EP2612707B1 - Dispositif et procédé pour tester des échantillons biologiques - Google Patents

Dispositif et procédé pour tester des échantillons biologiques Download PDF

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Publication number
EP2612707B1
EP2612707B1 EP20120150239 EP12150239A EP2612707B1 EP 2612707 B1 EP2612707 B1 EP 2612707B1 EP 20120150239 EP20120150239 EP 20120150239 EP 12150239 A EP12150239 A EP 12150239A EP 2612707 B1 EP2612707 B1 EP 2612707B1
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EP
European Patent Office
Prior art keywords
reaction chamber
housing
insertion area
reaction
test cassette
Prior art date
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EP20120150239
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German (de)
English (en)
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EP2612707A1 (fr
Inventor
Douglas Casterlin
Larry Ferringo
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American Bio Medica Corp
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American Bio Medica Corp
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Priority to PT12150239T priority Critical patent/PT2612707E/pt
Priority to ES12150239.7T priority patent/ES2501843T3/es
Priority to EP20120150239 priority patent/EP2612707B1/fr
Publication of EP2612707A1 publication Critical patent/EP2612707A1/fr
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Publication of EP2612707B1 publication Critical patent/EP2612707B1/fr
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/52—Containers specially adapted for storing or dispensing a reagent
    • B01L3/523—Containers specially adapted for storing or dispensing a reagent with means for closing or opening
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/04—Exchange or ejection of cartridges, containers or reservoirs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/08—Ergonomic or safety aspects of handling devices
    • B01L2200/087—Ergonomic aspects
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/043—Hinged closures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0829—Multi-well plates; Microtitration plates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0633—Valves, specific forms thereof with moving parts
    • B01L2400/0638—Valves, specific forms thereof with moving parts membrane valves, flap valves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5085—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
    • B01L3/50853—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates with covers or lids

Definitions

  • the present invention relates in general to a device and method for testing biological samples for an analyte of interest. More particularly, the present invention relates to a device and method for testing biological samples, such as blood, plasma, serum, urine, or saliva samples, that makes use of a reaction chamber and a housing that can be placed in fluid communication with one another and used to create a convenient platform for mixing, incubating, and depositing a reaction mixture onto a test strip in a test cassette.
  • biological samples such as blood, plasma, serum, urine, or saliva samples
  • Immunoassay devices that make use of immunochromatography are often utilized as a means to test a biological sample for the presence of an analyte of interest, such as a drug of abuse.
  • an analyte of interest such as a drug of abuse.
  • a specified volume of a biological sample can be contacted with one end of a test strip that contains a colored reagent and that also contains an antigen or antibody dried to the test strip in discrete zones.
  • the analyte in the sample reacts with the antigens or antibodies and any reactions, if present, can then simply be observed by the appearance or non-appearance of color in the discrete zones.
  • a device and method for testing a biological sample for an analyte of interest such as a drug of abuse, that allows for not only control over the biological sample being tested, but that also allows for the quick and accurate testing of drugs of abuse or other analytes of interest would be both highly-desirable and beneficial.
  • US 2009/0320623 discloses a device for a test strip holder.
  • a device for testing a biological sample includes a first reaction chamber and a second reaction chamber, where each reaction chamber has an interior wall that defines an open top of each reaction chamber and that further defines a cavity for receiving a reaction mixture.
  • the device further includes a housing that is positioned below the first reaction chamber and the second reaction chamber.
  • the housing includes a top portion, a bottom portion, a back wall, and two opposing side walls that define an open end of the housing as well as an interior insertion area that is designed to receive a test cassette containing a test strip for determining an amount of the analyte of interest in the biological sample.
  • each door includes a ramp that extends downwardly into the insertion area of the housing.
  • the ramp is biased upward, such as by the insertion of the test cassette into the insertion area of the housing, the doors are opened into the cavity of their respective reaction chambers and the reaction chambers are placed in fluid communication with the insertion area.
  • each door includes a perimeter portion that is configured to easily separate from the top portion of the housing when each ramp is biased upward.
  • each ramp includes a front edge that is angled away from the open end of the housing such that, as a test cassette is inserted into the insertion area, the test cassette progressively engages the angled front edge of each ramp and progressively pushes the doors upward into each reaction chamber.
  • a pair of stops are further included in the housing.
  • the stops are positioned on the top portion of the housing and extend downwardly into the insertion area such that the stops initially provide some resistance to the insertion of the test cassette, but then suitably engage a portion of the test cassette and secure it within the insertion area as the test cassette is fully inserted.
  • a guide is also attached to each side wall of the housing and is used to further secure the test cassette within the housing, while also preventing the test cassette from being inserted too far into the housing and prematurely contacting the ramps on the doors of the housing.
  • the guides are additionally used to align the reaction wells of the test cassettes underneath the doors such that, upon opening the doors into the cavities of their respective reaction chambers and placing the reaction chambers in fluid communication with the insertion area, the reaction mixtures flow down directly into the reaction wells of the test cassette.
  • each test cassette generally includes: a top cover that defines two reaction wells for receiving the reaction mixture from the reaction chambers and two windows for reading test results; a base that is configured to attach to the top cover; and at least one test strip that is interposed between the top cover and the base.
  • the two reaction wells are typically positioned on the top cover such that each reaction well can be aligned with each door in the top portion of the housing to allow the reaction mixture to flow directly into each reaction well upon opening the doors.
  • the top cover further includes a bridge that is positioned across each reaction well and provides support for the ramp upon the insertion of the test cassette into the insertion area.
  • the bridges allow the ramps to remain biased upward and the doors to remain open such that the reaction mixture can continue to flow into each reaction well upon the insertion of the cassette.
  • a cap is further provided for covering the open top of the first reaction chamber and the open top of the second reaction chamber.
  • the cap is connected to the housing by a flexible arm.
  • the flexible arm includes a notch that is positioned in the flexible arm such that bending the flexible arm at the notch allows the cap to be aligned with the open top of the first reaction chamber and the open top of the second reaction chamber.
  • the cap can then be easily placed down onto the reaction chambers and secured to the reaction chamber by various means to allow for the mixing and/or incubating of a biological sample and one or more reagents as part of a particular test for an analyte of interest.
  • a device of the present invention includes: a reaction chamber having an interior wall defining an open top and a cavity for receiving a reaction mixture; a housing positioned below the reaction chamber, and having a top portion, a bottom portion, a back wall, and two opposing side walls defining an open end and an insertion area for receiving a test cassette; and a door that is positioned in the top surface of the housing and includes a ramp that extends downwardly into the insertion area.
  • a biological sample and one or more reagents are placed into the cavity to thereby create a desired reaction mixture.
  • an immunoassay test cassette is inserted into the insertion area such that the test cassette biases the ramp upwards and opens the door into the cavity of the reaction chamber.
  • the reaction mixture is then allowed to flow into the reaction well of each test cassette and onto an immunoassay test strip. Then, the results of the test are read and an amount of the analyte of interest in the biological sample is determined by analyzing the results through the windows in the test cassette.
  • the methods of the present invention are useful for determining the amounts of a drug of abuse, including, but not limited to, amphetamines, benzodiazepines, cocaine, methadone, methamphetamines, phencyclidine, and tetrahydrocannabinol, in a biological sample.
  • a drug of abuse including, but not limited to, amphetamines, benzodiazepines, cocaine, methadone, methamphetamines, phencyclidine, and tetrahydrocannabinol
  • the present invention provides devices and methods for testing biological samples, such as blood, plasma, serum, urine, or saliva samples, that make use of a reaction chamber and a housing that can be placed in fluid communication with one another and used to create a convenient platform for mixing, incubating, and depositing a reaction mixture onto test strip in a test cassette.
  • biological samples such as blood, plasma, serum, urine, or saliva samples
  • an exemplary device 10 for testing a biological sample for an analyte of interest in accordance with the present invention includes a first reaction chamber 20a and a second reaction chamber 20b.
  • Each reaction chamber 20a, 20b includes an interior wall 22a, 22b that defines an open top 24a, 24b of each reaction chamber 20a, 20b and further defines a cavity 26a, 26b within each reaction chamber 20a, 20b for receiving a reaction mixture, as described in further detail below.
  • each interior wall 22a, 22b is continuous such that the cavity 26a, 26b defined by each interior wall 22a, 22b is substantially cylindrical in shape.
  • reaction chambers having various other shapes and sizes can be provided for a particular application or device.
  • the device 10 includes a first reaction chamber 20a and a second reaction chamber 20b, it is, of course, contemplated that an exemplary device can be provided with any number of reaction chambers.
  • a device for testing a biological sample can be provided in accordance with the present invention where the device includes a single reaction chamber or includes three or more reaction chambers.
  • the device 10 further includes a housing 30 that is positioned below the first reaction chamber 20a and the second reaction chamber 20b.
  • the housing 30 includes a top portion 31, a bottom portion 32, a back wall 33, and two opposing side walls 34, 35 that define an open end 36 and an insertion area 37 for receiving a test cassette 50 including reaction wells 54a, 54b, as also described in further detail below.
  • the housing 30 includes a pair of doors 40a, 40b that are positioned in the top portion 31 of the housing 30.
  • Each door 40a, 40b includes a ramp 42a, 42b that extends downwardly into the insertion area (e.g., in a direction perpendicular to the doors 40a, 40b).
  • each ramp 42a, 42b is biased upward, such as by the insertion of the test cassette 50 into the insertion area 37, the doors 40a, 40b are opened into the cavities 26a, 26b of their respective reaction chambers 20a, 20b and the reaction chambers 20a, 20b are placed in fluid communication with the insertion area 37.
  • each door 40a, 40b further includes a perimeter portion 44a, 44b that is configured to separate from the top portion 31 of the housing 30 when each ramp 42a, 42b is biased upwards and the doors 40a, 40b are opened.
  • the perimeter portions 44a, 44b of the doors 40a, 40b can be molded from a very thin section of material such that only a small amount of force needs to be applied to the ramps 42a, 42b to separate the doors 40a, 40b from the remainder of the top portion 31 of the housing 30 at the location of the perimeter portions 44a, 44b.
  • each ramp 42a, 42b includes a front edge 45a, 45b that is angled away from the open end 36 of the housing 30.
  • the triangular-shaped ramps 42a, 42b are thus configured such that, as a test cassette 50 is inserted into the insertion area 37, the test cassette 50 progressively engages the angled front edge 45a, 45b of each ramp 42a, 42b and progressively pushes the doors 40a, 40b upward into the reaction chambers 20a, 20b.
  • the housing 30 also includes a pair of stops 60a, 60b.
  • the stops 60a, 60b are positioned on the top portion 31 of the housing 30 and extend downwardly into the insertion area 37 such that, upon insertion of the test cassette 50 in the housing 30, the stops 60a, 60b initially provide some resistance to the insertion of the test cassette 50.
  • the stops 60a, 60b then suitably engage a portion of the test cassette 50 to thereby secure the test cassette 50 within the housing 30 and prevent the test cassette 50 from falling out of the housing 30 during use.
  • the housing 30 also includes a guide 64, only one of which is shown in FIG. 4 , that is attached to each side wall 34, 35 of the housing 30.
  • the test cassette 50 when the test cassette 50 is inserted in the insertion area 37 of the housing 30, the test cassette 50 also initially encounters some resistance from the guides 64, but, upon application of a slight amount of force, the test cassette 50 can then be slidably disposed into the guides 64 such that the guides 64 hold the test cassette 50 within a particular position in the insertion area 37 while the stops 60a, 60b are pushing against the test cassette 50 to thereby secure the test cassette 50 in the insertion area 37. Additionally, by completely inserting the test cassette 50 into the insertion area 37 along the guides 64, the guides 64 act to align the reaction wells 54a, 54b underneath the doors 40a, 40b.
  • reaction wells 54a, 54b of the test cassette are aligned underneath the doors 40a, 40b, upon opening the doors 40a, 40b into the cavities 26a, 26b of the reaction chambers 20a, 20b and placing the reaction chambers 20a, 20b in fluid communication with the insertion area 37, the reaction mixtures within the reaction chambers 20a, 20b can simply flow directly into the reaction wells 54a, 54b of the test cassette 50.
  • each test cassette 50 generally includes a top cover 52, as shown in FIG. 5A , and a base 58 that is configured to attached to the top cover 52, as shown in FIG. 5B .
  • Various means known to those of ordinary skill in the art can, of course, be used for attaching the base 58 of the test cassette 50 to the top cover 52 of the test cassette 50.
  • FIGS. 5A-5B and FIG. 7 In the exemplary test cassette 50 shown in FIGS. 5A-5B and FIG.
  • the top cover 52 includes a series of posts 57 that can be inserted into a series of apertures 59 in the base 58 and used to attach (e.g., snap) the base 58 to the top cover 52.
  • each test cassette 50 also includes a test strip 53 that is interposed between the top cover 52 and the base 58 prior to attaching the base 58 to the top cover 52.
  • the test strip 53 when the test strip 53 is interposed between the base 58 and the top cover 52 and the base 58 and top cover 52 are attached to one another, the base 58 and the top cover 52 act to secure the test strip 53 in a desired position within the base.
  • Various test strips known and routinely used by those of ordinary skill in the art for testing for an analyte of interest in a biological sample can be used in accordance with the present invention, and can be selected for a particular application depending on the particular analyte to be detected.
  • the test strips comprise an immunoassay test strip, such as those described in U.S. Patent Nos. 6,406,922 , 7,090,803 , and 7,695,953 .
  • the two reaction wells 54a, 54b are typically positioned at a distal end 51 of the top cover 52, such that each reaction well 54a, 54b can be aligned with each door 40a, 40b in the top portion 31 of the housing 30 upon placing the test cassette 50 in the insertion area 37 of the housing 30, as described further below.
  • the top cover 52 further includes a pair of bridges 55a, 55b, where each bridge 55a, 55b is positioned over a reaction well 54a, 54b to provide support for the ramp 42a, 42b upon insertion of the test cassette 50 into the insertion area 37.
  • the bridges 55a, 55b allow the ramps 42a, 42b to remain biased upward such that the reaction mixture can continue to flow into each reaction well 54a, 54b at a controlled rate upon the insertion of the cassette 50.
  • a device 210 for testing a biological sample includes a bridge 255a having a low height such that, upon insertion of the test cassette 250, the bridge 255a supports the ramp 242a and the door 240a of the housing 230 in a position where the door 240a is only opened slightly into the reaction chamber 220a and where only a minimal amount of reaction mixture is able to flow from the reaction chamber 220a at a given time.
  • a device 310 for testing a biological sample includes a bridge 355a having an intermediate height such that, upon insertion of the test cassette 350, the bridge 355a supports the ramp 342a and the door 340a of the housing 330 in a position where the door 340a is opened into the reaction chamber 320a in a manner that allows the reaction mixture to flow from the reaction chamber 320a at an intermediate rate.
  • a device 410 for testing a biological sample includes a bridge 455a having an increased height such that, upon insertion of the test cassette 450, the bridge 455a supports the ramp 442a and the door 440a of the housing 430 in a position where the door 440a is fully opened into the reaction chamber 420a to thereby allow the reaction mixture to flow from the reaction chamber 420a at faster rate.
  • a bridge 455a having an increased height such that, upon insertion of the test cassette 450, the bridge 455a supports the ramp 442a and the door 440a of the housing 430 in a position where the door 440a is fully opened into the reaction chamber 420a to thereby allow the reaction mixture to flow from the reaction chamber 420a at faster rate.
  • test cassette bridges having various other heights are also contemplated and can be easily selected to provide a particular flow rate for a particular application.
  • reaction mixtures are typically wicked up by the test strip 53.
  • the test strip 53 then allows the reaction mixture to laterally flow along the test strip 53 such that the results of the particular test can be read and the amount of the analyte in the biological sample can be determined by analyzing the results of the test through windows 56a, 56b in the test cassette 50.
  • test cassettes of the present invention it is appreciated that the number of reaction wells in a particular test cassette can also be varied and that test cassettes having various numbers of reaction wells can be provided for a particular application or for a particular device such that the number of reaction wells in the test cassette corresponds with the number of reaction chambers included in an exemplary device.
  • a test cassette is provided that, like the exemplary test cassette 50 shown in FIGS. 5A-5B and FIG. 7 , includes a top cover 152 and a base 158 as well as a series of posts 157 and apertures 159 for connecting the top cover 152 to the base 158.
  • the top cover 152 only includes a single reaction well 154 for receiving a reaction mixture and a single window 156 for reading a test result.
  • the test cassette formed by the attachment of the top cover 152 to the base 158 would be configured for use with a device of the present invention having only a single reaction chamber.
  • each device 10 also includes a cap 70 for covering the open top 24a of the first chamber 20a and the open top 24b of the second chamber 20b.
  • the cap 70 is connected to the housing 30 by a flexible arm 72, which includes a notch 74.
  • the notch 74 is positioned in the flexible arm 72 such that bending the flexible arm 72 at the notch 74 allows the cap 70 to be aligned with the open top 24a of the first reaction chamber 20a and the open top 24b of the second reaction chamber 20b. Once the cap 70 is aligned with each open top 24a, 24b, the cap 70 can then be easily placed onto the reaction chambers 20a, 20b and secured to each reaction chamber 20a, 20b.
  • the cap 70 provides a convenient means to cover each reaction chamber 20a, 20b and provide a closed environment to thereby facilitate the mixing and/or incubating of a biological sample and one or more reagents.
  • Various means, including gaskets, threaded portions, and the like, can, of course, be included on the cap 70 to secure the cap 70 to the reaction chambers 20a, 20b. In some embodiments, and as shown in FIGS.
  • the cap 70 of the device 10 includes raised portions 75, 77 that are configured to matingly engage corresponding depressions 76, 78 defined by the interior walls 22a, 22b of the reaction chambers 20a, 20b to thereby secure the cap 70 to the reaction chambers 20a, 20b.
  • the testing commences by providing a device for testing a biological sample that includes a reaction chamber having an interior wall defining an open top and a cavity for receiving a reaction mixture; a housing positioned below the reaction chamber, and having a top portion, a bottom portion, a back wall, and two opposing side walls defining an open end and an insertion area for receiving a test cassette; and a door that is positioned in the top surface of the housing and includes a ramp that extends downwardly into the insertion area.
  • the biological sample can include any body fluid or tissue in which an analyte of interest can be detected, including, but not limited to, blood, plasma, serum, urine, or oral fluid samples.
  • the biological sample is an oral fluid sample, such as a saliva sample.
  • the one or more reagents include a suitable buffer solution and a suitable identifying reagent that is capable of targeting a particular analyte of interest, such as a drug of abuse.
  • a buffer solution that assists in the removal or reduction of interferents that may potentially interfere with the detection of the analyte of interest can be used along with a gold particle attached to a suitable antibody or antigen that is used to target the particular analyte of interest, as described in U.S. Patent No. 7,695,953 .
  • the drugs targeted by the antibody or antigen can be any drug or other compound of interest that can be detected in a biological sample.
  • drugs include, but are not limited to, amphetamines, benzodiazepines, cocaine, methadone, methamphetamines, phencyclidine (PCP), and tetrahydrocannabinol (THC).
  • a gold-labeled antibody specific to the target drug can be provided in the reaction chamber, e.g., in dry form, prior to the addition of the buffer solution and biological sample to the reaction chamber.
  • the biological sample and the one or more reagents are added to the cavity of the reaction chamber of the device, the biological sample and the reagents are generally mixed together, as indicated by block 520, and allowed to incubate for a suitable time period such that the identifying reagent has sufficient time to target and bind to the analyte of interest.
  • the device can be slightly shaken or otherwise agitated by gently moving the device from side to side on a flat surface.
  • the cap of the devices is used to cover the open tops of the reaction chambers such that more vigorous shaking can be used to mix the reaction mixtures as needed.
  • the biological sample can be mixed with a suitable buffer solution prior to placing the biological sample and buffer mixture into the reaction chamber and combining it with the reagents (e.g., reagents that are provided in a dried form in the reaction chamber).
  • reagents e.g., reagents that are provided in a dried form in the reaction chamber.
  • an immunoassay test cassette which includes a test strip specific for the analyte to be detected, is inserted into the insertion area of the device, as indicated by block 530.
  • the test cassette is first pushed past the stops included in the top portion of the housing of the device and is inserted along the guides in each opposing side wall to thereby secure the cassette in the housing and to align the reaction wells of the cassette with the doors included in the top portion of the housing.
  • the test cassette initially begins to encounter the angled front edge of the ramps extending downwardly from the doors.
  • the triangular shape of the ramp progressively engages the test cassette and the perimeter portion of the door eventually breaks away from the remainder of the top portion of the housing and allows the doors to be opened into the reaction chamber.
  • the upward movement of the door into the reaction chamber then allows the reaction mixture to flow downward through the doors into the reaction wells of the test cassette and onto the test strip that is interposed between the top cover and the base of the test cassette.
  • determining an amount of an analyte of interest, such as a drug of abuse, in a biological sample can include only a qualitative assessment of the presence or absence of the analyte of interest in the biological sample.
  • a quantitative assessment of the amounts of the analyte of interest in the biological sample can be made. Such quantitative assessments can be made by various techniques known to those of ordinary skill in the art.
  • the above-described devices and methods for testing a biological sample that make use of a reaction chamber and a housing, which are capable of being placed in fluid communication with one another, thus provide a convenient platform for mixing, incubating, and depositing a reaction mixture onto test strip in a test cassette, with the added benefit that the reaction chambers and housing allow for a controlled release of a reaction mixture onto a test cassette in a manner that provides a quick and accurate testing for drugs of abuse or other analytes of interest.

Claims (27)

  1. Dispositif de test d'un échantillon biologique comprenant :
    une chambre de réaction comportant une paroi intérieure définissant un sommet ouvert et une cavité pour recevoir un mélange de réaction ;
    un logement positionné au-dessous de la chambre de réaction, le logement comportant une portion de sommet, une portion de fond, une paroi arrière, et deux parois latérales opposées définissant une extrémité ouverte et une zone d'insertion pour recevoir une cassette de test ; et caractérisé par
    une porte positionnée dans la portion de sommet du logement et comprenant une rampe s'étendant vers le bas dans la zone d'insertion de sorte que la sollicitation de la rampe vers le haut ouvre la porte dans la cavité de la chambre de réaction et place la chambre de réaction en communication fluidique avec la zone d'insertion.
  2. Dispositif selon la revendication 1, dans lequel la porte comprend une portion de périmètre configurée pour se séparer de la portion de sommet du logement lors de la sollicitation de la rampe vers le haut ou dans lequel un bord avant de la rampe est écarté angulairement de l'extrémité ouverte du logement.
  3. Dispositif selon la revendication 1, comprenant en outre une butée positionnée sur la portion de sommet du logement et s'étendant vers le bas dans la zone d'insertion, la butée servant à fixer la cassette de test dans la zone d'insertion.
  4. Dispositif selon la revendication 1, comprenant en outre un guide attaché à chaque paroi latérale du logement pour aligner la cassette de test dans la zone d'insertion.
  5. Dispositif selon la revendication 1, dans lequel la cassette de test comprend :
    un couvercle de sommet définissant un puits de réaction pour recevoir le mélange de réaction à partir de la chambre de réaction et définissant en outre une fenêtre pour lire un résultat de test ;
    une base configurée pour s'attacher au couvercle de sommet ; et
    une bande de test interposée entre le couvercle de sommet et la base.
  6. Dispositif selon la revendication 5, dans lequel le puits de réaction est positionné sur le couvercle de sommet de sorte que le puits de réaction soit aligne avec la porte lors du placement de la cassette de test dans la zone d'insertion.
  7. Dispositif selon la revendication 5, dans lequel le couvercle de sommet comprend un pont positionné à travers le puits de réaction, le pont servant à supporter la rampe lors du placement de la cassette de test dans la zone d'insertion.
  8. Dispositif selon la revendication 1, comprenant en outre un capuchon pour recouvrir le sommet ouvert de la chambre de réaction.
  9. Dispositif selon la revendication 8, dans lequel le capuchon est relié au logement par un bras flexible.
  10. Dispositif selon la revendication 9, dans lequel le bras flexible comprend une encoche positionnée dans le bras flexible de sorte qu'une flexion du bras flexible au niveau de l'encoche permette d'aligner le capuchon avec le sommet ouvert de la chambre de réaction.
  11. Dispositif selon la revendication 8, dans lequel le capuchon comprend un moyen pour fixer le capuchon à la chambre de réaction.
  12. Dispositif de test d'un échantillon biologique, comprenant :
    une première chambre de réaction et une deuxième chambre de réaction, chaque chambre de réaction comportant une paroi intérieure définissant un sommet ouvert et une cavité pour recevoir un mélange de réaction ;
    un logement positionné au-dessous de la première chambre de réaction et de la deuxième chambre de réaction, le logement comportant une portion de sommet, une portion de fond, une paroi arrière, et deux parois latérales opposées définissait une extrémité ouverte et une zone d'insertion pour recevoir une cassette de test ; et caractérisé par
    une paire de portes positionnées dans la portion de sommet du logement, chaque porte comprenant une rampe s'étendant vers le bas dans la zone d'insertion de sorte que la sollicitation de la rampe vers le haut ouvre la porte dans la cavité de chaque chambre de réaction et place chaque chambre de réaction en communication fluidique avec la zone d'insertion.
  13. Dispositif selon la revendication 12, dans lequel chaque porte comprend une portion de périmètre configurée pour se séparer de la portion de sommet du logement lors de la sollicitation de chaque rampe vers le haut.
  14. Dispositif selon la revendication 12, dans lequel un bord avant de chaque rampe est écarté angulairement de l'extrémité ouverte du logement.
  15. Dispositif selon la revendication 12, comprenant en outre une paire de butées positionnées sur la portion de sommet du logement et s'étendant vers le bas dans la zone d'insertion, les butées servant à fixer la cassette de test dans la zone d'insertion.
  16. Dispositif selon la revendication 12, comprenant en outre un guide attaché à chaque paroi latérale du logement pour aligner la cassette de test dans la zone d'insertion.
  17. Dispositif selon la revendication 12, dans lequel la cassette de test comprend :
    un couvercle de sommet définissant deux puits de réaction pour recevoir chaque mélange de réaction à partir de chaque chambre de réaction et définissant en outre deux fenêtres pour lire des résultats de test ;
    une base configurée pour s'attacher au couvercle de sommet ; et
    au moins une bande de test interposée entre le couvercle de sommet et la base.
  18. Dispositif selon la revendication 12, dans lequel les deux puits de réaction sont positionnés sur le couvercle de sommet de sorte que chaque puits de réaction soit aligné avec chaque porte dans la portion de sommet du logement lors du placement de la cassette de test dans la zone d'insertion.
  19. Dispositif selon la revendication 12, dans lequel le couvercle de sommet comprend un pont positionné à travers chaque puits de réaction, chaque pont servant à supporter la rampe lors de l'insertion de la cassette de test dans la zone d'insertion.
  20. Dispositif selon la revendication 12, comprenant en outre un capuchon pour recouvrir le sommet ouvert de la première chambre de réaction et le sommet ouvert de la deuxième chambre de réaction.
  21. Procédé de test d'un échantillon biologique pour un analyte d'intérêt, comprenant :
    la fourniture d'un dispositif comprenant :
    une chambre de réaction comportant une paroi intérieure définissant un sommet ouvert et une cavité pour recevoir un mélange de réaction ;
    un logement positionné au-dessous de la chambre de réaction, le logement comportant une portion de sommet, une portion de fond, une paroi arrière, et deux parois latérales opposées définissant une extrémité ouverte et une zone d'insertion pour recevoir une cassette de test ; et caractérisé par
    une porte positionnée dans la portion de sommet du logement et comprenant une rampe s'étendant vers le bas dans la zone d'insertion de sorte que la sollicitation de la rampe vers le haut ouvre la porte dans la cavité de la chambre de réaction et place la chambre de réaction en communication fluidique avec la zone d'insertion ;
    le placement de l'échantillon biologique et d'un ou plusieurs réactifs dans la cavité pour créer de ce fait le mélange de réaction ;
    l'insertion d'une cassette de test d'immunoessai dans la zone d'insertion de sorte que la cassette de test sollicite la rampe vers le haut et ouvre la porte dans la cavité de la chambre de réaction pour permettre au mélange de réaction d'entrer en contact avec une bande de test d'immunoessai ; et
    la détermination d'une quantité de l'analyte d'intérêt dans l'échantillon biologique.
  22. Procédé selon la revendication 21, dans lequel l'échantillon biologique comprend du sang, du plasma, du sérum, de l'urine ou de la salive.
  23. Procédé selon la revendication 21, comprenant en outre l'étape du mélange de l'échantillon biologique et de l'un ou plusieurs réactifs après le placement de l'échantillon biologique et de l'un ou plusieurs réactifs dans la cavité.
  24. Procédé selon la revendication 21, comprenant en outre l'étape du recouvrement du sommet ouvert de la cavité après le placement de l'échantillon biologique et de l'un ou plusieurs réactifs dans la cavité.
  25. Procédé selon la revendication 21, dans lequel l'analyte d'intérêt est une drogue.
  26. Procédé selon la revendication 25, dans lequel la drogue est sélectionnée dans le groupe se composant d'amphétamines, benzodiazépines, cocaïne, méthadone, et méthamphétamines, phencyclidine et tétrahydrocannabinol.
  27. Dispositif de test d'un échantillon biologique, comprenant :
    une chambre de réaction comportant une paroi intérieure définissant un sommet ouvert et une cavité pour redevoir un mélange de réaction
    un logement positionné au-dessous de la chambre de réaction, le logement comportant une portion de sommet, une portion de fond, une paroi arrière, et deux parois latérales opposées définissant une extrémité ouverte et une zone d'insertion pour recevoir une cassette de test ; caractérisé par
    une porte positionnée dans la portion de sommet du logement et comprenant une rampe s'étendant vers le bas dans la zone d'insertion de sorte que la sollicitation de la rampe vers le haut ouvre la porte dans la cavité de la chambre de réaction et place la chambre de réaction en communication fluidique avec la zone d'insertion ; et
    une cassette de test.
EP20120150239 2012-01-05 2012-01-05 Dispositif et procédé pour tester des échantillons biologiques Active EP2612707B1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PT12150239T PT2612707E (pt) 2012-01-05 2012-01-05 Dispositivo e método para testar amostras biológicas
ES12150239.7T ES2501843T3 (es) 2012-01-05 2012-01-05 Dispositivo y procedimiento de análisis de muestras biológicas
EP20120150239 EP2612707B1 (fr) 2012-01-05 2012-01-05 Dispositif et procédé pour tester des échantillons biologiques

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20120150239 EP2612707B1 (fr) 2012-01-05 2012-01-05 Dispositif et procédé pour tester des échantillons biologiques

Publications (2)

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EP2612707A1 EP2612707A1 (fr) 2013-07-10
EP2612707B1 true EP2612707B1 (fr) 2014-06-11

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ES (1) ES2501843T3 (fr)
PT (1) PT2612707E (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6406922B2 (en) 1996-03-11 2002-06-18 American Bio Medica Corp. Device for the testing of body fluid samples
US6890484B2 (en) * 2001-05-18 2005-05-10 Acon Laboratories, Inc. In line test device and methods of use
US7090803B1 (en) 2003-10-28 2006-08-15 American Bio Medica Corporation Lateral flow immunoassay device
JP2007064829A (ja) * 2005-08-31 2007-03-15 Fujirebio Inc 試験用具
US7695953B2 (en) 2007-01-09 2010-04-13 American Bio Medica Corporation Apparatus for high-sensitivity body fluid testing device
DE102007014729A1 (de) * 2007-03-24 2008-09-25 Michael Matallana Kielmann Vorrichtung zur Abarbeitung von Lateral Flow Immunoassay Testen
ITPD20080338A1 (it) * 2008-11-19 2010-05-20 Kaltek S R L Dispositivo per la realizzazione di test rapidi "in loco" su liquidi biologici

Also Published As

Publication number Publication date
ES2501843T3 (es) 2014-10-02
EP2612707A1 (fr) 2013-07-10
PT2612707E (pt) 2014-09-17

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