BS EN ISO 20186-2:2019

Overview

BS EN ISO 20186-2:2019 specifies the requirements for pre-examination processes for venous whole blood samples intended for molecular in vitro diagnostic examinations. This standard focuses on the isolation of genomic DNA, ensuring that the processes involved are robust and reliable. It is essential for laboratories engaged in molecular diagnostics to adhere to these specifications to maintain the integrity of test results and ensure patient safety.

Key Requirements

• Sample Collection: Guidelines for the collection of venous whole blood are outlined, ensuring that samples are collected in a manner that minimizes contamination and degradation.
• Sample Handling: Detailed instructions on the handling of samples post-collection are provided, including temperature control and time limits for processing.
• DNA Isolation Procedures: The standard describes validated methods for the isolation of genomic DNA from whole blood, ensuring that the extracted DNA is suitable for downstream applications.
• Quality Control Measures: Requirements for quality control throughout the pre-examination process are specified, including the use of controls and validation of methods.

Implementation Benefits

Adopting BS EN ISO 20186-2:2019 provides numerous benefits for healthcare laboratories:

• Enhanced Reliability: By following the specified procedures, laboratories can ensure that the genomic DNA extracted is of high quality, leading to more reliable diagnostic results.
• Standardisation: The standard promotes uniformity in laboratory practices, which is crucial for multi-site studies and collaborations.
• Improved Compliance: Adhering to this standard helps laboratories meet regulatory requirements, thereby reducing the risk of non-compliance during audits.

Compliance Value

Compliance with BS EN ISO 20186-2:2019 is vital for laboratories engaged in molecular diagnostics. It not only ensures that the processes are scientifically sound but also enhances the credibility of the laboratory's results. Regulatory bodies often require adherence to international standards, and compliance with this standard can facilitate smoother accreditation processes.

Furthermore, laboratories that implement these guidelines can demonstrate their commitment to quality and patient safety. This can enhance their reputation and foster trust among healthcare providers and patients alike.

In conclusion, BS EN ISO 20186-2:2019 is an essential standard for laboratories involved in molecular in vitro diagnostics. Its comprehensive guidelines for pre-examination processes ensure that genomic DNA is isolated effectively and reliably, thereby supporting accurate diagnostic outcomes.