EP4348253A4 - H-ngal pour la détection de la péritonite - Google Patents

H-ngal pour la détection de la péritonite

Info

Publication number
EP4348253A4
EP4348253A4 EP22815218.7A EP22815218A EP4348253A4 EP 4348253 A4 EP4348253 A4 EP 4348253A4 EP 22815218 A EP22815218 A EP 22815218A EP 4348253 A4 EP4348253 A4 EP 4348253A4
Authority
EP
European Patent Office
Prior art keywords
ngal
peritonitis
detection
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.)
Pending
Application number
EP22815218.7A
Other languages
German (de)
English (en)
Other versions
EP4348253A1 (fr
Inventor
YongSheng JI
Fangfang HUANG
Jesus Eduardo MUNOZ-SILVA
Tao Jiang
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.)
Fresenius Medical Care Deutschland GmbH
Fresenius Medical Care Holdings Inc
Original Assignee
Fresenius Medical Care Deutschland GmbH
Fresenius Medical Care Holdings Inc
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 Fresenius Medical Care Deutschland GmbH, Fresenius Medical Care Holdings Inc filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP4348253A1 publication Critical patent/EP4348253A1/fr
Publication of EP4348253A4 publication Critical patent/EP4348253A4/fr
Pending 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
    • G01N33/54386Analytical elements
    • G01N33/54387Immunochromatographic test strips
    • G01N33/54388Immunochromatographic test strips based on lateral flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601Control or regulation
    • A61M1/1619Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • 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
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56911Bacteria
    • 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
    • G01N33/577Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies
    • 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
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • G01N33/6869Interleukin
    • 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
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6866Extracorporeal blood circuits, e.g. dialysis circuits
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0627Sensor or part of a sensor is integrated
    • B01L2300/0636Integrated biosensor, microarrays
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0825Test strips
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52Assays involving cytokines
    • G01N2333/54Interleukins [IL]
    • G01N2333/5412IL-6
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/26Infectious diseases, e.g. generalised sepsis
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/50Determining the risk of developing a disease
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/70Mechanisms involved in disease identification
    • G01N2800/7095Inflammation

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Emergency Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Virology (AREA)
  • Clinical Laboratory Science (AREA)
  • Peptides Or Proteins (AREA)
EP22815218.7A 2021-05-31 2022-05-30 H-ngal pour la détection de la péritonite Pending EP4348253A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202110605930.XA CN115480061A (zh) 2021-05-31 2021-05-31 H-ngal用于检测腹膜炎
PCT/CN2022/095940 WO2022253173A1 (fr) 2021-05-31 2022-05-30 H-ngal pour la détection de la péritonite

Publications (2)

Publication Number Publication Date
EP4348253A1 EP4348253A1 (fr) 2024-04-10
EP4348253A4 true EP4348253A4 (fr) 2025-06-18

Family

ID=84322816

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22815218.7A Pending EP4348253A4 (fr) 2021-05-31 2022-05-30 H-ngal pour la détection de la péritonite

Country Status (3)

Country Link
EP (1) EP4348253A4 (fr)
CN (2) CN115480061A (fr)
WO (1) WO2022253173A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117741165A (zh) * 2023-11-29 2024-03-22 浙江鼎创医疗科技有限公司 一种高特异性、高灵敏度hnl检测用胶体金免疫层析试纸条及其制备方法以及使用方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130177923A1 (en) * 2007-11-15 2013-07-11 Bioporto Diagnostics A/S Diagnostic use of individual molecular forms of a biomarker
CN105974128A (zh) * 2016-06-12 2016-09-28 吉林大学 一种人中性粒细胞载脂蛋白同源二聚体的定量装置
US20180193546A1 (en) * 2016-09-09 2018-07-12 Medtronic, Inc. Peritoneal dialysis fluid testing system
US20180356413A1 (en) * 2015-11-23 2018-12-13 Mologic Limited Diagnostic Test with Lateral Flow Test Strip
WO2022020760A1 (fr) * 2020-07-23 2022-01-27 Fresenius Medical Care Holdings, Inc. Système pour déterminer la péritonite en utilisant la lipocaline associée à la gélatinase neutrophile de type homodimère

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009063307A2 (fr) * 2007-11-14 2009-05-22 Bio-Technology General (Israel) Ltd. Procédé de détection de l'activité inflammatoire en utilisant l'il-6
CN102759623A (zh) * 2012-07-06 2012-10-31 南京基蛋生物科技有限公司 一种检测ngal胶体金试纸条及其制备方法
CN105891503A (zh) * 2015-03-31 2016-08-24 北京科美生物技术有限公司 用于检测嗜中性粒细胞明胶酶相关脂质(ngal)的胶体金免疫比色法试剂盒及其制备方法
US11280788B2 (en) * 2019-01-31 2022-03-22 Fresenius Medical Care Holdings, Inc. Rapid diagnosis of peritonitis in peritoneal dialysis patients

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130177923A1 (en) * 2007-11-15 2013-07-11 Bioporto Diagnostics A/S Diagnostic use of individual molecular forms of a biomarker
US20180356413A1 (en) * 2015-11-23 2018-12-13 Mologic Limited Diagnostic Test with Lateral Flow Test Strip
CN105974128A (zh) * 2016-06-12 2016-09-28 吉林大学 一种人中性粒细胞载脂蛋白同源二聚体的定量装置
US20180193546A1 (en) * 2016-09-09 2018-07-12 Medtronic, Inc. Peritoneal dialysis fluid testing system
WO2022020760A1 (fr) * 2020-07-23 2022-01-27 Fresenius Medical Care Holdings, Inc. Système pour déterminer la péritonite en utilisant la lipocaline associée à la gélatinase neutrophile de type homodimère

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Neutrophil gelatinase-associated lipocalin (NGAL)", HYTEST TECHNOTES, 17 February 2020 (2020-02-17), pages 1 - 4, XP055850311, Retrieved from the Internet <URL:https://hytest.fi/sites/5cd13840ff4f702c0cbc4c8d/content_entry5cd13897ff4f702c0cbc4cb2/5e32b5bdff4f7006ce1deab7/files/NGAL_TechNotes.pdf?1583742319> [retrieved on 20211012] *
JONSSON N ET AL: "Performance of plasma measurement of neutrophil gelatinase-associated lipocalin as a biomarker of bacterial infections in the intensive care unit", JOURNAL OF CRITICAL CARE, vol. 53, 2 July 2019 (2019-07-02), pages 264 - 270, XP085754775, [retrieved on 20190702], DOI: 10.1016/J.JCRC.2019.07.001 *
MARTINO FRANCESCA KATIANA ET AL: "Neutrophil Gelatinase-Associated Lipocalin in the Early Diagnosis of Peritonitis: The Case of Neutrophil Gelatinase-Associated Lipocalin", CONTRIBUTIONS TO NEPHROLOGY, vol. 178, 30 May 2012 (2012-05-30), CH, pages 258 - 263, XP055850586, ISSN: 0302-5144, Retrieved from the Internet <URL:http://dx.doi.org/10.1159/000337888> DOI: 10.1159/000337888 *
NASIOUDIS D ET AL: "Neutrophil gelatinase-associated lipocalin and innate immune responses to bacterial infections", MEDICAL MICROBIOLOGY AND IMMUNOLOGY, vol. 204, no. 4, 26 February 2015 (2015-02-26), pages 471 - 479, XP035519662, [retrieved on 20150226], DOI: 10.1007/S00430-015-0394-1 *
See also references of WO2022253173A1 *

Also Published As

Publication number Publication date
EP4348253A1 (fr) 2024-04-10
CN115480061A (zh) 2022-12-16
WO2022253173A1 (fr) 2022-12-08
CN115715369A (zh) 2023-02-24

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Owner name: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

Owner name: FRESENIUS MEDICAL CARE HOLDINGS, INC.