WO1999056111A1 - Dispositif d'essai electronique - Google Patents

Dispositif d'essai electronique Download PDF

Info

Publication number
WO1999056111A1
WO1999056111A1 PCT/EP1999/002840 EP9902840W WO9956111A1 WO 1999056111 A1 WO1999056111 A1 WO 1999056111A1 EP 9902840 W EP9902840 W EP 9902840W WO 9956111 A1 WO9956111 A1 WO 9956111A1
Authority
WO
WIPO (PCT)
Prior art keywords
test liquid
reagent
analyte
assay device
labelled
Prior art date
Application number
PCT/EP1999/002840
Other languages
English (en)
Inventor
Thomas Augustinus Maria Beumer
Hermanus Johannes Maria Kreuwel
Petrus Franciscus Hendrikus Maria Verheijden
Original Assignee
Akzo Nobel N.V.
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 Akzo Nobel N.V. filed Critical Akzo Nobel N.V.
Priority to AU38240/99A priority Critical patent/AU3824099A/en
Publication of WO1999056111A1 publication Critical patent/WO1999056111A1/fr

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band

Definitions

  • the invention relates to a device for the detection of an analyte in a test liquid by means of a radial solid phase diffusion assay.
  • the assay device is equipped with a light source and detector, processing and display means for electronic reading of the assay results and is especially suitable for home use or use by non-professional organisations.
  • porous materials enabled a close contact between the various reagents thereby reducing the reaction time dramatically.
  • the drawback of these filter tests was that quite a number of handlings were required, which made them less suitable for use by unskilled people. This problem could be solved when porous test strips were used, which contained all or part of the reagents required, and which could be dipped into the test liquid.
  • enzyme labels were used, a further simplification was achieved by using the so-called "direct" labels which did not require any additional reagents or equipment, such as enzymes or radioisotope labels.
  • Well-known direct labels are the particulate labels as for example described in EP 291 194.
  • dipstick tests comprising an immobilized capture antibody and a freely mobile particle labelled antibody, proved to be highly suited for use by unskilled people.
  • a complex is formed between the labelled antibody and the analyte when present.
  • this complex is transported to the capture antibody whereby a sandwich is formed.
  • colloidal gold particles are used as a label
  • a magenta coloured spot is observed when the analyte to be determined, for example hCG, is present in the test liquid. This colour can be observed visually. In general no problems are observed with strongly positive or absolutely negative samples.
  • US 5,580,794 describes an electronic assay device comprising a bibulous support with dried assay reagents, a light source and a light detector, as well as a data processor and a display unit, all encapsulated in a unitary housing.
  • the test liquid is applied to the oblong bibulous support through an opening in the housing,
  • This oblong bibulous support comprises various zones with reagents, such as a mobile labelled binding reagent for the analyte to be determined and an immobilized binding reagent for said analyte.
  • the label is preferably a physically detectable label such as colloidal metal particles.
  • the analyte to be detemined reacts with the mobile labelled binding reagent and the analyte/labelled binding reagent complex formed, as well as any unreacted reagent, is transported to a detection zone with the immobilized binding reagent for the analyte.
  • the amount of physically detectable label present in the complex of immobilized binding reagent/analyte/labelled binding reagent formed in the detection zone is measured using a light source and light detector.
  • the object of the present invention is to overcome these disadvantages. These improvements have been achieved with an assay device for detection or determination of the amount of an analyte in a test liquid comprising - a bibulous support comprising a zone with an immobilized first reagent and a sample application spot;
  • a light detector capable of producing an electrical signal, the light source and the light detector defining a measuring area
  • -electronic processing means for deriving an output signal from the electrical output signal of the light detector
  • at least one of the first reagent and a mobile, labelled second reagent being capable of reacting specifically with an analyte to be determined in the test liquid
  • the electronic processing means being capable of determining the electrical signal in a time-dependant manner and capable of processing the data obtained to yield a value corresponding to the analyte concentration
  • sample application spot and the measuring area are located within the perimeter of said zone containing an immobilized first reagent.
  • test liquid is applied to the bibulous support, that has been pre-coated with a first immobilized reagent, and allowed to diffuse radially through said bibulous support.
  • a mobile labelled second reagent capable of reacting directly or indirectly with the analyte to be determined in the test liquid, is applied to said bibulous support coated with a first immobilized reagent before, together with, or after application of the test liquid, and allowed to diffuse radially. The amount of labelled second reagent bound is then measured kinetically.
  • EP 207 152 Such a radial solid phase diffusion assay is also described in European Patent No. 207 152, wherein a test liquid comprising a labelled compound diffuses radially from a point of application on a bibulous support comprising immobilized first reagent. Generally, the size of a labelled spot is measured as an indication for the amount of analyte present.
  • EP 207 152 does, however, not suggest or disclose an electronic measurement for an accurate indication of the amount of analyte, let alone a kinetic measurement.
  • the device of the present invention comprises a bibulous support comprising a material which transports the test liquid essentially by capillary forces.
  • absorbent, porous or fibrous material is used, which is suitable for rapid uptake and transport of liquid.
  • Suitable materials involve amorphous sponge-like structures or various porous synthetic materials such as polypropylene, polyethylene, polyvinylidene fluoride, ethylene/vinyl acetate copolymer, polyacrylonitrile and polytetrafluoroethylene
  • certain materials with an inherent hydrophobicity can also be pretreated with surface-active agents to such an extent that they are able to take up a test liquid and transport it by capillary forces.
  • multilayer materials are used and materials which are already generally applied in analytical test strips such as paper or paper-like materials.
  • a most preferred material is nitrocellulose.
  • Said bibulous support is coated with an immobilized first reagent which is capable of reacting directly or indirectly with the analyte to be determined.
  • Said first reagent is preferably a member of a specific binding pair such as an antigen or antibody or their fragments, a DNA or RNA fragment, avidin or biotin, a hormone or hormone receptor, etc.
  • the first reagent can be immobilized onto the bibulous support in a variety of ways.
  • the first reagent such as an antibody can be immobilized onto the bibulous support by adsorption or covalent binding.
  • the antibodies can be coupled directly without a previous chemical treatment of the bibulous support.
  • the remaining binding sites can be blocked with, for example, treatment with hydrophilic synthetic polymers, such as polyvinylalcohol, or hydrophylic biopolymers, such as human and bovine serum albumin, ovalbumin, casein and the like. It is, however, also possible to add these compounds to the labelled second reagent.
  • the bibulous support consists of other materials such as paper, covalent coupling can be achieved with CNBr or carbonyldiimidazole. It is also possible to use printing processes, such as ink jet and screen printing techniques, for this purpose.
  • the reagent may either merely be applied to the surface of the bibulous support or impregnated into the bibulous support. Either the entire surface of the bibulous support is coated with the immobilized first reagent or that part which is defined by the borderline of the recess of the absorbing element described below.
  • an absorbing element provided with a recess is placed on top of said bibulous support to enhance the diffusion rate and to speed up the reaction.
  • the recess defines a borderline in contact with the bibulous support, which borderline is substantially continuous and substantially circular, and which defines a centre substantially coinciding with the sample application spot.
  • the material of the absorber is not critical and can be any material that is capable of absorbing liquids for a sufficient volume and/or period of time, for example a paper-like material or a sponge-like material such as, for example, cotton wool or hydrophilic and hydrophilized synthetic polymer materials, such as polyethylene vinylacetate, as well as other polyesters, and polypropylene.
  • the dimensions of the absorbing element are chosen in such a way that it is capable of maintaining a substantially constant flux through the bibulous support.
  • the cover sheet is prepared from a water-impermeable material, such as thermoplastic material, polystyrene, polypropylene or the like.
  • a hole with well-defined dimensions can be prepared by treating the water- impermeable material with a laser beam, matched metal cutting, rotary die cutting, or other cutting techniques.
  • the reaction between the analyte to be determined, the mobile labelled second reagent and the first immobilized reagent is accompanied by a physically detectable change, for example a change in colour.
  • a physically detectable change for example a change in colour.
  • Such a change can be detected with a light source and light detector positioned under the bibulous carrier.
  • the light source couples light into the bibulous support in a direction suitable to cause the substance of the light to enter the bibulous support, as described in our copending unpublished European patent application PCT EP 97/05984, the contents of which are hereby incorporated by reference.
  • PCT EP 97/05984 the contents of which are hereby incorporated by reference.
  • a prolonged path for the light imparted in the carrier's interior for travelling to the detector is realised.
  • the light is scattered and diffused allowing for an increased interaction through absorption of the light by such area of the carrier where the analyte in the test liquid and the mobile labelled second reagent are bound to the first reagent immobilized to said carrier.
  • the sensitivity and accuracy for measuring the occurrence and the extent of any such reaction is highly increased.
  • the sensitivity of the test device for the light transmitted by the light source is improved by the application of blocking means to prevent the light to travel directly from the light source towards the detector.
  • the blocking means are formed as a light shield, such as the shield of material which is not translucent.
  • the centre of the measuring area is defined by the light source and light detector, and substantially corresponds to the sample application spot.
  • the analyte to be determined and the first immobilized reagent as soon as the mobile labelled second reagent and/or test liquid are applied to the spot.
  • the mobile labelled second reagent will not be bound to the bibulous support with the immobilized first reagent. Instead, the mobile labelled second reagent will diffuse radially to the circular borderline of the absorber and is ultimately taken up by the absorber.
  • the test liquid comprising said analyte, the mobile labelled second reagent and the complex formed between analyte and labelled second reagent, will diffuse radially through the bibulous support with the immobilized first reagent, whereby the mobile labelled seccond reagent will eventually be bound to said immobilized first reagent via the analyte.
  • the distribution of the labelled second has substantially the shape of a 2-dimensional bell-curve.
  • the whole volume under this curve can be measured as an indication for the total amount of bound particles, it is advantageous to restrict the measuring area to the upper part, close to the axis of symmetry of said bell-curve; in this way the highest signal value is obtained. Furthermore, the positioning of the light source and detector, defining said measuring area, is less critical: a minor shift in the position of light source and detector will cause a decrease of the measuring area in one half of the curve, while at the same time the measuring area is increased similarly in the other half of said curve.
  • the light detector is located substantially under the sample application spot, whereas the light source is positioned at a small distance from said sample application spot.
  • This allows for a simple construction of the assay device, where the light source and detector are positioned in substantially the same plane substantially parallel to the bibulous support.
  • the light source and the light detector are located optimally at a substantially equal distance from said sample application spot, surprisingly, it was found that more accurate signals are obtained when the detector is mounted under the sample application spot.
  • the optical axis of symmetry of a LED-diode combination is not the same as the mechanical axis of symmetry.
  • the bibulous support is illuminated by a LED that is used without its normal housing with lens.
  • a LED that is used without its normal housing with lens.
  • the wavelength should be selected to match with the absorption maximum of the applied labelled second reagent.
  • this label is a carbon sol particle. In that case, the particles behave like a neutral density filter with absorption rougly constant over the entire UV-VIS spectrum.
  • the wavelength can be selected on (a) economic arguments and (b) to fit with the detector's optimum spectral sensitivity.
  • the detector's output current is led to the processing means, for example an ASIC.
  • the current value is digitized using a known capacitor and a timer, in this way digitization accuracies better than 99% can be achieved at any current value
  • the time series of these digitized values is then used for quantitative or qualitative interpretation of the concentration of the analyte to be determined.
  • the ASIC forms the electronic interface between light source/light detector and the output device that the user experiences
  • the electrical current is measured as a function of the time.
  • This current-to-time curve can ideally be described by a single exponential function, which is based on the following assumptions the amount of bound labelled second reagent, for example the number of colloidal carbon sol particles coated with second reagent, increases approximately linear with time and analyte concentration, furthermore the photometric reading behaves like an absorption measurement, following Lambert-Beer's law and thereby causing output currents to behave exponentially to the above number of bound particles
  • the dynamics of such an exponential are fully described by its so-called time constant value ⁇ , which is a direct measure for the speed at which photometric current decreases with increasing amount of bound second reagent labelled with colloidal carbon sol particles
  • This time constant value ⁇ can be approximated from only two data points using a first order Taylor series expansion These two data points are with best possible reliability obtained as described below It should be considered that any other method of reading two dinstinctly different data values will enable a similar mathematical means to estimating ⁇
  • the first point is obtained by reading the current value as short as possible after wetting of the bibulous support, which is characterized by a sharp decrease in the current value
  • the ⁇ value is calculated for a reference (cut-off) value and the ⁇ value found for a test sample is subsequently compared with that of the cut-off value, which gives a positive/negative or yes/no answer
  • a display means for reading by, for example, non-skilled persons.
  • the mobile labelled second reagent can either be included in the device or supplied separately. In the latter case the mobile labelled second reagent is mixed with the test liquid outside the device and the mixture is applied onto the sample application spot. Mixing of test liquid and label can also effectively be accomplished by using a porous element (static mixing means) which is placed on top of said bibulous support.
  • test liquid and mobile labelled second compound Upon application of test liquid and mobile labelled second compound to said static mixing means, an adequate mixing between the test liquid comprising the analyte to be determined, and the mobile labelled second reagent takes place, while at the same time a pre-incubation between analyte and labelled second component is achieved.
  • Said static mixing means is preferably made of porous sintered. material, and comprises most preferably polyethylene. The pore size typically is 5 to 70 ⁇ m.
  • a transfer element on top of said bibulous support, which transfer element is capable of establishing a direct contact between said static means and said bibulous support.
  • a transfer element comprises preferably a porous sheet, which is most preferably made of a non-woven material, for example glass fibre with a negligible flow resistance.
  • the pore size distribution of the transfer element has intermediate values between those of the bibulous support and static means respectively.
  • the test liquid is filtered prior to application onto the bibulous support in order to avoid clogging by non-soluble materials that can be encountered in every urine specimen.
  • Suitable filter materials are rigid porous media (e.g. plastics, sintered metals), plastic sheets (e.g. plastic porous sheets), membranes (e.g. polymeric membranes), woven fabrics (e.g. staple fibre yarns), non woven media (e.g. paper media such as cellulose, glass and polymeric non wovens such as melt blown and spun bounded materials). Defining the required filter specifications depend very much on the filtering characteristics of the bibulous support. Normally, particle diameters must exceed half the average pore diameter of the filter before it is certain whether they will be retained by the bibulous support.
  • the mobile labelled second reagent is incorporated into the device.
  • Said reagent can be diffusibly immobilized onto the bibulous support, but most preferably said mobile labelled second component is incorporated in a separate porous element which is either placed directly onto the bibulous support or onto said static means, so that said porous element with the mobile labelled second compound is in direct or indirect fluid flow contact with the bibulous support.
  • the mobile labelled second reagent is incorporated in the upper part of said porous element, while the lower part of said porous element serves as the static measn described above.
  • the porous element with the labelled second reagent should be capable of a rapid uptake of test liquid and an easy release of test liquid and labelled second reagent.
  • Suitable materials for use in said porous element are sintered plastics, paper-like materials (for example glass, cellulose) and polymeric non-woven materials. In a most preferred embodiment sintered polyethylene beads are used.
  • the pore size distribution of the porous element has intermediate values between those of the sample collector and the static means.
  • the mobile labelled second reagent is capable of reacting directly or indirectly with the analyte to be determined and is preferably a member of a specific binding pair such as an antigen or antibody or their fragments, a DNA or RNA fragment, avidin or biotin, a hormone or hormone receptor, etc.
  • the mobile second reagent is preferably provided with a label.
  • a label in principle all kinds of labels can be used, provided that this label is capable of absorbing and/or scattering light.
  • a direct particulate label is used, which gives a direct visible test result without the need for additional reagents.
  • said direct particulate label comprises small coloured particles, such as gold sol particles, latex particles, dyestuff particles, liposomes or microcapsules including a dye, carbon- and selenium sol particles etc. These particles are as such insoluble in water, but resuspendible in solution. All these particulate labels are well known in the literature (see Clin. Chem.
  • Carbon sol particles are particularly advantageous.
  • the carbon sol particles preferably have a diameter of about 60 to 250 nm, most preferably 90 to 140 nm.
  • conjugates are preferably incorporated in a porous element by application of a dispersion of these conjugates in a buffer solution to said element, followed by a drying process, preferably a freeze drying process
  • Suitable buffer solutions comprise non-ionogemc buffers such as CHES, Hepes, MES, CHAPS and preferably T ⁇ s
  • these buffers comprise complexing agents such as EDTA, proteins and sugars
  • a preferred protein is casem
  • suitable sugars comprise dextran and sucrose
  • Addition of a sugar to the buffer composition enables a controlled release of the conjugate, 1 e the mobile second reagent labelled with colloidal particles This controlled release is either based on a gradual dissolution or on an instantaneous dissolution In the latter case the dissolution time is much faster than the time needed to fill the porous carrier with sample fluid
  • test liquid possibly containing the analyte to be determined can directly be introduced into the device, for example with a pipette, or indirectiv with a separate sample collector, the latter obviously being preferred
  • sample collector is incorporated into the device
  • said sample collector can tempora ⁇ lv be removed from the device for uptake of test liquid and then replaced into the device in such a way that contact is made with the porous element comp ⁇ sing the mobile labelled second reagent
  • the sample collector comprises a material which can readily absorb test liquid, but also easily releases this test liquid for example under mechanical pressure or capillary transfer It can thus be a spongelike mate ⁇ al such as, for example, cotton wool or hydrophilic and hydrophi zed synthetic polymer materials, such as polyethylene vinylacetate as well as other polyesters, and polypropylene
  • additional reagents can be added as, for example, buffering compounds to adjust the pH of the test liquid, or compounds able to eliminate possibly interfering substances present in the test liquid
  • buffering compounds to adjust the pH of the
  • the device preferably comprises a housing which is
  • this housing is equipped with an opening for introduction of the sample collector and a window for observation of the test result.
  • the present invention is further directed to the use of a device as described above for the detection or determination of the amount of an analyte, such as an antigen, hapten, antibody or antibody fragment, DNA- or RNA fragment, and in particular hCG, in a test liquid, such as urine, and a method wherein such a device is used.
  • an analyte such as an antigen, hapten, antibody or antibody fragment, DNA- or RNA fragment, and in particular hCG
  • Such a method comprises for example the following steps:
  • the above method is applicable to devices comprising at least a bibulous support with a sample application spot located within the zone coated with an immobilized first reagent, a light source and light detector defining a measuring area within said zone, processing and display means. These devices may further comprise an absorbing element and a cover sheet with a hole.
  • the mixture of test liquid and labelled second reagent is applied to said transfer element.
  • the above described devices are preferably also provided with a static means, which is an element meant for mixing and pre-incubation of the test liquid and mobile labelled second reagent.
  • Said static means is placed on top of said devices and the mixture of test liquid and mobile
  • the mobile labelled second reagent is incorporated into the bibulous support.
  • the method for detection of the presence or amount of the analyte to be determined is then carried out by applying the test liquid directly, or via the transfer element, onto the sample application spot on the porous support, followed by measuring and processing the values obtained from the light detector as described above.
  • the device further comprises a porous element comprising the mobile labelled second reagent.
  • This element is placed on top of the bibulous support, provided with a coversheet with a hole and an absorbing element, and optionally with a transfer element.
  • the device also comprises a static means, said porous element is placed on top of said static means.
  • Test liquid is then applied to said porous element by means of, for example, a pipette, or a separate sample collector which is preferably incorporated into the device.
  • the method for detecting the presence or amount of the analyte to be determined with the above described device then comprises the following steps:
  • the present invention is also directed to a test kit for determination of the presence or amount of an analyte in a test liquid, which comprises a device as described above and, depending on the integration of the various reagents and components into said device, other reagents and components required
  • Figure 1 is a schematic cross-sectional view of an embodiment of the device described in the present invention, wherein the housing surrounding the various elements is omitted
  • Figure 2B is an embodiment of the presentation of the device described in the present invention, while Figure 2A shows the separate sample collector incorporated in said device
  • the device depicted in Figure 1 comprises a sample collector with a handle 1 and an absorbent tip 2 which fits into a housing, but which can temporarily be removed from said housing for collection of test liquid After collection of test liquid the sample collector is brought back into the housing whereby contact is made with a filtration means 3, which is placed on top of a porous element 4 comprising a labelled reagent for the analyte to be determined in the test liquid
  • the lower part of said porous element 4 is in contact with the upper part of a static means 5, i e a porous element for mixing and pre-incubation of analyte and labelled reagent
  • Said static means is in fluid flow contact with a bibulous support 9, comprising an immobilized reagent for the analyte, via a transfer element 7
  • the upper part of said bibulous support is in contact with the lower part of an absorber 6 with a recess, defining a circular borderline in contact with said bibulous support The area on the upper part of said
  • the sample collector 1 presented in Figure 2A comprises a handle 2 and an absorbent tip 3.
  • the complete device depicted in Figure 2B has a housing 2 comprising the handle 1 of the sample collector (as depicted in Figure
  • the housing 1 further comprises a window 5 through which the test result 4 can be read.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un dispositif servant à détecter ou à déterminer la quantité d'une substance à analyser dans un liquide d'essai. Ce dispositif d'essai est équipé d'une source de lumière (11) et d'un détecteur de lumière (13), ainsi que de moyens de traitement (14) et d'affichage (15) permettant la lecture électronique des résultats de l'essai, tandis que l'essai proprement dit est basé sur une diffusion radiale en phase solide. Ce dispositif élimine la nécessité d'effectuer un positionnement exact des composants optiques et de la zone de mesure.
PCT/EP1999/002840 1998-04-28 1999-04-22 Dispositif d'essai electronique WO1999056111A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU38240/99A AU3824099A (en) 1998-04-28 1999-04-22 Electronic test device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP98201362 1998-04-28
EP98201362.5 1998-04-28

Publications (1)

Publication Number Publication Date
WO1999056111A1 true WO1999056111A1 (fr) 1999-11-04

Family

ID=8233651

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1999/002840 WO1999056111A1 (fr) 1998-04-28 1999-04-22 Dispositif d'essai electronique

Country Status (2)

Country Link
AU (1) AU3824099A (fr)
WO (1) WO1999056111A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2013204428B2 (en) * 2010-01-28 2016-03-31 Ellume Pty Ltd Sampling and testing device for the human or animal body
US9877672B2 (en) 2010-01-28 2018-01-30 Ellume Pty Ltd Sampling and testing device for the human or animal body
US10786229B2 (en) 2015-01-22 2020-09-29 Ellume Limited Diagnostic devices and methods for mitigating hook effect and use thereof
US10890590B2 (en) 2012-09-27 2021-01-12 Ellume Limited Diagnostic devices and methods

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0426967A2 (fr) * 1989-09-08 1991-05-15 Terumo Kabushiki Kaisha Appareil pour mesurer à l'aide de lumière la concentration d'un spécimen
US5580794A (en) * 1993-08-24 1996-12-03 Metrika Laboratories, Inc. Disposable electronic assay device
EP0816849A2 (fr) * 1986-08-13 1998-01-07 Lifescan, Inc. Procédé pour déterminer des analytes
US5728352A (en) * 1994-11-14 1998-03-17 Advanced Care Products Disposable electronic diagnostic instrument

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0816849A2 (fr) * 1986-08-13 1998-01-07 Lifescan, Inc. Procédé pour déterminer des analytes
EP0426967A2 (fr) * 1989-09-08 1991-05-15 Terumo Kabushiki Kaisha Appareil pour mesurer à l'aide de lumière la concentration d'un spécimen
US5580794A (en) * 1993-08-24 1996-12-03 Metrika Laboratories, Inc. Disposable electronic assay device
US5728352A (en) * 1994-11-14 1998-03-17 Advanced Care Products Disposable electronic diagnostic instrument

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2013204428B2 (en) * 2010-01-28 2016-03-31 Ellume Pty Ltd Sampling and testing device for the human or animal body
US9877672B2 (en) 2010-01-28 2018-01-30 Ellume Pty Ltd Sampling and testing device for the human or animal body
US10890590B2 (en) 2012-09-27 2021-01-12 Ellume Limited Diagnostic devices and methods
US10786229B2 (en) 2015-01-22 2020-09-29 Ellume Limited Diagnostic devices and methods for mitigating hook effect and use thereof

Also Published As

Publication number Publication date
AU3824099A (en) 1999-11-16

Similar Documents

Publication Publication Date Title
US4818677A (en) Membrane assay using focused sample application
EP0607170B1 (fr) Procede et dispositif servant a analyser des specimens de fluide
KR920009420B1 (ko) 고체상 분석장치 및 이를 이용하는 방법
US8367013B2 (en) Reading device, method, and system for conducting lateral flow assays
CA2219176C (fr) Dispositif de detection ameliore pour diagnostic
US6812038B1 (en) Assay device and use thereof
US5087556A (en) Method for quantitative analysis of body fluid constituents
US5147780A (en) Multiwell stat test
EP0286371A2 (fr) Dispositif pour les essais immunologiques
EP2284538B1 (fr) Biocapteur
EP0269876B1 (fr) Dispositif de concentration d'échantillon pour un appareil analytique de phase solide
JPH0457226B2 (fr)
CA2460072C (fr) Dispositif de test multi-analytes a zone de detection multipoints
JPH01140066A (ja) 指示流診断装置および方法
WO1999022238A1 (fr) Dispositif de dosage d'analysat
JPH03118473A (ja) 流量調整手段を含む試験装置
CA2389741C (fr) Dispositif d'analyse et utilisation connexe
JPWO2003029822A1 (ja) 特異結合分析装置および特異結合分析方法
US20030073121A1 (en) Multi-analyte assay device with multi-spot detection zone
CA2629290A1 (fr) Analyse par agglutination
JPH10185920A (ja) アッセイ装置およびそれを用いるアッセイ方法
WO1999056111A1 (fr) Dispositif d'essai electronique
EP0439917B1 (fr) Appareil pour la détection et la mesure semiquantitative de composés
KR910001313B1 (ko) 면역 분석 방법 및 장치

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AU CA ID JP KR US ZA

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
NENP Non-entry into the national phase

Ref country code: KR

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: CA