WO2000037939A1 - Dispositif de test pour dosages immunologiques - Google Patents

Dispositif de test pour dosages immunologiques Download PDF

Info

Publication number
WO2000037939A1
WO2000037939A1 PCT/EP1999/007717 EP9907717W WO0037939A1 WO 2000037939 A1 WO2000037939 A1 WO 2000037939A1 EP 9907717 W EP9907717 W EP 9907717W WO 0037939 A1 WO0037939 A1 WO 0037939A1
Authority
WO
WIPO (PCT)
Prior art keywords
test device
carrier
coated
possibly
immunoassays
Prior art date
Application number
PCT/EP1999/007717
Other languages
German (de)
English (en)
Inventor
Matthias Werner Engel
Ulrich Schwarz
Original Assignee
Matthias Werner Engel
Ulrich Schwarz
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 Matthias Werner Engel, Ulrich Schwarz filed Critical Matthias Werner Engel
Publication of WO2000037939A1 publication Critical patent/WO2000037939A1/fr

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • 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
    • 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
    • B01L2300/0887—Laminated structure
    • 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 test devices for immunoassays.
  • Immunoassays in particular enzyme immunoassays, are today the means of choice for the determination of a large number of biologically active substances such as hormones, pharmaceuticals, opiates, diagnostically important proteins etc. and are based on the highly specific antigen-antibody reaction.
  • enzyme immunoassays EIA
  • the specificity of the antigen-antibody reaction is coupled with an enzymatic reaction, in which either antibody or antigen-enzyme conjugates are used, which are determined by adding a suitable substrate by measuring the enzyme activity of the conjugate.
  • Immunoassays of this type are described, for example, in European patent EP 0 284 232 or in EP 0 291 194; these publications are referred to as prior art.
  • Corresponding analytical test devices are known which may have a hollow housing made of a moisture-impermeable solid material and which contain a dry porous carrier, usually consisting of nitroceilulose, which, if a housing is present, protrudes from this housing and contains a liquid aqueous sample can be associated with a content of the substance to be investigated, this carrier containing a labeled specific binding reagent for the detection substance and wherein this labeled binding reagent is freely movable in the porous carrier when it is in the moist state.
  • a dry porous carrier usually consisting of nitroceilulose
  • the carrier also contains an unlabeled specific binding reagent for the same detection substance, which, however, is permanently immobilized on the carrier material in a detection area and is therefore immobile even when moist. If a liquid sample is applied to the carrier, it can take up labeled reagent and then migrate to the detection area, where it can preferably be made visible by direct marking substances.
  • this first detection area there is a second area, spatially separated from the first area, which contains unlabelled specific binding reagent for the same detection substance, which immobilizes and is therefore immobile, so that the analyte that is on the porous carrier has been applied, can migrate over the first area into the second detection area and thus also the extent to which the labeled reagent is bound in the second area can be made visible.
  • this preferred embodiment which is preferred in the prior art, it is therefore not only possible to determine whether the sample is the presumed biologically active Connection contains, but also check whether the liquid has migrated further into the second detection area, ie that the test worked correctly.
  • Enzyme immunoassays are used for numerous applications in clinics and medical practices, but a significant and growing market is pregnancy or ovulation tests, which can be carried out by women themselves at home. Buyers are increasingly finding these tests; Whereas in the past women used an pregnancy test once a year on average, according to recent studies this happens several times, on average four to five times a year.
  • the invention is therefore based on the object of the known test devices for immunoassays, in particular those for the Mass demand to develop so that the disadvantages described are avoided.
  • test devices according to claim 1 are proposed.
  • the test devices for immunoassays consist of a dry porous carrier, preferably of nitrocellulose, which has one or more reaction zones for the detection of biologically active substances.
  • the carrier membrane preferably has a first reaction zone which contains a labeled specific binding reagent for the substance to be detected, which is freely movable within the porous carrier membrane in the moist state.
  • a second, spaced-apart reaction zone contains an unlabeled specific binding reagent for the same substance to be detected, this unlabeled reagent being permanently immobilized on the porous support and therefore not movable in the moist state.
  • the reaction zones are designed so that a liquid aqueous sample can take up the labeled reagent and then penetrate into the detection zone.
  • the liquid sample applied can then penetrate through this first zone into the second reaction zone in ascending order by capillarity.
  • This carrier membrane is provided with a covering with a viewing window in such a way that a part of the carrier protrudes from this covering and can be brought into connection with the liquid sample, for example in pregnancy tests by immersing this part of the carrier in the urine sample to be examined.
  • the carrier is embedded in an envelope, which consists of an upper and a lower part made of cardboard strips, in which at least the upper part has one or more viewing windows for reading the test results and is therefore positioned so that both the first and possibly the second reaction zone is clearly visible within the viewing window.
  • the carrier membrane is positioned between the upper and lower part of the wrapping consisting of cardboard strips and the two parts of the wrapping are then firmly connected to one another, for example by applying a thin layer or spaced-apart areas of a pressure-sensitive adhesive or by, for example, painting the inside the cardboard strip with weldable polymers or in another manner familiar to the person skilled in the art.
  • the carrier itself and the viewing window are left out of the coating with adhesive or other substances necessary for the connection of the cardboard parts.
  • the adhesives or polymer mixtures should be water-based in order to avoid that only traces of volatile organic solvents, which can possibly impair the antibody-antigen reaction, could be present after production.
  • Both the upper and lower part of the wrapping preferably have a recessed grip molded into the cardboard strip on the side opposite the exit point of the carrier.
  • the carrier membrane is preferably completely or partially covered with a thin transparent plastic cover made of preferably degradable plastics in order to keep the effects of environmental influences away from the carrier.
  • this thin plastic cover completely covers the carrier membrane, but is separable in the region of the exit of the carrier from the covering, so that the part of the carrier protruding from the covering, which also serves as an absorbent sample holder during the test, during transport and storage is protected, but this envelope can be removed in a simple manner, for example by perforation in this area.
  • the inside of the upper part of the casing can instead or additionally be coated with a thin transparent film in order to prevent the carrier membrane from being impaired, for example, by splashes or other environmental influences.
  • a thin transparent film in order to prevent the carrier membrane from being impaired, for example, by splashes or other environmental influences.
  • the entire test device is again protected by, for example, a welded plastic film for protection during transport or storage, which should preferably be biodegradable.
  • the outer sides of both the upper and lower part of the wrapping made of cardboard strips are coated or coated with plastic in order to achieve good printability; measures of this type to improve the printing properties are familiar to the person skilled in the art. The invention is explained in more detail below with reference to the drawings:
  • Fig. 1 shows the three essential components of the test device in plan view
  • Fig. 2 shows the fully assembled device in supervision.
  • the test device for immunoassays essentially consists of the upper part 1 of the wrapper in the form of a cardboard strip and the lower part 2 and the carrier 3, the upper part 1 of the wrapper having at least one viewing window 4. Both the upper part 1 and the lower part 2 are preferably provided at one end with a recessed grip 5a, 5b.
  • the test strip 3 lies with its end protruding from the casing, the sampling 7 between the interconnected upper and lower parts 1 and 2 of the casing and is positioned between these parts in a manner known per se, for example by gluing or welding that the sample holder 7 protrudes from the casing at point 6.
  • the reaction zones, shown as lines in FIG. 2, are positioned so that they can be clearly seen in the viewing window 4.
  • the upper and lower parts 1 and 2 of the casing can preferably be printed, for example, with a brand name, instructions for use, etc.
  • the test device is removed from an optional protective cover and immersed with the aid of the recessed grip so far into the aqueous liquid to be analyzed that the sample holder is in the liquid and this is absorbed into the carrier membrane due to the capillarity.
  • the liquid to be analyzed migrates through the carrier membrane and settles in the reaction zone or zones with the labeled binding reagents present there, which are provided with a direct labeling substance, to form visually visible reaction products.
  • test devices according to the invention contain only very small amounts of plastic in the form of thin foils, which are generally produced from biodegradable polymers.
  • the previously usual solid plastic housing made of polyethylene or polypropylene and the resulting non-degradable plastic mü II are no longer required, since the cardboard strips used can be completely degraded in a short time and the use of such cardboard strips also leads to significantly reduced production costs.

Abstract

L'invention concerne des dispositifs de test pour dosages immunologiques, qui comprennent un support (3) poreux sec dans une enveloppe munie d'une fenêtre (4). Ce support (3) peut être mis en contact avec un échantillon liquide et présente des zones de réaction à distance, pour mettre la présence de substances biologiquement actives en évidence. Ce support se caractérise en ce que l'enveloppe comprend une bande de carton éventuellement couché, constituant la partie supérieure (1) et une bande de carton éventuellement couché, solidarisée avec la précédente et constituant la partie inférieure (2).
PCT/EP1999/007717 1998-12-22 1999-10-14 Dispositif de test pour dosages immunologiques WO2000037939A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1998159066 DE19859066C2 (de) 1998-12-22 1998-12-22 Testvorrichtung für Immunoassays
DE19859066.0 1998-12-22

Publications (1)

Publication Number Publication Date
WO2000037939A1 true WO2000037939A1 (fr) 2000-06-29

Family

ID=7891994

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1999/007717 WO2000037939A1 (fr) 1998-12-22 1999-10-14 Dispositif de test pour dosages immunologiques

Country Status (2)

Country Link
DE (1) DE19859066C2 (fr)
WO (1) WO2000037939A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6833111B2 (en) 2001-04-13 2004-12-21 Varian, Inc. Multiple analyte assaying device with a multiple sample introduction system
US9404911B2 (en) * 2008-04-21 2016-08-02 Quidel Corporation Integrated assay device and housing
GB2619127A (en) * 2022-05-23 2023-11-29 Zhejiang Orient Gene Biotech Co Ltd Test device for analyte in a fluid sample

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5364266B2 (ja) 2004-11-01 2013-12-11 インターナショナル・バイオ−セラピューティック・リサーチ・インコーポレイテッド ディスポーザブル免疫診断検査システム

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4518565A (en) * 1983-06-06 1985-05-21 Miles Laboratories, Inc. Reagent test device holder
EP0291194A1 (fr) * 1987-04-27 1988-11-17 Unilever N.V. Dosages immunologiques et appareils pour leur mise en oeuvre
US5366872A (en) * 1992-12-09 1994-11-22 Envirocon International Corporation Test kits and methods for evaluating sterilization cycles
EP0673680A2 (fr) * 1994-03-22 1995-09-27 Roche Diagnostics GmbH Support pour tubes à essais
WO1996028715A1 (fr) * 1995-03-14 1996-09-19 Howard Milne Chandler Dispositif de prelevement d'echantillons
WO1996038727A1 (fr) * 1995-06-02 1996-12-05 Smithkline Diagnostics, Inc. Dispositif d'essai a element opposable dote d'une barriere conductrice
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
US5846487A (en) * 1996-11-26 1998-12-08 Bennett, Ii; Edward R. Specimen cartridge

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4443386C2 (de) * 1994-12-06 1996-09-19 Seratec Ges Fuer Biotechnologi Vorrichtung zur Durchführung eines Schwangerschaftstests

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4518565A (en) * 1983-06-06 1985-05-21 Miles Laboratories, Inc. Reagent test device holder
EP0291194A1 (fr) * 1987-04-27 1988-11-17 Unilever N.V. Dosages immunologiques et appareils pour leur mise en oeuvre
US5366872A (en) * 1992-12-09 1994-11-22 Envirocon International Corporation Test kits and methods for evaluating sterilization cycles
EP0673680A2 (fr) * 1994-03-22 1995-09-27 Roche Diagnostics GmbH Support pour tubes à essais
WO1996028715A1 (fr) * 1995-03-14 1996-09-19 Howard Milne Chandler Dispositif de prelevement d'echantillons
WO1996038727A1 (fr) * 1995-06-02 1996-12-05 Smithkline Diagnostics, Inc. Dispositif d'essai a element opposable dote d'une barriere conductrice
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
US5846487A (en) * 1996-11-26 1998-12-08 Bennett, Ii; Edward R. Specimen cartridge

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6833111B2 (en) 2001-04-13 2004-12-21 Varian, Inc. Multiple analyte assaying device with a multiple sample introduction system
US9404911B2 (en) * 2008-04-21 2016-08-02 Quidel Corporation Integrated assay device and housing
GB2619127A (en) * 2022-05-23 2023-11-29 Zhejiang Orient Gene Biotech Co Ltd Test device for analyte in a fluid sample

Also Published As

Publication number Publication date
DE19859066C2 (de) 2003-04-17
DE19859066A1 (de) 2000-07-06

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