WO2001007921A3 - Stabilized coagulation control reagent - Google Patents

Stabilized coagulation control reagent Download PDF

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Publication number
WO2001007921A3
WO2001007921A3 PCT/US2000/040453 US0040453W WO0107921A3 WO 2001007921 A3 WO2001007921 A3 WO 2001007921A3 US 0040453 W US0040453 W US 0040453W WO 0107921 A3 WO0107921 A3 WO 0107921A3
Authority
WO
WIPO (PCT)
Prior art keywords
coagulation
plasma
control
thaw
freeze
Prior art date
Application number
PCT/US2000/040453
Other languages
French (fr)
Other versions
WO2001007921A2 (en
Inventor
Rebecca J Hunt
Lori J Elder
S Mohsen Fakhari
Original Assignee
Medical Analysis Systems 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 Medical Analysis Systems Inc filed Critical Medical Analysis Systems Inc
Priority to AU71379/00A priority Critical patent/AU7137900A/en
Publication of WO2001007921A2 publication Critical patent/WO2001007921A2/en
Publication of WO2001007921A3 publication Critical patent/WO2001007921A3/en

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
    • G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • 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
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2496/00—Reference solutions for assays of biological material
    • G01N2496/05—Reference solutions for assays of biological material containing blood cells or plasma
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2496/00—Reference solutions for assays of biological material
    • G01N2496/45—Reference solutions for assays of biological material containing protease inhibitors, e.g. sulfonylfluorides, chloromethylketones, organophosphates

Abstract

This invention relates generally to the preparation of coagulation control compositions suitable for measuring human coagulation characteristics. The coagulation controls provided herein include novel combinations of reagents and novel processing which provide superior performance characteristics including long term stability as a liquid formulation at 4 °C after freeze thaw or lyophilization and reconstitution. The control is based on mammalian plasma, of which the majority is primate plasma and a minority is non-primate plasma as well as a variety of other stabilizing materials such as a buffer, a fibrinolysis inhibitor, a coagulation factor stabilizer, a carbohydrate for stabilizing proteins upon freeze-thaw and a preservative to maintain sterility. The invention also includes a new method to prepare coagulation controls with abnormal clotting times by adding coagulation control inhibitors to the plasma.
PCT/US2000/040453 1999-07-23 2000-07-21 Stabilized coagulation control reagent WO2001007921A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU71379/00A AU7137900A (en) 1999-07-23 2000-07-21 Stabilized coagulation control reagent and method of making same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14545499P 1999-07-23 1999-07-23
US60/145,454 1999-07-23

Publications (2)

Publication Number Publication Date
WO2001007921A2 WO2001007921A2 (en) 2001-02-01
WO2001007921A3 true WO2001007921A3 (en) 2001-06-07

Family

ID=22513196

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/040453 WO2001007921A2 (en) 1999-07-23 2000-07-21 Stabilized coagulation control reagent

Country Status (2)

Country Link
AU (1) AU7137900A (en)
WO (1) WO2001007921A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108169467A (en) * 2017-11-27 2018-06-15 中国科学院苏州生物医学工程技术研究所 A kind of thrombelastogram instrument quality-control product and its preparation method and application

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7588942B2 (en) * 2006-08-04 2009-09-15 Bio-Rad Laboratories, Inc. Standard/reference/control for blood coagulation testing
EA020194B1 (en) 2009-02-02 2014-09-30 Бёрингер Ингельхайм Интернациональ Гмбх Lyophilised dabigatran
ES2475492B1 (en) * 2014-03-13 2015-01-15 Grifols Worldwide Operations Limited Composition for use as an abnormal coagulation control plasma in in vitro assays
CN105652022B (en) * 2015-12-31 2017-10-10 浙江盛域医疗技术有限公司 Thrombelastogram instrument quality-control product and preparation method thereof
US11965178B2 (en) 2018-11-30 2024-04-23 Cellphire, Inc. Platelets loaded with anti-cancer agents
AU2020267368B2 (en) 2019-05-03 2023-05-04 Cellphire, Inc. Materials and methods for producing blood products
CN110470849B (en) * 2019-08-16 2021-06-29 青岛海润禾生物技术有限公司 Abnormal value quality control product for blood coagulation detection and preparation method thereof
CA3170134A1 (en) * 2020-02-04 2021-08-12 Cellphire, Inc. Treatment of von willebrand disease
EP4139689A1 (en) * 2020-04-24 2023-03-01 Perosphere Technologies Inc. Whole blood control sample systems and method of preparing and using the same
CN111638374B (en) * 2020-06-08 2022-10-18 深圳市国赛生物技术有限公司 In-vitro diagnostic kit for determining prothrombin time
CN112697557A (en) * 2020-12-30 2021-04-23 郑州普湾医疗技术有限公司 Quality control product of 2-level thrombus elastogram, preparation method and application thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991001497A1 (en) * 1989-07-20 1991-02-07 Analytical Control Systems, Inc. Improved stable coagulation controls
US5147803A (en) * 1988-09-12 1992-09-15 Nippon Shoji Kabushiki Kaisha Method and composition for stabilizing blood coagulation factors and blood control plasmas containing the composition
US5753510A (en) * 1994-11-09 1998-05-19 Behring Diagnostics Gmbh Calibrator for use in test methods for detecting a defective coagulation factor V

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5147803A (en) * 1988-09-12 1992-09-15 Nippon Shoji Kabushiki Kaisha Method and composition for stabilizing blood coagulation factors and blood control plasmas containing the composition
WO1991001497A1 (en) * 1989-07-20 1991-02-07 Analytical Control Systems, Inc. Improved stable coagulation controls
US5753510A (en) * 1994-11-09 1998-05-19 Behring Diagnostics Gmbh Calibrator for use in test methods for detecting a defective coagulation factor V

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
AKERBLOM OLOF ET AL: "Freezing technique and quality of fresh-frozen plasma.", INFUSIONSTHERAPIE UND TRANSFUSIONMEDIZIN, vol. 19, no. 6, 1992, pages 283 - 287, XP000981447, ISSN: 1019-8466 *
DOELLGAST G J ET AL: "ENZYME-LINKED COAGULATION ASSAY A CLOT-BASED SOLID-PHASE ASSAY FOR THROMBIN", ANALYTICAL BIOCHEMISTRY, vol. 147, no. 2, 1985, pages 529 - 534, XP000981444, ISSN: 0003-2697 *
RIGGERT J ET AL: "Prestorage inline filtration of whole blood for obtaining white cell-reduced blood components.", TRANSFUSION (BETHESDA), vol. 37, no. 10, 1997, pages 1039 - 1044, XP000981445, ISSN: 0041-1132 *
ZEIGLER Z R: "EFFECTS OF EPSILON AMINOCAPROIC ACID ON PRIMARY HEMOSTASIS", HAEMOSTASIS, vol. 21, no. 5, 1991, pages 313 - 320, XP000981450, ISSN: 0301-0147 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108169467A (en) * 2017-11-27 2018-06-15 中国科学院苏州生物医学工程技术研究所 A kind of thrombelastogram instrument quality-control product and its preparation method and application
CN108169467B (en) * 2017-11-27 2019-09-20 中国科学院苏州生物医学工程技术研究所 A kind of thrombelastogram instrument quality-control product and its preparation method and application

Also Published As

Publication number Publication date
AU7137900A (en) 2001-02-13
WO2001007921A2 (en) 2001-02-01

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