PD CEN/TS 17329-1 is the first part in a multi-series of documents that describes the performance characteristics and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs.
PD CEN/TS 17329-1 is applicable also for single-laboratory validation of qualitative PCR methods used for the analysis of other food materials, e.g. for species detection and identification.
PD CEN/TS 17329-1 does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.
PD CEN/TS 17329-1 on validation of real-time PCR methods for foodstuffs is applicable to:
PD CEN/TS 17329-1 provides a protocol for single-laboratory validation of qualitative real-time PCR methods which are applied for food analysis.
PD CEN/TS 17329-1 is useful as it is used to confirm that the procedure to be employed for a specific test is suitable for its intended purpose. Test method validation gives an overall understanding of the uncertainty of the method.
PD CEN/TS 17329-1 is helpful as it assures the scientific veracity of analytical results and helps in improvement of quality management. Proper validation of a method provides documented evidence of method performance and prescribes ongoing measures to ensure quality monitoring for the life of the method.
CEN/TS 17329-1