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

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

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What is CEN/TS 176882 about? 

CEN/TS 176882 is the second part of a series of documents. CEN/TA 17688-2 provides guidelines on the handling, documentation, storage, and processing of fine-needle aspirates (FNAs) intended for protein 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 176882. 

Note: 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 176882, but in EN ISO 20184-2

Note 2: CEN/TS 17688-2 is not applicable for protein examination by immunohistochemistry. 

Who is CEN/TS 176882 for? 

CEN/TS 176882 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 176882? 

CEN/TS 17688-2 provides guidelines for the handling, documentation, storage, and processing which is a crucial part of collecting Fine-needle aspirates (FNAs), CEN/TS 17688-2 specifies recommendations for the pre-examination phase of protein examination. As a result, the test findings of protein examination studies become more reliable and credible. 

CEN/TS 17688-2 provides globally accepted standard guidelines for collecting fine-needle aspirates (FNAs) which is important in the prevention and detection of disease.