Source: https://patents.google.com/patent/EP0830206B1/en
Timestamp: 2019-04-26 16:28:03
Document Index: 598224853

Matched Legal Cases: ['art 21', 'art 22', 'art 21', 'art 22', 'arts 21', 'art 22', 'art 21', 'arts 21', 'arts 21', 'art 21', 'art 22', 'art 21', 'art 22', 'art 21', 'art 22', 'art 22', 'art 21', 'art. 29']

EP0830206B1 - Test strip holder and method of use - Google Patents
Test strip holder and method of use Download PDF
EP0830206B1
EP0830206B1 EP19960918803 EP96918803A EP0830206B1 EP 0830206 B1 EP0830206 B1 EP 0830206B1 EP 19960918803 EP19960918803 EP 19960918803 EP 96918803 A EP96918803 A EP 96918803A EP 0830206 B1 EP0830206 B1 EP 0830206B1
EP19960918803
EP0830206A1 (en
Dana H. Mackay
Diagnostic Chemicals Ltd
1995-06-07 Priority to US476036 priority Critical
1995-06-07 Priority to US08/476,036 priority patent/US5656502A/en
1996-06-07 Application filed by Diagnostic Chemicals Ltd filed Critical Diagnostic Chemicals Ltd
1996-06-07 Priority to PCT/IB1996/000650 priority patent/WO1996040434A1/en
1998-03-25 Publication of EP0830206A1 publication Critical patent/EP0830206A1/en
2001-01-24 Publication of EP0830206B1 publication Critical patent/EP0830206B1/en
A test strip holder (1) includes an elongated hollow member (2) having an open end (3) and a closed end (4). A support is provided that positions a test strip (9) within the elongated hollow member (2) spaced from inner walls of the elongated hollow member (2). At least one vent (10) is positioned between the open end (3) and the closed end (4) of the elongated hollow member (2). The distance from the open end (3) to the at least one vent opening (10) defines the maximum height (L1) of liquid able to enter the elongated hollow member (2) from the open end (3) other than by capillary action. The elongated member (2) may be formed as a tubular conduit. Alternatively, the elongated member may include a test strip receiving part (21) and a test strip covering part (22), wherein the test strip receiving part (21) may or may not be hingedly connected to the test strip covering part (22).
This invention relates to a holder for a test strip and a method of using the holder. The test strip holder positions a test strip within a liquid to ensure that liquid contacts and moves up the test strip only by capillary action.
U.S. Patent No. 4,999,285 to Stiso is directed to a chromatographic device. The device comprises, in combination, a housing and a strip of bibulous material non-removably confined in the housing. The strip has a length and width only slightly less than the length and width of the inner walls of the housing. The inner walls of the housing have means attached thereto for supportively confining the strip in the housing. The strip is confined so that (1) the front and back of the strip are essentially free from contact with the walls of the housing and (2) the capillary action of the strip remains substantially unchanged, and (3), where the strip is paper, the strip is allowed to expand as it is traversed by the liquid medium. The bottom end of the housing contains means for enabling contact of a portion of the strip with the liquid medium. The housing further contains means for visually observing the strip and can also contain indicating means cooperative therewith to assist in determining the result of a chromatographic test.
WO 94/02850 is directed to a test device for detecting or measuring analytes in a test sample, which comprises a transparent, impervious, rigid and hollow housing containing an assay test material. The device is constructed such that light can pass through both the housing and assay material. Various assays can be conducted using the device, resulting in an optical change or changes usually based upon the amount of analyte in the test sample, which change is detected visually or by an optical instrument.
U.S. Patent No. 5,135,873 to Patel et al. is directed to methods and devices for permitting capillary flow of liquid between two or more pieces of bibulous material which, prior to actuation, are in a non-capillary flow relationship. In particular, the device is actuated and capillary flow relationship is initiated between the two or more pieces of bibulous material in non-capillary flow relationship by utilizing a liquid expandable piece of bibulous material.
U.S. Patent No. 5,384,264 to Chen et al. is directed to a method and apparatus for performing assays in a single step, which does not require the user to perform a washing step, does not require the user to add any reagent or other solution other than analyte sample fluid to the apparatus, and does not require the user to come into contact with the apparatus at any point during the assay procedure after the fluid suspected of containing a particular ligand is added to the apparatus. The apparatus for performing the assay consists of a single container with at least three ports disposed through different planes in the body of the apparatus beneath which labelled antiligand (the first port), unlabelled antiligand (the second port), and unlabelled ligand (the third port) are disposed. Said labelled antiligand is complementary to both the analyte of interest and the unlabelled ligand, the latter of which serves as a control display for comparison of any color changes mediated by the label visible through the second port. The antiligands and ligands disposed beneath each port are bound to separate membranes. At least the first membrane is bibulous and is disposed at one end of a ramp where, at the top of which, it overlaps the second membrane thus slowing the flow of sample and improving the performance of the assay.
U.S. Patent No. 5,500,375 to Lee-Own et al. is directed to integrated package-holder assay devices for detecting the presence of analyte in a sample. The device serves the dual roles of supporting and protecting an immunochromatographic assay. The device is compatible with any immunochromatographic assay format. The assay can be performed in a single apparatus for use in a laboratory or a field setting. In a specific example, the assay device is a nylon membrane formatted for an immunochromatographic assay sealed between transparent adhesive tape and a stiff plastic strip. White tape placed over the plastic strip defines a window for observing the assay results.
EP 0 560 411 is directed to an analytical test device comprising a hollow casing constructed of moisture-impervious solid material, such as plastic materials, containing a dry porous carrier which communicates indirectly with the exterior of the casing via a bibulous sample receiving member which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier. The carrier contains, in a first zone, a labelled specific binding reagent that is freely mobile within the porous carrier when in the moist state, and in a second zone, spatially distinct from the first zone, unlabelled specific binding reagent for the same analyte, which unlabelled reagent is permanently immobilized on the carrier material and is therefore not mobile in the moist state. The two zones are arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone. The device incorporates means, such as an aperture in the casing, enabling the extent, if any, to which the labelled reagent becomes bound in the second zone to be observed.
U.S. Patent No. 5,356,782 to Moorman et al. is directed to an apparatus useful in carrying out an analytical assay. The apparatus has a positive and negative control, as well as a site for determining the presence, amount, or lack of an analyte in a sample. The apparatus comprises an absorptive material and a plurality of zones in the direction of fluid flow. A first negative control zone of said absorptive material contains an immobilized reactant which does not bind to said analyte of interest. A second analytic control zone of said absorptive material contains an immobilized reactant which specifically binds to said analyte of interest. A third positive control zone of said absorptive material contains both an immobilized reactant which specifically binds to said analyte of interest, and a portion of the analyte of interest in solubilizable form, wherein said portion of the analyte is solubilized when contacted with the liquid sample and reacts with the immobilized reactant of said third zone.
The invention provides a reliable test strip holder and method of use of the test strip holder. The test strip holder can be inserted into any depth in a liquid to be tested and left in the liquid with testing zones of the test strip out of direct contact with the liquid. The tester is not required to continuously monitor the insertion depth of the test strip. The test strip holder maintains the test strip spaced from the sides of the test strip holder, wherein the liquid flows up the test strip by capillary action within the strip only. The test strip is not wetted by liquid on the inner walls of the elongated hollow member. This avoids premature contact of the test strip with the liquid and unreliable testing results.
The invention provides a test strip holder and method of use that overcomes the problems associated with known test strip holders and methods especially that of US Patent 4 999 285 which represents the closest prior art. The test strip holder accurately positions a test strip in a liquid so liquid travels up the test strip only by capillary action of the strip and liquid.
The invention provides a test strip holder or holding apparatus having the features of claim 1 and a method of use having the features of claim 17.
Embodiments of the invention will be described in detail with reference to the following drawings in which like reference numerals refer to like elements and wherein:
Fig. 2 is a cross-sectional view along line II-II of Figure 1;
Fig. 7 is a cut away top sectional view of the test strips holder of Fig. 4;
Fig. 10 is a front view of the test strip holder in a closed condition of Fig. 9.
The elongated hollow member of the holder may be formed with a rounded cross-section, for example, as a tubular conduit. Alternatively, the elongated hollow member may be formed as two separate mateable parts, which are sealed around their periphery. The elongated hollow member may be formed in other configurations, as long as the elongated hollow member defines an open end and a sealed closed end with at least one vent positioned between the open and closed ends. The position of the at least one vent in the elongated hollow member can be varied to vary the depth of immersion of the test strip.
The support structure may take any form appropriate complementary to the test strip holder, as long as the test strip is maintained spaced from the walls of the elongated hollow member. This prevents the test strip zones from being contacted by any liquid on the sidewalls of the elongated hollow member. Liquid normally flows by capillary action in a path of "least resistance." Contact between the test strip and the sidewalls of the test strip holder creates a low resistance capillary channel and provides a "short circuit" for the liquid up the edges of the test strip, thereby bypassing a front surface of the test strip. This can lead to erroneous and unreliable results.
The operation of the test strip holder will now be discussed, with reference to Figures 3A-3C. Initially, the test strip holder 1 is inserted into a container C holding the liquid L to be tested. Upon initial contact of the test strip holder 1 with the liquid L, the liquid L enters the open end 3 of the elongated hollow member 2 through the through passage 7 in the open rubber plug 6. Air within the elongated hollow member 2 is displaced up and exits the interior of the elongated hollow member 2 through the vents 10, as indicated by vent path A.
A second embodiment of the test strip holder 1', is shown in Figures 4-8C. Here, an elongated hollow member 20 is formed by a test strip receiving part 21, which positions the test strip, and a test strip covering part 22. The test strip receiving part 21 and the test strip covering part 22 are connected at hinge 23. The parts 21, 22 are hinged together so the test strip covering part 22 closes onto the strip receiving part 21 to define the elongated hollow member 20. While the hinge 23 is shown parallel to a longitudinal axis of the parts 21, 22, the hinge could be provided parallel to an axis transverse to the parts 21, 22.
Further, the test strip may include a sample pad 34, and conjugate pad under the sample pad and a wicking pad 35 contacting the membrane 33. A piece of white opaque waterproof tape (not shown) may be applied over the sample pad 34 and a part of the membrane 33. The opaque waterproof tape masks the test strip 9 during development. The tape also eliminates confusion regarding the location of the zones Z1, Z2 during testing. The tape applies pressure to the sample pad 34 and to the underlying conjugate pad to facilitate the liquid's flow up the test strip 9. The tape protects the test strip 9 during manufacturing and during insertion of the test strip 9 into the test strip holder 1,1' or 1".
Test strip zones Z1, Z2 determine the presence of certain substances. The number of test strip zones is not limited to two, and any number of test strip zones Z1, Z2 may be provided. Further, any test strip 9 may be used with the test strip holders 1,1' or 1". The type of test strip 9 may be changed, as needed, for the specified compound that the test is designed to discover.
Suitable test strips 9 include strips of material impregnated with compounds, which react with other compounds, normally in a liquid. The reaction may , for example, cause a change in color of the impregnated strip, where the change in color is representative of the concentration of the compounds in the liquid. Examples of such strips are pH strips; pregnancy test strips; immunoassay test strips; antigen, antibody and polynucleotide test strips; and test strips of analytes, such as drugs, metabolites, pesticides, pollutants and the like. The above types of test strips are only examples and any other suitable test strip may be used in the test strip holder 1, 1' or 1". A detailed discussion of examples of suitable test strips appears in U.S. Patent No. 4,857,453. U.S. Patent No. 4,857,453 to Ullman et al. is directed to a device for conducting an assay method. The device comprises a housing, means enclosed in the housing for capturing a member of a specific binding pair in a zone and for allowing liquid to be transported by capillary action away from the zone, one or more self-contained liquid reagents enclosed in the housing for conducting an assay method for the determination of an analyte in the sample, and means in the housing for introducing the sample into the device. Preferably, the self-contained reagents are liquid reagents which are contained in a breakable container. The device of the invention finds use in assay methods for the determination of an analyte in a sample suspected of containing the analyte.
Figures 8A-8C show the immersion of the test strip holder 1' into a liquid L in a container C. Upon initial contact of the test strip holder 1' with the liquid L, the liquid L enters the open end 29 of the elongated hollow member 20. The air within the elongated hollow member 20 is displaced through the vent 42, as indicated by vent path B. Upon further insertion of the test strip holder 1' into the liquid L, the liquid L rises within the elongated hollow member 20. When the elongated hollow member 20 is immersed in the liquid L up to level L1 and covering the vent 42, the vent path B is no longer open to air. Therefore, the pressure within the remainder portion of the elongated hollow member 20 increases. Liquid L is thereby prevented from further entering the elongated hollow member 20.
The test strip 9 is in contact with the liquid L only in a predetermined designated area, designed for direct contact with the liquid. The position of the vent 42 on the sidewall of the elongated hollow member 20 determines the maximum height that the liquid L can actually enter the elongated hollow member 20. The actual test strip test zones Z1,Z2 are preferably not in direct contact with the liquid L and are wetted only by capillary action of the liquid on the test strip 9.
Figures 9 and 10 illustrate a third embodiment of the test strip holder. The test strip holder 1'' is similar in construction to the second embodiment and similar elements are designated with similar, but primed, reference characters.
The test strip holder 1'' includes an elongated hollow member 20'', which is formed from a test strip receiving part 21'', which positions the test strip, and a test strip covering part 22''. Unlike the second embodiment, the test strip receiving part 21'' and the test strip covering part 22'' are not hingedly connected and are separate components before being brought together to form the elongated hollow member 20''.
In the embodiment of Figs. 9 and 10, the test strip receiving part 21'' includes a planar surface 21A, which is spaced from a test strip receiving channel 26''. The test strip covering part 22'' includes a mating planar surface 22A, which is formed in a shape and size complementary to the planar surface 21A. When the test strip covering part 22'' is brought into overlying relation to the test strip receiving part 21'', the planar surfaces 21A,22A mate together. The surfaces can then be sealingly joined together by an appropriate method of connection, such as sealing by ultrasonic welding, rf (radio frequency) welding, plasma welding, adhesive or the like.
A test strip holding apparatus, comprising:
an elongated hollow member having an open end and a closed end;
a support configured to hold a test strip within the elongated hollow member in a position spaced from inner walls of the elongated hollow member; and
one or more vents positioned between the open end and the closed end,
characterized in that said one or more vents are positioned at the same distance from said open end to vent the elongated hollow member at a distance from the closed end and to limit, by air pressure in the closed end, which is air tight sealed, the maximum height that a liquid can travel through said elongated hollow member from said open end toward said close end other than by capillary force along a test strip held on said support when said opened is dipped into said liquid.
The apparatus according to claim 1, characterized in that said one or more vents comprise a plurality of vents.
An apparatus according to claim 1, characterized in that the elongated hollow member has a circular cross-section.
An apparatus according to claim 1, characterized in that the closed end is formed by walls of the elongated hollow member.
An apparatus according to claim 1, characterized in that the closed end is closed by a sealing plug.
An apparatus according to claim 1, characterized in that the open end includes a plug having a through passage inserted into the open end of the elongated hollow member.
An apparatus according to claim 6, characterized in that the plug defines at least a portion of the support.
An apparatus according to claim 6, characterized in that the through passage has a diameter substantially equivalent to the width of the test strip to frictionally support the test strip within the through passage of the plug, spaced from inner walls of the elongated hollow member.
An apparatus according to claim 1, further including a test strip held by the support.
An apparatus according to claim 1, characterized in that the elongated hollow member includes a test strip receiving part and a test strip covering part, wherein the test strip receiving part is connectable to the test strip covering part.
An apparatus according to claim 10, characterized in that the elongated hollow member includes a test strip receiving part, including a flat surface and a test strip covering part including another flat surface complementary with the flat surface, wherein the flat surface and the another flat surface are sealed together.
An apparatus according to claim 10, characterized in that one of the test strip covering part and the test strip receiving part includes a groove and the other of the test strip covering part and the test strip receiving part includes aprojection, the projection being configured to sealingly fit into the groove, wherein the groove and projection fit together to define the elongated hollow member.
An apparatus according to claim 10, characterized in that the test strip receiving part includes a test strip channel configured to receive the test strip, the support being located within the test strip channel.
An apparatus according to claim 13, further including a stop proximate the open end capable of maintaining the test strip within the test strip channel.
An apparatus according to claim 13, characterized in that the channel comprises a center planar support surface surrounded by raised side portions that constrain movement of a test strip.
An apparatus according to claim 10, characterized in that said one or more vents are formed in the test strip covering part.
A method of testing a liquid using a test strip within a test strip holder, the method comprising the steps of: ,
supporting a test strip within an elongated hollow member having an open end, a closed end and a sidewall with one or more vents in the sidewall between the open end and the closed end, the test strip being spaced from inner walls of the elongated hollow member;
immersing the elongated hollow member into a liquid to be tested to at least a depth of the one or more vents, characterized in that said one or more vents are positioned at the same distance from said open end to vent the elongated hollow member at a distance from the closed end and to limit, by air pressure in the closed end, which is air tight sealed, the maximum height that said liquid travels through said elongated hollow member from said open end toward said closed end other than by capillary force along said test strip when said open end is dipped into said liquid up to and covering said one or more vents, thereby allowing the liquid to enter said hollow member only up to the level of said vent; and
observing an effect of the liquid on the test strip above said one or more vents .
The method according to claim 17, characterized in that the step of supporting the test strip includes frictionally supporting the test strip at a portion of the elongated hollow member where liquid enters.
The method according to claim 17, characterized in that the step of supporting the test strip includes supporting the test strip at a plurality of locations.
The method according to claim 17, characterized in that liquid travels up the test strip only by capillary action within the test strip.
EP19960918803 1995-06-07 1996-06-07 Test strip holder and method of use Expired - Lifetime EP0830206B1 (en)
US476036 1995-06-07
US08/476,036 US5656502A (en) 1995-06-07 1995-06-07 Test strip holder and method of use
PCT/IB1996/000650 WO1996040434A1 (en) 1995-06-07 1996-06-07 Test strip holder and method of use
EP0830206A1 EP0830206A1 (en) 1998-03-25
EP0830206B1 true EP0830206B1 (en) 2001-01-24
ID=23890237
EP19960918803 Expired - Lifetime EP0830206B1 (en) 1995-06-07 1996-06-07 Test strip holder and method of use
US (1) US5656502A (en)
EP (1) EP0830206B1 (en)
JP (1) JP3042544B2 (en)
AT (1) AT198842T (en)
AU (1) AU6134996A (en)
DE (2) DE69611672T2 (en)
WO (1) WO1996040434A1 (en)
US7172873B2 (en) 2001-03-28 2007-02-06 Heska Corporation Methods of detecting early renal disease in animals
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
WO2004063084A2 (en) * 2003-01-06 2004-07-29 Nutri-Check Technologies, Llc Individual need-based system for providing supplements
US20120199506A1 (en) * 2011-02-03 2012-08-09 Beach Thomas A Apparatus and method for protecting mounted almen strips
CA2869899A1 (en) 2012-03-28 2013-10-03 The United States Of America, As Represented By The Secretary, Department Of Health And Human Services A novel interferon-.lambda.4 (ifnl4) protein, related nucleic acid molecules, and uses thereof
US9222891B1 (en) 2014-06-26 2015-12-29 Industrial Test Systems, Inc. Reflectometry apparatus and method
WO1994002850A1 (en) * 1992-07-21 1994-02-03 Medix Biotech, Inc. Transparent assay test devices and methods
1995-06-07 US US08/476,036 patent/US5656502A/en not_active Expired - Fee Related
1996-06-07 JP JP50026997A patent/JP3042544B2/en not_active Expired - Fee Related
1996-06-07 AT AT96918803T patent/AT198842T/en not_active IP Right Cessation
1996-06-07 DE DE1996611672 patent/DE69611672T2/en not_active Expired - Lifetime
1996-06-07 AU AU61349/96A patent/AU6134996A/en not_active Abandoned
1996-06-07 WO PCT/IB1996/000650 patent/WO1996040434A1/en active IP Right Grant
1996-06-07 DE DE1996611672 patent/DE69611672D1/en not_active Expired - Fee Related
1996-06-07 EP EP19960918803 patent/EP0830206B1/en not_active Expired - Lifetime
JPH11504717A (en) 1999-04-27
US5656502A (en) 1997-08-12
EP0830206A1 (en) 1998-03-25
AT198842T (en) 2001-02-15
DE69611672T2 (en) 2001-09-06
DE69611672D1 (en) 2001-03-01
JP3042544B2 (en) 2000-05-15
AU6134996A (en) 1996-12-30
WO1996040434A1 (en) 1996-12-19
US6805837B2 (en) 2004-10-19 Assaying device and method for in field urinalysis
CA2478608C (en) 2011-06-28 Apparatus and methods for analyte measurement and immunoassay
JP3498201B2 (en) 2004-02-16 A suction pressure generating device and sample analyzer using the same
ES2374541T3 (en) 2012-02-17 Test element for the analysis of body fluids.
2001-01-24 PG25 Lapsed in a contracting state announced via postgrant inform. from nat. office to epo
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2001-04-06 ITF It: translation for a ep patent filed
2001-04-24 PG25 Lapsed in a contracting state announced via postgrant inform. from nat. office to epo
2001-04-27 PG25 Lapsed in a contracting state announced via postgrant inform. from nat. office to epo
2001-07-02 NLV1 Nl: lapsed or annulled due to failure to fulfill the requirements of art. 29p and 29m of the patents act