公开(公告)号：WO0184153A3

公开(公告)日：2002-07-11

申请号：PCT/US0111773

申请日：2001-04-11

Applicant: IDEXX LAB INC

Inventor： CLARK SCOTT M ,  SUVA ROBERT H ,  KEPRON MICHAEL R ,  BARSKI STANISLAW JR ,  WORKMAN ERWIN F JR

IPC: G01N33/566 ,  C12M1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00

CPC classification number: G01N33/558 ,  G01N33/54366 ,  Y10T436/11 ,  Y10T436/12 ,  Y10T436/255

Abstract: Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flow path delivers the analyte of interest (if present in the sample) and conjugate soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, and optionally to deliver detection reagents.

Abstract translation: 用于进行测定以确定流体样品中感兴趣的特定分析物的存在或数量的装置和方法。 在根据本发明的设备中，在具有单个用户激活步骤的设备中依次建立两个单独的流路径。 第一流路传送感兴趣的分析物（如果存在于样品中）并将可溶性结合试剂与固相结合。 如果存在分析物，则形成并固定分析物：缀合物。 由该第一路径输送的样品的体积由固相的吸收能力确定，而不是通过添加到装置中的样品的量来确定，从而减轻了用户不必测量样品的量。 由于毛细管力和第二流路的表面能阻止其被该混合物润湿，因此防止样品/共轭物混合物进入第二流动路径。 第二流动路径允许洗涤剂将未结合的结合物和样品从固相除去到吸收剂，并且任选地递送检测试剂。

公开(公告)号：EP0600929A4

公开(公告)日：1996-01-17

申请号：EP92916533

申请日：1992-07-31

Applicant: IDEXX LAB INC

Inventor： CLARK SCOTT M

IPC: G01N33/538 ,  B01L3/00 ,  G01N30/02 ,  G01N30/40 ,  G01N30/90 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00 ,  C12Q1/00

CPC classification number: G01N33/558 ,  B01L3/5023 ,  B01L3/5055 ,  B01L2300/0663 ,  B01L2300/0672 ,  B01L2400/0677 ,  B01L2400/0683 ,  G01N30/02 ,  G01N30/40 ,  G01N30/90 ,  Y10S435/805 ,  Y10S435/81 ,  Y10S435/97 ,  Y10S435/974 ,  Y10S435/975 ,  Y10S436/805 ,  Y10S436/807 ,  Y10S436/809 ,  Y10S436/81 ,  B01D15/3804

Abstract: Disclosed are devices and methods for performing an assay which determines the presence or quantity of an analyte in a fluid sample by detecting binding of the analyte to at least one immobilized analyte capture reagent and washing unbound material from the immobilized analyte capture reagent. The devices and methods involve an elongated solid phase flow matrix, including capillary channels capable of driving capillary fluid movement, and further including (i) a first region adapted for receipt of the fluid sample, (ii) a second region at which the analyte capture reagent is immobilized, (iii) a third region for application of a wash reagent capable of removing unbound substances from the second region; and (iv) an absorbent reservoir of high volume capacity. The second region is positioned intermediate to the first region and the third region and intermediate to the absorbent reservoir and the third region. The device also includes means to detect analyte bound at the second region. The flow matrix and the regions thereof are sized and positioned to cause the fluid sample to flow initially along the elongated flow matrix in one direction toward and through the second region, and subsequently, the liquid reagent to flow along the elongated flow matrix in a second direction opposite the first direction, through the second region, and into the absorbent reservoir, drawing unbound substances with it.

公开(公告)号：AU2001253354B2

公开(公告)日：2005-05-26

申请号：AU2001253354

申请日：2001-04-11

Applicant: IDEXX LAB INC

Inventor： BARSKI STANISLAW JR ,  KEPRON MICHAEL R ,  SUVA ROBERT H ,  CLARK SCOTT M ,  WORKMAN ERWIN F JR

IPC: G01N33/566 ,  C12M1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00 ,  G01N033/543

Abstract: Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flow path delivers the analyte of interest (if present in the sample) and conjugate soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, and optionally to deliver detection reagents. The invention may be adapted to many assay formats including, sandwich immunoassays, colloidal gold, or sol particle assays, heterogeneous generic capture assays and competitive assays. In one embodiment, sandwich assays can be performed by immobilizing an analyte binding reagent on the solid phase, and drying a labeled analyte binding reagent in the first flow path. In a competitive assay embodiment, the first flow path would contain labeled analyte that is dissolved by the sample, and the analyte binding reagent is immobilized on the solid phase. In each of these embodiments, the assay can be further modified to run in a "generic capture" format, where the solid phase binding reagent is instead conjugated to a generic ligand such as biotin, and dried in the first flow path (either together or separately from the other assay reagents), and a generic ligand binding reagent (such as avidin) is immobilized on the solid phase. Another aspect of the present invention includes a subassembly for the immunoassay device that is comprised of a plastic housing and a means for delivering fluid and/or wash solution. This subassembly comprises a structure formed from a hydrophobic polymer selectively treated with a water insoluble surface active agent that has been applied as a solution in an organic solvent rendering portions of the surface hydrophilic. When the surface is contacted with an aqueous liquid, it flows only along the treated areas, creating a defined fluid flow path, thereby delivering sample/conjugate solutions to said solid phase.

公开(公告)号：AU5335401A

公开(公告)日：2001-11-12

申请号：AU5335401

申请日：2001-04-11

Applicant: IDEXX LAB INC

Inventor： CLARK SCOTT M ,  SUVA ROBERT H ,  KEPRON MICHAEL R ,  BARSKI STANISLAW JR ,  WORKMAN ERWIN F JR

IPC: G01N33/566 ,  C12M1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00

Abstract: Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flow path delivers the analyte of interest (if present in the sample) and conjugate soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, and optionally to deliver detection reagents. The invention may be adapted to many assay formats including, sandwich immunoassays, colloidal gold, or sol particle assays, heterogeneous generic capture assays and competitive assays. In one embodiment, sandwich assays can be performed by immobilizing an analyte binding reagent on the solid phase, and drying a labeled analyte binding reagent in the first flow path. In a competitive assay embodiment, the first flow path would contain labeled analyte that is dissolved by the sample, and the analyte binding reagent is immobilized on the solid phase. In each of these embodiments, the assay can be further modified to run in a "generic capture" format, where the solid phase binding reagent is instead conjugated to a generic ligand such as biotin, and dried in the first flow path (either together or separately from the other assay reagents), and a generic ligand binding reagent (such as avidin) is immobilized on the solid phase. Another aspect of the present invention includes a subassembly for the immunoassay device that is comprised of a plastic housing and a means for delivering fluid and/or wash solution. This subassembly comprises a structure formed from a hydrophobic polymer selectively treated with a water insoluble surface active agent that has been applied as a solution in an organic solvent rendering portions of the surface hydrophilic. When the surface is contacted with an aqueous liquid, it flows only along the treated areas, creating a defined fluid flow path, thereby delivering sample/conjugate solutions to said solid phase.

公开(公告)号：CA2406724A1

公开(公告)日：2001-11-08

申请号：CA2406724

申请日：2001-04-11

Applicant: IDEXX LAB INC

Inventor： WORKMAN ERWIN F JR ,  BARSKI STANISLAW JR ,  CLARK SCOTT M ,  SUVA ROBERT H ,  KEPRON MICHAEL R

IPC: G01N33/566 ,  C12M1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00

Abstract: Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flo w path delivers the analyte of interest (if present in the sample) and conjuga te soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, a nd optionally to deliver detection reagents.

公开(公告)号：CA2113351A1

公开(公告)日：1993-02-18

申请号：CA2113351

申请日：1992-07-31

Applicant: IDEXX LAB INC

Inventor： CLARK SCOTT M

IPC: G01N33/538 ,  B01L3/00 ,  G01N30/02 ,  G01N30/40 ,  G01N30/90 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00 ,  G01N33/569

Abstract: 2113351 9303176 PCTABS00019 Disclosed are devices and methods for performing an assay which determines the presence or quantity of an analyte in a fluid sample by detecting binding of the analyte to at least one immobilized analyte capture reagent and washing unbound material from the immobilized analyte capture reagent. The devices and methods involve an elongated solid phase flow matrix, including capillary channels capable of driving capillary fluid movement, and further including (i) a first region adapted for receipt of the fluid sample, (ii) a second region at which the analyte capture reagent is immobilized, (iii) a third region for application of a wash reagent capable of removing unbound substances from the second region; and (iv) an absorbent reservoir of high volume capacity. The second region is positioned intermediate to the first region and the third region and intermediate to the absorbent reservoir and the third region. The device also includes means to detect analyte bound at the second region. The flow matrix and the regions thereof are sized and positioned to cause the fluid sample to flow initially along the elongated flow matrix in one direction toward and through the second region, and subsequently, the liquid reagent to flow along the elongated flow matrix in a second direction opposite the first direction, through the second region, and into the absorbent reservoir, drawing unbound substances with it.

公开(公告)号：AU2001253354B9

公开(公告)日：2005-11-03

申请号：AU2001253354

申请日：2001-04-11

Applicant: IDEXX LAB INC

Inventor： BARSKI STANISLAW JR ,  KEPRON MICHAEL R ,  CLARK SCOTT M ,  WORKMAN ERWIN F JR ,  SUVA ROBERT H

IPC: G01N33/566 ,  C12M1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00 ,  G01N033/543

Abstract: Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flow path delivers the analyte of interest (if present in the sample) and conjugate soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, and optionally to deliver detection reagents. The invention may be adapted to many assay formats including, sandwich immunoassays, colloidal gold, or sol particle assays, heterogeneous generic capture assays and competitive assays. In one embodiment, sandwich assays can be performed by immobilizing an analyte binding reagent on the solid phase, and drying a labeled analyte binding reagent in the first flow path. In a competitive assay embodiment, the first flow path would contain labeled analyte that is dissolved by the sample, and the analyte binding reagent is immobilized on the solid phase. In each of these embodiments, the assay can be further modified to run in a "generic capture" format, where the solid phase binding reagent is instead conjugated to a generic ligand such as biotin, and dried in the first flow path (either together or separately from the other assay reagents), and a generic ligand binding reagent (such as avidin) is immobilized on the solid phase. Another aspect of the present invention includes a subassembly for the immunoassay device that is comprised of a plastic housing and a means for delivering fluid and/or wash solution. This subassembly comprises a structure formed from a hydrophobic polymer selectively treated with a water insoluble surface active agent that has been applied as a solution in an organic solvent rendering portions of the surface hydrophilic. When the surface is contacted with an aqueous liquid, it flows only along the treated areas, creating a defined fluid flow path, thereby delivering sample/conjugate solutions to said solid phase.

公开(公告)号：CA2113351C

公开(公告)日：2005-09-27

申请号：CA2113351

申请日：1992-07-31

Applicant: IDEXX LAB INC

Inventor： CLARK SCOTT M

IPC: G01N33/538 ,  B01L3/00 ,  G01N30/02 ,  G01N30/40 ,  G01N30/90 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00 ,  G01N33/569

Abstract: Disclosed are devices and methods for performing an assay which determines t he presence or quantity of an analyte in a fluid sample by detecting binding of the analyze to at least one immobilized analyze capture reagent and washing unbound mate- rial from the immobilized analyze capture reagent. The devices and methods involve an elongated solid phase flow matrix, includ- ing capillary channels capable of driving capillary fluid movement, and further including (i) a first region adapted for receipt of the fluid sample, (ii) a second region at which the analyze capture reagent is immobilized, (iii) a third region for application of a wash reagent capable of removing unbound substances from the second region; and (iv) an absorbent reservoir of high volume capacity. The second region is positioned intermediate to the first region a nd the third region and intermediate to the absorbent reservoir and the third region. The device also includes means to detect analyze bound at the second region. The flow matrix and the regions thereof are sized and positioned to cause the fluid sample to fl ow initially along the elongated flow matrix in one di- rection toward and through the second region, and subsequently, the liquid reagent to flow along the elongated flow matrix in a second direction opposite the first direction, through the second region, an d into the absorbent reservoir, drawing unbound sub- stances with it.

公开(公告)号：AU2001253354B8

公开(公告)日：2005-09-22

申请号：AU2001253354

申请日：2001-04-11

Applicant: IDEXX LAB INC

Inventor： BARSKI STANISLAW JR ,  KEPRON MICHAEL R ,  SUVA ROBERT H ,  CLARK SCOTT M ,  WORKMAN ERWIN F JR

IPC: G01N33/566 ,  C12M1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00 ,  G01N033/543

Abstract: Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flow path delivers the analyte of interest (if present in the sample) and conjugate soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, and optionally to deliver detection reagents. The invention may be adapted to many assay formats including, sandwich immunoassays, colloidal gold, or sol particle assays, heterogeneous generic capture assays and competitive assays. In one embodiment, sandwich assays can be performed by immobilizing an analyte binding reagent on the solid phase, and drying a labeled analyte binding reagent in the first flow path. In a competitive assay embodiment, the first flow path would contain labeled analyte that is dissolved by the sample, and the analyte binding reagent is immobilized on the solid phase. In each of these embodiments, the assay can be further modified to run in a "generic capture" format, where the solid phase binding reagent is instead conjugated to a generic ligand such as biotin, and dried in the first flow path (either together or separately from the other assay reagents), and a generic ligand binding reagent (such as avidin) is immobilized on the solid phase. Another aspect of the present invention includes a subassembly for the immunoassay device that is comprised of a plastic housing and a means for delivering fluid and/or wash solution. This subassembly comprises a structure formed from a hydrophobic polymer selectively treated with a water insoluble surface active agent that has been applied as a solution in an organic solvent rendering portions of the surface hydrophilic. When the surface is contacted with an aqueous liquid, it flows only along the treated areas, creating a defined fluid flow path, thereby delivering sample/conjugate solutions to said solid phase.

公开(公告)号：ES2145745T3

公开(公告)日：2000-07-16

申请号：ES92916533

申请日：1992-07-31

Applicant: IDEXX LAB INC

Inventor： CLARK SCOTT M

IPC: B01L3/00 ,  G01N30/02 ,  G01N30/40 ,  G01N30/90 ,  G01N33/538 ,  G01N33/543 ,  G01N33/558 ,  G01N37/00 ,  C12Q1/00 ,  G01N33/569

Abstract: Disclosed are devices and methods for performing an assay which determines the presence or quantity of an analyte in a fluid sample by detecting binding of the analyte to at least one immobilized analyte capture reagent and washing unbound material from the immobilized analyte capture reagent. The devices and methods an elongated solid phase flow matrix, including capillary channels capable of driving capillary fluid movement, and further including (i) a first region adapted for receipt of the fluid sample, (ii) a second region at which the analyte capture reagent is immobilized, (iii) a third region for application of a wash reagent capable of removing unbound substances from the second region; and (iv) an absorbent reservoir of high volume capacity. The second region is positioned intermediate to the first region and the third region and intermediate to the absorbent reservoir and the third region. The device also includes means to detect analyte bound at the second region. The flow matrix and the regions thereof are sized and positioned to cause the fluid sample to flow initially along the elongated flow matrix in one direction toward and through the second region, and subsequently, the liquid reagent to flow along the elongated flow matrix in a second direction opposite the first direction, through the second region, and into the absorbent reservoir, drawing unbound substances with it.