WO2018002364A1 - Lecteur destiné à un dispositif d'analyse - Google Patents

Lecteur destiné à un dispositif d'analyse Download PDF

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Publication number
WO2018002364A1
WO2018002364A1 PCT/EP2017/066385 EP2017066385W WO2018002364A1 WO 2018002364 A1 WO2018002364 A1 WO 2018002364A1 EP 2017066385 W EP2017066385 W EP 2017066385W WO 2018002364 A1 WO2018002364 A1 WO 2018002364A1
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WO
WIPO (PCT)
Prior art keywords
reader
detector
assay device
light source
channel
Prior art date
Application number
PCT/EP2017/066385
Other languages
English (en)
Inventor
Irwin ARMSTRONG
Original Assignee
CIGA Healthcare 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
Application filed by CIGA Healthcare Limited filed Critical CIGA Healthcare Limited
Priority to GB1901235.0A priority Critical patent/GB2569241B/en
Publication of WO2018002364A1 publication Critical patent/WO2018002364A1/fr

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    • 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 present invention relates to a reader for an assay device, and in particular to a reader for determining the presence and/or amount of one or more analytes in a sample carried by an assay device.
  • An assay device is also known as a test strip, and refers generally to a device on which an assay is performed.
  • Assay devices include lateral flow diagnostic tests, the most recognisable of which is the pregnancy test which measures the presence/amount of the pregnancy hormone human chorionic gonadotropin (hCG) and is widely used in home environments without supervision from a clinician.
  • Other such assay devices include those for measuring the presence of hormones associated with fertility and ovulation, and in particular measure the presence of lutenizing hormone (LH), and estrone-3-glucuronide (E3G).
  • Additional applications of assay devices include measuring cholesterol, cardiac enzymes and infectious diseases.
  • Lateral flow assay devices comprise a porous substrate including a freely mobile specific binding reagent which is coloured or otherwise marked, and an immobilised specific binding reagent which is located in one or more assay result zones on the porous substrate.
  • a liquid sample is introduced to the substrate and the analytes of interest (if present) in the sample bind with the freely mobile specific binding reagent to form a coloured/marked complex, the coloured/marked complex travels to the assay result zones via capillary attraction where it binds with the immobilised specific binding reagent to form a final stationary complex.
  • a user then visually inspects the assay result zones to determine the presence/amount of the final stationary complex such as by comparing the results to a look-up table.
  • Electronic readers typically comprise a housing which is sized to receive assay devices. Optics present in the reader will determine the intensity of the coloured/marked complex present in the assay result zones of the assay device using either transmittance or reflectance measurements. It is important for such readers that the optics are precisely aligned with the assay result zones to ensure that precise measurements are taken. The visible signal formed in the assay result zone is fairly narrow, so a small displacement of the assay result zone relative to the optics may affect the reading. It is generally also important that the optics are as close as possible to the assay device because the signal intensity diminishes rapidly as the separation between the assay device and the optics increases. The user is therefore required to carefully align the assay device and the reader, which can be difficult for an untrained member of the public. If the assay device is incorrectly aligned then the result will potentially be incorrect or misleading.
  • EP 0 833 145 Inverness Medical Switzerland GMBH is one known reader which attempts to overcome the alignment problem highlighted above by only activating the reader when the assay device forms a specific “lock and key” three-dimensional arrangement with the reader.
  • the reader of EP 0 833 145 comprises a flattened oval body with a recess defined therein which includes an elongate slot for receiving the working portion of the assay device.
  • An illumination system is placed behind an optical diffuser in the forward wall of the slot and a series of optical sensors are placed behind a cover on the rear wall of the slot. Projections and actuating switches are positioned on the side walls of the recess and the slot.
  • Corresponding recesses are formed on the assay device to engage with the projections on the reader and help guide the assay device into position in the recess.
  • the actuating switch is only activated when there is precise registration of the various features on the assay device/reader.
  • the present invention provides a reader for determining the presence and/or amount of one or more analytes in a sample carried by an assay device, the reader comprising: at least one light source; and at least one detector arranged to detect light emitted by the at least one light source, the at least one light source and the at least one detector being arranged to define the walls of a channel for receiving at least an end portion of the assay device therethrough, the walls of the channel being adaptable to restrict the lateral displacement of the assay device as it is inserted longitudinally through the channel.
  • the at least one light source and the at least one detector which form the optics of the reader act to guide the assay device by restricting the lateral displacement of the assay device as it is inserted longitudinally through the channel.
  • This enables the assay device to be reproducibly arranged in the correct position with its assay result zone(s) being in lateral alignment with the at least one light source and the at least one detector.
  • the optics of the reader themselves therefore operate to provide the alignment mechanism to guide the assay device into alignment.
  • a separately formed channel having front and rear walls positioned in front of the light source/detector, and various projections is not required, and therefore the problem associated with manufacturing/construction variations in these components is avoided.
  • the present invention provides an intuitive system for the user as they simply have to insert the assay device into the channel with the at least one light source and the at least one detector acting to help ensure lateral alignment. It further reduces the cost and complexity of manufacturing the device by requiring fewer components.
  • the channel being a narrow channel sized to be slightly larger than the assay device which is designed/intended to be inserted therethrough. This means that there is minimum separation between the assay result zone(s) of the assay device and the at least one light source and at least one detector. As such, there is minimal loss of intensity in the signal as it passes from the light source to the assay result zone(s) and from the assay result zone(s) to the detector.
  • the at least one light source being mounted on a circuit board.
  • the at least one detector being mounted on a circuit board.
  • the at least one light source and the at least one detector being mounted on the same circuit board.
  • the relative position of the at least one light source and the at least one detector can be precisely controlled. This helps to precisely align the at least one light source and the at least one detector with the assay result zone(s) on the assay device.
  • the circuit board being a printed circuit board (PCB).
  • PCB printed circuit board
  • the at least one light source and/or the at least one detector being mounted on the circuit board using surface mount technology (SMT).
  • SMT surface mount technology
  • the at least one light source and/or the at least one detector can be mounted on the circuit board using SMT, otherwise known as “pick-and-place” technology. This enables the components to be mounted on the circuit board at high speed and with high precision.
  • the circuit board being arranged to define the base of the channel.
  • the base of the channel being adaptable to restrict the vertical displacement of the assay device as it is inserted longitudinally through the channel.
  • the circuit board forms the base of the channel and acts to restrict the vertical displacement of the assay device to help ensure that the assay result zone(s) of the assay device are in vertical alignment with the at least one light source and the at least one detector. Separate guiding components/projections are not required, and instead the circuit board, light source(s) and detector(s) co-operate to restrict the lateral and vertical displacement of the assay device.
  • the at least one light source being adaptable to emit light in the direction of the at least one detector.
  • the detector detects the light transmitted from the light source and through the assay result zone(s) in the assay device. It therefore operates to measure the transmittance of the sample in the assay device rather than the reflectance.
  • the at least one light source defining a first wall of the channel
  • the at least one detector defining a second wall of the channel opposite to the first wall
  • the first wall and the second wall being spaced apart to receive the assay device therebetween, the at least one light source being adaptable to emit light in the direction of the at least one detector such that light emitted by the at least one light source is able to pass through the assay device and be detectable by the at least one detector.
  • reader determines the presence and/or amount of one or more analytes in a sample carried by an assay device based on the transmittance of the assay device at the assay result zones.
  • the assay result zones will contain light absorbing material at the assay result zones in varying quantities based on the concentration of the one or more analytes at the assay result zones.
  • the source of light emits light at a wavelength which is absorbed by the light absorbing material, and so the intensity of the light detecting at the at least one detector will correspond to the amount of light absorbing material present in the assay result zone.
  • the at least one light source is aligned with the at least one detector.
  • the at least one light source comprises a plurality of light sources and/or the at least one detector comprises a plurality of detectors.
  • the plurality of light sources being arranged to define the first wall of the channel
  • the plurality of detectors being arranged to define the second wall of the channel opposite to the first wall.
  • first wall and second wall of the channel being defined by a mixture of light sources and detectors.
  • the number of light sources correspond to the number of detectors.
  • each light source having an associated detector located on the opposite wall of the channel, the light source being aligned with the associated detector such that light emitted by the light source is detectable by the associated detector.
  • the reader forms a number of light source-detector pairs, with each pair being associated with one of the assay result zone(s) of the assay device.
  • the alignment mechanism provided by the cooperation of the circuit board, light sources and light detectors will help guide the assay device such that the assay result zone(s) are in lateral and vertical alignment with the corresponding light source-detector pair. Therefore, each LED is aligned with the corresponding sensing zone of the lateral flow strip.
  • Each LED can provide controlled high-intensity illumination with fixed wavelength. LEDs with different wavelengths can be used for different sensing zones.
  • individual light sources can be activated separately/independently.
  • the individual light sources can be activated in a predetermined sequence.
  • activating the light sources independently of one another and/or in a predetermined sequence means that effect of interference between different light source-detector pairs can be minimised.
  • the at least one light source comprises a light emitting diode (LED).
  • LED light emitting diode
  • the at least one detector comprises a photodiode, and most preferably a LED detector.
  • the at least one light source comprises a plurality of LEDs
  • the at least one detector comprises a plurality of photodiodes, the plurality of LEDs and the plurality of photodiodes being arranged to form LED-photodiode pairs.
  • the at least one light source comprises a plurality of LED emitters
  • the at least one detector comprises a plurality of LED detectors, the plurality of LED emitters and the plurality of LED detectors being arranged to form LED emitter-detector pairs.
  • LED emitter-detector pairs reduces costs and simplifies the construction of the reader. By using LEDs for both the light sources and the detectors, they can be set with the same solder reflow conditions allowing for the simple and quick attachment of the light sources/detectors to the circuit board using surface mount technology and reflow soldering.
  • the reader further comprising a housing, the at least one light source and the at least one detector being disposed within the housing.
  • the housing surrounds the at least one light source/detector, covering them, and protecting them during normal use.
  • the at least one light source and/or detector being mounted on a circuit board, the circuit board being disposed within the housing.
  • the housing defining an opening sized to receive at least an end portion of the assay device therethrough.
  • the opening in the housing being aligned with the channel. This means that the user can insert the assay device through the opening and through the channel in a single longitudinally advancing movement.
  • the assay device and a surface or surfaces of the opening in the housing are so shaped and dimensioned that the assay device can only be successfully inserted into the reader in an orientation where the assay result zone(s) face the at least one light source and the at least one detector.
  • this provides a simple and low-cost mechanism to help prevent or make it harder for the user to insert the assay device incorrectly.
  • the opening prevents the assay device from being inserted in such a way that the assay result zones are not facing the walls of the channel defined by the light source(s) and detector(s). This prevents the user from inserting the assay device in such a way that no meaningful result would be obtainable.
  • the opening being a narrow aperture or slot sized to be slightly larger than the cross-sectional size of the portion of the assay device to be inserted.
  • the cross-section of the opening is substantially the same shape as the cross-section of the assay device.
  • the opening is formed in an end portion of the housing.
  • the housing is adaptable to restrict the amount by which the assay device is longitudinally inserted through the opening. This means that the assay device is only able to be inserted a certain distance through the opening, preferably such that at the maximally inserted distance the light sources/detectors are aligned with the assay result zones on the assay device.
  • the housing, circuit board, at least one light source and at least one detector cooperate together to align the assay result zones of the assay device with the at least one light source and the at least one detector in lateral, vertical, and longitudinal directions.
  • the housing is adaptable to restrict the amount by which the assay device is longitudinally inserted through the opening by a predetermined distance.
  • the housing further comprises a lipped section surrounding the opening.
  • the lipped section being adaptable to mechanically engage with the assay device once the assay device has been longitudinally inserted through the opening by a predetermined amount.
  • the lipped section comprises cut away portions shaped to receive and mechanically engage with a portion of the assay device once the assay device has been longitudinally inserted through the opening by the predetermined amount.
  • the housing further comprises a mechanism for producing audible and/or tactile feedback to indicate that the assay device has been correctly inserted longitudinally through the channel.
  • the housing comprises a first housing component and a second housing component, the first housing component and the second housing component being adaptable to be attached together.
  • the circuit board is arranged to be sandwiched between the first housing component and the second housing component.
  • first housing component and the second housing component are adaptable to be attached together using a snap fit means.
  • the snap fit means comprises at least one male member depending from the first housing component and at least one correspondingly located and shaped female member on the second housing component.
  • the housing having a cross-section in the form of a triangle, and more preferably in the form of a Reuleaux triangle.
  • the housing having curved or otherwise smooth edges.
  • the reader being adaptable to removably receive the assay device, and most preferably the reader being a reusable reader.
  • This means assay devices can be inserted into the channel and later removed after the measurements have been completed and disposed of.
  • the reader is able to be subsequently used with additional assay devices and is therefore reusable.
  • the reader further comprising a power means for powering the reader.
  • the power means being mounted on the circuit board.
  • the power means being a cell or battery.
  • the power means being a button cell.
  • the power means being a kinetic source or a solar source.
  • the reader further comprising a switch means for activating the power means when the assay device is inserted/being inserted through the channel.
  • a switch means for activating the power means when the assay device is inserted/being inserted through the channel. This means that when the assay device is not in the channel, the power means is not activated and therefore the reader is not powered. This improves the energy efficiency of the reader as it is only activated when the assay device is inserted therethrough. As a result, the operating life of the reader is increased as unnecessary drain on, for example a battery, is avoided.
  • the switch means being adaptable to activate the power means when the assay device is inserted/being inserted through the channel by a predetermined distance.
  • the switch means comprises a mechanical arrangement adaptable to be physically contacted by the end portion of the assay device. This means that the mechanical arrangement is physically contacted by the end portion of the assay device once the assay device has been inserted through the channel by the desired amount.
  • the mechanical arrangement of the switch means being mounted downstream of the at least one light source and at least on detector. This means that the mechanical arrangement of the switch means is physically contacted only once the end portion of the assay device has been inserted all the way through the channel.
  • the switch means comprises a microswitch.
  • the mechanical arrangement of the switch means being a mechanical lever.
  • the switch means is mounted on the circuit board.
  • the reader further comprising a controller for controlling the reader.
  • the controller being adaptable to control the activation of the at least one light source and/or the at least one detector.
  • the controller being adaptable to receive measurement data form the at least one detector.
  • the controller is adaptable to process the measurement data to determine the presence and/or amount of one or more analytes in a sample carried by the assay device.
  • the controller being adaptable to process the measurement data by comparing the measurement data with a calibration look-up table for the one or more analytes.
  • the reader further comprising a storage means, the calibration look-up table being stored in the storage means, more preferably, the storage means being part of the controller.
  • the controller being one of as microcontroller, microprocessor, digital signal processor (DSP), application specific or general application integrated circuit (ASIC), field programmable gate array (FPGA), or other programmable logic device, discrete gate or transistor logic.
  • DSP digital signal processor
  • ASIC application specific or general application integrated circuit
  • FPGA field programmable gate array
  • controller being a microcontroller.
  • the reader further comprising a transmitter for transmitting data to a computing device.
  • the transmitter being integrated with controller.
  • the transmitter being a separate discrete element, preferably mounted on the circuit board.
  • the reader further comprising a receiver for receiving data or the transmitter being a transceiver adaptable to transmit and receive data.
  • the computing device being a mobile computing device such as a mobile phone, smartphone, tablet or wearable computing device such as a smart watch.
  • the transmitter being adaptable to transmit the measurement data to the computing device.
  • the transmitter being adaptable to transmit result data indicative of the presence and/or amount of one or more analytes in a sample carried by the assay device to the computing device.
  • the transmitter being adaptable to wirelessly transmit data to the computing device.
  • the transmitter being configured to wirelessly transmit data using at least one of BluetoothTM (e.g., IEEE 802.15), Low Energy BluetoothTM (e.g., IEEE 802.15.4), near field communication (e.g., ISO/IEC 18000-3 and/or ISO/IEC 14443), wireless LAN (e.g., WiFi IEEE 802.11), and cellular telephone (e.g., 3G, 4G, LTE, etc.) communication protocols.
  • BluetoothTM e.g., IEEE 802.15
  • Low Energy BluetoothTM e.g., IEEE 802.15.4
  • near field communication e.g., ISO/IEC 18000-3 and/or ISO/IEC 14443
  • wireless LAN e.g., WiFi IEEE 802.11
  • cellular telephone e.g., 3G, 4G, LTE, etc.
  • the transmitter being adaptable to transmit data to the computing device using a low energy wireless communication protocol.
  • the transmitter being adaptable to transmit data to the computing device using the Low Energy BluetoothTM communication protocol.
  • a low energy wireless transmission protocol such as Low Energy BluetoothTM reduces the power consumption of the reader.
  • the reader being adaptable to be adaptable to determine the presence and/or amount of one or more body fluid analytes in a sample carried by the assay device.
  • the one or more body fluid analytes comprising one or more of human chorionic gonadotropin (hCG), lutenizing hormone (LH), and estrone-3-glucuronide (E3G).
  • hCG human chorionic gonadotropin
  • LH lutenizing hormone
  • E3G estrone-3-glucuronide
  • the reader being adaptable to determine the presence of more than one analyte.
  • the reader being adaptable for use with more than one kind of assay device.
  • the reader is able to determine the presence of analytes from more than one kind of assay device which could include for example, an assay device suitable for use for hCG measurements and an assay device suitable for E3G measurements.
  • the reader comprising means for determining the type of assay device inserted through the channel.
  • the means for determining the type of assay device comprises means for determining whether a distinctive physical feature is present in the distal end portion of the assay device.
  • the distinctive physical feature being a hole in the assay device or alternatively a protuberance on the assay device.
  • the reader further comprises a status indicating means for indicating to the user the status of the reader.
  • the status indicating means being one or both of a visible or auditory means for indicating the status of the reader.
  • the status indicating means comprising a light source, such as an LED, preferably mounted on the circuit board, the status indicating means being separate from the at least one light source for interrogating the assay device.
  • the housing comprises one or more apertures or transparent sections arranged to accommodate the status indicating means such that the status indicating means are visible to the user.
  • the housing is constructed from a material which is sufficiently thin/translucent that the status indicating means is visible without separate apertures or translucent/transparent windows being required.
  • the reader will be supplied as part of a kit further comprising one or more assay devices adapted to be inserted longitudinally through the channel in the reader.
  • the assay device comprising one or more assay result zones, and preferably more than one assay result zone.
  • the more than one assay result zone comprise a detection zone, control zone and reference zone.
  • the assay device being a lateral flow assay device comprising a porous carrier material having one more assay result zones.
  • the assay device further comprising a protective outer casing which surrounds the porous carrier material.
  • the protective outer casing having apertures aligned with the one or more assay result zones in the porous carrier material such that light transmitted by the at least one light source can pass through the reagent zones and enter the at least one detector.
  • the protective outer casing having apertures aligned with one or more wicking zones on the porous carrier material such that liquid may be introduced to the one or more wicking zones.
  • the assay device comprises an elongate body having a first end portion and a second end portion, the first end portion having the one or more assay result zones, and the second end portion having the one or more wicking zones.
  • the second end portion of the assay device being sized to be larger than the channel in the reader. This means that the second end portion is not able to be inserted into the reader.
  • the assay device further comprises a removable cap adaptable to be positioned over both the first end portion and the second end portion.
  • the assay device comprise a centre portion positioned between the first end portion and the second end portion, the centre portion comprises a recessed portion shaped to permit users to place their thumb into the recessed portion and their forefinger on the bottom of the assay device.
  • the centre portion further comprises one or more projections adaptable to both engage with the removable cap to hold it in place and engage with the cut-away portions formed on the lipped section of the reader to hold the assay device securely in place with the reader.
  • the present invention further provides a method of manufacturing a reader for determining the presence and/or amount of one or more analytes in a sample carried by an assay device, the method comprising:
  • circuit board preferably a printed circuit board (PCB).
  • PCB printed circuit board
  • mounting at least one light source preferably an LED emitter, and at least one detector, preferably a photodiode/LED detector, on the circuit board, the at least one detector being arranged to detect light emitted by the at least one light source, wherein mounting the at least one light source and the at least one detector comprise arranging the at least one light source and the at least one detector to define the walls of a channel for receiving at least an end portion of the assay device therethrough, the walls of the channel being adaptable to restrict the lateral displacement of the assay device as it is inserted longitudinally through the channel.
  • mounting the at least one light source and the at least one detector on the circuit board comprises using surface mount technology (SMT) otherwise known as “pick and place” technology to place the at least one light source and/or at least one detector on the circuit board.
  • SMT surface mount technology
  • mounting the at least one light source and the at least one detector on the circuit board comprises applying solder paste to contact pads on the circuit board; attaching the at least one light source and the at least one detector to the contact pads on the circuit board using surface mount technology; and applying heat to melt the solder paste and form a permanent connection between the circuit board and the at least one light source and the at least one detector.
  • the method further comprises providing a housing; and positioning the circuit board within the housing.
  • providing a housing comprises forming a housing with an opening sized to receive at least an end portion of the assay device therethrough.
  • disposing the circuit board within the housing comprises aligning the opening in the housing with the channel.
  • forming the housing comprises forming a first housing component and a second housing component; placing the circuit board between the first housing component and the second housing component; and attaching the first housing component to the second housing component.
  • attaching the first housing component to the second housing component comprises connecting at least one male member depending from the first housing component to at least one correspondingly located and shaped female member on the second housing component.
  • the method according to the present invention reduces the number of circuit boards required and saves on fabrication/manufacturing cost considering there is a patterning/etch and pick and place process that all require alignment, materials and process steps.
  • the reduction of these steps reduces cost to set up and mass scale production.
  • the costs of manufacture the housing by plastic injection moulding costs simplified and reduced as the housing is limited to a small set of components.
  • Figure 1 is a schematic diagram of certain components in arrangements of the present invention.
  • Figure 2 is a partial perspective view of the assay device being inserted between the light sources and detectors defining the channel;
  • Figure 3 is a partial perspective view of the assay device being fully inserted between the light sources and detectors defining the channel;
  • Figure 4 is an exploded perspective view of the reader according to arrangements of the present invention.
  • Figure 5 is an assembled perspective view of the reader in Figure 4.
  • Figure 6 is a perspective view of an assay device according to arrangements of the present invention with a cap covering the assay result zones leaving the wicking end of the assay device exposed;
  • Figure 7 is another perspective view of the assay device in Figure 6 with the cap covering the wicking end of the assay device leaving the assay result zones exposed;
  • Figure 8 is a flow diagram showing a particular implementation of one embodiment of the present invention.
  • Figure 1 there is shown a schematic diagram of a reader generally indicated by the reference numeral 1 for determining the presence and/or amount of one or more analytes in a sample carried by an assay device 20.
  • the assay device 20 as shown in the drawings is a lateral flow assay device 20 comprising three assay result zones 23.
  • the assay result zones 23 may all be for the same analyte or for different analytes.
  • the assay result zones 23 will contain light absorbing material in varying quantities based on the concentration of the one or more analytes at the assay result zones 23.
  • the assay result zones 23 comprise a detection zone, control zone and reference zone.
  • the specific manner with which the assay result device 20 operates is not critical to the present invention.
  • the reader 1 comprises at least one light source 3 and at least one detector 5 arranged to detect light emitted by the at least one light source 3.
  • the at least one light source 3 emits light at a wavelength which is absorbed by the light absorbing material, and so the intensity of the light detected by the at least one detector 5 will correspond to the amount of light absorbing material present in the assay result zone 23.
  • the at least one light source 3 is shown as three LED emitters 3 to correspond to the three assay result zones 23 on the assay device 20.
  • the at least one detector 5 is shown as three LED detectors 5 to correspond to the three light sources 3 / assay result zones 23.
  • the LED emitters 3 and LED detectors 5 can be considered as forming three LED emitter-detector pairs, with each pair being associated with one of the assay result zones 23.
  • the use of LED emitter-detector pairs reduces costs and simplifies the construction of the reader.
  • the present invention is not limited to the use of LED emitters/detectors, and other types of light sources 3 and detectors 5 are within the scope of the present invention.
  • the lights sources 3 are activated separately/independently and in a predetermined sequence.
  • the light sources 3 and the detectors 5 are arranged to define the walls of a channel for receiving at least an end portion 25 of the assay device 20 therethrough.
  • the walls of the channel restrict the lateral displacement of the assay device 20 as it is inserted longitudinally through the channel.
  • the light sources 3 and detectors 5 guide the assay device 20 by restricting lateral displacement of the assay device 20 as it is inserted longitudinally through the channel.
  • the reader 1 does not require a separately formed channel having front and rear walls positioned in front of the light source/detector or various projections to ensure precise three-dimensional alignment. Therefore the problem associated with manufacturing/construction variations in these components is avoided.
  • the reader 1 provides an intuitive system for the user as they simply have to insert the assay device 20 into the channel with the light sources 3 and detectors 5 acting to help ensure lateral alignment. It further reduces the cost and complexity of manufacturing the reader 1 by requiring fewer components.
  • the reader 1 is able to removably receive the assay device 20 it can function as a reusable reader 1. This means assay devices 20 can be inserted into the channel and later removed after the measurements have been completed and disposed of. The reader 1 is able to be subsequently used with additional assay devices 20.
  • controller 7 for controlling the reader 1, a power device 9 for powering the reader 1, and a switching device for selectively activating the power device 9.
  • the controller 7 can be any suitable hardware unit executing software or firmware instructions such as, but not limited to, microcontrollers, microprocessors, digital signal processors (DSP), application specific or general application integrated circuits (ASIC), field programmable gate arrays (FPGA), or other programmable logic devices, discrete gates or transistor logic.
  • DSP digital signal processors
  • ASIC application specific or general application integrated circuits
  • FPGA field programmable gate arrays
  • the controller 7 is shown as a microcontroller 7.
  • the controller 7 controls the activation of the light sources 3 and detectors 5 and receives measurement data from the detectors 5.
  • the controller 7 is able to process the measurement data to determine the presence and/or amount of one or more analytes in the sample carried by the assay device 20.
  • the controller 7 may perform these processes using known algorithms and by comparing the measurement data to a calibration look-up table or curve for the one or more analytes, which may be stored in a storage area of the controller 7 or on a separate memory device.
  • the reader 1 will be able to determine the presence of more than one type of analyte in assay devices 20.
  • This reader 1 could be, for example, adaptable to measure one or more of human chorionic gonadotropin (hCG), luteinizing hormone (LH), and estrone-3-glucuronide (E3G) so that it can act as both a pregnancy test and/or fertility indicator.
  • the reader 1 can store calibration data for the different analytes in the memory and select the appropriate calibration data to use based on the type of assay device 20 inserted into the reader 1.
  • the reader 1 can comprise a mechanism 55 to determine the type of assay device 20 inserted through the channel.
  • the mechanism 55 can operate by determining whether a distinctive physical feature such as a hole 55 or protuberance 55 is present on the end portion 25 of the assay device 20 or the reader.
  • the hole or protuberance would be added by the manufacturer of the assay device 20 to indicate that it is an assay device for hCG, for example.
  • the controller 7 is able to transmit the result data to a computing device 51 using a transmitter 52 which may be a separate component or an integral part of the controller 7.
  • the reader 1 may further comprise a receiver 53 for receiving data from the computing device 51, or alternatively the transmitter 52 may be a transceiver.
  • the controller 7 includes a built-in transmitter and an antenna 54 that is integrated with the printed circuit board 13.
  • the computing device 51 can comprise a mobile computing device such as a mobile phone, smartphone, tablet or wearable computing device such as a smart watch. This enables the user to view/manipulate the measurement data on their computing device 51. This simplifies the construction of the reader 1, and reduces the cost and drain on the power device, as graphic displays and extensive computational power are not required.
  • the reader 1 will directly transmit the raw measurement data obtained from the detectors 5 to the computing device 51 without performing substantive/any data processing. This arrangement is particularly beneficial as the reader 1 is not be required to store calibration data for multiple different analytes in memory.
  • the computing device 51 would be provided with an application to process the data and display an easy to understand result to the user.
  • the transmitter 52, 54 wirelessly transmits data to the computing device 51 and will generally be configured to be compliant with at least one of BluetoothTM (e.g., IEEE 802.15), Low Energy BluetoothTM (e.g., IEEE 802.15.4), near field communication (e.g., ISO/IEC 18000-3 and/or ISO/IEC 14443), wireless LAN (e.g., WiFi IEEE 802.11), and cellular telephone (e.g., 3G, 4G, LTE, etc.) communication protocols. It is beneficial if the transmitter 52, 54 transmits data to the computing device 51 using a low energy wireless communication protocol, such as the Low Energy BluetoothTM communication protocol. Using a low energy wireless transmission protocol such as Low Energy BluetoothTM reduces the power consumption of the reader 1.
  • BluetoothTM e.g., IEEE 802.15
  • Low Energy BluetoothTM e.g., IEEE 802.15.4
  • near field communication e.g., ISO/IEC 18000-3 and/or ISO/IEC 14443
  • wireless LAN e.g.,
  • the power device 9 is a cell or battery, or alternatively a kinetic or solar source.
  • the switching device 11 operates to activate the power device 9 when the assay device 20 is inserted through the channel. This means that when the assay device 20 is not in the channel, the power device 9 is not activated and therefore the reader 1 is not powered. This improves the energy efficiency of the reader 1 as it is only activated when the assay device 20 is inserted therethrough. As a result, the operating life of the reader 1 is increased as unnecessary drain on the power device 9 is avoided.
  • Figure 2 shows a perspective view of the reader 1 and assay device 20 with the assay device 20 being inserted through the channel defined by the light sources 3 and detectors 5.
  • the light sources 3, detectors 5, power device 9 and switching device 11 are shown mounted on a circuit board 13, which is a printed circuit board (PCB).
  • the microcontroller 7 is not shown in Figure 2 but is mounted on the underside of the circuit board 13 . It will be appreciated that not all of these components have to be mounted on the same circuit board 13, but it is generally preferred in certain advantageous embodiments of the present invention as it simplifies the construction of the reader 1 and reduces costs.
  • mounting the light sources 3 and detectors 5 on the same circuit board 13 means that the relative position of the light sources 3 and the detectors 5 can be precisely controlled, which helps to precisely align the at least one light source 3 and the at least one detector 5 with the assay result zone(s) 23 on the assay device 20.
  • the light sources 3 and detectors 5 are mounted on the circuit board 13 using surface mount technology (SMT), which is otherwise known as “pick-and-place” technology. This means that the light sources 3 and detectors 5 are provided as surface mountable components which can be surface mounted onto contact pads on the circuit board 13 using an SMT assembling machine. This enables the components to be mounted on the circuit board 13 at high speed and with high precision.
  • SMT surface mount technology
  • LEDs are used for both the light sources 3 and the detectors 5, as they can be set with the same solder reflow conditions allowing for the simple and quick attachment of the light sources/detectors to a circuit board using SMT and reflow soldering.
  • the circuit board 13 defines the base of the channel and acts to restrict the vertical displacement of the assay device 20 as it is inserted longitudinally through the channel. This helps to ensure that the assay result zones 23 of the assay device 20 are in vertical alignment with the light sources 3 and detectors 5. Separate guiding components/projections are not required, and instead the circuit board 13, light sources 3 and detectors 5 cooperate to restrict the lateral and vertical displacement of the assay device 20. In use, the cooperation of the circuit board, light sources 3 and light detectors 5 will help guide the assay device 20 such that the assay result zones 23 are in lateral and vertical alignment with the corresponding pair of light sources 3 and detectors 5.
  • the power device 9 is a button cell mounted on the underside of the circuit board 13.
  • the switching device 11 is a microswitch mounted on the circuit board 13 downstream of the light sources 3 and detectors 5 such that the switching device 11 is activated when the end portion 25 of the assay device 20 is inserted/is being inserted through the channel by a predetermined distance.
  • the switching device 11 comprises a mechanical arrangement, such as a mechanical lever adaptable to be physically contacted by the end portion 25 of the assay device 20.
  • Other than mechanical such as electrical, electromagnetic or optical constructions of switching device 11 are within the scope of the present invention.
  • Figure 3 shows the assay device 20 fully inserted through the channel of the reader 1.
  • the three assay result zones 23 are aligned with the three light sources 3 and the three detectors 5.
  • the assay device 20 is not fully inserted through the channel so that the assay device 20 can easily be grasped by the user and pulled out of the channel.
  • the channel is a narrow channel sized to be slightly larger than the assay device 20 which is designed/intended to be inserted therethrough. This means that there is minimum separation between the assay result zones 23 of the assay device 20 and the light sources 3 and detectors 5. As such, there is minimal loss of intensity in the signal as it passes from the light source 3 to the assay result zone(s) 23 and from the assay result zone(s) 23 to the detectors 5.
  • the light sources 3 and detectors 5 are shown as forming separate first and second walls of the channel with the assay device 20 received therebetween.
  • the first wall and second wall of the channel are defined by a mixture of light sources 3 and detectors 5.
  • the first wall of the channel is defined by two light sources 3 and one detector 5 whereas the second wall of the channel is defined by one light source 3 and two detectors 5.
  • the number of light sources 3 will generally correspond to the number of detectors 5, and each light source 3 has an associated detector 5 located on the opposite wall of the channel.
  • the light sources 3 will be aligned with the associated detectors 5 such that light emitted by the light sources 3 are detectable by the associated detectors 5.
  • the light sources 3 emit light through the assay result zones 23 and towards the detectors 5, to therefore measure the transmittance of the sample in the assay device 20.
  • reader 1 determines the presence and/or amount of one or more analytes in a sample carried by the assay device 20 based on the transmittance of the assay device 20 at the assay result zones 23.
  • Figure 4 is an exploded diagram which shows that the reader 1 can further comprises a housing 31, 33 which the at least one light source 3, at least one detector 5, and circuit board 13 and other electronics components can be disposed within.
  • the housing 31, 33 comprises a first housing component 31 and a second housing component 33.
  • the first housing component 31 and the second housing component 33 are attached together to form the completed housing 31, 33 as shown in Figure 5.
  • the circuit board 13 is sandwiched between the housing components 31, 33.
  • the housing components 31, 33 are attached together using a snap fit mechanism which in Figure 4 is shown as being at least one male member 41 provided on the first housing component 31 and at least one correspondingly located and shaped female member 43 on the second housing component 33.
  • the housing 31, 33 has a cross-section in the form of a triangle, or Reuleaux triangle and has curved or otherwise smooth edges. Other shapes and arrangements of housing 31, 33 are within the scope of the present invention.
  • the housing 31, 33 is therefore a two part housing 31, 33 which can be manufactured and constructed in a simple manner.
  • the combination of the two part housing 31, 33 and the single circuit board 13 is particularly advantageous in that it provides a simple and cost effective reader 1 that is still able to provide precise three-dimensional alignment of the assay result zones 23 with the light sources 3, 5.
  • Figure 5 shows the housing components 31, 33 in there attached configuration.
  • the housing 31, 33 surrounds the components disposed within the housing 31, 33, covering them and protecting them during normal use.
  • the housing 31, 33 defines an opening 35 sized to receive at least the end portion 25 of the assay device 20 therethrough.
  • the opening 35 is aligned with the channel such that the user can insert the assay device 20 through the opening 35 and through the channel in a single longitudinally advancing movement.
  • the assay device 20 and a surface or surfaces of the opening 35 in the housing 31, 33 are so shaped and dimensioned that the assay device 20 can only be successfully inserted into the reader 1 in an orientation where the assay result zones 23 face the at least light sources 3 and detectors 5.
  • the opening 35 prevents the assay device 20 from being inserted in such a way that the assay result zones 23 are not facing the walls of the channel defined by the light sources 3 and detectors 5.
  • the opening 35 is shown as a narrow aperture or slot sized to be slightly larger than the cross-sectional size of the portion 25 of the assay device 20 to be inserted.
  • the cross-section of the opening 35 is substantially the same shape as the cross-section of the assay device 20.
  • the opening 35 is formed in an end portion of the housing 31, 33.
  • the housing 31, 33 is adaptable to restrict the amount by which the assay device 20 is longitudinally inserted through the opening 35. This means that the assay device 20 is only able to be inserted a certain, or predetermined, distance through the opening 35, preferably such that at the maximally inserted distance the light sources/detectors 3, 5 are aligned with the assay result zones 23 on the assay device 20.
  • the housing 31, 33, circuit board 13, light sources 3 and detectors 5 cooperate together to align the assay result zones 23 of the assay device 20 with the light sources 3 and detectors 5 in lateral, vertical, and longitudinal directions.
  • the reader 1 is provided with a lipped section 37 which surrounds the opening 35.
  • the lipped section 37 mechanically engages with the assay device 20 once the assay device 20 has been longitudinally inserted through the opening 35 by a predetermined amount.
  • the lipped section 37 comprises cut away portions 39 shaped to receive and mechanically engage with a portion of the assay device 20 once the assay device 20 has been longitudinally inserted through the opening 35 by the predetermined amount. This arrangement helps to hold the assay device 20 firmly in place in the reader 1.
  • the cut away portion 39 is sized to engage with the protruding portions 29 of assay device as detailed in Figure 7.
  • the housing 31, 33 can also comprise a mechanism 56 for producing audible and/or tactile feedback to indicate that the assay device 20 has been correctly inserted longitudinally through the channel.
  • the reader 1 can further comprise a status indicating mechanism 57 for indicating to the user the status of the reader 1.
  • the status indicating mechanism can be one or both of a visible or auditory mechanism for indicating the status of the reader 1 to the user.
  • the status indicating mechanism comprises a light source 57, such as an LED, which is mounted on the circuit board 13. This light source will be separate to the light sources 3 used for interrogating the assay device 20.
  • the light source will, for example, emit light at a certain colour or flash in a certain pattern when the assay device 20 is correctly inserted in the housing, separate colours/patterns may be used to indicate that a measurement is ongoing, and other colours/patterns may be used to indicate that the measurement is complete.
  • the housing 31, 33 may comprise one or more apertures or transparent sections 58 arranged to accommodate the status indicating mechanism 57 such that the emitted light is visible to the user.
  • the housing 31, 33 will be constructed from a material which is sufficiently thin/translucent that the status indicating mechanism is visible without separate apertures or translucent/transparent windows being required.
  • the reader 1 will in some arrangements of the present invention be supplied as a part of a kit comprising one or more assay devices.
  • the reader 1 has a long shelf life which is further held by the switching device 11 which can help to preserve the battery life of the reader 1, and so is suitable for use as a reader 1 which can be reused multiple times with different assay devices 20.
  • a particularly advantageous kit would comprise one reader 1 and around seven or more assay devices 20. Approximately three or four of the assay devices 20 would be for measuring analytes associated with fertility/ovulation while the remainder of the assay devices 20 will be pregnancy tests.
  • the assay device 20 comprises a porous carrier material which is surrounded by a protective outer casing.
  • the assay device 20 has an elongate body and defines a first end portion 25 ( Figure 7) and a second end portion 21 ( Figure 6).
  • the first end portion 25 comprises apertures 22 in the protective outer casing which are aligned with the assay result zones 23 in the porous carrier material such that light transmitted by the light sources 3 can pass through the reagent zones and enter the detectors 5.
  • the second end portion 21 further comprises one or more apertures 122 which allow liquid to be introduced to wicking zones in the porous carrier material.
  • the assay device 20 further comprises a removable cap 27 which is able to be positioned over both the first end portion 25 and the second end portion 21. Further, the assay device comprise a centre portion 26 separates the first end portion 25 from the second end portion 21.
  • the centre portion 26 comprises a recessed portion shaped to permit users to place their thumb into the recessed portion and their forefinger on the bottom of the assay device 20.
  • the centre portion 26 further comprises one or more projections 29 which are able to both engage with the removable cap 27 to hold it in place and engage with the cut-away portions 39 formed on the lipped section 37 of the reader 1 to hold the assay device 20 securely in place with the reader 1.
  • a body fluid such as urine will be introduced to the wicking zones of the assay device via the apertures 122 formed in the second end portion 21 of the assay device.
  • the user will then remove the cap 27 from the first end portion 21 and place it over the second end portion 21 to cover the wicking portion.
  • the first end portion 21 is inserted longitudinally through the opening 35 into the reader 1 until the assay device 20 cannot be inserted any further or audible/tactile feedback is felt by the user.
  • the circuit board 13, light sources 3, detectors 5 and housing 31, 33 will cooperate to guide the assay device 20 such that the assay results zones 23 are in three-dimensional alignment with the light sources 3 and 5.
  • the switching device 11 will activate the power device 9 and therefore power the components of the reader such as the controller 7, light sources 3, detectors 5 and the status indicating mechanism.
  • the controller 7 will initially wait a period of time such as around two minutes to allow for the assay device 20 to completely develop. Once this is completed, the controller 7 will trigger the light sources 3 to emit light towards the assay result zones 23. The emitted light which passes through the assay result zones 23 is detected by the detectors 3 and the resultant data is provided to controller 7.
  • the controller 7 can then either directly process the measurement data or transmit the raw data to a separate computing device. In either event, the data will be processed to determine the presence/amount of one or more analytes, and the results will be displayed to the user on the computing device.
  • the reader 1 coordinates the running of the test and the display of system messages and/or result date with a software application which can be run on a computing device.
  • the user will initially activate the software application such as by clicking/touching an icon on the display of the computing device or by other known methods (Step 701).
  • the software application will direct the user to insert the assay device 20 into the reader 1 (Step 703).
  • the reader 1 Before the assay device 20 is inserted into the reader 1, the reader 1 will be operating in sleep mode (Step 801). Sleep mode will be understood as a mode where the reader 1 minimises power consumption. This can include the reader 1 suspending any data processing, data transmission/retrieval, and light detection/receiving operations.
  • the reader 1 will detect insertion of the assay device 20 as a result of the switching device 11 being activated and will wake up from sleep mode (Step 803).
  • the status indicating mechanism 57 on the reader 1 will indicate to the user that the reader 1 has activated (Step 805). This can include the status indicating mechanism activating a light source/LED.
  • the reader 1 will then perform a calibration test (Step 807), record the calibration test values and update the test threshold values (Step 809).
  • the reader 1 will analyse the results of the calibration test (Step 813) and if the test is successful will enter a waiting mode (Step 813). If the calibration test is unsuccessful, the status indicating mechanism will indicate that there was a problem with the calibration (Step 815) such as by flashing a light source/LED.
  • the reader 1 will wait for a period of time (Step 811), typically 30 seconds, and return to sleep mode (Step 801).
  • the software application will also indicate to the user that there was a problem with the calibration (Step 705) such as by displaying a message that the reader 1 is faulty on the display of the computing device.
  • the reader 1 will measure the time (TE) that the assay device 20 has been inserted into the reader 1 (Step 819). The reader 1 will compare time TE with the threshold value (TI) (Step 821). The reader 1 will determine whether TE is greater than TI (Step 823), and if so will proceed to start strip detection (Step 825). If TE is less than or equal to TI, the reader 1 will return to Step 819.
  • TE time
  • TI threshold value
  • the reader 1 will prompt the software application to request the user indicate the type of test to be performed (Step 707).
  • This can include the software application displaying a message on the display of the computing device with several user selectable icons each associated with a different type of test such as “ovulation test” or “pregnancy test”.
  • the reader 1 measures the time (TS) the assay device 20 has been inserted into the reader 1 (Step 827) and compares TS with a threshold value (TPO) (Step 829). At Step 831, the reader 1 determines whether TS is less than TPO, and if so performs a pregnancy test (Step 835). Otherwise, the reader 1 performs an ovulation test (Step 833).
  • TS time
  • TPO threshold value
  • the reader 1 outlined above can be manufactured according to the following method.
  • the method comprises providing the circuit board 13 and mounting the at least one light source 3 and at least one detectors 5 to the circuit board 13.
  • the step of mounting the at least one light source 3 and the at least one detector 5 comprises arranging the at least one light source 3 and the at least one detector 5 to define the walls of a channel for receiving at least the end portion 25 of the assay device 20 therethrough.
  • the step of mounting may further be performed using SMT to place the at least one light source 3 and/or at least one detector 5 on the circuit board 13.
  • this may comprise applying solder paste to contact pads on the circuit board 13, attaching the at least one light source 3 and the at least one detector 5 to the contact pads on the circuit board 13 using SMT, and applying heat to melt the solder paste and form a permanent connection between the circuit board 13 and the at least one light source 3 and the at least one detector 5.
  • the method further comprises providing the housing 31, 33 and positioning the circuit board 13 within the housing 31, 33.
  • the step of providing the housing 31, 33 comprises forming the housing 31, 33 with the opening 35 sized to receive at least an end portion 21 of the assay device 20 therethrough.
  • Positioning the circuit board 13 within the housing 31, 33 comprises aligning the opening 35 in the housing 31, 33 with the channel.
  • the step of forming the housing 31, 33 comprises forming the first housing component 31 and the second housing component 33, placing the circuit board 13 between the first housing component 31 and the second housing component 33, and attaching the first housing component 31 to the second housing component 33. Attaching the first housing component 31 to the second housing component 33 comprises connecting at least one male member 3

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  • 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 Optical Means (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)

Abstract

L'invention concerne un lecteur destiné à déterminer la présence et/ou la quantité d'un ou de plusieurs analytes dans un échantillon supporté par un dispositif d'analyse. Le lecteur comporte au moins une source de lumière ; et au moins un détecteur agencé pour détecter la lumière émise par ladite source de lumière, ladite source de lumière et ledit détecteur étant agencés pour délimiter les parois d'un canal destiné à recevoir au moins une partie d'extrémité du dispositif d'analyse. Les parois du canal peuvent être conçues pour limiter le déplacement latéral du dispositif d'analyse lorsqu'il est introduit longitudinalement à travers le canal.
PCT/EP2017/066385 2016-06-30 2017-06-30 Lecteur destiné à un dispositif d'analyse WO2018002364A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB1901235.0A GB2569241B (en) 2016-06-30 2017-06-30 A reader for an assay device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1611502.4A GB201611502D0 (en) 2016-06-30 2016-06-30 A reader for an assay device
GB1611502.4 2016-06-30

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WO2018002364A1 true WO2018002364A1 (fr) 2018-01-04

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WO (1) WO2018002364A1 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4305058A1 (de) * 1993-02-19 1994-08-25 Boehringer Mannheim Gmbh Testträger-Analysesystem zur Analyse eines Bestandteils einer flüssigen Probe
EP0833145A1 (fr) 1996-09-27 1998-04-01 Unilever Plc Ensemble de test et dispositifs
US6707554B1 (en) * 1998-09-29 2004-03-16 Roche Diagnostics Gmbh Method for the photometric analysis of test elements
EP1484601A2 (fr) * 2003-06-04 2004-12-08 Inverness Medical Switzerland GmbH Arrangement optique pour un lecteur de test
GB2445187A (en) * 2006-12-29 2008-07-02 Mologic Ltd Diagnostic test device
US20110253224A1 (en) * 2010-04-16 2011-10-20 Claros Diagnostics, Inc. Feedback control in microfluidic systems
EP2615453A2 (fr) * 2010-09-10 2013-07-17 Ceragem Medisys Inc. Appareil de mesure
US20150068923A1 (en) * 2013-09-12 2015-03-12 Joinsoon Medical Technology Co., Ltd. Biosensor monitors, test strips and activation mechanisms and methods thereof
GB2523135A (en) * 2014-02-13 2015-08-19 Molecular Vision Ltd Assay device
WO2015168515A1 (fr) * 2014-05-01 2015-11-05 Arizona Board Of Regents On Behalf Of Arizona State University Biocapteur optique flexible pour détection de multiples pathogènes au point d'utilisation

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7141212B2 (en) * 1993-11-12 2006-11-28 Inverness Medical Switzerland Gmbh Reading devices and assay devices for use therewith

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4305058A1 (de) * 1993-02-19 1994-08-25 Boehringer Mannheim Gmbh Testträger-Analysesystem zur Analyse eines Bestandteils einer flüssigen Probe
EP0833145A1 (fr) 1996-09-27 1998-04-01 Unilever Plc Ensemble de test et dispositifs
US6707554B1 (en) * 1998-09-29 2004-03-16 Roche Diagnostics Gmbh Method for the photometric analysis of test elements
EP1484601A2 (fr) * 2003-06-04 2004-12-08 Inverness Medical Switzerland GmbH Arrangement optique pour un lecteur de test
GB2445187A (en) * 2006-12-29 2008-07-02 Mologic Ltd Diagnostic test device
US20110253224A1 (en) * 2010-04-16 2011-10-20 Claros Diagnostics, Inc. Feedback control in microfluidic systems
EP2615453A2 (fr) * 2010-09-10 2013-07-17 Ceragem Medisys Inc. Appareil de mesure
US20150068923A1 (en) * 2013-09-12 2015-03-12 Joinsoon Medical Technology Co., Ltd. Biosensor monitors, test strips and activation mechanisms and methods thereof
GB2523135A (en) * 2014-02-13 2015-08-19 Molecular Vision Ltd Assay device
WO2015168515A1 (fr) * 2014-05-01 2015-11-05 Arizona Board Of Regents On Behalf Of Arizona State University Biocapteur optique flexible pour détection de multiples pathogènes au point d'utilisation

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GB2569241A (en) 2019-06-12
GB201611502D0 (en) 2016-08-17
GB201901235D0 (en) 2019-03-20

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