National reference center

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As a National Reference Center (NRC) are in Germany since 1995 institutions in the field of infectious diseases , virology and microbiology appointed to special tasks for public health in areas such as diagnosis of pathogens , advising the public health service and perceive the advice of doctors. For pathogens that, according to certain criteria, represent a lower priority for the health service in Germany with regard to special diagnostics, resistance or a lower epidemiological risk, institutions become consultant laboratories in addition to the NRZs(KL) appointed. There are currently 19 national reference centers and 42 consultant laboratories. (see also Konsil )

As reference laboratories , however, several very different laboratory diagnostic facilities are called, meet for professional societies, government agencies or commercial associations related duties, standardization of laboratory methods or manufacturing controls. For similar tasks as the National Reference Centers in the field of veterinary pathogen diagnostics and monitoring are National Reference Laboratories appointed.

Tasks of the reference centers

The required tasks, which a reference center or a consulting laboratory should fulfill, differ in detail depending on the specialist area and the pathogen spectrum to be covered. The adaptations in the detailed tender catalogs often have different focuses or additional special requirements. Nevertheless, there are common general requirements that are adapted to the respective question. These are:

  • Development and improvement of diagnostic procedures
  • Special diagnostics that go beyond routine diagnostics and the possibility of fine-tuning pathogens
  • The clarification of epidemiological relationships, for example in the event of an outbreak , e.g. B. with molecular biological examination methods
  • Keeping a strain collection , d. H. the pathogens isolated from clinical samples are multiplied if necessary and stored for comparative tests
  • Participation in or development of appropriate diagnostic networks (mainly the so-called "NRZ networks" composed of several thematically overlapping NRZs and KLs)
  • Consultancy for the public health service, laboratories, resident doctors , hospitals and research institutes
  • Implementation of further training and public relations
  • Cooperation with reference laboratories in other countries and the World Health Organization (WHO)
  • If necessary, statements on the epidemiological situation, cooperation in surveillance projects , detection of outbreaks or outbreak risks and notification to the Robert Koch Institute , support of the health service and the RKI in outbreak investigations
  • Studies on the development of resistance and virulence in pathogens
  • Advising the Robert Koch Institute and contributing to the development of recommendations for the Robert Koch Institute for diagnostics, therapy, epidemiology, disease definitions and disease prevention
  • Participation in specialist committees and commissions as well as in commissions for the preparation of medical guidelines
  • Standardization and dissemination of generally applicable test procedures or biological standard preparations
  • Tasks of laboratory diagnostic quality assurance, for example by participating in the organization and implementation of round robin tests with WHO, EU or INSTAND

Since 2009, the RKI has tried to merge various NRZs with their associated KLs to form "reference networks". Joint synergies should be used in carrying out thematically similar epidemiological studies and exchanges between them should be promoted. The network affiliation is determined by the RKI. The network meetings are mainly financed from the budgets of the NRZs and KLs. The financial support of individual network projects is assessed and evaluated by the RKI. Due to the lack of funding for the network projects overall, only a few network projects could be carried out; for the most part, the funding of network projects in which NRZs and KLs were involved that are based at the RKI itself succeeded.

Selection process and evaluation

The appointments to NRZs and KLs are public and a. advertised in the epidemiological bulletin . The application process is managed by the Scientific Advisory Board for Public Health Microbiology (formerly known as the "Commission for Infection Epidemiology") and, after being assessed by them, with the involvement of international experts, a recommendation is made to the Federal Ministry of Health . In the case of the reference centers, it decides on the appointment as NRZ on the basis of the recommendations and pronounces this appointment through the President of the RKI. In the case of the consulting laboratories, an appointment is made by the President of the RKI after consultation with the Federal Ministry. The appointment is limited in time, usually for three years. Thereafter, a renewed evaluation is carried out by the advisory board with the help of external international experts for an extension of the appointment period.

The decision on the composition of the NRZs and KLs with regard to the issues to be covered is made by the Scientific Advisory Board, the RKI and the Federal Ministry, which ultimately has budgetary authority over the NRZs and KLs. The basis for the decision as to whether a pathogen or a disease is not represented, or whether it is represented by a reference center or a consulting laboratory, was in part attempted to objectify with epidemiological scores with regard to the pathogen prioritization. Among other things, due to the reassessment of the national risk situation or the changed significance of pathogens, subject areas are re-tendered or tasks are split up and merged.

Current reference centers

NRZ for bacterial pathogens

NRZ for viral pathogens

NRZ for other questions

Current consulting laboratories

There are currently 42 consulting laboratories for selected pathogens and clinical syndromes . They complement the network of reference centers with regard to diagnostics and advice. For the following diseases, pathogens or groups of pathogens or special diagnostic procedures, consultant laboratories are currently appointed:

Switzerland

In Switzerland, the FOPH defines various laboratories as national reference centers. Their job is to ensure epidemiological surveillance of selected communicable diseases and to detect outbreaks. In addition, the cantons operate a network of regional laboratories to enable analyzes of rare or dangerous pathogens.

National Reference Centers of Notifiable Communicable Diseases 2019
Surname institution Reference diagnostics for
National Center for Enteropathogenic Bacteria and Listeria (NENT) University of Zurich

Institute for Food Safety and Hygiene

Salmonella , Shigella , Campylobacter , enterovirulent Escherichia coli ( STEC / EHEC , EPEC, ETEC , EIEC , EAEC), Yersinia spp., Vibrio cholerae , Listeria
National Reference Center for Anthrax (NANT) Laboratory Spiez Bacillus anthracis , Francisella tularensis , Yersinia pestis , Brucella melitensis , Brucella abortus , Brucella suis
National Reference Laboratory for the Early Detection of New Antibiotic Resistance and Resistance Mechanisms (NARA) University of Friborg Molecular and genetic analyzes of resistant bacterial strains (especially confirmatory diagnostics)

Genetic comparison of bacterial strains showing novel resistance characteristics

National Center for Retroviruses (NZR) University of Zurich

Institute for Medical Virology

HIV
National Center for Influenza (NZI) Hôpitaux Universitaires de Genève (HUG) Seasonal influenza , new subtype influenza A (HxNy)
National Reference Center for Measles and Rubella (NRMR) Hôpitaux Universitaires de Genève (HUG) Measles , rubella
National Center for Mycobacteria (NZM) University of Zurich

Institute for Medical Microbiology

Mycobacterium tuberculosis
National Meningococcal Center (CNRM) Hôpitaux Universitaires de Genève (HUG) Neisseria meningitidis
National Reference Center for Legionella (NRZL) Duck Ospedaliero Cantonale Legionella
National Center for Human Prion Diseases (NRPE / NHUP) University Hospital Zurich

Institute for Neuropathology

Prions
National Reference Laboratory for Poliomyelitis (NZPo) University Hospital Basel poliomyelitis
National Center for Imported Parasitoses (NZIP) Swiss Tropical and Public Health Institute (Swiss TPH) malaria
National Center for Invasive Pneumococci (NZPn) University of Bern

Institute for Infectious Diseases (ifik)

Pneumococci
National Center for Emerging Viral Diseases (NAVI) Hôpitaux Universitaires de Genève (HUG) Ebola , Crimean Congo , Lassa , Marburg , Smallpox / Variola , Chikungunya , Dengue , Yellow Fever , Hanta , MERS , Rift Valley Fever , SARS , West Nile Fever , Zika , COVID-19
Swiss Rabies Center (National Reference and Research Laboratory for Rabies) Swiss rabies headquarters Rabies / rabies
National Reference Center for Tick-borne Diseases (NRZK) Laboratory Spiez Lyme borreliosis , early summer meningoencephalitis (TBE) , Q fever

criticism

The medical societies involved, such as the GfV and DGHM , noted that the increasing settlement of reference centers and consulting laboratories with a single federal authority (the RKI) is increasingly contrary to the original intention of the reference centers, namely that external expertise outside the RKI should be consulted and not the RKI advises itself about its own NRZs and KLs. This concentration is all the more worrying, as members of the RKI themselves participated in the decision on the appointment and the evaluation.

The decisions, evaluations and also the very different allocation of funds to the NRZs and KLs are not publicly transparent. The financial resources of university NRZs and KLs to fulfill their tasks are very limited and resources of the respective universities or third-party funded projects are often used . In order to carry out laboratory tests, the NRZs and KLs rely on billing the sender for these.

proof

Individual evidence

  1. ↑ RKI: Catalog of tasks for national reference centers (as of March 2014)
  2. ↑ Task catalog for consulting laboratories (as of March 2014)
  3. ↑ G. Laude, M. Kist, G. Krause: Reference networks from national reference centers with associated consulting laboratories in Germany . Bundesgesundheitsblatt (2012) 55; 2, pp. 223-230 doi : 10.1007 / s00103-011-1417-8 pdf
  4. ↑ Scientific Advisory Board for Public Health Microbiology , RKI as of September 2013.
  5. ↑ Evaluation of the National Reference Centers (NRZ) in 2013 (pdf) In: Epidem. Bulletin. No. 47 (2013) of November 25, 2013.
  6. ^ A. Gilsdorf, G. Krause: Prioritization of infectious diseases in public health: feedback on the prioritization methodology, 15 July 2008 to 15 January 2009 . In: Euro Surveillance. (2011) 16; 18: pii: 19861. pdf
  7. ↑ Federal Office of Public Health FOPH: Laboratory diagnostics for infectious diseases. Retrieved January 25, 2020 .
  8. ^ Federal Office of Public Health FOPH: Regional laboratory network. Retrieved January 25, 2020 .
  9. ↑ Federal Office of Public Health: National Reference Centers for Notifiable Communicable Diseases 2019 . 2019th edition. September 9, 2019.
  10. ↑ Federal Office of Public Health FOPH: Outbreak of a new coronavirus in China. Retrieved January 25, 2020 .
  11. ↑ Financial support for National Reference Centers (NRZ) and Consiliarlaboratorien (KL) RKI, December 15, 2011.