WO2000063697A1 - Dispositif pour tester des echantillons de liquide et procede de production dudit dispositif - Google Patents

Dispositif pour tester des echantillons de liquide et procede de production dudit dispositif Download PDF

Info

Publication number
WO2000063697A1
WO2000063697A1 PCT/US2000/008736 US0008736W WO0063697A1 WO 2000063697 A1 WO2000063697 A1 WO 2000063697A1 US 0008736 W US0008736 W US 0008736W WO 0063697 A1 WO0063697 A1 WO 0063697A1
Authority
WO
WIPO (PCT)
Prior art keywords
test
card
test card
test strips
multiple drug
Prior art date
Application number
PCT/US2000/008736
Other languages
English (en)
Other versions
WO2000063697A9 (fr
Inventor
Douglas Casterlin
Henry J. Wells
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 claimed from US09/295,095 external-priority patent/US6372515B1/en
Application filed by American Bio Medica Corporation filed Critical American Bio Medica Corporation
Priority to EP00923112A priority Critical patent/EP1088230A4/fr
Priority to IL14023000A priority patent/IL140230A0/xx
Priority to HU0102458A priority patent/HUP0102458A2/hu
Priority to BR0006069-0A priority patent/BR0006069A/pt
Priority to AU43291/00A priority patent/AU4329100A/en
Priority to CA002334802A priority patent/CA2334802C/fr
Priority to GB0028544A priority patent/GB2354320A/en
Publication of WO2000063697A1 publication Critical patent/WO2000063697A1/fr
Priority to NO20006492A priority patent/NO20006492L/no
Publication of WO2000063697A9 publication Critical patent/WO2000063697A9/fr

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/94—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
    • 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
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer analytical elements
    • 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

Definitions

  • the present invention relates to the collection and testing of fluid samples for drugs of abuse, more particularly, to a multiple drug test card for indicating visually the presence of particular drugs of abuse in urine and a process for making the test card.
  • test apparatus must be such so as
  • test card having a plurality of immunoassay test strips on one or both sides thereof with each
  • test card
  • abuse test device which may comprise a cup-like transparent container for retaining a urine sample to be tested.
  • the open top of the container has
  • the slit is of such a size to accommodate a test card
  • each test strip is
  • test card is
  • a second closure cap which is solid, i.e., not slit, is provided which may be threaded into the open end of the cup-like container. The test card is removed from the
  • the solid closure cap is threaded on to close the
  • test kit includes a drug abuse test device for collecting and testing a urine sample.
  • test device comprises a cup-like container having a substantially
  • Fig. 1 is a perspective view of the drug abuse test kit according to the present invention generally showing the
  • test card partially inserted to the testing
  • Fig. 2 is an exploded perspective view of the container
  • Fig. 3 is a plan view of the test side of a test card
  • Fig. 4 is a plan view of the reverse side of the test
  • Fig. 5 is an end elevational view of the test card shown
  • Fig. 6 is a sectional view taken along the line VI-VI of
  • Fig. 7 is a plan view of the opened two piece test card
  • Fig. 8 is a plan view of another modification of the test card
  • Fig. 10 is a plan view of the test side of a further modification of the test card
  • Fig. 11 is a plan view of the center ply of the test card
  • Fig. 12 is a plan view of the reverse side of the test
  • Fig. 13 is a sectional view taken along the line XIII-
  • Fig. 16 is an end view of the test card shown in Fig. 10;
  • Fig. 17 is a plan view of a further modification of the
  • Fig. 18 is a plan view of the reverse side of the test
  • Fig. 19 is an end view of the test card of Fig. 17;
  • Fig. 20 is a sectional view taken along the line XX-XX of
  • Fig. 21 is a side elevational view of the test card of Fig. 17.
  • Figs. 22-24 are plan views of further modifications of
  • Fig. 25 is a schematic view illustrating the assembly of
  • Fig. 26 is a plan view of a foil pouch with a test card
  • a drug abuse test kit As may be seen in Figs. 1 and 2, a drug abuse test kit
  • the cylindrical wall 12 may have a slight
  • the open end 14 of the test cup 11 is provided with
  • the cover 22 has a circular top surface 23 from the periphery of which depends a
  • the cover surface 23 has a
  • the cover 22 but is solid or unslit so that the covers 15 and
  • test cup 11 The cover 15 is generally
  • the cup container is essentially a specimen cup as
  • the container may be formed or molded from any suitable material,
  • a transparent wall is not necessary and the wall may be translucent or even opaque. It is sufficient that the material
  • test strips through the wall of the container when the test
  • test card 25 which will indicate the presence or
  • test card is of the
  • Test strips 26-30 may be of the type as made by Bionike of
  • test strips are characterized as immunoassay strips and employ colloidal gold chemistry. Each test strip is submerged
  • test area indicates "negative" or the absence of the test
  • test strips may be completely recessed as shown in
  • the test card may b e 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.
  • portions 34 and 35 are folded over at end 36 and are adhered
  • test strips are then placed into the slots as
  • the cap 22 is provided with a readily removable adhesive sealing strip 18 which is placed over the slit 19.
  • the protective strip 18 is
  • test card is inserted into the slit until the bottom of the test card
  • test can be read on each individual test strip through the test
  • test card A modification of the test card is shown at 44 in Fig. 8.
  • the test card 44 comprises a
  • test strips and slots are provided in the center ply to
  • the top and bottom faces of the central ply 45 are covered by a bottom ply 46 and a top ply 47
  • top and bottom plys may
  • the top ply 47 is provided with a plurality of test windows 50
  • sample openings 51 are provided.
  • sample openings 51 through which the liquid test
  • the bottom and top plys 46 and 47 are then laminated.
  • the bottom and top plys 46 and 47 are then laminated.
  • the center ply 45 is made of styrene having a thickness of
  • the top ply 47 similarly has the test openings
  • the central ply 45 is provided with a plurality of longitudinally extending slots 52 and a test strip 53 is
  • test card has provision
  • windows 50 and 51 for the omitted strips are usually solid.
  • Test card 54 has a front face or surface 55
  • reverse side of the test card may vary as shown in the rear
  • the test card 54 has the front and back plys or faces 55
  • slots 52 in the intermediate plys may be assembled with a test
  • test strips would be assembled in intermediate ply 62 to
  • the front panel 55 is provided with a plurality of test
  • openings 64 are positioned to correspond with
  • the central ply 60 is imperforate so as to maintain
  • the template 68 may have one .or more
  • the back panel 46 may be positioned in the
  • the central panel will have the longitudinally extending side-by-side parallel slots therein and an immunoassay test strip is then positioned in one or more of these slots.
  • the front panel 55 is then positioned over the middle or center panel 45 to enclose the test strips therein.
  • the front panel 55 has the appropriate test window 63 and sample receiving window 64 therein as described above. The assembled test card having test strips on one face thereof is then removed from
  • test card such as illustrated in Figs. 18 and 22-24
  • the assembled test card as described above is turned over and repositioned in the recess so that the front face or panel 55 is seated in the template. Subsequently, a second middle or central ply 45 which has adhesive on both faces thereof is positioned
  • test card such as 54 shown in Fig. 26 is
  • test strips 26-30 and 53 is a one-step
  • the test strip consists of a membrane strip onto which a drug conjugate has been immobilized.
  • reaction occurs forming a visible line in the test area.
  • the formation of a visible line in the test area occurs when the
  • 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
  • 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 .
  • test card can also be used as a carrier or delivery
  • a novel and improved drug abuse test kit which comprises a
  • test card through the wall of the container.
  • the test card thus comprises a number of individual test strips of 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

Abstract

L'invention concerne une carte de test pour dépister la présence de drogues illicites dans un liquide, comportant un élément mince et plat présentant la forme et les dimensions d'une carte de crédit. Une pluralité de bandelettes de test immunologique s'étendent longitudinalement du haut vers le base de la carte et sont fixées, en étant juxtaposées parallèlement les unes aux autres, sur l'une ou les deux faces de la carte, à l'intérieur du contour de cette dernière. Chaque bandelette test est réactive afin de fournir une indication visuelle en réaction à la présence de drogues illicites. Cette carte de test permet en outre la détection simultanée d'une pluralité de substances à analyser. L'invention concerne également des procédés pour produire ladite carte de test comportant des bandelettes test sur un ou deux de ses côtés.
PCT/US2000/008736 1997-11-05 2000-04-19 Dispositif pour tester des echantillons de liquide et procede de production dudit dispositif WO2000063697A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP00923112A EP1088230A4 (fr) 1999-04-21 2000-04-19 Dispositif pour tester des echantillons de liquide et procede de production dudit dispositif
IL14023000A IL140230A0 (en) 1999-04-21 2000-04-19 Device for the testing of fluid samples and process for making the device
HU0102458A HUP0102458A2 (hu) 1997-11-05 2000-04-19 Többszörös kábítószer vizsgálati kártya kábítószer használatának vizsgálatára szolgáló folyadékminták számára, valamint eljárás ilyen vizsgálati kártyák előállítására
BR0006069-0A BR0006069A (pt) 1999-04-21 2000-04-19 Cartão de testes para múltiplas drogas para teste de amostras de fluido e processo para produzì-lo
AU43291/00A AU4329100A (en) 1999-04-21 2000-04-19 Device for the testing of fluid samples and process for making the device
CA002334802A CA2334802C (fr) 1999-04-21 2000-04-19 Dispositif pour tester des echantillons de liquide et procede de production dudit dispositif
GB0028544A GB2354320A (en) 1999-04-21 2000-04-19 Device for the testing of fluid samples and process for making the device
NO20006492A NO20006492L (no) 1999-04-21 2000-12-19 Innretning for testing av fluidpröver og fremgangsmåte til fremstilling av samme

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US98166597A 1997-11-05 1997-11-05
US09/295,095 1999-04-21
US09/295,095 US6372515B1 (en) 1996-03-11 1999-04-21 Device for the testing of fluid samples and process for making the device

Publications (2)

Publication Number Publication Date
WO2000063697A1 true WO2000063697A1 (fr) 2000-10-26
WO2000063697A9 WO2000063697A9 (fr) 2002-01-24

Family

ID=26968917

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/008736 WO2000063697A1 (fr) 1997-11-05 2000-04-19 Dispositif pour tester des echantillons de liquide et procede de production dudit dispositif

Country Status (2)

Country Link
HU (1) HUP0102458A2 (fr)
WO (1) WO2000063697A1 (fr)

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2377016A (en) * 2001-06-28 2002-12-31 Surescreen Diagnostics Ltd Test strips for determining analytes in a fluid
WO2003086200A1 (fr) * 2002-04-08 2003-10-23 Varian, Inc. Dispositif de test a disque
WO2005031355A1 (fr) * 2003-09-22 2005-04-07 Quidel Corporation Dispositifs de detection d'analysats multiples dans un echantillon
GB2410087A (en) * 2003-12-19 2005-07-20 Bloomsbury Innovations Ltd Multiple drug assay kit for testing beverages
WO2006118622A1 (fr) * 2005-04-29 2006-11-09 Kimberly-Clark Worldwide, Inc. Technique de mesure pour appareils de dosage a ecoulement lateral
US7438852B2 (en) 2003-11-14 2008-10-21 Inverness Medical Switzerland Gmbh Sample collection cup with integrated sample analysis system
US7550112B2 (en) 2003-11-14 2009-06-23 Oakville Hong Kong Company Limited Sample collection cup with integrated activatable sample analysis system
US7790471B2 (en) 2005-12-13 2010-09-07 Kimberly-Clark Worldwide, Inc. Metering technique for lateral flow assay devices
US7794656B2 (en) 2006-01-23 2010-09-14 Quidel Corporation Device for handling and analysis of a biological sample
US7838258B2 (en) 2005-12-14 2010-11-23 Kimberly-Clark Worldwide, Inc. Meter strip and method for lateral flow assay devices
US7858384B2 (en) 2005-04-29 2010-12-28 Kimberly-Clark Worldwide, Inc. Flow control technique for assay devices
US7871568B2 (en) 2006-01-23 2011-01-18 Quidel Corporation Rapid test apparatus
WO2013001102A1 (fr) * 2011-06-27 2013-01-03 V.P. Pharma Baru, S.L. Système pour la détection de substances d'abus
US8535617B2 (en) 2007-11-30 2013-09-17 Kimberly-Clark Worldwide, Inc. Blood cell barrier for a lateral flow device
US8563317B2 (en) 2004-03-12 2013-10-22 Bloomsbury Innovations Ltd. Apparatus for detecting gamma hydroxybutyrate, ketamines and related drugs in beverages
US9011770B2 (en) 2005-10-25 2015-04-21 Alere Switzerland Gmbh Device for detecting analytes in fluid samples
WO2021017417A1 (fr) * 2019-07-30 2021-02-04 南通伊仕生物技术股份有限公司 Papier réactif de détection semi-quantitative de gonadotrophine chorionique humaine et son procédé de préparation, coupelle de réactif de détection semi-quantitative de gonadotrophine chorionique humaine, et ses applications

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4518565A (en) * 1983-06-06 1985-05-21 Miles Laboratories, Inc. Reagent test device holder
US5119830A (en) * 1991-04-03 1992-06-09 Code Blue Medical Corporation Analytical specimen cup with testing means
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
US5500375A (en) * 1993-04-13 1996-03-19 Serex, Inc. Integrated packaging-holder device for immunochromatographic assays in flow-through or dipstick formats
WO1997033519A1 (fr) * 1996-03-11 1997-09-18 American Bio Medica Corporation Dispositif de prelevement, d'analyse et d'expedition d'echantillons de liquide biologique
US5807752A (en) * 1992-09-11 1998-09-15 Boehringer Mannheim Corporation Assay using an unblocked solid phase with immobilized analyte binding partner

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4518565A (en) * 1983-06-06 1985-05-21 Miles Laboratories, Inc. Reagent test device holder
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
US5119830A (en) * 1991-04-03 1992-06-09 Code Blue Medical Corporation Analytical specimen cup with testing means
US5807752A (en) * 1992-09-11 1998-09-15 Boehringer Mannheim Corporation Assay using an unblocked solid phase with immobilized analyte binding partner
US5500375A (en) * 1993-04-13 1996-03-19 Serex, Inc. Integrated packaging-holder device for immunochromatographic assays in flow-through or dipstick formats
WO1997033519A1 (fr) * 1996-03-11 1997-09-18 American Bio Medica Corporation Dispositif de prelevement, d'analyse et d'expedition d'echantillons de liquide biologique

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2377016A (en) * 2001-06-28 2002-12-31 Surescreen Diagnostics Ltd Test strips for determining analytes in a fluid
WO2003086200A1 (fr) * 2002-04-08 2003-10-23 Varian, Inc. Dispositif de test a disque
US7691644B2 (en) 2003-09-22 2010-04-06 Quidel Corporation Devices for the detection of multiple analytes in a sample
WO2005031355A1 (fr) * 2003-09-22 2005-04-07 Quidel Corporation Dispositifs de detection d'analysats multiples dans un echantillon
US8722426B2 (en) 2003-09-22 2014-05-13 Quidel Corporation Devices for the detection of multiple analytes in a sample
US10415104B2 (en) 2003-09-22 2019-09-17 Quidel Corporation Devices for the detection of multiple analytes in a sample
US7378285B2 (en) 2003-09-22 2008-05-27 Paul Lambotte Devices for the detection of multiple analytes in a sample
US9207241B2 (en) 2003-09-22 2015-12-08 Quidel Corporation Devices for the detection of multiple analytes in a sample
US9797019B2 (en) 2003-09-22 2017-10-24 Quidel Corporation Devices for the detection of multiple analytes in a sample
US7438852B2 (en) 2003-11-14 2008-10-21 Inverness Medical Switzerland Gmbh Sample collection cup with integrated sample analysis system
US7550112B2 (en) 2003-11-14 2009-06-23 Oakville Hong Kong Company Limited Sample collection cup with integrated activatable sample analysis system
GB2410087B (en) * 2003-12-19 2008-11-19 Bloomsbury Innovations Ltd Drug assay kit for testing beverages
GB2410087A (en) * 2003-12-19 2005-07-20 Bloomsbury Innovations Ltd Multiple drug assay kit for testing beverages
US8563317B2 (en) 2004-03-12 2013-10-22 Bloomsbury Innovations Ltd. Apparatus for detecting gamma hydroxybutyrate, ketamines and related drugs in beverages
US7803319B2 (en) 2005-04-29 2010-09-28 Kimberly-Clark Worldwide, Inc. Metering technique for lateral flow assay devices
US8124421B2 (en) 2005-04-29 2012-02-28 Kimberly-Clark Worldwide, Inc. Flow control technique for assay devices
CN101166978B (zh) * 2005-04-29 2012-06-13 金伯利-克拉克环球有限公司 用于侧流测定装置的计量技术
US7858384B2 (en) 2005-04-29 2010-12-28 Kimberly-Clark Worldwide, Inc. Flow control technique for assay devices
WO2006118622A1 (fr) * 2005-04-29 2006-11-09 Kimberly-Clark Worldwide, Inc. Technique de mesure pour appareils de dosage a ecoulement lateral
US9011770B2 (en) 2005-10-25 2015-04-21 Alere Switzerland Gmbh Device for detecting analytes in fluid samples
US7790471B2 (en) 2005-12-13 2010-09-07 Kimberly-Clark Worldwide, Inc. Metering technique for lateral flow assay devices
US7838258B2 (en) 2005-12-14 2010-11-23 Kimberly-Clark Worldwide, Inc. Meter strip and method for lateral flow assay devices
US7871568B2 (en) 2006-01-23 2011-01-18 Quidel Corporation Rapid test apparatus
US7794656B2 (en) 2006-01-23 2010-09-14 Quidel Corporation Device for handling and analysis of a biological sample
US8535617B2 (en) 2007-11-30 2013-09-17 Kimberly-Clark Worldwide, Inc. Blood cell barrier for a lateral flow device
WO2013001102A1 (fr) * 2011-06-27 2013-01-03 V.P. Pharma Baru, S.L. Système pour la détection de substances d'abus
WO2021017417A1 (fr) * 2019-07-30 2021-02-04 南通伊仕生物技术股份有限公司 Papier réactif de détection semi-quantitative de gonadotrophine chorionique humaine et son procédé de préparation, coupelle de réactif de détection semi-quantitative de gonadotrophine chorionique humaine, et ses applications

Also Published As

Publication number Publication date
WO2000063697A9 (fr) 2002-01-24
HUP0102458A2 (hu) 2001-11-28

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