PD CEN/TS 17747:2022 - Molecular in vitro diagnostic examinations

Standard Number: PD CEN/TS 17747:2022

Pages: 30

Released: 2022-05-26

ISBN: 978 0 539 06273 1

Status: Standard

Overview

The PD CEN/TS 17747:2022 standard is a comprehensive guideline for molecular in vitro diagnostic examinations, specifically focusing on the pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. This standard is crucial for ensuring the accuracy and reliability of diagnostic results, particularly when analyzing DNA, RNA, and proteins.

Key Features

• Comprehensive Guidelines: This standard provides detailed specifications for the pre-examination processes, ensuring that all steps are meticulously followed to maintain the integrity of the samples.
• Focus on Exosomes and Extracellular Vesicles: The standard specifically addresses the handling and processing of exosomes and other extracellular vesicles, which are critical for various diagnostic applications.
• Applicable to Venous Whole Blood: The guidelines are tailored for samples derived from venous whole blood, making it highly relevant for clinical and research settings.
• DNA, RNA, and Proteins: The standard covers the pre-examination processes for analyzing DNA, RNA, and proteins, ensuring comprehensive diagnostic capabilities.

Why This Standard is Essential

In the field of molecular diagnostics, the accuracy and reliability of test results are paramount. The PD CEN/TS 17747:2022 standard plays a critical role in achieving these goals by providing a structured approach to the pre-examination processes. By adhering to these guidelines, laboratories can minimize the risk of sample degradation and contamination, thereby ensuring that the diagnostic results are both accurate and reproducible.

Detailed Specifications

The standard spans 30 pages and was released on 2022-05-26. It is identified by the ISBN 978 0 539 06273 1. As a recognized standard, it provides a reliable framework for laboratories and researchers involved in molecular diagnostics.

Applications

The PD CEN/TS 17747:2022 standard is applicable in various settings, including:

• Clinical Laboratories: Ensuring the accuracy of diagnostic tests for patient care.
• Research Institutions: Providing a reliable framework for scientific studies involving exosomes and extracellular vesicles.
• Biotechnology Companies: Supporting the development of new diagnostic tools and technologies.

Benefits of Adherence

By adhering to the PD CEN/TS 17747:2022 standard, laboratories and researchers can achieve several benefits:

• Enhanced Accuracy: Minimize errors and variability in diagnostic results.
• Improved Reproducibility: Ensure that results can be consistently replicated across different settings.
• Increased Reliability: Build trust in the diagnostic processes and outcomes.
• Regulatory Compliance: Meet industry standards and regulatory requirements.

Conclusion

The PD CEN/TS 17747:2022 standard is an indispensable resource for anyone involved in molecular in vitro diagnostic examinations. By providing detailed specifications for the pre-examination processes of exosomes and other extracellular vesicles in venous whole blood, it ensures the highest standards of accuracy, reliability, and reproducibility. Whether you are working in a clinical laboratory, a research institution, or a biotechnology company, this standard will help you achieve the best possible outcomes in your diagnostic endeavors.

PD CEN/TS 17747:2022

This standard PD CEN/TS 17747:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for DNA, RNA and protein examination from exosomes and other extracellular vesicles during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in isolated DNA, RNA and proteins from enriched 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 health care institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken during the pre-examination phase for venous whole blood circulating cell-free RNA (ccfRNA) examination and for venous whole blood circulating cell-free DNA (ccfDNA) examination, both without prior enrichment of exosomes and other extracellular vesicles. These are not described in this document but are covered in EN ISO 20186 3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma and CEN/TS 17742, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.