WO1997033519A1 - Device for the collection, testing and shipment of body fluid samples - Google Patents

Device for the collection, testing and shipment of body fluid samples Download PDF

Info

Publication number
WO1997033519A1
WO1997033519A1 PCT/US1997/003347 US9703347W WO9733519A1 WO 1997033519 A1 WO1997033519 A1 WO 1997033519A1 US 9703347 W US9703347 W US 9703347W WO 9733519 A1 WO9733519 A1 WO 9733519A1
Authority
WO
WIPO (PCT)
Prior art keywords
test
drug
card
container
flat member
Prior art date
Application number
PCT/US1997/003347
Other languages
French (fr)
Inventor
Stan Cipkowski
Original Assignee
American Bio Medica Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to AU21953/97A priority Critical patent/AU715966B2/en
Application filed by American Bio Medica Corporation filed Critical American Bio Medica Corporation
Priority to DE19780221T priority patent/DE19780221T1/en
Priority to AT0900197A priority patent/AT408696B/en
Priority to PL97323189A priority patent/PL323189A1/en
Priority to APAP/P/1997/001102A priority patent/AP9701102A0/en
Priority to BR9702113-0A priority patent/BR9702113A/en
Priority to CA002219529A priority patent/CA2219529C/en
Priority to EP97914848A priority patent/EP0830082B1/en
Priority to GB9721480A priority patent/GB2314625B/en
Priority to JP9532656A priority patent/JPH11506213A/en
Publication of WO1997033519A1 publication Critical patent/WO1997033519A1/en
Priority to US09/985,705 priority patent/US20020031845A1/en
Priority to US10/153,205 priority patent/US20020137231A1/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—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
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/007—Devices for taking samples of body liquids for taking urine samples
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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
    • G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated 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
    • A61B10/0096—Casings for storing test 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
    • 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
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N2001/002—Devices for supplying or distributing samples to an analysing apparatus
    • G01N2001/005—Packages for mailing or similar transport of samples
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N2001/002—Devices for supplying or distributing samples to an analysing apparatus
    • G01N2001/007—Devices specially adapted for forensic samples, e.g. tamper-proofing, sample tracking
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/97—Test strip or test slide
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/975—Kit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/815—Test for named compound or class of compounds
    • Y10S436/816—Alkaloids, amphetamines, and barbiturates
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/901—Drugs of abuse, e.g. narcotics, amphetamine

Definitions

  • Typical drug screening tests are performed for the purpose of quickly identifying on a qualitative basis the presence of drugs in a body fluid which may be urine. A complete analysis of the sample may then be carried out in a laboratory only if the preliminary screening results are positive. More and more such drug screenings are taking place on site or the work place and are generally carried out by testing personnel who are generally not technically trained, such as laboratory technicians. It is thus important that the drug screening procedure is simple but yet reliable. Further, the test apparatus must be such so as to enable the testing personnel to avoid all contact with the fluid specimen which is being tested.
  • the containers incorporated the structure by means of which reagent strips were mounted in a test compartment of the container and which structure also enabled the fluid sample to flow into the test compartment into contact with the reagent strips.
  • Such a mounting of the reagent strips further resulted in complicating the structure of the container since it was also necessary that provision be made to view the reagent strips from outside of the container. This was generally achieved by providing a transparent window or some other mounting of the reagent strips so as to be visible to testing personnel.
  • the drug abuse test device may comprise a cup-like transparent container for retaining a urine sample to be tested.
  • the open top of the container has a closure cover or cap and there is a diametrical slit in the cap.
  • the slit is of such a size to accommodate a test care which as a plurality of immunoassay test strips mounted thereon in parallel on one side and each test strip is responsive to a particular drug of abuse.
  • the test card is insertable through the slit so as to have one end immersed in the urine sample to a predetermined depth whereby the visual results of each test strip can be seen through the transparent wall of the container without removing the test card from the container so as to indicate the presence or absence of a particular drug of abuse in the urine sample. If the sample should test "positive" to indicate the presence of a drug in the urine, it is then necessary to send the sample to a certified laboratory for confirmatory testing.
  • a second closure cap which is solid, i.e., not slit, is provided which may be threaded onto the open end of the cup-like container. The test card is removed from the container, the solid closure cap is threaded on to close the container and the container is then ready for shipment to a laboratory.
  • the test kit includes a drug abuse test device for collecting and testing a urine sample.
  • This test device comprises a cup-like container having a transparent wall and having an open top upon which is threaded a closure cover provided with a slit therein to receive a test card.
  • a solid second closure cap which threads over the outer end of the cup-like container is provided to seal the container to permit the safe shipment of a fluid sample therein.
  • Fig. 1 is a perspective view of the drug abuse test kit according to the present invention generally showing the container, the test card partially inserted to the testing position in the container through a slit in the cover;
  • Fig. 2 is an exploded perspective view of the container according to the present invention for collecting and testing a fluid sample and generally showing the container, a cover having a slit covered with a removable adhesive seal and a second solid closure cap;
  • Fig. 3 is a plan view of the test side of a test card according to the present invention.
  • Fig. 4 is a plan view of the reverse side of the test card shown in Fig. 3;
  • Fig. 6 is a sectional view taken along the lines VI-VI of Fig. 3;
  • Fig. 9 is a plan view of another modification of the test card.
  • Fig. 10 is a sectional view taken along the lines IX-IX of Fig. 8;
  • Fig. 12 is a plan view of the center ply of the test card of Fig. 11 and showing a test strip in a slot thereof;
  • Fig. 13 is a plan view of the reverse side of the test card of Fig. 11;
  • a drug abuse test kit according to the present invention is indicated generally at 10 and comprises a cup-like transparent test container or cup 11 having a cylindrical side wall 12, a closed bottom 13 and an open top 14.
  • the cylindrical wall 12 may have a slight taper or be straight.
  • the open end 14 of the test cup 11 is provided with external threads 21 upon which is seated an outer closure cover or cap 22 provided with corresponding internal threads which are not shown in the drawing.
  • the cover 22 has a circular top surface 23 from the periphery of which depends a cylindrical wall 24 on the inner surface of which there are provided internal threads.
  • the cover surface 23 has a diametrical slit 19 therein shaped to accommodate a test card as will be presently described.
  • a solid cover or cap 15 which is similar in size and shape to the cover 22 but is solid or unslit so that the covers 15 and 22 may be interchangeably mounted on the open end 14 of the test cup 11.
  • the cover 15 is generally fitted on the bottom of the test cup.
  • a temperature strip 16 is mounted on the bottom side wall of the test cup so as to be responsive to the temperature of the test sample within a test cup.
  • test strips are characterized as immunoassay strips and employ colloidal gold chemistry.
  • Each test strip is submerged up to a maximum line indicated at 32 and the results of the test are read in a test area indicated at 33.
  • a blue line in the test area indicates positive or the presence of the particular drug in the test sample.
  • the test strips are actually recessed in slots in the card so that portions of the test strips project above the test surface 31 of the card as may be seen in Fig. 5.
  • the test card may be formed of two plys 34 and 35 as may be seen in Fig. 7 and these plys in turn are formed from a single strip having a bend or fold 36.
  • the ply 35 is formed with a plurality of die cut slots 37 which are shaped and sized to receive each of the test strips.
  • the two portions 34 and 35 are folded over at end 36 and are adhered together.
  • the test strips are then placed into the slots as shown in Fig. 6 and each of the test strips is adhered to the surface of the first portion 34 upon which the second portion 35 has been folded.
  • test card In order to conduct a drug abuse test utilizing the test card according to the present invention a person being tested must first provide a urine specimen into the transparent test cup 11.
  • the quantity of specimen provided must be such as to permit insertion of the test card up to about the maximum line indicated at 32. It is also possible to provide fill lines on the wall surface of the test container.
  • Fig. 8 there is shown at 40 a modification of the test card as described above and is similarly constructed with two plys but is also provided with a third or top ply 41 which is adhered to the two plys and covers the test strips.
  • the third play 41 is provided with an opening 42 through which the test and control lines may be seen.
  • those portions of the plys below the maximum fill line 32 are removed such that the test strips 26-30 project beyond a bottom end 43 of the shortened test card. Otherwise, this test card functions in precisely the same manner as described above.
  • the top ply 47 is provided with a plurality of test windows 50 through which the test results as indicated by the test strips can be seen.
  • sample openings 51 At the lower end of the card are provided sample openings 51 through which the liquid test specimen is able to contact the absorbent or sample portions of the test strips.
  • Figs. 11-14 there is shown a modification of the test card 44 in which the card is made of three separate plys which are then laminated.
  • the bottom and top plys 46 and 47 are made of a thin vinyl sheet having a thickness of 0.33 mm. and the center ply 45 is made of styrene having a thickness of about 1.25 mm.
  • the top ply 47 similarly has the test openings or windows 50 and the sample openings 51 and the bottom ply 46 is solid as shown.
  • the central ply 45 is provided with a plurality of longitudinally extending slots 52 and a test strip 53 is seated in each of these slots as shown.
  • the test strip generally has a length less than that of the slot 52.
  • only a single test strip for THC (marijuana) is shown. While this embodiment of the test card has provision for five test strips, it is to be understood that the card can be made in the same manner with less than five strips and even a single strip if so desired. In such a modification, the windows 50 and 51 for the omitted strips are usually solid.
  • Each of the test strips 26-30 is a one-step immunoassay in which a specially labeled drug, (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on an antibody.
  • the test strip consists of a membrane strip onto which a drug conjugate has been immobilized.
  • a colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate.
  • An antibody-antigen reaction occurs forming a visible line in the test area. The formation of a visible line in the test area occurs when the test is negative for the drug.
  • the drug or its metabolite When a drug is present in the urine sample, the drug or its metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If a sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the label antibody to the drug conjugate. An absence of a color line or band in the test area is indicative of a positive result. A control band or line comprised of a different antibody/antigen reaction is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine and therefore should be present in all reactions.
  • the present invention discloses a novel and improved drug abuse test kit which comprises a container for the fluid specimen being tested and a multiple drug test card which is inserted in the specimen within the container and the visual results of the test are read on the test card through the transparent wall of the container.
  • the test card thus comprises a number of individual test strips of the immunoassay type and each strip is responsive or indicative to a particular drug of abuse.
  • the test card may be made of plastic coated cardboard or thin sheets of plastic which are laminated together.

Abstract

A drug abuse test kit has a transparent cup-like container (1) for retaining a fluid sample to be tested and the open top end (14) of the container (11) is closed by a closure cap (22) seated upon the open end (14). There is a slit (19) in the closure cap (22) to receive a multiple drug test card (25) having a plurality of immunoassay test strips thereon with visual endpoints to indicate presence or absence of a particular drug. The container (11) is provided with a second cover (15) which is solid and unslit to close and seal the container (11) when a sample therein is to be transported.

Description

DEVICE FOR THE COLLECTION, TESTING AND SHIPMENT OF BODY FLUID SAMPLES
RELATED APPLICATIONS
For purposes of the United States of America, this is a continuation-in-part application of United States Patent Application Serial No. 08/613,487 filed March 11, 1996.
TECHNICAL FIELD
The present invention relates to a test kit for the collection and testing of urine samples for drugs of abuse and subsequent shipment of the sample, more particularly, to such a test kit having a cup-like container and a test card for indicating visually the presence of particular drugs of abuse.
BACKGROUND ART
The increased availability and use of drugs of abuse by the general population has caused employers, governmental agencies, sports groups and other organizations to utilize drug screening both as a condition of employment and in order to maintain safety in the work place. Typical drug screening tests are performed for the purpose of quickly identifying on a qualitative basis the presence of drugs in a body fluid which may be urine. A complete analysis of the sample may then be carried out in a laboratory only if the preliminary screening results are positive. More and more such drug screenings are taking place on site or the work place and are generally carried out by testing personnel who are generally not technically trained, such as laboratory technicians. It is thus important that the drug screening procedure is simple but yet reliable. Further, the test apparatus must be such so as to enable the testing personnel to avoid all contact with the fluid specimen which is being tested.
Various forms of devices have been proposed for the collection and taking of body fluids, such as urine, which have proved to be cumbersome in operation since they involve a number of separate steps. Initially, the sample was collected and several additional steps were then required to transfer the urine sample to an analysis device. This multiple step procedure required the manual handling of the specimen through various devices and the use of such transfer devices inevitably caused spills which may result in contamination to the tester and surroundings. In addition, nontechnical personnel who perform the screening tests on urine samples objected to coming into any kind of contact with the urine sample and even the handling of the sample itself.
Many of the known testing devices were rather complex in that tvey included a container for the specimen, and, subsequently it was necessary to transfer the specimen or at least a portion thereof to another compartment of the container in order to perform the test. This transfer of the specimen required vigorous shaking of the container or turning the container upside down in order to cause the flow of the specimen into a test compartment. It was therefore necessary to make the containers leak proof under such condition and the results was a complicated and expensive container structure.
Further, the containers incorporated the structure by means of which reagent strips were mounted in a test compartment of the container and which structure also enabled the fluid sample to flow into the test compartment into contact with the reagent strips. Such a mounting of the reagent strips further resulted in complicating the structure of the container since it was also necessary that provision be made to view the reagent strips from outside of the container. This was generally achieved by providing a transparent window or some other mounting of the reagent strips so as to be visible to testing personnel.
DISCLOSURE OF INVENTION
It is therefore the principal object of the present invention to provide a simplified and inexpensive device for the collection and testing of body fluid samples, particularly urine, for drugs of abuse and subsequent shipment of the sample. It is an additional object of the present invention to provide such a device which includes a closed container for retaining a urine sample having such a closure structure that test card having a plurality of test strips thereon may be introduced into the container such that the test strips contact the urine sample.
It is a further object of the present invention to provide a test card having a plurality of immunoassay test strips thereon with each strip being responsive to a particular drug of abuse and having a visual endpoint to indicate the presence or absence of a particular drug.
The objects of the present invention are achieved and the disadvantages of the prior art are eliminated by the drug abuse test device according to the present invention which may comprise a cup-like transparent container for retaining a urine sample to be tested. The open top of the container has a closure cover or cap and there is a diametrical slit in the cap. The slit is of such a size to accommodate a test care which as a plurality of immunoassay test strips mounted thereon in parallel on one side and each test strip is responsive to a particular drug of abuse. The test card is insertable through the slit so as to have one end immersed in the urine sample to a predetermined depth whereby the visual results of each test strip can be seen through the transparent wall of the container without removing the test card from the container so as to indicate the presence or absence of a particular drug of abuse in the urine sample. If the sample should test "positive" to indicate the presence of a drug in the urine, it is then necessary to send the sample to a certified laboratory for confirmatory testing. For this purpose, a second closure cap which is solid, i.e., not slit, is provided which may be threaded onto the open end of the cup-like container. The test card is removed from the container, the solid closure cap is threaded on to close the container and the container is then ready for shipment to a laboratory.
As described above, the test kit includes a drug abuse test device for collecting and testing a urine sample. This test device comprises a cup-like container having a transparent wall and having an open top upon which is threaded a closure cover provided with a slit therein to receive a test card. A solid second closure cap which threads over the outer end of the cup-like container is provided to seal the container to permit the safe shipment of a fluid sample therein.
The test kit also includes a screen test card for drugs of abuse which may comprise a thin flat member having the size and shape of a business card. A plurality of immunoassay test strips are fastened side by side in parallel on one side of the test card within the outline of the card. Each test strip is reactive to provide a visual indication in response to a particular drug of abuse. This test card thus provides for the simultaneous detection of multiple analytes .
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects and advantages of the present invention will be apparent upon reference to the accompanying description when taken in conjunction with the following drawings, which are exemplary, wherein;
Fig. 1 is a perspective view of the drug abuse test kit according to the present invention generally showing the container, the test card partially inserted to the testing position in the container through a slit in the cover;
Fig. 2 is an exploded perspective view of the container according to the present invention for collecting and testing a fluid sample and generally showing the container, a cover having a slit covered with a removable adhesive seal and a second solid closure cap;
Fig. 3 is a plan view of the test side of a test card according to the present invention;
Fig. 4 is a plan view of the reverse side of the test card shown in Fig. 3;
Fig. 5 is an end elevational view of the test card shown in Fig. 3;
Fig. 6 is a sectional view taken along the lines VI-VI of Fig. 3;
Fig. 7 is a plan view of the opened two piece test card before it is folded over to form the test card shown in Figs. 3 -6 ;
Fig. 8 is a plan view of the test side of a modification of the test card;
Fig. 9 is a plan view of another modification of the test card;
Fig. 10 is a sectional view taken along the lines IX-IX of Fig. 8;
Fig. 11 is a plan view of the test side of a further modification of the test card;
Fig. 12 is a plan view of the center ply of the test card of Fig. 11 and showing a test strip in a slot thereof;
Fig. 13 is a plan view of the reverse side of the test card of Fig. 11;
Fig. 14 is a sectional view taken along the lines XIII- XIII of Fig. 11.
MODES FOR CARRYING OUT THE INVENTION
As may be seen in Figs. 1 and 2, a drug abuse test kit according to the present invention is indicated generally at 10 and comprises a cup-like transparent test container or cup 11 having a cylindrical side wall 12, a closed bottom 13 and an open top 14. The cylindrical wall 12 may have a slight taper or be straight.
The open end 14 of the test cup 11 is provided with external threads 21 upon which is seated an outer closure cover or cap 22 provided with corresponding internal threads which are not shown in the drawing. The cover 22 has a circular top surface 23 from the periphery of which depends a cylindrical wall 24 on the inner surface of which there are provided internal threads. The cover surface 23 has a diametrical slit 19 therein shaped to accommodate a test card as will be presently described. There is also provided a solid cover or cap 15 which is similar in size and shape to the cover 22 but is solid or unslit so that the covers 15 and 22 may be interchangeably mounted on the open end 14 of the test cup 11. During shipment, the cover 15 is generally fitted on the bottom of the test cup. A temperature strip 16 is mounted on the bottom side wall of the test cup so as to be responsive to the temperature of the test sample within a test cup.
A test card 25 which will indicate the presence or absence of any one of 5 different drugs of abuse is shown in Fig. 1 inserted within the slit 19 in the closure cap 22 and in further detail in Figs. 3-6. The test card is of the multiple drug type in that test strips for five different drugs of abuse are mounted on the test card. The test strips 26-30 are spaced apart in parallel on a test side 31 of the test card. These test strips indicate the presence or absence of the following specific drugs of abuse: PCP, cocaine, amphetamines (AMP) , marijuana (THC) and opiates. Test strips 26-30 may be of the type as made by Bionike of South San Francisco, California, Pha atech of San Diego, California and Arista Biological of Bethlehem, Pennsylvania. Such test strips are characterized as immunoassay strips and employ colloidal gold chemistry. Each test strip is submerged up to a maximum line indicated at 32 and the results of the test are read in a test area indicated at 33. A blue line in the test area indicates positive or the presence of the particular drug in the test sample.
The test strips are actually recessed in slots in the card so that portions of the test strips project above the test surface 31 of the card as may be seen in Fig. 5. The test card may be formed of two plys 34 and 35 as may be seen in Fig. 7 and these plys in turn are formed from a single strip having a bend or fold 36. The ply 35 is formed with a plurality of die cut slots 37 which are shaped and sized to receive each of the test strips. Thus, in the fabrication of a test card, the two portions 34 and 35 are folded over at end 36 and are adhered together. The test strips are then placed into the slots as shown in Fig. 6 and each of the test strips is adhered to the surface of the first portion 34 upon which the second portion 35 has been folded.
It is also within the scope of this invention to make this test card of two separate or individual plys 34 and 35 which are then adhered together and the strips are fixed in the slots as described above.
In order to conduct a drug abuse test utilizing the test card according to the present invention a person being tested must first provide a urine specimen into the transparent test cup 11. The quantity of specimen provided must be such as to permit insertion of the test card up to about the maximum line indicated at 32. It is also possible to provide fill lines on the wall surface of the test container.
The test cup with a sufficient quantity of test specimen therein is then closed by threading the cap 22 on the top of the test cup. The cap 22 is provided with a readily removable adhesive sealing strip 18 which is placed over the slit 19. Thus, when the container with the test specimen is brought to the person conducting the test, the protective strip 18 is removed and the multiple drug test card 25 inserted into the slit so that the bottom of the test card rests upon the bottom of the test cup. Fifteen (15) ml. of specimen will ensure that the specimen does not go above the maximum fill line 32. The test card then remains in place for at least three minutes and the results of the test can be read on each individual test strip through the transparent wall of the container. Thus, if a blue line appears on any one of the test strips, this indicates positive and the presence of that particular drug of abuse in the test specimen. If no such blue line appears then the absence of any of the five drugs of abuse from the specimen is indicated. With such a negative result, the urine sample and the container are discarded.
However, when the results of the test are positive, it is preferable to send the specimen to a certified laboratory for a confirmatory analysis by more specific methods of testing such as gas chromatography or mass spectrometry. In order to ship the sample in the container, the closure 22 is removed and the solid cover 15 is threaded down tightly upon the open end of the container.
In Fig. 8, there is shown at 40 a modification of the test card as described above and is similarly constructed with two plys but is also provided with a third or top ply 41 which is adhered to the two plys and covers the test strips. The third play 41 is provided with an opening 42 through which the test and control lines may be seen. In this modification, those portions of the plys below the maximum fill line 32 are removed such that the test strips 26-30 project beyond a bottom end 43 of the shortened test card. Otherwise, this test card functions in precisely the same manner as described above.
A modification of the test card is shown at 44 in Fig. 9. In this modification, the test strips are covered but the pertinent test and sample portions of the test strips are exposed through openings. The test card 44 comprises a central ply 45 of styrene which has a thickness of 1.25 mm. corresponding to or slightly greater than the thickness of the test strips and slots are provided in the center ply to receive the test strips. The top and bottom faces of the central ply 45 are covered by a bottom ply 46 and a top ply 47 which may be made from a single piece of material double scored at 48 and 49 so as to wrap around the central ply 45 in the manner as shown in Fig. 9. The top and bottom plys may be of a thin vinyl sheet or cardboard coated with plastic. The top ply 47 is provided with a plurality of test windows 50 through which the test results as indicated by the test strips can be seen. At the lower end of the card are provided sample openings 51 through which the liquid test specimen is able to contact the absorbent or sample portions of the test strips.
In Figs. 11-14 there is shown a modification of the test card 44 in which the card is made of three separate plys which are then laminated. The bottom and top plys 46 and 47 are made of a thin vinyl sheet having a thickness of 0.33 mm. and the center ply 45 is made of styrene having a thickness of about 1.25 mm. The top ply 47 similarly has the test openings or windows 50 and the sample openings 51 and the bottom ply 46 is solid as shown.
The central ply 45 is provided with a plurality of longitudinally extending slots 52 and a test strip 53 is seated in each of these slots as shown. The test strip generally has a length less than that of the slot 52. In this embodiment, only a single test strip for THC (marijuana) is shown. While this embodiment of the test card has provision for five test strips, it is to be understood that the card can be made in the same manner with less than five strips and even a single strip if so desired. In such a modification, the windows 50 and 51 for the omitted strips are usually solid.
Each of the test strips 26-30 is a one-step immunoassay in which a specially labeled drug, (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on an antibody. The test strip consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the test area. The formation of a visible line in the test area occurs when the test is negative for the drug. When a drug is present in the urine sample, the drug or its metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If a sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the label antibody to the drug conjugate. An absence of a color line or band in the test area is indicative of a positive result. A control band or line comprised of a different antibody/antigen reaction is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine and therefore should be present in all reactions.
In summary, if a single band appears in the control zone and no band appears in the test zone then the results are "positive" which indicates that that particular drug is present above a predetermined level which is usually around 50ng/ml. If two color bands appear, one in the control region and the other in the test region then the test results are "negative" which indicates that the level of that particular drug is below the predetermined detection of sensitivity.
In the event that there are no distinct color bands visible in both the test zone and the control zone or if there is a visible band in the test zone but not in the control zone, then the result is invalid and retesting of the specimen is recommended with another test card.
The test card can also be used as a carrier or delivery system for a biological detection or monitor device by replacing the drug test strips with strips treated with suitable chemicals so as to be responsive to different and selected biological warfare agents. The strips would then function similarly to drug abuse strips to provide a visual indication of the presence in a predetermined quantity of a specific biological warfare agent or the absence of such an agent.
INDUSTRIAL APPLICABILITY
Thus it can be seen that the present invention discloses a novel and improved drug abuse test kit which comprises a container for the fluid specimen being tested and a multiple drug test card which is inserted in the specimen within the container and the visual results of the test are read on the test card through the transparent wall of the container. The test card thus comprises a number of individual test strips of the immunoassay type and each strip is responsive or indicative to a particular drug of abuse. The test card may be made of plastic coated cardboard or thin sheets of plastic which are laminated together. This drug abuse test kit enables one to obtain rapidly a visual, qualitative result which is very advantageous for forensic purposes but is not limited to such purposes.
It will be understood that this invention is susceptible to modification in order to adapt it to different usages and conditions, and accordingly, it is desired to comprehend such modifications within this invention as may fall within the scope of the appended claims.

Claims

What is claimed is:
1. A drug abuse test kit comprising a cup-like transparent container having an open top end for retaining a urine sample to be tested, a closure cap seated upon said open top end and having a diametrically disposed slit therein, a test card having a plurality of visual indication test strips disposed in parallel on one side thereof and each strip being responsive to a particular drug of abuse, said test card having such a width and thickness that one end of said test card is insertable through said slit to be immersed in a urine sample retained therein to a predetermined depth, the results of each test strip can be seen through the transparent wall of the container without removing the test card from the container to indicate the presence or absence of a particular drug of abuse in said urine sample.
2. A drug abuse test kit as claimed in claim 1 and further comprising a solid second closure cap positionable over the open end of the container in place of said closure cap with a slit.
3. A drug abuse test device for collecting and testing a urine sample comprising a cup-like transparent container having an open top end for retaining a urine sample to be tested, a first closure cap seated upon said open top end and having a diametrically disposed slit therein, and a solid second closure cap positionable over said open top end in place of said first closure cap to seal the container so as to permit transportation of a fluid sample therein without leakage.
4. A drug abuse test device as claimed in claim 3 and further comprising a protective adhesive strip over said slit which is removable prior to testing the specimen within the container.
5. A multiple drug test card for drugs of abuse comprising a thin flat member having the size and shape of a business card and having a first side, a plurality of immunoassay test strips with visual endpoints to indicate presence or absence of a drug adhered side-by-side in parallel on said first side within the outline of said flat member and having at least portions thereof exposed, each test strip indicating the presence or absence of a particular drug of abuse.
6. A multiple drug test card as claimed in claim 5 wherein said test strips are each recessed in said first side.
7. A multiple drug test card as claimed in claim 5 wherein said test strips are disposed parallel to the longer dimension of said flat member.
8. A multiple drug test card as claimed in claim 5 wherein there are a plurality of spaced parallel slots on said first side and said test strips are seated in said slots.
9. A multiple drug test card as claimed in claim 5 wherein exposed portions of said test strips are recessed inwardly of said first side surface.
10. A multiple drug test card as claimed in claim 5 wherein said thin flat member comprises three laminated sheets, one of said sheets defining a backing sheet, a second of said sheets having a plurality of parallel slots therein to receive said test strips, and a third of said sheets having spaced parallel slots therein corresponding with said test strips, said sheets being adhered together such that said first and third sheets sandwich the second sheet there between.
11. A multiple drug test card as claimed in claim 5 wherein said thin flat member has front and rear surfaces and a thickness substantially equal to the thickness of said test strips, there being slots in said thin flat member to receive said test strips therein, a second thin flat member adhered to said rear surface of said thin flat member, a third thin flat member adhered to the front surface of said thin flat member, there being openings in said third thin flat member to expose the sample and test portions of each of said test strips.
12. A multiple drug test card as claimed in claim 5 wherein said second and third thin flat members comprise a single sheet of material having a fold therein and folded around said first thin flat member.
13. A multiple drug test card as claimed in claim 11 wherein said second and third thin flat members are thinner than said first thin flat member.
14. A multiple drug test card as claimed in claim 5 wherein said test card has a bottom end and said test strips have ends projecting outwardly of said bottom end.
15. A multiple drug test card as claimed in claim 14 and further comprising a cover sheet covering said first side of said thin flat member and said test strips, there being an opening in said cover sheet to expose portions of said test strips.
PCT/US1997/003347 1996-03-11 1997-03-11 Device for the collection, testing and shipment of body fluid samples WO1997033519A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
BR9702113-0A BR9702113A (en) 1996-03-11 1997-03-11 Device for collecting, testing and transporting samples of bodily fluids
DE19780221T DE19780221T1 (en) 1996-03-11 1997-03-11 Device for collecting, testing and sending body fluid samples
AT0900197A AT408696B (en) 1996-03-11 1997-03-11 DEVICE FOR COLLECTING, TESTING AND SENDING BODY LIQUID SAMPLES
PL97323189A PL323189A1 (en) 1996-03-11 1997-03-11 Device for collecting, testing and sending samples of body fluids
APAP/P/1997/001102A AP9701102A0 (en) 1996-03-11 1997-03-11 Device for the collection, testing and shipment of body fluid samples.
AU21953/97A AU715966B2 (en) 1996-03-11 1997-03-11 Device for the collection, testing and shipment of body fluid samples
CA002219529A CA2219529C (en) 1996-03-11 1997-03-11 Device for the collection, testing and shipment of body fluid samples
JP9532656A JPH11506213A (en) 1996-03-11 1997-03-11 Equipment for collecting, testing and transporting body fluid samples
GB9721480A GB2314625B (en) 1996-03-11 1997-03-11 Device for the collection, testing and shipment of body fluid samples
EP97914848A EP0830082B1 (en) 1996-03-11 1997-03-11 Device for the collection, testing and shipment of body fluid samples
US09/985,705 US20020031845A1 (en) 1996-03-11 2001-11-06 Device for the collection, testing and shipment of body fluid samples
US10/153,205 US20020137231A1 (en) 1996-03-11 2002-05-23 Device for the collection, testing and shipment of body fluid samples

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/613,487 1996-03-11
US08/613,487 US5976895A (en) 1996-03-11 1996-03-11 Device for the collection, testing and shipment of body fluid samples

Publications (1)

Publication Number Publication Date
WO1997033519A1 true WO1997033519A1 (en) 1997-09-18

Family

ID=24457511

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/003347 WO1997033519A1 (en) 1996-03-11 1997-03-11 Device for the collection, testing and shipment of body fluid samples

Country Status (15)

Country Link
US (1) US5976895A (en)
EP (1) EP0830082B1 (en)
JP (1) JPH11506213A (en)
CN (1) CN1181695A (en)
AP (1) AP9701102A0 (en)
AT (1) AT408696B (en)
AU (1) AU715966B2 (en)
BR (1) BR9702113A (en)
CA (2) CA2181775C (en)
DE (1) DE19780221T1 (en)
ES (1) ES2210508T3 (en)
GB (1) GB2314625B (en)
OA (1) OA10630A (en)
PL (1) PL323189A1 (en)
WO (1) WO1997033519A1 (en)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999038001A1 (en) * 1998-01-21 1999-07-29 Bayer Corporation Optical sensor and method of operation
EP1018004A1 (en) * 1998-07-22 2000-07-12 Syntron Bioresearch, Inc. Multiple analyte assay device
WO2000063697A1 (en) * 1997-11-05 2000-10-26 American Bio Medica Corporation Device for the testing of fluid samples and process for making the device
GB2354320A (en) * 1999-04-21 2001-03-21 American Bio Medica Corp Device for the testing of fluid samples and process for making the device
DE19906005C2 (en) * 1998-06-19 2002-12-19 Biomar Diagnostic Systems Gmbh tester
US6808682B1 (en) * 1997-09-23 2004-10-26 Dtx, Inc. Assaying device consisting of the test cartridge or cassette with a cap or cover which attaches onto the cartridge or cassette to cover and seal the well or opening into which the sample has been deposited
DE10330982A1 (en) * 2003-07-09 2005-02-17 Prisma Diagnostika Gmbh Apparatus and method for the simultaneous determination of blood group antigens
AU2003262462B2 (en) * 1998-07-22 2006-03-09 Syntron Bioresearch, Inc. Multiple analyte assay device
WO2007046044A2 (en) * 2005-10-18 2007-04-26 Agamatrix, Inc Vial for test strips
US7244392B1 (en) * 2000-05-22 2007-07-17 Inverness Medical Switzerland Gmbh Slide-in cassette for a cup for testing of drugs of abuse
US20130109104A1 (en) * 2011-10-26 2013-05-02 Benjamin S. Harmon Substance detecting apparatus
US8865458B2 (en) 2003-01-04 2014-10-21 Alere Switzerland Gmbh Specimen collection and assay container

Families Citing this family (109)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030232451A1 (en) * 1996-03-11 2003-12-18 Douglas Casterlin Device for the testing of fluid samples and process for making the device
US6406922B2 (en) * 1996-03-11 2002-06-18 American Bio Medica Corp. Device for the testing of body fluid samples
US20020031845A1 (en) * 1996-03-11 2002-03-14 American Bio Medica 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
US6342183B1 (en) * 1997-02-14 2002-01-29 Escreen System for collecting and locally analyzing a fluid specimen
US6514461B1 (en) * 1997-02-14 2003-02-04 Escreen, Inc. System for automatically testing a fluid specimen
US6097831A (en) * 1997-10-14 2000-08-01 Chiron Corporation Non-contract method for assay reagent volume dispense verification
ITPD980166A1 (en) * 1998-07-02 2000-01-02 Kaltek Srl CONTAINER OF LIQUIDS PARTICULARLY FOR ANALYSIS OF BIOLOGICAL LIQUIDS.
US8623291B2 (en) 1998-07-14 2014-01-07 Jin Po Lee Multiple analyte assay device
US8202487B2 (en) * 1998-07-22 2012-06-19 Jin Po Lee Multiple analyte assay devices
US6203757B1 (en) * 1998-12-02 2001-03-20 Bionike, Inc. Fluid sample distriution system for test device
US6461873B1 (en) * 1999-03-18 2002-10-08 Daniel Catania Caffeine detector
US7108662B2 (en) 1999-04-21 2006-09-19 Quest Diagnostics Incorporated Device and method for sample collection
US6488669B1 (en) * 1999-04-21 2002-12-03 Peter J. Sagona Collection cup for an automatic on-site drug testing system
US6709633B2 (en) * 1999-04-30 2004-03-23 Donald E. Etes Disposable devices for testing body fluids
EP1230545B1 (en) * 1999-11-12 2006-01-11 Tuan Pham Diagnostic testing kit for collection and testing of fluid samples with user configurable test strips and timer
GB2357143A (en) * 1999-12-10 2001-06-13 Surescreen Diagnostics Ltd Analytical test device
US6375897B1 (en) * 2000-02-14 2002-04-23 Ansys Technologies, Inc. Urine collection cup
US6689618B1 (en) * 2000-04-03 2004-02-10 Shuenn Tzong Chen Method and test strip of detecting oxidizing adulterant in urine
US6627152B1 (en) 2000-04-29 2003-09-30 Branan Medical Corp. Fluid testing apparatus
US20020132267A1 (en) * 2000-07-21 2002-09-19 Wong Raphael C. Combination drug test and adulterant test device
US6576193B1 (en) 2000-10-27 2003-06-10 Shujie Cui Device and method for collecting and testing fluid specimens
IL139806A0 (en) * 2000-11-21 2002-02-10 Zer Hitech 1976 Ltd A device for the analytical determination of certain compounds
US7431882B2 (en) * 2000-12-28 2008-10-07 Modern Optics, Inc. Drug test kit
US6833111B2 (en) 2001-04-13 2004-12-21 Varian, Inc. Multiple analyte assaying device with a multiple sample introduction system
US6770487B2 (en) 2001-05-01 2004-08-03 Ischemia Technologies, Inc. Bar code readable diagnostic strip test
US7300626B2 (en) 2001-05-21 2007-11-27 John Wu Fluid-specimen collecting and testing device and method for recording chromatographic assay test results
US6669908B2 (en) 2001-07-25 2003-12-30 Applied Biotech, Inc. Urine test device
US6680027B2 (en) 2001-07-30 2004-01-20 Princeton Biomeditech Corporation Fluid sample collection and isolation cup
US7879293B2 (en) * 2001-09-28 2011-02-01 Orasure Technologies, Inc. Sample collector and test device
US6720160B2 (en) 2001-10-11 2004-04-13 Helica Biosystems, Inc. Method for simultaneous detection of multiple microbial antigens in biological specimens from mastitic animals
ATE438098T1 (en) * 2002-01-09 2009-08-15 Inverness Medical Switzerland TEST STRIPS CONTAINING CONTROL AGENTS AND TIME SETTING AGENTS
US20030190745A1 (en) * 2002-04-08 2003-10-09 Galloway R. Keith Disk testing apparatus
US7192418B2 (en) * 2002-05-10 2007-03-20 Ming-Jeng Shue Disposable syringe
US6915919B2 (en) * 2002-11-21 2005-07-12 American Bio Medica Corporation Container closure cap with self-sealing slot
US20040184965A1 (en) * 2003-03-18 2004-09-23 Smith Jack V. Testing cup
DE10331108B4 (en) * 2003-07-04 2005-09-01 Levin, Felix, Dr. Universally applicable test container for sterile analysis and its use
US20050009203A1 (en) * 2003-07-11 2005-01-13 Wong Johnson N.S. Multi-drug testing device and method
CN1823273B (en) * 2003-07-11 2012-05-30 因韦尔尼斯医药瑞士股份有限公司 Compact analyte testing cassette with true positive and negative analyte controls
GB0318808D0 (en) * 2003-08-11 2003-09-10 Toshiba Res Europ Ltd An encoded carrier
US7223248B2 (en) * 2003-08-13 2007-05-29 Lifescan, Inc. Packaged medical device with a deployable dermal tissue penetration member
EP1692501B1 (en) 2003-11-14 2016-01-06 Alere Switzerland GmbH Rapid sample analysis and storage devices and methods of use
CN100357738C (en) * 2004-03-26 2007-12-26 博奥生物有限公司 Method of detecting small molecule compound and its special biochip
US7458942B2 (en) * 2004-09-22 2008-12-02 Medtox Systems and methods for collecting, testing and transporting liquid biological specimens
WO2006042004A2 (en) * 2004-10-06 2006-04-20 Binax, Inc. Sample receiving device and methods of use thereof
US7189522B2 (en) 2005-03-11 2007-03-13 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
WO2006098804A2 (en) 2005-03-11 2006-09-21 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
US20060292034A1 (en) * 2005-06-28 2006-12-28 American Bio Medica Corporation Saliva sample testing device
US20070041867A1 (en) * 2005-08-17 2007-02-22 Alex Guan Urinary Diagnosis process
US20070196234A1 (en) * 2005-09-22 2007-08-23 Blane Huff Urine collection and drug testing cup
US20070065339A1 (en) * 2005-09-22 2007-03-22 Blane Huff Urine collection and drug testing cup
JP4632915B2 (en) * 2005-09-27 2011-02-16 シスメックス株式会社 Immunochromatography kit
JP2009524799A (en) 2005-11-30 2009-07-02 インバーネス・メデイカル・スウイツツアーランド・ゲゼルシヤフト・ミツト・ベシユレンクテル・ハフツング Apparatus and method for detecting the presence or amount of an analyte in a fluid sample
US8162140B2 (en) * 2006-04-06 2012-04-24 2 View, Llc Specimen retention container
CA2658795A1 (en) 2006-07-26 2008-02-07 Abon Biopharm (Hangzhou) Co., Ltd. A test device for detecting an analyte in a liquid sample
US20080153110A1 (en) * 2006-10-25 2008-06-26 Tim Scherkenback Combination Rapid Detection Cartridges For Biological and Environmental Agents, Methods of Production and Uses Thereof
JP4399492B2 (en) * 2007-11-30 2010-01-13 森永乳業株式会社 Test container, test piece, test kit and test method
US9404911B2 (en) * 2008-04-21 2016-08-02 Quidel Corporation Integrated assay device and housing
US8511149B2 (en) 2008-07-07 2013-08-20 Hangzhou D2 Technology Co., Ltd Detection device for fluid sample
US20100022916A1 (en) 2008-07-24 2010-01-28 Javanbakhsh Esfandiari Method and Apparatus for Collecting and Preparing Biological Samples for Testing
US8715590B2 (en) * 2008-08-15 2014-05-06 Prognosys LLC Multiplexed lateral flow assay arrays
US20110294228A1 (en) * 2009-01-16 2011-12-01 Bowsher Ronald R Detection devices and methods
DE102009010563A1 (en) 2009-02-16 2010-08-26 Matthias W. Engel Device for the detection of analytes in body fluids
WO2011017325A1 (en) 2009-08-04 2011-02-10 3M Innovative Properties Company Sampling devices and methods of use
US8844725B2 (en) * 2010-01-20 2014-09-30 Roche Diagnostics Operations, Inc. Test strip container with strip retainer and methods of manufacturing and utilization thereof
CN102375054A (en) * 2010-08-06 2012-03-14 艾博生物医药(杭州)有限公司 Detection device comprising immune test strips and production method of detection device
US8992855B2 (en) 2011-01-26 2015-03-31 James Lin Low volume liquid specimen apportionment device
US8603835B2 (en) 2011-02-10 2013-12-10 Chembio Diagnostic Systems, Inc. Reduced step dual path immunoassay device and method
EP2677315A1 (en) * 2011-02-15 2013-12-25 Takahito Matumura Urine test sheet
BR112014011563B1 (en) 2011-11-15 2022-05-24 University Of Miami Method to determine an increased risk of head and neck squamous cell carcinoma (hnscc) in a human subject infected with human papilloma virus (hpv), and kit
USD690826S1 (en) 2012-04-12 2013-10-01 Becton Dickinson And Company Vessel assembly
US20140134073A1 (en) 2012-11-13 2014-05-15 Premier Biotech, Inc. Screening device for analysis of bodily fluids
US20160188937A1 (en) * 2013-07-30 2016-06-30 Express Diagnostics Int'l., Inc. Universal assay reader
US10376880B2 (en) 2013-07-30 2019-08-13 Carehealth America Corporation Lateral flow devices and methods of manufacture and use
CN103424547B (en) * 2013-08-15 2015-02-25 广州万孚生物技术股份有限公司 Liquid detection cup and method for manufacturing same
CN104965095A (en) 2013-11-18 2015-10-07 埃伦·Q·孟 Liquid specimen cup including movable caddy and translucent adulteration panel
CA2944488C (en) 2014-04-02 2023-03-21 Chembio Diagnostic Systems, Inc. Immunoassay utilizing trapping conjugate
USD770636S1 (en) * 2014-09-17 2016-11-01 Assure Tech.(Hangzhou) Co., Ltd. Detection device for medical purposes
JP6357616B2 (en) * 2014-10-02 2018-07-18 アドテック株式会社 Sheet immunoassay
US20160116466A1 (en) 2014-10-27 2016-04-28 Chembio Diagnostic Systems, Inc. Rapid Screening Assay for Qualitative Detection of Multiple Febrile Illnesses
USD739952S1 (en) 2014-11-18 2015-09-29 Ellen Meng Adhesive film mounted adulteration test panel
USD836209S1 (en) * 2015-01-16 2018-12-18 Assure Tech. (Hangzhou) Co., Ltd. Detection device for medical purposes
USD797303S1 (en) * 2015-01-26 2017-09-12 W.H.P.M. Bioresearch and Technology Co., Ltd. Body fluid testing cup
WO2016149253A1 (en) * 2015-03-16 2016-09-22 Dots Technology Corp. Portable allergen detection system
USD865992S1 (en) * 2015-11-02 2019-11-05 Jon A. Petty Fluid test strip
US10386376B2 (en) * 2015-11-09 2019-08-20 Jeimei, Llc Sample container with integrated test strip
USD767158S1 (en) * 2015-11-13 2016-09-20 Alfa Scientific Designs, Inc. Rapid test cup
US11340213B2 (en) 2016-07-08 2022-05-24 Healgen Scientific Limited Apparatus for detecting analyte in a liquid sample and method thereof
JP6889990B2 (en) * 2016-07-29 2021-06-18 株式会社カネカ Inspection tool
TWI620923B (en) * 2016-10-19 2018-04-11 邦睿生技股份有限公司 Collection bottle and method for checking characteristic of sample
TWD183283S (en) * 2016-10-19 2017-05-21 邦睿生技股份有限公司 Collection bottle
WO2018116301A1 (en) * 2016-12-20 2018-06-28 D. C. Paper And Plastic Industries Ltd A biological diagnostic apparatuses
USD867611S1 (en) * 2018-01-29 2019-11-19 Sandstone Diagnostics, Inc. Sample cup
USD908914S1 (en) * 2019-02-26 2021-01-26 Testcard Ltd. Medical test card
DE102019117413A1 (en) * 2019-06-27 2020-12-31 Testo SE & Co. KGaA Flow test unit, set and use of a flow test unit to carry out a detection reaction
US20220273209A1 (en) * 2019-07-29 2022-09-01 Siscapa Assay Technologies, Inc. Devices and methods for sample collection
EP3865874B1 (en) 2020-02-13 2022-10-05 Zhejiang Orient Gene Biotech Co., LTD Distinguishing smoking e-cigarettes from smoking cigarettes
JP7208640B2 (en) * 2020-03-30 2023-01-19 アドテック株式会社 Solvent-containing substance test kit
EP3896447A1 (en) 2020-04-16 2021-10-20 Hangzhou Biotest Biotech Co., Ltd. A lateral flow detection device for detecting a coronavirus by immunoassay
CN114814206A (en) 2020-04-30 2022-07-29 杭州博拓生物科技股份有限公司 Lateral flow detection device for detecting coronavirus antibody by immunoassay
CA3168406A1 (en) 2021-08-27 2023-02-27 Zhejiang Orient Gene Biotech Co., Ltd. Test device for presence of an analyte
KR102654052B1 (en) * 2021-10-14 2024-04-03 주식회사 바이오니트 Diagnosis kit for qualitative test, and automated apparatus for comprising the kit
US20230128887A1 (en) 2021-10-21 2023-04-27 Zhejiang Orient Gene Biotech Co., LTD Foldable test tube rack
CN116448494A (en) 2022-01-10 2023-07-18 浙江东方基因生物制品股份有限公司 Apparatus for producing collector for collecting sample
CA3182128A1 (en) 2022-01-11 2023-07-11 Hangzhou Xunling Biotech Co., Ltd. Test device for nucleic acid
CA3167468A1 (en) 2022-03-15 2023-09-15 Zhejiang Orient Gene Biotech Co., Ltd. Device for detecting an analyte in a liquid sample
AU2023201301A1 (en) 2022-05-23 2023-12-07 Zhejiang Orient Gene Biotech Co., LTD Test device for analyte in a fluid sample
CN117168866A (en) 2022-05-27 2023-12-05 杭州博拓生物科技股份有限公司 Sample collector
CN117423095A (en) 2022-07-18 2024-01-19 浙江东方基因生物制品股份有限公司 Automatic identification method, device and equipment for detection result of immunoreagent card

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2581194A1 (en) * 1985-04-29 1986-10-31 Materiel Biomedical Device for the analysis of a biological liquid
US4873193A (en) * 1987-08-26 1989-10-10 Forensic Applications Corporation Method and apparatus for the collection and preservation of fluid biological evidence
US5119830A (en) * 1991-04-03 1992-06-09 Code Blue Medical Corporation Analytical specimen cup with testing means
WO1994006940A1 (en) * 1992-09-18 1994-03-31 Abbott Laboratories Multiple assay test strip devices
US5352410A (en) * 1993-06-03 1994-10-04 Hansen Warren D Fluid specimen collection and testing apparatus
US5368583A (en) * 1993-08-03 1994-11-29 Gkr Industries, Inc. Bodily fluid test kit
EP0634215A1 (en) * 1993-07-15 1995-01-18 Roche Diagnostics GmbH Device for simultaneous determination of analytes
WO1995007659A1 (en) * 1993-09-16 1995-03-23 F.Hoffmann-La Roche Ag Assaying device

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3006735A (en) * 1959-09-22 1961-10-31 Morton Salt Co Quick-dip indicator
US3900019A (en) * 1973-08-23 1975-08-19 Barbara Ann Logiadis Urine sampling device and method
AT360176B (en) * 1977-07-01 1980-12-29 Roehm Gmbh TEST CARD FOR DETECTING THE Occult BLOOD IN THE CHAIR
WO1980000406A1 (en) * 1978-08-23 1980-03-20 Lucas & Soehne Kunststoffwerk Container for analysis,particularly for analysing a urine sample
US4361537A (en) * 1979-01-12 1982-11-30 Thyroid Diagnostics, Inc. Test device and method for its use
US4308028A (en) * 1980-04-14 1981-12-29 Elkins Carlos D Device and method for the chemical testing and microscopic examination of liquid specimens
DE8231834U1 (en) * 1982-11-12 1987-01-02 Walter Sarstedt Kunststoff-Spritzgusswerk, 5223 Nuembrecht, De
US4518565A (en) * 1983-06-06 1985-05-21 Miles Laboratories, Inc. Reagent test device holder
DE3416933A1 (en) * 1984-05-04 1985-11-07 Dora 1000 Berlin Köhler CARRIER COVERED WITH ANTIQUE OR ANTIBODY
US5006474A (en) * 1987-12-16 1991-04-09 Disease Detection International Inc. Bi-directional lateral chromatographic test device
US5238652A (en) * 1990-06-20 1993-08-24 Drug Screening Systems, Inc. Analytical test devices for competition assay for drugs of non-protein antigens using immunochromatographic techniques
DE4022655A1 (en) * 1990-07-17 1992-01-23 Boehringer Mannheim Gmbh TEST KIT FOR DETERMINING ANALYTES IN A PASTOESE SAMPLE, ESPECIALLY IN CHAIR
BE1005090A5 (en) * 1991-06-25 1993-04-13 Saliva Diagnostic Systems Inc Device and sampling system fitness sample.
DE4205894A1 (en) * 1992-02-26 1993-09-02 Martin Rahe DEVICE FOR DETECTING AND / OR MEASURING OR CONTROLLING THE TEXTURE, ESPECIALLY CHEMICAL AND / OR BIOLOGICAL RELATIONSHIPS WITH THE HELP OF AT LEAST ONE INDICATOR IN LIQUID MILIEU, ESPECIALLY AQUEOUS MILIEU, AND LIKE
US5500375A (en) * 1993-04-13 1996-03-19 Serex, Inc. Integrated packaging-holder device for immunochromatographic assays in flow-through or dipstick formats
US5441698A (en) * 1993-09-10 1995-08-15 Beckman Instruments, Inc. Bevel closure and device
US5712172A (en) * 1995-05-18 1998-01-27 Wyntek Diagnostics, Inc. One step immunochromatographic device and method of use

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2581194A1 (en) * 1985-04-29 1986-10-31 Materiel Biomedical Device for the analysis of a biological liquid
US4873193A (en) * 1987-08-26 1989-10-10 Forensic Applications Corporation Method and apparatus for the collection and preservation of fluid biological evidence
US5119830A (en) * 1991-04-03 1992-06-09 Code Blue Medical Corporation Analytical specimen cup with testing means
WO1994006940A1 (en) * 1992-09-18 1994-03-31 Abbott Laboratories Multiple assay test strip devices
US5352410A (en) * 1993-06-03 1994-10-04 Hansen Warren D Fluid specimen collection and testing apparatus
EP0634215A1 (en) * 1993-07-15 1995-01-18 Roche Diagnostics GmbH Device for simultaneous determination of analytes
US5368583A (en) * 1993-08-03 1994-11-29 Gkr Industries, Inc. Bodily fluid test kit
WO1995007659A1 (en) * 1993-09-16 1995-03-23 F.Hoffmann-La Roche Ag Assaying device

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6808682B1 (en) * 1997-09-23 2004-10-26 Dtx, Inc. Assaying device consisting of the test cartridge or cassette with a cap or cover which attaches onto the cartridge or cassette to cover and seal the well or opening into which the sample has been deposited
WO2000063697A1 (en) * 1997-11-05 2000-10-26 American Bio Medica Corporation Device for the testing of fluid samples and process for making the device
WO1999038001A1 (en) * 1998-01-21 1999-07-29 Bayer Corporation Optical sensor and method of operation
US6306347B1 (en) 1998-01-21 2001-10-23 Bayer Corporation Optical sensor and method of operation
US6387709B1 (en) 1998-01-21 2002-05-14 Bayer Corporation Method of operating an optical sensor adapted for selective analyte-sensing contact with a plurality of samples
US6488891B2 (en) 1998-01-21 2002-12-03 Bayer Corporation Optical sensor and method of operation
DE19906005C2 (en) * 1998-06-19 2002-12-19 Biomar Diagnostic Systems Gmbh tester
EP1018004A1 (en) * 1998-07-22 2000-07-12 Syntron Bioresearch, Inc. Multiple analyte assay device
AU2003262462B2 (en) * 1998-07-22 2006-03-09 Syntron Bioresearch, Inc. Multiple analyte assay device
EP1018004A4 (en) * 1998-07-22 2002-04-17 Syntron Biores Inc Multiple analyte assay device
EP1088230A4 (en) * 1999-04-21 2001-08-22 American Bio Medica Corp Device for the testing of fluid samples and process for making the device
EP1088230A1 (en) * 1999-04-21 2001-04-04 American Bio Medica Corporation Device for the testing of fluid samples and process for making the device
GB2354320A (en) * 1999-04-21 2001-03-21 American Bio Medica Corp Device for the testing of fluid samples and process for making the device
US7244392B1 (en) * 2000-05-22 2007-07-17 Inverness Medical Switzerland Gmbh Slide-in cassette for a cup for testing of drugs of abuse
US8865458B2 (en) 2003-01-04 2014-10-21 Alere Switzerland Gmbh Specimen collection and assay container
DE10330982A1 (en) * 2003-07-09 2005-02-17 Prisma Diagnostika Gmbh Apparatus and method for the simultaneous determination of blood group antigens
US8053226B2 (en) 2003-07-09 2011-11-08 Medion Diagnostics Ag Device and method for simultaneously identifying blood group antigens
WO2007046044A2 (en) * 2005-10-18 2007-04-26 Agamatrix, Inc Vial for test strips
WO2007046044A3 (en) * 2005-10-18 2007-09-13 Agamatrix Inc Vial for test strips
US7501093B2 (en) 2005-10-18 2009-03-10 Agamatrix, Inc. Vial for test strips
US20130109104A1 (en) * 2011-10-26 2013-05-02 Benjamin S. Harmon Substance detecting apparatus
US8771608B2 (en) * 2011-10-26 2014-07-08 Timothy Lee Nowlin Substance detecting apparatus

Also Published As

Publication number Publication date
AT408696B (en) 2002-02-25
US5976895A (en) 1999-11-02
EP0830082A1 (en) 1998-03-25
JPH11506213A (en) 1999-06-02
CN1181695A (en) 1998-05-13
AU715966B2 (en) 2000-02-10
GB2314625A (en) 1998-01-07
EP0830082B1 (en) 2003-12-03
PL323189A1 (en) 1998-03-16
OA10630A (en) 2001-04-24
DE19780221T1 (en) 1998-04-23
ES2210508T3 (en) 2004-07-01
BR9702113A (en) 1999-12-28
ATA900197A (en) 2001-06-15
AP9701102A0 (en) 1997-10-31
CA2181775C (en) 2004-07-06
CA2181775A1 (en) 1997-09-12
AU2195397A (en) 1997-10-01
CA2219529C (en) 2004-12-07
CA2219529A1 (en) 1997-09-18
GB2314625B (en) 1999-12-08
GB9721480D0 (en) 1997-12-10

Similar Documents

Publication Publication Date Title
EP0830082B1 (en) Device for the collection, testing and shipment of body fluid samples
US6372515B1 (en) Device for the testing of fluid samples and process for making the device
US6406922B2 (en) Device for the testing of body fluid samples
US6403383B1 (en) Diagnostic test kit for immunological assays of fluid samples
US8206661B2 (en) Assay device and process for the testing of fluid samples
AU764945B2 (en) Multiple analyte assay device with sample integrity monitoring system
US6120733A (en) Self-contained assay device
US6375897B1 (en) Urine collection cup
US7347972B1 (en) Multiple analyte assay device
WO2000063697A9 (en) Device for the testing of fluid samples and process for making the device
JP2007511769A (en) High speed sample collection and analysis device and method of use
US20020137231A1 (en) Device for the collection, testing and shipment of body fluid samples
US5817522A (en) Self-contained assay device and method
US20030232451A1 (en) Device for the testing of fluid samples and process for making the device
US8623291B2 (en) Multiple analyte assay device
GB2339616A (en) Drug testing and sample transporting device
AU6301799A (en) Device for the testing of body fluid samples
MXPA01000051A (en) Device for the testing of fluid samples and process for making the device
MXPA97008669A (en) Device for the collection, testing and shipment of body fluid samples
AU2003262462B2 (en) Multiple analyte assay device

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 97190174.0

Country of ref document: CN

AK Designated states

Kind code of ref document: A1

Designated state(s): AT AU BR CA CH CN CZ DE GB IL JP MX NO NZ PL RU SG SI US VN AM AZ BY KG KZ MD RU TJ TM

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH KE LS MW SD SZ UG AT BE CH DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN ML MR NE SN TD TG

ENP Entry into the national phase

Ref document number: 2219529

Country of ref document: CA

Ref document number: 2219529

Country of ref document: CA

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 1997 9001

Country of ref document: AT

Date of ref document: 19970918

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 19979001

Country of ref document: AT

WWE Wipo information: entry into national phase

Ref document number: 1997914848

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 1997 532656

Country of ref document: JP

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: PA/a/1997/008669

Country of ref document: MX

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWP Wipo information: published in national office

Ref document number: 1997914848

Country of ref document: EP

RET De translation (de og part 6b)

Ref document number: 19780221

Country of ref document: DE

Date of ref document: 19980423

WWE Wipo information: entry into national phase

Ref document number: 19780221

Country of ref document: DE

WWG Wipo information: grant in national office

Ref document number: 1997914848

Country of ref document: EP