ISO 11781:2025 pdf download,Molecular biomarker analysis — Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods.
ISO 11781:2025 provides minimum requirements and performance criteria for performing a single-laboratory validation of qualitative (binary) real-time PCR methods used to detect specific DNA sequences in foods. It is designed to ensure that a newly developed PCR assay is “fit for purpose” before being adopted in-house. The standard applies to qualitative real-time PCR targeting food-related DNA markers, such as those used for identifying genetically modified organisms and derived products, or for species determination, including species associated with allergenic proteins. It does not apply to validation of qualitative microbiological real-time PCR methods, and it does not cover evaluating whether a method is applicable or practicable for a particular scope. Overall, it gives a structured protocol and acceptance-oriented criteria so laboratories can produce defensible validation data, supporting decisions about implementing the method and whether further collaborative validation may be needed.
