BS ISO 20395:2019 Biotechnology Standard

Welcome to the comprehensive guide on the BS ISO 20395:2019 Biotechnology Standard, a pivotal document for professionals in the field of biotechnology. This standard is essential for those involved in the evaluation of quantification methods for nucleic acid target sequences, specifically focusing on qPCR and dPCR techniques.

Overview

The BS ISO 20395:2019 standard provides a detailed framework for assessing the performance of quantification methods used in the analysis of nucleic acid target sequences. This document is crucial for ensuring accuracy, reliability, and consistency in biotechnological applications, particularly in the realms of quantitative Polymerase Chain Reaction (qPCR) and digital Polymerase Chain Reaction (dPCR).

Key Features

• Standard Number: BS ISO 20395:2019
• Pages: 60
• Release Date: August 12, 2019
• ISBN: 978 0 580 95165 7
• Status: Standard

Why This Standard is Important

In the rapidly evolving field of biotechnology, the need for precise and reliable quantification methods cannot be overstated. The BS ISO 20395:2019 standard addresses this need by providing a robust set of requirements for evaluating the performance of these methods. This ensures that results are not only accurate but also reproducible across different laboratories and settings.

By adhering to this standard, laboratories can enhance their credibility and ensure compliance with international best practices. This is particularly important for research institutions, clinical laboratories, and companies involved in the development of diagnostic tools and therapeutic solutions.

Applications of the Standard

The BS ISO 20395:2019 standard is applicable in various sectors of biotechnology, including:

• Medical Diagnostics: Ensuring the accuracy of diagnostic tests that rely on nucleic acid quantification.
• Pharmaceutical Research: Supporting the development of new drugs and therapies by providing reliable data on genetic sequences.
• Agricultural Biotechnology: Assisting in the development of genetically modified organisms (GMOs) by ensuring precise genetic analysis.
• Environmental Biotechnology: Facilitating the monitoring of environmental samples for genetic material.

Understanding qPCR and dPCR

Quantitative Polymerase Chain Reaction (qPCR) and Digital Polymerase Chain Reaction (dPCR) are two powerful techniques used for the quantification of nucleic acids. While qPCR is widely used for its speed and efficiency, dPCR offers unparalleled precision and sensitivity, making it ideal for applications where absolute quantification is required.

The BS ISO 20395:2019 standard provides guidelines for both methods, ensuring that users can select the most appropriate technique for their specific needs and achieve the highest level of accuracy in their results.

Benefits of Implementing the Standard

Implementing the BS ISO 20395:2019 standard offers numerous benefits, including:

• Enhanced Accuracy: By following the standard, laboratories can achieve more accurate and reliable results.
• Increased Reproducibility: The standard ensures that results can be consistently reproduced across different settings.
• International Recognition: Compliance with the standard demonstrates adherence to globally recognized best practices.
• Improved Efficiency: The guidelines help streamline processes, reducing the time and resources required for nucleic acid quantification.

Conclusion

The BS ISO 20395:2019 Biotechnology Standard is an indispensable resource for professionals in the field of biotechnology. By providing a comprehensive framework for evaluating the performance of quantification methods for nucleic acid target sequences, this standard ensures that laboratories can achieve the highest levels of accuracy, reliability, and consistency in their work.

Whether you are involved in medical diagnostics, pharmaceutical research, agricultural biotechnology, or environmental monitoring, the BS ISO 20395:2019 standard is your key to success in the ever-evolving world of biotechnology.

BS ISO 20395:2019

This standard BS ISO 20395:2019 Biotechnology. Requirements for evaluating the performance of quantification methods for nucleic acid target sequences. qPCR and dPCR is classified in these ICS categories:

• 07.080 Biology. Botany. Zoology

This document provides generic requirements for evaluating the performance and ensuring the quality of methods used for the quantification of specific nucleic acid sequences (targets).

This document is applicable to the quantification of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) target sequences using either digital (dPCR) or quantitative real-time PCR (qPCR) amplification technologies. It applies to target sequences present in nucleic acid molecules including double-stranded DNA (dsDNA) such as genomic DNA (gDNA) and plasmid DNA, single stranded DNA (ssDNA), complementary DNA (cDNA), and single stranded RNA (ssRNA) including ribosomal RNA (rRNA), messenger RNA (mRNA), and long and short non-coding RNA [microRNAs (miRNAs) and short interfering RNAs (siRNAs)], as well as double-stranded RNA (dsRNA).

This document applies to nucleic acids derived from biological sources such as viruses, prokaryotic and eukaryotic cells, cell-free biological fluids (e.g. plasma or cell media) or in vitro sources [e.g. oligonucleotides, synthetic gene constructs and in vitro transcribed (IVT) RNA].

This document is not applicable to quantification of very short DNA oligonucleotides (<50 bases).

This document covers:

• analytical design including quantification strategies (nucleic acid copy number quantification using a calibration curve as in qPCR or through molecular counting as in dPCR, quantification relative to an independent sample and ratio measurements) and use of controls;

• quantification of total nucleic acid mass concentration and quality control of a nucleic acid sample including assessment of nucleic acid quality (purity and integrity);

• PCR assay design, optimization, in silico and in vitro specificity testing;

• data quality control and analysis including acceptance criteria, threshold setting and normalization;

• method validation (precision, linearity, limit of quantification, limit of detection, trueness and robustness) with specific requirements for qPCR and dPCR;

• approaches to establishing metrological traceability and estimating measurement uncertainty.

This document does not provide requirements or acceptance criteria for the sampling of biological materials or processing of biological samples (i.e. collection, preservation, transportation, storage, treatment and nucleic acid extraction). Nor does it provide requirements and acceptance criteria for specific applications (e.g. food or clinical applications where specific matrix issues can arise).