US20040157242A1 - Diagnosis of sepsis or SIRS using biomarker profiles - Google Patents

Diagnosis of sepsis or SIRS using biomarker profiles Download PDF

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Publication number
US20040157242A1
US20040157242A1 US10/704,758 US70475803A US2004157242A1 US 20040157242 A1 US20040157242 A1 US 20040157242A1 US 70475803 A US70475803 A US 70475803A US 2004157242 A1 US2004157242 A1 US 2004157242A1
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United States
Prior art keywords
individual
sepsis
biomarker profile
sirs
biomarker
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.)
Abandoned
Application number
US10/704,758
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English (en)
Inventor
Richard Ivey
Thomas Gentle
Richard Moore
Michael Towns
Nicholas Bachur
Robert Rosenstein
James Nadeau
Paul Goldenbaum
Song Shi
Donald Copertino
James Garrett
Gregory Tice
Gary Siuzdak
Elizabeth Want
Zhouxin Shen
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Becton Dickinson and Co
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Becton Dickinson and Co
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Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to US10/704,758 priority Critical patent/US20040157242A1/en
Assigned to BECTON, DICKINSON AND COMPANY reassignment BECTON, DICKINSON AND COMPANY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SHEN, ZHOUXIN, SIUZDAK, GARY, COPERTINO, DONALD, GOLDENBAUM, PAUL E., NADEAU, JAMES G., ROSENSTEIN, ROBERT W., SHI, SONG, TICE, GREGORY, TOWNS, MICHAEL L., WANT, ELIZABETH, BACHUR, NICHOLAS, JR., GARRETT, JAMES, MOORE, RICHARD L., GENTLE, THOMAS M., JR., IVEY, RICHARD M.
Publication of US20040157242A1 publication Critical patent/US20040157242A1/en
Priority to US11/647,689 priority patent/US7632685B2/en
Priority to US11/647,688 priority patent/US7645613B2/en
Abandoned legal-status Critical Current

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    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • 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
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/26—Infectious diseases, e.g. generalised sepsis
    • 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
    • Y10T436/24—Nuclear magnetic resonance, electron spin resonance or other spin effects or mass spectrometry

Definitions

  • the present invention provides a method of diagnosing SIRS in an individual having or suspected of having SIRS.
  • This method comprises obtaining a biomarker profile at a single point in time from the individual and comparing the individual's biomarker profile to a reference biomarker profile. Comparison of the biomarker profiles can diagnose SIRS in the individual with an accuracy of at least about 60%. This method may also be repeated on the individual at any time.
  • “predicting the onset of sepsis” means to classify the patient's biomarker profile as corresponding to the profile derived from individuals who are progressing from a particular stage of SIRS to sepsis or from a state of being infected to sepsis (i.e., from infection to infection with concomitant SIRS).
  • “Detecting the progression” or “determining the progression” of sepsis or SIRS means to classify the biomarker profile of a patient who is already diagnosed as having sepsis or SIRS. For instance, classifying the biomarker profile of a patient who has been diagnosed as having sepsis can encompass detecting or determining the progression of the patient from sepsis to severe sepsis or to sepsis with MOD.
  • the reference populations may be chosen from individuals who do not have SIRS (“SIRS-negative”), from individuals who do not have SIRS but who are suffering from an infectious process, from individuals who are suffering from SIRS without the presence of sepsis (“SIRS-positive”), from individuals who are suffering from the onset of sepsis, from individuals who are sepsis-positive and suffering from one of the stages in the progression of sepsis, or from individuals with a physiological trauma that increases the risk of developing sepsis. Furthermore, the reference populations may be SIRS-positive and are then subsequently diagnosed with sepsis using conventional techniques.
  • any immunoassay may use any antibodies, antibody fragment or derivative capable of binding the biomarker molecules (e.g., Fab, Fv, or scFv fragments). Such immunoassays are well-known in the art. If the biomarker is a protein, it may be sequenced and its encoding gene may be cloned using well-established techniques.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Analytical Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • General Engineering & Computer Science (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
US10/704,758 2002-11-12 2003-11-12 Diagnosis of sepsis or SIRS using biomarker profiles Abandoned US20040157242A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US10/704,758 US20040157242A1 (en) 2002-11-12 2003-11-12 Diagnosis of sepsis or SIRS using biomarker profiles
US11/647,689 US7632685B2 (en) 2002-11-12 2006-12-28 Method of predicting the onset of sepsis in SIRS-positive individuals using mass spectrometry
US11/647,688 US7645613B2 (en) 2002-11-12 2006-12-28 Mass spectrometry techniques for determining the status of sepsis in an individual

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US42532202P 2002-11-12 2002-11-12
US50354803P 2003-09-17 2003-09-17
US10/704,758 US20040157242A1 (en) 2002-11-12 2003-11-12 Diagnosis of sepsis or SIRS using biomarker profiles

Related Child Applications (2)

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US11/647,688 Continuation US7645613B2 (en) 2002-11-12 2006-12-28 Mass spectrometry techniques for determining the status of sepsis in an individual
US11/647,689 Continuation US7632685B2 (en) 2002-11-12 2006-12-28 Method of predicting the onset of sepsis in SIRS-positive individuals using mass spectrometry

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US20040157242A1 true US20040157242A1 (en) 2004-08-12

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US10/704,758 Abandoned US20040157242A1 (en) 2002-11-12 2003-11-12 Diagnosis of sepsis or SIRS using biomarker profiles
US11/647,689 Expired - Lifetime US7632685B2 (en) 2002-11-12 2006-12-28 Method of predicting the onset of sepsis in SIRS-positive individuals using mass spectrometry
US11/647,688 Active 2025-07-07 US7645613B2 (en) 2002-11-12 2006-12-28 Mass spectrometry techniques for determining the status of sepsis in an individual

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US11/647,689 Expired - Lifetime US7632685B2 (en) 2002-11-12 2006-12-28 Method of predicting the onset of sepsis in SIRS-positive individuals using mass spectrometry
US11/647,688 Active 2025-07-07 US7645613B2 (en) 2002-11-12 2006-12-28 Mass spectrometry techniques for determining the status of sepsis in an individual

Country Status (8)

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US (3) US20040157242A1 (ja)
EP (1) EP1565570A4 (ja)
JP (1) JP4643445B2 (ja)
AU (1) AU2003291483A1 (ja)
BR (1) BR0316232A (ja)
CA (1) CA2505921A1 (ja)
MX (1) MXPA05005031A (ja)
WO (1) WO2004044555A2 (ja)

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US20080114576A1 (en) * 2004-12-09 2008-05-15 Matthew Christo Jackson Early Detection of Sepsis
US20080138832A1 (en) * 2002-11-12 2008-06-12 Becton, Dickinson And Company Diagnosis of sepsis or SIRS using biomarker profiles
US20090104605A1 (en) * 2006-12-14 2009-04-23 Gary Siuzdak Diagnosis of sepsis
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