WO1998000703A1 - Bandelette d'analyse integrant une structure retardant l'ecoulement d'un echantillon - Google Patents

Bandelette d'analyse integrant une structure retardant l'ecoulement d'un echantillon Download PDF

Info

Publication number
WO1998000703A1
WO1998000703A1 PCT/US1996/010967 US9610967W WO9800703A1 WO 1998000703 A1 WO1998000703 A1 WO 1998000703A1 US 9610967 W US9610967 W US 9610967W WO 9800703 A1 WO9800703 A1 WO 9800703A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
test strip
flow
retarding
active structure
Prior art date
Application number
PCT/US1996/010967
Other languages
English (en)
Inventor
Gary Krantz
Shuenn-Tzong Chen
Adam Zipp
Joanne Zeng
Original Assignee
Plus Bio, Inc.
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 Plus Bio, Inc. filed Critical Plus Bio, Inc.
Priority to PCT/US1996/010967 priority Critical patent/WO1998000703A1/fr
Publication of WO1998000703A1 publication Critical patent/WO1998000703A1/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
    • G01N33/52—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

Definitions

  • a test strip comprises an active structure with a top surface and a bottom surface.
  • the active structure comprises a first layer having a first porous substrate with a first-layer chemical system impregnated therein, the first-layer chemical system comprising an indicator reagent, and desirably, a reactive reagent.
  • the first layer has a top surface and a bottom surface which forms the bottom surface of the active structure.
  • the test strip further has means for reducing the fraction of red blood cells in a whole blood specimen applied to the top surface of the active structure and percolated therethrough, such that the concentration of red blood cells in a percolate reaching the bottom surface of the active structure is from about 10 to about 90 percent of the concentration of red blood cells in the liquid specimen applied to the top surface of the active structure.
  • An inert backing overlies the top surface of the active structure, and the backing has an aperture therethrough to the active structure.
  • Figure 8 is a graph showing stability of a test strip of the invention.
  • the measurement of the glucose content of the blood is important for diabetics, and its measurement is the preferred utilization of the present invention.
  • the glucose content of the blood can be measured by a technique such as that described in US Patent 4,935,346, whose disclosure is incorporated by reference.
  • a specimen of whole blood is placed into the aperture of a test strip and allowed to react with the reactants provided in a reaction layer.
  • the color change in the reaction layer which is an indicator of the extent of the chemical reaction, is measured optically by reflection from the back side of the test strip in an instrument during a specific time period, 45 seconds in a commercial product, after a change of color is first detected in the reaction layer.
  • the first layer 24 is a hydrophilic, porous material impregnated with a first-layer chemical system.
  • the hydrophilic, porous material of the first layer is preferably a piece of nylon-66 membrane having a thickness of about 0.005-0.0075 inches and lateral dimensions of about 0.3 by 0.6 inches.
  • This porous substrate material is available commercially from Pall Corp. as Biodyne A. This material is made from nylon 66 and has a porosity size of about 5 micrometers.
  • Other operable membranes having porosity sizes of from 0.45 to 5 micrometers include polysulfone membrane such as Thermopor membrane available from Gelman Scientific and polyether sulfone membrane such as Ultrabind membrane available from Gelman Sciences.

Abstract

Une bandelette d'analyse (20) comporte une première couche (24) recouverte d'une couche retardant l'écoulement différentiel (26), laquelle réduit la fraction d'un constituant d'un échantillon liquide que l'on fait passer à travers. Un support inerte (28), pourvu de préférence d'une ouverture (30), recouvre la couche retardant l'écoulement (26). Pour l'analyse d'un échantillon sanguin, la couche retardant l'écoulement (26) est formée de fibres de verre qui réduisent la fraction des érythrocytes dans le percolat, laissant principalement, mais pas uniquement, du plasma dans le percolat. La première couche (24) comprend des produits chimiques réagissant avec un constituant du plasma tel que le glucose dans une réaction mesurable, de préférence une réaction mesurable visuellement. Lors de l'utilisation de cette bandelette d'analyse (20), on place l'échantillon sanguin dans l'ouverture (30) du support (28) et on le fait passer à travers la couche retardant l'écoulement (26) de telle manière qu'une fraction des érythrocytes est éliminée du percolat. Les produits chimiques de la première couche (24) réagissent avec le glucose contenu dans le plasma pour produire une modification qui est visuellement mesurable depuis la face inférieure de la couche active, avec une interférence visuelle réduite due à la coloration rouge du sang entier sur la face inférieure de la couche de réaction.
PCT/US1996/010967 1996-07-03 1996-07-03 Bandelette d'analyse integrant une structure retardant l'ecoulement d'un echantillon WO1998000703A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US1996/010967 WO1998000703A1 (fr) 1996-07-03 1996-07-03 Bandelette d'analyse integrant une structure retardant l'ecoulement d'un echantillon

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1996/010967 WO1998000703A1 (fr) 1996-07-03 1996-07-03 Bandelette d'analyse integrant une structure retardant l'ecoulement d'un echantillon

Publications (1)

Publication Number Publication Date
WO1998000703A1 true WO1998000703A1 (fr) 1998-01-08

Family

ID=22255390

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/010967 WO1998000703A1 (fr) 1996-07-03 1996-07-03 Bandelette d'analyse integrant une structure retardant l'ecoulement d'un echantillon

Country Status (1)

Country Link
WO (1) WO1998000703A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003089938A1 (fr) * 2002-04-17 2003-10-30 Biosafe Medical Technologies, Inc. Methode et dispositif de mesure de l'hematocrite
USRE41309E1 (en) 1997-12-05 2010-05-04 Roche Diagnostics Operations, Inc. Electrochemical biosensor test strip
US7935497B2 (en) 2006-02-23 2011-05-03 Mologic Ltd Protease detection
US8241588B2 (en) 2006-02-23 2012-08-14 Mologic Ltd Binding assay
US8361386B2 (en) 2006-02-23 2013-01-29 Mologic Ltd Enzyme detection

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5135716A (en) * 1989-07-12 1992-08-04 Kingston Diagnostics, L.P. Direct measurement of HDL cholesterol via dry chemistry strips
US5215712A (en) * 1989-09-14 1993-06-01 Terumo Kabushiki Kaisha Apparatus for determination of ion concentration, specific gravity, or osmotic pressure of solution
US5227310A (en) * 1988-12-01 1993-07-13 Kyoto Daiichi Kagaku Co., Ltd. Device and method for assay of liquid sample

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5227310A (en) * 1988-12-01 1993-07-13 Kyoto Daiichi Kagaku Co., Ltd. Device and method for assay of liquid sample
US5135716A (en) * 1989-07-12 1992-08-04 Kingston Diagnostics, L.P. Direct measurement of HDL cholesterol via dry chemistry strips
US5215712A (en) * 1989-09-14 1993-06-01 Terumo Kabushiki Kaisha Apparatus for determination of ion concentration, specific gravity, or osmotic pressure of solution

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE41309E1 (en) 1997-12-05 2010-05-04 Roche Diagnostics Operations, Inc. Electrochemical biosensor test strip
USRE42924E1 (en) 1997-12-05 2011-11-15 Roche Diagnostics Operations, Inc. Electrochemical biosensor test strip
USRE42953E1 (en) 1997-12-05 2011-11-22 Roche Diagnostics Operations, Inc. Electrochemical biosensor test strip
WO2003089938A1 (fr) * 2002-04-17 2003-10-30 Biosafe Medical Technologies, Inc. Methode et dispositif de mesure de l'hematocrite
US7115421B2 (en) * 2002-04-17 2006-10-03 Biosafe Medical Technologies, Inc. Method and device for measurement of hematocrit
US7935497B2 (en) 2006-02-23 2011-05-03 Mologic Ltd Protease detection
US8241588B2 (en) 2006-02-23 2012-08-14 Mologic Ltd Binding assay
US8361386B2 (en) 2006-02-23 2013-01-29 Mologic Ltd Enzyme detection
US8846328B2 (en) 2006-02-23 2014-09-30 Mologic Ltd Method for detecting the presence of a protease enzyme in a sample

Similar Documents

Publication Publication Date Title
US6036919A (en) Diagnostic test carrier with multilayer field
US4994238A (en) Constant volume chemical analysis test device
US5755231A (en) Test strip including integral specimen flow retarding structure
CA1213817A (fr) Cuvette pour la determination analytique des composantes chimiques de fluides
EP0071934B1 (fr) Procédé de préparation d'un élément analytique chromogène de couleur stable
CA2457665C (fr) Methode pour reduire l'effet de l'hematocrite sur le dosage d'un analyte dans le sang total, et trousse et article d'essai utiles pour suivre cette methode
EP0654659B1 (fr) Dispositif d'épreuve de volume déterminé
US6555061B1 (en) Multi-layer reagent test strip
AU696428B2 (en) A method and apparatus for detecting hemolysis in a fluid sample
JP2589053B2 (ja) 分析物測定用試薬試験ストリップ及びその測定方法
KR100490185B1 (ko) 혈중글루코스함량측정용시약시험스트립
CA1114268A (fr) Indicateur de glucose et methode d'utilisation
MXPA97005534A (en) Diagnostic test carrier with multiple layer test field and method in which it is used to determine an analyst or substance going to anali
JPH10505674A (ja) 蛇状ストリップチャンネルを有する分析物検出器
EP0130335B1 (fr) Dispositif de test
US6455001B1 (en) Functional layers of high precision, process for their production and test strips containing these functional layers
NO753773L (fr)
JPH01318963A (ja) 分析物測定用の最少工程システム
EP0041175B2 (fr) Elément analytique à spécificité ionique
EP1271147A1 (fr) Papier reactif
WO1998000703A1 (fr) Bandelette d'analyse integrant une structure retardant l'ecoulement d'un echantillon
US6299838B1 (en) Test apparatus for assaying a component in a liquid sample
WO2002035216A1 (fr) Element analytique a couches multiples et procede de determination d'analytes dans des fluides renfermant des substances interferantes
GB2215045A (en) Process and apparatus for determining the oxygen content of a substance

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): JP

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FI FR GB GR IE IT LU MC NL PT SE

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: JP

Ref document number: 98504061

Format of ref document f/p: F

122 Ep: pct application non-entry in european phase