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WO2008042033A2 - Dispositif de chambre de test d'échantillon divisé - Google Patents

Dispositif de chambre de test d'échantillon divisé Download PDF

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Publication number
WO2008042033A2
WO2008042033A2 PCT/US2007/016660 US2007016660W WO2008042033A2 WO 2008042033 A2 WO2008042033 A2 WO 2008042033A2 US 2007016660 W US2007016660 W US 2007016660W WO 2008042033 A2 WO2008042033 A2 WO 2008042033A2
Authority
WO
WIPO (PCT)
Prior art keywords
sample
test
test chamber
sample solution
sample inlet
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.)
Ceased
Application number
PCT/US2007/016660
Other languages
English (en)
Other versions
WO2008042033A8 (fr
WO2008042033A3 (fr
Inventor
Greg Liang
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.)
Individual
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Publication of WO2008042033A2 publication Critical patent/WO2008042033A2/fr
Publication of WO2008042033A3 publication Critical patent/WO2008042033A3/fr
Publication of WO2008042033A8 publication Critical patent/WO2008042033A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • G01N33/53—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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0605—Metering of fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • B01L2300/0663—Whole sensors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
    • 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
    • B01L2400/0694—Valves, specific forms thereof vents used to stop and induce flow, backpressure valves

Definitions

  • the present invention is related to sample solution testing, particularly related to test devices for testing a portion of a sample solution without contaminating the remaining of the sample solution.
  • Test cup devices for fluid sample collection and testing limits tester exposure and reserves a portion of the collected fluid sample for re-testing (see, e.g. U.S. Pat. Nos. 6,805,838 and 6,616,893). These test cups are capable of collecting large volumes of specimen; however, the collected specimen is in direct contact with the test components and thus become contaminated by the test components. . Such reserved specimens are in many situations considered unsuitable for re-testing. For example, in December 2000, the US Department of Transportation (DOT) released employee drug and alcohol testing rules stating that the original urine sample must be split into two separate containers to allow for retesting—to make sure that the original testing lab did not make an error. US pat. No.
  • DOT US Department of Transportation
  • 6,576,193 discloses a test cup device that connects the sample collection reservoir and a test chamber with a valve.
  • the operator manually manipulates the valve to aliquot a portion of the collected sample solution into the test chamber.
  • This device effectively reserves a clean specimen for re-testing.
  • the operator is exposed to the risk of contacting the fluid specimen when operating the valve.
  • the valve is relatively costly to produce and the valve parts must be precisely made and assembled to prevent sample leakage.
  • the present invention is a test chamber device for splitting a test sample solution, and testing a split portion of the sample solution.
  • the test chamber device comprises a test component enclosed by air impermeable walls having a sample inlet, an air vent, and a means for controlling the permeability of the air vent so as to control liquid inflow through the sample inlet.
  • the test chamber is so structured that when, in a test position, a sample solution is permitted through the sample inlet into the test chamber while the displaced air vacates the test chamber through the vent.
  • the vent is sealed off, the liquid inflow is resisted by the buildup of pressure within the chamber. With the air vent sealed off, liquid exit from the test chamber through the liquid inlet is also resisted due to negative pressure buildup within the chamber.
  • the device keeps the test component from contaminating the exterior of the test chamber or the remaining sample solution.
  • the split sample test chamber is used in combination with a sample container by connecting the sample inlet of the test chamber and the sample solution in the sample container. Such connection is achieved by connecting the sample inlet with the sample container chamber prior or after the sample solution is collected in the sample container.
  • the test chamber can be pre-attached to or constructed in the interior of a cup container or part of a cup container, e.g., a lit of the cup or a sidewall of the cup, or connected to the interior of the cup container through an aperture on a wall or a lid of the cup container.
  • the interior opening of the sample inlet is positioned away from the test component and, when in a test position of the device, e.g., an upright position of a test cup, maintains a higher altitude than the liquid level within the test chamber.
  • the liquid level within the test chamber is controlled by sealing off the air vent before the liquid level reaches the sample inlet.
  • an absorbent material within the test chamber is employed to absorb excess sample solution and reduce liquid level inside the test chamber.
  • the device of the invention is suited for testing sample solutions including, but not limited to, to bodily fluids, environmental water, and liquid extractions of a dry material.
  • Sample solutions including, but not limited to, to bodily fluids, environmental water, and liquid extractions of a dry material.
  • Substances in such sample solutions can be detected include, but not limited to, drugs, infectious pathogens, chemicals, antigens, antibodies, proteins, and enzymes.
  • test components e.g., lateral flow test strips
  • test components e.g., liquid reagents, reagents in dry powder, granules, or tablets
  • test component e.g., liquid reagents, reagents in dry powder, granules, or tablets
  • Figure 1 is a perspective view of a device of the invention.
  • Figure 2 is a perspective view of the transparent inner layer of the device also depicted by figure 1.
  • Figure 3 is a perspective view of the transparent outer layer of the device also depicted by figure 1 and figure 2.
  • Figure 4 is a perspective view of another embodiment of the invention.
  • Figure 5 is a perspective view of a part of the device of Figure 4.
  • Figure 6 is a perspective view of another part of the device of Figure 4.
  • FIG. 1 , figure 2, and figure 3 collectively depict an example test device 100 of the invention, which comprises a split sample test chamber 109 disposed at the bottom 102 and along the side wall 103 of the cup device, comprising a test component 105, liquid inlet 113, and a sealable air vent 125 .
  • the sample collection reservoir 101 is defined by the bottom 102, sidewall 103, and the opening 104 opposing the bottom end 102.
  • the device is constructed by binding an inner layer 107 and an outer layer 108 at the rim areas 115 of the inner layer and 116 of the outer layer.
  • the test component 105 comprises lateral flow test strips 106 attached to the test strip backing area 112 of the inner layer of the test chamber walls.
  • the lateral flow test strip comprises a sample addition end 110 and a test area 111, with the sample addition end of the lateral flow test strip is disposed towards the bottom of the device.
  • the inner layer has a sample inlet aperture 113 proximal to the bottom end of the container that permits liquid flow from the reservoir 101 into the test chamber 109.
  • the test area 111 of the test strip is visible from the outside of the device through a transparent window 114.
  • the bottom 118 of the outer layer 108 comprises an inwardly protruding section 119 forming a curvy space 120 between the protruding section 119 and the side wall 121.
  • a fluid receiving port 124 capable of receiving the fluid released from the container reservoir through the aperture 1 13.
  • an air vent 125 Disposed at the second end 123 of the curvy space is an air vent 125 disposed on the bottom of the outer layer and filled with a porous plug 126.
  • the curvy space 120 constitutes the lower section of the test chamber.
  • the porous plug 126 permits air to flow through and will lose permeability to air or liquid when it is wetted by a sample solution.
  • Such hydraulic seal function of the porous plug can be achieved by controlling the pore size of the plug material, or by incorporating a solid material that becomes viscous when moisturized in a porous material.
  • test strips are attached to the inner layer side wall by an attaching means, e.g., gluing or taping.
  • an attaching means e.g., gluing or taping.
  • the inner layer and the outer layer are coupled to each other by connecting at the rim areas 115 of the inner layer and 116 of the outer layer.
  • a sealing line 117 is disposed at the outer layer rim on the side proximal to the opening. When the two layers are bound together, the sealing line warrants a tight seal between the two layers.
  • Means for binding the two layers include gluing and high frequency welding, which are known to those familiar in such fields.
  • test solution When a sample solution is collected in the test cup, a volume of the sample flows through the inlet 113 into the test chamber 109 while the displaced air exits the test chamber through the air vent. Upon contact, the test solution inside the test chamber will migrate along the test strip to the test area 111, where the test solution reacts with the assay reagents and produces a test signal readable through window 114. The sample flow will reach the air vent area, moisturize the porous plug, and seal off the air vent before the liquid level within the test chamber reaches the level of the sample inlet 113.
  • FIG 4 in conjunction with figure 5 and figure 6 depicts another test chamber device 200 of the invention.
  • Device 200 is a urine test cup device comprising a cup lid assembly 201 comprising a split sample test chamber 202 constructed to a transparent lid part 203.
  • the lid assembly is capable of covering the opening 204 of sample collection cup 205.
  • the test chamber 202 comprises a test component 206 comprising lateral flow test strips 207 enclosed by a plastic base part 208 shaped to form the test chamber when bound to the interior side of the center 208 of the lid part 203.
  • the test chamber comprises a front end 209, a back end 210, an upper side 211, and a lower side 212, a sample inlet 213 and longitudinal space 214 proximal to the lower side of the front end, an air vent 219 filled with a hydraulic sealing air vent plug 220 disposed at the upper side of the front end in contact with the absorbent member 218, and an elevated test component support area 215 proximal to the back end.
  • the lateral flow test strip 207 comprises a sample addition end 216 and a test area 217. The sample addition end 216 of the test strip is disposed towards the front end 209 in fluid connection with a longitudinal absorbent member 218 disposed in the longitudinal space 214.
  • Two legs 221 protruding horizontally from the rim 222 of the lid assembly are disposed at the front end direction of the test chamber.
  • the legs 220 supports and orients the test device in the test position, i.e., with the front end of the test chamber oriented below the back end of the test chamber.
  • the lid assembly 201 When a sample solution is collected in the sample collection cup 205, the lid assembly 201 is securely placed to the opening 204 of the cup and tiled towards the front end of the test chamber to submerge the lower side of the front end of the test chamber in - the sample solution. Consequently, the sample solution flows through the sample inlet into the test chamber.
  • the sample solution is absorbed by the longitudinal absorbent member and the sample addition end of the test strips.
  • the porous plug 220 is moisturized by the sample solution of the absorbent member 218, the air is vent 209 shuts off. Liquid inflow at the sample inlet 211 is resisted. The majority of the sample solution within the test chamber is absorbed by the absorbent member and the lateral test strips. Therefore, liquid outflow from the test chamber or component diffusion into the sample solution in the sample collection cup will. not occur.

Landscapes

  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un dispositif pour tester une solution d'échantillon. Ledit dispositif comporte une chambre de test renfermant un composant de test contenu dans une enveloppe imperméable à l'air ; unr entrée d'échantillon distal du composant de test peut être relié à une solution d'échantillon et peut, dans une position de test, se maintenir à un niveau supérieur au niveau de liquide contenu dans la chambre de test ; un orifice de mise à l'air libre obturable, distal de l'entrée d'échantillon peut permettre à l'air de sortir de la chambre de test lorsqu'une solution d'échantillon s'écoule dans la chambre de test par l'entrée d'échantillon, peut être fermée par des moyens d'étanchéification et peut arrêter l'écoulement d'échantillon entrant par l'entrée d'échantillon lorsque suffisamment de solution d'échantillon s'écoule dans la chambre de test et avant que le niveau du liquide présent dans la chambre de test n'atteigne le niveau de l'entrée d'échantillon. Le dispositif est utile pour tester une partie d'une solution d'échantillon sans contaminer le reste de la solution d'échantillon.
PCT/US2007/016660 2006-07-21 2007-07-24 Dispositif de chambre de test d'échantillon divisé Ceased WO2008042033A2 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US80794606P 2006-07-21 2006-07-21
US60/807,946 2006-07-21
US86557306P 2006-11-13 2006-11-13
US60/865,573 2006-11-13
US78124707A 2007-07-21 2007-07-21
US11/781,247 2007-07-21

Publications (3)

Publication Number Publication Date
WO2008042033A2 true WO2008042033A2 (fr) 2008-04-10
WO2008042033A3 WO2008042033A3 (fr) 2008-07-10
WO2008042033A8 WO2008042033A8 (fr) 2008-08-14

Family

ID=39268938

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/016660 Ceased WO2008042033A2 (fr) 2006-07-21 2007-07-24 Dispositif de chambre de test d'échantillon divisé

Country Status (1)

Country Link
WO (1) WO2008042033A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011116706A1 (fr) * 2010-03-25 2011-09-29 ABON Biopharm (Hangzhou) Co., Ltd Dispositif de détection pour détecter des analytes dans un échantillon liquide
WO2012003805A1 (fr) * 2010-07-09 2012-01-12 万华普曼生物工程有限公司 Dispositif d'inspection de fluide corporel

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050096563A1 (en) * 2003-11-05 2005-05-05 Greg Liang Oral fluid sampling device and method
NZ547175A (en) * 2003-11-14 2009-11-27 Oakville Hong Kong Co Ltd Sample collection cup with integrated sample analysis system

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011116706A1 (fr) * 2010-03-25 2011-09-29 ABON Biopharm (Hangzhou) Co., Ltd Dispositif de détection pour détecter des analytes dans un échantillon liquide
US10073088B2 (en) 2010-03-25 2018-09-11 ABON Biopharm (Hangzhou) Co., Ltd Detection device for detecting analytes in liquid specimen
US11131662B2 (en) 2010-03-25 2021-09-28 Abon Biopharm (Hangzhou) Co., Ltd. Detection device for detecting analytes in liquid specimen
WO2012003805A1 (fr) * 2010-07-09 2012-01-12 万华普曼生物工程有限公司 Dispositif d'inspection de fluide corporel

Also Published As

Publication number Publication date
WO2008042033A8 (fr) 2008-08-14
WO2008042033A3 (fr) 2008-07-10

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