Presentation of the centre
The Centre of Metrological Traceability in Laboratory Medicine (CIRME) of the UNIMI was created in 2006 with the scope to join in a unique entity teachers and investigators of various UNIMI Departments interested in the development of higher order metrological calibration materials and reference methods in the field of the Laboratory Medicine. The lack of comparability of analytical results, especially when they originate from different laboratories using different methods, may cloud interpretations of reported data, creating a substantive problem for both clinicians and laboratory communities. Suitable reference materials and reference measurement procedures are used to assign traceable values to calibrator and control materials, allowing the implementation of standardization of laboratory measurements, assuring interchangeability of results over time and space, significantly contributing to improvements in healthcare since results of clinical studies undertaken in different locations or times could be universally applied.
In compliance with the UNIMI regulations, the CIRME can:
1. participate in annual comparison interlaboratory exercises organized by IFCC for the reference laboratories (IFCC Ring Trials for Reference Laboratories), coordinated by the IFCC Committee on Traceability in Laboratory Medicine in collaboration with the Working Group 2 of the Joint Committee for Traceability in Laboratory Medicine (JCTLM);
2. develop new reference methods and characterize new reference materials for clinically significant blood analytes, with particular reference to human haemoglobins (HbA1c, haemoglobin A2), enzymes (alkaline phosphatase) and the most important cardiac biomarkers (eg cardiac troponin I, natriuretic peptides);
3. establish collaborations with companies of the diagnostic and pharmaceutical industry or with public and private agencies and scientific groups interested in the research activities of the Centre. In addition:
4. organize courses, seminars and contribute to promote teaching of the third level on issues concerning Traceability and Standardization in Laboratory Medicine, Clinical Biochemistry and Clinical Molecular Biology, Clinical Pathology, Technical Sciences in Laboratory Medicine and their applications;
5. organize conferences about metrological traceability issues, development of reference materials and reference methods, certification standards;
6. collaborate in research with public or private organisations on the basis of specific contracts or agreements;
7. institute awards or scholarships for the achievement of its objectives;
8. accommodate foreign researchers, as part of joint research projects, with the possibility of trade;
9. make publication of articles, texts and manuals concerning the metrological traceability in biomedical diagnostics;
10. work to achieve accreditation, according to the standards cited above, for the following method of interest: − serum creatinine;
11. work to maintain the accreditation, according to the standard of ISO/IEC 17025 and ISO 15195, for: − glicated haemoglobin (HbA1c), with HPLC-CE method, − serum enzymes, in particular alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase (CK), gamma – glutamyltransferase (GGT) and lactate dehydrogenase (LDH), alkaline phosphatase (ALP), − serum glucose.