WO2012078455A1 - Kit de test allergène - Google Patents

Kit de test allergène Download PDF

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Publication number
WO2012078455A1
WO2012078455A1 PCT/US2011/062960 US2011062960W WO2012078455A1 WO 2012078455 A1 WO2012078455 A1 WO 2012078455A1 US 2011062960 W US2011062960 W US 2011062960W WO 2012078455 A1 WO2012078455 A1 WO 2012078455A1
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WO
WIPO (PCT)
Prior art keywords
sample
food
chamber
mixing
diluent
Prior art date
Application number
PCT/US2011/062960
Other languages
English (en)
Inventor
Joshua Makower
Clint Slone
Imraan Aziz
Michael Strasser
James Joslin
Earl Bright Ii
Urs Andres Ramel
Sae Hyun Choo
Original Assignee
Exploramed Iii, Inc.
Choo, Dan
Kim, Mina
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 Exploramed Iii, Inc., Choo, Dan, Kim, Mina filed Critical Exploramed Iii, Inc.
Publication of WO2012078455A1 publication Critical patent/WO2012078455A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/02—Food

Definitions

  • a mobile test kit that can identify the presence of an allergen will provide additional confidence to someone suffering from severe allergies in a context where the source of food is not trusted.
  • Figure 1 illustrates options for a part durable, part disposable embodiment.
  • FIG. 2 illustrates some of the devices that can be used for sampling food in accordance with certain embodiments of the present invention.
  • Figure 3 illustrates diluent reservoirs and methods for releasing diluent in accordance with certain embodiments of the present invention.
  • Figure 4 illustrates several kinds of mixing according to various embodiments of the present invention.
  • FIG. 5 illustrates a variety of heating technologies and heating methods in accordance with various embodiments of the present invention.
  • Figure 6 illustrates consumable heat technologies and disposable heating features.
  • Figure 7 illustrates mixing technologies according to certain embodiments of the present invention.
  • Figure 8 illustrates various filtering and metering methods according to embodiments of the present invention.
  • Figure 9 illustrates lateral flow technology testers according to embodiments of the present invention.
  • Figure 10 illustrates testing technologies according to various embodiments of the present invention.
  • Figure 1 1 illustrates a system according to certain embodiments of the present invention.
  • Figure 12 illustrates a color changer kit according to an embodiment of the present invention.
  • Figure 13 illustrates a disposable kit employing lateral flow technology.
  • Figure 14 illustrates an embodiment that employs a fmger crusher.
  • Figure 15 illustrates an embodiment that employs a fmger crusher and pop packet.
  • Figure 16 illustrates an embodiment that employs a fmger crusher and corer.
  • Figure 17 illustrates an embodiment employing a corer and wiper.
  • Figure 18 illustrates an embodiment employing a corer and abrasive beads.
  • Figure 19 illustrates an embodiment employing a corer and shaker.
  • Figure 20 illustrates a corer pen according to an embodiment of the present invention.
  • Figure 21 illustrates an embodiment including a blender.
  • a manually operated blender is provided.
  • Figure 22 illustrates an embodiment including a rotor/stator blender.
  • Figure 23 illustrates an embodiment including a ladle/scraper/scoop.
  • Figure 24 illustrates a method according to an embodiment of the present invention.
  • Certain embodiments of the present invention can provide sensing of allergens such as proteins, including peanut proteins, via an allergen test kit.
  • certain embodiments provide ways of testing foods, where generally anything edible is viewed as a food, including liquids such as juices and shakes. Other things besides foods can be tested with embodiments of the present invention, with foods providing one example of the samples that can be tested.
  • Certain embodiments of the present invention can be used to test for allergens of other food types such as almond, egg, gluten, hazelnut, shellfish, soy, and milk.
  • kits can be made and used in accordance with embodiments of the present invention.
  • the systems may be characterized by having three major components: an instrument, a sample preparation and assay cartridge, and a sample collector.
  • the sample collector can be used to collect the sample. In some cases, the sample collector also ensures that a precisely measurable quantity of the sample is collected.
  • the sample preparation and assay cartridge can interface with the sample collector and the instrument.
  • the sample collector can, in certain embodiments, be inserted into the sample preparation and assay cartridge during the test of the sample.
  • the sample preparation and assay cartridge can contain a buffer, a strip, and other elements that are used to prepare the sample for testing, such as diluent.
  • the instrument component can be a component that connects with the sample preparation and assay cartridge to provide a qualitative result to the user.
  • the parts of an instrument component may include a display, a battery, electronics, and software to read a strip or similar item in the sample preparation and assay cartridge.
  • kits there are several possible embodiments for a kit according to certain embodiments of the present invention.
  • the kit is largely reusable or durable, whereas a portion of the kit can be disposable.
  • the kit is largely or entirely disposable.
  • Certain embodiments of the present invention may permit separation of the durable and disposable components so that the kit can be reconstructed by adding a new disposable portion to the durable portion.
  • certain embodiments of the present invention may permit separation of the kit into a recyclable portion and a non- recyclable portion, even if the entire kit is disposable.
  • Other parts of the kit may be reusable over many uses, but may need to be periodically replaced, such as a battery. Alternatively, the battery can be configured to be recharged while in the kit.
  • a durable portion of the kit may be able to be cleaned for storage or reuse by rinsing the disposable portion in water.
  • the durable portion of the kit may be arranged in a configuration in which there is no need to perform maintenance, such as rinsing, on the durable portion.
  • the durable and disposable parts can be variously selected.
  • Figure 1 illustrates options for a part durable, part disposable embodiment.
  • the durable part may include a heater, a mixing device, a strip reader, and an output or display.
  • the output or display may be a liquid crystal display (LCD) or light emitting diode display (LED).
  • the strip reader may be a single strip reader or a multi-strip reader.
  • the disposable parts may include parts for cutting or collecting, parts for diluting, parts for mixing, parts for heating, as well as parts for filtering or metering.
  • the mixing and heating parts are mentioned both as possible durable parts as well as possible disposable parts.
  • One factor that can be considered in deciding whether to make something a disposable is the level and kind of contamination it receives in use. For example, if a mixing tool has been used on a sample that has tested positive, it may be time to replace the mixing tool. On the other hand, it may be necessary to remove a testing strip after every use, because it may not be possible to adequately clean the strips before the next use.
  • the heating part may heat using a chemical reaction and consequently may need to be disposed of because the reactive chemicals are depleted by the reaction.
  • the first part of a kit that may be contaminated is the collection portion of the kit. This is the section that may come in direct contact with the food. Accuracy of tests may be dependent on the quality of the sample. In particular, it may be helpful to ensure that the sample is representative of the food being sampled. Moreover, it may be desirable that the collection portion be configured to be large enough to collect representative samples of an entire plate of food. Thus, the collection portion may be configured with an appropriately large volume.
  • FIG. 2 illustrates some of the devices that can be used for sampling food in accordance with certain embodiments of the present invention.
  • the user's own utensils can be used.
  • a scoop, corer, slicer, sharp spoon, or the like can be used.
  • a swab such as a micro-grating swab, a soft swab, or a honeycomb swab may be used.
  • Other devices such as an auger or a pipette/dropper can also be used.
  • a combination device such as a slicer/scoop/ladle can also be used.
  • a sample Once a sample has been collected, it can be sealed in a chamber. This chamber can be the place where diluting and mixing take place. These steps can be performed in any order that is desired or convenient, though for the purposes of illustration a step of adding the diluent is discussed as coming first.
  • FIG. 3 illustrates diluent reservoirs and methods for releasing diluent in accordance with certain embodiments of the present invention.
  • the diluent can be stored in a reservoir for the purpose of keeping the diluent constantly on hand.
  • the reservoir can be contained behind a foil seal, contained in a squeeze- to-burst packet, or placed within a body of the device, such as within a cap-lid of the device, or within a disposable compartment.
  • the diluent can be a buffer formulation or protein mixture. Various customized additives, stabilizers, and the like can be incorporated into the diluent.
  • the diluent can be configured to alter and optimize the characteristics of the sample for testing. Any diluent can be used, but an appropriate diluent can be selected based on the type of assay being performed.
  • a protein quantitation diluent may be used in certain embodiments.
  • Foil sealing in the diluent can be punctured with a sharp object, a weld can be peeled apart, or a packet or seal can be squeezed until it bursts.
  • the mixing and morsellation (turning into morsels or fragments) of the sample may benefit from complexity that is more conveniently rendered durable than disposable.
  • motors, batteries, buttons, levers, and gears can be part of a durable reader kit.
  • Mixing can fall into two categories: manual mixing and powered mixing.
  • Other kinds of mixing, such as chemical or incidental mixing in which natural movements are used to mix, are also possible.
  • Figure 4 illustrates several kinds of mixing according to various embodiments of the present invention.
  • Powered mixing can be accomplished by an electric motor, a solenoid, a film transducer, or an ultrasonic transducer.
  • manual mixing can be accomplished by a push-push mechanism or a squeeze-crush mechanism, where by a user either with assisted, ratcheted, or unassisted power breaks up a sample.
  • a push-push mechanism the user can apply force to a button of the device, and a system of gears can convert the lateral motion of the button into rotational motion of a set of blades in a blender within a sample chamber.
  • the user can press on a floating plate supported by bellows, springs, or other suspension device, and can crush or grind the sample by applying downward force onto the plate and rotating the plate.
  • the underside of the plate and/or the bottom surface of the sample chamber may have a roughened or ridged surface that may assist in breaking up the sample.
  • twist-crank device may have a chamber with an inner gearing directed toward the sample, and an insert with an outer gear configured to rotate around the outer gear within the sample chamber.
  • the shaking device can include a ball, beads, or similar internal device to assist in breaking up the sample.
  • the ball may be caged or may be in a chamber that includes ribs. The ribs can permit flow of small particles around the ball and permit the ball to move easily in the sample chamber.
  • mixing include manual approaches such as squishing, shaking (with a ball or beads included), or grinding with the aid of a grinding element (or stator/rotor grinding pair).
  • a grinding element or stator/rotor grinding pair.
  • chamber to chamber flow via a small orifice or some form of induced turbulence can serve to help mix the sample and diluent.
  • Another option is blending with a blender.
  • Further options such as mixing chemically and using ultrasonic transduction are also permitted.
  • heating component or element may help to reduce the processing time of the assay and the overall user wait time. Incorporating the heating element into a durable component may reduce the complexity of the disposable portion of the device.
  • Figure 5 illustrates a variety of heating technologies and heating methods in accordance with various embodiments of the present invention.
  • the entire sample may be heated, or there may simply be momentary or spot heating.
  • the sample may be heated uniformly, and mixing may be used to assist in making the heating uniform.
  • momentary or spot heating the heating may be performed on a particular area of interest in the sample, such as the portion closest to a sensor.
  • heating pads or wire heaters may be broad categories of heating components that can be employed.
  • a heating pad can be either a chemical heating pad or an electrical heating pad.
  • a chemical heating pad may operate by inducing a strongly exothermic chemical reaction.
  • An electrical heating pad may operate by driving electrical power through a conductive mesh.
  • Wire heaters can operate by driving electrical power through a wire or coil that is located within or near the sample chamber.
  • the heating technologies may fall into one of several categories.
  • an external heat source can be used, such as cup of hot water, a lighter (such as a cigarette lighter), or the like.
  • User energy sources are also permitted.
  • body heat can be used.
  • the user can generate heat using turbulent mixing or compression techniques. These techniques can, of course, be combined.
  • a device-contained energy source This may be a chemical or biochemical reactive source as mentioned above. Approaches such as sodium acetate or exothermic oxidation of iron may be used.
  • the source may be a gas or liquid fuel, an electric power source such as a battery or capacitor.
  • the electric energy source can supply electricity to a nichrome wire, cartridge, printed film/polymer, cartridge, or the like.
  • Certain features of the heater to heat the sample may need to be in a disposable component, so as to effect the best possible heat transfer.
  • the heat source could, of course, be entirely located in the disposable component. If the heat is strong enough, insulation can also be provided for the device.
  • Figure 6 illustrates consumable heat technologies and disposable heating features.
  • the consumable heat technologies can include sodium acetate or exothermic oxidation of iron.
  • combustible fuels such as naphtha or butane can be used as a consumable heat technology.
  • Disposable heating features can vary.
  • a disposable component is placed into electrical connection with a durable component.
  • electricity stored in the durable component can be used to heat an element in the disposable component.
  • a conductive surface in a reusable component may serve as a lead to connect to a corresponding surface in a disposable component.
  • the disposable component may be equipped with features such as double walls and insulation. These measures may help to ensure more efficient transfer of heat to the sample and may also help to protect the hands of the user of the kit.
  • a temperature sensor and/or display can be used to determine that an appropriate temperature has been reached.
  • the appropriate temperature may be around 60 °C, from 60-70 °C, from 60-80 °C, or from 50-100 °C.
  • the temperature display may be a thermometer, which may be useful if the user is attempting to control the temperature manually.
  • the device may contain a thermostat or thermal breaker that discontinues heating the sample when a certain temperature has been reached.
  • Figure 7 illustrates mixing technologies according to certain embodiments of the present invention.
  • the mixing can take place before, during, or after heating.
  • Technologies for mixing include manual squishing, manual shaking (optionally with balls or beads), and chamber-to- chamber flow in which a small orifice or induced turbulence helps to mix.
  • Other technologies including grinding with a set of spinning stators (also known as rotors) and stationary stators and blending with a bladed mechanism. The preceding mechanisms are primarily reliant simply on mechanical forces, but other techniques such as chemical mixing or ultrasonic mixing are also permitted.
  • Filtering can be variously performed.
  • Figure 8 illustrates various filtering and metering methods according to embodiments of the present invention.
  • filtering can be done with a simple polymer screen, a fine porous membrane, or a non-woven organic absorber, such as cotton.
  • various metering methods can be performed. For example, a method of excess fluid absorption can be used to help meter the sample. Likewise, a controlled air pump can used to controllably dispense a precise amount of sample. Other metering techniques, such as a plunger, are also permitted.
  • FIG. 9 illustrates lateral flow technology testers according to embodiments of the present invention. Two examples are shown that incorporate various features already discussed above. A first example is all disposable, whereas a second example is part disposable, part durable.
  • a lateral flow enzyme-linked immunosorbent assay (ELISA) and an optical reader can be used in combination to detect the presence of proteins, such as peanut proteins.
  • the analyte may be a protein that is not cell associated.
  • the protein may have a molecular weight in the range of 17kd to 65kd.
  • Antibodies may be used, but it may be valuable to ensure that the antibodies are of high quality.
  • the concentration ranges may vary depending on the food source being tested and the method of obtaining the sample, the sensor should be configured not to give false indications (either positive or negative) in the event that the analyte is overloaded.
  • the strips may be provided in card form, or they may be provided as part of an assembled cartridge.
  • Nano-tube sensors can be used. Nano-tube sensors can electrically sense various proteins.
  • the nano-tube sensor can be equipped with self-contained reagent reservoirs.
  • the nano-tube sensor can also include a single-use disposable cartridge and sensor arrays.
  • Nano-bio sensors can mimic the way that human (and other mammal) noses respond to odors and may be able to detect proteins (such as peanut proteins) in very small concentrations.
  • a further alternative is to use optical sensors. Proteins, such as peanut proteins, can be identified based on a spectrum of light absorption, reflection, or diffraction. The optical analysis may be performed on a powder or slurry sample.
  • liquid microwell assay may be equipped with a color-changing indicator to indicate to the user the presence of proteins of interest, such as peanut proteins.
  • bio/chemically engineered immunosensor may rely on biochemical reactive patches in a manner similar to a pH strip, thereby providing an indication of the presence and strength of particular proteins of interest, such as peanut proteins.
  • the sample can then be incubated, if needed to allow the desired protein or other target to be extracted. Subsequently, a portion of the sample can be introduced, in a metered amount to the sensor, which may be a lateral flow strip. Ensuring that a properly metered and filter amount of the sample is applied may require both filtering and metering sub-components.
  • the system may be constructed to include an instrument portion and a consumable portion.
  • the consumable portion may include a sample preparation enterer (SPE) and a sample collector, as well as a strip.
  • the sample collector may feed sample to a buffer.
  • the buffer may be serviced by heating/dilution and mixing components.
  • the buffer then may provide the sample to the strip, via a delivery system.
  • the strip can include a variety of zones.
  • a first zone of the strip may be a sample/filter pad (SP).
  • SP sample/filter pad
  • the sample/filter pad may filter and transport extracted sample to the strip.
  • a second zone may be a label zone.
  • This label zone may contain an indicator that binds in the measurement zone (MZ) when analyte is present.
  • MZ measurement zone
  • CZ control zone
  • EP end pad
  • a consumable switch may be configured to determine that a consumable portion has been attached to the instrument.
  • a sample switch may monitor the sample/filter pad to determine whether sample has entered the strip.
  • the sample switch and/or the consumable switch may be configured to "wake up" the instrument, so that measurements may be performed.
  • the sample strip and the consumable switch may be operably connected to micro digital and/or micro- analog circuitry.
  • the micro analog (or micro digital) circuitry may be connected to a light emitting diode and a photovoltaic diode. The light emitting diode may provide optics emissions directed at the control zone and measurement zone.
  • Optics detection may be performed on the control zone and measurement zone by the photovoltaic diode to determine the status of those zones.
  • the micro analog and/or micro digital circuitry which may (like the entire instrument) be powered by a battery, may provide a signal to a display based on the results obtained via processing the output of the photovoltaic diode.
  • the circuitry in the instrument may optionally direct the display to display a result for 30 minutes or an hour unless a new sample preparation and assay cartridge is inserted. There is no need for the circuitry to clear the display when the cartridge is removed.
  • the circuitry in the instrument may also count the number of tests that have been performed and may display the number of tests performed on the display. Furthermore, the circuitry may prevent more than a specified number of tests from being performed, and may indicate that a last test has been performed on the screen. Additionally, the circuitry in the instrument may indicate a battery level on the display.
  • the time for a test may vary depending on the type of test being conducted. In certain embodiments the time of the test is less then three minutes or less than five minutes.
  • the casing of the system may be fabricated from materials that are suitable for contact with human skin.
  • the materials used for the casing may be non-allergenic or hypoallergenic materials. For example, latex and nickel materials may be avoided.
  • the display of the system may be variously configured.
  • the instrument's display may indicate the presence of the sample target with a message of "LOW” for low concentrations, "MED” for medium concentrations, and "HIGH” for high concentrations. Additionally, the instrument can display the absence of protein of interest in the sample by displaying the message "NO” or "CLEAR.”
  • the display may also or alternatively be configured to display a countdown timer from the time that sample preparation and assay kit is inserted into the instrument.
  • the countdown display may indicate a time in minutes and seconds or an icon that is flashing at a predetermined rate, either at a constant rate or at a rate that varies depending on the length of time remaining in the test.
  • the display may be configured to indicate if any faults occur during the test. For example, if there is an analyte overload, the display may be configured to indicate that this situation has occurred.
  • An aural display may also or alternatively be included.
  • This aural display may provide beeps, chimes, or recorded or synthesized voice to communicate information to the user.
  • the information may be the same information as indicated above.
  • Figure 12 illustrates a color changer kit according to an embodiment of the present invention.
  • the color change kit can utilize a completely disposable liquid assay methodology rather than a lateral flow strip methodology.
  • This kit can present the user with a change of color in a visible packet when an allergen is detected.
  • the disposable package can include a rigid frame that incorporates a scraper/cutter scoop tip, which loads a sample into a multi-chambered soft mixing packet.
  • the soft mixing packet can include at least two chambers separated by a temporary partition. One chamber may be the sample chamber, and the other chamber may be the diluent chamber. Once a sample is taken, capping the device can drive the sample into the soft mixing chamber.
  • the cap may be configured to serve as a sample pusher to force the sample along the scraper/scoop tip and into the sample chamber.
  • a grill or large filter may be placed at the entrance of the sample chamber from the scraper/scoop to assist in breaking up the sample when the sample pusher in the cap presses the sample into the sample chamber.
  • the device can contain a secondary reagent separated by a dissolvable or pierceable membrane.
  • This secondary reagent may combine with the mixed diluent to produce a color change in the presence of a particular protein, such as a peanut protein. If heating is to be used, a chemical heating pack can be laminated into a backside of the soft mixing packet.
  • the temporary partition between the diluent chamber and the sample chamber can be overcome by squeezing the diluent chamber.
  • the sample can then be diluted by alternately squeezing the sample and diluent chambers. This squeezing of the chambers can also activate the optional chemical heating pack, if used.
  • Figure 13 illustrates a disposable kit employing lateral flow technology.
  • a sample chamber may be manually loaded by the user.
  • the sample chamber may be separated from the diluent chamber with a temporary partition. After the sample is loaded, a sensor and filter part can be used to cover the sample chamber.
  • the diluent chamber can be crushed, thereby breaking the temporary partition.
  • the diluent and sample chambers can be alternately crushed, as in the embodiment shown in Figure 12, until a satisfactory mix has been accomplished.
  • the sample chamber can then be inverted, such that gravity pulls the mixed sample and diluent through the filter and onto the lateral flow strip. If the presence of a protein or proteins of interest is sensed, the lateral flow strip can indicate the presence of the protein or proteins.
  • the embodiment shown in Figure 13 may be heated by a chemical heat pack laminated into a back side of the chambers that are to be crushed.
  • Figure 14 illustrates an embodiment that employs a finger crusher.
  • a durable reader such as a durable strip reader
  • two disposable parts are included.
  • the two disposable parts can be inserted into the reader and then separated from one another, leaving one disposable part in the reader.
  • a sample can be placed in a spoon-style sample receptacle, either by placing the sample into the receptacle, or by using the receptacle to scrape or scoop a sample of the food.
  • the two disposable parts can then be rejoined. Once the parts are rejoined, a diluent chamber can be crushed to break a temporary partition or seal between the diluent and the sample.
  • the user can then mix the sample and diluent by crushing and/or rotating an abrasive plate that is suspended in a floating position on bellows. While the mixing is being performed, a later flow strip can begin to wick up the sample through a porous filter.
  • Figure 15 illustrates an embodiment that employs a finger crusher and pop packet.
  • the construction of this embodiment may be similar to that discussed above in reference to Figure 14.
  • the embodiment shown Figure 15 has a diluent pop packet rather than a diluent chamber.
  • the diluent pop packet is burst by the use of the abrasive crush plate, operated as discussed with reference to Figure 14.
  • Figure 15 also illustrates a reader output display.
  • a liquid crystal display can indicate a safety condition and optionally a percentage of confidence, for example, "Safe 100%.”
  • Figure 16 illustrates an embodiment that employs a finger crusher and corer.
  • the construction of the crusher portion of the device may be similar to that discussed above.
  • the sample receptacle may be supplied by a corer that is configured to provide a core of a sample.
  • a cap for the corer may include a pusher that is configured to push the core into the sample receptacle and seal the receptacle.
  • the corer may be provided with minimum/maximum lines to help the user determine what size core to take. Alternatively, a physical fill to stop point may be employed to ensure a consistent sample size.
  • Diluent may be variously supplied to the sample receptacle. One example is by providing a pop packet within the receptacle.
  • FIG 17 illustrates an embodiment employing a corer and wiper.
  • a disposable core-sampling tip can allow for a controlled sample size to be taken from a wide variety of foods.
  • the corer may be covered with a cap that includes a pusher for pushing the core into a sample chamber. Once an appropriate number of core samples have been taken, the disposable portion can be slid into a reusable reader.
  • the reusable reader can be equipped with a wiper element that crushes a diluent chamber in the disposable portion thereby supplying diluent to the sample chamber.
  • the sample can then be heated by a chemical heat wrap disposed around the sample chamber, and the user can mix the sample and diluent by vigorously shaking the device.
  • the flow strip can then wick the sample through a porous filter, and the reusable reader can provide a reading based on the flow strip.
  • Figure 18 illustrates an embodiment employing a corer and abrasive beads.
  • This embodiment may be constructed similarly to that shown in Figure 17, but the sample chamber may further incorporate abrasive beads, for example polyhedrons or spheres, to aid in the mixing process.
  • the heating element may be a wire loop disposed in the sample chamber and supplied with a source of electrical power. The source of the electrical power can be in the reusable reader. Additionally, in this embodiment, a one-way valve is used to supply the diluent into the sample chamber.
  • Figure 19 illustrates an embodiment employing a corer and shaker.
  • the corer portion may be constructed similarly to the embodiments shown in Figure 16.
  • the corer may feed a sample receptacle that is designed to be vigorously shaken until the sample is sufficiently pulverized.
  • the sample receptacle may be pre-loaded with diluent.
  • the diluent may initially be contained by a barrier that is broken when the core sample is forced into the sample receptacle.
  • Figure 20 illustrates a corer pen according to an embodiment of the present invention.
  • the corer and cover may function similarly to the covers and corers shown in Figures 16 and 17.
  • a pressuring cap may be supplied on the cover to provide air pressure to assist in pushing a core through a corer and into a sample chamber.
  • the sample chamber may be supplied with a mixing ball that may be designed to crush and mix the sample.
  • Ribs may be provided in the sample chamber to permit flow of sample, diluent, and diluted sample.
  • the diluent may be provided in the sample chamber initially, and a membrane may be provided at the entrance to the sample chamber to be pushed aside by the core samples as they enter the sample chamber.
  • a filter and strip may be connected to another end of the sample chamber.
  • a reusable reader can be configured to read the strip in use.
  • a temporary blocking device such as a gate, may be placed between the sample chamber and the strip to prevent early wetting of the strip by the diluent.
  • a chemical wrap around the sample chamber may be used to heat the sample and diluent.
  • FIG 21 illustrates an embodiment including a blender.
  • a manually operated blender is provided.
  • the manually operated blender can provide for a very thorough mixing of a sample.
  • the blender may be contained in a disposable part, but may be powered through a gearing mechanism that is at least partly contained in a reusable section.
  • the gearing mechanism can be powered by a push-button drive.
  • the construction of the embodiment may be similar to the embodiments shown in Figure 17 and Figure 18.
  • inserting the disposable portion into the durable portion can squeeze the diluent into the sample chamber and engage a spur gear in the disposable portion with a durable drive train in the reusable portion.
  • conductive heat pads can be used under the sample chamber to heat the sample. Leads for the heat pads can be provided such that electrical power for the heat pads can be supplied from the reusable portion of the kit.
  • the sample chamber can be double walled, which may permit it to better retain heat.
  • Figure 22 illustrates an embodiment including a rotor/stator blender.
  • the sample chamber may be filled by the user using the user's own utensils. The sample may then be closed to seal the sample during mixing. The disposable component may then be slid onto the durable reader, which may squeeze the diluent into the sample chamber and engage a spur gear in the disposable part with a durable drivetrain.
  • a user of the kit can then mix the sample and diluent into a solution by pressing a button to drive the blender, while conductive pads on the durable component heat the sample from the bottom.
  • the lateral flow strip can wick diluted sample through a porous sponge filter and can be read by the durable optical reader.
  • the blender may have multiple settings, shown as “1", “2", and “3”, which may designate "off,” “low speed,” and “high speed.”
  • the liquid crystal display may provide a binary indication of safety, such as the message, "CLEAR" or the like.
  • Figure 23 illustrates an embodiment including a ladle/scraper/scoop.
  • one end of the disposable portion may be configured to serve as a ladle for liquids, or for a scoop or scraper for other types of food samples.
  • the scraper or ladle can be provided with a grating that can break up a sample as it enters the ladle area.
  • a cap not shown, can cover the end of the disposable portion, once the sample is collected. Squeezing the diluent reservoir can deliver diluent into the sample chamber. Subsequently, a wick or perforated tube can provide the diluted sample to a testing chamber.
  • the diluted sample is drawn into the testing chamber by squeezing on the testing chamber or alternately squeezing the testing and diluting chambers.
  • the reader for this embodiment may operate as in other illustrated embodiments.
  • Figure 24 illustrates a method according to certain embodiments of the present invention.
  • a method can performed using a test kit as described herein.
  • the method can include detecting the presence of at least one allergen in a sample of food using the test kit. More specifically, the method can include adding 2210 a sample of food to the receptacle of the kit.
  • the adding 2210 the sample of food to the receptacle can include at least one of scraping 2212, scooping 2214, ladling 2216, or coring 2218 the sample of food.
  • the method can also include moving 2220 the sample of food from the receptacle to the sample chamber.
  • the moving 2220 the sample of food from the receptacle into the sample chamber can include at least one of pushing 2222 the sample of food into the chamber and applying 2224 air pressure to the sample of food.
  • the method can further include adding 2230 diluent to the sample of food in the sample chamber.
  • the adding 2230 the diluent can include at least one of puncturing 2232 foil with a sharp object, peeling 2234 apart a weld, squeezing 2236 a squeeze-to-burst packet, or squeezing 2238 a squeeze-to-burst line seal.
  • the method can include inserting 2240 a disposable portion of the apparatus into a reusable portion of the apparatus.
  • the inserting 2240 the disposable portion of apparatus into the reusable portion of the apparatus can include simultaneously adding 2242 diluent to the sample of food.
  • the method can also include mixing 2250 the sample and diluent in the sample chamber.
  • the mixing 2250 can include at least one of powered mixing 2251 or manual mixing 2255.
  • the powered mixing 2251 can include using 2252 at least one of an electric motor, a solenoid, a film transducer, or an ultrasonic transducer.
  • the powered mixing 2251 can include at least one of blending 2253 or grinding 2254.
  • the manual mixing 2255 can include at least one of manual squishing 2256, push-push mixing 2257, squeeze/crush mixing 2258, shaking 2259, chamber to chamber flow 2249, shaking assisted by a ball or beads 2248, or twist-crank mixing 2247.
  • the method can include heating 2260 the sample in the sample chamber.
  • the heating 2260 can include at least one of providing 2261 an external heat source, providing 2262 a user energy source, and providing 2263 a device contained energy source.
  • the providing 2261 the external heat source can include heating 2264 the apparatus with at least one of a cup of hot water or a lighter.
  • the providing 2262 the user energy source can include heating 2265 the apparatus with at least one of body heat, turbulent mixing, or compression.
  • the providing 2263 the device contained energy source can include heating 2266 using at least one of an electric heater or a fueled heater.
  • the heating 2260 can include at least one of heating 2267 the entirety of the sample or momentary/spot heating 2268 of the sample.
  • the method can additionally include filtering 2270 the sample before providing the sample to a sensor. Moreover, the method can also include testing 2280 the sample of food.
  • the testing 2280 the sample of food can include providing 2281 the sample of food to at least one of a bio/chemically engineered immuno-sensor, a microwell assay, a later flow strip, an optical sensor, an olfactory sensor, or a nanotube sensor.
  • the method can additionally include displaying 2290 a detection result of the detecting to a user of the device.
  • the displaying 2290 the detection result can include displaying 2292 an indicator of whether a protein of interest was detected.
  • the displaying 2290 the detection result can include displaying 2294 an indicator of how much of a protein of interest was detected.
  • Certain embodiments of the present invention may have various advantages. For example, certain embodiments may provide a minimal number of user steps and a minimal amount of user interaction. Likewise, certain embodiments may perform tests with minimal costs and a minimal overall testing time. Moreover, certain embodiments may provide a universal collection tool for all food types. Moreover, certain embodiments may permit sample mixing and homogenization. Embodiments may be portable and of small form profile. Thus, for example, certain embodiments may be able to fit in a pocket, purse, pocketbook, or into the pocket of a backpack. Certain embodiments of the present invention may be suitable for use in schools or restaurants, or on vacation. Because the container of diluent may be small, certain embodiments of the present invention may be suitable for air travel and for testing food while onboard an airplane.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Food Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
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  • Biochemistry (AREA)
  • Biotechnology (AREA)
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  • Microbiology (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

La présente invention concerne la possibilité de réaliser soi-même un test allergène dans un restaurant, chez soi, lors d'une fête etc. au moyen d'un kit, afin d'aider les personnes souffrant d'allergies à vivre plus en sécurité. En particulier, un kit de test portable apte à identifier la présence d'un allergène peut permettre de donner davantage confiance à une personne souffrant d'allergies graves, dans un contexte dans lequel la source d'un aliment n'est pas fiable.
PCT/US2011/062960 2010-12-06 2011-12-01 Kit de test allergène WO2012078455A1 (fr)

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US61/420,124 2010-12-06

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US9987633B2 (en) 2014-06-09 2018-06-05 3M Innovative Properties Company Assay devices and method of detecting a target analyte
EP3183575A1 (fr) * 2014-08-22 2017-06-28 NMI Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen Appareil de test pour analyser un aliment au sujet d'un analyte et bandelette réactive destinée à cet effet
EP3268733A4 (fr) * 2015-03-09 2018-11-14 Nima Labs, Inc. Procédé et système de détection d'allergènes dans un produit consommable
WO2016145061A1 (fr) * 2015-03-09 2016-09-15 6SensorLabs, Inc. Procédé et système de détection d'allergènes dans un produit consommable
US10835897B2 (en) 2015-03-16 2020-11-17 Dots Technology Corp. Portable allergen detection system
WO2016149253A1 (fr) * 2015-03-16 2016-09-22 Dots Technology Corp. Système de détection d'allergènes portable
US20180154350A1 (en) * 2015-03-16 2018-06-07 Dots Technology Corp. Portable allergen detection system
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US10605740B2 (en) 2015-04-28 2020-03-31 Aterica Inc. Portable organic molecular sensing device and related systems and methods
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US20180188139A1 (en) * 2015-06-22 2018-07-05 Dots Technology Corp. Improved assays and methods for allergen detection
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US10908139B2 (en) 2016-03-15 2021-02-02 Dots Technology Corp. Systems and methods for allergen detection
WO2017160616A1 (fr) * 2016-03-15 2017-09-21 Dots Technology Corp. Systèmes et procédés pour la détection d'allergènes
CN108780027A (zh) * 2016-03-15 2018-11-09 多茨技术公司 变应原检测的系统和方法
US20190079063A1 (en) * 2016-03-15 2019-03-14 Dots Technology Corp. Systems and methods for allergen detection
CN107037208A (zh) * 2016-11-18 2017-08-11 百奥森（江苏）食品安全科技有限公司 一种多功能荧光免疫层析快速定量检测卡
US11591557B2 (en) 2017-02-21 2023-02-28 Dots Technology Corp. Systems for allergen detection
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CN107633134A (zh) * 2017-09-19 2018-01-26 中国核动力研究设计院 一种防振条扭转对蒸汽发生器传热管磨损影响的分析方法
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