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Title Clinical molecular diagnostics / Shiyang Pan, Jinhai Tang, editors
Published Singapore : Springer, 2021

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Description 1 online resource (888 pages)
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
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
Notes Degree of Nonlinearity
Online resource; title from PDF title page (SpringerLink, viewed July 28, 2021)
Subject Molecular diagnosis.
Biochemical markers.
Medical laboratory technology.
Molecular probes.
Biomarkers
Clinical Laboratory Techniques
Molecular Diagnostic Techniques
Molecular Probes
Molecular diagnosis
Diagnòstic molecular.
Genre/Form Llibres electrònics.
Form Electronic book
Author Pan, Shiyang
Tang, Jinhai
ISBN 9789811610370
9811610371