BookShiyang Pan, Jinhai Tang, editors.
Summary: This book covers the discovery of molecular biomarkers, the development of laboratory testing techniques and their clinical applications, focusing on basic research to clinical practice. It introduces new and crucial knowledge and ethics of clinical molecular diagnosis. This book emphasizes the applications of clinical molecular diagnostic test on health management, especially from different diseased organs. It lets readers to understand and realize precision healthcare.
Contents:
Intro
Foreword
Coordinators
Preface
Acknowledgments
Contents
About the Editors and Contributors
About the Editors
Editorial Board
Contributors
Part I: Principles of Clinical Molecular Diagnostics
1: Molecules of Disease and Their Detection Methods
1.1 Overview
1.2 Molecular Mechanism of Diseases
1.3 Nucleic Acid Detection Methods
1.3.1 Nucleic Acid Amplification Technology
1.3.2 Sequencing Technology
1.3.3 Nucleic Acid Hybridization Technology
1.3.4 Chip Technology
1.3.5 Biosensing Technology
1.4 Protein Detection Methods 1.4.1 Spectrum Technology
1.4.2 Protein Chip Technology
1.4.3 Labeled Immunoassay
1.4.4 Mass Spectrometric Technique
1.5 Future Trends
References
2: Assay Performance Evaluation
2.1 Precision
2.1.1 Terminology and Definitions
2.1.2 Overview of the Precision Evaluation Process (Fig. 2.1)
2.1.3 Features of the EP5-A2 Program
2.1.4 EP5-A2 Experimental Protocol and Requirements
2.1.4.1 Experimental Preparation
Experimental Sample
2.1.4.2 Experimental Method
2.1.4.3 Quality Control
2.1.5 Data Collection, Processing, and Statistical Analysis 2.1.5.1 Experimental Data Record
2.1.5.2 Outlier Test
2.1.5.3 Repeatability Estimate
2.2 Accuracy
2.2.1 Definitions
2.2.2 Features of the EP9-A2 Program
2.2.3 EP9-A2 Experimental Protocol and Requirements
2.2.3.1 Experimental Preparation
Sample Preparation
Comparison Method Selection
2.2.3.2 Experimental Method
2.2.3.3 Quality Control
2.2.4 Simple Accuracy Evaluation Plan
2.2.4.1 Comparison of Patient Sample Results to Those of Another Procedure
2.2.4.2 Method of Setting Reference Materials
Sources of Reference Materials Procedure for Demonstration of Accuracy with Reference Materials
2.3 Sensitivity
2.3.1 Definitions
2.3.2 Discussion of Several Common Terms
2.3.3 Lower Limit of Linear Range (LLR), Biological Limit of Detection (BLD), and Functional Sensitivity (FS)
2.3.3.1 Lower Limit of Linear Range (LLR)
2.3.3.2 Biological Limit of Detection (BLD)
2.3.3.3 Functional Sensitivity (FS)
2.3.3.4 Experimental Precautions
Blank Sample
Detection Limit Sample
Time Required for the Experiment
2.3.4 Limits of Blank, Limits of Detection, and Limits of Quantitation 2.3.4.1 Overview
2.3.4.2 General Method for Determining the Limits of Blank (LoB)
2.4 Analytical Measurement Range
2.4.1 Definitions
2.4.2 EP6-A Protocol and Requirements
2.4.2.1 Experimental Requirements
Device Familiarization Period
Duration of the Experiment
Specimen of the Experiment
Number of Samples
Matrix Effects
Selection of Materials Used to Supplement Samples
Analyte Range
Sample Preparation and Value Assignment
2.4.2.2 Analytical Sequence
2.4.2.3 Preliminary Data Check
Outlier Inspection
Determination of the Linear Range