EP1091808B1 - Dispositif de determination d'un analyte dans un echantillon liquide - Google Patents

Dispositif de determination d'un analyte dans un echantillon liquide Download PDF

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Publication number
EP1091808B1
EP1091808B1 EP99925064A EP99925064A EP1091808B1 EP 1091808 B1 EP1091808 B1 EP 1091808B1 EP 99925064 A EP99925064 A EP 99925064A EP 99925064 A EP99925064 A EP 99925064A EP 1091808 B1 EP1091808 B1 EP 1091808B1
Authority
EP
European Patent Office
Prior art keywords
zone
capillary
diffusion means
support
capillary diffusion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP99925064A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1091808A1 (fr
Inventor
Milovan Stankov
Raphael Donati
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
VEDA LAB
Original Assignee
VEDA LAB
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Filing date
Publication date
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Application filed by VEDA LAB filed Critical VEDA LAB
Publication of EP1091808A1 publication Critical patent/EP1091808A1/fr
Application granted granted Critical
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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
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0633—Valves, specific forms thereof with moving parts
    • B01L2400/065—Valves, specific forms thereof with moving parts sliding valves
    • 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
    • Y10S435/806—Fertility tests

Definitions

  • the present invention relates to a device for determination of an analyte present in a sample liquid.
  • Analyte means any entity, chemical, biochemical, or biological, that we want to determine, that is to say, identify or detect, and / or quantify, and / or measure.
  • the present invention will be introduced, defined, and described by reference to the determination of a biological entity, especially a hormone, for example the hormone hcG to detect the pregnancy status of a woman.
  • Liquid sample means any sample in which the analyte sought is in solution or suspension, as directly applied or treated by the device of determination of which it will be question below.
  • This liquid sample can itself have been obtained from a sample or other sample containing the analyte, for example a fluid body, by physical treatment, and / or chemical, and / or organic. This means in particular that the middle of Dissolution or dispersion belonging to the sample liquid is not necessarily aqueous.
  • the user removes the cap, then puts the liquid sample, for example a stream of urine, in direct contact with the collection area of the second means of capillary diffusion.
  • the liquid sample migrates first, in the reference direction, to the zone upstream of the first capillary diffusion means, in which, on the one hand, causes the first reagent, and on the other hand the analyte binds to the latter, to form a conjugate.
  • the aforementioned conjugate arrives via capillary drive in the downstream zone, in which the second reagent captures, and therefore immobilizes and concentrate, directly or indirectly, the first reagent, and hence the conjugate.
  • the existence and / or the captured quantity of the conjugate can be read, and / or measured, directly or indirectly, for example to the naked eye in the case of a particulate marker, or by any means of detection and / or appropriate measure.
  • the two devices previously described have in on the one hand, the provision of the two means of capillary diffusion, on one and the same element, know the grip support in the first case, and the movable organ in the second case, and on the other hand a structural continuity of capillary flow, this is at say permanent, the liquid sample of the second means of capillary diffusion to the first means of capillary diffusion.
  • the present invention relates to a device for removing any additional means of removable protection of the collection area of the liquid sample, while isolating the latter from the outside of the device, as the latter is not used, ie used or armed for taking a liquid sample, and then reading the result concerning the analyte.
  • a device Compared to WO 97/26083, a device according to the present invention is distinguished in that the transfer zone of the second capillary diffusion means is removably arranged with respect to an upstream zone of the first capillary diffusion means, so that, in the projecting position of the capturing member, said transfer zone is not in continuity of capillary flow with said upstream zone, and in the retracted position of said capturing member, said transfer zone and said zone upstream are in continuity of capillary flow, while a set of reagents predetermined for the detection and / or quantification of the analyte comprises at least, on the one hand a first reagent comprising a marker, visible and / or measurable, deposited in the free state, or on the first capillary diffusion means, upstream of said downstream zone, or on the second capillary diffusion means, and secondly a second reagent fixed in the zone e downstream of the first capillary diffusion means, for the direct or indirect capture of the first reagent.
  • the device according to the invention is distinguished by the dissociation of the two means of capillary diffusion, and by the possibility of isolating temporarily these two means with respect to the flow capillary of the liquid sample.
  • the device according to the invention is distinguished, besides the set of predetermined reagents chosen for the detection and / or quantification of the analyte, by the fact that the first means of capillary diffusion remains side of the gripping support, and as a result the capture organ is essentially assigned to the sampling of the liquid sample.
  • the invention brings the following advantages.
  • the displacement of the second diffusion means capillary, away from and away from the first means of capillary diffusion, allows for a length or a given size of the device, to have a more large collection length of the liquid sample, in the projecting or protruding position of said device.
  • a device according to the invention can be used with any set of predetermined reagents, depending of the desired analyte in the liquid sample, of a and the operating protocol adopted for the determination on the other hand.
  • Reagent means any entity, chemical, biochemical, or biological likely to bind with the analyte and / or another reagent.
  • binding is meant any link strong, for example covalent, or weak, for example type antigen / antibody or avidin / streptavidin.
  • the reagents considered according to the invention are entities ligand or anti-ligand type, and this by relative to the analyte or other reagent, of type organic.
  • the reagents such as antibodies, antigens, haptens, avidin / streptavidin, but also peptides, proteins, and polynucleotides.
  • the first and second reagents are respectively two monoclonal antibodies specific, identical or different, directed against the analyte.
  • Marker means any physical entity, chemical, biochemical, or biological, allowing directly or indirectly the determination of the first reagent, particularly when bound, directly or indirectly indirectly, to the analyte.
  • a marker known per se, can be for example an enzyme, or particles metal, for example gold particles, obtained by example from colloidal gold.
  • the first reagent is deposited on the second means of capillary diffusion, in particular downstream of the organ collection area of capture, or the first reagent is deposited on the first means of capillary diffusion, in particular downstream of the upstream zone of the said first means, but upstream of the downstream zone accessible to an observation external.
  • an analyte constituted by a biological entity comprising two ligands, likely to link with the first reagent and a third reagent the latter is deposited at the free state, on a porous support, in this case the second means of capillary diffusion or the first means capillary scattering at a functionally upstream of the downstream zone of the first diffusion means.
  • the second reagent is predetermined for capturing the third reagent.
  • another predetermined reagent for binding directly or indirectly with the first reagent is fixed in a adjacent area but downstream of the downstream zone of the first means of diffusion, this adjacent zone being also accessible to an external observation.
  • the first reagent comprises a particulate marker, for example gold particles, visible and / or directly measurable, when concentrated in the downstream zone of the first diffusion means.
  • a particulate marker for example gold particles, visible and / or directly measurable
  • the support of 1 comprises a longitudinal slide 5, of which the shape is adapted to the movement path of said member 4, and the latter comprises a control member 6 manual crossing this slide.
  • the race of the organ 6 in the slide 5 determines the two extreme positions of the capture member 4, and as shown in FIG. has a length greater than the recovery length of the transfer zone 41b of the second diffusion means 41 capillary, and the upstream zone (2b) of the first means of capillary diffusion, in the retracted position of device.
  • the first means 2 of capillary diffusion is obtained by assembling different sections or pieces, themselves fixed on a band 28 made of plastic transparent, and in permanent continuity of flow capillary when assembled to each other.
  • the capture member 4 comprises a carriage 42 of supporting the second means 41 of capillary diffusion, included in the housing 1 or gripping support.
  • This last and the carriage 42 comprise guide means moving said carriage, more particularly visible in Figure 6, consisting of two slides 45 and 46 belonging to the housing 1, the superior and the other bottom, and aligned, and in two ribs 43 and 44 corresponding to the carriage 42, sliding in the slides 45 and 46 respectively.
  • the second diffusion means 41 is in the form of a relatively rigid rod, and the carriage 42 comprises a rear stop 42a with respect to the direction of travel said carriage, and a member 42b for holding the rod 41, having the shape of a ring.
  • the housing 1 also includes a means 47 for actuating the carriage 42, with manual control 48. More specifically, the actuating means 47 comprises a band 49 semi-rigid, shaped hairpin, one of which branch 49a has on its outer face a member 48 the other limb has one end linked to the carriage 42.
  • the housing 1 comprises a path 50 for guiding and pulling the strip, also shaped hairpin, and secondly a 1f window adapted to the passage of the organ of 48, the length of which is adapted to the race of displacement of the capture organ 4. as shown the comparison between figures 4 and 5, this race a much longer length than the recovery length of the transfer zone 41b of the second means of capillary diffusion 41, and the upstream zone 2b of the first capillary diffusion means 2, in the position retracted device.
  • the band 49 circulates in the guide path 50 and pushes the carriage 42 towards the protruding position of the capture member 2. In sense reverse, the carriage 42 is moved to the position retracted from the capture member 4.
  • the first means 2 of capillary diffusion is tight and kept inside the housing between ribs on arranged parallel to the flow direction 60 capillary.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Analysing Materials By The Use Of Radiation (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
EP99925064A 1998-06-30 1999-06-10 Dispositif de determination d'un analyte dans un echantillon liquide Expired - Lifetime EP1091808B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9808480 1998-06-30
FR9808480A FR2780317B1 (fr) 1998-06-30 1998-06-30 Dispositif de determination d'un analyte dans un echantillon liquide
PCT/FR1999/001380 WO2000000288A1 (fr) 1998-06-30 1999-06-10 Dispositif de determination d'un analyte dans un echantillon liquide

Publications (2)

Publication Number Publication Date
EP1091808A1 EP1091808A1 (fr) 2001-04-18
EP1091808B1 true EP1091808B1 (fr) 2003-07-09

Family

ID=9528186

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99925064A Expired - Lifetime EP1091808B1 (fr) 1998-06-30 1999-06-10 Dispositif de determination d'un analyte dans un echantillon liquide

Country Status (16)

Country Link
US (1) US7459125B1 (zh)
EP (1) EP1091808B1 (zh)
JP (1) JP4505138B2 (zh)
CN (1) CN1185050C (zh)
AT (1) ATE244602T1 (zh)
AU (1) AU4148399A (zh)
CA (1) CA2335458A1 (zh)
DE (1) DE69909484T2 (zh)
ES (1) ES2204132T3 (zh)
FR (1) FR2780317B1 (zh)
HU (1) HUP0102735A3 (zh)
IL (1) IL140165A (zh)
PL (1) PL194051B1 (zh)
RS (1) RS49670B (zh)
RU (1) RU2205693C2 (zh)
WO (1) WO2000000288A1 (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2873208A1 (fr) * 2004-07-13 2006-01-20 Vedalab Sa Dispositif avec organe de prelevement pour la detection d'un analyte dans un echantillon liquide
US8709826B2 (en) 2005-08-23 2014-04-29 Vedalab Analyte assaying by means of immunochromatography with lateral migration

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US6773677B2 (en) * 2002-01-09 2004-08-10 Caliper Life Sciences, Inc. Slide cassette for fluidic injection
ES2525318T3 (es) * 2002-10-11 2014-12-22 Zbx Corporation Dispositivos de diagnóstico
EP1718973B1 (en) * 2004-02-09 2009-09-09 Rapid Pathogen Screening Inc. Method for the rapid diagnosis of targets in human body fluids
CN101498717B (zh) * 2005-04-30 2013-08-28 美艾利尔瑞士公司 用于收集固体或者半固体样本的样本收集装置
GB0811132D0 (en) * 2008-06-18 2008-07-23 Secr Defence Detection device
WO2010009301A1 (en) * 2008-07-17 2010-01-21 The Procter & Gamble Company Method of using a flow cell apparatus for visualizing additive deposition on a substrate
AU2010330825B2 (en) * 2009-12-18 2014-03-06 Abbott Point Of Care, Inc. Biologic fluid analysis cartridge
BG110608A (bg) * 2010-03-01 2011-09-30 Zentax Limited Тестер за бременност
US9744014B2 (en) * 2010-10-15 2017-08-29 Nestec S.A. Oral engagement assemblies
FR2997194B1 (fr) 2012-10-24 2014-11-28 Milovan Stankov Dispositif pour la determination d'au moins un analyte susceptible d'etre contenu dans un echantillon liquide
US9592507B2 (en) * 2012-06-22 2017-03-14 Abbott Point Of Care Inc. Integrated cartridge housings for sample analysis
MX2017013898A (es) * 2015-04-30 2018-08-15 Wellmetris Llc Dispositivo y método para recolección de muestras de orina y otros fluidos.
WO2018079916A1 (ko) * 2016-10-28 2018-05-03 주식회사 바이탈스미스 배란일 측정을 위한 영상처리 및 분석 시스템, 이의 제어 방법
CN109890297A (zh) * 2016-10-28 2019-06-14 株式会社马尼金 用于确定排卵日的影像处理和分析系统及其控制方法
EP3619532B1 (en) 2017-05-02 2022-07-13 Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. Plasma/serum separator device and methods using the same
GB201816559D0 (en) * 2018-10-10 2018-11-28 Spd Swiss Prec Diagnostics Gmbh Compact testing device
EP4188600B1 (en) 2020-07-29 2024-06-05 Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. Device for separation and/or preservation of a biofluid at a point-of-care, kit and method for identifying a disease
CA3167468A1 (en) * 2022-03-15 2023-09-15 Zhejiang Orient Gene Biotech Co., Ltd. Device for detecting an analyte in a liquid sample

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IT1281738B1 (it) * 1996-01-17 1998-02-27 Boehringer Mannheim Italia Dispositivo per l'esecuzione di test diagnostici rapidi su campioni di liquidi
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2873208A1 (fr) * 2004-07-13 2006-01-20 Vedalab Sa Dispositif avec organe de prelevement pour la detection d'un analyte dans un echantillon liquide
WO2006016051A2 (fr) * 2004-07-13 2006-02-16 Vedalab Dispositif avec organe de prelevement pour la detection d’un analyte dans un echantillon liquide
WO2006016051A3 (fr) * 2004-07-13 2006-08-10 Vedalab Dispositif avec organe de prelevement pour la detection d’un analyte dans un echantillon liquide
US8709826B2 (en) 2005-08-23 2014-04-29 Vedalab Analyte assaying by means of immunochromatography with lateral migration

Also Published As

Publication number Publication date
IL140165A0 (en) 2002-02-10
IL140165A (en) 2004-05-12
RU2205693C2 (ru) 2003-06-10
ES2204132T3 (es) 2004-04-16
CN1185050C (zh) 2005-01-19
FR2780317A1 (fr) 1999-12-31
HUP0102735A2 (hu) 2001-11-28
YU83300A (sh) 2003-04-30
RS49670B (sr) 2007-09-21
DE69909484D1 (de) 2003-08-14
DE69909484T2 (de) 2004-04-15
US7459125B1 (en) 2008-12-02
JP2002519650A (ja) 2002-07-02
EP1091808A1 (fr) 2001-04-18
WO2000000288A1 (fr) 2000-01-06
ATE244602T1 (de) 2003-07-15
AU4148399A (en) 2000-01-17
JP4505138B2 (ja) 2010-07-21
PL194051B1 (pl) 2007-04-30
CA2335458A1 (en) 2000-01-06
CN1308562A (zh) 2001-08-15
FR2780317B1 (fr) 2000-08-11
HUP0102735A3 (en) 2005-11-28
PL345160A1 (en) 2001-12-03

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