CA2327127A1 - Improved test strip for the assay of an analyte in a liquid sample - Google Patents

Improved test strip for the assay of an analyte in a liquid sample Download PDF

Info

Publication number
CA2327127A1
CA2327127A1 CA002327127A CA2327127A CA2327127A1 CA 2327127 A1 CA2327127 A1 CA 2327127A1 CA 002327127 A CA002327127 A CA 002327127A CA 2327127 A CA2327127 A CA 2327127A CA 2327127 A1 CA2327127 A1 CA 2327127A1
Authority
CA
Canada
Prior art keywords
test strip
test
infrared dye
infrared
strip
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
CA002327127A
Other languages
French (fr)
Other versions
CA2327127C (en
Inventor
Paul F. Corey
Michael J. Pugia
Gary E. Rehm
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.)
Siemens Healthcare Diagnostics Inc
Original Assignee
Bayer Corp
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=23852543&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2327127(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Corp filed Critical Bayer Corp
Publication of CA2327127A1 publication Critical patent/CA2327127A1/en
Application granted granted Critical
Publication of CA2327127C publication Critical patent/CA2327127C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/521—Single-layer analytical elements
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/17—Nitrogen containing
    • Y10T436/173076—Nitrite or nitrate

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

An improved test strip for determining the presence or concentration of unknown or a constituent in a liquid test sample is disclosed. The test strip comprises a support strip and a test pad, wherein the test pad includes a carrier matrix incorporating a reagent composition capable of interacting with the constituent of interest to produce a detectable or measurable response. The test strip further comprises an in-frared dye, applied either to the support strip or incorpo-rated into a test pad, which ensures proper alignment of the test strip in an apparatus having a detection system for the detectable or measurable response. The improved test strip reduces the number of erroneous assays for the constituent of interest.

Claims (15)

1. A test strip for determining the presence or concentra-tion of one or more predetermined analytes in a liquid test sample comprising:
(a) a support handle;
(b) one or more test pads positioned on the support han-dle, each test pad comprising (i) a carrier matrix incorporating (ii) a reagent composition capable of interacting with a predetermined analyte to provide a detectable response; and (c) an infrared dye positioned at a predetermined loca-tion on the test strip.
2. The test strip of Claim 1 wherein about 0.05 to about 0.3 micrograms of the infrared dye are positioned on the test strip.
3. The test strip of Claim 1 wherein the infrared dye is po-sitioned on the support handle of the test strip.
4. The test strip of Claim 1 wherein the infrared dye is in-corporated into one or more test pad.
5. The test strip of Claim 1 wherein the infrared dye is in-corporated into one or more test pad and positioned on the support handle of the test strip.
6. The test strip of Claim 1 wherein the infrared dye ab-sorbs infrared radiation at least at one infrared wavelength.
7. The test strip of Claim 6 wherein the infrared dye lacks a visible color.
8. The test strip of Claim 1 wherein the infrared dye is se-lected from the group consisting of 5,5'-dichloro-11-diphenylamino-3,3'-diethyl-10,12-ethylenethiatricarbocyanine perchlorate, 3-(5-carboxypentyl)-2-[2-[3[[3- (5-carboxypentyl)-1,3-dihydro-1,1-dimethyl-2H-benz[e]indol-2-ylidene]-ethyl-idene]-2-(2-sulfoethylthio)-1-cyclohexene-1-yl]ethenyl]1,1-dimethyl-1H-benz[e]indolinium, 3-(5-carboxypentyl)-2-[2-[3-[[3-(5-carboxypentyl-1,3-dihydro-1,1-dimethyl-2H-benz[e]indol-2-ylidene]-ethylidene]-2-(n-hexylthio)-1-cyclohexen-1-yl]-ethenyl]-1,1-dimethyl-1H-benz[e]indolium, copper (II) 5,9,14, 18,23,27,32,36-octabutoxy-2,3-naphthalocyanine, 5,9,14,18,23, 27,32,36-octabutoxy-2,3-naphthalocyanine, and mixtures thereof.
9. The test strip of Claim 1 wherein the infrared dye is in-corporated into a test pad capable of assaying for nitrite or for occult blood.
10. The test strip of Claim 1 wherein the infrared dye is ap-plied to the support handle and is positioned adjacent to a test pad capable of assaying for nitrite.
11. A method of monitoring alignment of a test strip in an optical pathway of a detection apparatus comprising:
(a) providing a test strip, said test strip comprising (i) a support handle;
(ii) one or more test pads positioned on the support handle, each test pad comprising (i) a carrier matrix incorporating (ii) a reagent composition capable of interacting with a predetermined analyte to provide a detectable response; and (iii) an infrared dye positioned at a predetermined location on the test strip;
(b) inserting the test strip in the detection apparatus;
(c) illuminating the predetermined location of the in-frared dye on the test strip with infrared radia-tion;

(d) measuring a reflectance of infrared radiation from the predetermined location on the test strip; and (e) correlating the reflectance measurement to the alignment of the test strip in the detection appara-tus.
12. The method of Claim 11 wherein the detection apparatus is a scanning-type apparatus.
13. The method of Claim 11 wherein the detection apparatus is a camera-type apparatus.
14. The method of Claim 11 wherein the test strip is rejected by the detection apparatus when misaligned by about 0.05 inch or greater.
15. The method of Claim 11 wherein misalignment of the test strip in the detection apparatus by an amount of 0.030 inch or greater is detected.
CA2327127A 1999-12-17 2000-11-30 Improved test strip for the assay of an analyte in a liquid sample Expired - Lifetime CA2327127C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/466,637 1999-12-17
US09/466,637 US6316264B1 (en) 1999-12-17 1999-12-17 Test strip for the assay of an analyte in a liquid sample

Publications (2)

Publication Number Publication Date
CA2327127A1 true CA2327127A1 (en) 2001-06-17
CA2327127C CA2327127C (en) 2010-08-17

Family

ID=23852543

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2327127A Expired - Lifetime CA2327127C (en) 1999-12-17 2000-11-30 Improved test strip for the assay of an analyte in a liquid sample

Country Status (9)

Country Link
US (1) US6316264B1 (en)
EP (1) EP1111386B2 (en)
JP (2) JP4571300B2 (en)
AT (1) ATE290693T1 (en)
AU (1) AU778320B2 (en)
CA (1) CA2327127C (en)
DE (1) DE60018537T3 (en)
DK (1) DK1111386T4 (en)
ES (1) ES2238244T3 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8292826B1 (en) 2011-06-21 2012-10-23 YofiMETER, Inc. Cocking and advancing mechanism for analyte testing device

Families Citing this family (53)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4841990A (en) * 1985-06-29 1989-06-27 Tokyo Keiki Co., Ltd. Applicator for use in hyperthermia
US8071384B2 (en) 1997-12-22 2011-12-06 Roche Diagnostics Operations, Inc. Control and calibration solutions and methods for their use
US20050103624A1 (en) 1999-10-04 2005-05-19 Bhullar Raghbir S. Biosensor and method of making
CA2366802A1 (en) * 2001-01-17 2002-07-17 Bayer Corporation Method and apparatus for using infrared readings to detect misidentification of a diagnostic test strip in a reflectance spectrometer
DE10248555B4 (en) 2002-10-18 2004-12-02 Roche Diagnostics Gmbh Method and analysis system for determining the concentration of an analyte in a sample, which consists of the analyte and the sample matrix, and test element therefor
US20040132092A1 (en) * 2003-01-03 2004-07-08 Stetson Christopher M. Determining the density of functional moieties on polymer reagents
WO2005001444A1 (en) * 2003-06-03 2005-01-06 Bayer Healthcare Llc. Verification device and method for optical inspection machine
US8679853B2 (en) 2003-06-20 2014-03-25 Roche Diagnostics Operations, Inc. Biosensor with laser-sealed capillary space and method of making
US7645421B2 (en) 2003-06-20 2010-01-12 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
US7645373B2 (en) 2003-06-20 2010-01-12 Roche Diagnostic Operations, Inc. System and method for coding information on a biosensor test strip
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
US7488601B2 (en) 2003-06-20 2009-02-10 Roche Diagnostic Operations, Inc. System and method for determining an abused sensor during analyte measurement
US8058077B2 (en) 2003-06-20 2011-11-15 Roche Diagnostics Operations, Inc. Method for coding information on a biosensor 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
US8071030B2 (en) 2003-06-20 2011-12-06 Roche Diagnostics Operations, Inc. Test strip with flared sample receiving chamber
CA2529378C (en) 2003-06-20 2014-04-15 F.Hoffmann-La Roche Ag Method and reagent for producing narrow, homogenous reagent strips
US7452457B2 (en) 2003-06-20 2008-11-18 Roche Diagnostics Operations, Inc. System and method for analyte measurement using dose sufficiency electrodes
US8206565B2 (en) 2003-06-20 2012-06-26 Roche Diagnostics Operation, Inc. System and method for coding information on a biosensor test strip
AU2004203280A1 (en) * 2003-07-28 2005-02-17 Bayer Healthcare Llc Swing Lance with Integrated Sensor
WO2005078118A1 (en) 2004-02-06 2005-08-25 Bayer Healthcare Llc Oxidizable species as an internal reference for biosensors and method of use
US7569126B2 (en) 2004-06-18 2009-08-04 Roche Diagnostics Operations, Inc. System and method for quality assurance of a biosensor test strip
US7264971B2 (en) * 2004-07-20 2007-09-04 Siemens Medical Solutions Diagnostics Read-head for optical diagnostic device
WO2006098804A2 (en) 2005-03-11 2006-09-21 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
US7189522B2 (en) 2005-03-11 2007-03-13 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
EP3026874B1 (en) * 2005-04-01 2019-11-06 Polymer Technology Systems, Inc. Body fluid testing component for analyte detection
US20060275920A1 (en) * 2005-06-01 2006-12-07 Petrilla John F Apparatus and method for discriminating among lateral flow assay test indicators
AU2006272909B2 (en) 2005-07-20 2013-02-07 Bayer Healthcare Llc Gated amperometry
AU2006297572B2 (en) 2005-09-30 2012-11-15 Ascensia Diabetes Care Holdings Ag Gated Voltammetry
CA2698118C (en) * 2007-08-30 2018-01-16 Chris T. Zimmerle Non-visible detectable marking for medical diagnostics
WO2009076302A1 (en) 2007-12-10 2009-06-18 Bayer Healthcare Llc Control markers for auto-detection of control solution and methods of use
EP2304437A4 (en) * 2008-07-22 2012-06-20 Siemens Healthcare Diagnostics Disease specific diagnostic aid
US20100022916A1 (en) 2008-07-24 2010-01-28 Javanbakhsh Esfandiari Method and Apparatus for Collecting and Preparing Biological Samples for Testing
PL2361357T3 (en) * 2008-10-28 2019-05-31 Optodot Corp Stable infrared films
EP2350709A4 (en) 2008-10-28 2016-07-13 Optodot Corp Stable infrared reflective films
US20150369747A1 (en) * 2011-07-15 2015-12-24 Siemens Healthcare Diagnostics Inc. Device and method for detection of humidity-compromised urine test strips
MX2011004308A (en) 2009-01-26 2011-07-29 Siemens Healthcare Diagnostics Device and method for detection of humidity-compromised urine test strips.
US8603835B2 (en) 2011-02-10 2013-12-10 Chembio Diagnostic Systems, Inc. Reduced step dual path immunoassay device and method
US20130085349A1 (en) 2011-06-21 2013-04-04 Yofimeter, Llc Analyte testing devices
US8333716B1 (en) 2011-06-21 2012-12-18 Yofimeter, Llc Methods for using an analyte testing device
JP6252058B2 (en) * 2013-09-16 2017-12-27 株式会社テクノメデイカ Method for determining false positive reaction of urinary urobilinogen in qualitative analysis using color reaction and qualitative analyzer using the same determination method
GB2548653A (en) 2014-04-02 2017-09-27 Chembio Diagnostic Systems Inc Immunoassay utilizing trapping conjugate
CN107003294B (en) 2014-10-19 2020-04-21 B·布兰斯格洛夫 Tape positioning system and method
US20160116466A1 (en) 2014-10-27 2016-04-28 Chembio Diagnostic Systems, Inc. Rapid Screening Assay for Qualitative Detection of Multiple Febrile Illnesses
GB201515964D0 (en) 2015-09-09 2015-10-21 Global Icle Test Ltd Disposable urine test device
US10281407B2 (en) * 2015-11-02 2019-05-07 Jon A. Petty Multi-fluid strip test
USD865992S1 (en) * 2015-11-02 2019-11-05 Jon A. Petty Fluid test strip
WO2018017197A1 (en) * 2016-07-18 2018-01-25 Siemens Healthcare Diagnostics Inc. Improved low sample volume urinalysis assay strip, analytical kits, and methods of use related thereto
KR20190096345A (en) * 2016-12-15 2019-08-19 베크만 컬터, 인코포레이티드 Sheared Pad Detection System and Method
WO2018147077A1 (en) * 2017-02-08 2018-08-16 富士フイルム株式会社 Immunological testing device
US11143502B2 (en) * 2019-03-29 2021-10-12 Polymer Technology Systems, Inc. Systems and methods for test strip insertion positioning check and type match
US11259687B2 (en) * 2019-04-04 2022-03-01 Biosense Webster (Israel) Ltd. Medical instrument calibration
EP3948226A4 (en) * 2019-04-05 2023-09-06 Essenlix Corporation Assay accuracy and reliability improvement
FR3130975A1 (en) * 2021-12-16 2023-06-23 Commissariat A L'energie Atomique Et Aux Energies Alternatives DETECTION SYSTEM FOR THE DETECTION OF ONE OR MORE CHEMICAL COMPOUNDS

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3133826A1 (en) * 1981-08-27 1983-03-10 Boehringer Mannheim Gmbh, 6800 Mannheim ANALYSIS TEST STRIP AND METHOD FOR THE PRODUCTION THEREOF
DE3137174A1 (en) * 1981-09-18 1983-04-07 Boehringer Mannheim Gmbh, 6800 Mannheim DEVICE FOR THE OPTICAL DETECTION OF A CODING ON A DIAGNOSTIC TEST STRIP
JPS5892666U (en) * 1981-12-16 1983-06-23 株式会社富士通ゼネラル Test paper for chemical analysis
US5360628A (en) 1986-04-30 1994-11-01 Butland Trust Organization Technique for labeling an object for its identification and/or verification
JPS6340840A (en) * 1986-08-07 1988-02-22 Fuji Photo Film Co Ltd Chemical analyzer
US4935346A (en) * 1986-08-13 1990-06-19 Lifescan, Inc. Minimum procedure system for the determination of analytes
JPH04113267A (en) * 1990-09-04 1992-04-14 Toto Ltd Specimen positioning component for urine data analysis
JPH04339257A (en) * 1991-02-27 1992-11-26 Terumo Corp Standard color testing body and manufacture thereof
JP2955803B2 (en) 1992-07-22 1999-10-04 富士写真フイルム株式会社 Silver halide photographic material
US5351919A (en) 1993-03-29 1994-10-04 Primetech Electroniques Inc. Trainline communication link using radio frequency signal
DE4310371A1 (en) * 1993-03-30 1994-10-06 Basf Ag Process for the preparation of naphthalocyanines
US5453505A (en) 1994-06-30 1995-09-26 Biometric Imaging, Inc. N-heteroaromatic ion and iminium ion substituted cyanine dyes for use as fluorescence labels
DE4426892A1 (en) * 1994-07-29 1996-02-15 Riedel De Haen Ag Use of indolenine cyanine disulfonic acid derivatives
US5515170A (en) * 1994-09-08 1996-05-07 Lifescan, Inc. Analyte detection device having a serpentine passageway for indicator strips
JP3578542B2 (en) * 1996-02-02 2004-10-20 三共株式会社 Portable diagnostic tool
US5883246A (en) 1996-03-07 1999-03-16 Qlt Phototherapeutics, Inc. Synthesis of polypyrrolic macrocycles from meso-substituted tripyrrane compounds
US5885677A (en) * 1996-04-24 1999-03-23 Minnesota Mining And Manufacturing Company Security label with diffusing indentifier medium and method of making same
US5724148A (en) * 1996-05-09 1998-03-03 Bayer Corporation Apparatus and method for determination of urine color
JP3687015B2 (en) * 1996-05-31 2005-08-24 アークレイ株式会社 Sample analyzer and sample analysis method
US5945341A (en) * 1996-10-21 1999-08-31 Bayer Corporation System for the optical identification of coding on a diagnostic test strip
US5922551A (en) * 1997-03-20 1999-07-13 Accumetrics, Inc. Agglutrimetric platelet binding assays in blood
JPH11161172A (en) * 1997-11-25 1999-06-18 Aoyama:Kk Label, method and device for reading the label
WO2000029831A1 (en) * 1998-11-13 2000-05-25 Bangs Laboratories, Inc. Labeling microparticles capable of absorbing infrared light and methods of making and using the same

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8292826B1 (en) 2011-06-21 2012-10-23 YofiMETER, Inc. Cocking and advancing mechanism for analyte testing device

Also Published As

Publication number Publication date
ES2238244T3 (en) 2005-09-01
DE60018537D1 (en) 2005-04-14
DE60018537T3 (en) 2015-02-12
DK1111386T4 (en) 2015-01-05
US6316264B1 (en) 2001-11-13
JP2001194368A (en) 2001-07-19
AU778320B2 (en) 2004-11-25
DE60018537T2 (en) 2006-02-23
CA2327127C (en) 2010-08-17
AU7212300A (en) 2001-06-21
ATE290693T1 (en) 2005-03-15
EP1111386B1 (en) 2005-03-09
EP1111386B2 (en) 2014-09-17
JP4571300B2 (en) 2010-10-27
EP1111386A2 (en) 2001-06-27
JP2010160164A (en) 2010-07-22
EP1111386A3 (en) 2002-12-18
DK1111386T3 (en) 2005-05-30

Similar Documents

Publication Publication Date Title
CA2327127A1 (en) Improved test strip for the assay of an analyte in a liquid sample
CA2698118C (en) Non-visible detectable marking for medical diagnostics
KR100363989B1 (en) Longitudinally extended test strip
KR970003312B1 (en) Minimum procedure system for the determination of analysis
EP0725275B1 (en) Test element and method for quantitative NIR spectroscopic analysis
US7758744B2 (en) Dual glucose-turbidimetric analytical sensors
DK0779367T3 (en) Analyzer with stable coupling dye for photometric determination of analytes
EP0794261A3 (en) Methods for detection and discrimination of multiple analytes using fluorescent technology
EP1167540A3 (en) Dye couple for spectrophotometric determination of analytes
NO984356L (en) Method and apparatus for testing and analyzing immunofluorescent material
CA2336985A1 (en) Method of glucose or galactose detection with glucose/galactose binding protein
CA2024206A1 (en) Test device and method of assaying for fructoasmines
PT797097E (en) IMMUNOLOGICAL TESTING OF PARTICLES WITH COMPACT MATRIX
US8124367B2 (en) Device for applying a detector reagent to the skin for measuring cholesterol
KR20040018893A (en) Rapid Diagnosis Kit and Detection Method for Hemoglobin A1c Using Immunochoromatography
EP0791829A3 (en) Test apparatus for assaying a component in a liquid sample
EP0840124A3 (en) Analytical element with dry reagent
JP3100472B2 (en) Analyzer for dry analytical element
JPH0628591B2 (en) Dot blot method and reactor therefor

Legal Events

Date Code Title Description
EEER Examination request
MKEX Expiry

Effective date: 20201130