New ISO and CEN Technical specifications for the pre-analytical process in molecular diagnostics

Testimonial from previous course participant:

“Excellent, very useful information and practical knowledge.” Ivan Romero, Roche Diagnostics, Mexico



1 day New ISO and CEN Technical Specifications for the pre-analytical process in molecular diagnostics

Target audience: Quality managers at medical and diagnostic laboratories, Laboratory personnel at medical and diagnostic laboratories, Pathologists, Biobank personnel, Managers and researchers coordinating or performing biomarker studies and trial.

Entrance qualifications: Basic Molecular biology or similar
Description: During 2015 The International Organization for Standardization (ISO) released Specifications and the European Committee for standardization (CEN) Technical Specifications about the pre-examination process for DNA, RNA and proteins from several sample types including fresh frozen tissue, formalin fixed tissue, blood and serum/plasma. The specifications are based on results from the FP7-funded project SPIDIA. TATAA Biocenter was partner of SPIDIA and contributed to the drafting of the new guidelines. These are of great value for reliable and robust sample handling and preparation in a standardized way to ensure measured data are of high quality and comparable across laboratories. The new guidelines are particularly relevant for accredited laboratories, and also for research and discovery based work, were procedures needs to be standardized and data compared. This course presents the new Specifications and brings them into context for smooth implementation in your laboratory procedures.

The course contains:

  • Background about standardization and the pre-analytical process.
  • Introduction to the new ISO Specifications and CEN Technical Specifications.
  • What to consider about the workflow of sampling, storage, transportation and extraction of nucleic acids and proteins.
  • What to consider about the workflow of sampling, storage, transportation and extraction of nucleic acids and proteins.
  • General information and considerations of RNA, DNA and protein extraction.
  • How to do quality assessment of RNA, DNA and proteins.



Tremendous teamwork within BBMRI-ERIC improves quality in biobanking

Newsletter BBMRIs Biobanks Europe, 6 2017

“Being part of SPIDIA and addressing the various challenges in the pre-analytical process and contributing to the writing of the CEN and ISO guidelines was most instrumental to us at TATAA Biocenter. It guided our development of quality control tools such as the RNA and DNA spikes, InterPlate Calibrator, ValidPrime for genomic background subtraction, and the DAmp assays to assess RNA integrity. We can now provide our customers with high quality and exceedingly robust data in their biomarker discovery and validation processes.“

Prof. Mikael Kubista, TATAA Biocenter