Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Isolated genomic DNA

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Isolated genomic DNA

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What is CEN/TS 17688-3 about? 

CEN/TS 17688-3 is the third part of a series of documents. CEN/TS 17688-3 provides guidelines on the handling, documentation, storage and processing of fine-needle aspirates (FNAs) intended for gDNA examination during the pre-examination phase before a molecular examination is performed. 

International, national, or regional regulations or requirements can also apply to specific topics covered in CEN/TS 17688-3 

Note: CEN/TS 17688-3 is not applicable for pathogen DNA examination and gDNA examination by in situ detection. Different dedicated measures are taken for collecting, stabilizing, transporting, and storing core needle biopsies (FNA Biopsy or FNA B) and are not covered in CEN/TS 17688-3 

Who is CEN/TS 17688-3 for? 

CEN/TS 17688-3 on molecular In vitro diagnostic examinations are applicable to: 

  • Medical laboratories 
  • Laboratory customers 
  • Vitro diagnostics developers and manufacturers 
  • Biobanks 
  • Institutions and commercial organizations performing biomedical research 
  • Regulatory authorities 

Why should you use CEN/TS 17688-3? 

CEN/TS 17688-3 provides guidelines for the handling, documentation, storage, and processing which is a crucial part of collecting Fine-needle aspirates (FNAs). CEN/TS 17688-3 specifies recommendations for the pre-examination phase of Isolated genomic DNA examination. As a result, the test findings of Isolated genomic DNA studies become more reliable and credible. 

CEN/TS 17688-3 provides globally accepted standard guidelines for collecting fine-needle aspirates (FNAs) which is important in the prevention and detection of disease.