Clinical molecular diagnostics / Shiyang Pan, Jinhai Tang, editors.

Format:

Book

Contributor:

Pan, Shiyang.

Tang, Jinhai.

Language:

English

Subjects (All):

Molecular diagnosis.

Genre:

Electronic books.

Physical Description:

1 online resource (888 pages)

Place of Publication:

Singapore : Springer, 2021.

System Details:

text file

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

Notes:

Degree of Nonlinearity.

Online resource; title from PDF title page (SpringerLink, viewed July 28, 2021).

Other Format:

Print version: Pan, Shiyang Clinical Molecular Diagnostics

ISBN:

9789811610370

9811610371

OCLC:

1260346208

Access Restriction:

Restricted for use by site license.