WO2014051425A1 - Test strip reading device and method for reading a test strip - Google Patents

Test strip reading device and method for reading a test strip Download PDF

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Publication number
WO2014051425A1
WO2014051425A1 PCT/NL2013/050683 NL2013050683W WO2014051425A1 WO 2014051425 A1 WO2014051425 A1 WO 2014051425A1 NL 2013050683 W NL2013050683 W NL 2013050683W WO 2014051425 A1 WO2014051425 A1 WO 2014051425A1
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WO
WIPO (PCT)
Prior art keywords
test strip
slit
electronic device
processing unit
holding
Prior art date
Application number
PCT/NL2013/050683
Other languages
French (fr)
Inventor
Pierre Tesseraud
Mylène Patrice Dominique CAUSSETTE
Giuseppe PIZZOCRI
Didier Marcel Anne-Marie BOELENS
Original Assignee
Dsm Ip Assets B.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 Dsm Ip Assets B.V. filed Critical Dsm Ip Assets B.V.
Publication of WO2014051425A1 publication Critical patent/WO2014051425A1/en

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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 present invention relates to an electronic device for reading a test strip. Also the present invention relates to a method for reading test strip.
  • test strips for testing the presence of an analyte in a fluid are well known in the art.
  • a test strip comprises a carrier strip and a indicator region with one or more reactive surface layers on the carrier strip, wherein the one or more reactive surface layers comprise agent(s) that display a change of their chemical or physical state when exposed to a fluid that may contain the analyte being tested.
  • a change of chemical or physical state involves an optical change of the indicator region (i.e. the surface of the exposed part) of the test strip for example a change of color, reflectance, scattering, emissivity, or absorbance.
  • an electronic device for analysis of a fluid by means of a test strip with an indicator surface holding a reactive surface region comprising: a processing unit, memory, display means, receiving means for a test strip,
  • the processing unit being coupled to the memory and to the display means, the optical detector being arranged in the receiving means and coupled to the processing unit;
  • the casing comprises a slit on a surface of the casing, the slit having first and second side walls and a bottom wall, the first and second side wall being opposite and parallel to each other with the bottom wall surface facing towards the opening of the slit;
  • the slit being arranged for receiving the test strip in a transverse direction with respect to the length of the test strip, the first side wall surface of the slit being arranged as a support surface for supporting in use an longitudinal edge of the test strip;
  • the optical detector being arranged in the first side wall of the slit for detecting an optical state of the reactive surface region of the test strip, and the electronic device is provided with holding means for holding the test strip within the slit and for pressing the indicator surface against the first side wall.
  • this electronic device provides a relatively quick and reliable manner for inserting a test strip.
  • This arrangement improves the positioning of the strip in the slit and also assists in guiding the test strip through the slit.
  • the invention relates to an electronic device as described above, wherein the holding means is a resilient flap within the slit, attached to the casing and moveable toward the first side wall.
  • the invention relates to an electronic device as described above, wherein the holding means comprise a flexible support structure for holding test strip, the support structure comprising two upward notches each running parallel to the length of the slit, and being arranged to create a holding space between them for taking up the test strip.
  • This structure advantageously prevents transverse movement of the test strip while inserted in the electronic device.
  • the invention relates to an electronic device as described above, wherein the upward notch adjacent to the opening of the slit has a rounded outer rim at the side of the opening of the slit.
  • the rounded rim assists during the insertion of the test strip in the electronic device.
  • the invention relates to an electronic device as described above, wherein the support structure is flexibly attached to the casing over a flexible beam portion.
  • the invention relates to an electronic device as described above, wherein the slit comprises openings at each of its longitudinal ends, in such a way that the test strip can be slideably moved along its longitudinal direction through the slit.
  • the openings allow sliding of the test strip along its length through the slit.
  • the complete surface of the test strip is allowed to pass under a single optical detector. This allows a relatively simple set-up of the detector arrangement of the electronic device.
  • the invention relates to an electronic device as described above, wherein the optical detector is arranged in the first side wall adjacent to one of the longitudinal ends of the slit.
  • the invention relates to an electronic device as described above, wherein the optical detector comprises a single photodetector and illumination means, wherein the illumination means are arranged adjacent to the photodetector, in such a way that in use when the test strip is received in the slit, the illumination means light the indicator surface of the test strip.
  • the invention relates to an electronic device as described above, wherein the illumination means comprise at least one LED arranged adjacent to the photodetector in the longitudinal direction of the slit.
  • the invention relates to an electronic device as described above, wherein the photodetector is positioned intermediate a pair of LEDs.
  • the invention relates to an electronic device as described above, wherein the first side wall comprises a transparent window portion at the location of the optical detector.
  • the invention relates to an electronic device as described above, further comprising a sensor or switch which is coupled to the processing unit and is arranged within the slit for detecting a presence of the test strip so as to power on the electronic device when the test strip is present.
  • the sensor or switch can control the power consumption of the electronic device.
  • the optical detector is arranged as a sensor to detect a presence of the test strip.
  • the optical detector then operates in a pulsed mode while the illumination means are yet inactive. If in this mode a test strip is detected by the detector, the electronic device is arranged to activate the illumination means to initiate measuring the optical state of the indicator region of the test strip.
  • the invention relates to an electronic device as described above, wherein the sensing device is arranged for identifying the test strip by reading information from an information holding region on the test strip.
  • identifying the test strip can be used to prevent use of incompatible test strips.
  • the invention relates to an electronic device as described above, wherein the sensing device comprises a barcode reader arranged for reading barcode information from the test strip.
  • the invention relates to an electronic device as described above, wherein the sensing device comprises a wireless reader arranged for reading information from a wirelessly readable tag or chip that is embedded or attached to the test strip.
  • the invention relates to an electronic device as described above, wherein the processing unit is arranged for evaluating the information from the sensing device, e.g. by comparison with predetermined data, and for activating the electronic device for operation.
  • the invention relates to an electronic device as described above, wherein the processing unit is arranged to calculate a test result signal based on the optical state of the reactive surface region of the test strip as detected by the optical detector, and the processing unit is arranged to generate an output result signal based on the test result signal to the display means.
  • the invention relates to an electronic device as described above, wherein the output result signal is a two-state signal, having a result value indicating either a positive or a negative result of the analysis.
  • this embodiment provides a test result that can be interpreted directly.
  • the invention relates to an electronic device as described above, wherein the display means comprise one or more LEDs for indicating the output result signal.
  • the invention relates to an electronic device as described above, wherein the display means comprise an audio generator for generating an audio signal associated with the output result signal.
  • the invention relates to an electronic device as described above, further comprising output means arranged for transmitting the output result signal electronically or electromagnetically.
  • the invention relates to an electronic device as described above, wherein the output means comprises an electric interface for transmitting the output result signal in a wired mode.
  • the invention relates to an electronic device as described above, wherein the output means comprises a radio interface for transmitting the output result signal in a wireless mode.
  • the invention relates to an electronic device as described above, wherein the radio interface comprises one or more of a Wi-Fi interface, a Bluetooth interface or a Near Field (NFC) radio interface.
  • the radio interface comprises one or more of a Wi-Fi interface, a Bluetooth interface or a Near Field (NFC) radio interface.
  • the invention relates to an electronic device as described above, wherein the indicator surface of the test strip comprises at least two reactive surface regions, and the processing unit is arranged to determine the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is measured while the test strip is being moved along the optical detector in the slit.
  • the invention relates to an electronic device as described above, wherein the optical state of the reactive surface region is one selected from a group comprising absorption, emissivity, scattering, or reflectance of the respective reactive surface region.
  • the invention relates to an electronic device as described above, wherein the processing unit is arranged to determine the test result signal based on the difference between the optical state of each of the at least two reactive surface regions.
  • the invention relates to an electronic device as described above, wherein the processing unit is arranged to add a code stamp to the output result signal.
  • the invention relates to an electronic device as described above, wherein the code stamp comprises one or more of an identifier code, a location code, a (serial) number.
  • the invention relates to an electronic device as described above, further comprising a timer which is coupled to the processing unit, and the processing unit is arranged to derive a time code from the timer and to add a time stamp to the output result signal.
  • the invention relates to an electronic device as described above, wherein the processing unit is arranged for storing the output result signal in the memory.
  • the invention relates to an electronic device as described above, wherein the processing unit is arranged to read a stored output result signal from the memory.
  • the invention relates to an electronic device as described above, wherein the processing unit is arranged to control the transmission of the output result signal by the output means.
  • the invention relates to an electronic device as described above, wherein the one or more reactive surface regions of the test strip comprise a substance for determining an analyte in a liquid.
  • the invention relates to an electronic device as described above, wherein the analyte is an antibiotic substance and the liquid is a dairy related fluid.
  • the invention relates to a method for analysis of a fluid by means of a test strip with an indicator surface holding at least one reactive surface region and by an electronic device as described above; the method comprising:
  • the invention relates to a method as described above, further comprising: - activating the operation of the electronic device during or after insertion of the test strip. In an embodiment, the invention relates to a method as described above, further comprising:
  • the invention relates to a method as described above, wherein the operation of the electronic device is controlled by the processing unit of the electronic device.
  • the invention relates to a method as described above, wherein the processing unit calculates a test result signal based on the optical state of the at least one reactive surface region of the test strip as detected by the optical detector.
  • the invention relates to a method as described above, wherein the processing unit compares the peak intensities, and determines from this comparison a presence of an analyte in the fluid being tested.
  • the invention relates to a method as described above, wherein the test strip comprises at least two reactive surface regions, and the processing unit determines the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit.
  • the invention relates to a method as described above, further comprising that the processing unit determines the test result signal based on a difference between the optical state of each of the at least two reactive surface regions.
  • the invention relates to use of an electronic device as described above for determining the presence of an analyte in a fluid.
  • the invention relates to a kit of parts for analysis of a fluid comprising a test strip with an indicator surface holding a reactive surface region and an electronic device as described above.
  • Figure 1 shows a schematic layout of a circuit of the electronic device according to an embodiment of the invention
  • Figure 2 shows schematically a test strip compatible with the electronic device according to the invention
  • Figures 3 a, 3b shows perspective views of an electronic device for reading a test strip according to an embodiment of the invention
  • Figures 4a, 4b, 4c show a cross-sectional view of the electronic device for reading a test strip
  • Figures 5a, 5b, 5c, 5d show an electronic device for reading a test strip according to an embodiment of the invention
  • Figures 6a - 6c show arrangements of the test strip and the electronic device during a procedure for reading the test strip
  • Figures 7a, 7b show a cross-sectional view of the electronic device for reading a test strip
  • Figure 8 shows a schematic curve of a temporal signal measurable by the electronic device
  • Figure 9 shows a flow diagram of a measurement procedure for the electronic device in accordance with the invention.
  • Figure 1 shows a schematic layout of a circuit of an electronic device according to an embodiment of the invention.
  • the electronic device 1 comprises a processing unit
  • the processing unit is coupled to a detector 20 for receiving data obtained by the detector 20.
  • the detector is arranged for sensing an optical state of a indicator region of a test strip, when such a test strip is brought in a detection region of the detector.
  • the detector 20 may be either a digital or an analog detecting device. In the latter case, the detector 20 may be coupled to the processing unit 10 through a analog-to-digital converter (not shown).
  • the processing unit 10 is coupled to the memory 30 for storing and retrieving data. In an embodiment, the processing unit is arranged for storing and retrieving data obtained by the detector 20 to and from the memory 30.
  • the processing unit 10 is coupled to display means 40, wherein the display means are arranged to indicate a value calculated by the processing unit in conjunction with the optical state of the indicator region of the test strip.
  • the display means 40 can be an alphanumeric display.
  • the display means 40 comprise at least one LED (light emitting diode) for indicating the output result signal.
  • such a LED is a multi-color LED.
  • the at least one LED is a red/green multi-color or the at least one LED comprises a red LED and a green LED.
  • the at least one LED is arranged to provide one signal (e.g. red signal) to indicate the presence of the analyte in the fluid (i.e. antibiotic in milk) and another signal (e.g. green signal) to indicate absence of the analyte in the fluid.
  • the electronic device may comprise a sensing device 50 that is coupled to the processing unit 10.
  • the sensing device is arranged for sensing the presence of the test strip near the detector and functions as a switch for
  • the sensing device may additionally or alternatively be arranged for identifying the test strip.
  • the sensing device 50 comprises a reader arranged for reading visual information from a test strip.
  • the sensing device 50 comprises a barcode reader arranged for reading barcode information from the test strip.
  • the sensing device 50 comprises a wireless reader
  • the processing unit evaluates the information, e.g. by comparison with predetermined data. Based on the information and the comparison, the processing unit can activate or release the electronic device 1 for operation.
  • the optical detector is arranged as sensor to detect a presence of the test strip.
  • the optical detector then operates in a pulsed mode while the illumination means are yet inactive. If in this mode a presence of a test strip is detected by the detector, the electronic device is arranged to activate the illumination means to initiate measuring the optical state of the indicator region of the test strip.
  • the electronic device comprises a
  • Such output means are arranged for transmitting output signals electronically or electromagnetically.
  • the communication device 60 is arranged for at least transmitting data from the processing unit 10 to an external electronic unit (not shown).
  • the communication device 60 can be arranged for either wired or wireless communications to the external unit.
  • the communication device comprises an electric interface for transmitting the output result signal in a wireless mode.
  • Such an electric interface relates to a radio interface that may comprise one or more of a mobile telecom interface, a Wi-Fi interface, a Bluetooth interface or a Near Field (NFC) radio interface.
  • the communication device comprises an electric interface for transmitting the output result signal in a wired mode: interfaces of this type including serial communication by using one or more from USB, RS232 may also be available on the electronic device.
  • the processing unit 10 is arranged to receive data from the detector 20.
  • the data are obtained by the detector 20 by sensing the optical state of a indicator region of a test strip, that has been exposed to a fluid for testing the presence of an analyte in the fluid.
  • the processing unit 10 Upon reception of the data from the detector 20, the processing unit 10 is arranged to determine the presence of the analyte in the fluid from the received detector data. In an embodiment, the processing unit is arranged to calculate a value associated with the observed optical state of the indicator region of the test strip. Next, the processing unit 10 is capable of comparing the calculated value with a reference or threshold value and of generating an indicating signal on the presence of the analyte based on the comparison. The processing unit is arranged to output the indicating signal to the display means 40. Below, an embodiment for the determination of the presence of analyte by the processing unit 10 will be explained in more detail with reference to figures 8 and 9.
  • FIG. 2 shows a perspective view of a test strip 300 compatible for use with the electronic device 1 according to the invention.
  • the test strip 300 comprises an elongated base layer 302 as carrier strip.
  • the base layer may be made of a plastic, either thermoplastic or thermosetting.
  • the base layer material may be (plasticized or coated) paper, (plasticized or coated) cardboard, metal, or any other material suitable for making base layers of test strips.
  • test strip 300 On a surface of the base layer 302, the test strip 300 comprises on an end region
  • an indicator region surface 304 which includes one or more reactive surface layers on the base layer.
  • These one or more reactive surface layers comprise specific agent(s) of which a chemical or physical state changes when exposed to a fluid that contains an analyte to be detected, i.e. the one or more indicator regions of the test strip comprise a substance for determining an analyte in the fluid.
  • the reactive surface layers may be located adjacent to each other on the base layer.
  • the reactive surface layers may be stacked.
  • the fluid to be tested is transported by capillary forces through the reactive surface layers.
  • the base layer 302 may comprise markings 308, 309 for positioning the test strip in the electronic device 1.
  • the markings 308, 309 may be visual lines on the surface of the base layer. Alternatively, or additionally, the markings may comprise indents or ribs or steps in the surface of the base layer.
  • the indicator region 304 comprises a reference (control) region 304a and an measuring (detection) region 304b.
  • the reference region 304a is arranged to indicate whether the strip functions correctly and/or whether the strip has been treated correctly by a user.
  • the measuring region 304b is arranged to indicate a result associated with a presence of the analyte in the fluid that is tested.
  • the reference region is located closer to marking 309 than the measuring region.
  • the strip comprises a plurality of reference regions 304a and/or a plurality of measuring regions 304b.
  • the test strip comprises first and second liquid storage volumes 310, 311 that are arranged on two opposite ends of the indicator region 304 to provide capillary transport of the fluid to be tested through the indicator region 304.
  • the first and second storage volumes 310, 311 are embodied by sponge bodies (or pads).
  • One sponge body 310 is arranged at a distal tip 305 of the test strip, which is arranged to be immersed in the fluid to be tested.
  • the other sponge body 31 1 is located near the proximal end 302 of the test strip and is arranged to take in fluid to assist the movement of the fluid from the first sponge body 310 through the indicator region 304.
  • the edges of the sponges facing towards the indicator region 304 may be used as markings for positioning the test strip in the electronic device.
  • test strip may be arranged with an information holding region 312.
  • information holding region is a surface arranged for holding visual information containing symbols or a barcode.
  • the information holding region is located on the surface opposite the surface holding the indicator region 304.
  • the information holding region 312 is arranged to hold an electronic tag, such as an RFID tag (not shown).
  • the tag can either be attached to the surface of the information holding region or be embedded below this surface.
  • the electronic device 1 uses a test strip as disclosed in international patent application PCT/EP2012/067944,
  • PCT/EP2012/067945 PCT/EP2012/067946, and/or PCT/EP2012/067948.
  • Figures 3 a, 3b shows perspective views of an electronic device for reading a test strip according to an embodiment of the invention.
  • the electronic device 1 is incorporated in a casing 70 which in an embodiment has a rectangular shape.
  • the electronic device 1 has a length between about 2 cm and 10 cm, a width between about 1cm and 5cm and a height between a few (about 5) millimeters and about 1 cm.
  • a surface 80 of the casing 70 comprises a slit 100.
  • the slit 100 has first and second side walls 110, 114 and a bottom wall 112.
  • the first and second side walls 110, 114 are arranged opposite and parallel to each other.
  • the bottom surface 112 faces towards the opening of the slit 100, is preferably perpendicular to the first and second side walls.
  • the slit 100 is arranged for receiving the test strip in a transverse direction with respect to the length of the test strip.
  • the second side wall surface 114 of the slit 100 is arranged as a supporting surface for supporting in use a longitudinal edge of the test strip.
  • the base layer (back) surface of the test strip is placed on the supporting second side wall surface 114, while the indicator region of the test strip faces towards the first side wall 110.
  • the optical detector 20 is arranged in the casing 70 near the first side wall of the slit to be capable to sense an optical state of the indicator region of the test strip, associated with the chemical or physical state of the agent(s).
  • the first side wall 110 is arranged with a transparent viewing window 120 at the location of the optical detector 20 such that the test strip and its indicator region are exposed to the detecting region of the detector 20.
  • the viewing window 120 is
  • the viewing window 120 comprises a transparent surface area.
  • a window 40' may be arranged to allow a user to view the display means 40.
  • the display means are arranged in a portion of the surface 80 that is comprising the slit.
  • the slit 100 comprises openings 116 at each of its longitudinal ends, in such a way that the test strip can be slideably moved along its longitudinal direction through the slit.
  • the sliding of the strip in the longitudinal direction through the slit allows to use a single detector while a detection of the surface of the test strip can done over a relatively large length of the test strip. This is in particular useful when the test strip has two or more indicator regions adjacent to each other. Also, the sliding of such a test strip with two or more adjacent indicator regions over a single detector 20 provides the capability to compare the optical state of these two or more indicator regions.
  • the optical detector is arranged in the first side wall adjacent to one of the longitudinal ends of the slit.
  • the casing 70 also comprises a power source (not shown), such as a (re-chargeable) battery or an external power supply.
  • a power source such as a (re-chargeable) battery or an external power supply.
  • the sensing device 50 as described above is shown as arranged in the side wall 114 opposite the detector 20, but alternatively the sensing device 50 may be located in the same side wall 110 as the detector 20.
  • the sensing device 50 may be integrated with the detector or the detector 20 may be arranged to have the capabilities of the afore mentioned sensing device 50.
  • Figures 4a, 4b, 4c show a cross-sectional view of the electronic device for reading a test strip.
  • the casing 70 of the electronic device 1 is provided with holding means for holding the test strip and for pressing the indicator region against the first side wall.
  • the holding means advantageously provide that after placing the test strip in the slit 100, the test strip is secured within the slit during the measurement by the electronic device 1.
  • the holding means is a resilient flap 130 within the slit, attached to the second side wall 114 and moveable toward the first side wall 110.
  • FIG 4c an alternative holding means is shown which comprises a spring 140 attached to the second side wall 114 and pressing toward the first side wall 110.
  • a (micro) switch that acts as sensing device 50 for sensing the presence of the test strip in the slit is located within the slit 100.
  • the switch is coupled to the electronic device 1 for activating or deactivating the electronic device when the test strip is respectively inserted in and removed from the slit 100.
  • sensors such as a proximity sensor, such as a wireless tag reader, or an optical sensor, such as a barcode reader, could be used as sensing device 50.
  • the sensing device 50 as described above is located in the side wall 114 opposite the detector 20, but alternatively the sensing device 50 may be located in the same side wall 110 as the detector 20.
  • Figures 5a, 5b, 5c, 5d show details of an electronic device for reading a test strip according to an embodiment.
  • Figure 5a shows a perspective view of the electronic device 1.
  • a flexible or resilient support structure 150 as holding means is located within the slit 100 of the casing 70.
  • FIG 5b a cross-section of the flexible support structure 150 is shown.
  • the support structure comprises a holding space 151 arranged as holding means for holding an inserted test strip.
  • the inserted test strip is oriented in a manner that the indicator region 304 faces towards the detector 20, that is arranged in the casing 70 near the first side wall of the slit.
  • the support structure 150 comprises two upward notches 152, 153 that run parallel to the length of the slit and that are arranged to create the holding space 151 between them for taking up the test strip 300.
  • the notches are arranged to prevent the test strip to move transversely.
  • One notch 152 is arranged adjacent the opening of the slit 100.
  • the outer rim of this notch at the side of the opening of the slit may be rounded to allow flexibility of the support structure by bending downwards; the upward notch adjacent to the opening of the slit has a rounded outer rim at the side of the opening of the slit. This allows easy insertion of the test strip transversely in the slit.
  • the other notch 153 is arranged internally and has the function to stop the test strip being inserted.
  • Figure 5c shows a cross-sectional view of the electronic device 1, while the support structure 150 is in a position bent downwards during insertion of a test strip 300 in transverse direction.
  • the support structure 150 is flexibly attached over a flexible beam (portion) 154 to the lower part of the casing 70 by a connection, which may be for example a screw connection 155, 156.
  • a connection which may be for example a screw connection 155, 156.
  • Other connections between the casing and the support structure are also conceivable.
  • Figure 5d shows a cross-sectional view of the electronic device 1, while the support structure 150 holds a test strip 300 adjacent the first side wall 110.
  • Figure 6a - 6c shows arrangements of the test strip 300 and the electronic device 1 during a procedure for reading the test strip.
  • test strip 300 After the test strip 300 has been exposed to a fluid which may contain the analyte to be detected, the test strip indicates if analyte is present or absent in the fluid to be analyzed and the result (signal) of the test strip can be detected by the electronic device.
  • the test strip 300 is held separately from the electronic device 1, ready to be inserted into the slit 100 of the electronic device 1.
  • the inserting direction PI is substantially transverse to the length of the test strip 300, in such a way that the slit 100 receives the test strip 300 in a transverse direction with respect to the length of the test strip.
  • the markings 308, 309 and/or the liquid storage volumes 310, 311 of the test strip 300 are aligned with the casing 70 (or markings on the casing) of the electronic device so as to ensure a correct position of the indicator region 304 in the slit 100 of the electronic device 1 relative to the position of the detector 20 arranged in the slit 100.
  • the holding means 130; 140; 150 move to allow the test strip 300 to enter the slit.
  • the holding means 130; 140; 150 are biased to press the surface of the test strip 300 holding the indicator regions to the first side wall surface 110 of the slit.
  • the test strip end region 305 extends at an end of the slit.
  • the test strip end 302 may extend at the opposite end of the slit.
  • test strip 300 is shown in its inserted position in the electronic device 1.
  • the electronic device 1 is activated either manually by the user or in an embodiment by the sensing device 50 for sensing the presence of the test strip in the slit.
  • the electronic device 1 may indicate that it is activated (or powered on) and ready for reading the test strip.
  • the indication that the electronic device is ready may be shown by the display means 40.
  • the user can now move the test strip 300 through the slit along the longitudinal direction of the slit as indicated by arrow P2. During this action, the test strip moves through the slit substantially parallel to the surface 80 in which the slit 100 is located.
  • the holding means 130; 140; 150 press the test strip 300 to the first side wall surface of the slit.
  • the indicator region 304 on the test strip 300 passes along the detector 20 arranged in/under the first side wall 110 in the slit. As explained below with reference to figure 6, the detector 20 senses the optical state of the reactive surface indicator region of the test strip.
  • Figure 6c shows a third stage of the procedure after the test strip 300 has passed through the slit 100, and is again separated from the electronic device 1.
  • the sponge body 310 is removed before or during movement of the test strip through the slit 100.
  • the height of the slit opening is at least equal to the thickness of the test strip but less than the thickness of the sponge body (or sponge bodies) and the test strip.
  • Figures 7a and 7b shows a cross-sectional view of the electronic device for reading a test strip.
  • the detector 20 is an optical detector comprising a photovoltaic cell or photodetector 201 and illumination means i.e. a light source 202, 203.
  • the illumination means are arranged adjacent to the photodetector, in such a way that in use when the test strip is received in the slit, the illumination means light the indicator surface of the test strip.
  • the light source comprises at least one LED device, arranged adjacent to the photovoltaic cell in the longitudinal direction of the slit.
  • the detector 20 is arranged at the location of the viewing window 120 in the first side wall (supporting surface) 110.
  • the light source 202, 203 illuminates the surface of the test strip placed in the slit 100 which enhances the detection capabilities of the photovoltaic cell 201.
  • the photovoltaic cell 201 is positioned in between two light sources (i.e. a pair of LEDs) 202 and 203. In this manner, illumination of the surface of the test strip 300 is improved and optical detection of the test strip surface is further enhanced.
  • the photodetector 201 can be arranged in an orientation wherein the light sources 202 and 203 are arranged on a line parallel to the length of the slit, thus in a line parallel to the sliding direction (arrow P2) of the test strip when reading the test strip.
  • the light sources 202 and 203 are aligned on a line transverse to the length of the slit, thus in the inserting direction transverse (arrow PI) to the sliding direction of the test strip when reading the test strip.
  • the embodied orientations may provide enhanced illumination of the test strip.
  • Figure 8 shows a schematic curve of a temporal signal measurable by the electronic device.
  • the test strip 300 can be slideably moved along its longitudinal direction through the slit 100. In this manner, the surface of the test strip is passing substantially completely over the detector 20.
  • the indicator region 304 of the test strip 300 comprises a number of indicator regions adjacent to each other in the longitudinal direction of the test strip, that each associate with a specific analyte in the fluid to be analysed (or with a reference)
  • this sliding movement advantageously allows to detect signals consecutively from each indicator region with a single detector 20.
  • the single detector 20 records the optical state of the indicator region(s) during exposure to light emitted by the light source(s) 202, 203 as a temporal variable signal during the movement of the strip.
  • the temporal variable signal is recorded in the memory of the electronic device.
  • an exemplary curve of a temporal variable intensity signal C for a test strip with two adjacent indicator regions is shown.
  • the intensity signal C that may relate to measured reflectance or measured absorbance or measured emission of the indicator region(s), comprises two peaks, in this example a first peak CI with a first intensity Ml and a second peak C2 with a second intensity M2.
  • the first peak CI relates to a first indicator region, the second peak C2 to a second indicator region .
  • the intensity of each peak depends on many things, among others the degree of reaction of a test substance with analyte in the fluid.
  • one of the indicator regions is a reference indicator, from a comparison of the respective intensity of the two peaks it may be determined if the analyte to be detected is actually present in the fluid.
  • the electronic device is arranged to evaluate the presence of the analyte and to indicate this on the display means and/or by a loudspeaker that generates an audio signal.
  • the electronic device comprises an audio generator for generating the audio signal associated with the output result signal.
  • the reference indicator may provide an indication whether the test strip functions correctly and/or whether the test strip has been treated correctly by a user.
  • the electronic device is arranged to evaluate the state of operation and may indicate this on the display means and/or by a loudspeaker that generates an audio signal.
  • the electronic device is arranged to detect if the absolute value of both peaks in the temporal signal is above certain minimal threshold level. This minimal threshold detection step can be used to determine if the electronic device functions correctly, e.g., if the viewing window is clean enough for measuring the optical state of the indicator regions on the test strip.
  • the electronic device can be arranged for determining a background intensity level before or during the procedure of determining the intensity levels of the peaks.
  • the background level can be determined for example from a blank portion of the test strip surface.
  • the background level can be used for correction of the measured peak levels and to improve accuracy of the test results.
  • the electronic device is arranged to evaluate if the viewing condition for the detector is sufficient or not, and to indicate this on the display means and/or by a loudspeaker that generates an audio signal.
  • the detection method can be extended to two or more analytes by providing more than two specific indicator regions on the test strip.
  • the indicator surface of the test strip comprises at least two indicator regions
  • the processing unit is arranged to determine the test result signal based on the respective optical state of each of the at least two indicator regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit.
  • the processing unit is arranged to determine the presence of the peaks of the respective indicator regions and their respective intensity.
  • the processing unit is arranged to compare the intensity values of the peaks and to determine from the difference(s) or ratio(s) if the analyte(s) was present in the fluid.
  • the processing unit of the electronic device is arranged to produce an output result signal associated with the presence of the analyte.
  • Such an output result signal may be stored temporarily in the memory and later be transmitted to a computer for data processing.
  • the processing unit is arranged to add a code stamp to the output result signal. This may simplify the data processing at later time.
  • the code stamp may comprise one or more of an identifier code, a location code, a number, to allow identification of the associated instance of testing of fluid.
  • the electronic device comprises a timer which is coupled to the processing unit, and the processing unit is arranged to derive a time code from the timer and to add a time stamp to the output result signal.
  • the detector may alternatively be arranged to measure absorbance in stead of reflectivity. As known to the skilled in the art, this may yield a differently shaped curve for the measured temporal signals of the respective reactive regions in the indicator region, but a similar principle as above to compare between the first and second absorption values CI, C2 to determine presence of analyte in the fluid can be applied.
  • Figure 9 shows a flow diagram of a measurement procedure 700 for use of the electronic device in accordance with the invention.
  • the procedure 700 starts with action 701, wherein a test strip with indicator region(s) is inserted in a fluid to be tested for the presence or absence of an analyte.
  • the test strip After exposing the test strip to the fluid, the test strip is inserted transversely to its longitudinal direction in the slit 100 of the electronic device 1 (see action 702).
  • the surface of the test strip holding the indicator region(s) is facing the first side wall 110.
  • the holding means 130; 140; 150 provide that the test strip is held against the first side wall 110 of the slit.
  • the electronic device 1 is activated by the sensing device 50 that senses the insertion of the test strip.
  • test strip is slideably moved along the longitudinal direction of the slit. In this manner, the indicator region(s) of the test strip passes over the detector 20 under the viewing window 120 in the first side wall 110.
  • the detector 20 detects the optical state of the indicator region(s) and transmits the data to the processing unit 10.
  • the processing unit compares the measured peak intensities and the processing unit 10 calculates a test result signal based on the optical state of the indicator region(s) of the test strip as detected by the optical detector (for example, the difference or ratio of the intensity peaks in the signal detected by the detector).
  • action 706 the processing unit determines from this comparison if the analyte is present in the fluid.
  • the processing unit generates an output result signal associated with the presence to the display means. Additionally, the processing unit may process the output result signal further with a code or time stamp, and may store the output result signal in memory and/or may control transmitting the output result signal to a further computing device (e.g. a server).
  • a further computing device e.g. a server
  • the invention relates to a method for analysis of a fluid by means of a test strip with an indicator surface holding at least one indicator region and by an electronic device as described above; wherein the method comprises:
  • the method comprises: - activating the operation of the electronic device during or after insertion of the test strip.
  • the method comprises: - sensing the insertion or presence of the test strip in the slit of the electronic device by a sensing device; and - based on the sensed insertion or presence activating the operation of the electronic device.
  • the method as described above comprises that the operation of the electronic device is controlled by the processing unit of the electronic device.
  • the method as described above comprises that the processing unit calculates a test result signal based on the optical state of the at least one reactive surface region of the test strip as detected by the optical detector.
  • the method as described above comprises that the processing unit compares the peak intensities, and determines from this comparison a presence of an analyte in the fluid being tested.
  • the method as described above comprises determining a background intensity level and using the background intensity level as a correction for measuring the peak intensities.
  • test strip comprises at least two reactive surface regions
  • the processing unit determines the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit.
  • the method as described above comprises that the processing unit determines the test result signal based on a difference between the optical state of each of the at least two reactive surface regions.
  • the invention relates to a method in which the test strip comprises at least two reactive surface regions, and the processing unit is arranged to determine the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit.
  • the method comprises that the processing unit is arranged to determine the test result signal based on the difference between the optical state of each of the at least two reactive surface regions.
  • the analyte is an antibiotic substance such as a beta-lactam antibiotic and the liquid is a dairy related fluid such as milk.

Abstract

An electronic device (1) for analysis of a fluid by means of a test strip with an indicator surface holding a reactive surface region, includes a processing unit, memory, display means, receiving means for a test strip, an optical detector, and a casing. Within the casing the processing unit is coupled to the memory and to the display means. The optical detector is arranged in the receiving means and coupled to the processing unit. The casing includes a slit (100) on a surface of the casing. The slit is arranged for receiving the test strip in a transverse direction with respect to the length of the test strip. A surface of the slit is arranged as a support surface for supporting in use an longitudinal edge of the test strip. The optical detector (20) is arranged behind a viewing window (120) in a side wall of the slit for detecting an optical state of the reactive surface region of the test strip,

Description

Test strip reading device and method for reading a test strip
Field of the invention
The present invention relates to an electronic device for reading a test strip. Also the present invention relates to a method for reading test strip.
Background
Test strips for testing the presence of an analyte in a fluid are well known in the art. Such a test strip comprises a carrier strip and a indicator region with one or more reactive surface layers on the carrier strip, wherein the one or more reactive surface layers comprise agent(s) that display a change of their chemical or physical state when exposed to a fluid that may contain the analyte being tested. Usually such a change of chemical or physical state involves an optical change of the indicator region (i.e. the surface of the exposed part) of the test strip for example a change of color, reflectance, scattering, emissivity, or absorbance.
It is known to observe the optical change in various ways. It is known to visually analyze the appearance of the test strip with a color map to obtain information on the presence of the analyte in the fluid. Also, automated devices that can improve the quality of such an analysis in comparison to human visual inspection are known.
It is an object of the present invention to provide a test strip reading device and associated method that overcomes one or more disadvantages from the prior art.
Summary of the invention
The object is achieved by an electronic device for analysis of a fluid by means of a test strip with an indicator surface holding a reactive surface region, comprising: a processing unit, memory, display means, receiving means for a test strip,
an optical detector, and a casing; within the casing the processing unit being coupled to the memory and to the display means, the optical detector being arranged in the receiving means and coupled to the processing unit; wherein the casing comprises a slit on a surface of the casing, the slit having first and second side walls and a bottom wall, the first and second side wall being opposite and parallel to each other with the bottom wall surface facing towards the opening of the slit; the slit being arranged for receiving the test strip in a transverse direction with respect to the length of the test strip, the first side wall surface of the slit being arranged as a support surface for supporting in use an longitudinal edge of the test strip; the optical detector being arranged in the first side wall of the slit for detecting an optical state of the reactive surface region of the test strip, and the electronic device is provided with holding means for holding the test strip within the slit and for pressing the indicator surface against the first side wall.
Advantageously, this electronic device provides a relatively quick and reliable manner for inserting a test strip.
This arrangement improves the positioning of the strip in the slit and also assists in guiding the test strip through the slit.
In an embodiment, the invention relates to an electronic device as described above, wherein the holding means is a resilient flap within the slit, attached to the casing and moveable toward the first side wall.
In an embodiment, the invention relates to an electronic device as described above, wherein the holding means comprise a flexible support structure for holding test strip, the support structure comprising two upward notches each running parallel to the length of the slit, and being arranged to create a holding space between them for taking up the test strip.
This structure advantageously prevents transverse movement of the test strip while inserted in the electronic device.
In an embodiment, the invention relates to an electronic device as described above, wherein the upward notch adjacent to the opening of the slit has a rounded outer rim at the side of the opening of the slit.
Advantageously, the rounded rim assists during the insertion of the test strip in the electronic device.
In an embodiment, the invention relates to an electronic device as described above, wherein the support structure is flexibly attached to the casing over a flexible beam portion.
In an embodiment, the invention relates to an electronic device as described above, wherein the slit comprises openings at each of its longitudinal ends, in such a way that the test strip can be slideably moved along its longitudinal direction through the slit.
Advantageously, the openings allow sliding of the test strip along its length through the slit. In this manner, the complete surface of the test strip is allowed to pass under a single optical detector. This allows a relatively simple set-up of the detector arrangement of the electronic device.
In an embodiment, the invention relates to an electronic device as described above, wherein the optical detector is arranged in the first side wall adjacent to one of the longitudinal ends of the slit.
In an embodiment, the invention relates to an electronic device as described above, wherein the optical detector comprises a single photodetector and illumination means, wherein the illumination means are arranged adjacent to the photodetector, in such a way that in use when the test strip is received in the slit, the illumination means light the indicator surface of the test strip.
In an embodiment, the invention relates to an electronic device as described above, wherein the illumination means comprise at least one LED arranged adjacent to the photodetector in the longitudinal direction of the slit.
In an embodiment, the invention relates to an electronic device as described above, wherein the photodetector is positioned intermediate a pair of LEDs.
In an embodiment, the invention relates to an electronic device as described above, wherein the first side wall comprises a transparent window portion at the location of the optical detector.
In an embodiment, the invention relates to an electronic device as described above, further comprising a sensor or switch which is coupled to the processing unit and is arranged within the slit for detecting a presence of the test strip so as to power on the electronic device when the test strip is present.
Advantageously, the sensor or switch can control the power consumption of the electronic device.
In an embodiment, the optical detector is arranged as a sensor to detect a presence of the test strip. The optical detector then operates in a pulsed mode while the illumination means are yet inactive. If in this mode a test strip is detected by the detector, the electronic device is arranged to activate the illumination means to initiate measuring the optical state of the indicator region of the test strip.
In an embodiment, the invention relates to an electronic device as described above, wherein the sensing device is arranged for identifying the test strip by reading information from an information holding region on the test strip. Advantageously, identifying the test strip can be used to prevent use of incompatible test strips.
In an embodiment, the invention relates to an electronic device as described above, wherein the sensing device comprises a barcode reader arranged for reading barcode information from the test strip.
In an embodiment, the invention relates to an electronic device as described above, wherein the sensing device comprises a wireless reader arranged for reading information from a wirelessly readable tag or chip that is embedded or attached to the test strip.
In an embodiment, the invention relates to an electronic device as described above, wherein the processing unit is arranged for evaluating the information from the sensing device, e.g. by comparison with predetermined data, and for activating the electronic device for operation.
In an embodiment, the invention relates to an electronic device as described above, wherein the processing unit is arranged to calculate a test result signal based on the optical state of the reactive surface region of the test strip as detected by the optical detector, and the processing unit is arranged to generate an output result signal based on the test result signal to the display means.
In an embodiment, the invention relates to an electronic device as described above, wherein the output result signal is a two-state signal, having a result value indicating either a positive or a negative result of the analysis.
Advantageously, this embodiment provides a test result that can be interpreted directly.
In an embodiment, the invention relates to an electronic device as described above, wherein the display means comprise one or more LEDs for indicating the output result signal.
In an embodiment, the invention relates to an electronic device as described above, wherein the display means comprise an audio generator for generating an audio signal associated with the output result signal.
In an embodiment, the invention relates to an electronic device as described above, further comprising output means arranged for transmitting the output result signal electronically or electromagnetically. In an embodiment, the invention relates to an electronic device as described above, wherein the output means comprises an electric interface for transmitting the output result signal in a wired mode.
In an embodiment, the invention relates to an electronic device as described above, wherein the output means comprises a radio interface for transmitting the output result signal in a wireless mode.
In an embodiment, the invention relates to an electronic device as described above, wherein the radio interface comprises one or more of a Wi-Fi interface, a Bluetooth interface or a Near Field (NFC) radio interface.
In an embodiment, the invention relates to an electronic device as described above, wherein the indicator surface of the test strip comprises at least two reactive surface regions, and the processing unit is arranged to determine the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is measured while the test strip is being moved along the optical detector in the slit.
In an embodiment, the invention relates to an electronic device as described above, wherein the optical state of the reactive surface region is one selected from a group comprising absorption, emissivity, scattering, or reflectance of the respective reactive surface region.
In an embodiment, the invention relates to an electronic device as described above, wherein the processing unit is arranged to determine the test result signal based on the difference between the optical state of each of the at least two reactive surface regions.
In an embodiment, the invention relates to an electronic device as described above, wherein the processing unit is arranged to add a code stamp to the output result signal.
In an embodiment, the invention relates to an electronic device as described above, wherein the code stamp comprises one or more of an identifier code, a location code, a (serial) number.
In an embodiment, the invention relates to an electronic device as described above, further comprising a timer which is coupled to the processing unit, and the processing unit is arranged to derive a time code from the timer and to add a time stamp to the output result signal. In an embodiment, the invention relates to an electronic device as described above, wherein the processing unit is arranged for storing the output result signal in the memory.
In an embodiment, the invention relates to an electronic device as described above, wherein the processing unit is arranged to read a stored output result signal from the memory.
In an embodiment, the invention relates to an electronic device as described above, wherein the processing unit is arranged to control the transmission of the output result signal by the output means.
In an embodiment, the invention relates to an electronic device as described above, wherein the one or more reactive surface regions of the test strip comprise a substance for determining an analyte in a liquid.
In an embodiment, the invention relates to an electronic device as described above, wherein the analyte is an antibiotic substance and the liquid is a dairy related fluid.
In an embodiment, the invention relates to a method for analysis of a fluid by means of a test strip with an indicator surface holding at least one reactive surface region and by an electronic device as described above; the method comprising:
- exposing the test strip to the fluid to be tested;
- inserting the test strip into the slit of the electronic device wherein an inserting direction is substantially transverse to a length of the test strip, in such a way that the slit receives the test strip in a transverse direction with respect to the length of the test strip;
- moving the test strip through the slit along the longitudinal direction of the slit wherein the test strip moves through the slit substantially parallel to the surface of the electronic device in which the slit is located;
- operating the electronic device, comprising sensing by a detector of the electronic device an optical state of the reactive surface indicator region of the test strip, while the test strip moves through the slit.
In an embodiment, the invention relates to a method as described above, further comprising: - activating the operation of the electronic device during or after insertion of the test strip. In an embodiment, the invention relates to a method as described above, further comprising:
- sensing the insertion or presence of the test strip in the slit of the electronic device by a sensing device;
- based on the sensed insertion or presence activating the operation of the electronic device.
In an embodiment, the invention relates to a method as described above, wherein the operation of the electronic device is controlled by the processing unit of the electronic device.
In an embodiment, the invention relates to a method as described above, wherein the processing unit calculates a test result signal based on the optical state of the at least one reactive surface region of the test strip as detected by the optical detector.
In an embodiment, the invention relates to a method as described above, wherein the processing unit compares the peak intensities, and determines from this comparison a presence of an analyte in the fluid being tested.
In an embodiment, the invention relates to a method as described above, wherein the test strip comprises at least two reactive surface regions, and the processing unit determines the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit.
In an embodiment, the invention relates to a method as described above, further comprising that the processing unit determines the test result signal based on a difference between the optical state of each of the at least two reactive surface regions.
In an embodiment, the invention relates to use of an electronic device as described above for determining the presence of an analyte in a fluid.
In an embodiment, the invention relates to a kit of parts for analysis of a fluid comprising a test strip with an indicator surface holding a reactive surface region and an electronic device as described above.
Brief Description of Drawings
The invention will be explained in more detail below with reference to drawings in which illustrative embodiments of the invention are shown. It will be appreciated by the person skilled in the art that other alternative and equivalent embodiments of the invention can be conceived and reduced to practice without departing from the true spirit of the invention, the scope of the invention being limited only by the appended claims.
Figure 1 shows a schematic layout of a circuit of the electronic device according to an embodiment of the invention;
Figure 2 shows schematically a test strip compatible with the electronic device according to the invention;
Figures 3 a, 3b shows perspective views of an electronic device for reading a test strip according to an embodiment of the invention;
Figures 4a, 4b, 4c show a cross-sectional view of the electronic device for reading a test strip;
Figures 5a, 5b, 5c, 5d show an electronic device for reading a test strip according to an embodiment of the invention;
Figures 6a - 6c show arrangements of the test strip and the electronic device during a procedure for reading the test strip;
Figures 7a, 7b show a cross-sectional view of the electronic device for reading a test strip;
Figure 8 shows a schematic curve of a temporal signal measurable by the electronic device;
Figure 9 shows a flow diagram of a measurement procedure for the electronic device in accordance with the invention.
Detailed Description of Embodiments
Figure 1 shows a schematic layout of a circuit of an electronic device according to an embodiment of the invention.
The electronic device 1 according to the invention comprises a processing unit
10, a detector 20, a memory 30, and display means 40.
The processing unit is coupled to a detector 20 for receiving data obtained by the detector 20. The detector is arranged for sensing an optical state of a indicator region of a test strip, when such a test strip is brought in a detection region of the detector. The detector 20 may be either a digital or an analog detecting device. In the latter case, the detector 20 may be coupled to the processing unit 10 through a analog-to-digital converter (not shown). The processing unit 10 is coupled to the memory 30 for storing and retrieving data. In an embodiment, the processing unit is arranged for storing and retrieving data obtained by the detector 20 to and from the memory 30.
Also, the processing unit 10 is coupled to display means 40, wherein the display means are arranged to indicate a value calculated by the processing unit in conjunction with the optical state of the indicator region of the test strip. The display means 40 can be an alphanumeric display. In a preferred embodiment, the display means 40 comprise at least one LED (light emitting diode) for indicating the output result signal. In a further preferred embodiment, such a LED is a multi-color LED.
In an embodiment, the at least one LED is a red/green multi-color or the at least one LED comprises a red LED and a green LED. In this arrangement the at least one LED is arranged to provide one signal (e.g. red signal) to indicate the presence of the analyte in the fluid (i.e. antibiotic in milk) and another signal (e.g. green signal) to indicate absence of the analyte in the fluid.
Additionally, the electronic device may comprise a sensing device 50 that is coupled to the processing unit 10. The sensing device is arranged for sensing the presence of the test strip near the detector and functions as a switch for
activating/deactivating the electronic device depending on the presence of the test strip in or near the detection region of the detector 20.
The sensing device may additionally or alternatively be arranged for identifying the test strip. In an embodiment, the sensing device 50 comprises a reader arranged for reading visual information from a test strip. In a further embodiment, the sensing device 50 comprises a barcode reader arranged for reading barcode information from the test strip.
In an alternative embodiment the sensing device 50 comprises a wireless reader
(e.g. an RFID chip reader) arranged for reading information stored in a wirelessly readable tag or chip, e.g. an RFID chip, that is embedded or attached to the test strip. The processing unit evaluates the information, e.g. by comparison with predetermined data. Based on the information and the comparison, the processing unit can activate or release the electronic device 1 for operation.
In an embodiment, the optical detector is arranged as sensor to detect a presence of the test strip. The optical detector then operates in a pulsed mode while the illumination means are yet inactive. If in this mode a presence of a test strip is detected by the detector, the electronic device is arranged to activate the illumination means to initiate measuring the optical state of the indicator region of the test strip.
In a further preferred embodiment, the electronic device comprises a
communication device 60 that is coupled to the processing unit 10. Such output means are arranged for transmitting output signals electronically or electromagnetically.
The communication device 60 is arranged for at least transmitting data from the processing unit 10 to an external electronic unit (not shown). The communication device 60 can be arranged for either wired or wireless communications to the external unit. In case of a wireless communication device, the communication device comprises an electric interface for transmitting the output result signal in a wireless mode. Such an electric interface relates to a radio interface that may comprise one or more of a mobile telecom interface, a Wi-Fi interface, a Bluetooth interface or a Near Field (NFC) radio interface.
Additionally or alternatively, the communication device comprises an electric interface for transmitting the output result signal in a wired mode: interfaces of this type including serial communication by using one or more from USB, RS232 may also be available on the electronic device.
In use, the processing unit 10 is arranged to receive data from the detector 20. The data are obtained by the detector 20 by sensing the optical state of a indicator region of a test strip, that has been exposed to a fluid for testing the presence of an analyte in the fluid.
Upon reception of the data from the detector 20, the processing unit 10 is arranged to determine the presence of the analyte in the fluid from the received detector data. In an embodiment, the processing unit is arranged to calculate a value associated with the observed optical state of the indicator region of the test strip. Next, the processing unit 10 is capable of comparing the calculated value with a reference or threshold value and of generating an indicating signal on the presence of the analyte based on the comparison. The processing unit is arranged to output the indicating signal to the display means 40. Below, an embodiment for the determination of the presence of analyte by the processing unit 10 will be explained in more detail with reference to figures 8 and 9.
Figure 2 shows a perspective view of a test strip 300 compatible for use with the electronic device 1 according to the invention. The test strip 300 comprises an elongated base layer 302 as carrier strip. The base layer may be made of a plastic, either thermoplastic or thermosetting. Alternatively, the base layer material may be (plasticized or coated) paper, (plasticized or coated) cardboard, metal, or any other material suitable for making base layers of test strips.
On a surface of the base layer 302, the test strip 300 comprises on an end region
305 of the base layer an indicator region surface 304 which includes one or more reactive surface layers on the base layer. These one or more reactive surface layers comprise specific agent(s) of which a chemical or physical state changes when exposed to a fluid that contains an analyte to be detected, i.e. the one or more indicator regions of the test strip comprise a substance for determining an analyte in the fluid. The reactive surface layers may be located adjacent to each other on the base layer.
Additionally or alternatively, the reactive surface layers may be stacked. In an embodiment, the fluid to be tested is transported by capillary forces through the reactive surface layers.
Further the base layer 302 may comprise markings 308, 309 for positioning the test strip in the electronic device 1. The markings 308, 309 may be visual lines on the surface of the base layer. Alternatively, or additionally, the markings may comprise indents or ribs or steps in the surface of the base layer.
The use of the markings 308, 309 is explained in more detail with reference to figure 6a.
In an embodiment, the indicator region 304 comprises a reference (control) region 304a and an measuring (detection) region 304b. The reference region 304a is arranged to indicate whether the strip functions correctly and/or whether the strip has been treated correctly by a user. The measuring region 304b is arranged to indicate a result associated with a presence of the analyte in the fluid that is tested. In an embodiment, the reference region is located closer to marking 309 than the measuring region.
In an embodiment, the strip comprises a plurality of reference regions 304a and/or a plurality of measuring regions 304b.
In an embodiment, the test strip comprises first and second liquid storage volumes 310, 311 that are arranged on two opposite ends of the indicator region 304 to provide capillary transport of the fluid to be tested through the indicator region 304. The first and second storage volumes 310, 311 are embodied by sponge bodies (or pads). One sponge body 310 is arranged at a distal tip 305 of the test strip, which is arranged to be immersed in the fluid to be tested. The other sponge body 31 1 is located near the proximal end 302 of the test strip and is arranged to take in fluid to assist the movement of the fluid from the first sponge body 310 through the indicator region 304. The edges of the sponges facing towards the indicator region 304 may be used as markings for positioning the test strip in the electronic device.
Further, the test strip may be arranged with an information holding region 312. In an embodiment the information holding region is a surface arranged for holding visual information containing symbols or a barcode.
Optionally, the information holding region is located on the surface opposite the surface holding the indicator region 304.
Additionally, or alternatively the information holding region 312 is arranged to hold an electronic tag, such as an RFID tag (not shown). The tag can either be attached to the surface of the information holding region or be embedded below this surface.
Preferably, the electronic device 1 according to the invention uses a test strip as disclosed in international patent application PCT/EP2012/067944,
PCT/EP2012/067945, PCT/EP2012/067946, and/or PCT/EP2012/067948.
Figures 3 a, 3b shows perspective views of an electronic device for reading a test strip according to an embodiment of the invention.
The electronic device 1 is incorporated in a casing 70 which in an embodiment has a rectangular shape.
In an embodiment, the electronic device 1 has a length between about 2 cm and 10 cm, a width between about 1cm and 5cm and a height between a few (about 5) millimeters and about 1 cm.
A surface 80 of the casing 70 comprises a slit 100. The slit 100 has first and second side walls 110, 114 and a bottom wall 112. The first and second side walls 110, 114 are arranged opposite and parallel to each other. The bottom surface 112 faces towards the opening of the slit 100, is preferably perpendicular to the first and second side walls.
The slit 100 is arranged for receiving the test strip in a transverse direction with respect to the length of the test strip.
The second side wall surface 114 of the slit 100 is arranged as a supporting surface for supporting in use a longitudinal edge of the test strip. Thus, when the test strip has been brought into the slit, the base layer (back) surface of the test strip is placed on the supporting second side wall surface 114, while the indicator region of the test strip faces towards the first side wall 110.
The optical detector 20 is arranged in the casing 70 near the first side wall of the slit to be capable to sense an optical state of the indicator region of the test strip, associated with the chemical or physical state of the agent(s). To this end the first side wall 110 is arranged with a transparent viewing window 120 at the location of the optical detector 20 such that the test strip and its indicator region are exposed to the detecting region of the detector 20. In figure 3a the viewing window 120 is
schematically displayed by dashed lines.
In an embodiment, the viewing window 120 comprises a transparent surface area. In the surface of the casing 70, a window 40' may be arranged to allow a user to view the display means 40. In an alternative embodiment, the display means are arranged in a portion of the surface 80 that is comprising the slit.
In an embodiment, the slit 100 comprises openings 116 at each of its longitudinal ends, in such a way that the test strip can be slideably moved along its longitudinal direction through the slit. Advantageously, the sliding of the strip in the longitudinal direction through the slit, allows to use a single detector while a detection of the surface of the test strip can done over a relatively large length of the test strip. This is in particular useful when the test strip has two or more indicator regions adjacent to each other. Also, the sliding of such a test strip with two or more adjacent indicator regions over a single detector 20 provides the capability to compare the optical state of these two or more indicator regions. In an embodiment, the optical detector is arranged in the first side wall adjacent to one of the longitudinal ends of the slit.
To make the electronic device portable, the casing 70 also comprises a power source (not shown), such as a (re-chargeable) battery or an external power supply.
The sensing device 50 as described above is shown as arranged in the side wall 114 opposite the detector 20, but alternatively the sensing device 50 may be located in the same side wall 110 as the detector 20.
According to a further embodiment of this alternative, the sensing device 50 may be integrated with the detector or the detector 20 may be arranged to have the capabilities of the afore mentioned sensing device 50. Figures 4a, 4b, 4c show a cross-sectional view of the electronic device for reading a test strip.
Within the slit 100, the casing 70 of the electronic device 1 is provided with holding means for holding the test strip and for pressing the indicator region against the first side wall. The holding means advantageously provide that after placing the test strip in the slit 100, the test strip is secured within the slit during the measurement by the electronic device 1.
As shown in Figure 4a and 4b, the holding means is a resilient flap 130 within the slit, attached to the second side wall 114 and moveable toward the first side wall 110.
In figure 4c an alternative holding means is shown which comprises a spring 140 attached to the second side wall 114 and pressing toward the first side wall 110.
In an embodiment, a (micro) switch that acts as sensing device 50 for sensing the presence of the test strip in the slit is located within the slit 100. The switch is coupled to the electronic device 1 for activating or deactivating the electronic device when the test strip is respectively inserted in and removed from the slit 100. Instead of a micro switch other sensors such as a proximity sensor, such as a wireless tag reader, or an optical sensor, such as a barcode reader, could be used as sensing device 50. The sensing device 50 as described above is located in the side wall 114 opposite the detector 20, but alternatively the sensing device 50 may be located in the same side wall 110 as the detector 20.
Figures 5a, 5b, 5c, 5d show details of an electronic device for reading a test strip according to an embodiment.
Figure 5a shows a perspective view of the electronic device 1. Within the slit 100 of the casing 70, a flexible or resilient support structure 150 as holding means is located.
In figure 5b a cross-section of the flexible support structure 150 is shown. The support structure comprises a holding space 151 arranged as holding means for holding an inserted test strip. The inserted test strip is oriented in a manner that the indicator region 304 faces towards the detector 20, that is arranged in the casing 70 near the first side wall of the slit.
Further, the support structure 150 comprises two upward notches 152, 153 that run parallel to the length of the slit and that are arranged to create the holding space 151 between them for taking up the test strip 300. The notches are arranged to prevent the test strip to move transversely. One notch 152 is arranged adjacent the opening of the slit 100. The outer rim of this notch at the side of the opening of the slit may be rounded to allow flexibility of the support structure by bending downwards; the upward notch adjacent to the opening of the slit has a rounded outer rim at the side of the opening of the slit. This allows easy insertion of the test strip transversely in the slit. The other notch 153 is arranged internally and has the function to stop the test strip being inserted.
Figure 5c shows a cross-sectional view of the electronic device 1, while the support structure 150 is in a position bent downwards during insertion of a test strip 300 in transverse direction. The support structure 150 is flexibly attached over a flexible beam (portion) 154 to the lower part of the casing 70 by a connection, which may be for example a screw connection 155, 156. Other connections between the casing and the support structure are also conceivable.
Figure 5d shows a cross-sectional view of the electronic device 1, while the support structure 150 holds a test strip 300 adjacent the first side wall 110.
Figure 6a - 6c shows arrangements of the test strip 300 and the electronic device 1 during a procedure for reading the test strip.
After the test strip 300 has been exposed to a fluid which may contain the analyte to be detected, the test strip indicates if analyte is present or absent in the fluid to be analyzed and the result (signal) of the test strip can be detected by the electronic device.
As shown in figure 6a, the test strip 300 is held separately from the electronic device 1, ready to be inserted into the slit 100 of the electronic device 1. The inserting direction PI is substantially transverse to the length of the test strip 300, in such a way that the slit 100 receives the test strip 300 in a transverse direction with respect to the length of the test strip.
During insertion of the test strip 300, the markings 308, 309 and/or the liquid storage volumes 310, 311 of the test strip 300 are aligned with the casing 70 (or markings on the casing) of the electronic device so as to ensure a correct position of the indicator region 304 in the slit 100 of the electronic device 1 relative to the position of the detector 20 arranged in the slit 100. During insertion of the test strip 300, the holding means 130; 140; 150 move to allow the test strip 300 to enter the slit. The holding means 130; 140; 150 are biased to press the surface of the test strip 300 holding the indicator regions to the first side wall surface 110 of the slit. In an embodiment, after insertion the test strip end region 305 extends at an end of the slit. Optionally, the test strip end 302 may extend at the opposite end of the slit.
In a second stage as shown in figure 6b, the test strip 300 is shown in its inserted position in the electronic device 1.
After or during insertion, the electronic device 1 is activated either manually by the user or in an embodiment by the sensing device 50 for sensing the presence of the test strip in the slit.
Optionally, after inserting the test strip, the electronic device 1 may indicate that it is activated (or powered on) and ready for reading the test strip. The indication that the electronic device is ready may be shown by the display means 40.
The user can now move the test strip 300 through the slit along the longitudinal direction of the slit as indicated by arrow P2. During this action, the test strip moves through the slit substantially parallel to the surface 80 in which the slit 100 is located. During movement of the test strip, the holding means 130; 140; 150 press the test strip 300 to the first side wall surface of the slit.
While moving through the slit, the indicator region 304 on the test strip 300 passes along the detector 20 arranged in/under the first side wall 110 in the slit. As explained below with reference to figure 6, the detector 20 senses the optical state of the reactive surface indicator region of the test strip.
Figure 6c shows a third stage of the procedure after the test strip 300 has passed through the slit 100, and is again separated from the electronic device 1.
The sponge body 310 is removed before or during movement of the test strip through the slit 100. In an embodiment, the height of the slit opening is at least equal to the thickness of the test strip but less than the thickness of the sponge body (or sponge bodies) and the test strip.
It is noted that the direction of movement of the test strip through the slit may be reversed in comparison with direction P2.
Figures 7a and 7b shows a cross-sectional view of the electronic device for reading a test strip.
Here an exemplary arrangement of the detector 20 and the supporting surface 110 is shown.
In this embodiment, the detector 20 is an optical detector comprising a photovoltaic cell or photodetector 201 and illumination means i.e. a light source 202, 203. The illumination means are arranged adjacent to the photodetector, in such a way that in use when the test strip is received in the slit, the illumination means light the indicator surface of the test strip. Preferably, the light source comprises at least one LED device, arranged adjacent to the photovoltaic cell in the longitudinal direction of the slit. The detector 20 is arranged at the location of the viewing window 120 in the first side wall (supporting surface) 110.
In use, the light source 202, 203 illuminates the surface of the test strip placed in the slit 100 which enhances the detection capabilities of the photovoltaic cell 201.
In a preferred embodiment, the photovoltaic cell 201 is positioned in between two light sources (i.e. a pair of LEDs) 202 and 203. In this manner, illumination of the surface of the test strip 300 is improved and optical detection of the test strip surface is further enhanced.
As shown in figure 7a, the photodetector 201 can be arranged in an orientation wherein the light sources 202 and 203 are arranged on a line parallel to the length of the slit, thus in a line parallel to the sliding direction (arrow P2) of the test strip when reading the test strip.
In an alternative embodiment as shown in figure 7b, the light sources 202 and 203 are aligned on a line transverse to the length of the slit, thus in the inserting direction transverse (arrow PI) to the sliding direction of the test strip when reading the test strip.
Depending on the layout of the test strip in particular, the location of the reactive surface areas and control areas of the indicator region(s) on the test strip, the embodied orientations may provide enhanced illumination of the test strip.
Figure 8 shows a schematic curve of a temporal signal measurable by the electronic device.
As mentioned above, the test strip 300 can be slideably moved along its longitudinal direction through the slit 100. In this manner, the surface of the test strip is passing substantially completely over the detector 20. In case the indicator region 304 of the test strip 300 comprises a number of indicator regions adjacent to each other in the longitudinal direction of the test strip, that each associate with a specific analyte in the fluid to be analysed (or with a reference), this sliding movement advantageously allows to detect signals consecutively from each indicator region with a single detector 20. The single detector 20 records the optical state of the indicator region(s) during exposure to light emitted by the light source(s) 202, 203 as a temporal variable signal during the movement of the strip.
The temporal variable signal is recorded in the memory of the electronic device. In figure 8, an exemplary curve of a temporal variable intensity signal C for a test strip with two adjacent indicator regions is shown. The intensity signal C that may relate to measured reflectance or measured absorbance or measured emission of the indicator region(s), comprises two peaks, in this example a first peak CI with a first intensity Ml and a second peak C2 with a second intensity M2. The first peak CI relates to a first indicator region, the second peak C2 to a second indicator region .
The intensity of each peak depends on many things, among others the degree of reaction of a test substance with analyte in the fluid. In case one of the indicator regions is a reference indicator, from a comparison of the respective intensity of the two peaks it may be determined if the analyte to be detected is actually present in the fluid. The electronic device is arranged to evaluate the presence of the analyte and to indicate this on the display means and/or by a loudspeaker that generates an audio signal. In an embodiment, the electronic device comprises an audio generator for generating the audio signal associated with the output result signal.
Additionally, or alternatively, the reference indicator may provide an indication whether the test strip functions correctly and/or whether the test strip has been treated correctly by a user. The electronic device is arranged to evaluate the state of operation and may indicate this on the display means and/or by a loudspeaker that generates an audio signal.
In an embodiment, the electronic device is arranged to detect if the absolute value of both peaks in the temporal signal is above certain minimal threshold level. This minimal threshold detection step can be used to determine if the electronic device functions correctly, e.g., if the viewing window is clean enough for measuring the optical state of the indicator regions on the test strip.
The electronic device can be arranged for determining a background intensity level before or during the procedure of determining the intensity levels of the peaks. The background level can be determined for example from a blank portion of the test strip surface. The background level can be used for correction of the measured peak levels and to improve accuracy of the test results. The electronic device is arranged to evaluate if the viewing condition for the detector is sufficient or not, and to indicate this on the display means and/or by a loudspeaker that generates an audio signal.
The skilled in the art will appreciate that the detection method can be extended to two or more analytes by providing more than two specific indicator regions on the test strip. In an embodiment, the indicator surface of the test strip comprises at least two indicator regions,
and the processing unit is arranged to determine the test result signal based on the respective optical state of each of the at least two indicator regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit.
In this embodiment, the processing unit is arranged to determine the presence of the peaks of the respective indicator regions and their respective intensity. Next the processing unit is arranged to compare the intensity values of the peaks and to determine from the difference(s) or ratio(s) if the analyte(s) was present in the fluid.
In an embodiment, the processing unit of the electronic device is arranged to produce an output result signal associated with the presence of the analyte. Such an output result signal may be stored temporarily in the memory and later be transmitted to a computer for data processing.
In an embodiment, the processing unit is arranged to add a code stamp to the output result signal. This may simplify the data processing at later time.
The code stamp may comprise one or more of an identifier code, a location code, a number, to allow identification of the associated instance of testing of fluid.
In yet a further embodiment, the electronic device comprises a timer which is coupled to the processing unit, and the processing unit is arranged to derive a time code from the timer and to add a time stamp to the output result signal.
It will be also appreciated that the detector may alternatively be arranged to measure absorbance in stead of reflectivity. As known to the skilled in the art, this may yield a differently shaped curve for the measured temporal signals of the respective reactive regions in the indicator region, but a similar principle as above to compare between the first and second absorption values CI, C2 to determine presence of analyte in the fluid can be applied. Figure 9 shows a flow diagram of a measurement procedure 700 for use of the electronic device in accordance with the invention.
The procedure 700 starts with action 701, wherein a test strip with indicator region(s) is inserted in a fluid to be tested for the presence or absence of an analyte.
After exposing the test strip to the fluid, the test strip is inserted transversely to its longitudinal direction in the slit 100 of the electronic device 1 (see action 702). The surface of the test strip holding the indicator region(s) is facing the first side wall 110. The holding means 130; 140; 150 provide that the test strip is held against the first side wall 110 of the slit. The electronic device 1 is activated by the sensing device 50 that senses the insertion of the test strip.
Next in action 703, the test strip is slideably moved along the longitudinal direction of the slit. In this manner, the indicator region(s) of the test strip passes over the detector 20 under the viewing window 120 in the first side wall 110.
In action 704, substantially simultaneous with action 703, the detector 20 detects the optical state of the indicator region(s) and transmits the data to the processing unit 10.
In subsequent action 705, the processing unit compares the measured peak intensities and the processing unit 10 calculates a test result signal based on the optical state of the indicator region(s) of the test strip as detected by the optical detector (for example, the difference or ratio of the intensity peaks in the signal detected by the detector).
In action 706 the processing unit determines from this comparison if the analyte is present in the fluid.
Finally in action 707, the processing unit generates an output result signal associated with the presence to the display means. Additionally, the processing unit may process the output result signal further with a code or time stamp, and may store the output result signal in memory and/or may control transmitting the output result signal to a further computing device (e.g. a server).
Thus, the invention relates to a method for analysis of a fluid by means of a test strip with an indicator surface holding at least one indicator region and by an electronic device as described above; wherein the method comprises:
- exposing the test strip to the fluid to be tested;
- inserting the test strip into the slit of the electronic device wherein an inserting direction is substantially transverse to a length of the test strip, in such a way that the slit receives the test strip in a transverse direction with respect to the length of the test strip;
- moving the test strip through the slit along the longitudinal direction of the slit wherein the test strip moves through the slit substantially parallel to the surface of the electronic device in which the slit is located;
- operating the electronic device, comprising sensing by a detector of the electronic device an optical state of the reactive surface indicator region of the test strip, while the test strip moves through the slit.
In an embodiment the method comprises: - activating the operation of the electronic device during or after insertion of the test strip.
In a further embodiment the method comprises: - sensing the insertion or presence of the test strip in the slit of the electronic device by a sensing device; and - based on the sensed insertion or presence activating the operation of the electronic device.
In a further embodiment the method as described above comprises that the operation of the electronic device is controlled by the processing unit of the electronic device.
In a further embodiment the method as described above comprises that the processing unit calculates a test result signal based on the optical state of the at least one reactive surface region of the test strip as detected by the optical detector.
In an additional embodiment the method as described above comprises that the processing unit compares the peak intensities, and determines from this comparison a presence of an analyte in the fluid being tested.
In a further embodiment, the method as described above comprises determining a background intensity level and using the background intensity level as a correction for measuring the peak intensities.
In a further embodiment the method as described above comprises that the test strip comprises at least two reactive surface regions,
and the processing unit determines the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit. In a further embodiment the method as described above comprises that the processing unit determines the test result signal based on a difference between the optical state of each of the at least two reactive surface regions.
Further, the invention relates to a method in which the test strip comprises at least two reactive surface regions, and the processing unit is arranged to determine the test result signal based on the respective optical state of each of the at least two reactive surface regions, wherein each of the respective optical states is established while the test strip is being moved along the optical detector in the slit.
In a further embodiment, the method comprises that the processing unit is arranged to determine the test result signal based on the difference between the optical state of each of the at least two reactive surface regions.
In an embodiment, the analyte is an antibiotic substance such as a beta-lactam antibiotic and the liquid is a dairy related fluid such as milk.
The invention has been described with reference to the preferred embodiment. Obvious modifications and alterations will occur to others upon reading and
understanding the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims.

Claims

Claims
1. Electronic device for analysis of a fluid by means of a test strip with an indicator surface holding a reactive surface region, comprising:
a processing unit, memory, display means, receiving means for a test strip, an optical detector, and a casing;
within the casing the processing unit being coupled to the memory and to the display means, the optical detector being arranged in the receiving means and coupled to the processing unit;
wherein the casing comprises a slit on a surface of the casing, the slit having first and second side walls and a bottom wall, the first and second side wall being opposite and parallel to each other with the bottom wall surface facing towards the opening of the slit;
the slit being arranged for receiving the test strip in a transverse direction with respect to the length of the test strip,
the first side wall surface of the slit being arranged as a support surface for supporting in use an longitudinal edge of the test strip;
the optical detector being arranged in the first side wall of the slit for detecting an optical state of the reactive surface region of the test strip, and
the electronic device is provided with holding means for holding the test strip within the slit and for pressing the indicator surface against the first side wall.
2. Electronic device according to claim 1, wherein the holding means is a resilient flap within the slit, attached to the casing and moveable toward the first side wall.
3. Electronic device according to claim 2, wherein the holding means comprise a flexible support structure for holding test strip, the support structure comprising two upward notches each running parallel to the length of the slit, and being arranged to create a holding space between them for taking up the test strip.
4. Electronic device according to any one of the preceding claims, wherein the slit comprises openings at each of its longitudinal ends, in such a way that the test strip can be slideably moved along its longitudinal direction through the slit.
5. Electronic device according to any one of claims 1 - 4, wherein the optical detector comprises a single photodetector and a pair of LEDS as illumination means, and the photodetector is positioned intermediate the pair of LEDs.
Electronic device according to any one of the preceding claims, further comprising a sensor or switch which is coupled to the processing unit and is arranged within the slit for detecting a presence of the test strip so as to power the electronic device when the test strip is present.
Electronic device according to claim 6, wherein the sensing device is arranged identifying the test strip by reading information from an information holding region on the test strip.
Electronic device according to claim 6 or claim 7, wherein the sensing device comprises a barcode reader arranged for reading barcode information from the test strip, or the sensing device comprises a wireless reader arranged for reading information from a wirelessly readable tag or chip that is embedded or attached to the test strip.
9. Electronic device according to any one of the preceding claims 6 - 8, wherein the processing unit is arranged for evaluating the information from the sensing device, e.g. by comparison with predetermined data, and for activating the electronic device for operation.
10. Electronic device according to any one of the preceding claims, wherein
the processing unit is arranged to calculate a test result signal based on the optical state of the indicator surface of the test strip as detected by the optical detector, and
the processing unit is arranged to generate an output result signal based on the test result signal to the display means.
11. Electronic device according to claim 10, wherein the output result signal is a two- state signal, having a result value indicating either a positive or a negative result of the analysis.
Method for analysis of a fluid by means of a test strip with an indicator surface holding at least one reactive surface region and by an electronic device for analysis of a fluid by means of a test strip with an indicator surface holding a reactive surface region, comprising:
a processing unit, memory, display means, receiving means for a test strip, an optical detector, and a casing;
within the casing the processing unit being coupled to the memory and to the display means, the optical detector being arranged in the receiving means and coupled to the processing unit;
wherein the casing comprises a slit on a surface of the casing, the slit having first and second side walls and a bottom wall, the first and second side wall being opposite and parallel to each other with the bottom wall surface facing towards the opening of the slit;
the slit being arranged for receiving the test strip in a transverse direction with respect to the length of the test strip,
the first side wall surface of the slit being arranged as a support surface for supporting in use an longitudinal edge of the test strip;
the optical detector being arranged in the first side wall of the slit for detecting an optical state of the reactive surface region of the test strip; the method comprising:
- exposing the test strip to the fluid to be tested;
- inserting the test strip into the slit of the electronic device wherein an inserting direction is substantially transverse to a length of the test strip, in such a way that the slit receives the test strip in a transverse direction with respect to the length of the test strip;
- moving the test strip through the slit along the longitudinal direction of the slit wherein the test strip moves through the slit substantially parallel to the surface of the electronic device in which the slit is located; - operating the electronic device, comprising sensing by a detector of the electronic device an optical state of the indicator region of the test strip, while the test strip moves through the slit.
13. Method according to claim 12, wherein the electronic device is provided with holding means for holding the test strip within the slit and for pressing the indicator surface against the first side wall, the method comprising:
holding the test strip within the slit and pressing the indicator surface against the first side wall by means of the holding means.
14. Method according to claim 12 or 13, wherein the electronic device is in
accordance with any one of the preceding claims 2 - 11.
15. Use of an electronic device for determining the presence of an analyte in a fluid in accordance with any one of the preceding claims 1 - 11.
16. A kit of parts for analysis of a fluid comprising a test strip with an indicator surface holding a reactive surface region and an electronic device for determining the presence of an analyte in a fluid according to any one of the preceding claims 1 - 11.
PCT/NL2013/050683 2012-09-28 2013-09-23 Test strip reading device and method for reading a test strip WO2014051425A1 (en)

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US201261706866P 2012-09-28 2012-09-28
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