ISO 20395 Biotechnology - Testing of Quantification Methods for Nucleic Acid Target Sequences

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 20395 testing. This standard provides general requirements for evaluating the performance and ensuring the quality of methods used to quantify certain nucleic acid sequences (targets).

This standard applies to the quantification of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) target sequences using digital (dPCR) or quantitative real-time PCR (qPCR) amplification technologies. It applies to target sequences found in nucleic acid molecules, including double-stranded DNA (dsDNA), single-stranded DNA (ssDNA), complementary DNA (cDNA), and single-stranded RNA (ssRNA), such as genomic DNA (gDNA) and plasmid DNA.

This standard does not apply to the quantification of very short DNA oligonucleotides (<50 bases).

This standard covers:

• Analytical design including quantification strategies (nucleic acid copy number quantification using a calibration curve as in qPCR or molecular counting as in dPCR, quantification against an independent sample and ratio measurements) and use of controls;
• Quantification and quality control of the total nucleic acid mass concentration of a nucleic acid sample, including evaluation 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 measurement, limit of detection, accuracy and robustness) with specific requirements for qPCR and dPCR;
• Approaches to establishing metrological traceability and estimating measurement uncertainty.

This standard does not provide requirements or acceptance criteria for sampling or processing of biological samples (ie collection, preservation, transport, storage, processing and nucleic acid extraction). Nor does it meet the requirements and acceptance criteria for certain applications (for example, food or clinical applications where certain matrix problems may arise).

EUROLAB assists manufacturers with ISO 20395 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.