The Belgian NRC in a Belgian context
First, the activities of the NRCs are of interest for the individual patient by improving the patient therapy choice, the confirmation of a screening diagnosis, or the typing of the germ allowing a specific therapy. Although difficult to measure financially, a precise and quick diagnosis makes it possible to avoid or reduce inappropriate or expensive treatments, and to reduce the period of incapacity. Similarly, the detection of (specific) resistance to antimicrobials makes it possible to use effective antibiotics, antifungals or antivirals in disease treatment or prevention. The NRCs use state-of-the-art validated laboratory methods and are able to deliver accurate confirmation of diagnostic results within described timeframes.
On the other hand, the implementation of the NRC will also have an impact on the public health for numerous reasons.
First, they will alert the medical authorities in time in the event of abnormal phenomena, such as the appearance of emerging or rare diseases, the early detection of outbreaks or epidemics, the abnormal increase in the incidence or the virulence of specific pathogens and identifying the sources of infection and the increased risk.
Second, they will assist the medical authorities by bringing a specific expertise in these pathogenic agents and by providing information allowing the adaptation of preventive (e.g. vaccine calendar) and curative (e.g. diagnosis, use of antibiotics) measures.
Third, they will take part in the monitoring of the infectious diseases at the national level by the follow-up of their evolution and characteristics (resistance to antimicrobials, biotyping, genotyping, virulence), as well as by detecting and analysing nosocomial infections.
Finally, they will take part in the international monitoring alert systems of WHO and ECDC in close cooperation with the WIV-ISP.
Furthermore, the implementation of a centrally coordinated network through the national WIV-ISP has an added value for several reasons. Firstly, it allows a central data collection and ensures the data flow and communication to different authorities and public agencies at different levels (European, national and regional).
The installation of one NRC per pathogen rather than multiple reference laboratories operating at different locations for keeping the balance between linguistic, political or governmental versus academic or private, improves the effectiveness of the NRC activities by the geographic coverage of its service. Since the disease surveillance not only includes the collection of data but also compilation, consolidation and analysis of data and inference, the implementation of national coordinated centers are an added value by bringing all expertise together. This expertise in specific pathogens will be shared with the relevant stakeholders. This can include technical advice on methods and procedures, and scientific support for and advice on the interpretation and the relevance of laboratory findings to relevant public health authorities or routine laboratories.
In case a BSL3 facility is necessary for the diagnosis of the particular pathogen, the centralization of the NRC activities makes the funding of the BSL3 facilities more viable.
Also, with the nomination of one NRC per pathogen, the pubic health authorities gave the laboratory a national spokesman role which reinforces their scientific recognition. They will promote the EU harmonization and standardization of key reference testing methods and the timely reporting of epidemiologic data. They will collaborate and interact with research programs on pathogenicity, drug resistance, epidemiologic determinants of human pathogens, presence of vector-borne pathogens in animals or molecular surveillance programs. They are at the forefront of technological and scientific development in their field of expertise particularly in areas relevant to public health action.
Similarly, the reference center plays a key role in the collection of relevant reference materials. These can include international reference strains and a representative strain collection of the Belgian circulating strains as well as sera and genetic materials to evaluate new assays. This collection of relevant reference material is to be shared with laboratories and organizations that require such materials for the varied purposes of quality assurance systems, method evaluation and validation.
The Belgian NRC in a European context
As in other EU reference laboratories, the Belgian NRCs are not limited to a subtask for clinical laboratories or a support function to the public health in general but rather perform a front line work in terms of monitoring, alerting, responding to crisis situations and supplying scientific advice.
Defining the roles and responsibilities of the Belgian NRCs in line with those in other EU countries will help to create a more stable and sustainable laboratory function across Europe [4
]. The NRCs will therefore participate in EU working groups to obtain agreements on collaborations for cross-section and cross-border activities and to formulate the appropriate responses to rare or emerging diseases. Sharing expertise, additional technical and scientific advice, support and training in methodology with other member states will reinforce the local capability [11
]. The NRCs could also help in establishing protocols, model agreements and standard operating procedures (SOP’s) at the EU level. The participation in a network of laboratories, able to help in surge situations, will be stimulated.
Furthermore, a harmonization for typing methods to achieve comparable results will be recommended to the NRCs. These allow the identification of cross-border outbreaks and zoonotic transmission. They will also allow to report accurate and comparable microbiology data to international surveillance systems in compliance with case definitions and surveillance protocols.
By requiring an ISO15189 accreditation from the NRCs, they will be conform to internationally agreed quality standards. This will be particularly useful in case of involvement in cross-border network activities.
Implementation of a new reporting system
An efficient and effective manner to communicate the aggregated information back to the data providers (NRCs and clinical laboratories) will be put in place by the WIV-ISP.
The WIV-ISP developed a web-based database allowing the NRC to report and consult the individual data from the patients, the samples and the results.
The variables to report to this database are based on the requirements of international organizations [12
] (e.g. ECDC, WHO) and national and regional health authorities [13
]. In function of the epidemiologic requirements, the timing of reporting can range from real-time to yearly.
These data will be used for automated and regular (weekly, monthly, yearly) reporting and, in case of an epidemic or outbreak, also for automated alerting based on defined threshold levels [14
Determination of the selection criteria for samples
Minimum testing requirements for informative laboratory-based surveillance will be further elaborated. Evidence-based technical guidance on appropriate sampling and microbiological testing for diagnosis of infection and further characterization of human pathogens of public health relevance will be provided.
Defining selection criteria for samples by the NRC and verifying whether the sample fulfills the criteria are crucial steps in avoiding redundant analyses. These selection criteria, the request forms, the transportation conditions and the turnaround time for analysis are available for all routine laboratories through the website of the NRC [15
As the available resources are limited, the volume of activity is the main item that needs to be controlled. For surveillance, the minimum investigation necessary to obtain representative results should be the starting point. Therefore, the NRC needs to estimate the minimal fraction of the received samples necessary to obtain a representative result for the population at risk.
Preparedness for emerging diseases
Preparedness for emerging diseases is a prerequisite to handle future threats caused by emerging pathogens and epidemic diseases. Therefore, a risk mitigation of a possible emerging disease should be performed by the simulation of incidents (i.e. increasing incidence, new pathogens and new strains) with a significant public health threat. An extra budget was made available for emerging diseases. The NRC should be prepared in case an emerging disease occurs in terms of the infrastructure, strain identification and typing, cross-sector work, specialist capabilities, and the choice of response (international, national, regional).