EP0634215A1 - Dispositif pour la détermination simultanée d'analytes - Google Patents

Dispositif pour la détermination simultanée d'analytes Download PDF

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Publication number
EP0634215A1
EP0634215A1 EP94110708A EP94110708A EP0634215A1 EP 0634215 A1 EP0634215 A1 EP 0634215A1 EP 94110708 A EP94110708 A EP 94110708A EP 94110708 A EP94110708 A EP 94110708A EP 0634215 A1 EP0634215 A1 EP 0634215A1
Authority
EP
European Patent Office
Prior art keywords
liquid
transport
zone
analytes
sample
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Withdrawn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
EP94110708A
Other languages
German (de)
English (en)
Inventor
Ada Dr. Goerlach-Graw
Reinhard Dr. Baer
Rolf Lerch
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.)
Roche Diagnostics GmbH
Original Assignee
Roche Diagnostics GmbH
Boehringer Mannheim 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 Roche Diagnostics GmbH, Boehringer Mannheim GmbH filed Critical Roche Diagnostics GmbH
Publication of EP0634215A1 publication Critical patent/EP0634215A1/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Withdrawn legal-status Critical Current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
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • 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
    • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
    • 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
    • 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
    • B01L2400/08—Regulating or influencing the flow resistance
    • B01L2400/084—Passive control of flow resistance
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/901—Drugs of abuse, e.g. narcotics, amphetamine

Definitions

  • the invention relates to a method for determining several analytes in a multi-zone device and a device suitable therefor.
  • So-called dry tests have proven their worth for quick and easy determination of analytes. They contain a reagent or a large number of reagents in dried form on a capillary carrier which is brought into contact with the sample liquid in order to carry out the test. The reagents dissolve in the liquid and result in a signal that is characteristic of the analyte, for example a color change, which can then be used for an evaluation. With simple tests it is sometimes possible to arrange the capillary, reagent-containing supports on a single test element, which is then immersed in the liquid so that all supports are wetted by the liquid.
  • An example of such test elements are urine test strips, the test fields for several analytes, e.g. B. leukocytes, density, pH and the like. contain.
  • EP-A-0 467 165 describes a method and a device for determining several analytes from a pasty sample, e.g. B. proposed by chair.
  • the device contains an eluent application field and a plurality of eluate transfer means which ensure fluid contact with test strips for ensure the desired provisions.
  • a transport route for the pure eluent which is designed in such a way that the eluent flow through the sample is greatly slowed down in order to achieve an effective elution of the relatively heterogeneous solid sample.
  • the pure eluent is placed on this eluent application field and transported from there to the sample application area without changing the ingredients.
  • the eluate which now contains analyte, flows through a transport zone widening in the direction of the test carrier, in which the transport routes are not separated from one another.
  • the method described in EP-A-0 467 165 has the disadvantage that the different test strips and thus also reagents come into contact with the eluate at different times and thus different test results are obtained in some cases for the same test strips on different eluate transfer agents. This can be disadvantageous, in particular for a quantitative evaluation of analyzes. In addition, the problems increase with an increasing number of eluate transfer agents.
  • Analytes of the method according to the invention are, in particular, constituents of body fluids, such as urine, blood, serum, saliva, sweat or plasma or liquids derived therefrom (e.g. diluted with water, buffer or alcohols) or other liquids, such as e.g. B. Solutions of powders to be tested for drug content.
  • body fluids such as urine, blood, serum, saliva, sweat or plasma
  • liquids derived therefrom e.g. diluted with water, buffer or alcohols
  • other liquids e.g. B. Solutions of powders to be tested for drug content.
  • Preferred body fluid is urine.
  • Preferred analytes are dissolved chemical substances, the presence or absence or concentration of which in the respective body fluid is an indication of a disease or a body condition.
  • Particularly preferred are analytes that are detectable immunologically, ie haptens, antigens or antibodies, but also nucleic acids and other biospecifically detectable substances.
  • Preferred analytes in the urine are drugs such as cocaine, cannabis (hashish) or opiates (heroin), or kidney parameters such as albumin, 1M, ⁇ -NAG.
  • the device according to the invention has at least 4 zones which are connected to one another by capillary action, namely 2 or more transport zones and 2 or more sampling zones. It also contains a sample drop point.
  • the sample application point is preferably on a capillary fleece or tissue that is chemically inert to the sample liquid. It is preferred by appropriate labeling, e.g. B. by applying visible signs such as circles, crosses, arrows or the like or by constructive separation, z. B. determined by covering the fleece surrounding the drop point.
  • a device preferably contains as many transport zones as sampling zones, the transport zones being spatially separated from one another at least in the vicinity of the sampling zone, so that no liquid can pass from one transport path to another.
  • the transport zones are constructed from capillary material, in particular a capillary fleece or tissue that is chemically inert to the sample liquid.
  • a transport zone is understood to be an area on which a flat material capable of absorbing liquid extends. This material has a thickness that is less than the width and length of the surface.
  • the sample liquid flows through the length of the transport zone.
  • the transport zones are either spatially separated from one another or their limits are given to one another by segments of the liquid volumes moving within the transport zones towards the associated sampling zone.
  • a sampling zone is understood to be an area of the device which is also capillary-active and which is or can be brought with a test element in an arrangement which enables liquid contact. As soon as the sampling zone receives liquid from the transport zone, the liquid can pass onto the adjacent test element.
  • a capillary volume is defined by the suction volume of the transport zones and the sampling zones. This volume is smaller or at most the same size as the volume of the sample liquid applied.
  • the volume of the liquid applied is particularly preferably as much greater than the capillary volume as it corresponds to the additional suction volume of the test elements adjacent to the sampling zone.
  • transport routes The distances that a certain volume of liquid travels between the sample application point and the sampling zone are referred to below as transport routes.
  • the applied sample liquid is not changed on these transport routes, at least with regard to the analytes.
  • Non-woven fabrics made of synthetic fibers e.g. polyester
  • cellulose fibers can be added if desired
  • the nonwovens are preferably between 0.35 and 1.5 mm thick.
  • test element is understood to be a means for detecting the presence or the amount of an analyte, the preferred elements being constructed in the manner of the test strips. This means that they have a carrier film on which absorbent materials are attached, on which the reagents required for detection are applied. Such a test element is described, for example, in EP-A-0 374 684. If such a test element is brought into contact with the sampling zone, this is preferably done via a zone of the test element which does not yet contain any reagents.
  • test carrier according to EP-A-0 374 684 is to be used to determine an analyte according to the device according to the invention
  • the starting zone 21 described there is brought into contact with the sampling zone 3 of the device according to the invention.
  • the simultaneous determination of several analytes as many test elements are brought into contact with the sampling zones as determinations are necessary.
  • An advantage of the device according to the invention is that the delay zones prevent the test elements from being flooded with sample liquid.
  • the simultaneity of the contact of the test carriers with the sample liquid means that not one of the reagent carriers receives more liquid than another. Since, to carry out reliable determinations, a signal must often be read from the test element within a certain period of time after the test element has been brought into contact with the sample liquid, the simultaneous encounter of the liquid front at all sampling points according to the invention is an essential advantage of the present invention.
  • the simultaneous arrival of the liquid also means that the test elements for different analytes do not necessarily have to be introduced into the device in an order directed at the respective sampling point, but that they can be interchanged. This is particularly important in the case of provisions in which the users themselves can provide evidence as required.
  • test elements for the determination of several analytes can be assembled into profiles as required.
  • the device according to the invention can either be used to create a kidney function profile, ie determination of several analytes characteristic of the kidney function, or a drug profile, e.g. B. Determination of several common drugs (drugs of abuse) can be used.
  • the device according to the invention can therefore be sold in a form in which the test elements are already connected to the sampling zones, e.g. B.
  • test elements in the housing, or in a form that the housing with the sample application zone, the transport route and the sampling zone as a part and a number of test elements in a further container by the person who wants to carry out the analysis, can be inserted into the housing, sold.
  • the sampling zones 4 are arranged essentially completely or partially radially around the sample application point 2 (FIG 1).
  • the shortest connecting routes are of the same length.
  • the transport routes can then first go through a radially symmetrical capillary-active fleece and then in parallel through as many fleeces as there are sampling zones.
  • the latter fleeces are designed so that no liquid flow is possible between them.
  • they can take the form of webs that extend from the edge of the sample application fleece to the sampling zones.
  • the material of the webs preferably overlaps a little with the sample application fleece, as a result of which, when the materials are compressed at the overlap point, there are locations with a smaller flow cross section, which act as delay zone 7.
  • the overlap point is preferably about 1 to 2 mm wide.
  • the delay is the same on all transport routes.
  • the liquid will first flow to the delay zones of the other transport routes after reaching the delay zone of the shortest transport route until the capillary pressure is the same at all delay zones. Then the liquid will pass through all of the delay zones substantially simultaneously. Since the subsequent parts of the transport routes are of the same length and of the same nature, the liquid will reach the test elements at the same time.
  • the ends of the webs located away from the point of application can themselves represent the sampling zones, or separate fleeces can be provided for this.
  • the test elements 5 are in capillary contact with the sampling zones 4. In this embodiment, flooding of the test strips is particularly prevented.
  • FIG. 2 the device is shown in section X - Y.
  • the sampling zones 4 lie on an imaginary straight line, so that all test elements 5 point essentially in the same direction.
  • the delay zones differ in their delay effect if the sampling zones are at different distances from the sample application point 2. Since liquids in uniform capillary-active material would spread radially, the liquid would arrive at the sampling point 4 / I closest to the sample application point first without a delay zone and would pass to the test element. The delay must therefore be greatest on this transport route. The further the other sampling points 4 / I, 4 / II or 4 / III are from the sample application point 2, the weaker the delay must be.
  • the transport routes 3 / I, 3 / II or 3 / III preferably run partially through webs made of nonwoven material.
  • the materials that make up the transport zones and the sampling zones are located in a housing.
  • This housing has an opening 9 in the area of the sample application point, so that the sample liquid can be applied to the material below the sample application point.
  • the housing also has openings 6 in the area of the sampling zones, into which the test elements can be inserted, so that the fleeces or fabrics of the test elements can come into contact with the material of the sampling zone.
  • Any sample liquid-impermeable material can be used as the material for the housing, e.g. B. one, which consists of a plastic or a paper impregnated against moisture absorption.
  • FIG. 4 shows how a delay in the flow of liquid from the sample application point 2 to the sampling zones 4 / I, 4 / II and 4 / III can be achieved.
  • the simultaneous wetting of the sampling zones 4 is achieved in that route B does not represent the shortest transport route for the liquid, but is extended in relation to it, so that routes A, B and C are approximately the same length.
  • FIG. 5 shows how a form of the capillary-active material that is suitable for the simultaneous wetting of the sampling points 4 / I, 4 / II and 4 / III can be determined.
  • the areas F1, F2 and F3, through which sample liquid flows on the way to the individual sampling points, and which lie between the sample application point and the sampling zone, should be essentially of the same size.
  • FIG. 6 the material is shown on a transport path in which a delay in the flow of liquid is achieved by vertical constriction, in this case by constant light compression of the nonwoven material.
  • the pressure can be generated by opposite or offset webs in the bottom and / or cover part of the device. The height of these webs can be used for a different transport delay on different transport routes.
  • FIG. 7 shows a cross section of a transport route in which the materials involved overlap at the sample application point and the sampling zone.
  • Impregnation of an absorbent material to be traversed by the liquid with a temporarily or permanently hydrophobicizing substance slows down the liquid flow.
  • a material with higher hydrophobicity e.g. a paper or a membrane
  • Such hydrophobic barriers can be integrated anywhere in the test strip between the sample application zone and the first reagent zone.
  • the sample liquid is applied at a single sample application point. This can be done, for example, by pipetting or dripping on the liquid. About as much or a little more liquid is preferably added than the entire device has a capillary-active volume. Due to capillary transport, the liquid travels along the transport routes to several sampling zones. By delaying the liquid transport on the transport routes that are closest to the sample application point, a simultaneous wetting of the test elements is achieved.
  • a piece of paper with the contours 10 of FIG. 3 is cut out of a paper TI 532 (from Binzer).
  • This piece of paper is inserted into a housing half 8 which is injection molded from polystyrene and which contains cutouts for the contour of the paper and the test strip 5.
  • the test strips 5 (for example Mikral® test strips from Boehringer Mannheim GmbH) are then inserted in such a way that the starting fleece or the first fleece on which the reagents are located are in direct contact with the sampling zones 4.
  • a second housing half, which contains no cutouts for the paper or the test strips, but which has a recess in the vicinity of the sample application point 2, through which sample liquid can be applied to the sample application point, is then glued on.
  • the entire device has a length of approximately 15 cm, a width of 7 cm and a thickness of 0.5 cm.
  • the dimensions of the capillary-active material should be approximately halved.

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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)
  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
EP94110708A 1993-07-15 1994-07-09 Dispositif pour la détermination simultanée d'analytes Withdrawn EP0634215A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE4323672A DE4323672A1 (de) 1993-07-15 1993-07-15 Vorrichtung zur gleichzeitigen Bestimmung von Analyten
DE4323672 1993-07-15

Publications (1)

Publication Number Publication Date
EP0634215A1 true EP0634215A1 (fr) 1995-01-18

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EP94110708A Withdrawn EP0634215A1 (fr) 1993-07-15 1994-07-09 Dispositif pour la détermination simultanée d'analytes

Country Status (4)

Country Link
US (1) US5556789A (fr)
EP (1) EP0634215A1 (fr)
JP (1) JPH0777525A (fr)
DE (1) DE4323672A1 (fr)

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US5556789A (en) 1996-09-17
DE4323672A1 (de) 1995-01-19

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