BS EN ISO 16256:2021 - Clinical Laboratory Testing and In Vitro Diagnostic Test Systems

Standard Number: BS EN ISO 16256:2021

Pages: 28

Released: 2021-10-27

ISBN: 978 0 539 14268 6

Status: Standard

Overview

The BS EN ISO 16256:2021 standard is an essential document for clinical laboratories and professionals involved in in vitro diagnostic testing. This standard provides a comprehensive broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi that are implicated in infectious diseases. This method is crucial for ensuring accurate and reliable results in the diagnosis and treatment of fungal infections.

Key Features

• Comprehensive Guidelines: The standard offers detailed guidelines on the broth micro-dilution method, ensuring that laboratories can perform tests with precision and consistency.
• In-Depth Methodology: It includes step-by-step procedures for preparing and conducting tests, making it easier for laboratory personnel to follow and implement.
• Quality Assurance: By adhering to this standard, laboratories can ensure the quality and reliability of their test results, which is critical for patient care and treatment.
• International Recognition: As an ISO standard, it is recognized and accepted globally, facilitating international collaboration and standardization in clinical testing.

Benefits

Implementing the BS EN ISO 16256:2021 standard in your laboratory offers numerous benefits:

• Enhanced Accuracy: The standardized method reduces variability and enhances the accuracy of test results, leading to better patient outcomes.
• Improved Efficiency: Clear and detailed procedures streamline the testing process, saving time and resources.
• Regulatory Compliance: Adhering to this standard helps laboratories meet regulatory requirements and maintain accreditation.
• Global Compatibility: The international acceptance of this standard ensures compatibility with other laboratories and healthcare providers worldwide.

Who Should Use This Standard?

This standard is designed for use by:

• Clinical laboratories involved in the testing of antimicrobial agents against yeast fungi.
• Healthcare professionals responsible for diagnosing and treating fungal infections.
• Researchers and scientists working in the field of microbiology and infectious diseases.
• Regulatory bodies and accreditation organizations overseeing laboratory practices.

Detailed Content

The BS EN ISO 16256:2021 standard spans 28 pages and covers a wide range of topics, including:

• Introduction to the broth micro-dilution method.
• Preparation of test materials and reagents.
• Step-by-step procedures for conducting the tests.
• Interpretation of test results.
• Quality control measures and troubleshooting tips.
• Appendices with additional resources and references.

Release Information

This standard was released on October 27, 2021, and is available under the ISBN 978 0 539 14268 6. It is the latest and most up-to-date version, reflecting the current best practices and advancements in the field of clinical laboratory testing.

Conclusion

The BS EN ISO 16256:2021 standard is an invaluable resource for any clinical laboratory involved in the testing of antimicrobial agents against yeast fungi. By providing a detailed and standardized method, it ensures the accuracy, reliability, and consistency of test results, ultimately contributing to better patient care and treatment outcomes. Whether you are a healthcare professional, researcher, or regulatory body, this standard is a must-have for maintaining high standards in clinical laboratory testing.

BS EN ISO 16256:2021

This standard BS EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as Blastomyces dermatitidis and/or Histoplasma capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Those methods are beyond the scope of this document.

This document describes the broth micro-dilution reference method, which can be implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method)^{[ 1 ][ 5 ]}; the second pathway involves spectrophotometric determination of MICs (EUCAST method)^{[ 2 ][ 10 ]}. The MIC reflects the activity of the drug under the described test conditions and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or antifungal resistance mechanisms. In addition, MIC distributions can be used to define wild type or non-wild type fungal populations. Clinical interpretation of the MIC value is beyond the scope of this document; interpretive category breakpoints specific to the CLSI- and EUCAST-derived methods can be found by consulting the latest interpretive tables provided by the organizations^{[ 5 ][ 15 ]}. Routine susceptibility testing methods or diagnostic test devices can be compared with this reference method in order to ensure comparable and reliable results for validation or registration purposes.