Kurt Zatloukal 1- BIOBANQUES May 17, 2016
Biobanking National Infrastructure Meeting
Quality matters: Improving the quality of biological resources
Session 1 : Controlling preanalytical factors
How to define sample quality in a rapidly developing field?
There is general acceptance that even the best analytical technology cannot deliver reliable results when the quality of the samples analysed is not appropriate. The problem in reproducing scientific data is increasingly recognized a major issue resulting in major financial losses of R&D spendings and potential harm for patients. There are several reasons for lack of reproducibility identified, such as shortcomings in study design and lack of experimental details, particularly detailed description of identity and quality of biological samples analysed. This generates a major need for better standardization and description of pre-analytical details essentially in all fields of biological and medical research. This need has been boosted by recent developments in personalized medicine. The European commission has funded under its framework programme 7 the project SPIDIA (Standardization and improvement of generic pre-analytical tools and procedures for in-vitro diagnostics) to develop the scientific basis for reliable performance of molecular test and to translate this into standards and norms. The work of SPIDIA has led to several new CEN Technical Specifications (TS) for molecular in vitro diagnostic examinations – specifications for the pre-examination processes, which are addressing specific pre-analytical quality requirements for human blood and tissue samples as well as the most relevant analytes (i.e., DNA, RNA, proteins, metabolites). The TS are developed for molecular in vitro diagnostic laboratories but give explicit reference also to biobanks and developers of diagnostics. The TS are defining all critical steps of sample pre-analytics from collecting the sample from the patient to transport, processing, storage (biobanking) and isolation of the analyte. They do not deal with issues of analytical technologies, medical diagnosis or patient treatment. TS have to be generally applicable and may not refer to specific products; therefore, TS do not refer to the same level of technical detail as Standard Operating Procedures (SOPs). Nevertheless TS define critical issues to be further specified in SOPs. The CEN TS for molecular in vitro diagnostic examinations – specifications for the pre-examination processes provide a series of useful definitions, few concrete recipes (e.g., for Standard Formalin Solution) and a long list of documentation requirements of quality relevant parameters. These TS will also gain relevance in the context of the upcoming European regulatory framework for in vitro diagnostic (EU IVD Regulation), which requests validation of several key pre-analytical parameters in the development of molecular diagnostics.
TUESSDAY MAY 17, 2016