CA2334269A1 - Diagnostic assay requiring a small sample of biological fluid - Google Patents

Diagnostic assay requiring a small sample of biological fluid Download PDF

Info

Publication number
CA2334269A1
CA2334269A1 CA002334269A CA2334269A CA2334269A1 CA 2334269 A1 CA2334269 A1 CA 2334269A1 CA 002334269 A CA002334269 A CA 002334269A CA 2334269 A CA2334269 A CA 2334269A CA 2334269 A1 CA2334269 A1 CA 2334269A1
Authority
CA
Canada
Prior art keywords
sample
optical reading
opening
reading chamber
layer
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.)
Granted
Application number
CA002334269A
Other languages
French (fr)
Other versions
CA2334269C (en
Inventor
Sie Ting Wong
Robert G. Hiltibran
Tung-Ming Huang
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.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
Sie Ting Wong
Robert G. Hiltibran
Tung-Ming Huang
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22253133&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2334269(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Abbott Laboratories, Sie Ting Wong, Robert G. Hiltibran, Tung-Ming Huang filed Critical Abbott Laboratories
Publication of CA2334269A1 publication Critical patent/CA2334269A1/en
Application granted granted Critical
Publication of CA2334269C publication Critical patent/CA2334269C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54373Apparatus specially adapted for solid-phase testing involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302Apparatus specially adapted for immunological test procedures
    • G01N33/5304Reaction vessels, e.g. agglutination plates

Abstract

An article and a method for monitoring the concentration of glucose in blood. In one aspect, the invention involves an article comprising a multiple-layer element utilizing reagents capable of reacting with an analyte of interest. In a prefered embodiment, the element comprises: (a) a core layer having two major surfaces, an optical reading chamber extending from a first opening in one of said two major surfaces to a second opening in the other of said two major surfaces, said core layer further having a third opening therein and a flow channel, one end of which flow channel communicates with the third opening and the other end of which flow channel communicates with the optical reading chamber; and (b) a base layer in face-to-face contact with one major surface of said core layer; and (c) a cover layer in face-to-face contact with the other major surface of said core layer, said cover layer having an opening therein to vent the element. In this embodiment, the optical reading chamber extends completely through the core layer. The sample is introduced into the third opening and then flows through the flow channel into the optical reading chamber. The reagents with which the analyte in the sample reacts to form an optically detectable reaction product can be disposed in the optical reading chamber or can be added to the sample before the sample enters the optical reading chamber. In another aspect, the invention involves a method comprising the steps of:
(a) obtaining a sample of biological fluid, e.g., interstitial fluid, from the body of a patient; (b) introducing the sample to article comprising a multiple-layer element having an optical reading chamber, (c) allowing reagents to react with an analyte of interest in the sample; and (d) measuring the concentration of analyte in the sample by means of an optical instrument.
CA002334269A 1998-06-10 1999-06-03 Diagnostic assay requiring a small sample of biological fluid Expired - Lifetime CA2334269C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/095,683 US6077660A (en) 1998-06-10 1998-06-10 Diagnostic assay requiring a small sample of biological fluid
US09/095,683 1998-06-10
PCT/US1999/012294 WO1999064620A2 (en) 1998-06-10 1999-06-03 Diagnostic assay requiring a small sample of biological fluid

Publications (2)

Publication Number Publication Date
CA2334269A1 true CA2334269A1 (en) 1999-12-16
CA2334269C CA2334269C (en) 2008-08-19

Family

ID=22253133

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002334269A Expired - Lifetime CA2334269C (en) 1998-06-10 1999-06-03 Diagnostic assay requiring a small sample of biological fluid

Country Status (10)

Country Link
US (1) US6077660A (en)
EP (1) EP1102991B1 (en)
JP (1) JP2003534526A (en)
AT (1) ATE227848T1 (en)
AU (1) AU766762B2 (en)
CA (1) CA2334269C (en)
DE (2) DE69903954T2 (en)
ES (1) ES2187165T3 (en)
IT (1) ITMI20070307U1 (en)
WO (1) WO1999064620A2 (en)

Families Citing this family (63)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3694424B2 (en) * 1998-09-29 2005-09-14 松下電器産業株式会社 Glucose sensor
US6704587B1 (en) * 1999-04-01 2004-03-09 Spectrx, Inc. Dual function assay device
US6334851B1 (en) * 1999-05-10 2002-01-01 Microfab Technologies, Inc. Method for collecting interstitial fluid from the skin
US20050103624A1 (en) 1999-10-04 2005-05-19 Bhullar Raghbir S. Biosensor and method of making
DE60024965T2 (en) 1999-10-05 2006-07-13 Matsushita Electric Industrial Co., Ltd., Kadoma GLUCOSE SENSOR
US6612111B1 (en) * 2000-03-27 2003-09-02 Lifescan, Inc. Method and device for sampling and analyzing interstitial fluid and whole blood samples
US6540675B2 (en) * 2000-06-27 2003-04-01 Rosedale Medical, Inc. Analyte monitor
US7326564B2 (en) 2001-02-20 2008-02-05 St. Jude Medical, Inc. Flow system for medical device evaluation and production
US7004928B2 (en) * 2002-02-08 2006-02-28 Rosedale Medical, Inc. Autonomous, ambulatory analyte monitor or drug delivery device
US7993108B2 (en) 2002-10-09 2011-08-09 Abbott Diabetes Care Inc. Variable volume, shape memory actuated insulin dispensing pump
US7727181B2 (en) * 2002-10-09 2010-06-01 Abbott Diabetes Care Inc. Fluid delivery device with autocalibration
AU2003279237A1 (en) 2002-10-09 2004-05-04 Therasense, Inc. Fluid delivery device, system and method
US7052652B2 (en) 2003-03-24 2006-05-30 Rosedale Medical, Inc. Analyte concentration detection devices and methods
US7679407B2 (en) 2003-04-28 2010-03-16 Abbott Diabetes Care Inc. Method and apparatus for providing peak detection circuitry for data communication systems
JP2004343275A (en) * 2003-05-14 2004-12-02 Murata Mach Ltd Image processing system and scanner
US8071028B2 (en) 2003-06-12 2011-12-06 Abbott Diabetes Care Inc. Method and apparatus for providing power management in data communication systems
US7645373B2 (en) 2003-06-20 2010-01-12 Roche Diagnostic Operations, Inc. System and method for coding information on a biosensor test strip
US8206565B2 (en) 2003-06-20 2012-06-26 Roche Diagnostics Operation, Inc. System and method for coding information on a biosensor test strip
US7452457B2 (en) 2003-06-20 2008-11-18 Roche Diagnostics Operations, Inc. System and method for analyte measurement using dose sufficiency electrodes
US7645421B2 (en) 2003-06-20 2010-01-12 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
US8058077B2 (en) 2003-06-20 2011-11-15 Roche Diagnostics Operations, Inc. Method for coding information on a biosensor test strip
US8071030B2 (en) 2003-06-20 2011-12-06 Roche Diagnostics Operations, Inc. Test strip with flared sample receiving chamber
US8148164B2 (en) 2003-06-20 2012-04-03 Roche Diagnostics Operations, Inc. System and method for determining the concentration of an analyte in a sample fluid
CA2530297C (en) 2003-06-20 2011-04-12 F. Hoffmann-La Roche Ag Reagent stripe for test strip
US7718439B2 (en) 2003-06-20 2010-05-18 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
US7920906B2 (en) 2005-03-10 2011-04-05 Dexcom, Inc. System and methods for processing analyte sensor data for sensor calibration
US9247900B2 (en) 2004-07-13 2016-02-02 Dexcom, Inc. Analyte sensor
US7569126B2 (en) 2004-06-18 2009-08-04 Roche Diagnostics Operations, Inc. System and method for quality assurance of a biosensor test strip
US20060270922A1 (en) 2004-07-13 2006-11-30 Brauker James H Analyte sensor
US7713574B2 (en) 2004-07-13 2010-05-11 Dexcom, Inc. Transcutaneous analyte sensor
CN101180093B (en) 2005-03-21 2012-07-18 雅培糖尿病护理公司 Method and system for providing integrated medication infusion and analyte monitoring system
US7768408B2 (en) 2005-05-17 2010-08-03 Abbott Diabetes Care Inc. Method and system for providing data management in data monitoring system
US7620437B2 (en) 2005-06-03 2009-11-17 Abbott Diabetes Care Inc. Method and apparatus for providing rechargeable power in data monitoring and management systems
US20060281187A1 (en) 2005-06-13 2006-12-14 Rosedale Medical, Inc. Analyte detection devices and methods with hematocrit/volume correction and feedback control
AU2006291130A1 (en) * 2005-09-13 2007-03-22 Home Diagnostics, Inc. Method of manufacturing a diagnostic test strip
US7756561B2 (en) 2005-09-30 2010-07-13 Abbott Diabetes Care Inc. Method and apparatus for providing rechargeable power in data monitoring and management systems
CA2624059C (en) 2005-09-30 2019-04-02 Intuity Medical, Inc. Multi-site body fluid sampling and analysis cartridge
US8801631B2 (en) 2005-09-30 2014-08-12 Intuity Medical, Inc. Devices and methods for facilitating fluid transport
US7583190B2 (en) 2005-10-31 2009-09-01 Abbott Diabetes Care Inc. Method and apparatus for providing data communication in data monitoring and management systems
US8344966B2 (en) 2006-01-31 2013-01-01 Abbott Diabetes Care Inc. Method and system for providing a fault tolerant display unit in an electronic device
US8579853B2 (en) 2006-10-31 2013-11-12 Abbott Diabetes Care Inc. Infusion devices and methods
EP2252196A4 (en) 2008-02-21 2013-05-15 Dexcom Inc Systems and methods for processing, transmitting and displaying sensor data
US8262874B2 (en) * 2008-04-14 2012-09-11 Abbott Diabetes Care Inc. Biosensor coating composition and methods thereof
EP2293719B1 (en) 2008-05-30 2015-09-09 Intuity Medical, Inc. Body fluid sampling device -- sampling site interface
WO2009148626A1 (en) 2008-06-06 2009-12-10 Intuity Medical, Inc. Medical diagnostic devices and methods
WO2009148624A1 (en) 2008-06-06 2009-12-10 Intuity Medical, Inc. Detection meter and mode of operation
US20110117673A1 (en) * 2008-07-16 2011-05-19 Johnson Brandon T Methods and systems to collect and prepare samples, to implement, initiate and perform assays, and to control and manage fluid flow
US8021873B2 (en) 2008-07-16 2011-09-20 Boston Microfluidics Portable, point-of-care, user-initiated fluidic assay methods and systems
US8012428B2 (en) * 2008-10-30 2011-09-06 Lifescan Scotland, Ltd. Analytical test strip with minimal fill-error sample viewing window
US8560082B2 (en) 2009-01-30 2013-10-15 Abbott Diabetes Care Inc. Computerized determination of insulin pump therapy parameters using real time and retrospective data processing
US8467972B2 (en) 2009-04-28 2013-06-18 Abbott Diabetes Care Inc. Closed loop blood glucose control algorithm analysis
EP2437887B1 (en) 2009-06-04 2016-05-11 Lockheed Martin Corporation Multiple-sample microfluidic chip for dna analysis
DK3173014T3 (en) 2009-07-23 2021-09-13 Abbott Diabetes Care Inc Real-time control of data on physiological control of glucose levels
WO2011065981A1 (en) 2009-11-30 2011-06-03 Intuity Medical, Inc. Calibration material delivery devices and methods
US10330667B2 (en) 2010-06-25 2019-06-25 Intuity Medical, Inc. Analyte monitoring methods and systems
CA2814720C (en) 2010-10-15 2016-12-13 Lockheed Martin Corporation Micro fluidic optic design
EP3750480B1 (en) 2011-08-03 2022-02-02 Intuity Medical, Inc. Body fluid sampling arrangement
US9322054B2 (en) 2012-02-22 2016-04-26 Lockheed Martin Corporation Microfluidic cartridge
US9121050B2 (en) 2013-03-15 2015-09-01 American Sterilizer Company Non-enzyme based detection method for electronic monitoring of biological indicator
US8858884B2 (en) 2013-03-15 2014-10-14 American Sterilizer Company Coupled enzyme-based method for electronic monitoring of biological indicator
WO2014205412A1 (en) 2013-06-21 2014-12-24 Intuity Medical, Inc. Analyte monitoring system with audible feedback
KR20160073016A (en) 2014-12-16 2016-06-24 삼성전자주식회사 Structure for optic analysis and ink composition for making of the same
CN114599961A (en) * 2020-03-23 2022-06-07 泰尔茂株式会社 Test strip

Family Cites Families (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE399768B (en) * 1975-09-29 1978-02-27 Lilja Jan E CYVETT FOR SAMPLING, MIXING OF, THE SAMPLE WITH A REAGENTS AND DIRECT PERFORMANCE OF, SPECIAL OPTICAL, ANALYSIS OF THE SAMPLE MIXED WITH THE REAGENTS
US4243753A (en) * 1978-02-27 1981-01-06 Purdue Research Foundation Apparatus for enzyme detection
DE2850603A1 (en) * 1978-11-22 1980-06-19 Merck Patent Gmbh HAEMOLYSIS SOLUTION AND METHOD FOR HAEMOLYSING BLOOD
US4276051A (en) * 1980-01-28 1981-06-30 Coulter Electronics, Inc. System and program for chemical reaction observation with a moving photometer
US4323536A (en) * 1980-02-06 1982-04-06 Eastman Kodak Company Multi-analyte test device
JPS58139067A (en) * 1982-02-12 1983-08-18 Fuji Photo Film Co Ltd Measurement of liquid sample
CA1219040A (en) * 1983-05-05 1987-03-10 Elliot V. Plotkin Measurement of enzyme-catalysed reactions
US4594327A (en) * 1983-11-02 1986-06-10 Syntex (U.S.A.) Inc. Assay method for whole blood samples
US4708933A (en) * 1984-06-12 1987-11-24 Leaf Huang Immunoliposome assay-methods and products
DE3582532D1 (en) * 1984-06-13 1991-05-23 Ares Serond Research & Dev Ltd DEVICES FOR USE IN CHEMICAL ANALYSIS.
US4772561A (en) * 1985-12-23 1988-09-20 Miles Inc. Test device and method of determining concentration of a sample component
US5000922A (en) * 1986-02-19 1991-03-19 Jon Turpen Sample filtration, separation and dispensing device
US4775361A (en) * 1986-04-10 1988-10-04 The General Hospital Corporation Controlled removal of human stratum corneum by pulsed laser to enhance percutaneous transport
DE3630999A1 (en) * 1986-09-12 1988-03-17 Boehringer Mannheim Gmbh MULTI-LAYER TEST CARRIER
US4920056A (en) * 1988-02-19 1990-04-24 The Dow Chemical Company Apparatus and method for automated microbatch reaction
US5037737A (en) * 1988-06-29 1991-08-06 Apec, Inc. Analysis by sensor placement in recprocating flow
SE466158B (en) * 1989-04-25 1992-01-07 Migrata Uk Ltd METHOD OF ANALYSIS FOR GLUCOSE DETERMINATION IN WHOLE BLOOD
JP2630005B2 (en) * 1990-03-23 1997-07-16 日本電気株式会社 Liquid component measuring device and measuring method
US5161532A (en) * 1990-04-19 1992-11-10 Teknekron Sensor Development Corporation Integral interstitial fluid sensor
US5250439A (en) * 1990-07-19 1993-10-05 Miles Inc. Use of conductive sensors in diagnostic assays
US5202261A (en) * 1990-07-19 1993-04-13 Miles Inc. Conductive sensors and their use in diagnostic assays
US5147606A (en) * 1990-08-06 1992-09-15 Miles Inc. Self-metering fluid analysis device
US5423803A (en) * 1991-10-29 1995-06-13 Thermotrex Corporation Skin surface peeling process using laser
JP2561367Y2 (en) * 1992-04-03 1998-01-28 東亞医用電子株式会社 Sample suction and discharge device
US5508200A (en) * 1992-10-19 1996-04-16 Tiffany; Thomas Method and apparatus for conducting multiple chemical assays
US5643252A (en) * 1992-10-28 1997-07-01 Venisect, Inc. Laser perforator
JPH06265447A (en) * 1993-03-16 1994-09-22 Hitachi Ltd Trace quantity reactor and trace element measuring instrument therewith
US5843691A (en) * 1993-05-15 1998-12-01 Lifescan, Inc. Visually-readable reagent test strip
US5538857A (en) * 1994-06-01 1996-07-23 Isolab, Inc. Assay for enzyme activity from a red blood sample using a direct microfluorometric assay
CA2156226C (en) * 1994-08-25 1999-02-23 Takayuki Taguchi Biological fluid analyzing device and method
US5607565A (en) * 1995-03-27 1997-03-04 Coulter Corporation Apparatus for measuring analytes in a fluid sample
JPH08294639A (en) * 1995-04-27 1996-11-12 Nitto Denko Corp Chip for blood test
CN1174713C (en) * 1995-08-29 2004-11-10 光谱股份有限公司 Microporation method of human skin for drug delivery and monitoring applications
US5801057A (en) * 1996-03-22 1998-09-01 Smart; Wilson H. Microsampling device and method of construction
JP3213566B2 (en) * 1996-04-26 2001-10-02 アークレイ株式会社 Sample analysis tool, sample analysis method and sample analyzer using the same
DE19629657A1 (en) * 1996-07-23 1998-01-29 Boehringer Mannheim Gmbh Volume-independent diagnostic test carrier and method for determining analyte with its aid
DE69809391T2 (en) * 1997-02-06 2003-07-10 Therasense Inc SMALL VOLUME SENSOR FOR IN-VITRO DETERMINATION

Also Published As

Publication number Publication date
ATE227848T1 (en) 2002-11-15
CA2334269C (en) 2008-08-19
ES2187165T3 (en) 2003-05-16
AU766762B2 (en) 2003-10-23
DE29924971U1 (en) 2007-07-19
WO1999064620A3 (en) 2001-01-18
AU4414599A (en) 1999-12-30
WO1999064620A2 (en) 1999-12-16
US6077660A (en) 2000-06-20
EP1102991B1 (en) 2002-11-13
JP2003534526A (en) 2003-11-18
DE69903954T2 (en) 2003-09-04
ITMI20070307U1 (en) 2008-12-11
EP1102991A2 (en) 2001-05-30
DE69903954D1 (en) 2002-12-19

Similar Documents

Publication Publication Date Title
CA2334269A1 (en) Diagnostic assay requiring a small sample of biological fluid
JP2003534526A5 (en)
US6544474B2 (en) Device for determination of an analyte in a body fluid using small sample sizes
TWI433662B (en) Fluid handling devices
US6592815B1 (en) Analytical test element with a narrowed capillary channel
US20020160520A1 (en) Silicon nano-collection analytic device
AU733985B2 (en) Analytic test element with a capillary channel
JP3173798B2 (en) Method and apparatus for determining an analyte of a body fluid
US20110027873A1 (en) Micro-nano fluidic biochip for assaying biological sample
EP1262768A1 (en) Analytical element, and measuring instrument and substrate determining method using the same
WO1999032883A3 (en) Embossed test strip system
EP1667581A1 (en) Sampling device with capillary action
ATE365226T1 (en) COUPLING DYE FOR SPECTROPHOTOMETRIC DETERMINATION OF ANALYTES
JPH0561577B2 (en)
EP0759555A3 (en) Direct-reading reagent test strip
KR101104391B1 (en) Sensor for measuring biomaterial used with measuring meter, and measuring device using this sensor
GB2312750A (en) Differential pH measurement apparatus
WO1994018559A1 (en) Asymmetric membrane sensor
WO2005024397A3 (en) Sampling instrument
Oki et al. Development of healthcare chips checking life-style-related diseases
JP2012529041A (en) Biosensor for measuring biological materials
US20030077205A1 (en) Diagnostic test optical fiber tips
JP4301906B2 (en) Biological fluid analysis instrument and biological fluid analysis method using such biological fluid analysis instrument
KR101101573B1 (en) Sensor for measuring biomaterial used with measuring meter, and measuring device using this sensor
MXPA00012251A (en) Diagnostic assay requiring a small sample of biological fluid

Legal Events

Date Code Title Description
EEER Examination request
MKEX Expiry

Effective date: 20190603