US20190369125A1 - Sample container with integrated test strip - Google Patents
Sample container with integrated test strip Download PDFInfo
- Publication number
- US20190369125A1 US20190369125A1 US16/542,716 US201916542716A US2019369125A1 US 20190369125 A1 US20190369125 A1 US 20190369125A1 US 201916542716 A US201916542716 A US 201916542716A US 2019369125 A1 US2019369125 A1 US 2019369125A1
- Authority
- US
- United States
- Prior art keywords
- test
- strip
- container
- test strip
- analyte
- 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.)
- Abandoned
Links
Images
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
- G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/007—Devices for taking samples of body liquids for taking urine samples
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B2010/0003—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
- A61B2010/0006—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person involving a colour change
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B2010/0009—Testing for drug or alcohol abuse
-
- 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
- B01L2200/14—Process control and prevention of errors
- B01L2200/141—Preventing contamination, tampering
-
- 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
-
- 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
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0627—Sensor or part of a sensor is integrated
- B01L2300/0663—Whole sensors
-
- 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
- B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
Definitions
- aspects of the present disclosure are related to analyte testing.
- the present disclosure is related to maintaining the sterile nature of an analyte testing assay during the sample collection and up to the exposure process.
- testing liquid samples such as bodily fluids
- An assay generally involves bringing a portion of the liquid sample into contact with an assay or test strip in order to qualitatively assess or measure the presence or amount of the functional activity of an anticipated analyte.
- Many such test assays or strips are known to detect for the presence of a specific chemical, hormone, or other material in liquid, such as blood, urine, or even saliva.
- Such tests have been designed, manufactured, produced, and marketed for use in such fields as home, industrial, veterinary, and occupational testing, among others.
- test devices which allow a user to test for the presence of HCG, an early indicator of pregnancy, in urine.
- Devices and assays have also been created for the detection of a variety of other chemicals in urine, including screenings for illegal drugs in a test subject in, for example, employment or correctional settings.
- These devices require that a user or test subject either urinate directly on the device or assay, or to deposit urine into a receptacle into which a testing assay or strip is placed.
- a testing assay or strip is placed.
- contamination of the sample and/or the assay is possible even when the utmost care is observed during all steps of these testing processes. Accordingly, a need for a test device which drastically reduces the potential opportunity for contamination of an assay or test strip is needed.
- FIG. 1 is a cutaway view of a sample collection and assay analysis device in accordance with aspects of the present disclosure.
- FIG. 2 is a cutaway view of a catheter-type sample collection and assay analysis device in accordance with aspects of the present disclosure.
- FIG. 3 is a flow diagram depicting a sample collection and assay analysis method according to aspects of the present disclosure.
- test device 100 for conducting an immunoassay to detect the presence of a specific analyte in a test sample of a fluid, for example, bodily fluid.
- a visual indication is provided to a user or other analyst of the test sample which represents the positive or negative presence of the analyte in the test sample.
- a control indicator is also provided to visually assure the user or other analyst of the validity of the assay or test result.
- Test device 100 is capable of detecting the presence of an analyte, antigen, ligand, or other macromolecule in fluids such as bodily fluids, including but not limited to urine, blood, saliva, mucus, or perspiration.
- the visual indicators use a reagent which reacts to the presence of the analyte and is a conjugate of reactive color particles and/or an antibody specific to the anticipated analyte.
- Device 100 is for example an antigen/receptor assay which can be used to detect the presence of an anticipated analyte in a test fluid such as urine.
- a test fluid such as urine.
- Such assays may involve an antigen/antibody reaction wherein a synthetic conjugate provides a visible tag.
- a specific antibody is provided specific to the antigen being detected.
- An absorbable indicator is provided, generally providing a simple positive/negative indicator for the presence of the antigen being detected.
- a control indicator is also provided to ensure the validity of the test result.
- Many test strips are commercially available and could be used to test for a plurality of anticipated analytes in accordance with the embodiments described herein.
- Test device 100 is a device for collecting and analyzing a sample such as, for example, a bodily fluid.
- the device generally includes a container 102 having an opening 110 which provides a means for collecting the body fluid and a chamber 104 which provides a means for storing the collected body fluid.
- the container 102 may include screw threads 112 formed into the container proximate the opening 110 which are sized for accepting a cap 122 , which may contain screw threads 114 .
- the screw threads 114 of cap 122 when screwed onto the threads 112 , provides a means for sealing the opening 110 .
- a typical container 102 may have a capacity of between about 100 to about 120 mL; however, the present invention is not intended to be limited to this size or capacity.
- Container 102 and cap 122 may be formed, or molded, from any suitable material, such as plastic, and it will be appreciated that container 102 and cap 122 may be provided in a wide variety of shapes, e.g., as a matter of design preference or intended application.
- container 102 and cap 122 are constructed of a transparent material such that the visual indications provided by a completed assay are visible through the surfaces of the container 102 , even when container 102 is sealed with cap 122 .
- test strip 150 is affixed to the bottom interior surface of container 102 .
- the test strip 150 may be affixed to an inside surface of the wall of container 102 .
- Test strip 150 may be designed to test for the presence of a specific analyte, and it should be appreciated that alternative embodiments of the present invention allow for any number of analyte specific tests be performed with the device 100 of the present invention.
- the test strip 150 is configured to test for the presence of Human Chorionic Gonadotropin (HCG), a hormone produced by a portion of the placenta following implantation of a blastocyst in human females during embryogenesis; the presence of this hormone in urine is an early indicator of pregnancy.
- HCG Human Chorionic Gonadotropin
- a removable protective strip 165 is secured in place over test strip 150 at the time container 102 is manufactured or when test strip 150 is affixed to container 102 .
- the test strip 150 and protective strip 165 comprise a replaceable “test panel” which can be loaded or fastened into an appropriately sterilized container 102 .
- Protective strip 165 prevents competing analytes or other contaminants from coming into contact with test strip 150 during the time period between manufacture/assembly and use. Such contaminants include, but are not limited to microbes and other atmospheric contaminants, and contaminants present on a user or analysts skin including hormones, microbes, oils, or perspiration.
- Protective strip 165 may be composed of any number of materials appropriate to preventing exposure of the test strip 150 to atmospheric or other contaminants, including but not limited to plastic, metal foil, or an adhesive coating.
- the protective strip 165 is a coating which is dissolvable in the desired test liquid, and accordingly, the protective strip 165 dissolves after a certain period of exposure to the test liquid, allowing the test strip 150 to be exposed to the test liquid.
- an adhesive is applied to the area surrounding the test strip 150 , and the protective strip 165 is secured in place around and over (respectively) the test strip 150 , preventing the test strip 150 from being exposed to atmospheric or other contaminants.
- protective strip 165 is to be removed once the container 102 has been filled with the desired sample of test liquid. This provides that the test strip 150 is exposed only to the desired sample of test liquid, and accordingly avoids contact with the atmosphere or any other potential contaminants in order to get the most accurate potential result.
- the protective strip 165 can be removed by a user or other analyst who has properly donned latex gloves, or by the use of an appropriately sterile grasping device, e.g., forceps, tweezers, etc.
- a portion of the protective strip 165 may extend beyond the opening 110 of container 102 , and accordingly may be removed from the surface of test strip 150 without further use or waste of sterile materials.
- the protective strip 165 may include a free end 167 that extends to the outside of the container 102 sufficiently that a user can grasp and pull the free end 167 to remove the protective strip 165 from the test strip 150 .
- a lip 124 is provided on the cap 122 such that, when the cap 122 is fastened onto the container 102 to seal the test sample from the environment, a portion of the protective strip 165 extends past the lip of the sealed container.
- a leak-proof seal 140 may be included on a side wall of the container 102 to allow a free end 167 of protective strip 165 to extend to the outside of the container 102 .
- the protective strip 165 may be removed from contact with the test strip 150 by pulling the protective strip through the leak-proof seal 140 .
- Such a configuration allows for the removal of the protective strip 165 from a sealed sample environment consisting of the container 102 and the cap 122 containing a desired sample of test liquid.
- the seal 140 may be implemented with a suitable elastomer material wedged tightly into an opening the container sidewall with a slit 141 in the elastomer wide enough for the protective strip 165 .
- the seal 140 , protective strip 165 , and free end 167 are configured so that the protective strip can be easily peeled back by pulling on the free end.
- the test strip 150 will be immediately exposed to the desired sample of test liquid present in the container 102 thereby contacting the minimum potential intermediary contaminants.
- the assay configured on the test strip 150 will develop accordingly, allowing a user or other analyst to determine whether or not an anticipated analyte is present in the test liquid via the visual indicator provided by the completed assay.
- FIG. 2 provides an alternative embodiment of the present invention wherein the test device is a container capable of being attached to a catheter. It should be appreciated that while FIG. 2 shows a standard Foley catheter for ease of recognition, alternative embodiments of the present invention allow for any number of analyte specific tests be performed in conjunction with various catheters and embodiments of the catheter testing system 200 of the present invention.
- FIG. 2 there is shown a testing system 200 for conducting an immunoassay to detect the presence of a specific analyte in a test sample of test fluid, for example, bodily fluid.
- a visual indication is provided to a user or other analyst of the test sample which represents the positive or negative presence of the analyte in the test sample.
- a control indicator is also provided to visually assure a user or other analyst of the validity of the assay or test result.
- the testing system 200 is capable of detecting the presence of an analyte, antigen, ligand, or other macromolecule in fluids such as bodily fluids, including but not limited to urine, blood, saliva, mucus, or perspiration.
- the visual indicators use a reagent which reacts to the presence of the analyte and is a conjugate of reactive color particles and/or an antibody specific to the anticipated analyte.
- the system 200 may utilize, for example, an antigen/receptor assay device which can be used to detect the presence of an anticipated, analytes, in a test fluid such as urine.
- an antigen/receptor assay device which can be used to detect the presence of an anticipated, analytes, in a test fluid such as urine.
- such devices may be utilized in home, industrial, veterinary, and occupational testing, among others.
- devices such as these are found in clinical testing systems, for example, pregnancy detection systems, disease detection systems, or apparatus for the detection of illegal drugs.
- Such assays may involve an antigen/antibody reaction wherein a synthetic conjugate provides a visible tag.
- a specific antibody is provided specific to the antigen being detected.
- An absorbable indicator is provided, generally providing a simple positive/negative indicator for the presence of the antigen being detected.
- a control indicator is also provided to ensure the validity of the test result.
- Many test strips are commercially available and could be used to test for a plurality of anticipated analytes in accord
- the testing system 200 is a system for both collecting and analyzing a sample such as, for example, a bodily fluid.
- the system generally includes a collection container in the form of a housing 202 attached to a catheter 204 .
- the housing 202 may be attached to the catheter 204 via a fastener 212 .
- the fastener 212 may attach the housing 202 to the catheter 204 in a number of ways, e.g., screw threads, valve attachments, etc.
- the fastener 212 may be in the form of a cap capable of attaching to a housing 202 .
- the cap may attach the housing 202 in a number of ways, e.g., screw threads, valve attachments, etc.
- a typical housing 202 may have a capacity of between about 10 to about 20 mL; however, the present invention is not intended to be limited to this size or capacity.
- the housing 202 may be formed, or molded, from any suitable material, such as plastic, and it will be appreciated that the housing 202 may be provided in a wide variety of shapes, e.g., as a matter of design preference or intended application.
- the housing 202 is constructed of a transparent material such that the visual indications provided by a completed assay are visible through the surfaces of the housing 202 .
- a test strip 250 is affixed to an interior surface of the housing 202 .
- the test strip 250 may be designed to test for the presence of a specific analyte, and it should be appreciated that alternative embodiments of the present invention allow for any number of analyte specific tests be performed with the system 200 of the present invention.
- the test strip 250 is configured to test for the presence of HCG.
- a removable protective strip 265 is secured in place over the test strip 250 at the time the housing 202 is manufactured or when the test strip 250 is affixed to the housing 202 .
- the test strip 250 and protective strip 265 comprise a replaceable “test panel” which can be loaded or fastened into an appropriately sterilized container 202 .
- the protective strip 265 prevents competing analytes or other contaminants from coming into contact with test strip 250 during the time period between manufacture/assembly and use. Such contaminants include, but are not limited to microbes and other atmospheric contaminants, and contaminants present on a user or analysts skin including hormones, microbes, oils, or perspiration.
- the protective strip 265 may be composed of any number of materials appropriate to preventing exposure of the test strip 250 to atmospheric or other contaminants, including but not limited to plastic film, metal foil, or an adhesive coating.
- the protective strip 265 is a coating which is dissolvable in the desired test liquid, and accordingly, the protective strip 265 dissolves after a certain period of exposure to the test liquid, allowing the test strip 250 to be exposed to the test liquid.
- an adhesive is applied to the area surrounding the test strip 250 , and the protective strip 265 is secured in place around and over (respectively) the test strip 250 , preventing the test strip 250 from being exposed to atmospheric or other contaminants.
- the nature of the mostly enclosed collection housing 202 and the system 200 allows for the protective strip 265 to be removed either before being attached to the catheter 204 or once the housing 202 has been filled/flooded with the desired sample of test liquid. This provides that the test strip 250 is exposed only to the desired sample of test liquid, and accordingly avoids contact with the atmosphere or any other potential contaminants in order to get the most accurate potential result.
- a portion of the protective strip 265 extends beyond the opening of the container 202 , and accordingly can be removed from the surface of the test strip 250 when a user pulls on the exposed portion of the protective strip 265 .
- the protective strip 265 may include a free end 267 that extends to the outside of the container 202 sufficiently that a user can grasp and pull the free end 267 to remove the protective strip 265 from the test strip 250 .
- the free end 267 of test strip 265 may extend beyond the opening of fastener 212 .
- a lip 224 is provided on the cap 212 such that, when the cap 212 is fastened onto the container 202 , a free end of the protective strip 265 extends past the lid of the now-sealed container 202 .
- Such an embodiment allows for the protective strip 265 to be removed from contact with the test strip 250 even when the container 202 and the lid 222 are in a sealed configuration.
- a leak-proof seal 240 may be included on the housing 202 to allow a portion of the protective strip 265 to extend externally from housing 202 .
- the protective strip 265 may be removed from contact with test strip 250 by pulling a free end of the protective strip through a slit 241 in the leak-proof seal 240 .
- Such a configuration allows for the removal of the protective strip 265 from a sealed sample environment consisting of the catheter system 200 of the catheter 204 attached to the collection housing 202 , which is able to contain a desired sample of test liquid as produced by a patient.
- the seal 240 may be implemented with a suitable elastomer material wedged tightly into an opening the container sidewall with a slit in the elastomer wide enough for the protective strip 265 .
- the seal 240 and protective strip 265 may be configured so that the protective strip can be easily peeled back by pulling on a free end of the protective strip that passes through the slit to the outside of the container.
- the test strip 250 will be exposed to the desired sample of test liquid present in the housing 202 , either immediately or as the patient produces the desired sample, thereby contacting the minimum potential intermediary contaminants.
- the assay configured on the test strip 250 will develop accordingly, allowing a user or other analyst to determine whether or not an anticipated analyte is present in the test liquid via the visual indicator provided by the completed assay.
- FIG. 3 depicts a flow diagram providing a sample collection and assay analysis the method 300 according to aspects of the present disclosure.
- a user, medical practitioner, or other analyst may select a testing container or system 301 for an anticipated analyte in accordance with the embodiments of the present invention described with respect to FIG. 1 , a collection container 100 , or with respect to FIG. 2 , a catheter testing container is attached in accordance with the catheter testing system 200 .
- the user or test subject fills the collection container 100 with the desired biological liquid sample (e.g., urine) as indicated at 312 .
- the desired biological liquid sample e.g., urine
- the user, medical practitioner, or other analyst responsible for analyzing the results of the assay may then optionally seal the test container 100 against further contamination as indicated at 314 .
- Certain embodiments of the present invention described with respect to FIG. 1 allow for the removal or dissolution of the protective strip from contact with the test strip as indicated at 316 when the collection container 100 is in a sealed configuration; other embodiments require that the user or analyst utilize a sterile device or accessory to remove the protective strip from the test strip.
- the assay is then allowed to develop and provide a visual indicator which indicates the presence or absence of the anticipated analyte as indicated at 318 .
- the catheter testing container 202 may be attached to a catheter line 204 as indicated at 322 .
- Certain embodiments of the present invention described with respect to FIG. 2 allow for the removal or dissolution of the protective strip from contact with the test strip as indicated at 324 when the catheter collection system 200 is in a sealed configuration; other embodiments require that a medical practitioner remove the protective strip from the test strip just prior to assembly of the catheter testing system 200 as indicated at 322 .
- the test subject's natural body processes then provide a sample of the test liquid into the catheter testing system as indicated at 326 .
- 324 and 326 may be reversed from that shown in FIG. 3 , i.e., the sample may be collected at 326 prior to removing the protective strip from the test strip at 324 , in order to collect a sterile sample.
- the assay is then allowed to develop and provide a visual indicator which indicates the presence or absence of the anticipated analyte as indicated at 328 .
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Urology & Nephrology (AREA)
- Endocrinology (AREA)
- Analytical Chemistry (AREA)
- Pathology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- General Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Clinical Laboratory Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physics & Mathematics (AREA)
- Reproductive Health (AREA)
- Biotechnology (AREA)
- Medicinal Chemistry (AREA)
- Food Science & Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Veterinary Medicine (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pulmonology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Sampling And Sample Adjustment (AREA)
Abstract
Description
- This application is a continuation of U.S. patent application Ser. No. 14/936,475, filed Nov. 9, 2015, the entire contents of which are incorporated herein by reference.
- Aspects of the present disclosure are related to analyte testing. In particular, the present disclosure is related to maintaining the sterile nature of an analyte testing assay during the sample collection and up to the exposure process.
- The field of medicine relies heavily on investigative testing performed on various compositions of biological material. Testing liquid samples, such as bodily fluids, often involves collecting a sample of a liquid and exposing the liquid to a diagnostic testing assay. An assay generally involves bringing a portion of the liquid sample into contact with an assay or test strip in order to qualitatively assess or measure the presence or amount of the functional activity of an anticipated analyte. Many such test assays or strips are known to detect for the presence of a specific chemical, hormone, or other material in liquid, such as blood, urine, or even saliva. Such tests have been designed, manufactured, produced, and marketed for use in such fields as home, industrial, veterinary, and occupational testing, among others.
- A plethora of test devices are available which allow a user to test for the presence of HCG, an early indicator of pregnancy, in urine. Devices and assays have also been created for the detection of a variety of other chemicals in urine, including screenings for illegal drugs in a test subject in, for example, employment or correctional settings. These devices, to date, require that a user or test subject either urinate directly on the device or assay, or to deposit urine into a receptacle into which a testing assay or strip is placed. Unfortunately, due to the exposure of both the receptacle and the assay to the test subject, support staff, lab personnel, and even the atmosphere, contamination of the sample and/or the assay is possible even when the utmost care is observed during all steps of these testing processes. Accordingly, a need for a test device which drastically reduces the potential opportunity for contamination of an assay or test strip is needed.
- It is within this context that the present disclosure arises.
- The teachings of the present disclosure can be readily understood by considering the following detailed description in conjunction with the accompanying drawings, in which:
-
FIG. 1 is a cutaway view of a sample collection and assay analysis device in accordance with aspects of the present disclosure. -
FIG. 2 is a cutaway view of a catheter-type sample collection and assay analysis device in accordance with aspects of the present disclosure. -
FIG. 3 is a flow diagram depicting a sample collection and assay analysis method according to aspects of the present disclosure. - Although the following detailed description contains many specific details for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the exemplary embodiments of the invention described below are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention.
- Referring now to
FIG. 1 of the drawings, there is shown atest device 100 for conducting an immunoassay to detect the presence of a specific analyte in a test sample of a fluid, for example, bodily fluid. A visual indication is provided to a user or other analyst of the test sample which represents the positive or negative presence of the analyte in the test sample. A control indicator is also provided to visually assure the user or other analyst of the validity of the assay or test result.Test device 100 is capable of detecting the presence of an analyte, antigen, ligand, or other macromolecule in fluids such as bodily fluids, including but not limited to urine, blood, saliva, mucus, or perspiration. The visual indicators use a reagent which reacts to the presence of the analyte and is a conjugate of reactive color particles and/or an antibody specific to the anticipated analyte. -
Device 100 is for example an antigen/receptor assay which can be used to detect the presence of an anticipated analyte in a test fluid such as urine. As provided above, such devices are used in home, industrial, veterinary, and occupational testing, among others. Generally, devices such as these are found in home testing or clinical testing devices, for example, pregnancy detection systems, disease detection systems, or apparatus for the detection of illegal drugs. Such assays may involve an antigen/antibody reaction wherein a synthetic conjugate provides a visible tag. A specific antibody is provided specific to the antigen being detected. An absorbable indicator is provided, generally providing a simple positive/negative indicator for the presence of the antigen being detected. A control indicator is also provided to ensure the validity of the test result. Many test strips are commercially available and could be used to test for a plurality of anticipated analytes in accordance with the embodiments described herein. -
Test device 100, in accordance with the present invention, is a device for collecting and analyzing a sample such as, for example, a bodily fluid. The device generally includes acontainer 102 having anopening 110 which provides a means for collecting the body fluid and achamber 104 which provides a means for storing the collected body fluid. Thecontainer 102 may includescrew threads 112 formed into the container proximate theopening 110 which are sized for accepting acap 122, which may containscrew threads 114. As hereinafter described, thescrew threads 114 ofcap 122, when screwed onto thethreads 112, provides a means for sealing theopening 110. For analysis, atypical container 102 may have a capacity of between about 100 to about 120 mL; however, the present invention is not intended to be limited to this size or capacity. -
Container 102 andcap 122 may be formed, or molded, from any suitable material, such as plastic, and it will be appreciated thatcontainer 102 andcap 122 may be provided in a wide variety of shapes, e.g., as a matter of design preference or intended application. In certain embodiments of the present invention,container 102 andcap 122 are constructed of a transparent material such that the visual indications provided by a completed assay are visible through the surfaces of thecontainer 102, even whencontainer 102 is sealed withcap 122. - As shown in the example of
FIG. 1 , atest strip 150 is affixed to the bottom interior surface ofcontainer 102. In alternative embodiments, thetest strip 150 may be affixed to an inside surface of the wall ofcontainer 102.Test strip 150 may be designed to test for the presence of a specific analyte, and it should be appreciated that alternative embodiments of the present invention allow for any number of analyte specific tests be performed with thedevice 100 of the present invention. In the present example, thetest strip 150 is configured to test for the presence of Human Chorionic Gonadotropin (HCG), a hormone produced by a portion of the placenta following implantation of a blastocyst in human females during embryogenesis; the presence of this hormone in urine is an early indicator of pregnancy. - In order to avoid contamination of
test strip 150, a removableprotective strip 165 is secured in place overtest strip 150 at thetime container 102 is manufactured or whentest strip 150 is affixed tocontainer 102. Alternative embodiments provide that thetest strip 150 andprotective strip 165 comprise a replaceable “test panel” which can be loaded or fastened into an appropriately sterilizedcontainer 102.Protective strip 165 prevents competing analytes or other contaminants from coming into contact withtest strip 150 during the time period between manufacture/assembly and use. Such contaminants include, but are not limited to microbes and other atmospheric contaminants, and contaminants present on a user or analysts skin including hormones, microbes, oils, or perspiration.Protective strip 165 may be composed of any number of materials appropriate to preventing exposure of thetest strip 150 to atmospheric or other contaminants, including but not limited to plastic, metal foil, or an adhesive coating. In certain embodiments, theprotective strip 165 is a coating which is dissolvable in the desired test liquid, and accordingly, theprotective strip 165 dissolves after a certain period of exposure to the test liquid, allowing thetest strip 150 to be exposed to the test liquid. In alternative embodiments, an adhesive is applied to the area surrounding thetest strip 150, and theprotective strip 165 is secured in place around and over (respectively) thetest strip 150, preventing thetest strip 150 from being exposed to atmospheric or other contaminants. - In accordance with certain embodiments of the present invention,
protective strip 165 is to be removed once thecontainer 102 has been filled with the desired sample of test liquid. This provides that thetest strip 150 is exposed only to the desired sample of test liquid, and accordingly avoids contact with the atmosphere or any other potential contaminants in order to get the most accurate potential result. In certain embodiments, theprotective strip 165 can be removed by a user or other analyst who has properly donned latex gloves, or by the use of an appropriately sterile grasping device, e.g., forceps, tweezers, etc. In alternative embodiments, a portion of theprotective strip 165 may extend beyond theopening 110 ofcontainer 102, and accordingly may be removed from the surface oftest strip 150 without further use or waste of sterile materials. In a particular implementation, theprotective strip 165 may include afree end 167 that extends to the outside of thecontainer 102 sufficiently that a user can grasp and pull thefree end 167 to remove theprotective strip 165 from thetest strip 150. - In alternative embodiments of the present invention, a
lip 124 is provided on thecap 122 such that, when thecap 122 is fastened onto thecontainer 102 to seal the test sample from the environment, a portion of theprotective strip 165 extends past the lip of the sealed container. Such an embodiment allows for theprotective strip 165 to be removed from contact with thetest strip 150 even when thecontainer 102 and thecap 122 are in a sealed configuration. In other alternative embodiments, a leak-proof seal 140 may be included on a side wall of thecontainer 102 to allow afree end 167 ofprotective strip 165 to extend to the outside of thecontainer 102. In such embodiments, theprotective strip 165 may be removed from contact with thetest strip 150 by pulling the protective strip through the leak-proof seal 140. Such a configuration allows for the removal of theprotective strip 165 from a sealed sample environment consisting of thecontainer 102 and thecap 122 containing a desired sample of test liquid. By way of example, and not by way of limitation, theseal 140 may be implemented with a suitable elastomer material wedged tightly into an opening the container sidewall with aslit 141 in the elastomer wide enough for theprotective strip 165. In the illustrated example, theseal 140,protective strip 165, andfree end 167 are configured so that the protective strip can be easily peeled back by pulling on the free end. - In embodiments of the present invention, once the
protective strip 165 is removed from contact with thetest strip 150, thetest strip 150 will be immediately exposed to the desired sample of test liquid present in thecontainer 102 thereby contacting the minimum potential intermediary contaminants. Once theprotective strip 165 is removed, the assay configured on thetest strip 150 will develop accordingly, allowing a user or other analyst to determine whether or not an anticipated analyte is present in the test liquid via the visual indicator provided by the completed assay. -
FIG. 2 provides an alternative embodiment of the present invention wherein the test device is a container capable of being attached to a catheter. It should be appreciated that whileFIG. 2 shows a standard Foley catheter for ease of recognition, alternative embodiments of the present invention allow for any number of analyte specific tests be performed in conjunction with various catheters and embodiments of thecatheter testing system 200 of the present invention. - In
FIG. 2 , there is shown atesting system 200 for conducting an immunoassay to detect the presence of a specific analyte in a test sample of test fluid, for example, bodily fluid. A visual indication is provided to a user or other analyst of the test sample which represents the positive or negative presence of the analyte in the test sample. A control indicator is also provided to visually assure a user or other analyst of the validity of the assay or test result. Thetesting system 200 is capable of detecting the presence of an analyte, antigen, ligand, or other macromolecule in fluids such as bodily fluids, including but not limited to urine, blood, saliva, mucus, or perspiration. The visual indicators use a reagent which reacts to the presence of the analyte and is a conjugate of reactive color particles and/or an antibody specific to the anticipated analyte. - The
system 200 may utilize, for example, an antigen/receptor assay device which can be used to detect the presence of an anticipated, analytes, in a test fluid such as urine. As provided above, such devices may be utilized in home, industrial, veterinary, and occupational testing, among others. Generally, devices such as these are found in clinical testing systems, for example, pregnancy detection systems, disease detection systems, or apparatus for the detection of illegal drugs. Such assays may involve an antigen/antibody reaction wherein a synthetic conjugate provides a visible tag. A specific antibody is provided specific to the antigen being detected. An absorbable indicator is provided, generally providing a simple positive/negative indicator for the presence of the antigen being detected. A control indicator is also provided to ensure the validity of the test result. Many test strips are commercially available and could be used to test for a plurality of anticipated analytes in accordance with the embodiments described herein. - The
testing system 200 is a system for both collecting and analyzing a sample such as, for example, a bodily fluid. The system generally includes a collection container in the form of ahousing 202 attached to acatheter 204. In some implementations, thehousing 202 may be attached to thecatheter 204 via afastener 212. Thefastener 212 may attach thehousing 202 to thecatheter 204 in a number of ways, e.g., screw threads, valve attachments, etc. In alternative implementations, thefastener 212 may be in the form of a cap capable of attaching to ahousing 202. The cap may attach thehousing 202 in a number of ways, e.g., screw threads, valve attachments, etc. For assay analysis, atypical housing 202 may have a capacity of between about 10 to about 20 mL; however, the present invention is not intended to be limited to this size or capacity. Thehousing 202 may be formed, or molded, from any suitable material, such as plastic, and it will be appreciated that thehousing 202 may be provided in a wide variety of shapes, e.g., as a matter of design preference or intended application. In certain embodiments of the present invention, thehousing 202 is constructed of a transparent material such that the visual indications provided by a completed assay are visible through the surfaces of thehousing 202. - As shown in the example of
FIG. 2 , atest strip 250 is affixed to an interior surface of thehousing 202. Thetest strip 250 may be designed to test for the presence of a specific analyte, and it should be appreciated that alternative embodiments of the present invention allow for any number of analyte specific tests be performed with thesystem 200 of the present invention. In the present example, thetest strip 250 is configured to test for the presence of HCG. - In order to avoid contamination of the
test strip 250, a removableprotective strip 265 is secured in place over thetest strip 250 at the time thehousing 202 is manufactured or when thetest strip 250 is affixed to thehousing 202. Alternative embodiments provide that thetest strip 250 andprotective strip 265 comprise a replaceable “test panel” which can be loaded or fastened into an appropriately sterilizedcontainer 202. Theprotective strip 265 prevents competing analytes or other contaminants from coming into contact withtest strip 250 during the time period between manufacture/assembly and use. Such contaminants include, but are not limited to microbes and other atmospheric contaminants, and contaminants present on a user or analysts skin including hormones, microbes, oils, or perspiration. Theprotective strip 265 may be composed of any number of materials appropriate to preventing exposure of thetest strip 250 to atmospheric or other contaminants, including but not limited to plastic film, metal foil, or an adhesive coating. In certain embodiments, theprotective strip 265 is a coating which is dissolvable in the desired test liquid, and accordingly, theprotective strip 265 dissolves after a certain period of exposure to the test liquid, allowing thetest strip 250 to be exposed to the test liquid. In alternative embodiments, an adhesive is applied to the area surrounding thetest strip 250, and theprotective strip 265 is secured in place around and over (respectively) thetest strip 250, preventing thetest strip 250 from being exposed to atmospheric or other contaminants. - In accordance with certain embodiments of the present invention, the nature of the mostly enclosed
collection housing 202 and thesystem 200 allows for theprotective strip 265 to be removed either before being attached to thecatheter 204 or once thehousing 202 has been filled/flooded with the desired sample of test liquid. This provides that thetest strip 250 is exposed only to the desired sample of test liquid, and accordingly avoids contact with the atmosphere or any other potential contaminants in order to get the most accurate potential result. In certain embodiments of the present invention, a portion of theprotective strip 265 extends beyond the opening of thecontainer 202, and accordingly can be removed from the surface of thetest strip 250 when a user pulls on the exposed portion of theprotective strip 265. In particular implementations of the present invention, theprotective strip 265 may include afree end 267 that extends to the outside of thecontainer 202 sufficiently that a user can grasp and pull thefree end 267 to remove theprotective strip 265 from thetest strip 250. In one such embodiment, thefree end 267 oftest strip 265 may extend beyond the opening offastener 212. - In another alternative embodiment, a
lip 224 is provided on thecap 212 such that, when thecap 212 is fastened onto thecontainer 202, a free end of theprotective strip 265 extends past the lid of the now-sealedcontainer 202. Such an embodiment allows for theprotective strip 265 to be removed from contact with thetest strip 250 even when thecontainer 202 and the lid 222 are in a sealed configuration. - In another alternative implementation of the present invention, a leak-
proof seal 240 may be included on thehousing 202 to allow a portion of theprotective strip 265 to extend externally fromhousing 202. In such embodiments, theprotective strip 265 may be removed from contact withtest strip 250 by pulling a free end of the protective strip through aslit 241 in the leak-proof seal 240. Such a configuration allows for the removal of theprotective strip 265 from a sealed sample environment consisting of thecatheter system 200 of thecatheter 204 attached to thecollection housing 202, which is able to contain a desired sample of test liquid as produced by a patient. By way of example, and not by way of limitation, theseal 240 may be implemented with a suitable elastomer material wedged tightly into an opening the container sidewall with a slit in the elastomer wide enough for theprotective strip 265. Theseal 240 andprotective strip 265 may be configured so that the protective strip can be easily peeled back by pulling on a free end of the protective strip that passes through the slit to the outside of the container. - In embodiments of the present invention, once the
protective strip 265 is removed from contact with thetest strip 250, thetest strip 250 will be exposed to the desired sample of test liquid present in thehousing 202, either immediately or as the patient produces the desired sample, thereby contacting the minimum potential intermediary contaminants. Once theprotective strip 265 is removed, the assay configured on thetest strip 250 will develop accordingly, allowing a user or other analyst to determine whether or not an anticipated analyte is present in the test liquid via the visual indicator provided by the completed assay. -
FIG. 3 , with respect to the example test device embodiments disclosed byFIGS. 1 and 2 , depicts a flow diagram providing a sample collection and assay analysis themethod 300 according to aspects of the present disclosure. As determined by the desired testing circumstance, a user, medical practitioner, or other analyst may select a testing container orsystem 301 for an anticipated analyte in accordance with the embodiments of the present invention described with respect toFIG. 1 , acollection container 100, or with respect toFIG. 2 , a catheter testing container is attached in accordance with thecatheter testing system 200. According to aspects of the present disclosure, if thecollection container 100 is chosen, the user or test subject fills thecollection container 100 with the desired biological liquid sample (e.g., urine) as indicated at 312. The user, medical practitioner, or other analyst responsible for analyzing the results of the assay may then optionally seal thetest container 100 against further contamination as indicated at 314. Certain embodiments of the present invention described with respect toFIG. 1 allow for the removal or dissolution of the protective strip from contact with the test strip as indicated at 316 when thecollection container 100 is in a sealed configuration; other embodiments require that the user or analyst utilize a sterile device or accessory to remove the protective strip from the test strip. The assay is then allowed to develop and provide a visual indicator which indicates the presence or absence of the anticipated analyte as indicated at 318. - According to alternative embodiments of the present disclosure, if the
catheter testing system 200 is chosen, thecatheter testing container 202 may be attached to acatheter line 204 as indicated at 322. This is optional and not strictly necessary if, e.g., thecontainer 202 andcatheter line 204 are manufactured as a unit. Certain embodiments of the present invention described with respect toFIG. 2 allow for the removal or dissolution of the protective strip from contact with the test strip as indicated at 324 when thecatheter collection system 200 is in a sealed configuration; other embodiments require that a medical practitioner remove the protective strip from the test strip just prior to assembly of thecatheter testing system 200 as indicated at 322. The test subject's natural body processes then provide a sample of the test liquid into the catheter testing system as indicated at 326. The order of 324 and 326 may be reversed from that shown inFIG. 3 , i.e., the sample may be collected at 326 prior to removing the protective strip from the test strip at 324, in order to collect a sterile sample. The assay is then allowed to develop and provide a visual indicator which indicates the presence or absence of the anticipated analyte as indicated at 328. - While the above is a complete description of the preferred embodiment of the present invention, it is possible to use various alternatives, modifications and equivalents. Therefore, the scope of the present invention should be determined not with reference to the above description but should, instead, be determined with reference to the appended claims, along with their full scope of equivalents. Any feature described herein, whether preferred or not, may be combined with any other feature described herein, whether preferred or not. In the claims that follow, the indefinite article “A”, or “An” refers to a quantity of one or more of the item following the article, except where expressly stated otherwise. The appended claims are not to be interpreted as including means-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase “means for.”
Claims (16)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/542,716 US20190369125A1 (en) | 2015-11-09 | 2019-08-16 | Sample container with integrated test strip |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/936,475 US10386376B2 (en) | 2015-11-09 | 2015-11-09 | Sample container with integrated test strip |
US16/542,716 US20190369125A1 (en) | 2015-11-09 | 2019-08-16 | Sample container with integrated test strip |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/936,475 Continuation US10386376B2 (en) | 2015-11-09 | 2015-11-09 | Sample container with integrated test strip |
Publications (1)
Publication Number | Publication Date |
---|---|
US20190369125A1 true US20190369125A1 (en) | 2019-12-05 |
Family
ID=58664282
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/936,475 Active 2037-11-26 US10386376B2 (en) | 2015-11-09 | 2015-11-09 | Sample container with integrated test strip |
US16/542,716 Abandoned US20190369125A1 (en) | 2015-11-09 | 2019-08-16 | Sample container with integrated test strip |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/936,475 Active 2037-11-26 US10386376B2 (en) | 2015-11-09 | 2015-11-09 | Sample container with integrated test strip |
Country Status (2)
Country | Link |
---|---|
US (2) | US10386376B2 (en) |
TW (1) | TW201727220A (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
USD844784S1 (en) * | 2014-03-14 | 2019-04-02 | Hologic, Inc. | Biopsy device |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4455140A (en) * | 1981-12-18 | 1984-06-19 | Sherwood Medical Company | Body fluid collection device |
US5500375A (en) * | 1993-04-13 | 1996-03-19 | Serex, Inc. | Integrated packaging-holder device for immunochromatographic assays in flow-through or dipstick formats |
US20080286879A1 (en) * | 2007-04-17 | 2008-11-20 | Steve Lee | Test device, and related methods |
US20090076471A1 (en) * | 2007-09-19 | 2009-03-19 | Nastaran Minassians | Closed specimen collection system |
US20100120073A1 (en) * | 2007-05-08 | 2010-05-13 | Superior Medical Llc | Methods and devices for detecting organisms causing urinary tract infections |
US20130071937A1 (en) * | 2010-03-01 | 2013-03-21 | Juerg Daniel Schmid | Test strip for the detection of equol |
US20130164858A1 (en) * | 2011-12-21 | 2013-06-27 | Church & Dwight Co., Inc. | Diagnostic detection device |
Family Cites Families (26)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3718543A (en) * | 1971-01-04 | 1973-02-27 | Bio Derivatives Corp | Bacterioria test material |
US4472353A (en) * | 1980-08-07 | 1984-09-18 | Gerald Moore | Gas detector badge |
US5030555A (en) * | 1988-09-12 | 1991-07-09 | University Of Florida | Membrane-strip reagent serodiagnostic apparatus and method |
US4952373A (en) | 1989-04-21 | 1990-08-28 | Biotrack, Inc. | Liquid shield for cartridge |
US5234813A (en) * | 1989-05-17 | 1993-08-10 | Actimed Laboratories, Inc. | Method and device for metering of fluid samples and detection of analytes therein |
US5607863A (en) | 1991-05-29 | 1997-03-04 | Smithkline Diagnostics, Inc. | Barrier-controlled assay device |
EP0622119B1 (en) | 1993-04-23 | 1999-11-03 | Roche Diagnostics GmbH | System for storing and dispensing test elements |
US5403551A (en) | 1993-09-16 | 1995-04-04 | Roche Diagnostic Systems, Inc. | Assaying device and container for in field analysis of a specimen and later shipment of the unadulterated specimen |
US5429804A (en) | 1994-07-15 | 1995-07-04 | Sayles; Philip W. | One-step testing device |
US20030232451A1 (en) * | 1996-03-11 | 2003-12-18 | Douglas Casterlin | Device for the testing of fluid samples and process for making the device |
US5976895A (en) * | 1996-03-11 | 1999-11-02 | American Biomedica Corporation | Device for the collection, testing and shipment of body fluid samples |
US6514461B1 (en) | 1997-02-14 | 2003-02-04 | Escreen, Inc. | System for automatically testing a fluid specimen |
US20020048819A1 (en) * | 2000-10-24 | 2002-04-25 | Kenneth Alley | Test strip for use in an apparatus for sampling and testing a specimen |
ATE438098T1 (en) | 2002-01-09 | 2009-08-15 | Inverness Medical Switzerland | TEST STRIPS CONTAINING CONTROL AGENTS AND TIME SETTING AGENTS |
EP1376131A1 (en) | 2002-06-27 | 2004-01-02 | Inverness Medical Switzerland GmbH | Assay device for liquid sample |
AU2004283721B2 (en) * | 2003-10-24 | 2009-08-13 | Adhesives Research, Inc. | Rapidly disintegrating film |
US7195878B2 (en) | 2004-09-30 | 2007-03-27 | Cryo-Genomics | Device and method for fecal testing |
JP4840940B2 (en) * | 2004-12-13 | 2011-12-21 | バイエル・ヘルスケア・エルエルシー | Self-contained inspection sensor |
US20070003115A1 (en) * | 2005-06-30 | 2007-01-04 | Eastman Kodak Company | Remote diagnostic device for medical testing |
GB2435510A (en) | 2006-02-23 | 2007-08-29 | Mologic Ltd | Enzyme detection product and methods |
CA2659116A1 (en) | 2006-07-26 | 2008-08-14 | Detectachem, Llc. | Apparatus and method for detection of trace chemicals |
EP2056109B1 (en) | 2006-08-21 | 2011-06-15 | Panasonic Corporation | Measuring device, measuring apparatus measuring method |
EP1975610B1 (en) | 2007-03-27 | 2009-01-07 | F. Hoffman-la Roche AG | Analysis device with exchangeable test element magazine |
GB0914001D0 (en) | 2009-08-11 | 2009-09-16 | Benson Jennifer M | Biodegradable pregnancy test |
AR085183A1 (en) | 2010-07-30 | 2013-09-18 | Lilly Co Eli | COMPOUND 6- (1-METHYL-1H-PIRAZOL-4-IL) -3- (2-METHYL-2H-INDAZOL-5-ILTIO) - [1,2,4] TRIAZOL [4,3-B] PIRIDAZINE, PHARMACEUTICAL COMPOSITION THAT UNDERSTAND AND USE IT TO PREPARE A USEFUL MEDICINAL PRODUCT TO TREAT CANCER |
US8927262B2 (en) | 2010-10-04 | 2015-01-06 | Church & Dwight Co., Inc. | Ovulation predictor test |
-
2015
- 2015-11-09 US US14/936,475 patent/US10386376B2/en active Active
-
2016
- 2016-10-12 TW TW105132914A patent/TW201727220A/en unknown
-
2019
- 2019-08-16 US US16/542,716 patent/US20190369125A1/en not_active Abandoned
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4455140A (en) * | 1981-12-18 | 1984-06-19 | Sherwood Medical Company | Body fluid collection device |
US5500375A (en) * | 1993-04-13 | 1996-03-19 | Serex, Inc. | Integrated packaging-holder device for immunochromatographic assays in flow-through or dipstick formats |
US20080286879A1 (en) * | 2007-04-17 | 2008-11-20 | Steve Lee | Test device, and related methods |
US20100120073A1 (en) * | 2007-05-08 | 2010-05-13 | Superior Medical Llc | Methods and devices for detecting organisms causing urinary tract infections |
US20090076471A1 (en) * | 2007-09-19 | 2009-03-19 | Nastaran Minassians | Closed specimen collection system |
US20130071937A1 (en) * | 2010-03-01 | 2013-03-21 | Juerg Daniel Schmid | Test strip for the detection of equol |
US20130164858A1 (en) * | 2011-12-21 | 2013-06-27 | Church & Dwight Co., Inc. | Diagnostic detection device |
Also Published As
Publication number | Publication date |
---|---|
TW201727220A (en) | 2017-08-01 |
US20170131299A1 (en) | 2017-05-11 |
US10386376B2 (en) | 2019-08-20 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20220280141A1 (en) | Method and apparatus for collecting and preparing biological samples for testing | |
US20200207523A1 (en) | Device for detecting analyte in sample | |
US11759783B2 (en) | Assay device | |
KR100617443B1 (en) | Disposable Test Vial with Sample Delivery Device | |
CN111107939B (en) | System and template for directing collection of harmful contaminant samples and method of using same | |
JP7275113B2 (en) | Sampling systems and techniques that collect hazardous pollutants with high pick-up and separation efficiencies | |
US20100288059A1 (en) | Specimen container, system, and method | |
KR101624962B1 (en) | Transport container for tissue samples | |
GB2350421A (en) | Testing biological fluids using a luminometer and a sampling dipstick | |
US8518342B2 (en) | Integrated analysis device which can be fitted to a container housing a sample to be analyzed | |
US10551373B2 (en) | Urine test device | |
US20040025603A1 (en) | Test tube insert | |
US20190369125A1 (en) | Sample container with integrated test strip | |
CN206270093U (en) | A kind of device collected and detect | |
CA2245031C (en) | Collection container assembly | |
US11793496B2 (en) | Means for collecting samples of urine, data and methods thereof | |
US20040025935A1 (en) | Test tube insert | |
EP0832689A2 (en) | Specimen collection kit | |
US20220334134A1 (en) | Clean screen contactless analyte detection test | |
US20090299305A1 (en) | Collection system for biological sample | |
EP0509158A1 (en) | Method of testing for urine antigen | |
US20230296632A1 (en) | Rapid parathormone identification test kit | |
JP3015092U (en) | Sample container with quantitative sampling tool | |
GB2572820A (en) | Liquid sample testers | |
WO2004014556A1 (en) | Apparatus and method for collecting sediment from a fluid sample |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: JEIMEI LLC, CONNECTICUT Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HOLLOWAY, CHRISTINA;REEL/FRAME:050074/0509 Effective date: 20151109 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: FINAL REJECTION MAILED |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |