PD CEN/TS 17688-3:2021 Molecular in vitro diagnostic examinations

Standard Number: PD CEN/TS 17688-3:2021

Pages: 40

Released: 2021-12-23

ISBN: 978 0 539 06271 7

Name: Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) Isolated genomic DNA

Status: Standard

Overview

Introducing the PD CEN/TS 17688-3:2021, a comprehensive standard that sets the benchmark for molecular in vitro diagnostic examinations. This document provides detailed specifications for pre-examination processes specifically tailored for Fine Needle Aspirates (FNAs) and the isolation of genomic DNA. Released on December 23, 2021, this 40-page standard is an essential resource for laboratories and healthcare professionals dedicated to ensuring the highest quality in diagnostic examinations.

Key Features

• Comprehensive Guidelines: This standard offers a thorough set of guidelines that cover every aspect of pre-examination processes for FNAs, ensuring that genomic DNA isolation is performed with the utmost precision and accuracy.
• Up-to-Date Information: Released in late 2021, the PD CEN/TS 17688-3:2021 incorporates the latest advancements and best practices in the field of molecular diagnostics.
• Quality Assurance: Adhering to this standard helps laboratories maintain high-quality control and consistency in their diagnostic processes, ultimately leading to more reliable and accurate results.
• International Recognition: As a recognized standard, PD CEN/TS 17688-3:2021 is trusted by professionals worldwide, making it a valuable addition to any laboratory's reference library.

Why Choose PD CEN/TS 17688-3:2021?

In the rapidly evolving field of molecular diagnostics, staying current with the latest standards is crucial. The PD CEN/TS 17688-3:2021 provides a robust framework for laboratories to follow, ensuring that pre-examination processes for FNAs are conducted with the highest level of precision. By adhering to this standard, laboratories can enhance their diagnostic capabilities, improve patient outcomes, and maintain compliance with international regulations.

Detailed Specifications

This standard delves into the specifics of pre-examination processes, offering detailed instructions and best practices for handling Fine Needle Aspirates. It covers various aspects, including:

• Sample Collection: Guidelines for the proper collection of FNAs to ensure sample integrity and prevent contamination.
• Sample Handling: Best practices for handling and transporting samples to maintain their quality and suitability for genomic DNA isolation.
• DNA Isolation: Step-by-step procedures for isolating genomic DNA from FNAs, ensuring high yield and purity.
• Quality Control: Methods for assessing the quality and quantity of isolated DNA, ensuring it meets the required standards for downstream applications.

Who Can Benefit?

The PD CEN/TS 17688-3:2021 is an invaluable resource for a wide range of professionals in the healthcare and diagnostics industry, including:

• Clinical Laboratories: Enhance the accuracy and reliability of diagnostic tests by following standardized pre-examination processes.
• Research Institutions: Ensure the integrity of samples and the quality of genomic DNA for research purposes.
• Healthcare Providers: Improve patient outcomes by utilizing high-quality diagnostic examinations based on standardized procedures.
• Regulatory Bodies: Reference a recognized standard to ensure compliance with international guidelines and regulations.

Conclusion

The PD CEN/TS 17688-3:2021 is more than just a standard; it is a comprehensive guide that empowers laboratories and healthcare professionals to achieve excellence in molecular diagnostics. By providing detailed specifications for pre-examination processes for Fine Needle Aspirates and the isolation of genomic DNA, this standard ensures that diagnostic examinations are conducted with the highest level of precision and accuracy. Stay ahead in the field of molecular diagnostics by incorporating the PD CEN/TS 17688-3:2021 into your laboratory's practices.

PD CEN/TS 17688-3:2021

This standard PD CEN/TS 17688-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine gDNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but EN ISO 20184-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA and EN ISO 20166-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA. This document is not applicable for pathogen DNA examination and gDNA examination by in situ detection. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.