Foodstuffs. General guidelines for the validation of qualitative real-time PCR methods - Single-laboratory validation
Foodstuffs. General guidelines for the validation of qualitative real-time PCR methods - Single-laboratory validation
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Foodstuffs. General guidelines for the validation of qualitative real-time PCR methods - Single-laboratory validation

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What is PD CEN/TS 17329-1 about?  

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. 

Who is PD CEN/TS 17329-1 for?  

PD CEN/TS 17329-1 on validation of real-time PCR methods for foodstuffs is applicable to: 

  • Food processing and manufacturing industry 
  • Food scientists and testing laboratories 
  • Authorities/agencies involved in testing ingredient list in foodstuff 

Why should you use PD CEN/TS 17329-1?  

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.