EP2612707A1 - Device and method for testing biological samples - Google Patents
Device and method for testing biological samples Download PDFInfo
- Publication number
- EP2612707A1 EP2612707A1 EP12150239.7A EP12150239A EP2612707A1 EP 2612707 A1 EP2612707 A1 EP 2612707A1 EP 12150239 A EP12150239 A EP 12150239A EP 2612707 A1 EP2612707 A1 EP 2612707A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- reaction chamber
- housing
- insertion area
- reaction
- test cassette
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
- 238000012360 testing method Methods 0.000 title claims abstract description 181
- 239000012472 biological sample Substances 0.000 title claims abstract description 68
- 238000000034 method Methods 0.000 title claims abstract description 30
- 238000006243 chemical reaction Methods 0.000 claims abstract description 148
- 238000003780 insertion Methods 0.000 claims abstract description 77
- 230000037431 insertion Effects 0.000 claims abstract description 77
- 239000011541 reaction mixture Substances 0.000 claims abstract description 44
- 239000012491 analyte Substances 0.000 claims abstract description 36
- 239000012530 fluid Substances 0.000 claims abstract description 14
- 238000004891 communication Methods 0.000 claims abstract description 12
- 239000003153 chemical reaction reagent Substances 0.000 claims description 18
- 229940079593 drug Drugs 0.000 claims description 16
- 239000003814 drug Substances 0.000 claims description 16
- 238000003018 immunoassay Methods 0.000 claims description 13
- ZPUCINDJVBIVPJ-LJISPDSOSA-N cocaine Chemical compound O([C@H]1C[C@@H]2CC[C@@H](N2C)[C@H]1C(=O)OC)C(=O)C1=CC=CC=C1 ZPUCINDJVBIVPJ-LJISPDSOSA-N 0.000 claims description 6
- 210000004369 blood Anatomy 0.000 claims description 5
- 239000008280 blood Substances 0.000 claims description 5
- 210000002381 plasma Anatomy 0.000 claims description 5
- 210000003296 saliva Anatomy 0.000 claims description 5
- 210000002966 serum Anatomy 0.000 claims description 5
- 210000002700 urine Anatomy 0.000 claims description 5
- CYQFCXCEBYINGO-UHFFFAOYSA-N THC Natural products C1=C(C)CCC2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3C21 CYQFCXCEBYINGO-UHFFFAOYSA-N 0.000 claims description 4
- CYQFCXCEBYINGO-IAGOWNOFSA-N delta1-THC Chemical compound C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@@H]21 CYQFCXCEBYINGO-IAGOWNOFSA-N 0.000 claims description 4
- 229960004242 dronabinol Drugs 0.000 claims description 4
- JTJMJGYZQZDUJJ-UHFFFAOYSA-N phencyclidine Chemical compound C1CCCCN1C1(C=2C=CC=CC=2)CCCCC1 JTJMJGYZQZDUJJ-UHFFFAOYSA-N 0.000 claims description 4
- USSIQXCVUWKGNF-UHFFFAOYSA-N 6-(dimethylamino)-4,4-diphenylheptan-3-one Chemical compound C=1C=CC=CC=1C(CC(C)N(C)C)(C(=O)CC)C1=CC=CC=C1 USSIQXCVUWKGNF-UHFFFAOYSA-N 0.000 claims description 3
- 238000005452 bending Methods 0.000 claims description 3
- 229940049706 benzodiazepine Drugs 0.000 claims description 3
- 150000001557 benzodiazepines Chemical class 0.000 claims description 3
- 229960003920 cocaine Drugs 0.000 claims description 3
- 229960001797 methadone Drugs 0.000 claims description 3
- 229950010883 phencyclidine Drugs 0.000 claims description 3
- 239000000427 antigen Substances 0.000 description 4
- 102000036639 antigens Human genes 0.000 description 4
- 108091007433 antigens Proteins 0.000 description 4
- 239000007853 buffer solution Substances 0.000 description 4
- 239000000523 sample Substances 0.000 description 4
- 238000000151 deposition Methods 0.000 description 3
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 2
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- 230000009286 beneficial effect Effects 0.000 description 1
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- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
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- 238000001514 detection method Methods 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 238000003317 immunochromatography Methods 0.000 description 1
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Images
Classifications
-
- 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
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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
- 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.
- 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 without departing from the spirit and scope of the present invention.
- 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 without departing from the spirit and scope of the present invention.
- 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 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.
- 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 , each of which is incorporated herein by this reference.
- 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 to be within the spirit and scope of the present invention, 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 patentially 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.
Abstract
Description
- 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.
- 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. For example, in many of these immunoassay devices and methods, 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. In this regard, as the biological sample is wicked up by the test strip, 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.
- Given the relative ease with which the immunoassay results can be read, a number of immunoassay devices and methods have been developed to date that allow for the rapid screening of drugs of abuse or other analytes of interest in biological fluids. Many of these prior immunoassay devices and methods, however, have required significant pre-treatment steps where the biological sample must first be modified with specific reagents to dilute or denature any interferents, to modify the analyte structure, and/or to release the analyte from binding molecules prior to adding the biological sample to the testing device. Additionally, in many of these prior devices and methods, once the test sample is introduced, there has been no control provided over either the speed or the timing of the subsequent immunoassay reactions. lndeed, in a number of the prior devices and methods, the quantity of the reaction mixture placed in the testing device is the major factor that determines the speed and timing of all of the subsequent reactions and, in many instances, this ultimately leads to an inefficient or inaccurate result.
- Accordingly, 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.
- It is thus an object of the present invention to provide a quick and accurate device and method for testing for an analyte of interest in a variety of biological samples, such as blood, plasma, serum, urine, or saliva samples, in a controlled manner.
- These and other objects are provided by virtue of the present invention which comprises devices and methods for testing biological samples for an analyte of interest. In one exemplary embodiment of the present invention, a device for testing a biological sample is provided that 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.
- To facilitate the contacting of the test strip with the reaction mixture, which includes the biological sample being tested, a pair of doors are positioned in the top portion of the housing, and each door includes a ramp that extends downwardly into the insertion area of the housing. In this regard, when 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. In certain embodiments of the devices of the present invention, 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. In some embodiments, to further facilitate the opening of the doors, 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.
- To prevent a test cassette from being prematurely inserted too far into the insertion area of the housing and prematurely contacting the ramps on the doors of the housing, and to also secure a test cassette in the insertion area, a pair of stops are further included in the housing. Generally, 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. In some embodiments, 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. In some embodiments, 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.
- With regard to the test cassette itself, 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. As noted above, 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. To facilitate the flow of the reaction mixture into the reaction wells, in some embodiments, 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. In this regard, instead of the ramp falling into the reaction well when the test cassette is inserted 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.
- To further facilitate the testing of a biological sample using the device of the present invention, in certain embodiments, a cap is further provided for covering the open top of the first reaction chamber and the open top of the second reaction chamber. In some embodiments, the cap is connected to the housing by a flexible arm. In certain embodiments, 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. Once the cap is aligned with the top of the reaction chambers, 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.
- Further provided by the present invention are methods for testing a biological sample for an analyte of interest. In one exemplary implementation of a method for testing a biological sample for an analyte of interest, a device of the present invention is first provided 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.
- Subsequent to the providing the device, a biological sample and one or more reagents are placed into the cavity to thereby create a desired reaction mixture. Then, following a suitable mixing and/or incubation period that, in certain embodiments, can be facilitated by the placement of a cap over the open top of the reaction chamber, 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. Once the door is opened, 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. In some embodiments, and as indicated above, 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.
- Each of these embodiments and implementations of the devices and methods of the present invention, as well as other alternatives and modifications within the spirit and scope of the presently-disclosed invention, will become readily apparent to those of ordinary skill in the art after a study of the description and Figures in this document.
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FIG. 1 is a perspective view of a device for testing biological samples made in accordance with the present invention; -
FIG. 2 is another perspective view of the device shown inFIG. 1 , but further illustrating the bottom of the device; -
FIG. 3 is yet another perspective view of the device shown inFIG. 1 , but further illustrating the top of the device; -
FIG. 4 is also another perspective view of the device shown inFIG. 1 , but further illustrating the side of the device opposite that shown inFIG. 1 ; -
FIGS. 5A-5B include perspective views of a top cover (FIG. 5A ) and a base (FIG. 5B ) of an exemplary test cassette used in accordance with the present invention; -
FIGS. 6A-6B include perspective views of a top cover (FIG. 6A ) and a base (FIG. 6B ) of an alternative exemplary test cassette used in accordance with the present invention; -
FIG. 7 is another perspective view of the exemplary test cassette shown inFIGS. 5A-5B , but further illustrating the top cover and the base attached to one another with a test strip interposed between the top cover and the base; -
FIG. 8 is a cross-sectional view of another device for testing biological samples made in accordance with the present invention, and illustrating a test cassette that includes a bridge with a low height inserted into the insertion area of the housing of the device; -
FIG. 9 is a cross-sectional view of yet another device for testing biological samples made in accordance with the present invention, and illustrating a test cassette that includes a bridge with an intermediate height inserted into the insertion area of the housing of the device; -
FIG. 10 is a cross-sectional view of a further device for testing biological samples made in accordance with the present invention, and illustrating a test cassette that includes a bridge with a high height inserted into the insertion area of the housing of the device; and -
FIG. 11 is a flow chart illustrating the steps included in an exemplary method for testing a biological sample for an analyte of interest in accordance with the present invention. - In accordance with the present invention, devices and methods for testing a biological sample are provided. In particular, 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.
- Referring first to
FIGS. 1-4 , anexemplary device 10 for testing a biological sample for an analyte of interest in accordance with the present invention includes afirst reaction chamber 20a and asecond reaction chamber 20b. Eachreaction chamber interior wall reaction chamber cavity reaction chamber device 10, eachinterior wall cavity interior wall device 10 includes afirst reaction chamber 20a and asecond reaction chamber 20b, it is, of course, contemplated that an exemplary device can be provided with any number of reaction chambers without departing from the spirit and scope of the present invention. For example, it is contemplated that 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. - Regardless of the number of reaction chambers included in an exemplary device, however, and referring now to
FIGS. 1-4 andFIG. 7 , thedevice 10 further includes ahousing 30 that is positioned below thefirst reaction chamber 20a and thesecond reaction chamber 20b. Thehousing 30 includes atop portion 31, abottom portion 32, aback wall 33, and two opposingside walls open end 36 and aninsertion area 37 for receiving atest cassette 50 includingreaction wells housing 30 includes a pair ofdoors top portion 31 of thehousing 30. Eachdoor ramp doors ramp test cassette 50 into theinsertion area 37, thedoors cavities respective reaction chambers reaction chambers insertion area 37. - To facilitate the opening of the
doors door perimeter portion top portion 31 of thehousing 30 when eachramp doors perimeter portions doors ramps doors top portion 31 of thehousing 30 at the location of theperimeter portions - To further facilitate the opening of the
doors device 10, eachramp front edge open end 36 of thehousing 30. By angling thefront edges open end 36 of thehousing 30, the triangular-shapedramps test cassette 50 is inserted into theinsertion area 37, thetest cassette 50 progressively engages the angledfront edge ramp doors reaction chambers - To prevent the
test cassette 50 from being prematurely inserted too far into theinsertion area 37 of thehousing 30 and prematurely contacting theramps doors housing 30, and to also secure thetest cassette 50 in theinsertion area 37 of thehousing 30, thehousing 30 also includes a pair ofstops stops top portion 31 of thehousing 30 and extend downwardly into theinsertion area 37 such that, upon insertion of thetest cassette 50 in thehousing 30, thestops test cassette 50. However, upon further insertion of thetest cassette 50, thestops test cassette 50 to thereby secure thetest cassette 50 within thehousing 30 and prevent thetest cassette 50 from falling out of thehousing 30 during use. To further secure thetest cassette 50 in thehousing 30, and also prevent thetest cassette 50 from being inserted too far into thehousing 30 and prematurely contacting theramps housing 30 also includes aguide 64, only one of which is shown inFIG. 4 , that is attached to eachside wall housing 30. In this regard, when thetest cassette 50 is inserted in theinsertion area 37 of thehousing 30, thetest cassette 50 also initially encounters some resistance from theguides 64, but, upon application of a slight amount of force, thetest cassette 50 can then be slidably disposed into theguides 64 such that theguides 64 hold thetest cassette 50 within a particular position in theinsertion area 37 while thestops test cassette 50 to thereby secure thetest cassette 50 in theinsertion area 37. Additionally, by completely inserting thetest cassette 50 into theinsertion area 37 along theguides 64, theguides 64 act to align thereaction wells doors reaction wells doors doors cavities reaction chambers reaction chambers insertion area 37, the reaction mixtures within thereaction chambers reaction wells test cassette 50. - With further regard to the
test cassette 50 itself, and referring now toFIGS. 5A-5B andFIG. 7 , for use in the exemplary embodiment of thedevice 10 described above, eachtest cassette 50 generally includes atop cover 52, as shown inFIG. 5A , and a base 58 that is configured to attached to thetop cover 52, as shown inFIG. 5B . Various means known to those of ordinary skill in the art can, of course, be used for attaching thebase 58 of thetest cassette 50 to thetop cover 52 of thetest cassette 50. In theexemplary test cassette 50 shown inFIGS. 5A-5B andFIG. 7 , however, to attach the base 58 to thetop cover 52 of thetest cassette 50, thetop cover 52 includes a series ofposts 57 that can be inserted into a series ofapertures 59 in thebase 58 and used to attach (e.g., snap) thebase 58 to thetop cover 52. - Referring now to only
FIG. 7 , eachtest cassette 50 also includes atest strip 53 that is interposed between thetop cover 52 and thebase 58 prior to attaching the base 58 to thetop cover 52. In this regard, when thetest strip 53 is interposed between the base 58 and thetop cover 52 and thebase 58 andtop cover 52 are attached to one another, thebase 58 and thetop cover 52 act to secure thetest 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. In some embodiments, the test strips comprise an immunoassay test strip, such as those described inU.S. Patent Nos. 6,406,922 ,7,090,803 , and7,695,953 , each of which is incorporated herein by this reference. - Regardless of the particular test strip utilized, however, and referring again to
FIGS. 5A-5B andFIG. 7 , the tworeaction wells distal end 51 of thetop cover 52, such that eachreaction well door top portion 31 of thehousing 30 upon placing thetest cassette 50 in theinsertion area 37 of thehousing 30, as described further below. To facilitate the flow of the reaction mixture from thereaction chambers doors reaction wells top cover 52 further includes a pair ofbridges bridge reaction well ramp test cassette 50 into theinsertion area 37. In this regard, instead of eachramp reaction wells test cassette 50 is inserted into theinsertion area 37, thebridges ramps reaction well cassette 50. - For example, to provide a device in which the reaction mixture flows from the wells at a desired rate, and referring now to
FIGS. 8-10 , in one exemplary embodiment, adevice 210 for testing a biological sample is provided that includes abridge 255a having a low height such that, upon insertion of thetest cassette 250, thebridge 255a supports theramp 242a and thedoor 240a of thehousing 230 in a position where thedoor 240a is only opened slightly into thereaction chamber 220a and where only a minimal amount of reaction mixture is able to flow from thereaction chamber 220a at a given time. As another example, in another exemplary embodiment, adevice 310 for testing a biological sample is provided that includes abridge 355a having an intermediate height such that, upon insertion of thetest cassette 350, thebridge 355a supports theramp 342a and thedoor 340a of thehousing 330 in a position where thedoor 340a is opened into thereaction chamber 320a in a manner that allows the reaction mixture to flow from thereaction chamber 320a at an intermediate rate. As yet another example, in yet another exemplary embodiment, adevice 410 for testing a biological sample is provided that includes abridge 455a having an increased height such that, upon insertion of thetest cassette 450, thebridge 455a supports theramp 442a and thedoor 440a of thehousing 430 in a position where thedoor 440a is fully opened into thereaction chamber 420a to thereby allow the reaction mixture to flow from thereaction chamber 420a at faster rate. Of course, other devices that make use of test cassette bridges having various other heights are also contemplated to be within the spirit and scope of the present invention, and can be easily selected to provide a particular flow rate for a particular application. - Regardless of the particular flow rate provided for a particular application, and referring again to
FIGS. 5A-5B andFIG. 7 , once the reaction mixture flows from eachreaction chamber reaction wells test strip 53. Thetest strip 53 then allows the reaction mixture to laterally flow along thetest 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 throughwindows test cassette 50. - With further regard to the 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. For example, and referring now to
FIGS. 6A-6B , in some embodiments, a test cassette is provided that, like theexemplary test cassette 50 shown inFIGS. 5A-5B andFIG. 7 , includes atop cover 152 and a base 158 as well as a series ofposts 157 andapertures 159 for connecting thetop cover 152 to thebase 158. However, unlike thetest cassette 50, thetop cover 152 only includes a single reaction well 154 for receiving a reaction mixture and asingle window 156 for reading a test result. In other words, the test cassette formed by the attachment of thetop cover 152 to the base 158 would be configured for use with a device of the present invention having only a single reaction chamber. - Finally, and referring again to
FIGS. 1-4 , eachdevice 10 also includes acap 70 for covering the open top 24a of thefirst chamber 20a and the open top 24b of thesecond chamber 20b. Thecap 70 is connected to thehousing 30 by aflexible arm 72, which includes anotch 74. Thenotch 74 is positioned in theflexible arm 72 such that bending theflexible arm 72 at thenotch 74 allows thecap 70 to be aligned with the open top 24a of thefirst reaction chamber 20a and the open top 24b of thesecond reaction chamber 20b. Once thecap 70 is aligned with each open top 24a, 24b, thecap 70 can then be easily placed onto thereaction chambers reaction chamber - As described in further detail below, by securing the
cap 70 to thereaction chambers cap 70 provides a convenient means to cover eachreaction chamber cap 70 to secure thecap 70 to thereaction chambers FIGS. 1-4 , thecap 70 of thedevice 10 includes raisedportions depressions interior walls reaction chambers cap 70 to thereaction chambers - Referring now to
FIG. 11 , further provided by the present invention are methods for testing a biological sample for an analyte of interest. In this exemplary implementation, and as indicated byblock 500, 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. - Subsequent to providing the device, a biological sample and one or more reagents are placed into the cavity of each reaction chamber to thereby create a suitable reaction mixture, as indicated by
block 510. With regard to the biological samples used in accordance with the present invention, 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. In some embodiments, for example, the biological sample is an oral fluid sample, such as a saliva sample. - Typically, 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. For example, in certain embodiments, a buffer solution that assists in the removal or reduction of interferents that may patentially 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 . In certain embodiments of the present invention, where the analyte of interest is a drug, such as a drug of abuse, 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. Such drugs include, but are not limited to, amphetamines, benzodiazepines, cocaine, methadone, methamphetamines, phencyclidine (PCP), and tetrahydrocannabinol (THC). In some embodiments, and as also described inU.S. Patent No. 7,695,953 , 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. - Once 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. In certain embodiments, to promote the mixing of the reagents and/or to promote the breakdown of any interfering molecules, the device can be slightly shaken or otherwise agitated by gently moving the device from side to side on a flat surface. In other embodiments, 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. In yet further embodiments, 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). - Once the biological sample and the reaction mixtures have been mixed, and following a suitable incubation period, 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. In inserting the immunoassay test cassette into the insertion area, 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. In this regard, as the test cassette is pushed into the insertion area of the housing, the test cassette initially begins to encounter the angled front edge of the ramps extending downwardly from the doors. As the test cassette then moves further inward, 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. - Once the reaction mixture flows down into reaction wells and onto the test strip, the reaction mixture is then wicked up by the test strip and laterally flows along the test strip such that the results of the test can be read and the amount of analyte in the biological sample can be determined by analyzing the results of the test through the windows of the test cassette, as indicated by
block 540. In some implementations of the methods for testing a biological sample for an analyte of interest, 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. In other implementations of the methods of the present invention, however, 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.
- One of ordinary skill in the art will recognize that additional embodiments are also possible without departing from the teachings of the presently-disclosed subject matter. This detailed description, and particularly the specific details of the exemplary embodiments disclosed herein, is given primarily for clarity of understanding, and no unnecessary limitations are to understood therefrom, for modifications will become apparent to those skilled in the art upon reading this disclosure and may be made without departing from the spirit or scope of the presently-disclosed subject matter.
Claims (27)
- A device for testing a biological sample, comprising: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, the housing 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; anda door positioned in the top portion of the housing and including a ramp downwardly extending into the insertion area such that biasing the ramp upwards opens the door into the cavity of the reaction chamber and places the reaction chamber in fluid communication with the insertion area.
- The device of claim 1, wherein the door includes a perimeter portion configured to separate from the top portion of the housing upon biasing the ramp upwards or wherein a front edge of the ramp is angled away from the open end of the housing.
- The device of claim 1, further comprising a stop positioned on the top portion of the housing and extending downwardly into the insertion area, the stop for securing the test cassette in the insertion area.
- The device of claim 1, further comprising a guide attached to each side wall of the housing for aligning the test cassette in the insertion area.
- The device of claim 1, wherein the test cassette comprises:a top cover defining a reaction well for receiving the reaction mixture from the reaction chamber and further defining a window for reading a test result;a base configured to attach to the top cover; anda test strip interposed between the top cover and the base.
- The device of claim 5, wherein the reaction well is positioned on the top cover such that the reaction well is aligned with the door upon placing the test cassette into the insertion area.
- The device of claim 5, wherein the top cover includes a bridge positioned across the reaction well, the bridge for supporting the ramp upon placing the test cassette into the insertion area.
- The device of claim 1, further comprising a cap for covering the open top of the reaction chamber.
- The device of claim 8, wherein the cap is connected to the housing by a flexible arm.
- The device of claim 9, wherein the flexible arm includes a notch 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 reaction chamber.
- The device of claim 8, wherein the cap includes a means for securing the cap to the reaction chamber.
- A device for testing a biological sample, comprising:a first reaction chamber and a second reaction chamber, each reaction chamber having an interior wall defining an open top and a cavity for receiving a reaction mixture;a housing positioned below the first reaction chamber and the second reaction chamber, the housing 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; anda pair of doors positioned in the top portion of the housing, each door including a ramp downwardly extending into the insertion area such that biasing the ramp upwards opens the door into the cavity of each reaction chamber and places each reaction chamber in fluid communication with the insertion area.
- The device of claim 12, wherein each door includes a perimeter portion configured to separate from the top portion of the housing upon biasing each ramp upwards.
- The device of claim 12, wherein a front edge of each ramp is angled away from the open end of the housing.
- The device of claim 12, further comprising a pair of stops positioned on the top portion of the housing and extending downwardly into the insertion area, the stops for securing the test cassette in the insertion area.
- The device of claim 12, further comprising a guide attached to each side wall of the housing for aligning the test cassette in the insertion area.
- The device of claim 12, wherein the test cassette comprises:a top cover defining two reaction wells for receiving each reaction mixture from each reaction chamber and further defining two windows for reading test results;a base configured to attach to the top cover; andat least one test strip interposed between the top cover and the base.
- The device of claim 12, wherein the two reaction wells are positioned on the top cover such that each reaction well is aligned with each door in the top portion of the housing upon placing the test cassette into the insertion area.
- The device of claim 12, wherein the top cover includes a bridge positioned across each reaction well, each bridge for supporting the ramp upon insertion of the test cassette into the insertion area.
- The device of claim 12, further comprising a cap for covering the open top of the first reaction chamber and the open top of the second reaction chamber.
- A method for testing a biological sample for an analyte of interest, comprising:providing a device, including :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, the housing 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; anda door positioned in the top portion of the housing and including a ramp downwardly extending into the insertion area such that biasing the ramp upwards opens the door into the cavity of the reaction chamber and places the reaction chamber in fluid communication with the insertion area;placing the biological sample and one or more reagents into the cavity to thereby create the reaction mixture;inserting an immunoassay test cassette into the insertion area such that the test cassette biases the ramp upwards and opens the door into the cavity of the reaction chamber to allow the reaction mixture to contact an immunoassay test strip; anddetermining an amount in the biological sample of the analyte of interest.
- The method of claim 21, wherein the biological sample comprises blood, plasma, serum, urine, or saliva.
- The method of claim 21, further comprising the step of mixing the biological sample and the one or more reagents after placing the biological sample and the one or more reagents into the cavity.
- The method of claim 21, further comprising the step of covering the open top of the cavity after placing the biological sample and the one or more reagents into the cavity.
- The method of claim 21, wherein the analyte of interest is a drug of abuse.
- The method of claim 25, wherein the drug of abuse is selected from the group consisting of amphetamines, benzodiazepines, cocaine, methadone, methamphetamines, phencyclidine, and tetrahydrocannabinol.
- A device for testing a biological sample, comprising: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, the housing 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;a door positioned in the top portion of the housing and including a ramp downwardly extending into the insertion area such that biasing the ramp upwards opens the door into the cavity of the reaction chamber and places the reaction chamber in fluid communication with the insertion area; anda test cassette.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20120150239 EP2612707B1 (en) | 2012-01-05 | 2012-01-05 | Device and method for testing biological samples |
PT12150239T PT2612707E (en) | 2012-01-05 | 2012-01-05 | Device and method for testing biological samples |
ES12150239.7T ES2501843T3 (en) | 2012-01-05 | 2012-01-05 | Device and procedure for analyzing biological samples |
Applications Claiming Priority (1)
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EP20120150239 EP2612707B1 (en) | 2012-01-05 | 2012-01-05 | Device and method for testing biological samples |
Publications (2)
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EP2612707A1 true EP2612707A1 (en) | 2013-07-10 |
EP2612707B1 EP2612707B1 (en) | 2014-06-11 |
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EP20120150239 Active EP2612707B1 (en) | 2012-01-05 | 2012-01-05 | Device and method for testing biological samples |
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EP (1) | EP2612707B1 (en) |
ES (1) | ES2501843T3 (en) |
PT (1) | PT2612707E (en) |
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WO2004038364A2 (en) * | 2002-10-22 | 2004-05-06 | 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 |
WO2007026814A1 (en) * | 2005-08-31 | 2007-03-08 | Fujirebio Inc. | Test tool |
US20090320623A1 (en) * | 2007-03-24 | 2009-12-31 | Michael Matallana-Kielmann | Device for a test strip holder, method and arrangement |
US7695953B2 (en) | 2007-01-09 | 2010-04-13 | American Bio Medica Corporation | Apparatus for high-sensitivity body fluid testing device |
EP2191896A1 (en) * | 2008-11-19 | 2010-06-02 | Kaltek S.r.l. | Device for performing rapid "on-site" tests of biological fluids |
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2012
- 2012-01-05 ES ES12150239.7T patent/ES2501843T3/en active Active
- 2012-01-05 PT PT12150239T patent/PT2612707E/en unknown
- 2012-01-05 EP EP20120150239 patent/EP2612707B1/en active Active
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US6406922B2 (en) | 1996-03-11 | 2002-06-18 | American Bio Medica Corp. | Device for the testing of body fluid samples |
WO2004038364A2 (en) * | 2002-10-22 | 2004-05-06 | 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 |
WO2007026814A1 (en) * | 2005-08-31 | 2007-03-08 | Fujirebio Inc. | Test tool |
US7695953B2 (en) | 2007-01-09 | 2010-04-13 | American Bio Medica Corporation | Apparatus for high-sensitivity body fluid testing device |
US20090320623A1 (en) * | 2007-03-24 | 2009-12-31 | Michael Matallana-Kielmann | Device for a test strip holder, method and arrangement |
EP2191896A1 (en) * | 2008-11-19 | 2010-06-02 | Kaltek S.r.l. | Device for performing rapid "on-site" tests of biological fluids |
Also Published As
Publication number | Publication date |
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EP2612707B1 (en) | 2014-06-11 |
PT2612707E (en) | 2014-09-17 |
ES2501843T3 (en) | 2014-10-02 |
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