CA2713206A1 - Apparatus and method for analyte detection - Google Patents

Apparatus and method for analyte detection Download PDF

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Publication number
CA2713206A1
CA2713206A1 CA2713206A CA2713206A CA2713206A1 CA 2713206 A1 CA2713206 A1 CA 2713206A1 CA 2713206 A CA2713206 A CA 2713206A CA 2713206 A CA2713206 A CA 2713206A CA 2713206 A1 CA2713206 A1 CA 2713206A1
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CA
Canada
Prior art keywords
samples
sample
testing device
testing
sample application
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
CA2713206A
Other languages
French (fr)
Other versions
CA2713206C (en
Inventor
Howard Milne Chandler
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.)
Enterix Inc
Original Assignee
Enterix Inc.
Howard Milne Chandler
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
Priority claimed from US08/944,858 external-priority patent/US6271046B1/en
Priority claimed from AUPP3461A external-priority patent/AUPP346198A0/en
Application filed by Enterix Inc., Howard Milne Chandler filed Critical Enterix Inc.
Publication of CA2713206A1 publication Critical patent/CA2713206A1/en
Application granted granted Critical
Publication of CA2713206C publication Critical patent/CA2713206C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/805—Test papers
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/81—Packaged device or kit
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/97—Test strip or test slide
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/805—Optical property
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y10S436/809—Multifield plates or multicontainer arrays
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y10S436/81—Tube, bottle, or dipstick
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/811—Test for named disease, body condition or organ function
    • Y10S436/813—Cancer

Abstract

Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Claims (23)

1. A testing device for the identification of an analyte of interest, comprising:
a. a housing having a sample application matrix for:
i. receipt of a liquid-containing sample;
ii. desiccation of the liquid-containing sample in situ; and iii. rehydration of the desiccated liquid-containing sample for transfer to a testing element; and b. at least one insertable testing element which, on insertion into the housing, makes direct liquid-conductive communication with the sample application matrix such that upon rehydration, resolubilized or resuspended components of the sample are carried from the sample application matrix to the testing element or elements.
2. The testing device of claim 1, wherein the or each testing element is adapted to be inserted into the test device so that the testing element is in liquid-conductive communication with said sample application matrix.
3. A testing device for the identification of an analyte of interest, said testing device comprising (a) a housing having a sample application matrix for receiving a plurality of samples at discrete locations thereon, and aggregating the samples;
(b) at least one insertable testing element which, on insertion into the housing, makes direct liquid-conductive communication with said sample application matrix such that upon hydration, solubilized or suspended components of said plurality of samples are carried from said sample application matrix to said testing element or elements wherein a single test may be performed to simultaneously determine presence of the analyte of interest in a plurality of samples having discrete origin.
4. The testing device of claim 3, wherein said sample application matrix is adapted for:
i. receipt of a liquid-containing sample;
ii. desiccation of the liquid-containing sample in situ; and iii. rehydration of the desiccated liquid-containing sample for transfer to said testing element or elements.
5. The testing device of claim 3, wherein said sample application matrix is adapted for receipt of a dried sample.
6. A testing device for the identification of an analyte of interest, said testing device comprising:
a. a housing having at least one sample orifice selectively openable and sealable for admitting and sealably maintaining a plurality of samples therein, and at least one test orifice adapted for insertion of a testing element or elements therein;
b. a sample application matrix disposed within said housing in communication with said at least one sample orifice and said at least one test orifice, said sample application matrix adapted for:
i. receipt of the plurality of samples thereon; and ii. aggregating the plurality of samples, wherein the plurality of samples of discrete origin are adapted for being applied and sealed within said testing device, and subsequently tested in the aggregate;

c. at least one insertable testing element adapted for insertion into the housing through the or each said test orifice, for testing the plurality of samples.
7. The testing device of claim 6, wherein said sample application matrix is adapted to receive the plurality of samples at a single location thereon.
8. The testing device of claim 7, wherein the plurality of samples are mixed with one another prior to receipt by said matrix.
9. The testing device of claim 6, wherein said sample application matrix is adapted to receive the plurality of samples at discrete locations thereon, said matrix being adapted for aggregating the samples upon said insertion of the testing element or elements.
10. The testing device of claim 6, wherein said at least one sample orifice further comprises a plurality of sample orifices selectively openable and sealable for admitting and sealably maintaining the plurality of samples therein.
11. The testing device of claim 6, wherein the plurality of samples are of discrete temporal origin.
12. The testing device of claim 6, wherein the plurality of samples are of discrete spatial origin.
13. The testing device of claim 6, wherein the plurality of samples are of discrete biological origin.
14. The testing device of claim 6, wherein said sample application matrix is further adapted for hydration of the plurality of samples.
15. The testing device of claim 14, wherein at least one of the plurality of samples contain liquid, and said sample application matrix is further adapted for:
desiccation of the at least one of the plurality of samples in situ;
rehydration of the desiccated at least one sample; and aggregation of resolubilized or resuspended components of said at least one sample with at least one other of the plurality of samples for testing.
16. The testing device of claim 14, wherein the or each said testing element is adapted for application of liquid to said sample application matrix for said hydration.
17. A testing device for the identification of an analyte of interest from a plurality of samples, at least one of the plurality of samples containing liquid, said testing device comprising:
(i) a housing having a sample application matrix for:
receipt of the plurality of samples at discrete locations thereon;
desiccation of the at least one of the plurality of samples in situ;
hydration of the plurality of samples; and aggregation of solubilized or suspended components of the plurality of liquid samples for analyte analysis, wherein a single test may be performed to simultaneously determine presence of the analyte of interest in a plurality of samples having discrete origin; and (ii) at least one insertable testing element which, on insertion into the housing, makes direct liquid-conductive communication with the sample application matrix such that components of the sample are carried from the sample application matrix to the testing element or elements.
18. A method for identification of an analyte of interest from a plurality of samples, said method comprising the steps of:
a. providing a testing device having a sample application matrix;
b. applying the plurality of samples to the matrix;
c. aggregating components of the plurality of samples for analyte analysis; and d. utilizing a single test to simultaneously determine presence of the analyte of interest in the plurality of samples.
19. The method of claim 18, wherein said aggregating step c. further comprises the step of hydrating the plurality of samples.
20. The method of claim 18, wherein said aggregating step c. further comprises the step of e. mixing the samples prior to said applying step b.
21. The method of claim 20, wherein said mixing step e. further comprises mixing samples in a liquid state.
22. The method of claim 20, wherein said mixing step e. further comprises mixing samples in a dried state.
23. The method of claim 20, wherein said mixing step e. further comprises stacking a plurality of samples in dried state on the sample application matrix.
CA2713206A 1997-10-06 1998-10-05 Apparatus and method for analyte detection Expired - Fee Related CA2713206C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US08/944,858 US6271046B1 (en) 1997-10-06 1997-10-06 Apparatus and method for analyte detection
US08/944,858 1997-10-06
AUPP3461 1998-05-11
AUPP3461A AUPP346198A0 (en) 1998-05-11 1998-05-11 Apparatus and method for analyte detection
CA2305275A CA2305275C (en) 1997-10-06 1998-10-05 Apparatus and method for analyte detection

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2305275A Division CA2305275C (en) 1997-10-06 1998-10-05 Apparatus and method for analyte detection

Publications (2)

Publication Number Publication Date
CA2713206A1 true CA2713206A1 (en) 1999-04-15
CA2713206C CA2713206C (en) 2012-06-19

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CA2305275A Expired - Fee Related CA2305275C (en) 1997-10-06 1998-10-05 Apparatus and method for analyte detection
CA2713206A Expired - Fee Related CA2713206C (en) 1997-10-06 1998-10-05 Apparatus and method for analyte detection

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2305275A Expired - Fee Related CA2305275C (en) 1997-10-06 1998-10-05 Apparatus and method for analyte detection

Country Status (13)

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US (5) US6221678B1 (en)
EP (1) EP1031036B1 (en)
JP (1) JP4469082B2 (en)
CN (1) CN1158526C (en)
AT (1) ATE395597T1 (en)
BR (1) BR9812728A (en)
CA (2) CA2305275C (en)
DE (1) DE69839490D1 (en)
DK (1) DK1031036T3 (en)
ES (1) ES2307324T3 (en)
IL (1) IL135082A0 (en)
PT (1) PT1031036E (en)
WO (1) WO1999018436A1 (en)

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US7972871B2 (en) 2011-07-05
EP1031036A4 (en) 2004-04-07
EP1031036B1 (en) 2008-05-14
CA2305275C (en) 2010-12-21
BR9812728A (en) 2000-08-22
DK1031036T3 (en) 2008-09-15
ES2307324T3 (en) 2008-11-16
CA2713206C (en) 2012-06-19
US20010004532A1 (en) 2001-06-21
US20090029452A1 (en) 2009-01-29
PT1031036E (en) 2008-08-20
JP4469082B2 (en) 2010-05-26
DE69839490D1 (en) 2008-06-26
CA2305275A1 (en) 1999-04-15
ATE395597T1 (en) 2008-05-15
US20050158878A9 (en) 2005-07-21
CN1274422A (en) 2000-11-22
JP2001519531A (en) 2001-10-23
US7371583B2 (en) 2008-05-13
US6221678B1 (en) 2001-04-24
US20050158869A1 (en) 2005-07-21
US6977173B2 (en) 2005-12-20
US7704729B2 (en) 2010-04-27
CN1158526C (en) 2004-07-21
EP1031036A1 (en) 2000-08-30
IL135082A0 (en) 2001-05-20
WO1999018436A1 (en) 1999-04-15
US20100167309A1 (en) 2010-07-01

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