The Lipidomic Laboratory authorized by the Italian Health Authority (Health Authorization n. PG 263274 08/11/2012) is located in the Research Area of Bologna of the National Research Council (CNR), since it was founded by CNR Researchers and is specialized on molecular diagnostics, in particular on the lipidomic analysis of erythrocyte membranes.
This Laboratory applies a Management system, with the aim at promoting the creation and maintenance of customer trust in the activities of our Company and Laboratory as well as in the impartiality and integrity of its associated technical and overall operativity. To ensure the effectiveness of this system, the Laboratory utilizes a series of procedures and rules, including:
- Quality management system (QMS) by which the laboratory has established, documented, implemented a management system able to support and verify the regular and consistent fulfilment of the general requirements for competence, impartiality and regular and consistent operation of the laboratory, referring to the requirements of the UNI CEI EN ISO / IEC 17025 standard “General requirements for the competence of testing and calibration laboratories” guaranteeing the quality of laboratory results;
- Good Laboratory Practice or GLP, a quality system of management controls for laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products, according to the 2004/10 /EC Directive and other international standards recognized as being equivalent by the Commission or the Agency;
- System of protection of individuals in respect of the processing of personal data, as well as the free movement of such data according to EU Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016;
- Standard operating procedures (POS) on the basis of national (DPR 14 January 1997, DDG 32856/2000), regional and local laws necessary for the operation and authorization as a health facility (Health Authorization n. PG 263274 08/11/2012) and which provide for the activation of specific “Internal Quality Control” (IQ) programs for the activities carried out;
- Regulations on workplace safety, the environment, privacy and management systems (organizational models) with constant verification of the associated risks.
The Lipidomic Laboratory uses a high-performance system, the first robotic unit worldwide, that is able to perform on an EDTA-treated blood sample the operations for the isolation of the mature erythrocytes and the work up of cell membranes, including chemical transformations, needed for the quantification, by gas chromatography, of the fatty acids that form the membrane of these cells. The robotic unit, called LNG-R1, has been designed by the Lipinutragen’s founders, Researchers at the CNR, on the basis of the literature methodologies applied manually for lipidomic analysis. This system guarantees the high-throughput process of a high number of samples, with repeatability and reliability, being evidently more convenient than manual procedures.
The operation of the robotic unit in terms of the controls on calibration and repeatability is part of the MEM_LIP1 Method, accredited according to the UNI CEI EN ISO / IEC 17025: 2018 standard.