Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

Infectious diseases seriously endanger human health. Rapid and accurate detection of pathogens is the key to effective treatment and precise prevention and control of infectious diseases. Traditional pathogen testing techniques cover a limited variety of microorganisms, making it difficult to meet clinical needs. Metagenomic Next Generation Sequencing (mNGS) theoretically can simultaneously detect all known gene sequences of pathogens, greatly improving the clinical capacity of diagnosing and treating patients with severe, complicated, rare, and emerging pathogen infections. In the context of individualized health needs, the laboratory developed test(LDT) of new technologies in laboratories can continuously improve the level of clinical diagnosis and treatment. Due to the high starting point of research and development and the complex operation process of the mNGS technology platform, this study reaches a consensus on the experimental procedure, assay validation, quality control, and report review of the mNGS-LDT in the fields of clinical testing, infection, critical care, and in vitro diagnosis to ensure the appropriate application of the technology and guarantee patient safety and proposes standardized requirements and suggestions.

With the development of information technology and the increasing demand for vaccination services among the people, it is a definite trend to enhance the quality of vaccination services through digitization. This article starts with a clear concept of digital services for vaccination, introduces the current development status in China and abroad, analyzes the advantages and disadvantages of existing models in leading regions, takes a glean from the summation, and proposes targeted solutions. This study suggests establishing a departmental coordination mechanism for data interconnection and sharing, formulating data standards and functional specifications, enhancing the functionalities of the immunization planning information system, strengthening data collection and analytical usage, and intensifying appointment management and science and health education to provide expert guidance for the construction of digital vaccination services across the country in the future.

Birth defects are a major problem threatening the health of children in China. Genetic factors play a major role in birth defect etiology. Molecular diagnosis is the key means for screening, diagnosing, and preventing birth defects caused by genetic factors. How to carry out large-scale and cost-effective molecular diagnosis in clinical practice is a major challenge in the prevention and treatment of birth defects in China. This article reviews the current status of birth defects in China, the application of molecular diagnostic technology in birth defect prevention and control, and the challenges in promoting its use, to provide references for clinical practice in birth defect molecular diagnosis.