LAB-Net as central laboratory and biobank for POS-Disease X
LAB-Net will serve as a central laboratory and biobank for ECRAID-Base’s Perpetual Observational Study (POS) Disease-X. The coordinating lab is located at the Laboratory of Medical Microbiology (LMM) in the University of Antwerp.
POS-Disease X is led by the Erasmus Medical Centre and aims to evaluate the use of a generic protocol for enrolling immunocompromised patients in an observational study for any unexplained febrile illness with unusual clinical presentation and/or epidemiology and of likely viral aetiology. Site selection for this multicenter platform trial that will be conducted in several EU countries started in January 2023.
LAB-Net will support the operational team throughout the entire site selection process. A feasibility questionnaire to assess the eligibility of the local laboratories to participate in this study will be distributed in early February 2023. Once selected, laboratories will receive a ‘Sample Collection and Management Manual’ containing detailed instructions for site sample collection and specimen management. LAB-Net will be responsible for providing sites with materials to collect, process and store samples. During the study, blood samples for serum and EDTA plasma, throat swabs, as well as urine and stool samples will be collected. If available, remaining materials from the routine samples will also be collected. Samples will be shipped periodically to LMM for further processing, redistribution to other laboratories for analyses, and long-term storage. For more information, please contact the LAB-Net team at LAB-Net@uantwerpen.be.
ECRAID-Base and POS-Disease-X
Emerging infectious diseases (EID) pose a significant threat to global public health and economies, as demonstrated by the recent severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) pandemic. The EU-funded ECRAID-Base project, part of Ecraid, aims to establish a European, multidisciplinary clinical research network for EID that is globally linked, sustainable and has a single-access. The network serves as a platform for European clinical research preparedness and response to EID threats. At the heart of ECRAID-Base are five Perpetual Observational Studies (POS). LAB-Net is involved in all these studies and continuously offers its expertise and support.
The patient population of POS-Disease-X includes immunocompromised patients presenting with a suspected infectious illness of unexplained etiology upon initial clinical evaluation. Patients who are immunocompromised due to treatment of malignant diseases and hematopoietic stem cell transplant recipients will not be included in this study. In case of an emerging disease outbreak, inclusion criteria may eventually be extended to include any adult patient with suspected or confirmed infection with an emerging viral pathogen.
The long-term objective of POS-Disease-X is to set up a European network for clinical research and diagnostic trials for emerging infections. Furthermore, novel diagnostic strategies (i.e. metagenomics) will be tested in this study, to increase the diagnostic yield and promote the discovery of new viruses.