CA2285919A1 - Diagnostic tests and kits for clostridium difficile - Google Patents

Diagnostic tests and kits for clostridium difficile Download PDF

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Publication number
CA2285919A1
CA2285919A1 CA002285919A CA2285919A CA2285919A1 CA 2285919 A1 CA2285919 A1 CA 2285919A1 CA 002285919 A CA002285919 A CA 002285919A CA 2285919 A CA2285919 A CA 2285919A CA 2285919 A1 CA2285919 A1 CA 2285919A1
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CA
Canada
Prior art keywords
toxin
difficile
kits
clostridium difficile
diagnostic tests
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
CA002285919A
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French (fr)
Other versions
CA2285919C (en
Inventor
Gunars E. Valkirs
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.)
Alere San Diego Inc
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Individual
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 Individual filed Critical Individual
Publication of CA2285919A1 publication Critical patent/CA2285919A1/en
Application granted granted Critical
Publication of CA2285919C publication Critical patent/CA2285919C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56911—Bacteria
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/26—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
    • C12Q1/32—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase involving dehydrogenase
    • 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
    • G01N33/573—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
    • 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
    • Y10S435/973—Simultaneous determination of more than one analyte
    • 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
    • Y10S436/808—Automated 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
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/811—Test for named disease, body condition or organ function

Abstract

This invention provides method, compositions, and kits for detecting the presence of toxigenic strains of C. difficile in a biological sample. One embodiment provides methods for C. difficile detection that involve assaying for both C. difficile glutamate dehydrogenase and C. difficile toxin A or toxin B. In another embodiment, the invention provides a highly sensitive assay for C. difficile toxin A that is useful for determining whether a C. difficile strain is toxigenic. This embodiment involves binding of toxin A to a moiety that reversibly binds to capture moiety present on a magnetic bead. A magnetic field is applied to the sample to concentrate the toxin A, after which the magnetic beads are dissociated and removed from the solution to obtain a highly concentrated preparation of toxin A, thus making possible a very sensitive assay.
CA002285919A 1997-04-04 1998-04-03 Diagnostic tests and kits for clostridium difficile Expired - Lifetime CA2285919C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/832,935 US5965375A (en) 1997-04-04 1997-04-04 Diagnostic tests and kits for Clostridium difficile
US08/832,935 1997-04-04
PCT/US1998/006702 WO1998045706A1 (en) 1997-04-04 1998-04-03 DIAGNOSTIC TESTS AND KITS FOR $i(CLOSTRIDIUM DIFFICILE)

Publications (2)

Publication Number Publication Date
CA2285919A1 true CA2285919A1 (en) 1998-10-15
CA2285919C CA2285919C (en) 2009-06-02

Family

ID=25262976

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002285919A Expired - Lifetime CA2285919C (en) 1997-04-04 1998-04-03 Diagnostic tests and kits for clostridium difficile

Country Status (7)

Country Link
US (2) US5965375A (en)
EP (1) EP1019724B1 (en)
JP (1) JP2002510385A (en)
AT (1) ATE339688T1 (en)
CA (1) CA2285919C (en)
DE (1) DE69835893T2 (en)
WO (1) WO1998045706A1 (en)

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Also Published As

Publication number Publication date
WO1998045706A1 (en) 1998-10-15
EP1019724A4 (en) 2004-10-06
DE69835893D1 (en) 2006-10-26
US5965375A (en) 1999-10-12
DE69835893T2 (en) 2007-03-08
CA2285919C (en) 2009-06-02
ATE339688T1 (en) 2006-10-15
JP2002510385A (en) 2002-04-02
US6503722B1 (en) 2003-01-07
EP1019724B1 (en) 2006-09-13
EP1019724A1 (en) 2000-07-19

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