test zone, which is in the range the test zone is transparent and wetting the test zone by the urine or other test liquid prevented.
  • test devices save a significant percentage of plastic material for the housing of the type of device discussed above and are lighter than closed-type devices Housing mountable because the test strip from one side of the device, not from the Shield is covered, is accessible.
  • these test devices still have the disadvantage that they must be mounted by hand and that thereby threaded the test strip in the holder must become. This is time consuming and can easily be the cause of significant scrap volumes because when threading the test strip this can buckle and thus is no longer usable.
  • These test devices can not be mounted by machine.
  • the problem underlying the invention was thus to provide a test device, in particular for immunological and chemical tests with an absorbent strip-shaped reagent carrier to get, which is easier to assemble and results in less rejects.
  • the device can be automated, installed by machine.
  • This object is achieved with the test device according to the invention.
  • This test device with a holder and an absorbent strip-shaped reagent carrier attached to the holder, wherein the reagent carrier at least one test zone and optionally at least one further in Row behind and / or before the test zone arranged functional zone and wherein the holder as a reagent covering at least the test zone, the reagent carrier on both sides with its edges formed superior shield and at least in the area of the test zone is transparent, should thereby be characterized in that at least one end of the holder at least one with the help a hinge in substantially plane-parallel on the holder swingable or at least one separated from the holder, substantially plane-parallel on the holder legbares, on the holder fastenable and in a substantially plane-parallel position the reagent carrier on the holder is provided by pressing pressure fixing part.
  • the one with the both opposite ends of the holder by means of a hinge swing parts preferred because during assembly mounting person except the test strip grab only a part must and at the same time move the hinged parts at both ends by thumb pressure and can attach.
  • the embodiment with the hinged parts is also because of this with separate parts of advantage, since the hinged parts automatically in the intended Aligned manner when it pivots substantially plane-parallel to the holder were.
  • the assembling person or the industrial robot needs only one part at a time grab and fix by simple or double pressure on the holder.
  • a fixation of the reagent carrier or test strip at one end of the Holder, wherein the other end of the test strip loose between the holder and to be fixed thereto Part can lie.
  • it is convenient to use the reagent carrier or test strips at both ends To fix the holder to prevent the later use of the test device that through Improper handling of the loose between two layers of material end of the test strip from slipping out.
  • the second, not necessarily to be fixed part can be arbitrarily fixed to the holder, only care must be taken that by fixing the absorbent porosity not lost. It is best if at both ends of the test strip by pressing pressure is held.
  • the pressing pressure can be used to further improve the fixation by ribs, knobs or pins are reinforced, which are arranged integrally on the part to be folded over on the holder in an area in which they are in the assembled state on the inserted test strip or Press reagent carrier.
  • the reagent carrier by such projections, in particular deformed by ribs on the swing-over or separate part substantially S-shaped, which ensures a permanent fixation in the sense of the test device according to the invention.
  • the shield expedients a longitudinal groove into which the test strip can be inserted, or guide ribs provided on both sides of the test strip.
  • the pressing pressure is caused on the test strip or reagent carrier in that the articulated or separate parts are connected to the holder by fixing means, wherein these fixing devices are preferably per se known push buttons, the appropriate self-locking push buttons are.
  • these self-locking snaps is in the one part a blind hole or a penetrating hole and on the other part a pin or dimples of slightly larger diameter than the inner diameter of the blind hole or arranged the bore.
  • the entire test device according to the invention expediently consists of a suitable for this purpose Plastic material, which in case of fixation with the described snaps so much elasticity must have that the pin or nubs easily in the blind hole or a through hole can be pressed and thereby deformed so that it creates a positive connection.
  • the swing-over or separate parts of the device have expediently substantially the same contour as the areas of the holder to which they are fixed in order to prevent by improper random manipulation, such as inserting a fingernail between these parts, the connection of the same is released and the device becomes unusable.
  • the above-mentioned hinge between the holder and the part to be fastened at The preferred embodiment is suitably made of a so-called film hinge.
  • This is a thinned section between the holder and the part to be tied, all consist of one piece.
  • the dimensioning of this film hinge is chosen that at the thumb pressure from outside the articulated parts plane-parallel so put on the holder, that the connecting elements of both parts become active, d. H. at the described push buttons the pins or knobs are pressed into the blind holes or holes.
  • test device shown in FIGS. 1 to 4, with the exception of Test strip, which has been omitted in the drawing for the sake of clarity, but for a functioning Test device is inserted into the recess 8, from a one-piece part, appropriate made of plastic.
  • This has in its central region a shield 1, which, as shown particularly in FIG. 3, the test strip or reagent carrier is projected on both sides and on its outer edges 12 is pulled down.
  • This mid-section forms the shield that floods the test zone prevented in the use of the device.
  • Test zone shown in the form of a funnel-shaped opening in the shield area 1.
  • Test strip is between the application zone 4 and the test zone 5, for example at Sandwich the zone with the mobile specific reagent and in the flow direction after Test zone of the area to be regarded as a suction zone, in which the excess test solution collects.
  • the parts 2 and 3 each have a distance 10 or 13 between the Holder and the unclipped parts 2 and 3. In this way, in the application zone, the test liquid not only through the top opening, but also through the side openings to the Get test strips.
  • a projection 11 in Form of a rib On the inside of the hinged by means of the hinge 6 Part 3 is a projection 11 in Form of a rib provided.
  • the pressing pressure which is exerted by the fixation of the part 2 or 3 on the holder 1, can in many cases hold the test strip without additional rib 11 in the recess.
  • This Pressing pressure can, however, the determination of the test strip in the region of the task zone by attachment of ribs, tenons or the like on the part 2 or 3 without additional operation improve.
  • the fact that the parts 2 and 3 are integrally connected to the part 1 via the film hinges 6 and 6a significantly facilitates the assembly of the device, reduces the waste and ensures a safer test result compared to currently known test devices. Furthermore the assembly is so simple that it can be easily machined without any significant scrap can be made. The assembly takes place in such a way that the test strip in the recess 8 is inserted and that then the parts 2 and 3 pivoted to the central region of the holder 1 and be fixed by pressing the push buttons into the holes 7 and 7a.
  • Fig. 5 which is a side view like Fig. 4, the test device is in the opposite direction to that described above Embodiment of three separate parts, since in this case the plane-parallel auf complicatden parts 22 and 23 are hinged to the holder 21 is not hinged, but are separate parts.
  • a pressing pressure on the reagent carrier By separating the parts 22 and 23 of However, part 21 makes assembly more difficult and increases the risk of rejects.
  • this Reason is the embodiment shown in Figs. 1 to 4, preferably.

Landscapes

  • 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)
EP04101025A 2003-12-05 2004-03-12 Dispositif de test Withdrawn EP1538444A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2003156951 DE10356951A1 (de) 2003-12-05 2003-12-05 Testvorrichtung
DE10356951 2003-12-05

Publications (1)

Publication Number Publication Date
EP1538444A1 true EP1538444A1 (fr) 2005-06-08

Family

ID=34442468

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04101025A Withdrawn EP1538444A1 (fr) 2003-12-05 2004-03-12 Dispositif de test

Country Status (2)

Country Link
EP (1) EP1538444A1 (fr)
DE (1) DE10356951A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107727648A (zh) * 2017-10-25 2018-02-23 上海菲伽生物科技有限公司 试纸颜色反应加速装置
CN108469521A (zh) * 2018-06-29 2018-08-31 深圳加美生物有限公司 一种全血全定量检测免疫层析装置

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5622870A (en) * 1989-11-27 1997-04-22 Behringwerke Ag Device and method for completing a fluidic circuit
WO1997026083A1 (fr) * 1996-01-17 1997-07-24 Boehringer Mannheim Italia S.P.A. Dispositif servant a effectuer des tests diagnostiques rapides sur des echantillons de liquides
EP0806666A2 (fr) * 1996-05-09 1997-11-12 Syntron Bioresearch, Inc. Procédé et appareil pour essais de sang complet en un seul temps
WO1998048280A1 (fr) * 1997-04-24 1998-10-29 Selfcare, Inc. Dispositif de detection d'une substance dans un echantillon liquide
US6046058A (en) * 1998-11-20 2000-04-04 Sun; Ming Color-coded test strip
WO2001029558A1 (fr) * 1999-10-21 2001-04-26 Oy Medix Biochemica Ab Dispositif a bande d'essai dote d'une partie de pretraitement a couvercle
US20030044317A1 (en) * 1993-11-12 2003-03-06 Michael Catt Reading devices and assay devices for use therewith

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5053197A (en) * 1989-07-19 1991-10-01 Pb Diagnostic Systems, Inc. Diagnostic assay module
US5468648A (en) * 1991-05-29 1995-11-21 Smithkline Diagnostics, Inc. Interrupted-flow assay device
DE4121493A1 (de) * 1991-06-28 1993-01-07 Draegerwerk Ag Analysevorrichtung zur quantitativen, immunologischen bestimmung von schadstoffen
US5356782A (en) * 1992-09-03 1994-10-18 Boehringer Mannheim Corporation Analytical test apparatus with on board negative and positive control
US5597532A (en) * 1994-10-20 1997-01-28 Connolly; James Apparatus for determining substances contained in a body fluid
US5739041A (en) * 1995-05-02 1998-04-14 Carter Wallace, Inc. Diagnostic detection device
DE29823204U1 (de) * 1998-12-26 1999-02-18 Care Diagnostica Produktions- und Vertriebsgesellschaft mbH, Möllersdorf Streifentest-Gerät
DE29911733U1 (de) * 1999-07-06 1999-09-09 Human Gesellschaft für Biochemica und Diagnostica mbH, 65205 Wiesbaden Testvorrichtung

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5622870A (en) * 1989-11-27 1997-04-22 Behringwerke Ag Device and method for completing a fluidic circuit
US20030044317A1 (en) * 1993-11-12 2003-03-06 Michael Catt Reading devices and assay devices for use therewith
WO1997026083A1 (fr) * 1996-01-17 1997-07-24 Boehringer Mannheim Italia S.P.A. Dispositif servant a effectuer des tests diagnostiques rapides sur des echantillons de liquides
EP0806666A2 (fr) * 1996-05-09 1997-11-12 Syntron Bioresearch, Inc. Procédé et appareil pour essais de sang complet en un seul temps
WO1998048280A1 (fr) * 1997-04-24 1998-10-29 Selfcare, Inc. Dispositif de detection d'une substance dans un echantillon liquide
US6046058A (en) * 1998-11-20 2000-04-04 Sun; Ming Color-coded test strip
WO2001029558A1 (fr) * 1999-10-21 2001-04-26 Oy Medix Biochemica Ab Dispositif a bande d'essai dote d'une partie de pretraitement a couvercle

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107727648A (zh) * 2017-10-25 2018-02-23 上海菲伽生物科技有限公司 试纸颜色反应加速装置
CN108469521A (zh) * 2018-06-29 2018-08-31 深圳加美生物有限公司 一种全血全定量检测免疫层析装置

Also Published As

Publication number Publication date
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