National reference center
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
- National reference center for Borrelia : Bavarian State Office for Health and Food Safety , Oberschleißheim
- National reference center for Clostridium difficile : Institute Hygiene, Saarland University Medical Center , Homburg
- National reference center for gram-negative hospital pathogens : Department of Medical Microbiology at the Ruhr University Bochum
- National Reference Center for Helicobacter pylori : Max von Pettenkofer Institute , Ludwig Maximilians University Munich
- National Reference Center for Meningococci and Haemophilus influenzae : Institute for Hygiene and Microbiology, University of Würzburg
- National reference center for mycobacteria : Research Center Borstel , Sülfeld
- National reference center for salmonella and other bacterial enteritis pathogens : At the Robert Koch Institute, area (area Wernigerode )
- National reference center for staphylococci and enterococci : At the Robert Koch Institute, area (area Wernigerode )
- National Reference Center for Streptococci : Institute for Medical Microbiology, University Hospital Aachen
NRZ for viral pathogens
- National Reference Center for Hepatitis B and D Viruses : Institute for Medical Virology Giessen , Justus Liebig University Giessen
- National Reference Center for Hepatitis C Viruses : Institute for Virology, Essen University Hospital
- National Reference Center for Influenza : FG 17 of the Robert Koch Institute , Berlin
- National reference center for measles , mumps , rubella : At the Robert Koch Institute, Berlin
- National reference center for papilloma and polyomaviruses : Institute for Virology, University Hospital Cologne
- National Reference Center for Poliomyelitis and Enteroviruses : At the Robert Koch Institute, Berlin
- National reference center for retroviruses : Max von Pettenkofer Institute , Ludwig Maximilians University Munich
NRZ for other questions
- National Reference Center for Invasive Fungal Infections : Leibniz Institute for Natural Product Research and Infection Biology , Jena
- National reference center for tropical infectious agents : Bernhard Nocht Institute for Tropical Medicine , Hamburg
- National reference center for surveillance of nosocomial infections : Institute for Hygiene and Environmental Medicine, Charité - Universitätsmedizin Berlin
- National Reference Center for Surveillance of Transmissible Spongiform Encephalopathies : Neurological Clinic, University Hospital Göttingen
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:
- Konsiliarlabore for selected bacteria: Anaerobic bacteria , Bacillus anthracis , Bartonella , Bordetella pertussis , Brucella , Chlamydia , Clostridium difficile , botulinum Clostridium , Coxiella burnetii , diphtheria , Ehrlichia , gonococci , hemolytic uremic syndrome (HUS), Haemophilus influenzae , Klebsiella , Legionella , Leptospirosis , listeria , cystic fibrosis bacteriology, mycoplasma , treponema (separated by diagnosis and therapy as well as pathogen differentiation), tularemia , Tropheryma whipplei , Yersinia pestis
- Consultation laboratories for selected parasites and fungi: Aspergillus , cryptococcosis , Scedosporiosis and imported systemic mycoses , dermatophytes , echinococci , toxoplasma
- Consultation laboratories for selected viruses: adenoviruses , coronaviruses , human cytomegalovirus , Epstein-Barr virus and human herpes viruses 6 , 7 and 8 , filoviruses , early summer meningoencephalitis , hantaviruses , hepatitis A virus and hepatitis E virus , herpes simplex Viruses and varicella zoster virus , noroviruses , parvoviruses , smallpox viruses , rotaviruses , respiratory syncytial viruses, parainfluenza viruses and metapneumoviruses , rabies , electron microscopic diagnosis of pathogens
- Consultation laboratories for selected syndromes: congenital viral infections , gastrointestinal infections (bacterial), CNS infections (viral). These three appointments expired on December 31, 2013.
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.
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
- National reference centers and consultant laboratories (appointment period 2017–2019) (pdf)
- National reference centers and consultant laboratories (appointment period 2014–2016) (pdf)
- National reference centers and consultant laboratories (appointment period 2005–2007) (pdf)
- National reference centers and consulting laboratories (appointment period 2002–2004) pdf In: Epidem. Bulletin. December 19, 2002
- G. Laude, A. Ammon: The national reference centers and consulting laboratories - meaning and tasks . Federal Health Gazette (2005) 48; 9: pp. 998-1004. doi : 10.1007 / s00103-005-1114-6
- National Reference Centers for Notifiable Communicable Diseases 2019 (pdf)
Individual evidence
- ↑ RKI: Catalog of tasks for national reference centers (as of March 2014)
- ↑ Task catalog for consulting laboratories (as of March 2014)
- ↑ 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
- ↑ Scientific Advisory Board for Public Health Microbiology , RKI as of September 2013.
- ↑ Evaluation of the National Reference Centers (NRZ) in 2013 (pdf) In: Epidem. Bulletin. No. 47 (2013) of November 25, 2013.
- ^ 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
- ↑ Federal Office of Public Health FOPH: Laboratory diagnostics for infectious diseases. Retrieved January 25, 2020 .
- ^ Federal Office of Public Health FOPH: Regional laboratory network. Retrieved January 25, 2020 .
- ↑ Federal Office of Public Health: National Reference Centers for Notifiable Communicable Diseases 2019 . 2019th edition. September 9, 2019.
- ↑ Federal Office of Public Health FOPH: Outbreak of a new coronavirus in China. Retrieved January 25, 2020 .
- ↑ Financial support for National Reference Centers (NRZ) and Consiliarlaboratorien (KL) RKI, December 15, 2011.