US20100022916A1 - Method and Apparatus for Collecting and Preparing Biological Samples for Testing - Google Patents
Method and Apparatus for Collecting and Preparing Biological Samples for Testing Download PDFInfo
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- US20100022916A1 US20100022916A1 US12/179,248 US17924808A US2010022916A1 US 20100022916 A1 US20100022916 A1 US 20100022916A1 US 17924808 A US17924808 A US 17924808A US 2010022916 A1 US2010022916 A1 US 2010022916A1
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- bottle
- dropper
- stick
- cap
- swab
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- 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
-
- 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
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
Definitions
- This invention relates broadly to the testing of biological samples such as blood, oral fluids, epithelia, urine, stool, etc. More particularly, this invention relates to methods and apparatus for collecting and preparing such samples prior to testing.
- ligand-receptor assays have been used to detect the presence of various substances, often generally called ligands, in body fluids such as blood, urine, or saliva. These assays involve antigen antibody reactions, synthetic conjugates comprising radioactive, enzymatic, fluorescent, or visually observable polystyrene or metal sol tags, and specially designed reactor chambers. In all these assays, there is a receptor, e.g., an antibody, which is specific for the selected ligand or antigen, and a means for detecting the presence, and in some cases the amount, of the ligand-receptor reaction product. Some tests are designed to make a quantitative determination, but in many circumstances all that is required is a positive/negative qualitative indication. Examples of such qualitative assays include blood typing, most types of urinalysis, pregnancy tests, and AIDS tests. For these tests, a visually observable indicator such as the presence of agglutination or a color change is preferred.
- a visually observable indicator such as the presence of
- U.S. Pat. No. 6,485,982 discloses what may be called a single path immunoassay device.
- the device has an elongate outer casing which houses an interior permeable material, e.g., glass fiber, capable of transporting an aqueous solution by capillary action, wicking, or simple wetting.
- the casing defines a sample inlet, and interior regions which, for ease of description, can be designated as a test volume and a reservoir volume.
- the reservoir volume is disposed in a section of the test cell spaced apart from the inlet, and preferably is filled with sorbent material.
- the reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume.
- test site comprising a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path, e.g., bound to the permeable material or to latex particles entrapped in or bonded to the permeable material.
- a window such as a hole or transparent section of the casing permits observations of the test site through the casing wall. The method requires that the test sample be mixed with a conjugate or buffer before it is dispensed into the inlet.
- U.S. Pat. No. 7,189,522 discloses both dry and liquid conjugate immunoassay device systems.
- the systems include test cells with a first sorbent having a first location for receiving a buffer solution (in the case of a dry conjugate system) or a conjugate solution (in the case of a liquid conjugate system) with the first sorbent defining a first horizontal flow path, a second sorbent having a second location for receiving a sample with the second sorbent defining a second horizontal flow path distinct from the first flow path, and a test line or test site with immobilized antigens or antibodies or other ligand binding molecules such as aptamers, nucleic acids, etc. located in a test zone at a junction of the first and second sorbents.
- test cell is provided in a housing, such as the housing 1 show in prior art FIG. 1
- the housing is provided with a first opening 2 adjacent the first location and a second opening 3 adjacent the second location.
- a viewing window 4 is provided in the housing above the test line 5 .
- the first sorbent and second sorbent are separate pieces which overlie one another and the test line is printed on one or both of the sorbent materials at the junction.
- the first and second sorbents can be integral with each other.
- the systems preferably also include a control line 6 or site which may be seen from the viewing window 4 .
- the sorbents (and the housing in which the sorbents are provided) are laid out in a T shape, where the first location 2 for receiving the buffer or buffer-conjugate solution is located near one end of the top bar of the T, the second location 3 for receiving the sample is located near the end of the stem of the T, and the sorbents overlie each other at the intersection.
- a sample of interest is provided to the second opening or location 3 .
- a liquid such as a buffer solution is added to the first opening or location 2 .
- the liquid is preferably simply a buffer solution.
- the sorbent is not supporting a conjugate (i.e., in a liquid conjugate system)
- the liquid is preferably a buffer-conjugate liquid subsystem.
- the disclosed system can be used in conjunction with different types of samples such as blood, urine, saliva, and feces, and can be used to test for the presence of any ligand.
- samples such as blood, urine, saliva, and feces
- the blood, saliva or feces may be diluted or mixed with buffer prior to being added through the second hole 3 .
- the sample may be added through the hole and then a diluent may be added through the same hole 3 .
- the present invention provides a kit and a method for collecting and preparing a biological sample for use with an immunoassay device where the sample is to be mixed with a buffer prior to being added to the device.
- the kit includes a sterile swab and a dropper bottle assembly containing the buffer solution to which the sample is added.
- the dropper bottle assembly includes a dropper cap having a hinged cover and a threaded base and a bottle having a threaded neck. When the kit is delivered for use, the dropper cap is threadably connected to the threaded neck of the bottle and the hinged cover is closed.
- the sterile swab includes a sorbent mounted on the end of a stick. The stick is preferably long enough so that a sample can be obtained without the person taking the sample contaminating it. The stick is provided with a weakened portion where the stick can be readily broken.
- a method according to the invention includes opening the dropper bottle assembly by unscrewing the cap, inserting the swab into the bottle, snapping the swab stick to break it, and screwing the cap back on the bottle.
- the bottle containing the sorbent end of the swab is then agitated by shaking it. Now the mixed sample and buffer are ready to dispense into the testing device. This is done by opening the hinged cover of the dropper cap, inverting the bottle and dispensing the appropriate number of drops onto the device by gently squeezing the bottle.
- the location of the weakened portion of the swab stick is such that when the swab is placed into the bottle and touching the bottom of the bottle, the weakened portion of the stick is directly adjacent to the upper lip of the bottle neck. In this manner, the stick can be broken simply by bending it against the bottle neck with the sorbent end in the bottle.
- the hinged cover on the dripper cap has a lock which prevents it from being inadvertently opened. This prevents contamination and loss of buffer solution.
- the kit according to the invention preferably also contains a second bottle of buffer solution for use with a test device employing a dual path immunoassay system.
- the kit includes an alcohol swab, a safety lancet, and a bandage.
- the kit may, and preferably does contain an immunoassay device, preferably a dual path immunoassay device.
- a method of testing a blood sample includes using the alcohol swab to clean the area of the skin from which the sample will be taken, pricking the skin with the safety lancet, and collecting blood using the collection swab. The method then proceeds as described above.
- FIG. 1 is a plan view of a prior art immunoassay test device
- FIG. 2 is a side elevation view of a swab according to the invention.
- FIG. 3 is a side elevation view of a dropper bottle assembly according to the invention.
- FIG. 4 is a front elevation view of the dropper bottle assembly
- FIG. 5 is a rear elevation view of the dropper bottle assembly
- FIG. 6 is a side elevation view of the dropper bottle assembly with the cap removed and the swab inserted into the bottle;
- FIG. 7 is a side elevation view of the dropper bottle with the sorbent end of the swab and the stick broken;
- FIG. 8 is a side elevation view of the dropper bottle assembly with the sorbent end of the swab contained therein and the hinged cover opened;
- FIG. 9 is a flow chart illustrating the method steps of the invention.
- FIG. 10 is a plan diagram of an expanded kit containing a dual path test device and related sampling items.
- a kit according to the invention includes a sterile swab 10 and a dropper bottle assembly 12 containing the buffer solution 14 to which the sample is to be added.
- the sterile swab 10 includes a sorbent 16 mounted on the end of a stick 18 .
- the stick 18 is preferably long enough so that a sample can be obtained without contaminating it.
- the stick is provided with a weakened portion 20 where the stick 18 can be readily broken.
- the dropper bottle assembly 12 includes a dropper cap 22 having a dropper spout 23 , a hinged cover 24 and a threaded base 26 and a bottle 28 having a threaded neck 30 ( FIGS. 6 and 7 ).
- the dropper cap is threadably connected to the threaded neck of the bottle and the hinged cover is closed as shown in FIGS. 3-5 .
- the dropper cap 22 includes a forward projecting finger 32 and two rearward projecting fingers 34 , 36 .
- the cover 24 has a rear slot which is bifurcated by a cross member 38 and a front slot which is either bifurcated or terminated by a cross member 40 .
- the rearward projecting fingers extend into the rear slot and embrace the cross member 38 thereby forming a hinge.
- the forward projecting finger 32 engages the front slot above the cross member 40 and thereby prevents the cover from accidentally opening.
- the cover 24 is made of resilient material which can be deformed by squeezing the sides of the cover.
- FIG. 9 A method according to the invention is illustrated in FIG. 9 .
- the method is preferably performed in a clean room which is free from food, drink, and smoke as illustrated at 100 .
- the person performing the method may don protective clothing such as a face mask and rubber gloves as indicated at 102 .
- the kit should be examined at 104 to determine whether it has expired or been contaminated through a broken package.
- the method then proceeds to opening the dropper bottle assembly at 106 by unscrewing the cap and preferably placing the bottle and the cap on a sterile surface.
- the swab is then removed from its sterile package (not shown) at 108 and is used to obtain a sample at 110 .
- the sorbent end of the swab is then placed into the open bottle ( FIG. 6 ) and the stick is broken at 112 ( FIG. 7 ).
- the cap is then screwed back onto the bottle at 114 with the broken-stick-swab therein and the bottle is agitated at 116 , preferably by shaking it a number of times, e.g. ten.
- the hinged cover is then opened ( FIG. 8 ) at 118 and the bottle inverted at 120 .
- the bottle is positioned over the test apparatus which has been removed from its sterile package (see 11 in FIG. 10 ) and an appropriate number of drops are dispensed at 122 through the dropper spout 23 by gently squeezing the bottle.
- pure buffer from a separate bottle discussed below
- the apparatus of the invention was tested on one hundred patients known to be infected with HIV.
- the tests involved collecting oral fluid and performing the procedure described above. Ninety-seven positive test results were obtained and one indeterminate result. This compared favorably with a currently (at the time of the tests) FDA approved test which obtained ninety-eight positive test results from the one hundred patients.
- the apparatus of the invention was tested on twenty-five patients known to be not infected with HIV. The tests involved collecting oral fluid and performing the procedure described above. All twenty-five patients tested negative for HIV. The FDA approved test achieved the same results.
- FIG. 10 shows a kit which is specifically intended for use with a dual path assay device ( 1 in FIG. 1 ) which is shown in a sterile package 11 .
- the kit includes the swab 10 which is preferably contained in a sealed sterile package (not shown) and bottle assembly 12 .
- a second dropper bottle 41 is provided containing the buffer solution to be added to hole 2 in FIG. 1 and as shown in phantom at 124 in FIG. 9 .
- the kit further includes a safety lancet 42 , a packaged alcohol swab 44 and a bandage 46 .
- the kit contains all that is needed to test several different kinds of samples, including blood.
- a method of testing a blood sample includes using the alcohol swab 44 to clean the area of the skin from which the sample will be taken, pricking the skin with the safety lancet 42 , collecting blood using the collection swab 10 , and bandaging the collection site with the bandage 46 . The method then proceeds as described above with reference to FIG. 9 . While the presently preferred embodiment of the kit and method are designed for use with a dual path immunoassay device, a kit and method for use with a single path device are also contemplated by the invention. When applied to a single path device, the kit need not contain the second dropper bottle 41 .
Abstract
A kit and a method are disclosed for collecting and preparing a biological sample for testing where the sample is to be mixed with a buffer prior to being tested.
Description
- This application is related to co-owned U.S. Pat. No. 7,189,522, entitled “Dual Path Immunoassay Device,” the complete disclosure of which is hereby incorporated by reference herein.
- 1. Field of the Invention
- This invention relates broadly to the testing of biological samples such as blood, oral fluids, epithelia, urine, stool, etc. More particularly, this invention relates to methods and apparatus for collecting and preparing such samples prior to testing.
- 2. State of the Art
- Many types of ligand-receptor assays have been used to detect the presence of various substances, often generally called ligands, in body fluids such as blood, urine, or saliva. These assays involve antigen antibody reactions, synthetic conjugates comprising radioactive, enzymatic, fluorescent, or visually observable polystyrene or metal sol tags, and specially designed reactor chambers. In all these assays, there is a receptor, e.g., an antibody, which is specific for the selected ligand or antigen, and a means for detecting the presence, and in some cases the amount, of the ligand-receptor reaction product. Some tests are designed to make a quantitative determination, but in many circumstances all that is required is a positive/negative qualitative indication. Examples of such qualitative assays include blood typing, most types of urinalysis, pregnancy tests, and AIDS tests. For these tests, a visually observable indicator such as the presence of agglutination or a color change is preferred.
- U.S. Pat. No. 6,485,982 discloses what may be called a single path immunoassay device. The device has an elongate outer casing which houses an interior permeable material, e.g., glass fiber, capable of transporting an aqueous solution by capillary action, wicking, or simple wetting. The casing defines a sample inlet, and interior regions which, for ease of description, can be designated as a test volume and a reservoir volume. The reservoir volume is disposed in a section of the test cell spaced apart from the inlet, and preferably is filled with sorbent material. The reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume. In the test volume is a test site comprising a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path, e.g., bound to the permeable material or to latex particles entrapped in or bonded to the permeable material. A window such as a hole or transparent section of the casing permits observations of the test site through the casing wall. The method requires that the test sample be mixed with a conjugate or buffer before it is dispensed into the inlet.
- Previously incorporated U.S. Pat. No. 7,189,522 discloses both dry and liquid conjugate immunoassay device systems. The systems include test cells with a first sorbent having a first location for receiving a buffer solution (in the case of a dry conjugate system) or a conjugate solution (in the case of a liquid conjugate system) with the first sorbent defining a first horizontal flow path, a second sorbent having a second location for receiving a sample with the second sorbent defining a second horizontal flow path distinct from the first flow path, and a test line or test site with immobilized antigens or antibodies or other ligand binding molecules such as aptamers, nucleic acids, etc. located in a test zone at a junction of the first and second sorbents.
- Where the test cell is provided in a housing, such as the
housing 1 show in prior artFIG. 1 , the housing is provided with afirst opening 2 adjacent the first location and a second opening 3 adjacent the second location. Aviewing window 4 is provided in the housing above thetest line 5. - In the preferred embodiment, the first sorbent and second sorbent are separate pieces which overlie one another and the test line is printed on one or both of the sorbent materials at the junction. Alternatively, although not preferred, the first and second sorbents can be integral with each other. The systems preferably also include a
control line 6 or site which may be seen from theviewing window 4. - According to one set of embodiments, the sorbents (and the housing in which the sorbents are provided) are laid out in a T shape, where the
first location 2 for receiving the buffer or buffer-conjugate solution is located near one end of the top bar of the T, thesecond location 3 for receiving the sample is located near the end of the stem of the T, and the sorbents overlie each other at the intersection. - According to one disclosed method, a sample of interest is provided to the second opening or
location 3. After a desired amount of time, a liquid such as a buffer solution is added to the first opening orlocation 2. If the sorbent is supporting a conjugate (i.e., in a dry conjugate system), the liquid is preferably simply a buffer solution. If the sorbent is not supporting a conjugate (i.e., in a liquid conjugate system), the liquid is preferably a buffer-conjugate liquid subsystem. In any event, after sufficient time to permit the conjugate to migrate to the test site 5 (andcontrol site 6 if provided), the test site (and control site if provided) is inspected in order to determine whether the sample is “positive” or not. - The disclosed system can be used in conjunction with different types of samples such as blood, urine, saliva, and feces, and can be used to test for the presence of any ligand. Where blood, saliva or feces is to be provided, the blood, saliva or feces may be diluted or mixed with buffer prior to being added through the
second hole 3. Alternatively, in some cases, the sample may be added through the hole and then a diluent may be added through thesame hole 3. - The present invention provides a kit and a method for collecting and preparing a biological sample for use with an immunoassay device where the sample is to be mixed with a buffer prior to being added to the device. The kit includes a sterile swab and a dropper bottle assembly containing the buffer solution to which the sample is added. The dropper bottle assembly includes a dropper cap having a hinged cover and a threaded base and a bottle having a threaded neck. When the kit is delivered for use, the dropper cap is threadably connected to the threaded neck of the bottle and the hinged cover is closed. The sterile swab includes a sorbent mounted on the end of a stick. The stick is preferably long enough so that a sample can be obtained without the person taking the sample contaminating it. The stick is provided with a weakened portion where the stick can be readily broken.
- A method according to the invention includes opening the dropper bottle assembly by unscrewing the cap, inserting the swab into the bottle, snapping the swab stick to break it, and screwing the cap back on the bottle. The bottle containing the sorbent end of the swab is then agitated by shaking it. Now the mixed sample and buffer are ready to dispense into the testing device. This is done by opening the hinged cover of the dropper cap, inverting the bottle and dispensing the appropriate number of drops onto the device by gently squeezing the bottle.
- From the foregoing, it will be appreciated that the location of the weakened portion of the swab stick is such that when the swab is placed into the bottle and touching the bottom of the bottle, the weakened portion of the stick is directly adjacent to the upper lip of the bottle neck. In this manner, the stick can be broken simply by bending it against the bottle neck with the sorbent end in the bottle.
- According to a presently preferred embodiment, the hinged cover on the dripper cap has a lock which prevents it from being inadvertently opened. This prevents contamination and loss of buffer solution. The kit according to the invention preferably also contains a second bottle of buffer solution for use with a test device employing a dual path immunoassay system. Optionally, the kit includes an alcohol swab, a safety lancet, and a bandage. The kit may, and preferably does contain an immunoassay device, preferably a dual path immunoassay device. A method of testing a blood sample includes using the alcohol swab to clean the area of the skin from which the sample will be taken, pricking the skin with the safety lancet, and collecting blood using the collection swab. The method then proceeds as described above.
- Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.
-
FIG. 1 is a plan view of a prior art immunoassay test device; -
FIG. 2 is a side elevation view of a swab according to the invention; -
FIG. 3 is a side elevation view of a dropper bottle assembly according to the invention; -
FIG. 4 is a front elevation view of the dropper bottle assembly; -
FIG. 5 is a rear elevation view of the dropper bottle assembly; -
FIG. 6 is a side elevation view of the dropper bottle assembly with the cap removed and the swab inserted into the bottle; -
FIG. 7 is a side elevation view of the dropper bottle with the sorbent end of the swab and the stick broken; -
FIG. 8 is a side elevation view of the dropper bottle assembly with the sorbent end of the swab contained therein and the hinged cover opened; -
FIG. 9 is a flow chart illustrating the method steps of the invention; and -
FIG. 10 is a plan diagram of an expanded kit containing a dual path test device and related sampling items. - Turning now to
FIGS. 2-5 , a kit according to the invention includes asterile swab 10 and adropper bottle assembly 12 containing thebuffer solution 14 to which the sample is to be added. Thesterile swab 10 includes asorbent 16 mounted on the end of astick 18. Thestick 18 is preferably long enough so that a sample can be obtained without contaminating it. The stick is provided with a weakenedportion 20 where thestick 18 can be readily broken. Thedropper bottle assembly 12 includes adropper cap 22 having adropper spout 23, a hingedcover 24 and a threadedbase 26 and abottle 28 having a threaded neck 30 (FIGS. 6 and 7 ). When the kit is delivered for use, the dropper cap is threadably connected to the threaded neck of the bottle and the hinged cover is closed as shown inFIGS. 3-5 . - Referring now to
FIGS. 3-5 and 8, thedropper cap 22 includes a forward projectingfinger 32 and two rearward projectingfingers cover 24 has a rear slot which is bifurcated by across member 38 and a front slot which is either bifurcated or terminated by across member 40. As seen best inFIGS. 5 , 6, and 8, the rearward projecting fingers extend into the rear slot and embrace thecross member 38 thereby forming a hinge. As seen best inFIG. 4 , when the cover is closed, the forward projectingfinger 32 engages the front slot above thecross member 40 and thereby prevents the cover from accidentally opening. Thecover 24 is made of resilient material which can be deformed by squeezing the sides of the cover. Squeezing the sides of the cover deforms it in a manner that causes thecross member 40 to move forward and out from under thefinger 32 thereby unlocking the cover and allowing it to be hingedly rotated aboutcross member 40 thereby opening the cover to the position shown inFIG. 8 with thespout 23 exposed. A dropper bottle assembly of the type described above is also described in U.S. Pat. No. 5,328,058, the complete disclosure of which is incorporated by reference herein. - A method according to the invention is illustrated in
FIG. 9 . The method is preferably performed in a clean room which is free from food, drink, and smoke as illustrated at 100. Optimally, the person performing the method may don protective clothing such as a face mask and rubber gloves as indicated at 102. Before beginning the method, the kit should be examined at 104 to determine whether it has expired or been contaminated through a broken package. The method then proceeds to opening the dropper bottle assembly at 106 by unscrewing the cap and preferably placing the bottle and the cap on a sterile surface. The swab is then removed from its sterile package (not shown) at 108 and is used to obtain a sample at 110. The sorbent end of the swab is then placed into the open bottle (FIG. 6 ) and the stick is broken at 112 (FIG. 7 ). The cap is then screwed back onto the bottle at 114 with the broken-stick-swab therein and the bottle is agitated at 116, preferably by shaking it a number of times, e.g. ten. The hinged cover is then opened (FIG. 8 ) at 118 and the bottle inverted at 120. The bottle is positioned over the test apparatus which has been removed from its sterile package (see 11 inFIG. 10 ) and an appropriate number of drops are dispensed at 122 through thedropper spout 23 by gently squeezing the bottle. When a dual path immunoassay device is used, at 124, pure buffer from a separate bottle (discussed below) is added to another location of the test apparatus. - The apparatus of the invention was tested on one hundred patients known to be infected with HIV. The tests involved collecting oral fluid and performing the procedure described above. Ninety-seven positive test results were obtained and one indeterminate result. This compared favorably with a currently (at the time of the tests) FDA approved test which obtained ninety-eight positive test results from the one hundred patients. The apparatus of the invention was tested on twenty-five patients known to be not infected with HIV. The tests involved collecting oral fluid and performing the procedure described above. All twenty-five patients tested negative for HIV. The FDA approved test achieved the same results.
- The above described kit and method can be used with a single path assay device or with a dual path assay device.
FIG. 10 shows a kit which is specifically intended for use with a dual path assay device (1 inFIG. 1 ) which is shown in asterile package 11. The kit includes theswab 10 which is preferably contained in a sealed sterile package (not shown) andbottle assembly 12. In addition, asecond dropper bottle 41 is provided containing the buffer solution to be added tohole 2 inFIG. 1 and as shown in phantom at 124 inFIG. 9 . The kit further includes asafety lancet 42, a packagedalcohol swab 44 and abandage 46. Thus, the kit contains all that is needed to test several different kinds of samples, including blood. - A method of testing a blood sample includes using the
alcohol swab 44 to clean the area of the skin from which the sample will be taken, pricking the skin with thesafety lancet 42, collecting blood using thecollection swab 10, and bandaging the collection site with thebandage 46. The method then proceeds as described above with reference toFIG. 9 . While the presently preferred embodiment of the kit and method are designed for use with a dual path immunoassay device, a kit and method for use with a single path device are also contemplated by the invention. When applied to a single path device, the kit need not contain thesecond dropper bottle 41. - There have been described and illustrated herein methods and apparatus for the collection and preparation of biological samples for testing. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.
Claims (11)
1. A method for collecting and preparing a biological sample to be tested, comprising:
obtaining the sample with a swab, the swab having a sorbent mounted on the end of a stick;
obtaining a dropper bottle assembly having a dropper cap with a spout, a threaded base and a bottle with a threaded neck, the bottle containing a buffer solution;
opening the dropper bottle assembly by unscrewing and removing the cap with the spout;
inserting the sorbent end of the swab into the bottle;
breaking the stick leaving the sorbent and a portion of the stick in the bottle;
closing the dropper bottle assembly by re-screwing the cap onto the threaded neck;
agitating the bottle to mix the sample with the buffer solution;
opening the dropper cap to expose the spout;
inverting the bottle; and
dispensing at least a portion of the mixed sample-buffer solution contents of the bottle through the spout onto a first location of said test device.
2. A method according to claim 1 , wherein:
said agitating is accomplished by shaking the bottle multiple times.
3. A method according to claim 1 , wherein:
the stick has a weakened portion at a particular place to facilitate said breaking.
4. A method according to claim 1 , wherein:
said dropper cap has a hinged cover.
5. A method according to claim 4 , wherein:
said opening the dropper cap comprises rotating the hinged cover.
6. A method according to claim 1 , further comprising:
obtaining a second dropper bottle containing buffer solution; and
dispensing at least a portion of said buffer solution of said second dropper bottle onto a second location different than said first location on said test device.
7. A kit for collecting and preparing a biological sample for testing, said kit comprising:
a sterile swab having a stick with a sorbent at one end of the stick, said stick having a weakened portion to facilitate breaking the stick at a pre-selected location;
a dropper bottle assembly, said assembly including a screw cap having a spout, a locking hinged cover and a threaded base and a first bottle with a threaded neck, said first bottle containing a liquid buffer and said screw cap being coupled to said threaded neck, wherein
the weakened portion of the stick located a distance from the end of the sorbent approximately equal to the height of the first bottle.
8. A kit according to claim 7 , further comprising:
a second dropper bottle containing a liquid buffer.
9. A kit according to claim 8 , further comprising:
an alcohol swab, a safety lancet, and a bandage.
10. A kit according to claim 8 , further comprising:
an immunoassay device having a first opening identified for receiving drops from said first bottle and a second opening identified for receiving drops from said second bottle.
11. A kit according to claim 7 , further comprising:
an immunoassay device having an opening for receiving drops from said first bottle.
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US13/055,536 US20120165699A9 (en) | 2008-07-24 | 2009-07-22 | Method and Apparatus for Collecting and Preparing Biological Samples for Testing |
US16/373,445 US11350913B2 (en) | 2008-07-24 | 2019-04-02 | Method and apparatus for collecting and preparing biological samples for testing |
US17/751,218 US20220280141A1 (en) | 2008-07-24 | 2022-05-23 | Method and apparatus for collecting and preparing biological samples for testing |
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US16/373,445 Active 2029-08-26 US11350913B2 (en) | 2008-07-24 | 2019-04-02 | Method and apparatus for collecting and preparing biological samples for testing |
US17/751,218 Pending US20220280141A1 (en) | 2008-07-24 | 2022-05-23 | Method and apparatus for collecting and preparing biological samples for testing |
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US16/373,445 Active 2029-08-26 US11350913B2 (en) | 2008-07-24 | 2019-04-02 | Method and apparatus for collecting and preparing biological samples for testing |
US17/751,218 Pending US20220280141A1 (en) | 2008-07-24 | 2022-05-23 | Method and apparatus for collecting and preparing biological samples for testing |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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US20230364603A1 (en) * | 2020-07-02 | 2023-11-16 | Mayo Foundation For Medical Education And Research | Lateral flow immunoassay casing and collection device |
WO2023075394A1 (en) * | 2021-10-29 | 2023-05-04 | 주식회사 씨젠 | Sample collecting swab tool and method for detection of respiratory pathogen |
Citations (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4803998A (en) * | 1986-01-27 | 1989-02-14 | Ncs Diagnostics, Inc. | Swab retaining vial cap and method of use |
US5320809A (en) * | 1991-06-03 | 1994-06-14 | Abbott Laboratories | Retrofit kit for changing single immunoassay instrument to flexible multiple immunoassay instrument |
US5543115A (en) * | 1995-07-17 | 1996-08-06 | Mizuho Usa, Inc. | Specimen handling device |
US20010007926A1 (en) * | 1998-09-25 | 2001-07-12 | David Trudil | Biological sample collection kit |
US20030199004A1 (en) * | 2002-04-10 | 2003-10-23 | Response Biomedical Corporation | Sensitive immunochromatographic assay |
US20040014237A1 (en) * | 2002-03-18 | 2004-01-22 | Nobuyuki Sugiyama | Swab testing device and method |
US20050130310A1 (en) * | 2002-04-23 | 2005-06-16 | Home Access Health Corporation | Quantitative analysis of a biological sample of unknown quantity |
US20060205059A1 (en) * | 2005-03-11 | 2006-09-14 | Javanbakhsh Esfandiari | Dual path immunoassay device |
US20070167900A1 (en) * | 2004-01-16 | 2007-07-19 | Sagarika Kanjilal | Sample collection device and method |
US20070208275A1 (en) * | 2006-03-01 | 2007-09-06 | Home Access Health Corporation | Specimen collection device |
US20070299364A1 (en) * | 2006-06-22 | 2007-12-27 | Sangha Jangbir S | Containerized sample collection apparatus and method |
US20080139962A1 (en) * | 2004-12-14 | 2008-06-12 | Ahmed Jehanli | Analyte Collection Apparatus and Method |
US20080254550A1 (en) * | 2007-02-05 | 2008-10-16 | Andrew Homer Nathaniel | Drug detection kit and method |
Family Cites Families (320)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5622871A (en) | 1987-04-27 | 1997-04-22 | Unilever Patent Holdings B.V. | Capillary immunoassay and device therefor comprising mobilizable particulate labelled reagents |
US4059405A (en) | 1972-04-11 | 1977-11-22 | Damon Corporation | Method and apparatus for analysis of constituent carried in fibrous medium |
US3815580A (en) * | 1972-08-31 | 1974-06-11 | C Oster | Apparatus for and method of collecting and preserving cytologic samples |
US3960488A (en) | 1974-04-01 | 1976-06-01 | General Electric Company | Method and apparatus for quantitative surface inhibition test |
US4041146A (en) | 1975-05-01 | 1977-08-09 | General Electric Company | Method for detection of biological particles |
US4042335A (en) | 1975-07-23 | 1977-08-16 | Eastman Kodak Company | Integral element for analysis of liquids |
US4094647A (en) | 1976-07-02 | 1978-06-13 | Thyroid Diagnostics, Inc. | Test device |
CA1095819A (en) | 1977-01-14 | 1981-02-17 | Eastman Kodak Company | Element for analysis of liquids |
US4235601A (en) | 1979-01-12 | 1980-11-25 | Thyroid Diagnostics, Inc. | Test device and method for its use |
US4361537A (en) | 1979-01-12 | 1982-11-30 | Thyroid Diagnostics, Inc. | Test device and method for its use |
US4323536A (en) | 1980-02-06 | 1982-04-06 | Eastman Kodak Company | Multi-analyte test device |
US4668619A (en) | 1980-10-30 | 1987-05-26 | Miles Laboratories, Inc. | Multilayer homogeneous specific binding assay device |
US4588555A (en) | 1982-10-04 | 1986-05-13 | Fmc Corporation | Device for use in chemical reactions and analyses |
JPH0665987B2 (en) | 1982-11-19 | 1994-08-24 | 富士写真フイルム株式会社 | Analysis element |
USRE34405E (en) | 1983-08-01 | 1993-10-12 | Abbott Laboratories | Determination of analytes in particle-containing medium |
US4522786A (en) | 1983-08-10 | 1985-06-11 | E. I. Du Pont De Nemours And Company | Multilayered test device for detecting analytes in liquid test samples |
US4595654A (en) | 1983-11-07 | 1986-06-17 | Immunomedics Inc. | Method for detecting immune complexes in serum |
US4532107A (en) | 1984-03-26 | 1985-07-30 | Miles Laboratories, Inc. | Reagent test device |
US4632901A (en) | 1984-05-11 | 1986-12-30 | Hybritech Incorporated | Method and apparatus for immunoassays |
US5362654A (en) | 1984-07-20 | 1994-11-08 | Sangstat Medical Corporation | Self-contained quantitative assay |
US4826759A (en) | 1984-10-04 | 1989-05-02 | Bio-Metric Systems, Inc. | Field assay for ligands |
DE3445816C1 (en) | 1984-12-15 | 1986-06-12 | Behringwerke Ag, 3550 Marburg | Flat diagnostic agent |
US5958790A (en) | 1984-12-20 | 1999-09-28 | Nycomed Imaging As | Solid phase transverse diffusion assay |
US4740468A (en) | 1985-02-14 | 1988-04-26 | Syntex (U.S.A.) Inc. | Concentrating immunochemical test device and method |
US5500350A (en) | 1985-10-30 | 1996-03-19 | Celltech Limited | Binding assay device |
US5482830A (en) | 1986-02-25 | 1996-01-09 | Biostar, Inc. | Devices and methods for detection of an analyte based upon light interference |
US4906439A (en) | 1986-03-25 | 1990-03-06 | Pb Diagnostic Systems, Inc. | Biological diagnostic device and method of use |
US4785796A (en) * | 1986-09-12 | 1988-11-22 | Mattson Philip D | Otoscope and flexible, disposable curette for use therewith |
US4960691A (en) | 1986-09-29 | 1990-10-02 | Abbott Laboratories | Chromatographic test strip for determining ligands or receptors |
US5156952A (en) | 1986-11-07 | 1992-10-20 | Syntex (U.S.A.) Inc. | Qualitative immunochromatographic method and device |
US5232835A (en) | 1986-11-07 | 1993-08-03 | Syntex (U.S.A.) Inc. | Qualitative immunochromatographic method and device |
US5169789A (en) | 1986-12-03 | 1992-12-08 | New Horizons Diagnostics Corporation | Device and method for self contained solid phase immunodiffusion assay |
DE3643516A1 (en) | 1986-12-19 | 1988-06-30 | Boehringer Mannheim Gmbh | TEST CARRIER FOR THE ANALYTICAL DETERMINATION OF INGREDIENTS OF BODY LIQUIDS |
US4920046A (en) | 1987-02-20 | 1990-04-24 | Becton, Dickinson And Company | Process, test device, and test kit for a rapid assay having a visible readout |
DE3705686C2 (en) | 1987-02-23 | 1995-11-30 | Boehringer Mannheim Gmbh | Methods for the determination of antibodies |
USRE38430E1 (en) | 1987-03-27 | 2004-02-17 | Becton, Dickinson And Company | Solid phase chromatographic immunoassay |
CA1303983C (en) | 1987-03-27 | 1992-06-23 | Robert W. Rosenstein | Solid phase assay |
US4849340A (en) | 1987-04-03 | 1989-07-18 | Cardiovascular Diagnostics, Inc. | Reaction system element and method for performing prothrombin time assay |
US5137808A (en) | 1987-04-07 | 1992-08-11 | Syntex (U.S.A.) Inc. | Immunoassay device |
US4857453A (en) | 1987-04-07 | 1989-08-15 | Syntex (U.S.A.) Inc. | Immunoassay device |
US4956275A (en) | 1987-04-14 | 1990-09-11 | Molecular Devices Corporation | Migratory detection immunoassay |
DE3856542T2 (en) | 1987-04-27 | 2003-10-30 | Inverness Medical Switzerland | Test device for carrying out specific binding tests |
DE3878820T2 (en) | 1987-04-29 | 1993-07-22 | Celltech Ltd | DEVICE FOR BINDING TEST. |
US5641639A (en) | 1987-04-29 | 1997-06-24 | Celltech Therapeutics Limited | Binding assay device |
DE3715485A1 (en) | 1987-05-09 | 1988-11-17 | Boehringer Mannheim Gmbh | STABILIZATION OF SS GALACTOSIDASE |
US4855240A (en) | 1987-05-13 | 1989-08-08 | Becton Dickinson And Company | Solid phase assay employing capillary flow |
US4943522A (en) | 1987-06-01 | 1990-07-24 | Quidel | Lateral flow, non-bibulous membrane assay protocols |
US4870003A (en) | 1987-06-15 | 1989-09-26 | Coulter Corporation | Simultaneous enzyme immunoassay for detecting antigen and/or antibody in humans |
US4886742A (en) | 1987-06-15 | 1989-12-12 | Coulter Corporation | Enzyme immunoassay for detecting HIV antigens in human sera |
AU1816888A (en) | 1987-06-26 | 1989-01-05 | Gerrard Abdool Rayman | Device for testing fluids |
US4981786A (en) | 1987-09-04 | 1991-01-01 | Syntex (U.S.A.) Inc. | Multiple port assay device |
US4956302A (en) | 1987-09-11 | 1990-09-11 | Abbott Laboratories | Lateral flow chromatographic binding assay device |
US4912034A (en) | 1987-09-21 | 1990-03-27 | Biogenex Laboratories | Immunoassay test device and method |
DE3733084A1 (en) | 1987-09-30 | 1989-04-13 | Boehringer Mannheim Gmbh | TEST CARRIER FOR ANALYTICAL DETERMINATION OF A COMPONENT OF A BODY LIQUID |
US5006464A (en) | 1987-10-01 | 1991-04-09 | E-Y Laboratories, Inc. | Directed flow diagnostic device and method |
US5571667A (en) | 1987-10-01 | 1996-11-05 | Chu; Albert E. | Elongated membrane flow-through diagnostic device and method |
US4891321A (en) | 1987-10-21 | 1990-01-02 | Hubscher Thomas T | Apparatus for performing determinations of immune reactants in biological fluids |
US5275785A (en) | 1987-10-30 | 1994-01-04 | Unilever Patent Holdings B.V. | Test device for detecting an analyte in a liquid sample |
DE3740471A1 (en) | 1987-11-28 | 1989-06-08 | Boehringer Mannheim Gmbh | TEST SUPPLIER FOR THE ANALYSIS OF A SAMPLING FLUID AND METHOD FOR THE PRODUCTION THEREOF |
US5006474A (en) | 1987-12-16 | 1991-04-09 | Disease Detection International Inc. | Bi-directional lateral chromatographic test device |
GB8800702D0 (en) | 1988-01-13 | 1988-02-10 | Nycomed As | Test method & reagent kit therefor |
US5670381A (en) | 1988-01-29 | 1997-09-23 | Abbott Laboratories | Devices for performing ion-capture binding assays |
US5238649A (en) | 1988-02-09 | 1993-08-24 | Nason Frederic L | Specimen test unit |
US5104793A (en) | 1988-02-16 | 1992-04-14 | Boehringer Mannheim Corporation | Method for determining an analyte in a liquid sample using a zoned test device and an inhibitor for a label used in said method |
US5912116A (en) | 1988-03-14 | 1999-06-15 | Nextec Applications, Inc. | Methods of measuring analytes with barrier webs |
FR2630827B1 (en) | 1988-04-28 | 1994-06-03 | Oris Ind | APPARATUS AND METHOD FOR QUICK QUALITATIVE AND QUANTITATIVE DETERMINATION OF THE PRESENCE OF A REACTIVE LIGAND IN A FLUID |
US5137804A (en) | 1988-05-10 | 1992-08-11 | E. I. Du Pont De Nemours And Company | Assay device and immunoassay |
US5334513A (en) | 1988-05-17 | 1994-08-02 | Syntex (U.S.A.) Inc. | Method for immunochromatographic analysis |
US4981785A (en) | 1988-06-06 | 1991-01-01 | Ventrex Laboratories, Inc. | Apparatus and method for performing immunoassays |
US4960710A (en) | 1988-06-06 | 1990-10-02 | Miles Inc. | Device and method of assaying for trace mounts of proteins |
US5620845A (en) | 1988-06-06 | 1997-04-15 | Ampcor, Inc. | Immunoassay diagnostic kit |
AU2684488A (en) * | 1988-06-27 | 1990-01-04 | Carter-Wallace, Inc. | Test device and method for colored particle immunoassay |
US5338513A (en) | 1988-07-30 | 1994-08-16 | Boehringer Mannheim Gmbh | Test carrier for the analytical determination of a component of a liquid sample |
DE3826057A1 (en) | 1988-07-30 | 1990-02-01 | Boehringer Mannheim Gmbh | TEST TESTER FOR THE ANALYTICAL DETERMINATION OF AN INGREDIENT OF A LIQUID SAMPLE |
US5075077A (en) | 1988-08-02 | 1991-12-24 | Abbott Laboratories | Test card for performing assays |
US5281540A (en) | 1988-08-02 | 1994-01-25 | Abbott Laboratories | Test array for performing assays |
US5240735A (en) | 1988-09-30 | 1993-08-31 | Miles Inc. | Method of manufacturing a test article for the determination of protein |
MY104234A (en) | 1988-11-17 | 1994-02-28 | Becton Dickinson Co | Immunoassay on a preblocked solid surface |
US5252484A (en) | 1988-11-29 | 1993-10-12 | Minnesota Mining And Manufacturing Company | Rapid read-out biological indicator |
JPH02176466A (en) | 1988-12-27 | 1990-07-09 | Mochida Pharmaceut Co Ltd | Method and instrument for measuring specified material in liquid specimen |
US5202268A (en) | 1988-12-30 | 1993-04-13 | Environmental Diagnostics, Inc. | Multi-layered test card for the determination of substances in liquids |
US5939272A (en) | 1989-01-10 | 1999-08-17 | Biosite Diagnostics Incorporated | Non-competitive threshold ligand-receptor assays |
US6352862B1 (en) | 1989-02-17 | 2002-03-05 | Unilever Patent Holdings B.V. | Analytical test device for imuno assays and methods of using same |
US5766933A (en) | 1989-04-26 | 1998-06-16 | Diagnostic Products Corporation | Method and element for measuring analytes in biological fluids using immobilized binder--analyte labeled complex |
US5411858A (en) | 1989-05-17 | 1995-05-02 | Actimed Laboratories, Inc. | Manufacturing process for sample initiated assay device |
US5087556A (en) | 1989-05-17 | 1992-02-11 | Actimed Laboratories, Inc. | Method for quantitative analysis of body fluid constituents |
AU640162B2 (en) | 1989-08-28 | 1993-08-19 | Lifescan, Inc. | Blood separation and analyte detection techniques |
US5306623A (en) | 1989-08-28 | 1994-04-26 | Lifescan, Inc. | Visual blood glucose concentration test strip |
US5639671A (en) | 1989-09-18 | 1997-06-17 | Biostar, Inc. | Methods for optimizing of an optical assay device |
US5541057A (en) | 1989-09-18 | 1996-07-30 | Biostar, Inc. | Methods for detection of an analyte |
US20020015663A1 (en) | 1989-09-21 | 2002-02-07 | Andrew S. Goldstein | Oral collection device and kit |
US5147780A (en) | 1989-12-01 | 1992-09-15 | Sangstat Medical Corporation | Multiwell stat test |
US5252496A (en) | 1989-12-18 | 1993-10-12 | Princeton Biomeditech Corporation | Carbon black immunochemical label |
US5435970A (en) | 1989-12-18 | 1995-07-25 | Environmental Diagnostics, Inc. | Device for analysis for constituents in biological fluids |
US5922615A (en) | 1990-03-12 | 1999-07-13 | Biosite Diagnostics Incorporated | Assay devices comprising a porous capture membrane in fluid-withdrawing contact with a nonabsorbent capillary network |
US5328058A (en) * | 1990-05-03 | 1994-07-12 | Nalge Company | Dropper bottle assembly with squeeze cap |
ES2089057T3 (en) | 1990-07-18 | 1996-10-01 | Abbott Lab | AN ANALYTE SUBSTITUTE REAGENT FOR USE IN SPECIFIC FIXATION TEST METHODS, DEVICES AND KITS. |
EP0475045B1 (en) | 1990-08-06 | 1996-12-11 | Bayer Corporation | Method and device for the assay of ions |
US5200321A (en) | 1990-09-07 | 1993-04-06 | The United States Of America As Represented By The Secretary Of The Navy | Microassay on a card |
JPH0810218B2 (en) | 1990-09-19 | 1996-01-31 | テルモ株式会社 | Test tool |
IE75720B1 (en) | 1990-10-08 | 1997-09-24 | Akzo Nv | Device for performing a rapid single manual assay |
US5091153A (en) | 1990-10-11 | 1992-02-25 | Toxi-Lab Incorporated | Chemical analysis test device |
US5173433A (en) | 1990-10-11 | 1992-12-22 | Toxi-Lab Incorporated | Method for chemical analysis |
AU9039691A (en) | 1990-11-14 | 1992-06-11 | Southern Research Institute | Rapid diagnostic device and kit |
WO1992012428A1 (en) | 1991-01-11 | 1992-07-23 | Quidel Corporation | A one-step lateral flow nonbibulous assay |
US5550063A (en) | 1991-02-11 | 1996-08-27 | Biostar, Inc. | Methods for production of an optical assay device |
US5955377A (en) | 1991-02-11 | 1999-09-21 | Biostar, Inc. | Methods and kits for the amplification of thin film based assays |
US5567594A (en) | 1991-04-26 | 1996-10-22 | Enteron, L.P. | Methods and compositions for the detection and treatment of diseases associated with antigens of microorganisms |
US5468648A (en) | 1991-05-29 | 1995-11-21 | Smithkline Diagnostics, Inc. | Interrupted-flow assay device |
US5877028A (en) | 1991-05-29 | 1999-03-02 | Smithkline Diagnostics, Inc. | Immunochromatographic assay device |
US5998220A (en) | 1991-05-29 | 1999-12-07 | Beckman Coulter, Inc. | Opposable-element assay devices, kits, and methods employing them |
US5869345A (en) | 1991-05-29 | 1999-02-09 | Smithkline Diagnostics, Inc. | Opposable-element assay device employing conductive barrier |
US5648274A (en) | 1991-05-29 | 1997-07-15 | Smithkline Diagnostics, Inc. | Competitive immunoassay device |
US5607863A (en) | 1991-05-29 | 1997-03-04 | Smithkline Diagnostics, Inc. | Barrier-controlled assay device |
US6168956B1 (en) | 1991-05-29 | 2001-01-02 | Beckman Coulter, Inc. | Multiple component chromatographic assay device |
US5686315A (en) | 1991-06-14 | 1997-11-11 | Quidel Corporation | Assay device for one step detection of analyte |
US5451504A (en) | 1991-07-29 | 1995-09-19 | Serex, Inc. | Method and device for detecting the presence of analyte in a sample |
US5726010A (en) | 1991-07-31 | 1998-03-10 | Idexx Laboratories, Inc. | Reversible flow chromatographic binding assay |
US5418136A (en) | 1991-10-01 | 1995-05-23 | Biostar, Inc. | Devices for detection of an analyte based upon light interference |
DE69220871T2 (en) | 1991-10-03 | 1997-11-20 | Bayer Ag | Device and method for the separation and analysis of whole blood |
US5334502A (en) | 1991-11-27 | 1994-08-02 | Osborn Laboratories, Inc. | Method of collecting, identifying, and quantifying saliva |
US5332548A (en) | 1991-12-30 | 1994-07-26 | Moore Robert E | Analytical device and method of using same |
DE4202850A1 (en) | 1992-01-31 | 1993-08-05 | Boehringer Mannheim Gmbh | ANALYSIS ELEMENT FOR IMMUNOASSAYS |
JP3382632B2 (en) | 1992-03-13 | 2003-03-04 | オリンパス光学工業株式会社 | Method for measuring biological substance and reaction vessel used for the method |
US5296192A (en) | 1992-04-03 | 1994-03-22 | Home Diagnostics, Inc. | Diagnostic test strip |
US6905882B2 (en) | 1992-05-21 | 2005-06-14 | Biosite, Inc. | Diagnostic devices and apparatus for the controlled movement of reagents without membranes |
US6019944A (en) | 1992-05-21 | 2000-02-01 | Biosite Diagnostics, Inc. | Diagnostic devices and apparatus for the controlled movement of reagents without membranes |
US6156270A (en) | 1992-05-21 | 2000-12-05 | Biosite Diagnostics, Inc. | Diagnostic devices and apparatus for the controlled movement of reagents without membranes |
US5244788A (en) | 1992-07-01 | 1993-09-14 | Hubscher Thomas T | Method and apparatus for performing determinations of immune rectants in biological fluids |
US5356782A (en) | 1992-09-03 | 1994-10-18 | Boehringer Mannheim Corporation | Analytical test apparatus with on board negative and positive control |
US5308775A (en) | 1992-09-15 | 1994-05-03 | Abbott Laboratories | Assay devices for concurrently detecting an analyte and confirming the test result |
US5384264A (en) | 1992-11-05 | 1995-01-24 | Syntron Bioresearch, Inc. | Method and apparatus for single step assays of ligand-containing fluids |
FI92882C (en) | 1992-12-29 | 1995-01-10 | Medix Biochemica Ab Oy | Disposable test strip and process for its manufacture |
US5477863A (en) * | 1993-04-14 | 1995-12-26 | Grant; Michael A. | Collection kit with a sample collector |
US5532133A (en) | 1993-06-02 | 1996-07-02 | New York University | Plasmodium vivax blood stage antigens, PvESP-1, antibodies, and diagnostic assays |
US5552272A (en) | 1993-06-10 | 1996-09-03 | Biostar, Inc. | Detection of an analyte by fluorescence using a thin film optical device |
DK0649904T3 (en) | 1993-09-14 | 2003-04-22 | Biomerieux Bv | Diagnostic reagent for detection of antibodies to EBV |
DE69408541T2 (en) | 1993-11-23 | 1998-08-06 | Genentech Inc | KINAS RECEPTOR ACTIVATION TEST |
GB9324310D0 (en) | 1993-11-26 | 1994-01-12 | Univ Birmingham | Liquid transfer device |
US5695928A (en) | 1993-12-10 | 1997-12-09 | Novartis Corporation | Rapid immunoassay for detection of antibodies or antigens incorporating simultaneous sample extraction and immunogenic reaction |
US5424215A (en) | 1994-02-07 | 1995-06-13 | Miles Inc. | Assay for the determination of protein in a biological sample |
US5714341A (en) | 1994-03-30 | 1998-02-03 | Epitope, Inc. | Saliva assay method and device |
US5658801A (en) | 1994-05-03 | 1997-08-19 | Spectral Diagnostics Inc. | Medical test kit |
US5514557A (en) | 1994-06-06 | 1996-05-07 | Genetic Testing Institute Inc. | Method and kit for detecting antibodies specific for HLA and/or platelet glycoproteins |
EP0690306A1 (en) | 1994-06-28 | 1996-01-03 | Mochida Pharmaceutical Co., Ltd. | Method and device for specific binding assay |
EP0699906B1 (en) | 1994-07-25 | 2002-04-24 | Roche Diagnostics GmbH | Method for detecting the contamination of a surface with an analyte |
US5521102A (en) | 1994-08-08 | 1996-05-28 | Quidel Corporation | Controlled sensitivity immunochromatographic assay |
GB9419267D0 (en) | 1994-09-23 | 1994-11-09 | Unilever Plc | Assay devices |
US5695930A (en) | 1994-11-10 | 1997-12-09 | Weinstein; David E. | HIV test kit method for detecting anti-HIV-I antibodies in saliva |
US5807756A (en) | 1995-01-10 | 1998-09-15 | At Point Bio | Ceramic assembly for use in biological assays |
US5712172A (en) | 1995-05-18 | 1998-01-27 | Wyntek Diagnostics, Inc. | One step immunochromatographic device and method of use |
US5786220A (en) | 1995-04-28 | 1998-07-28 | Quidel Corporation | Assays and devices for distinguishing between normal and abnormal pregnancy |
US6319676B1 (en) | 1995-05-02 | 2001-11-20 | Carter Wallace, Inc. | Diagnostic detection device and method |
US5739041A (en) | 1995-05-02 | 1998-04-14 | Carter Wallace, Inc. | Diagnostic detection device |
WO1996036878A1 (en) | 1995-05-19 | 1996-11-21 | Universal Healthwatch, Inc. | Rapid self-contained assay format |
DE19523049A1 (en) | 1995-06-24 | 1997-01-02 | Boehringer Mannheim Gmbh | Multilayer analysis element for the determination of an analyte in a liquid |
US5773234A (en) | 1995-08-07 | 1998-06-30 | Quidel Corporation | Method and device for chlamydia detection |
AU6720096A (en) | 1995-08-09 | 1997-03-05 | Quidel Corporation | Test strip and method for one step lateral flow assay |
US6057166A (en) | 1995-12-22 | 2000-05-02 | Universal Healthwatch, Inc. | Fecal test method |
US5766962A (en) | 1995-12-22 | 1998-06-16 | Universal Healthwatch, Inc. | Device for collecting and testing samples |
US6750031B1 (en) | 1996-01-11 | 2004-06-15 | The United States Of America As Represented By The Secretary Of The Navy | Displacement assay on a porous membrane |
US6027890A (en) | 1996-01-23 | 2000-02-22 | Rapigene, Inc. | Methods and compositions for enhancing sensitivity in the analysis of biological-based assays |
US5623942A (en) * | 1996-01-24 | 1997-04-29 | Mml Diagnostics | Cell collection swab |
US5874216A (en) | 1996-02-23 | 1999-02-23 | Ensys Environmental Products, Inc. | Indirect label assay device for detecting small molecules and method of use thereof |
US6406922B2 (en) | 1996-03-11 | 2002-06-18 | American Bio Medica Corp. | Device for the testing of body fluid samples |
US5976895A (en) | 1996-03-11 | 1999-11-02 | American Biomedica Corporation | Device for the collection, testing and shipment of body fluid samples |
US6403383B1 (en) | 1996-03-11 | 2002-06-11 | American Bio Medica Corp. | Diagnostic test kit for immunological assays of fluid samples |
US6372515B1 (en) | 1996-03-11 | 2002-04-16 | American Bio Medica Corporation | Device for the testing of fluid samples and process for making the device |
DE19609838A1 (en) | 1996-03-13 | 1997-09-18 | Boehringer Mannheim Gmbh | Methods and test strips for the determination of an analyte |
US5962215A (en) | 1996-04-05 | 1999-10-05 | Mercury Diagnostics, Inc. | Methods for testing the concentration of an analyte in a body fluid |
US5900379A (en) | 1996-04-11 | 1999-05-04 | Mizuho Usa, Inc. | Analytical device |
DE19622628A1 (en) | 1996-06-05 | 1997-12-11 | Boehringer Mannheim Gmbh | Stabilization of metal conjugates |
JP3323085B2 (en) * | 1996-09-11 | 2002-09-09 | 株式会社山洋 | Medical swabs |
US6194220B1 (en) | 1996-09-25 | 2001-02-27 | Becton, Dickinson And Company | Non-instrumented assay with quantitative and qualitative results |
US5998221A (en) | 1996-09-25 | 1999-12-07 | Becton, Dickinson And Company | Non-instrumented assay with quantitative and qualitative results |
US5710005A (en) | 1996-10-29 | 1998-01-20 | Biocode, Inc. | Analyte detection with a gradient lateral flow device |
EP2290362B1 (en) | 1996-10-30 | 2013-01-23 | F. Hoffmann-La Roche AG | Synchronized analyte testing system |
DE19649389A1 (en) | 1996-11-29 | 1998-06-04 | Boehringer Mannheim Gmbh | Antigen-specific IgM detection |
DE19649390A1 (en) | 1996-11-29 | 1998-06-04 | Boehringer Mannheim Gmbh | Antigen-specific IgG detection |
AU724089B2 (en) | 1996-12-05 | 2000-09-14 | Idego Aps | Sensor laminates and multi-sectioned fluid delivery devices for detecting by immunoassay target molecules in biological fluids |
US5879951A (en) | 1997-01-29 | 1999-03-09 | Smithkline Diagnostics, Inc. | Opposable-element assay device employing unidirectional flow |
US6924153B1 (en) | 1997-03-06 | 2005-08-02 | Quidel Corporation | Quantitative lateral flow assays and devices |
US5885526A (en) | 1997-03-25 | 1999-03-23 | Chu; Albert E. | Analytical device for membrane-based assays |
US5965375A (en) | 1997-04-04 | 1999-10-12 | Biosite Diagnostics | Diagnostic tests and kits for Clostridium difficile |
US6060326A (en) | 1997-04-07 | 2000-05-09 | Heska Corporation | Method to detect canine IgE and kit therefor |
JP3334558B2 (en) | 1997-04-23 | 2002-10-15 | 富士レビオ株式会社 | Enzyme immunoassay and test strips |
US6103536A (en) | 1997-05-02 | 2000-08-15 | Silver Lake Research Corporation | Internally referenced competitive assays |
US5939252A (en) | 1997-05-09 | 1999-08-17 | Lennon; Donald J. | Detachable-element assay device |
US6008056A (en) | 1997-05-28 | 1999-12-28 | Epitope, Inc. | Sample volume control for lateral flow chromatography |
US6258548B1 (en) | 1997-06-05 | 2001-07-10 | A-Fem Medical Corporation | Single or multiple analyte semi-quantitative/quantitative rapid diagnostic lateral flow test system for large molecules |
US7049130B2 (en) | 1997-06-10 | 2006-05-23 | Home Diagnostics, Inc. | Diagnostic sanitary test strip |
US6991940B2 (en) | 1997-06-10 | 2006-01-31 | Home Diagnostics, Inc. | Diagnostic sanitary test strip |
US6040195A (en) | 1997-06-10 | 2000-03-21 | Home Diagnostics, Inc. | Diagnostic sanitary test strip |
US5948695A (en) | 1997-06-17 | 1999-09-07 | Mercury Diagnostics, Inc. | Device for determination of an analyte in a body fluid |
US5985675A (en) | 1997-12-31 | 1999-11-16 | Charm Sciences, Inc. | Test device for detection of an analyte |
US6046013A (en) | 1997-08-01 | 2000-04-04 | Gti | Process for identifying specific antibodies associated with HLA |
US5922533A (en) | 1997-08-15 | 1999-07-13 | Abbott Laboratories | Rapid assay for simultaneous detection and differentiation of antibodies to HIV groups |
DE29715019U1 (en) | 1997-08-21 | 1997-10-16 | Lre Technology Partner Gmbh | Test strips for a measuring device for the optical determination of the concentration of a substance in a body fluid |
YU11500A (en) | 1997-08-29 | 2001-09-28 | Fertility Acoustics Inc. | Method and apparatus for rapid analysis in biological samples |
WO1999017117A1 (en) | 1997-09-30 | 1999-04-08 | Amira Medical | Analytical device with capillary reagent carrier |
US6271046B1 (en) | 1997-10-06 | 2001-08-07 | Enterix, Inc. | Apparatus and method for analyte detection |
WO1999018436A1 (en) | 1997-10-06 | 1999-04-15 | Enterix Inc. | Apparatus and method for analyte detection |
US7157234B2 (en) | 1997-10-24 | 2007-01-02 | Beckman Coulter, Inc. | Detection of very low quantities of analyte bound to a solid phase |
US6046057A (en) | 1997-10-24 | 2000-04-04 | Carter-Wallace, Inc. | Analyte assaying device |
US6087184A (en) | 1997-11-10 | 2000-07-11 | Beckman Coulter, Inc. | Opposable-element chromatographic assay device for detection of analytes |
US6306642B1 (en) | 1997-11-24 | 2001-10-23 | Quidel Corporation | Enzyme substrate delivery and product registration in one step enzyme immunoassays |
NZ504768A (en) | 1997-11-28 | 2002-11-26 | Provalis Diagnostics Ltd | Device and apparatus for conducting an assay |
DE19753849A1 (en) | 1997-12-04 | 1999-06-10 | Roche Diagnostics Gmbh | Analytical test element with a tapered capillary channel |
US5902722A (en) | 1997-12-05 | 1999-05-11 | The Perkin-Elmer Corporation | Method of detecting organisms in a sample |
EP1038176B1 (en) | 1997-12-19 | 2003-11-12 | Amira Medical | Embossed test strip system |
AUPP103497A0 (en) | 1997-12-19 | 1998-01-15 | Panbio Pty Ltd | Assay apparatus |
AU1944699A (en) | 1997-12-23 | 1999-07-12 | Vicam, L.P. | Generic signalling mechanism for detection of analytes |
DE19816550A1 (en) | 1997-12-24 | 1999-06-24 | Roche Diagnostics Gmbh | Universally applicable structure of an analysis element and its use for analyte determination |
US6394952B1 (en) | 1998-02-03 | 2002-05-28 | Adeza Biomedical Corporation | Point of care diagnostic systems |
TW356712U (en) | 1998-03-04 | 1999-04-21 | Yung-Shiang Liou | Testing apparatus of immune |
CA2324096A1 (en) | 1998-03-10 | 1999-09-16 | Strategic Diagnostics, Inc. | Integrated assay device and methods of production and use |
US6548309B1 (en) | 1998-03-19 | 2003-04-15 | Binax, Inc. | Procedure for assay of liquids containing undissolved solids, semisolids or colloids |
EP1086372B1 (en) | 1998-03-30 | 2006-05-31 | OraSure Technologies, Inc. | Collection device for single step assay of oral fluids |
US6224831B1 (en) | 1998-03-31 | 2001-05-01 | John Co., Inc. | Microassay device and methods |
US6106732A (en) | 1998-04-16 | 2000-08-22 | Binax Services, Inc. | Integral blood plasma or serum isolation, metering and transport device |
US7476548B2 (en) | 1998-04-23 | 2009-01-13 | Bayer Healthcare Llc | Dry reagent strip configuration, composition and method for multiple analyte determination |
CA2237209C (en) * | 1998-05-08 | 2002-01-29 | Institute Of Legal Medicine Of The University Of Berne | Foldable cardboard box for contact-free drying and long-term storage of biological evidence recovered on cotton swabs and forensic evidence collection kit including same |
EP1020726A4 (en) | 1998-07-01 | 2007-11-14 | Nitto Denko Corp | Immunologic test method and immunologic test kit |
GB2339615B (en) | 1998-07-14 | 2001-02-07 | Cozart Bioscience Ltd | Screening device and method of screening an immunoassay test |
CA2270797A1 (en) | 1998-07-27 | 2000-01-27 | Bayer Corporation | Transparent flow through membrane for dry reagent analytical devices |
AU764444B2 (en) | 1998-08-06 | 2003-08-21 | Spectral Diagnostics Inc. | Analytical test device and method |
ATE416674T1 (en) | 1998-08-14 | 2008-12-15 | Biocontrol Systems Inc | DETECTION OF CONTAMINATION USING INDEPENDENT UNITS THAT USE TARGET MATERIAL BINDING DYES |
US6824997B1 (en) | 1998-09-18 | 2004-11-30 | Binax, Inc. | Process and materials for the rapid detection of streptococcus pneumoniae employing purified antigen-specific antibodies |
US6248598B1 (en) | 1998-09-17 | 2001-06-19 | Stuart C. Bogema | Immunoassay that provides for both collection of saliva and assay of saliva for one or more analytes with visual readout |
US6372514B1 (en) | 1998-09-18 | 2002-04-16 | Syntron Bioresearch, Inc. | Even fluid front for liquid sample on test strip device |
US6140136A (en) | 1998-09-18 | 2000-10-31 | Syntron Bioresearch, Inc. | Analytical test device and method of use |
GB9821526D0 (en) | 1998-10-02 | 1998-11-25 | Genosis Inc | Capture assay |
CA2254223A1 (en) | 1998-11-16 | 2000-05-16 | Biophys, Inc. | Device and method for analyzing a biologic sample |
US7297554B2 (en) | 1998-11-18 | 2007-11-20 | Microdiagnostics, Inc. | Immunoassay system |
US20010026944A1 (en) | 1999-04-21 | 2001-10-04 | Roy Chung | Immunoassay system |
EP1159611A1 (en) | 1999-01-15 | 2001-12-05 | Medtox Scientific Inc. | Lateral flow test strip |
US6432358B2 (en) | 1999-01-27 | 2002-08-13 | Polaroid Corporation | Diagnostic assay device |
EP1173745A4 (en) | 1999-02-05 | 2006-04-12 | Taylor Technologies Inc | Multicomponent test systems useful in analyzing liquid samples, and uses therefor |
US6297020B1 (en) | 1999-03-01 | 2001-10-02 | Bayer Corporation | Device for carrying out lateral-flow assays involving more than one analyte |
CA2366309C (en) | 1999-03-16 | 2004-11-23 | Serex, Inc. | Method and device for detection of apo a, apo b and the ratio thereof in saliva |
US6632202B1 (en) * | 1999-03-16 | 2003-10-14 | James Hagele | Precision release eye dropper bottle |
US6551842B1 (en) | 1999-03-26 | 2003-04-22 | Idexx Laboratories, Inc. | Method and device for detecting analytes in fluids |
US6602719B1 (en) | 1999-03-26 | 2003-08-05 | Idexx Laboratories, Inc. | Method and device for detecting analytes in fluids |
US6511814B1 (en) | 1999-03-26 | 2003-01-28 | Idexx Laboratories, Inc. | Method and device for detecting analytes in fluids |
US6709633B2 (en) | 1999-04-30 | 2004-03-23 | Donald E. Etes | Disposable devices for testing body fluids |
US6716396B1 (en) * | 1999-05-14 | 2004-04-06 | Gen-Probe Incorporated | Penetrable cap |
GB2350421B (en) | 1999-05-18 | 2003-12-17 | Krysium Advisors Ltd | Apparatus and method of testing a biological fluid |
US6528323B1 (en) | 1999-06-14 | 2003-03-04 | Praxsys Biosystems, Inc. | Bidirectional lateral flow test strip and method |
US20020019062A1 (en) | 1999-06-18 | 2002-02-14 | Peter Lea | Assay devices |
US6514769B2 (en) | 1999-07-29 | 2003-02-04 | Jin Po Lee | Multiple analyte assay device with sample integrity monitoring system |
US6713309B1 (en) | 1999-07-30 | 2004-03-30 | Large Scale Proteomics Corporation | Microarrays and their manufacture |
ES2265957T3 (en) | 1999-08-06 | 2007-03-01 | Phadia Ab | A METHOD AND AN APPLIANCE TO DETERMINE ANALYTICS. |
US6500629B1 (en) | 1999-09-13 | 2002-12-31 | Equitech Laboratories, Inc. | Materials and methods for detection and quantitation of an analyte |
US6812038B1 (en) | 1999-11-18 | 2004-11-02 | Pharmacia Diagnostics Ab | Assay device and use thereof |
US6727073B1 (en) | 1999-11-19 | 2004-04-27 | Binax, Inc. | Method for detecting enteric disease |
US6316264B1 (en) | 1999-12-17 | 2001-11-13 | Bayer Corporation | Test strip for the assay of an analyte in a liquid sample |
WO2001049823A2 (en) | 2000-01-06 | 2001-07-12 | Biosite Diagnostics, Inc. | Assays for detection of bacillus anthracis |
US6316205B1 (en) | 2000-01-28 | 2001-11-13 | Genelabs Diagnostics Pte Ltd. | Assay devices and methods of analyte detection |
US6699722B2 (en) | 2000-04-14 | 2004-03-02 | A-Fem Medical Corporation | Positive detection lateral-flow apparatus and method for small and large analytes |
US6436722B1 (en) | 2000-04-18 | 2002-08-20 | Idexx Laboratories, Inc. | Device and method for integrated diagnostics with multiple independent flow paths |
US6627459B1 (en) | 2000-04-19 | 2003-09-30 | Applied Biotech, Inc. | Immunoassay controls |
US7018847B2 (en) | 2000-05-05 | 2006-03-28 | Pharmacia Diagnostics Ab | Assay device with timer function |
US6534324B1 (en) | 2000-05-12 | 2003-03-18 | Mizuho Usa, Inc. | Rapid assay strip and method of rapid competitive assay |
JP3680090B2 (en) | 2000-05-25 | 2005-08-10 | 株式会社ニチレイ | Analysis equipment |
US6656745B1 (en) | 2000-06-02 | 2003-12-02 | Francis X. Cole | Devices and methods for a multi-level, semi-quantitative immunodiffusion assay |
ATE287764T1 (en) | 2000-06-02 | 2005-02-15 | Biocontrol Systems Inc | INDEPENDENT DEVICES FOR DETECTING BIOLOGICAL CONTAMINANTS |
CU22968A1 (en) | 2000-06-07 | 2004-07-14 | Ct Ingenieria Genetica Biotech | PROCEDURE FOR THE DETECTION OF ANTI-TRANSGLUTAMINASE ANTIBODIES USED IN THE DIAGNOSIS OF CELIAC DISEASE |
US6528321B1 (en) | 2000-06-26 | 2003-03-04 | Beckman Coulter, Inc. | Opposable-element chromatographic assay device for detection of analytes in whole blood samples |
US6383804B1 (en) * | 2000-07-13 | 2002-05-07 | International Bioproducts, Inc. | Sampling device with snap-off head and method of use |
US7410807B2 (en) * | 2000-07-24 | 2008-08-12 | D Aurora Vito J | Pregnancy and sex identification test based on saliva or other bodily fluids |
US6632681B1 (en) | 2000-07-24 | 2003-10-14 | Ey Laboratories | Reagent delivery device and method of use |
JP3544962B2 (en) | 2000-08-21 | 2004-07-21 | エフ.ホフマン−ラ ロシュ アーゲー | Improved binding assay |
US6372516B1 (en) | 2000-09-07 | 2002-04-16 | Sun Biomedical Laboratories, Inc. | Lateral flow test device |
US6528325B1 (en) | 2000-10-13 | 2003-03-04 | Dexall Biomedical Labs, Inc. | Method for the visual detection of specific antibodies in human serum by the use of lateral flow assays |
US6797481B1 (en) | 2000-10-17 | 2004-09-28 | Dade Behring Marburg Gmbh | Simultaneous screening of multiple analytes |
WO2002033417A1 (en) | 2000-10-17 | 2002-04-25 | Besst-Test Aps | Assay for directly detecting a rs virus related biological cell in a body fluid sample |
US6786106B2 (en) | 2000-10-24 | 2004-09-07 | Kenneth Alley | Apparatus for sampling and testing a specimen |
US20020048819A1 (en) | 2000-10-24 | 2002-04-25 | Kenneth Alley | Test strip for use in an apparatus for sampling and testing a specimen |
US6492127B2 (en) | 2001-01-23 | 2002-12-10 | Varian, Inc. | Lateral flow testing device with on-board chemical reactant |
US6686167B2 (en) | 2001-02-03 | 2004-02-03 | Padma S. Bagaria | Test device for detecting semen and method of use |
US7087389B2 (en) | 2001-02-09 | 2006-08-08 | Council Of Scientific & Industrial Research | Highly cost-effective analytical device for performing immunoassays with ultra high sensitivity |
CA2337282C (en) * | 2001-03-05 | 2006-01-03 | Victor Daykin | Biological specimen collection apparatus |
US6767710B2 (en) | 2001-03-30 | 2004-07-27 | Praxsys Biosystems, Llc | Prewetting stop flow test strip |
US6818452B2 (en) | 2001-04-23 | 2004-11-16 | Branan Medical Corp. | Lateral flow contact test apparatus |
US20030045001A1 (en) | 2001-08-29 | 2003-03-06 | Deborah Burgess | Immunochromatographic test strip with arcuate sample application zone for ease-of-use in the field |
US6855561B2 (en) | 2001-09-10 | 2005-02-15 | Quidel Corporation | Method for adding an apparent non-signal line to a lateral flow assay |
US20040219694A1 (en) | 2001-09-11 | 2004-11-04 | Chittock Roger Steward | Lateral flow test format for enzyme assays |
CA2469935C (en) | 2001-12-12 | 2014-02-11 | Proteome Systems Intellectual Property Pty Ltd. | Diagnostic testing process |
US7244393B2 (en) | 2001-12-21 | 2007-07-17 | Kimberly-Clark Worldwide, Inc. | Diagnostic device and system |
US7049150B2 (en) | 2001-12-28 | 2006-05-23 | Varian, Inc. | Binding assay device with non-absorbent carrier material |
US6927068B2 (en) | 2002-01-30 | 2005-08-09 | The United States Of America As Represented By The Secretary Of The Navy | Rapid and non-invasive method to evaluate immunization status of a patient |
US20030180967A1 (en) | 2002-03-19 | 2003-09-25 | Matsushita Electric Industrial Co., Ltd. | Immunoassay method, test strip for use therein, and immunoassay apparatus |
US7781172B2 (en) | 2003-11-21 | 2010-08-24 | Kimberly-Clark Worldwide, Inc. | Method for extending the dynamic detection range of assay devices |
AU2003302254A1 (en) | 2002-12-16 | 2004-07-22 | Avery Dennison Corporation | Analyte detecting article and method |
US7459314B2 (en) | 2003-02-13 | 2008-12-02 | Inverness Medical Switzerland Gmbh | Lateral flow immunoassay controls |
US20040241779A1 (en) | 2003-02-24 | 2004-12-02 | Piasio Roger N. | Dry chemistry, lateral flow-reconstituted chromatographic enzyme-driven assays |
US20040184954A1 (en) | 2003-03-18 | 2004-09-23 | Huiyan Guo | Lateral flow immunoassay devices for testing saliva and other liquid samples and methods of use of same |
US20040235189A1 (en) | 2003-05-08 | 2004-11-25 | Lu Wei Zhao | Reversed chromatographic immunoassay |
US7374949B2 (en) * | 2003-05-29 | 2008-05-20 | Bayer Healthcare Llc | Diagnostic test strip for collecting and detecting an analyte in a fluid sample |
US7393697B2 (en) | 2003-06-06 | 2008-07-01 | Advantage Diagnostics Corporation | Diagnostic test for analytes in a sample |
WO2005008216A2 (en) * | 2003-07-11 | 2005-01-27 | Oakville Hong Kong Co., Limited | Sanitary fluid collection, application and storage device and methods of use of same |
US7238538B2 (en) | 2003-09-19 | 2007-07-03 | Freitag Helmut E | Chromatographic assay device and methods |
US7595196B2 (en) | 2003-09-23 | 2009-09-29 | Oakville Hong Kong Company Limited | Lateral flow assay devices with inhibiting backflow of the sample and methods of use |
US20050074900A1 (en) | 2003-10-07 | 2005-04-07 | Morgan Nicole Y. | Microfluidic flow-through immunoassay for simultaneous detection of multiple proteins in a biological sample |
DE10350880A1 (en) | 2003-10-31 | 2005-06-02 | Roche Diagnostics Gmbh | Method for determining an analyte by means of an extraction layer |
US7943395B2 (en) | 2003-11-21 | 2011-05-17 | Kimberly-Clark Worldwide, Inc. | Extension of the dynamic detection range of assay devices |
US20050130319A1 (en) | 2003-12-15 | 2005-06-16 | Xerox Corporation | Molecular binding event detection using separation channels |
US20050136500A1 (en) | 2003-12-19 | 2005-06-23 | Kimberly-Clark Worldwide; Inc. | Flow-through assay devices |
DE602004026155D1 (en) * | 2004-02-05 | 2010-05-06 | Ibsa Inst Biochimique Sa | Dropping |
EP1733232A1 (en) | 2004-03-23 | 2006-12-20 | Quidel Corporation | Hybrid phase lateral flow assay |
US7378054B2 (en) * | 2004-04-16 | 2008-05-27 | Savvipharm Inc | Specimen collecting, processing and analytical assembly |
ATE520029T1 (en) | 2004-11-05 | 2011-08-15 | Hoffmann La Roche | BIOCHEMICAL DEVICE AND DETECTION METHOD |
US7178703B2 (en) * | 2004-11-23 | 2007-02-20 | Allergan, Inc. | Autoclaveable small-volume dropper bottle |
US7648681B2 (en) * | 2004-12-01 | 2010-01-19 | Meridian Bioscience, Inc. | Specimen collection system |
US7465587B2 (en) | 2004-12-03 | 2008-12-16 | Genzyme Corporation | Diagnostic assay device |
US7387890B2 (en) * | 2004-12-16 | 2008-06-17 | Chembio Diagnostic Systems, Inc. | Immunoassay devices and use thereof |
US20060245977A1 (en) * | 2005-05-02 | 2006-11-02 | Saliva Diagnostic Systems Inc. | Collection device for a fluid specimen |
US7767448B2 (en) * | 2006-09-06 | 2010-08-03 | Yong Peter A K | PAP smear sampling device and system |
BRPI0715773A2 (en) * | 2006-09-07 | 2013-10-15 | Avon Prod Inc | accommodation |
US8722356B2 (en) * | 2007-06-29 | 2014-05-13 | Microworks, Inc. | Sampling system and method |
-
2008
- 2008-07-24 US US12/179,248 patent/US20100022916A1/en not_active Abandoned
-
2009
- 2009-07-22 WO PCT/US2009/051335 patent/WO2010011703A1/en active Application Filing
- 2009-07-22 US US13/055,536 patent/US20120165699A9/en not_active Abandoned
-
2019
- 2019-04-02 US US16/373,445 patent/US11350913B2/en active Active
-
2022
- 2022-05-23 US US17/751,218 patent/US20220280141A1/en active Pending
Patent Citations (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4803998A (en) * | 1986-01-27 | 1989-02-14 | Ncs Diagnostics, Inc. | Swab retaining vial cap and method of use |
US5320809A (en) * | 1991-06-03 | 1994-06-14 | Abbott Laboratories | Retrofit kit for changing single immunoassay instrument to flexible multiple immunoassay instrument |
US5543115A (en) * | 1995-07-17 | 1996-08-06 | Mizuho Usa, Inc. | Specimen handling device |
US20010007926A1 (en) * | 1998-09-25 | 2001-07-12 | David Trudil | Biological sample collection kit |
US20040014237A1 (en) * | 2002-03-18 | 2004-01-22 | Nobuyuki Sugiyama | Swab testing device and method |
US20030199004A1 (en) * | 2002-04-10 | 2003-10-23 | Response Biomedical Corporation | Sensitive immunochromatographic assay |
US20050130310A1 (en) * | 2002-04-23 | 2005-06-16 | Home Access Health Corporation | Quantitative analysis of a biological sample of unknown quantity |
US20070167900A1 (en) * | 2004-01-16 | 2007-07-19 | Sagarika Kanjilal | Sample collection device and method |
US20080139962A1 (en) * | 2004-12-14 | 2008-06-12 | Ahmed Jehanli | Analyte Collection Apparatus and Method |
US20060205059A1 (en) * | 2005-03-11 | 2006-09-14 | Javanbakhsh Esfandiari | Dual path immunoassay device |
US20070208275A1 (en) * | 2006-03-01 | 2007-09-06 | Home Access Health Corporation | Specimen collection device |
US20070299364A1 (en) * | 2006-06-22 | 2007-12-27 | Sangha Jangbir S | Containerized sample collection apparatus and method |
US20080254550A1 (en) * | 2007-02-05 | 2008-10-16 | Andrew Homer Nathaniel | Drug detection kit and method |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2543728B (en) * | 2014-08-12 | 2019-04-17 | Nextgen Jane Inc | Medical kit and method for processing a biological sample |
US11446011B2 (en) | 2016-04-13 | 2022-09-20 | Nextgen Jane, Inc. | Sample collection and preservation devices, systems and methods |
US11864740B2 (en) | 2016-04-13 | 2024-01-09 | Nextgen Jane, Inc. | Sample collection and preservation devices, systems and methods |
USD1021132S1 (en) | 2021-01-22 | 2024-04-02 | Leadway (Hk) Limited | Sample collection bottle |
US11320429B1 (en) | 2021-03-05 | 2022-05-03 | Global Diagnostic Systems, Benefit LLC | Diagnostic devices with fluid reservoirs and associated methods and kits |
Also Published As
Publication number | Publication date |
---|---|
US20120165699A9 (en) | 2012-06-28 |
US20110172560A1 (en) | 2011-07-14 |
US11350913B2 (en) | 2022-06-07 |
US20220280141A1 (en) | 2022-09-08 |
US20190261961A1 (en) | 2019-08-29 |
WO2010011703A1 (en) | 2010-01-28 |
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