Pillars of COMBACTE: LAB-Net
LAB-Net, the laboratory network within COMBACTE, consists of routine diagnostic laboratories and specialized research laboratories across Europe, and a central coordinating laboratory based at the University of Antwerp, Belgium. Its overarching objective is to establish, train, and maintain a high-quality geographically representative European COMBACTE laboratory network to support antibacterial drug development via various clinical trials.
In January 2013, the LAB-Net network started with less than 200 laboratories. Nowadays, the vast network counts 839 routine clinical microbiology labs, 14 research labs and 1,257 lab contacts across 41 European countries.
In addition, LAB-Net also collaborates with more than 300 laboratories and contacts outside Europe. In the past 7 years, LAB-Net has been involved in more than 20 clinical studies on different levels; including site selection and training, sample collection and management, manual preparation, supplying sites with sampling kits, selection of diagnostic tests for studies, and other central and research lab activities.
Training opportunities
As part of LAB-Net’s mission to establish, train, and maintain a high-quality European laboratory network, multiple trainings are provided to continuously educate the participating labs on current microbiological issues, techniques and operational matters for clinical studies. So far, LAB-Net has trained 1,400 staff members on sample collection, handling, storage and shipment at more than 500 site initiation visits. In addition, the team organized 4 workshops on antimicrobial resistance in the Balkan countries.
Good Clinical Practice (GCP) online training is available for LAB-Net members and face-to-face GCP trainings are organised together with CLIN-Net. These trainings allow LAB-Net to maintain a strong and sustainable collaboration for upcoming clinical trials and enhance the capacity of the region to perform the required lab work for these studies.
An informed Network
LAB-Net shares a newsletter within its network every 4 months. It includes upcoming events, recent publications and updates from within the network. LAB-Net’s updates and publications are regularly shared in the COMBACTE newsletter. A leaflet has been created in 2019 containing information about LAB-Net has been given out at conferences such as ECCMID. It highlights general information, the ambition and the benefits for members and sponsors. The leaflet was shared across relevant parties including clinicians and the industry. Since the start of COMBACTE, LAB-Net has participated in numerous congresses and meetings to share more information on LAB-Net and to connect with laboratories outside of the network.
MEASURING PERFORMANCE
To ensure that laboratories within the network provide work of the highest quality, LAB-Net has established site performance indicators. These performance indicators assess the capability of the sites to participate in clinical studies. During the study period, site performance indicators are measured. LAB-Net has also established an external quality assessment (EQA) system to monitor the performance of the laboratories.
LAB-Net has witnessed that the EQA panel has not only been useful as a performance measure, but also as an introduction to a potentially new diagnostic test and an opportunity to train sites on how to use it. To improve the quality of its activities, COMBACTE has established an evaluation scheme which involves evaluation of the performance of LAB-Net and the central lab by the sites involved in clinical trials.
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The external quality assessment system is perfect for monitoring the lab's performance, especially for the detection of carbapenem-resistant Gram-negative pathogens, a frequent target of antimicrobial drug development programmes.
Christine Lammens, Laboratory Lead at University of Antwerp, Member of LAB-Net
LAB-NET DURING COVID-19
Supported by its state-of-the-art laboratory expertise, LAB-Net has stepped up to support COVID-19 clinical trials by assessing the routine clinical laboratory practices for COVID-19. LAB-Net first sent out 306 surveys to check the level of preparedness of diagnostic laboratories for the detection of COVID-19. A new questionnaire on the same topic was put online when test capacities needed to be expand to outside reference laboratories. Results showed that 45% of the surveyed laboratories had a test in place by March 26th, far into the first wave of the pandemic in most countries. The main implementation barriers were availability of positive controls and a specificity panel.
LAB-Net is also actively involved in RECOVER. The clinical trials in RECOVER will address key knowledge gaps such as identifying best approaches to prevent further spread of the disease and the interaction pathways of the virus with its human host. LAB-Net is offering laboratory expertise related to strategies for sample collection and management.
“COMBACTE and PREPARE complement each other’s set of skills and strengthen each other’s networks. In the future, when we collaborate within ECRAID, we intend to round out the network of laboratories and clinical investigation sites with a European network of well-trained general practitioners.”
NEXT STEPS
The continuation of LAB-Net is ensured in ECRAID, where LAB-Net will provide state of the art laboratory services that offer extensive support to clinical studies. Within COMBACTE, LAB-Net has established and is maintaining a biobank that houses clinical samples and isolates from clinical studies. This biobank will be expanded within ECRAID to further establish a repository of well-defined clinical isolates and clinical samples that will be subject to in-depth investigation and characterization. This repository is also required to evaluate any developed diagnostic assay in cohorts resulting from clinical studies and for future fundamental work.
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