PD CEN/TS 17626:2021 - Molecular In Vitro Diagnostic Examinations

Overview

The PD CEN/TS 17626:2021 is a comprehensive standard that provides detailed specifications for pre-examination processes for human specimens, specifically focusing on isolated microbiome DNA. Released on May 10, 2021, this standard is an essential resource for laboratories and professionals involved in molecular in vitro diagnostic examinations. With a total of 42 pages, it offers in-depth guidance to ensure the accuracy and reliability of diagnostic results.

Key Features

• Standard Number: PD CEN/TS 17626:2021
• Pages: 42
• Release Date: May 10, 2021
• ISBN: 978 0 539 06269 4
• Status: Standard

Importance of Pre-Examination Processes

In the realm of molecular diagnostics, the pre-examination phase is crucial. It involves all the steps that occur before the actual analysis of the specimen, including collection, handling, transportation, and storage. The quality of these processes directly impacts the integrity of the DNA and, consequently, the accuracy of the diagnostic results. The PD CEN/TS 17626:2021 standard provides a structured approach to these processes, ensuring that the microbiome DNA remains intact and uncontaminated.

Why Choose PD CEN/TS 17626:2021?

This standard is designed to meet the needs of modern laboratories that require precise and reliable diagnostic results. By adhering to the guidelines set forth in PD CEN/TS 17626:2021, laboratories can enhance their operational efficiency and improve the quality of their diagnostic services. Here are some reasons why this standard is indispensable:

• Comprehensive Guidelines: It covers all aspects of pre-examination processes, ensuring that every step is performed with precision.
• Enhanced Accuracy: By following the standard, laboratories can minimize errors and improve the accuracy of their diagnostic results.
• Quality Assurance: The standard provides a framework for maintaining high-quality standards in molecular diagnostics.
• Up-to-Date Information: Released in 2021, it reflects the latest advancements and best practices in the field.

Who Can Benefit from This Standard?

The PD CEN/TS 17626:2021 standard is ideal for a wide range of professionals and organizations involved in molecular diagnostics, including:

• Clinical Laboratories: Ensure the reliability of diagnostic tests by adhering to standardized pre-examination processes.
• Research Institutions: Enhance the quality of research outcomes by maintaining the integrity of microbiome DNA samples.
• Healthcare Providers: Improve patient care by relying on accurate and reliable diagnostic results.
• Regulatory Bodies: Use the standard as a benchmark for evaluating the quality of diagnostic services.

Conclusion

The PD CEN/TS 17626:2021 standard is an invaluable resource for anyone involved in molecular in vitro diagnostic examinations. By providing detailed specifications for pre-examination processes, it ensures the integrity and reliability of microbiome DNA samples. Whether you are a laboratory professional, researcher, or healthcare provider, this standard will help you achieve the highest quality standards in your diagnostic processes. Embrace the PD CEN/TS 17626:2021 standard and take a significant step towards excellence in molecular diagnostics.

PD CEN/TS 17626:2021

This standard PD CEN/TS 17626:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA is classified in these ICS categories:

• 11.100.01 Laboratory medicine in general

This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.

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 are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.

Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated DNA.