BS EN ISO 20186-3:2019 - Molecular In-Vitro Diagnostic Examinations

Welcome to the world of precision and reliability in molecular diagnostics with the BS EN ISO 20186-3:2019 standard. This essential document is a cornerstone for laboratories and professionals involved in the pre-examination processes of venous whole blood, specifically focusing on the isolation of circulating cell-free DNA from plasma. Released on November 27, 2019, this standard is a testament to the ongoing advancements in the field of molecular diagnostics.

Key Features and Benefits

The BS EN ISO 20186-3:2019 standard is meticulously crafted to ensure that the pre-examination processes for venous whole blood are conducted with the highest level of accuracy and efficiency. Here are some of the key features and benefits:

• Comprehensive Guidelines: This standard provides detailed specifications for the pre-examination processes, ensuring that every step is performed with precision to maintain the integrity of the isolated circulating cell-free DNA.
• Enhanced Diagnostic Accuracy: By adhering to these guidelines, laboratories can significantly improve the accuracy of molecular in-vitro diagnostic examinations, leading to better patient outcomes.
• International Recognition: As an ISO standard, it is recognized globally, facilitating international collaboration and consistency in diagnostic practices.
• Quality Assurance: Implementing this standard helps laboratories achieve a high level of quality assurance, which is crucial for maintaining trust and reliability in diagnostic results.

Technical Specifications

For those who require detailed technical information, here are the specifications of the BS EN ISO 20186-3:2019 standard:

• Standard Number: BS EN ISO 20186-3:2019
• Pages: 26
• ISBN: 978 0 539 12203 9
• Status: Standard

Why Choose BS EN ISO 20186-3:2019?

In the rapidly evolving field of molecular diagnostics, staying ahead requires adherence to the most current and comprehensive standards. The BS EN ISO 20186-3:2019 is designed to meet the needs of modern laboratories by providing a robust framework for the pre-examination processes of venous whole blood. Here’s why this standard is indispensable:

• Consistency Across Laboratories: By following this standard, laboratories can ensure consistency in their processes, which is crucial for reliable and comparable results across different settings.
• Facilitates Research and Development: With clear guidelines, researchers can focus on innovation and development, knowing that their foundational processes are sound and standardized.
• Supports Regulatory Compliance: Adhering to internationally recognized standards helps laboratories meet regulatory requirements, reducing the risk of non-compliance.

Applications and Use Cases

The BS EN ISO 20186-3:2019 standard is applicable in a variety of settings, including:

• Clinical Laboratories: Ensuring accurate diagnostic results for patient care.
• Research Institutions: Providing a reliable framework for experimental studies involving cell-free DNA.
• Biotechnology Companies: Supporting the development of new diagnostic tools and technologies.

Conclusion

In conclusion, the BS EN ISO 20186-3:2019 standard is an invaluable resource for any laboratory or institution involved in molecular diagnostics. Its comprehensive guidelines and international recognition make it a critical component in ensuring the accuracy and reliability of diagnostic examinations. By implementing this standard, you are not only enhancing the quality of your processes but also contributing to the advancement of healthcare and patient outcomes worldwide.

Embrace the future of molecular diagnostics with the BS EN ISO 20186-3:2019 standard and ensure that your laboratory is at the forefront of innovation and excellence.

BS EN ISO 20186-3:2019

This standard BS EN ISO 20186-3:2019 Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems
• 11.100.30 Analysis of blood and urine

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination 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 stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.