ISO / IEC 17025 ACCREDITATION

Lipinutragen and advances in the biotech field

Lipinutragen, born in 2005 as a spin-off of the CNR of Bologna and leader for more than 15 years in the field of lipidomics, has developed since its inception the paradigm of the cell membrane of the mature red blood cell as the main marker of individual nutritional and metabolic status.

Lipidomics is a discipline that gathers the study of all lipids and which, focusing on the isolation and analysis of the fatty acids of the cell membrane, has acquired an added value as an evaluation of the basic molecular balance, an essential premise for maintaining the state of well-being.

Experimental and scientific methodology has always been Lipinutragen’s distinctive innovation. With the Lipidomics Laboratory, our Team has developed a very precise analytical process, then perform an automated procedure thanks to a dedicated robotics, LNG-R1, unique in the world. LNG-R1, conceived in 2012, represents the technological innovation in the field of lipidomics: starting from the whole blood sample in EDTA it reaches the separation of the mature red blood cell and its membrane, thus allowing to know the saturated, monounsaturated and polyunsaturated fatty acids with reliability and repeatability.

The achievement of this important goal has stimulated the continuous growth of the company and the development of activities with a solid scientific basis. Strengthened by this experience, and with the desire to show the scientific rigor and the study of the MEM_LIP1 method, “Test method for the analysis of fatty acids of the erythrocyte membrane”, we have embarked on the accreditation process, in accordance with the UNI CEI EN ISO / IEC 17025 standard “General requirements for the competence of testing and calibration laboratories”.

What the accreditation involve?

Accreditation is the official recognition of the competence, independence and impartiality of the laboratory in compliance with specific technical and management system requirements, necessary to offer technically valid results. These requirements are verified and certified by the Single Accreditation Institution, ACCREDIA, designated by the Italian government in application of the European Regulation 765/2008.

ACCREDIA certifies the Lipinutragen method

In May 2020, the ACCREDIA National Single institution issued the certification of laboratory technical competence in Lipinutragen for performing the lipidomic analysis of the mature erythrocyte cell membrane recognizing, with the number 1836 L, conformity with UNI CEI EN ISO / IEC 17025: 2018. The standard defines the requirements that a laboratory must reach to demonstrate the technical competence and independence of its staff and the availability of all technical resources, such as to guarantee data and results that are accurate and reliable for the specific analyzes or tests performed by the laboratory.

Differences between ISO 9001 and ISO / IEC 17025

Process management according to the ISO 9001 and ISO / IEC 17025 quality standards, both safety and reliability indices of the laboratory carrying out the “trial”, is rather common in the testing laboratories. It is therefore necessary to explain the difference between the two rules.

Certification according to ISO 9001, a standard for continuous quality management and improvement, does not constitute evidence that the laboratory is able to provide accurate and reliable tests. To be so, the laboratory must be accredited in accordance with ISO / IEC 17025, which contains more specific requirements for technical competence and impartiality, while also providing requirements for the management of the quality system. The test laboratories accredited by an accreditation institution such as ACCREDIA, signatory of the EA MLA and ILAC MRA * international mutual recognition agreements, guarantee competence in carrying out tests in compliance with international standards and, at the same time, compliance with the principles of ISO 9001.

OUR VISION AFTER ACCREDITATION

The membrane lipidomic analysis is performed with the accredited protocol called MEM_LIP_1, the first in the world to have been accredited STARTING FROM THE WHOLE BLOOD SAMPLE IN EDTA by selecting the mature red blood cells to isolate the membrane and quantify its composition in terms of fatty acids.

Obtaining this recognition reinforces our constant commitment, with the aim of:

– insert the membrane lipidomic analysis in the reference molecular analysis panel both in primary and secondary prevention, to be spread more and more in public and private structures;

– interest Professional and professional Orders towards membrane lipidomic analysis, as a useful tool for clinical and nutritional practice.

*European co-operation for Accreditation (EA) Multilateral Agreement (MLA); International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangements (MRA)

The commitment of the entire Lipinutragen group was rewarded with the acquisition of accreditation. As Scientific Director, I would like to emphasize that accreditation represents our “rod” always pointed upwards, to guarantee the reliability of the lipidomic membrane analysis in respect of patients and the activity of professionals who make use of these molecular results.

Dr. Carla Ferreri, Senior Researcher National Research Council and Scientific Director of Lipinutragen