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WO2008017819A1 - appareil d'analyse, appareil de lecture d'analyse et méthode associée - Google Patents

appareil d'analyse, appareil de lecture d'analyse et méthode associée Download PDF

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Publication number
WO2008017819A1
WO2008017819A1 PCT/GB2007/002974 GB2007002974W WO2008017819A1 WO 2008017819 A1 WO2008017819 A1 WO 2008017819A1 GB 2007002974 W GB2007002974 W GB 2007002974W WO 2008017819 A1 WO2008017819 A1 WO 2008017819A1
Authority
WO
WIPO (PCT)
Prior art keywords
indication
electromagnetic radiation
assay device
assay
reader
Prior art date
Application number
PCT/GB2007/002974
Other languages
English (en)
Inventor
Damian Bond
John Gilmour
Andrew Mitchell
Nasr-Eddine Djennati
Paul Couchman
Patricia Connolly
Original Assignee
Ivmd (Uk) Limited
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
Priority claimed from GB0615738A external-priority patent/GB0615738D0/en
Priority claimed from GB0619585A external-priority patent/GB0619585D0/en
Application filed by Ivmd (Uk) Limited filed Critical Ivmd (Uk) Limited
Publication of WO2008017819A1 publication Critical patent/WO2008017819A1/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
    • 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
    • G01N33/54373—Apparatus specially adapted for solid-phase testing involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
    • 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
    • G01N2021/8488—Investigating reagent band the band presenting reference patches
    • 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
    • G01N21/86—Investigating moving sheets
    • G01N2021/8645—Investigating moving sheets using multidetectors, detector array

Definitions

  • ASSAY APPARATUS ASSAY READING APPARATUS AND METHOD
  • the present invention relates to assay apparatus, assay reading apparatus and to a method of reading an assay using such apparatus.
  • the invention is particularly, although not exclusively, concerned with the reading of immunoassays, especially immunoassay strips.
  • Immunoassays are widely used in the medical field to detect the presence and/or concentration of substances of interest in body fluids. They are typically provided in the form of a test strip arranged to provide a visual indication of the results of the assay.
  • a test strip arranged to provide a visual indication of the results of the assay.
  • lateral flow immunoassay in which a test result is indicated by the appearance of a coloured line on a test strip.
  • Such strips are necessarily single use devices and so it is desirable that they can be manufactured at a reasonably low cost, and so that the environmental impact of their disposal is kept to a minimum.
  • a common feature of these devices is the provision of a powered light source to illuminate the test strip or equivalent together and a powered light detector, typically a photodiode, and associated circuitry to read the strip.
  • a powered light source typically illuminates the test strip or equivalent together
  • a powered light detector typically a photodiode
  • associated circuitry to read the strip.
  • This necessitates the provision of a power supply for both the light source and detector, which increases the cost and complexity of the device, and can cause an environmental problem on disposal.
  • provision of a separate reader brings its own technical problems, such as the need for accurate alignment of a test strip with the reader. Thus there is an increased risk of operator error as compared to
  • assay apparatus comprising an assay device arranged to provide an indication of the presence and/or concentration of a substance of interest in a sample, the indication being detectable using electromagnetic radiation, and comprising a device for converting electromagnetic radiation which has been affected by the indication into electrical energy, thereby to quantify any indication produced.
  • a reader for reading an assay device arranged to provide an indication of the presence and/or concentration of a substance of interest in a sample, the indication being detectable using electromagnetic radiation
  • the assay reader comprising a device for converting electromagnetic radiation which has been affected by the indication into electrical energy, thereby to quantify any indication produced.
  • a method of reading an assay device arranged to provide an indication of the presence and/or concentration of a substance of interest in a sample, the indication being detectable using electromagnetic radiation comprising the steps of: directing electromagnetic radiation towards a region of the assay device at which the indication may be provided, collecting the electromagnetic radiation after transmission and/or reflection by the device and converting the collected electromagnetic radiation into electrical energy, thereby to quantify any indication produced by the assay device.
  • Converting electromagnetic radiation into electrical energy as a means of quantifying an indication produced by the assay device significantly reduces the power requirement of the apparatus or method compared to other sensing techniques.
  • the assay device may be an immunoassay device.
  • the indication produced by the device is preferably detectable by electromagnetic radiation in the visible or near visible region of the electromagnetic spectrum.
  • the indication may therefore be a visible one. It could, however, only be detectable by use of near infra red or ultraviolet radiation, and thus be invisible, or substantially so.
  • An advantage of this latter arrangement is that a user would be unable to choose to read the assay device themselves.
  • the indication may result in a change in the way in which incident electromagnetic radiation is absorbed, reflected or refracted by the device, for example a colour change.
  • the device transmits visible electromagnetic radiation and the indication comprises a reduction of the amount of radiation transmitted by a given region of the device.
  • Example suitable assay devices include lateral flow immunoassay devices and devices where it is desired to measure the presence of a fluid, or a wave front or meniscus in a fluid.
  • the assay device may be an immunoassay strip.
  • the device for converting electromagnetic radiation into electrical energy is preferably a photovoltaic cell.
  • the assay device preferably comprises an at least partially transparent to light material and is arranged to produce a visible indication on a surface of and/or within the material.
  • the photovoltaic cell is preferably mounted relative to the assay device such that light transmitted through the device in the region where the indication may be produced enters the photovoltaic cell.
  • a visible indication is produced the proportion of light incident on the device which enters the photovoltaic cell after travelling through the device is altered. This, in turn, affects the output of electrical energy from the photovoltaic cell.
  • the apparatus may be operated using ambient light.
  • a light source may be provided.
  • Preferably means are provided for measuring the output of the photovoltaic cell, and outputting a measurement result to a user.
  • the apparatus is arranged to provide a binary output, for example yes or no.
  • means are provided for determining if the output of the photovoltaic cell is above or below a chosen threshold, and outputting an appropriate result to a user.
  • a second photovoltaic cell is provided at a location where it will not be affected by the indication and the output is compared with the output of the first photovoltaic cell to determine the presence or otherwise of the indication.
  • the second photovoltaic cell serves to provide a reference signal indicative of the ambient light level.
  • the apparatus may include means for determining if the difference between the output of two photovoltaic cells reaches a predetermined value.
  • Any suitable output means can be employed, for example a lamp such as an
  • LED which is illuminated or not illuminated to indicate a yes or no result, or a display screen such as a liquid crystal display (LCD) arranged to display the word YES or NO or some other word or indicia as appropriate.
  • LCD liquid crystal display
  • Any output device can be used as desired.
  • a timing device may be provided to measure a predetermined period of time between introduction of a sample to be tested to the assay device and reading of the device.
  • a sensing means may be provided to determine when a sample is introduced.
  • the sensing means may comprise a pair of electrodes.
  • the assay device may produce more than one indication, and a respective photovoltaic cell may be provided to quantify each indication.
  • the assay device may be arranged to produce a reference indication, to confirm that it is functioning correctly, at least in some respects.
  • the device comprises an elongate strip of material, forming a base, on which an immunoassay strip is mounted.
  • One, two, or three photovoltaic cells are mounted in apertures or transparent regions of the base beneath a chosen region or regions of the immunoassay strip, and arranged to receive light transmitted through the immunoassay strip.
  • One or two photovoltaic cells may be mounted beneath areas of the immunoassay strip where indications may be formed. The indication may comprise a reduction in the light transmitting properties of the strip, or a change in its colour, and may be caused by the build up of a substance in an area of the strip.
  • An additional photovoltaic cell may be mounted beneath an area of the strip where no indication can be formed, in order to provide a reference signal.
  • Figure 1 is a schematic plan view of an immunoassay apparatus according to the invention
  • Figure 2 is a side view of the apparatus of figure 1 ;
  • Figure 3 is a plan view of the base of the apparatus of figure 1 ;
  • Figure 4 is a plan view of the base of figure 4 with the photovoltaic cells removed.
  • Figure 5 is a schematic block circuit diagram of the test strip of figure
  • an immunoassay apparatus comprises a base 1 formed from an elongate substantially rectangular strip of plastics material, for example polystyrene.
  • An elongate immunoassay strip 2 of partially transparent porous material, such as nitrocellulose, is mounted on the base 1, and overhangs one end of the base.
  • the strip 2 stops short of the other end of the base 1, and an LCD display 3 and photovoltaic cell 4 are mounted over an electronic circuit 5 on the remainder of the base 1, to which each are electrically connected.
  • Three, spaced apart, elongate, substantially parallel apertures 6, 7 and 8 are formed in the base 1.
  • a respective matched photovoltaic cell 9, 10, 11 is mounted in each aperture, such that the light receiving part of the photovoltaic cell is directed towards the immunoassay strip 2.
  • Each photovoltaic cell 9, 10, 11 is electrically connected to the circuit 5.
  • the overhanging end of the immunoassay strip 2 is provided with two spaced apart electrodes 12 spaced from the free end of the strip 2 and electrically connected to the electronic circuit 5.
  • the electronic circuit comprises three amplifiers and three low pass filters 13, the output of each photovoltaic cell 9, 10, 11 mounted in the apertures 6, 7, 8 in the base 1 is connected to a respective amplifier and filter.
  • the filters remove any effects of noise pick up, to provide a substantially DC output.
  • the output of each amplifier and filter combination is connected to a logic control circuit 14.
  • the logic control circuit 14 is in turn connected to a timer 15 and to an LCD display driver 16 which drives the LCD display 3.
  • the timer is connected to the electrodes 12 on the immunoassay strip 2.
  • the outputs of the central photovoltaic cell 10 are also connected to a threshold circuit which is, in turn, connected to the logic control circuit 14.
  • the immunoassay strip 2 comprises a first area 18, the sample deposit area, extending from the electrical contacts to the free end of the strip 2. To the other side of the electrical contacts 12 is a central area 19 which extends up to the region of the strip which extends over the aperture 8 in the base 1 nearest the free end of the immunoassay strip 1. The remainder of the immunoassay strip 2 forms a test results area 20.
  • the apparatus is arranged to determine the presence of hCG
  • the sample deposit area 18 is intended to receive a fluid sample for analysis.
  • a urine sample is applied to the free end of the strip 10 and then flows by capillary action towards the test area 20, via the central area 19.
  • the central area 19 of the strip is provided with pre-deposited hCG 21, or an analogue thereof, labelled with colloidal gold tag particles 22 which contain a specific probe for the hCG molecule.
  • colloidal gold tag particles 22 which contain a specific probe for the hCG molecule.
  • the test result area 20 is provided with a line of capture reagent 24, the test line, extending over the aperture 8 nearest the free end of the immunoassay strip 2, and hence its associated photovoltaic cell 11.
  • the capture reagent 24 specifically binds to and captures hCG.
  • tagged hCG complexes which migrate to the test results area will become captured on the test line 24, resulting in a build up of colloidal gold on the test line 24 producing a visible line of colloidal gold on the strip 2, over the photovoltaic cell 11. Formation of the visible line reduces the amount of light which may be transmitted through the strip 2 onto the photovoltaic cell 11.
  • the reference line of another reagent chosen to capture the colloidal gold particles attached to the hCG specific probe, which will be present in any test solution migrating along the test strip.
  • colloidal gold will build up on this line of reagent during use, whether or not hGC is present in a test sample. Appearance of this line thus signifies correct operation of the test strip (at least in some respects), and is a common feature of such strips.
  • the line of reagent 25 is positioned over the aperture 5 in the base 1 closest to the circuit 5 end of the base 1, and its associated photovoltaic cell 9.
  • test 24 and reference 25 lines are narrower than their associated photovoltaic cells 9, 11 allowing for some tolerance is aligning the lines with the photovoltaic cells when manufacturing the apparatus.
  • the immunoassay strip is, save for provision of the electrodes 12, of conventional construction.
  • the purpose of the remainder of the apparatus is to automatically read a test result form the immunoassay strip.
  • Photovoltaic cell 4 Power for the electronic circuit 5 is provided by photovoltaic cell 4. Jn an alternative embodiment the photovoltaic cell could be replaced with a conventional chemical cell or battery, or indeed any other suitable electrical power supply.
  • the apparatus must be exposed to light, either natural or artificial. Light penetrates the immunoassay strip and in the region of the apertures 9, 10, 11 in the base 1 enters the photovoltaic cells, causing them to generate an electrical signal.
  • the logic circuit compares the output of the three photovoltaic cells 9, 10, 11 (amplified and filtered as appropriate) mounted on the base 1 in order to read the results of the test.
  • the output of the first photovoltaic cell 11 will be affected by any build up of colloidal gold on the test line of reagent 24.
  • the output of the second photovoltaic cell 10 will depend only on the level of incident light.
  • the output of the third photovoltaic cell 9 will be affected by the build up of colloidal gold on the reference line of reagent 25.
  • the output signal of the second 10 and third 9 photovoltaic cells are first compared by the logic circuit to determine if there is a build up of colloidal gold along the reference line 25, indicating that the immunoassay strip has functioned correctly.
  • the output of the first 11 and second 10 photovoltaic cells are compared to determine if there is a build up of colloidal gold along the test line 24. If the difference reaches a certain value the outcome of the test is positive, if not the outcome is negative, and the logical circuit causes the word YES or NO to be displayed on the LCD screen as appropriate. Alternatively, if the difference in output signals between the second 10 and third 9 photovoltaic cells does not reach the predetermined value the logic circuit causes the word VOID to be displayed on the LCD screen.
  • the apparatus provides a convenient and economic way to perform and automatically read the result of an immunoassay.
  • Use of photovoltaic cells to measure changes in the level of light transmitted by the immunoassay strip results in a lower power consumption than other approaches, enabling power requirements of the electronic circuit 5 to be met by way of a fourth photovoltaic cell if desired. This allows for reduced cost of manufacture, and lower environmental impact on disposal than for comparable apparatus.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Pathology (AREA)
  • Hematology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

L'invention concerne un appareil d'analyse comprenant un dispositif d'analyse (2) conçu pour fournir une indication sur la présence et/ou la concentration dans un échantillon d'une substance à laquelle on s'intéresse. Cette indication est détectable au moyen d'une radiation électromagnétique et le dispositif d'analyse comprend un dispositif, tel qu'une cellule photovoltaïque (4), destinée à convertir en énergie électrique la radiation électromagnétique qui a été affectée par l'indication recueillie, afin de quantifier toute indication fournie. On peut utiliser la sortie de la cellule photovoltaïque pour fournir un signal de sortie à un utilisateur, en particulier un signal de sortie binaire.
PCT/GB2007/002974 2006-08-08 2007-08-07 appareil d'analyse, appareil de lecture d'analyse et méthode associée WO2008017819A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB0615738.2 2006-08-08
GB0615738A GB0615738D0 (en) 2006-08-08 2006-08-08 Method of determining the presence of substance if interest in fluids
GB0619585A GB0619585D0 (en) 2006-10-04 2006-10-04 Assay apparatus, assay reading apparatus and method
GB0619585.3 2006-10-04

Publications (1)

Publication Number Publication Date
WO2008017819A1 true WO2008017819A1 (fr) 2008-02-14

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2007/002974 WO2008017819A1 (fr) 2006-08-08 2007-08-07 appareil d'analyse, appareil de lecture d'analyse et méthode associée

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WO (1) WO2008017819A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013150306A1 (fr) * 2012-04-04 2013-10-10 Bio Amd Holdings Limited Réseaux de capteurs photovoltaïques

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5171688A (en) * 1988-08-30 1992-12-15 Cholestech Corporation Self-corrected assay device
US5837546A (en) * 1993-08-24 1998-11-17 Metrika, Inc. Electronic assay device and method
US6055060A (en) * 1996-07-16 2000-04-25 Boehringer Mannheim Gmbh Analytical system with means for detecting too small sample volumes
WO2002070734A1 (fr) * 2001-02-28 2002-09-12 Home Diagnostics, Inc. Procede permettant de determiner la concentration d'un analyte dans une bandelette
EP1484613A2 (fr) * 2003-06-04 2004-12-08 Inverness Medical Switzerland GmbH Determination precoce de resultats d'essais

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5171688A (en) * 1988-08-30 1992-12-15 Cholestech Corporation Self-corrected assay device
US5837546A (en) * 1993-08-24 1998-11-17 Metrika, Inc. Electronic assay device and method
US6055060A (en) * 1996-07-16 2000-04-25 Boehringer Mannheim Gmbh Analytical system with means for detecting too small sample volumes
WO2002070734A1 (fr) * 2001-02-28 2002-09-12 Home Diagnostics, Inc. Procede permettant de determiner la concentration d'un analyte dans une bandelette
EP1484613A2 (fr) * 2003-06-04 2004-12-08 Inverness Medical Switzerland GmbH Determination precoce de resultats d'essais

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013150306A1 (fr) * 2012-04-04 2013-10-10 Bio Amd Holdings Limited Réseaux de capteurs photovoltaïques
US20150060642A1 (en) * 2012-04-04 2015-03-05 Bio Amd Holdings Limited Photovoltaic sensor arrays
US10088357B2 (en) 2012-04-04 2018-10-02 Bio Amd Holdings Limited Photovoltaic sensor arrays

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