Activities
The Euroimmun Italia Laboratory is a reference for specialized diagnostics, research and training.
It supports clinicians and laboratories through second-opinion and diagnostic service activities, contributing to translational research projects and interdisciplinary collaborations.
Research
Our laboratory promotes research activities in the fields of autoimmunity, infectious diseases, neurology, endocrinology, allergology and food intolerance.
A key focus of our work is the study and validation of new biomarkers to improve the diagnosis and monitoring of both systemic and organ-specific autoimmune diseases. Our research also includes:
• Development of innovative diagnostic methods
• Promotion of diagnostic test standardisations
• Evaluation of new diagnostic algorithms
• Analysis of autoantibody profiles in non-traditional clinical settings
We believe that synergy and interdisciplinarity are the essence of scientific innovation: to this end, our laboratory collaborates with laboratory specialists, clinicians, scientific societies, universities, research institutes, pharmaceutical companies and biotech firms, to ensure constant progress and maintain a leading position in the field.
We also value the sharing of knowledge as a driver of progress. This is why we actively participate in multicentre clinical studies, workshops and working groups, thus contributing to the improvement of test interpretation guidelines and to scientific outputs at both national and international levels.
In research, our vision is based on an integrated approach combining diagnostics, translational research and technological innovation. This ensures reliable results of high scientific value, with the ultimate goal of translating the latest scientific discoveries into concrete benefits for patient care.
The laboratory can support scientific projects at every stage, offering services such as:
• Study design definition
• Drafting of scientific projects
• Execution of laboratory tests
• Statistical analyses
• Preparation of scientific posters and publications
• Review of manuscripts and articles
Publications:
• Sacchi MC, Tamiazzo S, Bonometti R, Stobbione P, Agatea L, De Gaspari P, Lauritano EC, Maconi A, Ciriello MM. COVID-19 and Autoimmunity: A Single Center Prospective Follow-up Study. Archives of Clinical and Biomedical Research. 2021
• Sacchi MC, Tamiazzo S, Stobbione P, Agatea L, De Gaspari P, Stecca A, Lauritano EC, Roveta A, Tozzoli R, Guaschino R, Bonometti R. SARS-CoV-2 infection as a trigger of autoimmune response. Clin Transl Sci. 2021
• M.C. Sacchi, S. Tamiazzo, M.Bertolotti, D. Ielo, P. Stobbione, L. Agatea, P. De Gaspari, C. Pelazza, M. Grappiol1, T. Bolgeo, P. Novel, M.M. Ciriello, A. Maconi. The onset of de novo autoantibodies in healthcare professionals after mRNA based anti-SARS-CoV-2 vaccines: a single center prospective follow-up study. Autoimmunity. 2023
• Mariotto S, De Gaspari P, Jäger D, Hahn S, Forni C, Saschenbrecker S, Lattwein E, Dinoto A, Ferrari S. A novel cell-based immunofluorescence assay for the detection of autoantibodies to myelin-associated glycoprotein. Front Neurol. 2023 Dec 14;14:1289810. doi: 10.3389/fneur.2023.1289810. PMID: 38169815; PMCID: PMC10758835.
• Carraro A, De Gaspari P, Antoniello B, Marzenta D, Vianello E, Bussolati B, Tritta S, Collino F, Bertoldi L, Benvenuto G, Vedovelli L, Benetti E, Negrisolo S. New Insights into Pediatric Kidney Transplant Rejection Biomarkers: Tissue, Plasma and Urine MicroRNAs Compared to Protocol Biopsy Histology. Int J Mol Sci. 2024 Feb 5;25(3):1911. doi: 10.3390/ijms25031911. PMID: 38339187; PMCID: PMC10856071.
• Antoniello B, Negrisolo S, Marzenta D, Vadori M, De Gaspari P, Cozzi E, Benetti E. Non-HLA Autoantibodies Against Angiotensin II Receptor 1 (AT1R) and Endothelin A Receptor (ETAR) in Pediatric Kidney Transplantation. Int J Mol Sci. 2024 Nov 3;25(21):11817. doi: 10.3390/ijms252111817. PMID: 39519368; PMCID: PMC11545982.
Trial
Clinical studies are crucial scientific research projects aimed at evaluating the effectiveness and safety of new drugs, medical devices, treatments or diagnostic procedures. They are conducted according to rigorous protocols and under the supervision of ethics committees and regulatory authorities, involving either patients or healthy volunteers, and progressing through several phases — from initial trials to large-scale validation.
In this context, Laboratorio Euroimmun Italia plays a key role, providing objective and measurable data to monitor clinical parameters.
We work closely with healthcare facilities, clinical centres, sponsors and reference centres for cancer care, ensuring results that are reliable, reproducible and timely.
Our activities include:
• receiving, identifying, and ensuring full traceability of biological samples collected during studies;
• performing diagnostic and analytical tests according to specific study requirements;
• conducting internal quality controls to guarantee precision and accuracy;
• standardized reporting and delivery of results in formats compliant with study specifications;
• secure management of analytical data and biological materials, in full compliance with privacy regulations.
Our staff is specifically trained to work in a medical laboratory environment and operates in accordance with ISO 15189 requirements. Each test is performed in controlled environments, using appropriate instruments and computerised systems to guarantee process integrity.
Through our technical expertise and commitment, we contribute responsibly to the production of the scientific evidence that is essential for advancing medicine and protecting public health.
Validation
Our ISO 15189 certified laboratory offers validation services for diagnostic kits and methods, ensuring high quality standards, in compliance with international regulations.
Validation is a crucial step to guarantee that a test is actually suitable for clinical use. The process includes:
• Verification of analytical performance (sensitivity, specificity, precision, accuracy, linearity, detection limits)
• Comparison of results with reference data or reference tests
• Repeatability and reproducibility testing on multiple samples and over several working days
• Evaluation of potential interferences or cross-reactivity
• Verification of kit stability and storage conditions under laboratory settings
All the data collected are documented in detailed reports, prepared in accordance with regulatory requirements and good laboratory practice guidelines.
Completed activities
• ELISA test validation (endocrinology parameters) for Diagnostics Biochem Canada (DBC)
• Validation of Hep-2, ANCA and Hep2010/liver tests on UNIQO160 for Euroimmun AG
• Consultancy for laboratory certification (neurology parameters) for Euroimmun Brazil
• Consultancy for laboratory certification (neurology parameters) for Euroimmun Japan
• ELISA test validation for Diametra
What we offer
• Development of validation protocols
• Validation of third-party kits
• Validation of diagnostic methods
• Consultancy in diagnostic validation
Activities carried out
• Validation of ELISA tests (for endocrinology parameters) for Diagnostics Biochem Canada (DBC)
• Validation of Hep-2, ANCA, and Hep2010/liver tests on UNIQO160 for Euroimmun AG
• Consultancy for laboratory certification (neurological parameters) for Euroimmun Brazil
• Consultancy for laboratory certification (neurological parameters) for Euroimmun Japan
• Validation of ELISA tests for Diametra
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