Hemostasis and Thrombosis: Methods and Protocols

Dedication
Preface
Contents
Contributors
Part I: Introductory Chapters and Routine Coagulation Assays
Chapter 1: Hemostasis and Thrombosis: An Overview Focusing on Associated Laboratory Testing to Diagnose and Help Manage Relate...
1 Introduction
2 The Two Sides of the Coin That Is Hemostasis
3 Hemostasis Pathways
3.1 Overview of Primary Hemostasis
3.2 Overview of Secondary Hemostasis
3.3 Fibrinolysis
3.4 Cell-Based Model of Coagulation
3.5 Routine Coagulation Tests
3.5.1 Prothrombin Time (PT)
3.5.2 International Normalized Ratio (INR)
3.5.3 Activated Partial Thromboplastin Time (APTT)
3.5.4 Thrombin Time (TT)
3.5.5 Fibrinogen and FXIII
4 Thrombophilia Disorders and Associated Laboratory Assays
5 Treatment and Monitoring of Thrombosis and Associated Conditions
5.1 Unfractionated Heparin (UFH)
5.2 Low-Molecular-Weight Heparin (LMWH)
5.3 Vitamin K Antagonists (VKAs)
5.4 Direct Oral Anticoagulants (DOACs)
6 Bleeding Disorders and Associated Laboratory Assays
6.1 Inherited Bleeding Disorders
6.1.1 von Willebrand Disease (VWD) and Associated Laboratory Assays
6.1.2 Inherited Platelet Function Disorders and Associated Tests
6.1.3 Coagulation (``Secondary Hemostasis´´)-Related Bleeding Disorders and Associated Laboratory Tests
7 Quality Control (QC) and External Quality Assessment (EQA)
8 Pre-analytical Variables and Post-analytical Issues in Hemostasis
9 Conclusion
References
Chapter 2: Preanalytical Variables in Hemostasis Testing
1 Introduction
2 Pre-preanalytical Variables
3 Phlebotomy: Blood Collection Overview
3.1 Phlebotomy Step 1: Patient Identification
3.2 Phlebotomy Step 2: Identifying Proper Blood Collection Tubes
3.3 Phlebotomy Step 3: Pre-sample Collection
3.4 Phlebotomy Step 4: The Blood Collection Procedure
4 Transportation of Blood Collection Tubes
5 Processing of Blood Collection Tubes: Centrifugation
6 Post-processing: Sample Conditions
7 Conclusions
References
Chapter 3: Automation in the Thrombosis and Hemostasis Laboratory
1 Introduction
2 Pre-analytic Considerations
2.1 Sample Processing
2.2 Sample Characterization
2.3 Sample Acquisition
3 Analytic Considerations
4 Post-analytic Considerations
4.1 Laboratory Information System/Middleware
4.2 Other Considerations
5 Industry 4.0 and Conclusion
References
Chapter 4: Ultracentrifugation for Coagulation Testing
Abbreviations
1 Introduction
2 Materials
2.1 Instrument (See Note 2)
2.2 Consumables (See Note 2)
2.3 Patient Blood Collection and Processing (See Notes 4-6)
2.4 Verification Sample Testing
3 Methods
3.1 Sample Preparation (See Notes 10 and 11)
3.2 Ultracentrifuge Operation (See Note 10)
3.3 Sample Recovery and Removal
3.4 Result Reporting (See Note 9)
4 Notes
References
Chapter 5: Harmonization of Hemostasis Testing Across a Large Laboratory Network: An Example from Australia
1 Introduction
2 The NSW Health Pathology Network
3 Harmonization and Standardization in NSW Health Pathology Network
4 Harmonization/Standardization of Routine Coagulation Tests
5 Harmonization/Standardization of Congenital Thrombophilia Tests
6 Harmonization/Standardization of Lupus Anticoagulant Testing
7 Harmonization/Standardization of Factor Assay Testing
8 Harmonization/Standardization of Platelet Function Testing
9 Harmonization/Standardization of Residual Hemostasis Testing Across NSWHP
10 Harmonization/Standardization of Hemostasis Documentation Across NSWHP
11 Literature Review
12 Conclusion
References
Chapter 6: Auto-validation of Routine Coagulation/Hemostasis Assays with Reflex Testing of Abnormal Test Results
1 Introduction
2 Setting
3 Early History of the Reflex Testing and Auto-validation Rule System
4 Assessing Effectiveness of the Implementation and Rule Process
5 An Update
6 PubMed Search
7 Conclusion
References
Chapter 7: Laboratory Testing of Hemostasis in Pregnancy: A Brief Overview
1 Introduction
2 Hemostasis Changes During Normal Pregnancy and Puerperium
3 Basic Hemostasis Tests
3.1 Routine Coagulation Tests
3.2 Thrombin Time and Fibrinogen Assay
3.3 D-Dimer
3.4 Platelet Count and Function
4 Tissue-Type Plasminogen Activator (tPA) and PAI-1
5 Natural Anticoagulants
5.1 Antithrombin (AT)
5.2 Protein C and Protein S
6 Additional Specialized Tests
6.1 von Willebrand Factor (VWF) Workup
6.2 Testing for Antiphospholipid Antibody Syndrome
7 Global Hemostatic Assays
7.1 TEG and ROTEM
7.2 Thrombin Generation Assays
8 Conclusion
References
Chapter 8: Protocols for D-Dimer Measurements for Aid to Diagnosis or Exclusion of Venous Thromboembolism
Abbreviations
1 Introduction
2 General DDi Materials
2.1 General DDi Sample Requirements
2.2 General DDi Additional Materials
2.3 ELISA-Specific Materials
2.4 ELFA-Specific Materials
2.5 LIA-Specific Materials
2.6 CLIA-Specific Materials
2.7 POC-Specific Materials
3 Methods
3.1 ELISA Method (Asserachrom D-Di, Diagnostica Stago, REF 00947)
3.2 ELFA Method (VIDAS D-Dimer Exclusion II, bioMerieux, REF 30 455)
3.3 LIA Method (Diagnostica Stago STA-Liatest D-Di, REF 00515) (See Subheading 4.3 LIA Method, Note 1)
3.4 CLIA Method (Werfen/Instrumentation Laboratory HemosIL AcuStar D-Dimer #009802000) (See Subheading 4.4 CLIA Method, Note 1)
3.5 POC Method (One-Step D-Dimer Rapid Test Cassette, Home Health UK) (See Subheading 4.5 POC Method, Note 1)
4 Notes
4.1 Manual ELISA Notes
4.2 Automated ELFA: Notes
4.3 LIA Method: Notes
4.4 CLIA Method: Notes
4.5 POC Method Notes
References
Chapter 9: Performance and Interpretation of Clot Waveform Analysis
Abbreviations
1 Introduction
2 Materials
2.1 General Materials and Equipment
2.2 Reagents
3 Methods
3.1 Daily Preparations of Reagents and Samples
3.2 Kit RecombiPlasTin 2G Preparation
3.3 Samples from Patients and Healthy Subjects
3.4 Coagulometer Parameters and Setup
3.5 Assay Procedure
4 Notes
References
Part II: Thrombophilia Related Chapters
Chapter 10: Laboratory Evaluation of Thrombophilia
1 Introduction
2 Concept of Thrombophilia
3 Risk Factors
4 Risk Potential
5 Thrombophilia Risk Factors
5.1 Genetic Risk Factors of Thrombophilia
5.1.1 Antithrombin
5.1.2 Protein C
5.1.3 Protein S
5.1.4 Factor V Leiden (APC Resistance)
5.1.5 Prothrombin 20210 Mutation
6 Acquired Risk Factors of Thrombophilia
6.1 Antiphospholipid Antibody Syndrome/Lupus Anticoagulant
7 Thrombophilia Testing Decision
8 Testing Algorithms for Thrombophilia
8.1 Antithrombin
8.2 Protein C
8.3 Protein S
8.4 Activated Protein C Resistance
8.5 Acquired Risk Factors: Antiphospholipid Syndrome and Lupus Anticoagulant
9 Conclusions
References
Chapter 11: Laboratory Testing for Activated Protein C Resistance (APCR): An Update
1 Introduction
2 Materials
3 Methods
4 Notes
References
Chapter 12: Evaluation of Activated Protein C Resistance Using Thrombin Generation Test
Abbreviations
1 Introduction
2 Methods for ETP-Based APC Resistance
2.1 Blood Sample Collection
2.2 General Principle of the Test
2.3 Materials and Procedures
2.3.1 Analyzers and Software
2.3.2 Triggering Reagents
2.3.3 Calibrators, Controls, and Reference Plasma
2.3.3.1 Calibrators
2.3.3.2 Controls
2.3.3.3 Reference Plasma
3 Reporting Results
4 Other Considerations and Discussion
References
Chapter 13: Performance of Chromogenic Protein C (PC) Testing
1 Introduction
2 Materials
2.1 Specimens
2.2 General Materials
2.3 Reagents
3 Methods
3.1 Instrument Procedure
3.2 Calibration
3.3 Quality Controls (QC)
3.4 Patient Samples
3.5 Calculation of Values
3.6 Reference Range and Reporting Results
4 Notes
References
Chapter 14: Testing for Factor V Leiden (FVL) and Prothrombin G20210A Genetic Variants
1 Introduction
2 Materials
2.1 Sample
2.2 Controls
2.3 Reagents
2.4 Tubes and Other Consumables
2.5 Equipment
3 Methods
4 Notes
References
Chapter 15: An Overview of Laboratory Testing for Antiphospholipid Antibodies
1 Introduction
2 Solid-Phase Assays for aPL
3 Liquid-Phase (Clot-Based) Assays for aPL: The So-Called Lupus Anticoagulants (LA)
4 Assessing the Whole, Rather Than the Separate, Components
5 Residual and Ongoing Issues in Testing for aPL
6 Conclusion
References
Chapter 16: Lupus Anticoagulant Testing: Taipan Snake Venom Time with Ecarin Time as Confirmatory Test
1 Introduction
2 Materials
2.1 Test Plasma
2.2 Test Reagents
2.3 Quality Control Plasmas
2.4 Analytical Platform
3 Methods
3.1 TSVT Screening Test
3.2 ET Confirmatory Test
3.3 Worked Example of an LA Detected by TSVT/ET Analysis
3.4 Reporting the Results
4 Notes
References
Chapter 17: Lupus Anticoagulant Testing: Dilute Prothrombin Time (dPT)
1 Introduction
2 Materials
2.1 Test Plasma
2.2 Normal Pooled Plasma
2.3 Test Reagents
2.4 Quality Control Plasmas
2.5 Analytical Platform
3 Methods
3.1 dPT Screening Test
3.2 dPT Confirmatory Test
3.3 dPT Mixing Test
3.4 Worked Example of an LA Detected by dPT
3.5 Reporting the Results
4 Notes
References
Chapter 18: An Acute Need Inspiration: Autoneutralization of Lupus Anticoagulants in Affected Prothrombin Times (PT) and Activ...
Abbreviations
1 Introduction
2 Materials
2.1 Instrument
2.2 Reagents and Consumables
2.3 Patient Blood Collection and Processing
3 Methods
3.1 Reagents
3.2 Patient Sample: Baseline PT and APTT
3.3 Sample Storage: Thawing
3.4 Patient Sample: Thawed Samples
3.5 Interpretation
4 Notes
References
Chapter 19: Antiphospholipid Antibody Testing for Anti-cardiolipin and Anti-β2 Glycoprotein I Antibodies Using Chemiluminescen...
Abbreviations
1 Introduction
2 Materials
2.1 An Automated Analyzer with Validated aCL and aβ2GPI Assay Protocols Using These Reagents
2.2 aCL IgG Test Reagents and Consumables
2.3 aCL IgM Test Reagents and Consumables
2.4 aβ2GPI IgG Test Reagents and Consumables
2.5 aβ2GPI IgM Test Reagents and Consumables
2.6 Additional Materials
3 Methods
3.1 Preliminary Steps
3.2 Automated CLIA Procedure
3.3 Treatment of Results
4 Notes
References
Chapter 20: Laboratory Testing for Non-criteria Antiphospholipid Antibodies: Anti-phosphatidylserine/Prothrombin Antibodies (a...
1 Introduction
2 Materials
2.1 Patient Samples
2.2 Reagents Provided in a Commercial Kit (QUANTA Lite ELISA)
2.3 Additional Material
3 Methods
3.1 Assay Principle
3.2 Procedure
3.3 Data Analysis
3.4 Quality Control
3.5 Reporting Results
4 Notes
References
Chapter 21: Laboratory Testing for Non-criteria Antiphospholipid Antibodies: Antibodies Toward the Domain I of Beta2-Glycoprot...
1 Introduction
2 Materials
2.1 Patient Samples
2.2 Reagents Provided in the Commercial Chemiluminescence Kit
2.3 Additional Material
3 Methods
3.1 Assay Principle
3.2 Assay Procedure
3.3 Data Analysis
3.4 Quality Control and Quality Assurance
3.5 Reporting Results
4 Notes
References
Part III: Measuring or Monitoring Anticoagulants and Antithrombobotic Therapy
Chapter 22: An Overview of Heparin Monitoring with the Anti-Xa Assay
1 Introduction
2 Heparin
3 Laboratory Monitoring of UFH with the APTT Assay for VTE Treatment
4 Laboratory Monitoring of UFH with the Anti-Xa Assay for VTE Treatment
5 Laboratory Monitoring of LMWH and Fondaparinux
6 Other Laboratory Considerations for Anti-Xa Testing
7 Conclusions
References
Chapter 23: Ecarin-Based Methods for Measuring Thrombin Inhibitors
Abbreviations
1 Introduction
2 Materials
2.1 Instrument
2.2 Ecarin Clotting Time Reagents
2.3 Ecarin Clotting Time Supplies Required but Not Provided
2.4 Ecarin Chromogenic Reagents (See Note 8)
2.5 Ecarin Chromogenic Assay (Automated) Supplies Required but Not Provided
2.6 Patient Blood Collection and Processing
3 Methods
3.1 Ecarin Clotting Time (ECT)
3.2 Ecarin Chromogenic: Automated and Manual Method (See Note 16)
3.3 Ecarin Chromogenic: Manual Method
4 Notes
References
Chapter 24: Assays to Monitor Bivalirudin
1 Introduction
2 Methods to Measure or Monitor Bivalirudin
2.1 Activated Clotting Time (ACT)
2.2 Activated Partial Thromboplastin Time (APTT)
2.3 Thrombin Time/Dilute Thrombin Time
2.4 Ecarin Clotting Time
2.5 Chromogenic Assays
2.6 Prothrombinase-Induced Clotting Time (PiCT)
3 Additional Considerations and Conclusion
References
Chapter 25: Monitoring of Antiplatelet Therapy
1 Introduction
2 Antiplatelet Drugs and Those Tests Available: An Overview
3 How Do the Antiplatelet Drugs Work?
4 What Tests/Analyzers Do We Have Available to Monitor Platelet Function?
5 Methods of Platelet Function for Testing Antiplatelet Therapy
5.1 Light Transmission Aggregometry (LTA) (Gold Standard as Comparator)
5.2 Impact-R Cone and Plate(let) Analyzer (Matis Medical, Belgium)
5.3 Multiplate Electrode Platelet Aggregation (MEA) (Roche Diagnostics, Switzerland)
5.4 VerifyNow (Accriva Diagnostics, San Diego, CA)
5.5 PFA-100/PFA-200 (Siemens Healthcare Diagnostics, Marburg, Germany)
5.6 Plateletworks (Helena Biosciences, Boston, USA)
5.7 Thromboelastography (TEG Platelet Mapping/TEG 6) (Haemonetics, Boston, USA)
5.8 ROTEM (IL Werfen, Barcelona, Spain)
5.9 Quantra (HemoSonics LLC, Durham, USA)
5.10 Aggredyne: AggreGuide A-100 (Houston, Texas, USA)
5.11 T-TAS (Fujimori Kogyo Co., Ltd., Tokyo, Japan)
5.12 Sonoclot (Sienco Inc., Boulder, USA)
6 Discussion and Conclusion
References
Part IV: Heparin Induced Thrombocytopenia (HIT) and Vaccine Induced Immune Thrombotic Thrombocytopenia (VITT)
Chapter 26: Heparin-Induced Thrombotic Thrombocytopenia (HITT) and Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT): ...
1 Introduction
2 Pretesting Probability Assessment in HITT and VITT
3 Detecting Anti-PF4 Antibodies in HITT
4 Detecting Anti-PF4 Antibodies in VITT
5 Conclusion
References
Chapter 27: Functional Testing for Heparin-Induced Thrombocytopenia Using Whole Blood Multiplate Impedance Aggregometry
Abbreviations
1 Introduction
2 Materials
2.1 Instrument
2.2 Reagents and Consumables
2.3 Donor Blood Collection
2.4 High Responder Donor Selection
2.5 Plasma or Serum for HIT Antibody Testing
3 Methods
3.1 WBIA for HIT Functional Testing
3.2 ISTH-SSC HIMEA
3.3 Interpretation
4 Notes
References
Chapter 28: Multiple Electrode Aggregometry (Multiplate): Functional Assay for Vaccine-Induced (Immune) Thrombotic Thrombocyto...
1 Introduction
2 Materials
3 Methods
4 Notes
References
Chapter 29: Whole Blood Procoagulant Platelet Flow Cytometry Protocol for Heparin-Induced Thrombocytopenia (HIT) and Vaccine-I...
Abbreviations
1 Introduction
2 Materials
2.1 Blood Collection from Healthy Volunteers
2.2 Whole Blood Procoagulant Platelet Flow Cytometry
2.3 Plasma Samples for Testing
2.4 Identification of Suitable Healthy Donors
3 Methods
3.1 Blood Collection from Healthy Volunteers
3.2 Identification of Suitable Healthy Donors for HIT or VITT Plasma-Induced Procoagulant Platelet Assays
3.3 Plasma-Induced Procoagulant Platelet Assay for HIT and VITT
3.4 Flow Cytometric Acquisition and Analysis
3.5 Result Interpretation for HIT Testing
3.6 Result Interpretation for VITT Testing
4 Notes
References
Chapter 30: Serotonin Release Assay: Functional Assay for Heparin- and Vaccine-Induced (Immune) Thrombotic Thrombocytopenia
1 Introduction
2 Materials: Equipment, Buffers, and Reagents
3 Method for SRA
3.1 Method for HIT SRA
3.2 Method for VITT SRA
3.3 Calculation of Results
3.4 Interpretation of HIT SRA
3.5 Interpretation of VITT SRA
4 Notes
References
Part V: ADAMTS13
Chapter 31: An Overview of Laboratory Testing for ADAMTS13
1 Introduction
2 Deficiency of ADAMTS13
3 Assays That Measure ADAMTS13 Level and Activity
4 Assays That Measure Antibodies Against ADAMTS13
5 Conclusion
References
Chapter 32: Automated and Rapid ADAMTS13 Testing Using Chemiluminescence: Utility for Identification or Exclusion of TTP and B...
Abbreviations
1 Introduction
2 Materials
2.1 An Automated Analyzer with Validated ADAMTS13 Assay Protocol Using This Reagent
2.2 ADAMTS13 Test Reagents and Consumables
2.3 Additional Materials
3 Methods
3.1 Preliminary Steps
3.2 Automated CLIA Procedure
3.3 Treatment of Results
4 Notes
References
Chapter 33: Identification of ADAMTS13 Inhibitors in Acquired TTP
Abbreviations
1 Introduction
2 Materials
2.1 A Validated Method to Assess Residual ADAMTS13 Activity at Conclusion of the Bethesda-Like Procedure
2.2 ADAMTS13 Test Reagents and Consumables
2.3 Plasma Samples
2.4 Additional Materials
3 Methods
3.1 Preliminary Steps
3.2 Inhibitor Screen Procedure
3.3 Bethesda-Like Procedure
3.4 Assay Limitations and Treatment of Results
4 Notes
References
Chapter 34: ADAMTS13 Activity: Screening Test Protocol
1 Introduction
2 Materials
3 Method
3.1 Procedure
3.2 Reporting Results
4 Notes
References
Chapter 35: ADAMTS13 Activity Measurement by ELISA and Fluorescence Resonance Energy Transfer Assay
1 Introduction
2 Materials
2.1 Technozym ADAMTS13 Activity ELISA
2.2 Technofluor ADAMTS13 Activity FRET Assay
3 Methods
3.1 Technozym ADAMTS13 Activity ELISA
3.2 Method for Technofluor ADAMTS13 Activity FRET Assay
4 Notes
References
Chapter 36: ADAMTS13 Antibody and Inhibitor Assays
1 Introduction
2 Materials
2.1 Technozym ADAMTS13 Inhibitor ELISA
2.2 Functional Inhibitor Assays
3 Methods
3.1 Technozym ADAMTS13 Inhibitor ELISA
3.2 Rapid Screening Test for Neutralizing ADAMTS13 Inhibitor
3.3 Bethesda-Type Assay to Quantify Neutralizing ADAMTS13 Inhibitors
4 Notes
References
Part VI: Bleeding Disorders
Chapter 37: A Review of Factor VIII and Factor IX Assay Methods for Monitoring Extended Half-Life Products in Hemophilia A and...
1 Background
1.1 Fc Fusion
1.2 Glyco PEGylation
1.3 Albumin Fusion
1.4 Single-Chain Technology
2 Classification Criteria for a Replacement Factor to Be Termed an EHL Product
3 Considerations of Causes in Assay Variation of EHL FVIII and FIX Infusion Products
3.1 Product Characterization by Manufacturer
3.2 Assignment of Potency of EHLs
3.3 Pharmacokinetic Studies by the Manufacturers
3.4 Post-Infusion Testing in Clinical Laboratories
3.5 Application of Information Regarding EHLs to the Diagnostic Laboratory
4 Laboratory Challenges
4.1 Challenges Encountered with EHL Products
4.2 Challenges Encountered with Assay Result Discrepancies in Non-EHL Therapies
5 Conclusion
References
Chapter 38: Measuring Emicizumab Levels in the Hemostasis Laboratory
1 Introduction
2 Materials
3 Methods
4 Notes
References
Chapter 39: Chromogenic Factor VIII Assay for Patients with Hemophilia A and on Emicizumab Therapy
1 Introduction
2 Materials
2.1 Equipment
2.2 Reagents
2.3 Preparation of Reagents
3 Methods
3.1 Preparation of Samples
3.2 Calibration Line
3.3 Quality Control (QC)
3.4 Assay Procedure for Stago Analyzer Test Setup
3.5 Calculation of Results
3.6 Units
3.7 Reference Range
3.8 Interpretation
3.9 Assay Verification
4 Notes
References
Chapter 40: Assessment of Platelet Function by Automated Light Transmission Aggregometry
1 Introduction
2 Materials
2.1 Patient Preparation
2.2 Reagents
2.3 Instruments and Consumables
3 Methods
3.1 Preparation of Platelet Aggregation Agonists
3.2 Preparation of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP)
3.3 Installation of Aggregation-Specific SB Cuvettes II to Prepare Analyzer
3.4 Installation of Agonists, PRP, and PPP on the Analyzer
3.5 Performing the Platelet Aggregation Analysis
3.6 Interpretation of Platelet Aggregation Results (See Notes 6 and 7)
4 Notes
References
Chapter 41: Assessment of Platelet Function by High-Throughput Screening Light Transmission Aggregometry: Optimul Assay
1 Introduction
2 Materials
2.1 Pre-analytical Considerations
2.2 Reagents (See Note 1)
2.3 Apparatus and Remaining Materials (See Note 2)
2.3.1 For Optimul Aggregometry Assay, the Following Equipment and Materials Are Required
3 Methods
3.1 Manufacture of Optimul Plates (Standard Configuration)
3.2 Preparation of PRP and PPP
3.3 Ensure the Apparatus Is Ready for Analysis
3.4 Performing Analysis
3.5 Interpretation of the Results
4 Notes
References
Chapter 42: Preparing Surrogate Abnormal Quality Control Samples for Platelet Function Studies and Viscoelastic Testing
1 Introduction
2 Materials
2.1 Pharmaceutical Materials
2.2 Reagents
2.3 Instrumentation
2.4 General Laboratory Supplies
3 Methods
3.1 Functional Platelet Studies (See Note 13)
3.2 VET Testing
3.3 Method Results and Interpretations
3.3.1 Platelet Function Studies (See Note 16)
3.3.2 Thromboelastography (See Notes 7, 10, 12, 15, and 17)
3.3.3 Documentation
4 Notes
References
Chapter 43: Laboratory Testing for von Willebrand Disease Using a Composite Rapid 3-Test Chemiluminescence-Based von Willebran...
Abbreviations
1 Introduction
2 Materials
2.1 An Automated Analyzer with Validated VWF Assay Protocols Using These Reagents
2.2 VWF:Ag Test Reagents and Consumables
2.3 VWF:GPIbR Test Reagents and Consumables
2.4 VWF:CB Test Reagents and Consumables
2.5 Additional Materials
3 Methods
3.1 Preliminary Steps
3.2 Automated CLIA Procedure
3.3 Treatment of Results
4 Notes
References
Chapter 44: Laboratory Testing for von Willebrand Factor Activity by a Glycoprotein Ib-Binding Assay (VWF:GPIbR): HemosIL von ...
Abbreviations
1 Introduction
2 Materials
2.1 VWF:GPIbR Assay
3 Methods
3.1 Assay Principle
3.2 Assay Protocol
3.3 Interpretation of Results
4 Notes
References
Chapter 45: Laboratory Testing for von Willebrand Factor: Factor VIII Binding for the Diagnosis or Exclusion of Type 2N von Wi...
1 Introduction
2 Materials
3 Method
4 Notes
References
Chapter 46: Automation of a Factor XIII Activity Assay Utilizing a Plasma Blank Measurement
1 Introduction
2 Materials
2.1 General Supplies
2.2 Patient Specimens (See Note 1)
2.3 FXIII Activity Assay Reagents (See Note 2)
2.4 Instrumentation (See Note 4)
3 Method
4 Notes
References
Part VII: Global Assays, Research Applications, and Postanalytical Considerations
Chapter 47: Measurement of Blood Viscoelasticity Using Thromboelastography
1 Introduction
2 TEG 5000 Analyzer
3 TEG 6s Analyzer
4 Factors Influencing TEG Tracings
5 TEG Limitations
6 Interpretation of TEG
6.1 Reference Interval
6.2 Reportable Ranges
6.2.1 TEG 5000
6.2.2 TEG 6s
6.3 Lysis Interpretation
7 Agreement and Parameter Interchangeability Between TEG 5000 and TEG 6s
References
Chapter 48: The TEG 5000 System: System Description and Protocol for Measurements
1 Introduction
2 Materials
2.1 Materials Needed But Not Provided
2.2 Specimen Requirements
3 Methods
3.1 General Operation
3.2 TEG 5000 eTest
3.3 Quality Control
3.4 Sample Testing (for Citrated Kaolin, CK)
3.5 Presentation of Results
4 Notes
References
Chapter 49: The TEG 6s System: System Description and Protocol for Measurements
1 Introduction
2 Materials
2.1 Specimen Requirements
3 Methods
3.1 Quality Control (Internal)
3.2 Quality Control Cartridge Reagent QC LI and LII
3.3 Sample Testing (CK, CRT, CKH, CFF)
3.4 Presentation of Results
4 Notes
References
Chapter 50: The Quantra System: System Description and Protocols for Measurements
1 Introduction
1.1 Quantra Analyzer
1.2 Cartridges
1.2.1 QPlus Cartridge
1.2.2 QStat Cartridge
1.3 Normal Ranges
1.4 Reportable Ranges
1.5 Interpretation of Results
2 Materials
2.1 Supplies Needed
2.2 Specimen Requirements
3 Methods
3.1 General Operation
3.2 Quality Controls
3.2.1 Internal Quality Controls
3.2.2 External Quality Control (QC): Reconstitution for Use (See Notes 8-10)
3.2.3 Quantra Proficiency Testing/External Quality Assessment (EQA)
3.3 Sample Testing
3.4 Presentation of Results
3.5 Quantra Desktop Remote Viewer (QDRV)
4 Notes
References
Chapter 51: Modified Rotational Thromboelastometry Protocol Using Tissue Plasminogen Activator for Detection of Hypofibrinolys...
1 Introduction
2 Materials
2.1 Patient Preparation and Specimen
2.2 Reagents
2.2.1 List of Reagents
2.2.2 Preparation of Reagents
2.3 Apparatus and Utensils
3 Methods
3.1 Preparation of Apparatus
3.2 Performing the Analysis
3.3 Interpretation of Results
4 Notes
References
Chapter 52: Protocol for the Investigation of Plasma and Whole Blood Clot Property of Fibrin Fiber Thickness Using Scanning El...
1 Introduction
2 Materials
2.1 Blood Sampling, Plasma Preparation, and Blood Clot Generation
2.2 Sample Preparation for SEM
2.3 SEM Imaging and Image Analysis
2.4 Other Lab Consumables
3 Methods
3.1 Blood Sampling and Platelet-Poor Plasma Preparation
3.2 Plasma Clot and Whole Blood Clot Preparation
3.3 Blood Clot Fixation and Dehydration
3.4 Blood Clot Surface Gold Coating
3.5 Blood Clot SEM Imaging
3.6 SEM Image Analysis Using ImageJ Software
3.6.1 ImageJ Scale Setup
3.6.2 Fibrin Thickness Measurement (See Note 16)
4 Notes
References
Chapter 53: Post-analytical Issues in Hemostasis and Thrombosis Testing: An Update
Abbreviations
1 Introduction
2 Overview of Post-analytical Issues for Consideration
3 Conclusion
References
Index