PD CEN/TS 17742:2022 - Molecular in vitro diagnostic examinations

Standard Number: PD CEN/TS 17742:2022

Pages: 28

Released: 2022-05-11

ISBN: 978 0 539 06274 8

Name: Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma

Status: Standard

Overview

Introducing the PD CEN/TS 17742:2022, a comprehensive standard that sets the benchmark for molecular in vitro diagnostic examinations. This standard is specifically designed to provide detailed specifications for pre-examination processes involving venous whole blood and the isolation of circulating cell-free RNA from plasma. Released on May 11, 2022, this 28-page document is an essential resource for laboratories, researchers, and healthcare professionals who are involved in molecular diagnostics and RNA analysis.

Key Features

• Comprehensive Guidelines: The PD CEN/TS 17742:2022 offers thorough guidelines that cover every aspect of pre-examination processes for venous whole blood. This ensures that all procedures are standardized, leading to more reliable and reproducible results.
• Focus on RNA Isolation: This standard places a significant emphasis on the isolation of circulating cell-free RNA from plasma, a critical component in various diagnostic and research applications.
• Up-to-Date Information: Released in 2022, this standard incorporates the latest advancements and best practices in the field of molecular diagnostics.
• Internationally Recognized: As a standard, the PD CEN/TS 17742:2022 is recognized and respected globally, making it a valuable addition to any laboratory's reference library.

Why Choose PD CEN/TS 17742:2022?

The PD CEN/TS 17742:2022 is not just another standard; it is a vital tool that can significantly enhance the quality and accuracy of your molecular diagnostic examinations. Here are some reasons why you should consider integrating this standard into your laboratory practices:

• Enhanced Accuracy: By following the detailed specifications outlined in this standard, you can ensure that your pre-examination processes are precise and consistent, leading to more accurate diagnostic results.
• Improved Reproducibility: Standardized procedures help in achieving reproducible results, which are crucial for validating diagnostic tests and conducting reliable research.
• Quality Assurance: Adhering to internationally recognized standards like the PD CEN/TS 17742:2022 demonstrates your commitment to quality and excellence in molecular diagnostics.
• Regulatory Compliance: Many regulatory bodies require adherence to specific standards for diagnostic procedures. By following the PD CEN/TS 17742:2022, you can ensure compliance with these regulations.

Applications

The PD CEN/TS 17742:2022 is versatile and can be applied in various settings, including:

• Clinical Laboratories: Enhance the accuracy and reliability of diagnostic tests involving venous whole blood and circulating cell-free RNA.
• Research Institutions: Standardize pre-examination processes to ensure reproducible and reliable research outcomes.
• Biotechnology Companies: Implement best practices in RNA isolation and molecular diagnostics to improve product development and innovation.
• Academic Institutions: Provide students and researchers with a robust framework for conducting molecular diagnostic examinations.

Content Highlights

The PD CEN/TS 17742:2022 covers a wide range of topics, including but not limited to:

• Pre-Examination Processes: Detailed guidelines on the collection, handling, and processing of venous whole blood samples.
• RNA Isolation: Step-by-step procedures for isolating circulating cell-free RNA from plasma, ensuring high yield and purity.
• Quality Control: Best practices for maintaining the integrity and quality of RNA samples throughout the pre-examination process.
• Technical Specifications: Comprehensive technical details to ensure that all procedures are performed to the highest standards.

Conclusion

In the rapidly evolving field of molecular diagnostics, having a reliable and up-to-date standard is crucial. The PD CEN/TS 17742:2022 provides a robust framework for pre-examination processes involving venous whole blood and the isolation of circulating cell-free RNA from plasma. With its comprehensive guidelines, focus on RNA isolation, and commitment to quality, this standard is an invaluable resource for any laboratory or research institution. Enhance the accuracy, reproducibility, and quality of your molecular diagnostic examinations by integrating the PD CEN/TS 17742:2022 into your practices.

PD CEN/TS 17742:2022

This standard PD CEN/TS 17742:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, processing and documentation of venous whole blood specimens intended for ccfRNA examination. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/TS 17747, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - Isolated DNA, RNA and proteins, and in EN ISO 20186 1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.