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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>PD CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows Human DNA examination
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PD CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows Human DNA examination

PD CEN/TS 17981-1:2023

In vitro diagnostic Next Generation Sequencing (NGS) workflows Human DNA examination

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Standard number:PD CEN/TS 17981-1:2023
Pages:64
Released:2023-12-04
ISBN:978 0 539 21303 4
Status:Standard

PD CEN/TS 17981-1:2023 - In vitro Diagnostic Next Generation Sequencing (NGS) Workflows for Human DNA Examination

Unlock the future of genetic analysis with the PD CEN/TS 17981-1:2023 standard, a comprehensive guide designed to elevate your in vitro diagnostic Next Generation Sequencing (NGS) workflows for human DNA examination. This essential document is your key to ensuring precision, reliability, and efficiency in genetic testing and research.

Why Choose PD CEN/TS 17981-1:2023?

As the field of genomics continues to evolve, the need for standardized procedures in NGS workflows becomes increasingly critical. The PD CEN/TS 17981-1:2023 standard provides a robust framework that addresses the complexities and challenges associated with human DNA examination. Here’s why this standard is indispensable:

  • Comprehensive Coverage: Spanning 64 pages, this standard offers detailed guidelines and best practices for every step of the NGS workflow, from sample preparation to data analysis.
  • Up-to-Date Information: Released on December 4, 2023, this document reflects the latest advancements and innovations in the field of NGS.
  • ISBN: 978 0 539 21303 4 - Easily reference and cite this authoritative source in your research and documentation.
  • Standard Status: As a recognized standard, PD CEN/TS 17981-1:2023 ensures compliance with industry regulations and enhances the credibility of your laboratory’s findings.

Key Features and Benefits

The PD CEN/TS 17981-1:2023 standard is meticulously crafted to support laboratories and research institutions in achieving excellence in NGS workflows. Here are some of the standout features and benefits:

1. Enhanced Accuracy and Reliability

By adhering to the guidelines outlined in this standard, you can significantly improve the accuracy and reliability of your NGS results. This is crucial for clinical diagnostics, where precise genetic information can inform critical healthcare decisions.

2. Streamlined Workflow Processes

The standard provides a clear and structured approach to NGS workflows, helping you streamline processes and reduce the risk of errors. This leads to more efficient operations and faster turnaround times for genetic analysis.

3. Quality Assurance and Compliance

Compliance with the PD CEN/TS 17981-1:2023 standard ensures that your laboratory meets the highest quality assurance standards. This not only enhances the credibility of your results but also aligns with regulatory requirements, facilitating smoother audits and inspections.

4. Cutting-Edge Techniques and Technologies

Stay ahead of the curve with the latest techniques and technologies in NGS. The standard incorporates contemporary methodologies that enhance the sensitivity and specificity of human DNA examination, enabling you to achieve groundbreaking discoveries.

5. Comprehensive Documentation

With 64 pages of in-depth content, the standard serves as a valuable reference for both novice and experienced professionals in the field of genomics. It covers a wide range of topics, including sample collection, library preparation, sequencing protocols, data analysis, and interpretation.

Who Should Use This Standard?

The PD CEN/TS 17981-1:2023 standard is designed for a diverse audience, including:

  • Clinical Laboratories: Enhance the accuracy and reliability of diagnostic tests, leading to better patient outcomes.
  • Research Institutions: Standardize NGS workflows to ensure reproducibility and validity of research findings.
  • Biotechnology Companies: Implement best practices in NGS to drive innovation and product development.
  • Academic Institutions: Provide students and researchers with a solid foundation in NGS methodologies.

Table of Contents

Here’s a glimpse of what you can expect inside the PD CEN/TS 17981-1:2023 standard:

  1. Introduction to NGS Workflows
  2. Sample Collection and Preparation
  3. Library Preparation Techniques
  4. Sequencing Protocols
  5. Data Analysis and Interpretation
  6. Quality Control and Assurance
  7. Regulatory Compliance and Standards
  8. Case Studies and Applications
  9. Future Trends in NGS

Invest in Excellence

In the rapidly advancing field of genomics, staying updated with the latest standards is crucial for maintaining excellence in your work. The PD CEN/TS 17981-1:2023 standard is an invaluable resource that empowers you to achieve the highest levels of accuracy, reliability, and efficiency in human DNA examination through NGS workflows.

Don’t miss out on this opportunity to elevate your laboratory’s capabilities and stay ahead in the competitive landscape of genetic analysis. Invest in the PD CEN/TS 17981-1:2023 standard today and take a significant step towards excellence in genomics.

Note: This standard is available for purchase and immediate download. Ensure your laboratory is equipped with the latest guidelines and best practices in NGS workflows.

Conclusion

The PD CEN/TS 17981-1:2023 standard is more than just a document; it’s a comprehensive guide that empowers you to achieve precision and excellence in human DNA examination through NGS workflows. With its detailed guidelines, up-to-date information, and focus on quality assurance, this standard is an essential tool for any laboratory or research institution involved in genetic analysis.

Equip your team with the knowledge and best practices outlined in this standard, and take your NGS workflows to the next level. Embrace the future of genomics with confidence and ensure your laboratory remains at the forefront of genetic research and diagnostics.

Order your copy of the PD CEN/TS 17981-1:2023 standard today and embark on a journey towards unparalleled accuracy and reliability in human DNA examination.

DESCRIPTION

PD CEN/TS 17981-1:2023


This standard PD CEN/TS 17981-1:2023 In vitro diagnostic Next Generation Sequencing (NGS) workflows is classified in these ICS categories:
  • 11.100.10 In vitro diagnostic test systems
This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva. NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organizations performing biomedical research. This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.